Dermatology News

The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.

When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.

“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.

The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.

“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”

At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.

In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.

To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.

Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.

“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”

[email protected]

The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.

When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.

“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.

The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.

“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”

At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.

In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.

To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.

Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.

“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”

[email protected]

The U.S. Food and Drug Administration is tightening requirements for companies that develop COVID-19 antibody tests in an effort to combat fraud and better regulate the frenzy of tests coming to market.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The updated policy, announced May 4, requires commercial antibody test developers to apply for Emergency Use Authorization (EUA) from the FDA under a tight time frame and also provides specific performance threshold recommendations for test specificity and sensitivity. The revised requirements follow a March 16 policy that allowed developers to validate their own tests and bring them to market without an agency review. More than 100 coronavirus antibody tests have since entered the market, fueling a congressional investigation into the accuracy of tests.

When the March policy was issued, FDA Commissioner Stephen M. Hahn, MD, said it was critical for the FDA to provide regulatory flexibility for serology test developers, given the nature of the COVID-19 public health emergency and an understanding that the tests were not meant to be used as the sole basis for COVID-19 diagnosis.

“As FDA has authorized more antibody tests and validation data has become available, including through the capability at [the National Cancer Institute] the careful balancing of risks and benefits has shifted to the approach we have outlined today and our policy update,” Dr. Hahn said during a May 4 press conference.

The new approach requires all commercial manufacturers to submit EUA requests with their validation data within 10 business days from the date they notified the FDA of their validation testing or from the date of the May 4 policy, whichever is later. Additionally, the FDA has provided specific performance threshold recommendations for specificity and sensitivity for all serology test developers.

In a statement released May 4, FDA leaders acknowledged the widespread fraud that is occurring in connection to antibody tests entering the market.

“We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” wrote Anand Shah, MD, FDA deputy commissioner for medical and scientific affairs in a joint statement with Jeff E. Shuren, MD, director for the FDA’s Center for Devices and Radiological Health. “Some test developers have falsely claimed their serological tests are FDA approved or authorized. Others have falsely claimed that their tests can diagnose COVID-19 or that they are for at-home testing, which would fall outside of the policies outlined in our March 16 guidance, as well as the updated guidance.”

At the same time, FDA officials said they are aware of a “concerning number” of commercial serology tests that are being inappropriately marketed, including for diagnostic use, or that are performing poorly based on an independent evaluation by the National Institutes of Health, according to the May 4 statement.

In addition to tightening its requirements for test developers, the FDA also is introducing a more streamlined process to support EUA submissions and review. Two voluntary EUA templates for antibody tests are now available – one for commercial manufacturers and one for Clinical Laboratory Improvement Amendments-certified high-complexity labs seeking FDA authorization. The templates will facilitate the preparation and submission of EUA requests and can be used by any interested developer, according to the FDA.

To date, 12 antibody tests have been authorized under an individual EUA, and more than 200 antibody tests are currently the subject of a pre-EUA or EUA review, according to the FDA.

Many unknowns remain about antibody tests and how they might help researchers and clinicians understand and/or potentially treat COVID-19. Antibody tests may be able to provide information on disease prevalence and frequency of asymptomatic infection, as well as identify potential donors of “convalescent plasma,” an approach in which blood plasma containing antibodies from a recovered individual serves as a therapy for an infected patient with severe disease, Dr. Shah wrote in the May 4 statement.

“There are a lot of unanswered questions about this particular issue,” Dr. Hahn said during the press conference. “We need the data because we need to understand this particular aspect of the disease and put it as part of the puzzle around COVID-19.”

[email protected]

Major advances in understanding the nuanced mechanisms underlying atopic dermatitis have led to a plethora of novel topical, oral, and injectable biologic agents now in advanced-stage development, Jonathan I. Silverberg, MD, PhD, said during a virtual meeting held by the George Washington University department of dermatology. The virtual meeting included presentations that had been slated for the annual meeting of the American Academy of Dermatology, which was canceled due to the COVID-19 pandemic.

“In the next 2-3 years, we may have nine new treatments approved for atopic dermatitis,” said Dr. Silverberg, director of clinical research and contact dermatitis at the University.

All nine medications he discussed are either in ongoing pivotal phase 3 randomized controlled trials or have completed their phase 3 developmental programs. “This is not theoretical; these are things you’re going to be using in your toolbox imminently,” he stressed.
 

Oral JAK inhibitors

The Janus kinase (JAK) pathway is the intracellular signaling mediator that interacts with extracellular inflammatory cytokines, including interleukin-4, -13, and -31, which are familiar to dermatologists because they’re targeted by potent biologic monoclonal antibody therapies. For example, IL-4 goes through JAK1 and 3, while IL-31 signals through JAK1 and 2.

“You really need to know the key JAK and STAT pathways involved in atopic dermatitis because it will help you determine the selectivity of the agents you’re going to be using,” the dermatologist advised.

Three oral, once-daily JAK inhibitors – abrocitinib, upadacitinib, and baricitinib – are in an advanced stage of development.

“Upadacitinib and abrocitinib may be the two most potent options coming to market soon for us to be thinking about,” Dr. Silverberg said.

Abrocitinib: Three positive phase 3 studies featuring this selective JAK1 inhibitor have been completed in adults with moderate to severe atopic dermatitis (AD). The most recent, JADE COMPARE, featured a head-to-head randomized comparison of abrocitinib and the injectable IL-4/IL-13 inhibitor dupilumab. The results of this 837-patient study haven’t yet been formally presented at a conference because of the COVID-19 pandemic. However, Pfizer recently announced that abrocitinib at 200 mg/day achieved significantly greater improvements than dupilumab (Dupixent) in the coprimary endpoints of skin clearance as reflected in an Investigator’s Global Assessment (IGA) score of 0 or 1 (that is, clear or almost clear) and disease extent based upon 75% reduction from baseline in Eczema Area and Severity Index (EASI 75) at 12 weeks. The same was true at 16 weeks.

Also, a significantly larger proportion of abrocitinib-treated patients achieved at least a 4-point reduction in itch severity as measured using the Peak Pruritus Numerical Rating Scale at week 2. The company plans to file for regulatory approval later this year.

The JADE COMPARE data are exciting because of a pressing unmet need for treatment options that are even more powerful than dupilumab, Dr. Silverberg said.

Upadacitinib: This is selective JAK1 inhibitor is not as far along in the developmental pipeline as abrocitinib, but the efficacy appears to be comparable. In a phase 2 study of 126 adults with moderate to severe AD, upadacitinib at the top dose of 30 mg/day achieved efficacy results Dr. Silverberg deemed “quite extraordinary,” with a rate of IGA score of 0 or 1 of 50% at 16 weeks and an EASI 75 response rate of 69%. Those findings numerically eclipsed results seen in an earlier phase 3 pivotal trial for dupilumab, in which the IGA 0/1 rate was 37% and EASI 75 was 48%, albeit with the caveat that cross-trial comparisons must be taken with a large grain of salt.

Baricitinib: Multiple phase 3 studies of this JAK 1/2 inhibitor have reported positive results. At the top dose of 4 mg/day, baricitinib appears to be less effective than dupilumab in its earlier pivotal trials.

“This may be a good oral option for our patients. It could be similar to the Otezla [apremilast] story in psoriasis: It’s perhaps not as effective as a lot of the biologics, but patients often prefer an oral option,” Dr. Silverberg said.

Of note, in one large, placebo-controlled, phase 3 study of baricitinib on top of background low- or medium-potency topical steroids, the IGA 0/1 rate at 16 weeks with placebo plus topical steroids was a modest 14.7%, which underscores that this long-time workhorse topical therapy is objectively less effective than most physicians think. In contrast, the IGA 0/1 rate with baricitinib at 4 mg/day plus topical steroids was a more respectable 30.6%.

All three oral JAK inhibitors have rapid onset of efficacy, a key advantage over the biologic agents.

“The issue you have to keep in mind is safety. The safety in the atopic dermatitis population was overall quite good for all three drugs. However, safety concerns have come up with JAK inhibitors in rheumatoid arthritis. I think that’s the part we watch the most in this. The efficacy has become clear. Now the question is where does the safety take us,” he said.


 

Novel injectable biologics

Nemolizumab: This humanized monoclonal antibody inhibits IL-31 receptor alpha. Mounting evidence implicates IL-31 as both a proinflammatory and immunomodulatory cytokine linking the immune and neural systems.

Early on, most researchers pigeonholed IL-31 as being a key player only in the itch factor in AD. Not so. Indeed, Dr. Silverberg was the lead investigator in a recent phase 2b study of nemolizumab that demonstrated the biologic is also effective at rapidly clearing AD lesions. The study, which evaluated three different doses in 226 adults with moderate to severe AD and severe pruritus who were on background topical corticosteroids, showed that nemolizumab at 30 mg every 4 weeks trounced placebo in terms of itch reduction: The 69% drop from baseline in Peak Pruritus Numeric Rating Scale at week 16 was twice that in controls, with a significant difference apparent even at week 1.

But in addition, the 33% IGA 0/1 rate at the same time point bested the 12% rate in controls. The EASI 75 response rate was significantly higher as well – 49% versus 19% – as was the EASI 90 response of 33%, compared with 9% in controls. Moreover, nemolizumab-treated patients used close to 40% less topical steroids during the study (J Allergy Clin Immunol. 2020 Jan;145[1]:173-82).

“This is something that’s fascinating. The study gets into the idea that a subset of atopic dermatitis patients have the itch that rashes, and perhaps if you break the itch/scratch cycle you can modify the lesions. Or the effect may even be due to the direct anti-inflammatory action of IL-31 blockade,” Dr. Silverberg observed.

It appeared that a plateau hadn’t been reached for some endpoints out at week 24, when the study ended. Japanese phase 3 studies have been completed, with what he called “great results,” and others are ongoing in the United States.

Tralokinumab: This fully human monoclonal antibody binds to IL-13, but unlike dupilumab, it doesn’t also inhibit IL-4. Tralokinumab met all primary and secondary endpoints in three pivotal phase 3 clinical trials, known as ECZTRA 1-3, that assessed it as treatment for moderate to severe AD in adults and showed an overall adverse event rate comparable with placebo. Leo Pharma, the Danish company developing the biologic, has announced it will file for marketing approval before the end of 2020. Phase 3 data would have been presented at the annual meeting of the American Academy of Dermatology in Denver, had it not been canceled. Dr. Silverberg said that, based upon phase 2 results, it appears tralokinumab may not be quite as effective as dupilumab in the overall AD population, but he predicted the newcomer will still play a useful role.

“The complexities of the immune system are such that some patients will respond better to one drug than another. I think we still have a lot to learn about who the patients are for these novel assets,” he said.

Lebrikizumab: This is another selective IL-13 inhibitor, but this one binds to IL-13 in a slightly different way than tralokinumab. The Food and Drug Administration granted it Fast Track status in December 2019. Twin placebo-controlled phase 3 studies of lebrikizumab as monotherapy for moderate to severe AD are ongoing, and another phase 3 trial of the biologic in combination with topical steroids is planned. Based upon the results of a phase 2b study, the highest dose studied – 250 mg every 2 weeks – appears to be at least as effective as dupilumab.
 

Nonsteroidal topical agents

These three late-stage topical creams – ruxolitinib, delgocitinib, and tapinarof – have previously received considerable coverage in Dermatology News. Ruxolitinib, a selective JAK1/2 inhibitor, has completed a positive phase 3 trial in adolescents and adults with mild to moderate AD. Delgocitinib, a pan-JAK1/2/3 and Tyrosine kinase 2 inhibitor, is already approved in an ointment formulation in Japan, and the cream formulation is in phase 2 studies in the United States and Europe. Tapinarof has a unique mechanism of action – it’s an aryl hydrocarbon receptor modulator – and is now in phase 3 in adolescents and adults with moderate to severe AD.

These three drugs appear to offer efficacy that’s comparable to or even better than medium-potency topical steroids, and without the notorious steroidal side effects that have caused widespread parental steroid-phobia. Potential applications for other inflammatory diseases, including vitiligo and psoriasis, are under study.

Dr. Silverberg reported receiving research grants from Galderma and GlaxoSmithKline and serving as a consultant to those pharmaceutical companies and more than a dozen others.

[email protected]

Major advances in understanding the nuanced mechanisms underlying atopic dermatitis have led to a plethora of novel topical, oral, and injectable biologic agents now in advanced-stage development, Jonathan I. Silverberg, MD, PhD, said during a virtual meeting held by the George Washington University department of dermatology. The virtual meeting included presentations that had been slated for the annual meeting of the American Academy of Dermatology, which was canceled due to the COVID-19 pandemic.

“In the next 2-3 years, we may have nine new treatments approved for atopic dermatitis,” said Dr. Silverberg, director of clinical research and contact dermatitis at the University.

All nine medications he discussed are either in ongoing pivotal phase 3 randomized controlled trials or have completed their phase 3 developmental programs. “This is not theoretical; these are things you’re going to be using in your toolbox imminently,” he stressed.
 

Oral JAK inhibitors

The Janus kinase (JAK) pathway is the intracellular signaling mediator that interacts with extracellular inflammatory cytokines, including interleukin-4, -13, and -31, which are familiar to dermatologists because they’re targeted by potent biologic monoclonal antibody therapies. For example, IL-4 goes through JAK1 and 3, while IL-31 signals through JAK1 and 2.

“You really need to know the key JAK and STAT pathways involved in atopic dermatitis because it will help you determine the selectivity of the agents you’re going to be using,” the dermatologist advised.

Three oral, once-daily JAK inhibitors – abrocitinib, upadacitinib, and baricitinib – are in an advanced stage of development.

“Upadacitinib and abrocitinib may be the two most potent options coming to market soon for us to be thinking about,” Dr. Silverberg said.

Abrocitinib: Three positive phase 3 studies featuring this selective JAK1 inhibitor have been completed in adults with moderate to severe atopic dermatitis (AD). The most recent, JADE COMPARE, featured a head-to-head randomized comparison of abrocitinib and the injectable IL-4/IL-13 inhibitor dupilumab. The results of this 837-patient study haven’t yet been formally presented at a conference because of the COVID-19 pandemic. However, Pfizer recently announced that abrocitinib at 200 mg/day achieved significantly greater improvements than dupilumab (Dupixent) in the coprimary endpoints of skin clearance as reflected in an Investigator’s Global Assessment (IGA) score of 0 or 1 (that is, clear or almost clear) and disease extent based upon 75% reduction from baseline in Eczema Area and Severity Index (EASI 75) at 12 weeks. The same was true at 16 weeks.

Also, a significantly larger proportion of abrocitinib-treated patients achieved at least a 4-point reduction in itch severity as measured using the Peak Pruritus Numerical Rating Scale at week 2. The company plans to file for regulatory approval later this year.

The JADE COMPARE data are exciting because of a pressing unmet need for treatment options that are even more powerful than dupilumab, Dr. Silverberg said.

Upadacitinib: This is selective JAK1 inhibitor is not as far along in the developmental pipeline as abrocitinib, but the efficacy appears to be comparable. In a phase 2 study of 126 adults with moderate to severe AD, upadacitinib at the top dose of 30 mg/day achieved efficacy results Dr. Silverberg deemed “quite extraordinary,” with a rate of IGA score of 0 or 1 of 50% at 16 weeks and an EASI 75 response rate of 69%. Those findings numerically eclipsed results seen in an earlier phase 3 pivotal trial for dupilumab, in which the IGA 0/1 rate was 37% and EASI 75 was 48%, albeit with the caveat that cross-trial comparisons must be taken with a large grain of salt.

Baricitinib: Multiple phase 3 studies of this JAK 1/2 inhibitor have reported positive results. At the top dose of 4 mg/day, baricitinib appears to be less effective than dupilumab in its earlier pivotal trials.

“This may be a good oral option for our patients. It could be similar to the Otezla [apremilast] story in psoriasis: It’s perhaps not as effective as a lot of the biologics, but patients often prefer an oral option,” Dr. Silverberg said.

Of note, in one large, placebo-controlled, phase 3 study of baricitinib on top of background low- or medium-potency topical steroids, the IGA 0/1 rate at 16 weeks with placebo plus topical steroids was a modest 14.7%, which underscores that this long-time workhorse topical therapy is objectively less effective than most physicians think. In contrast, the IGA 0/1 rate with baricitinib at 4 mg/day plus topical steroids was a more respectable 30.6%.

All three oral JAK inhibitors have rapid onset of efficacy, a key advantage over the biologic agents.

“The issue you have to keep in mind is safety. The safety in the atopic dermatitis population was overall quite good for all three drugs. However, safety concerns have come up with JAK inhibitors in rheumatoid arthritis. I think that’s the part we watch the most in this. The efficacy has become clear. Now the question is where does the safety take us,” he said.


 

Novel injectable biologics

Nemolizumab: This humanized monoclonal antibody inhibits IL-31 receptor alpha. Mounting evidence implicates IL-31 as both a proinflammatory and immunomodulatory cytokine linking the immune and neural systems.

Early on, most researchers pigeonholed IL-31 as being a key player only in the itch factor in AD. Not so. Indeed, Dr. Silverberg was the lead investigator in a recent phase 2b study of nemolizumab that demonstrated the biologic is also effective at rapidly clearing AD lesions. The study, which evaluated three different doses in 226 adults with moderate to severe AD and severe pruritus who were on background topical corticosteroids, showed that nemolizumab at 30 mg every 4 weeks trounced placebo in terms of itch reduction: The 69% drop from baseline in Peak Pruritus Numeric Rating Scale at week 16 was twice that in controls, with a significant difference apparent even at week 1.

But in addition, the 33% IGA 0/1 rate at the same time point bested the 12% rate in controls. The EASI 75 response rate was significantly higher as well – 49% versus 19% – as was the EASI 90 response of 33%, compared with 9% in controls. Moreover, nemolizumab-treated patients used close to 40% less topical steroids during the study (J Allergy Clin Immunol. 2020 Jan;145[1]:173-82).

“This is something that’s fascinating. The study gets into the idea that a subset of atopic dermatitis patients have the itch that rashes, and perhaps if you break the itch/scratch cycle you can modify the lesions. Or the effect may even be due to the direct anti-inflammatory action of IL-31 blockade,” Dr. Silverberg observed.

It appeared that a plateau hadn’t been reached for some endpoints out at week 24, when the study ended. Japanese phase 3 studies have been completed, with what he called “great results,” and others are ongoing in the United States.

Tralokinumab: This fully human monoclonal antibody binds to IL-13, but unlike dupilumab, it doesn’t also inhibit IL-4. Tralokinumab met all primary and secondary endpoints in three pivotal phase 3 clinical trials, known as ECZTRA 1-3, that assessed it as treatment for moderate to severe AD in adults and showed an overall adverse event rate comparable with placebo. Leo Pharma, the Danish company developing the biologic, has announced it will file for marketing approval before the end of 2020. Phase 3 data would have been presented at the annual meeting of the American Academy of Dermatology in Denver, had it not been canceled. Dr. Silverberg said that, based upon phase 2 results, it appears tralokinumab may not be quite as effective as dupilumab in the overall AD population, but he predicted the newcomer will still play a useful role.

“The complexities of the immune system are such that some patients will respond better to one drug than another. I think we still have a lot to learn about who the patients are for these novel assets,” he said.

Lebrikizumab: This is another selective IL-13 inhibitor, but this one binds to IL-13 in a slightly different way than tralokinumab. The Food and Drug Administration granted it Fast Track status in December 2019. Twin placebo-controlled phase 3 studies of lebrikizumab as monotherapy for moderate to severe AD are ongoing, and another phase 3 trial of the biologic in combination with topical steroids is planned. Based upon the results of a phase 2b study, the highest dose studied – 250 mg every 2 weeks – appears to be at least as effective as dupilumab.
 

Nonsteroidal topical agents

These three late-stage topical creams – ruxolitinib, delgocitinib, and tapinarof – have previously received considerable coverage in Dermatology News. Ruxolitinib, a selective JAK1/2 inhibitor, has completed a positive phase 3 trial in adolescents and adults with mild to moderate AD. Delgocitinib, a pan-JAK1/2/3 and Tyrosine kinase 2 inhibitor, is already approved in an ointment formulation in Japan, and the cream formulation is in phase 2 studies in the United States and Europe. Tapinarof has a unique mechanism of action – it’s an aryl hydrocarbon receptor modulator – and is now in phase 3 in adolescents and adults with moderate to severe AD.

These three drugs appear to offer efficacy that’s comparable to or even better than medium-potency topical steroids, and without the notorious steroidal side effects that have caused widespread parental steroid-phobia. Potential applications for other inflammatory diseases, including vitiligo and psoriasis, are under study.

Dr. Silverberg reported receiving research grants from Galderma and GlaxoSmithKline and serving as a consultant to those pharmaceutical companies and more than a dozen others.

[email protected]

Major advances in understanding the nuanced mechanisms underlying atopic dermatitis have led to a plethora of novel topical, oral, and injectable biologic agents now in advanced-stage development, Jonathan I. Silverberg, MD, PhD, said during a virtual meeting held by the George Washington University department of dermatology. The virtual meeting included presentations that had been slated for the annual meeting of the American Academy of Dermatology, which was canceled due to the COVID-19 pandemic.

“In the next 2-3 years, we may have nine new treatments approved for atopic dermatitis,” said Dr. Silverberg, director of clinical research and contact dermatitis at the University.

All nine medications he discussed are either in ongoing pivotal phase 3 randomized controlled trials or have completed their phase 3 developmental programs. “This is not theoretical; these are things you’re going to be using in your toolbox imminently,” he stressed.
 

Oral JAK inhibitors

The Janus kinase (JAK) pathway is the intracellular signaling mediator that interacts with extracellular inflammatory cytokines, including interleukin-4, -13, and -31, which are familiar to dermatologists because they’re targeted by potent biologic monoclonal antibody therapies. For example, IL-4 goes through JAK1 and 3, while IL-31 signals through JAK1 and 2.

“You really need to know the key JAK and STAT pathways involved in atopic dermatitis because it will help you determine the selectivity of the agents you’re going to be using,” the dermatologist advised.

Three oral, once-daily JAK inhibitors – abrocitinib, upadacitinib, and baricitinib – are in an advanced stage of development.

“Upadacitinib and abrocitinib may be the two most potent options coming to market soon for us to be thinking about,” Dr. Silverberg said.

Abrocitinib: Three positive phase 3 studies featuring this selective JAK1 inhibitor have been completed in adults with moderate to severe atopic dermatitis (AD). The most recent, JADE COMPARE, featured a head-to-head randomized comparison of abrocitinib and the injectable IL-4/IL-13 inhibitor dupilumab. The results of this 837-patient study haven’t yet been formally presented at a conference because of the COVID-19 pandemic. However, Pfizer recently announced that abrocitinib at 200 mg/day achieved significantly greater improvements than dupilumab (Dupixent) in the coprimary endpoints of skin clearance as reflected in an Investigator’s Global Assessment (IGA) score of 0 or 1 (that is, clear or almost clear) and disease extent based upon 75% reduction from baseline in Eczema Area and Severity Index (EASI 75) at 12 weeks. The same was true at 16 weeks.

Also, a significantly larger proportion of abrocitinib-treated patients achieved at least a 4-point reduction in itch severity as measured using the Peak Pruritus Numerical Rating Scale at week 2. The company plans to file for regulatory approval later this year.

The JADE COMPARE data are exciting because of a pressing unmet need for treatment options that are even more powerful than dupilumab, Dr. Silverberg said.

Upadacitinib: This is selective JAK1 inhibitor is not as far along in the developmental pipeline as abrocitinib, but the efficacy appears to be comparable. In a phase 2 study of 126 adults with moderate to severe AD, upadacitinib at the top dose of 30 mg/day achieved efficacy results Dr. Silverberg deemed “quite extraordinary,” with a rate of IGA score of 0 or 1 of 50% at 16 weeks and an EASI 75 response rate of 69%. Those findings numerically eclipsed results seen in an earlier phase 3 pivotal trial for dupilumab, in which the IGA 0/1 rate was 37% and EASI 75 was 48%, albeit with the caveat that cross-trial comparisons must be taken with a large grain of salt.

Baricitinib: Multiple phase 3 studies of this JAK 1/2 inhibitor have reported positive results. At the top dose of 4 mg/day, baricitinib appears to be less effective than dupilumab in its earlier pivotal trials.

“This may be a good oral option for our patients. It could be similar to the Otezla [apremilast] story in psoriasis: It’s perhaps not as effective as a lot of the biologics, but patients often prefer an oral option,” Dr. Silverberg said.

Of note, in one large, placebo-controlled, phase 3 study of baricitinib on top of background low- or medium-potency topical steroids, the IGA 0/1 rate at 16 weeks with placebo plus topical steroids was a modest 14.7%, which underscores that this long-time workhorse topical therapy is objectively less effective than most physicians think. In contrast, the IGA 0/1 rate with baricitinib at 4 mg/day plus topical steroids was a more respectable 30.6%.

All three oral JAK inhibitors have rapid onset of efficacy, a key advantage over the biologic agents.

“The issue you have to keep in mind is safety. The safety in the atopic dermatitis population was overall quite good for all three drugs. However, safety concerns have come up with JAK inhibitors in rheumatoid arthritis. I think that’s the part we watch the most in this. The efficacy has become clear. Now the question is where does the safety take us,” he said.


 

Novel injectable biologics

Nemolizumab: This humanized monoclonal antibody inhibits IL-31 receptor alpha. Mounting evidence implicates IL-31 as both a proinflammatory and immunomodulatory cytokine linking the immune and neural systems.

Early on, most researchers pigeonholed IL-31 as being a key player only in the itch factor in AD. Not so. Indeed, Dr. Silverberg was the lead investigator in a recent phase 2b study of nemolizumab that demonstrated the biologic is also effective at rapidly clearing AD lesions. The study, which evaluated three different doses in 226 adults with moderate to severe AD and severe pruritus who were on background topical corticosteroids, showed that nemolizumab at 30 mg every 4 weeks trounced placebo in terms of itch reduction: The 69% drop from baseline in Peak Pruritus Numeric Rating Scale at week 16 was twice that in controls, with a significant difference apparent even at week 1.

But in addition, the 33% IGA 0/1 rate at the same time point bested the 12% rate in controls. The EASI 75 response rate was significantly higher as well – 49% versus 19% – as was the EASI 90 response of 33%, compared with 9% in controls. Moreover, nemolizumab-treated patients used close to 40% less topical steroids during the study (J Allergy Clin Immunol. 2020 Jan;145[1]:173-82).

“This is something that’s fascinating. The study gets into the idea that a subset of atopic dermatitis patients have the itch that rashes, and perhaps if you break the itch/scratch cycle you can modify the lesions. Or the effect may even be due to the direct anti-inflammatory action of IL-31 blockade,” Dr. Silverberg observed.

It appeared that a plateau hadn’t been reached for some endpoints out at week 24, when the study ended. Japanese phase 3 studies have been completed, with what he called “great results,” and others are ongoing in the United States.

Tralokinumab: This fully human monoclonal antibody binds to IL-13, but unlike dupilumab, it doesn’t also inhibit IL-4. Tralokinumab met all primary and secondary endpoints in three pivotal phase 3 clinical trials, known as ECZTRA 1-3, that assessed it as treatment for moderate to severe AD in adults and showed an overall adverse event rate comparable with placebo. Leo Pharma, the Danish company developing the biologic, has announced it will file for marketing approval before the end of 2020. Phase 3 data would have been presented at the annual meeting of the American Academy of Dermatology in Denver, had it not been canceled. Dr. Silverberg said that, based upon phase 2 results, it appears tralokinumab may not be quite as effective as dupilumab in the overall AD population, but he predicted the newcomer will still play a useful role.

“The complexities of the immune system are such that some patients will respond better to one drug than another. I think we still have a lot to learn about who the patients are for these novel assets,” he said.

Lebrikizumab: This is another selective IL-13 inhibitor, but this one binds to IL-13 in a slightly different way than tralokinumab. The Food and Drug Administration granted it Fast Track status in December 2019. Twin placebo-controlled phase 3 studies of lebrikizumab as monotherapy for moderate to severe AD are ongoing, and another phase 3 trial of the biologic in combination with topical steroids is planned. Based upon the results of a phase 2b study, the highest dose studied – 250 mg every 2 weeks – appears to be at least as effective as dupilumab.
 

Nonsteroidal topical agents

These three late-stage topical creams – ruxolitinib, delgocitinib, and tapinarof – have previously received considerable coverage in Dermatology News. Ruxolitinib, a selective JAK1/2 inhibitor, has completed a positive phase 3 trial in adolescents and adults with mild to moderate AD. Delgocitinib, a pan-JAK1/2/3 and Tyrosine kinase 2 inhibitor, is already approved in an ointment formulation in Japan, and the cream formulation is in phase 2 studies in the United States and Europe. Tapinarof has a unique mechanism of action – it’s an aryl hydrocarbon receptor modulator – and is now in phase 3 in adolescents and adults with moderate to severe AD.

These three drugs appear to offer efficacy that’s comparable to or even better than medium-potency topical steroids, and without the notorious steroidal side effects that have caused widespread parental steroid-phobia. Potential applications for other inflammatory diseases, including vitiligo and psoriasis, are under study.

Dr. Silverberg reported receiving research grants from Galderma and GlaxoSmithKline and serving as a consultant to those pharmaceutical companies and more than a dozen others.

[email protected]

The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.

A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.

The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.

These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.

The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.

In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.

None of the authors of the two reports and editorial had relevant commercial disclosures.

[email protected]

The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.

A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.

The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.

These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.

The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.

In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.

None of the authors of the two reports and editorial had relevant commercial disclosures.

[email protected]

The potential for serious arrhythmias from hydroxychloroquine treatment of COVID-19 patients received further documentation from a pair of studies released on May 1, casting further doubt on whether the uncertain benefit from this or related drugs to infected patients is worth the clear risks the agents pose.

A report from 90 confirmed COVID-19 patients treated with hydroxychloroquine at one Boston hospital during March-April 2020 identified a significantly prolonged, corrected QT (QTc) interval of at least 500 msec in 18 patients (20%), which included 10 patients whose QTc rose by at least 60 msec above baseline, and a total of 21 patients (23%) having a notable prolongation (JAMA Cardiol. 2020 May 4. doi: 10.1001/jamacardio.2020.1834). This series included one patient who developed torsades de pointes following treatment with hydroxychloroquine and azithromycin, “which to our knowledge has yet to be reported elsewhere in the literature,” the report said.

The second report, from a single center in Lyon, France, included 40 confirmed COVID-19 patients treated with hydroxychloroquine during 2 weeks in late March, and found that 37 (93%) had some increase in the QTc interval, including 14 patients (36%) with an increase of at least 60 msec, and 7 patients (18%) whose QTc rose to at least 500 msec (JAMA Cardiol. 2020 May. doi: 10.1001/jamacardio.2020.1787). However, none of the 40 patients in this series developed an identified ventricular arrhythmia. All patients in both studies received hydroxychloroquine for at least 1 day, and roughly half the patients in each series also received concurrent azithromycin, another drug that can prolong the QTc interval and that has been frequently used in combination with hydroxychloroquine as an unproven COVID-19 treatment cocktail.

These two reports, as well as prior report from Brazil on COVID-19 patients treated with chloroquine diphosphate (JAMA Netw Open. 2020;3[4]:e208857), “underscore the potential risk associated with widespread use of hydroxychloroquine and the combination of hydroxychloroquine and azithromycin in ambulatory patients with known or suspected COVID-19. Understanding whether this risk is worth taking in the absence of evidence of therapeutic efficacy creates a knowledge gap that needs to be addressed,” wrote Robert O. Bonow, MD, a professor of medicine at Northwestern University in Chicago, and coauthors in an editorial that accompanied the two reports (JAMA Cardiol. 2020 May 4;doi: 10.1001/jamacardio.2020.1782). The editorial cited two recently-begun prospective trials, ORCHID and RECOVERY, that are more systematically assessing the safety and efficacy of hydroxychloroquine treatment in COVID-19 patients.

The findings lend further support to a Safety Communication from the U.S. Food and Drug Administration on April 24 that reminded clinicians that the Emergency Use Authorization for hydroxychloroquine and chloroquine in COVID-19 patients that the FDA issued on March 28 applied to only certain hospitalized patients or those enrolled in clinical trials. The Safety Communication also said that agency was aware of reports of adverse arrhythmia events when COVID-19 patients received these drugs outside a hospital setting as well as uninfected people who had received one of these drugs for preventing infection.

In addition, leaders of the American College of Cardiology, the American Heart Association, and the Heart Rhythm Society on April 10 issued a summary of considerations when using hydroxychloroquine and azithromycin to treat COVID-19 patients, and noted that a way to minimized the risk from these drugs is to withhold them from patients with a QTc interval of 500 msec or greater at baseline (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). The summary also highlighted the need for regular ECG monitoring of COVID-19 patients who receive drugs that can prolong the QTc interval, and recommended withdrawing treatment from patients when their QTc exceeds the 500 msec threshold.

None of the authors of the two reports and editorial had relevant commercial disclosures.

[email protected]

Emma just celebrated her second birthday, and she has been working on the usual things that children start to master at this age: potty training, making friends, exerting her will through both actions and words, and generally enjoying life as the center of attention for both her parents and grandparents. Like everyone else in Maryland, Emma’s life changed suddenly with the coronavirus stay-at-home order that was issued on March 30. There is no more day care and her parents work from home while caring for her. Her grandparents visit, but only outside and only from a distance – there are no more hugs and there is no more sitting in her grandfather’s lap while he reads stories.

SbytovaMN/iStock/Getty Images Plus

One afternoon a few weeks ago, Emma was looking out the window when she saw her friend, Max, walk by with his parents. Before her parents could stop her, Emma bolted out the door, and she and little Max wrapped each other in a tight embrace. Their parents snapped a photo of the smiling toddlers hugging before they separated the children. The photo is adorable, but as all struggle with social distancing, the poignance of two innocent toddlers in a forbidden embrace is a bit heartbreaking.

Everyone who has ever observed children knows that social distancing is not in their nature. Children play, they hug, they wrestle and tackle and poke, and sometimes even bite. And every student of social psychology has been taught about Harry Harlow’s experiments with rhesus macaques who were separated from their mothers and given access to an inanimate object to serve as a surrogate mother. The Harlow studies, while controversial, were revolutionary in demonstrating that early interactions with both a mother and with playmates were essential in the development of normal social relationships.

Regine Galanti, PhD, is a clinical psychologist at Long Island Behavioral Psychology, Cedarhurst, N.Y., who specializes in the treatment of anxiety and behavior problems. With young children she uses parent-child interaction therapy (PCIT) to help build relationships and discipline. Dr. Galanti said: “I don’t think we’re well prepared as a field to answer questions about the long-term effects of social distancing. If you need young children to socially distance, the responsibility has to fall on the adults. It’s important to explain to children what’s going on and to be honest in a developmentally appropriate way.”

Dr. Galanti has noticed that the issues that people had before COVID-19 are exacerbated by the stress of the current situation. “But people are telling me they are too overwhelmed to seek treatment, and that’s unfortunate because the parents’ anxieties trickle down to the kids. What we do know is that young children thrive on structure.”

Tovah P. Klein, PhD, is the author of “How Toddlers Thrive” (Touchstone, 2015) and is the director of the Barnard College Center for Toddler Development in Manhattan. “When this started, we thought we would be closed for a few weeks,” Dr. Klein said. “We wanted to maintain a connection to the children, so we made videos for the parents to show to the kids, just to say ‘We’re still here.’ But as time went on and we realized it was going to be a while, we felt it was important to provide connection, so we launched a virtual program.”

Dr. Klein said that the teachers meet with their classes of 13 2-year-olds over Zoom, and when they first started, she asked the teachers to try to meet for 10 minutes. They are now meeting for 40 minutes twice a week. The children like seeing their teachers in their homes and they like seeing each other. In addition, the teachers make videos to send home and they are currently working on one to demystify masks. “We’re working on normalizing masks and showing children that when you put the mask on, you’re still there underneath.”

The center has existed for 48 years. There have been struggles for some of the children who attend; some of the parents have been hospitalized with the virus, and some work on the front line and so parents may be living away from a child.

“We’ve seen more challenging behaviors during this time, more tantrums, toileting issues, night awakenings, and more fragility. But as the new normal takes hold, things are settling in. Parents have been good about getting new routines and it helps if parents can handle their own stress,” Dr. Klein said. She also pointed out that for parents working at home while caring for their children, this can be particularly difficult on a young child. “The child knows the parent is home, but isn’t spending time with him, and he sees it as a rejection.”

Margaret Adams, MD, is a child psychiatrist in Maryland who works with very young children and their parents. She says that some of the children are thriving with the extra attention from their parents. “I often have seen difficulties with readjustment to the routine of separations to day care after a family vacation of a week, or sometimes even a weekend, even for those young ones who seem to love the social aspects of day care. I think it is likely a big impact will come upon return, depending on the developmental stage of the child,” Dr. Adams noted.

Despite the hardships of the moment, all three experts expressed hopefulness about the future for these children.

“Young children are super-resilient and that’s the blessing of this,” Dr. Galanti said. “I think they will be okay.”

Emma is home for now with her parents, who are expecting another child soon. Her mother notes: “The days are long and balancing work is an impossible challenge, but being with Emma has been a total blessing, and when would I ever have this much time to spend with my kid? She’s at such a fun age – so curious and adventurous – it’s amazing to watch her language and skills progress. I wish we weren’t in the midst of a pandemic, but Emma is definitely the bright spot.”
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

Emma just celebrated her second birthday, and she has been working on the usual things that children start to master at this age: potty training, making friends, exerting her will through both actions and words, and generally enjoying life as the center of attention for both her parents and grandparents. Like everyone else in Maryland, Emma’s life changed suddenly with the coronavirus stay-at-home order that was issued on March 30. There is no more day care and her parents work from home while caring for her. Her grandparents visit, but only outside and only from a distance – there are no more hugs and there is no more sitting in her grandfather’s lap while he reads stories.

SbytovaMN/iStock/Getty Images Plus

One afternoon a few weeks ago, Emma was looking out the window when she saw her friend, Max, walk by with his parents. Before her parents could stop her, Emma bolted out the door, and she and little Max wrapped each other in a tight embrace. Their parents snapped a photo of the smiling toddlers hugging before they separated the children. The photo is adorable, but as all struggle with social distancing, the poignance of two innocent toddlers in a forbidden embrace is a bit heartbreaking.

Everyone who has ever observed children knows that social distancing is not in their nature. Children play, they hug, they wrestle and tackle and poke, and sometimes even bite. And every student of social psychology has been taught about Harry Harlow’s experiments with rhesus macaques who were separated from their mothers and given access to an inanimate object to serve as a surrogate mother. The Harlow studies, while controversial, were revolutionary in demonstrating that early interactions with both a mother and with playmates were essential in the development of normal social relationships.

Regine Galanti, PhD, is a clinical psychologist at Long Island Behavioral Psychology, Cedarhurst, N.Y., who specializes in the treatment of anxiety and behavior problems. With young children she uses parent-child interaction therapy (PCIT) to help build relationships and discipline. Dr. Galanti said: “I don’t think we’re well prepared as a field to answer questions about the long-term effects of social distancing. If you need young children to socially distance, the responsibility has to fall on the adults. It’s important to explain to children what’s going on and to be honest in a developmentally appropriate way.”

Dr. Galanti has noticed that the issues that people had before COVID-19 are exacerbated by the stress of the current situation. “But people are telling me they are too overwhelmed to seek treatment, and that’s unfortunate because the parents’ anxieties trickle down to the kids. What we do know is that young children thrive on structure.”

Tovah P. Klein, PhD, is the author of “How Toddlers Thrive” (Touchstone, 2015) and is the director of the Barnard College Center for Toddler Development in Manhattan. “When this started, we thought we would be closed for a few weeks,” Dr. Klein said. “We wanted to maintain a connection to the children, so we made videos for the parents to show to the kids, just to say ‘We’re still here.’ But as time went on and we realized it was going to be a while, we felt it was important to provide connection, so we launched a virtual program.”

Dr. Klein said that the teachers meet with their classes of 13 2-year-olds over Zoom, and when they first started, she asked the teachers to try to meet for 10 minutes. They are now meeting for 40 minutes twice a week. The children like seeing their teachers in their homes and they like seeing each other. In addition, the teachers make videos to send home and they are currently working on one to demystify masks. “We’re working on normalizing masks and showing children that when you put the mask on, you’re still there underneath.”

The center has existed for 48 years. There have been struggles for some of the children who attend; some of the parents have been hospitalized with the virus, and some work on the front line and so parents may be living away from a child.

“We’ve seen more challenging behaviors during this time, more tantrums, toileting issues, night awakenings, and more fragility. But as the new normal takes hold, things are settling in. Parents have been good about getting new routines and it helps if parents can handle their own stress,” Dr. Klein said. She also pointed out that for parents working at home while caring for their children, this can be particularly difficult on a young child. “The child knows the parent is home, but isn’t spending time with him, and he sees it as a rejection.”

Margaret Adams, MD, is a child psychiatrist in Maryland who works with very young children and their parents. She says that some of the children are thriving with the extra attention from their parents. “I often have seen difficulties with readjustment to the routine of separations to day care after a family vacation of a week, or sometimes even a weekend, even for those young ones who seem to love the social aspects of day care. I think it is likely a big impact will come upon return, depending on the developmental stage of the child,” Dr. Adams noted.

Despite the hardships of the moment, all three experts expressed hopefulness about the future for these children.

“Young children are super-resilient and that’s the blessing of this,” Dr. Galanti said. “I think they will be okay.”

Emma is home for now with her parents, who are expecting another child soon. Her mother notes: “The days are long and balancing work is an impossible challenge, but being with Emma has been a total blessing, and when would I ever have this much time to spend with my kid? She’s at such a fun age – so curious and adventurous – it’s amazing to watch her language and skills progress. I wish we weren’t in the midst of a pandemic, but Emma is definitely the bright spot.”
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

Emma just celebrated her second birthday, and she has been working on the usual things that children start to master at this age: potty training, making friends, exerting her will through both actions and words, and generally enjoying life as the center of attention for both her parents and grandparents. Like everyone else in Maryland, Emma’s life changed suddenly with the coronavirus stay-at-home order that was issued on March 30. There is no more day care and her parents work from home while caring for her. Her grandparents visit, but only outside and only from a distance – there are no more hugs and there is no more sitting in her grandfather’s lap while he reads stories.

SbytovaMN/iStock/Getty Images Plus

One afternoon a few weeks ago, Emma was looking out the window when she saw her friend, Max, walk by with his parents. Before her parents could stop her, Emma bolted out the door, and she and little Max wrapped each other in a tight embrace. Their parents snapped a photo of the smiling toddlers hugging before they separated the children. The photo is adorable, but as all struggle with social distancing, the poignance of two innocent toddlers in a forbidden embrace is a bit heartbreaking.

Everyone who has ever observed children knows that social distancing is not in their nature. Children play, they hug, they wrestle and tackle and poke, and sometimes even bite. And every student of social psychology has been taught about Harry Harlow’s experiments with rhesus macaques who were separated from their mothers and given access to an inanimate object to serve as a surrogate mother. The Harlow studies, while controversial, were revolutionary in demonstrating that early interactions with both a mother and with playmates were essential in the development of normal social relationships.

Regine Galanti, PhD, is a clinical psychologist at Long Island Behavioral Psychology, Cedarhurst, N.Y., who specializes in the treatment of anxiety and behavior problems. With young children she uses parent-child interaction therapy (PCIT) to help build relationships and discipline. Dr. Galanti said: “I don’t think we’re well prepared as a field to answer questions about the long-term effects of social distancing. If you need young children to socially distance, the responsibility has to fall on the adults. It’s important to explain to children what’s going on and to be honest in a developmentally appropriate way.”

Dr. Galanti has noticed that the issues that people had before COVID-19 are exacerbated by the stress of the current situation. “But people are telling me they are too overwhelmed to seek treatment, and that’s unfortunate because the parents’ anxieties trickle down to the kids. What we do know is that young children thrive on structure.”

Tovah P. Klein, PhD, is the author of “How Toddlers Thrive” (Touchstone, 2015) and is the director of the Barnard College Center for Toddler Development in Manhattan. “When this started, we thought we would be closed for a few weeks,” Dr. Klein said. “We wanted to maintain a connection to the children, so we made videos for the parents to show to the kids, just to say ‘We’re still here.’ But as time went on and we realized it was going to be a while, we felt it was important to provide connection, so we launched a virtual program.”

Dr. Klein said that the teachers meet with their classes of 13 2-year-olds over Zoom, and when they first started, she asked the teachers to try to meet for 10 minutes. They are now meeting for 40 minutes twice a week. The children like seeing their teachers in their homes and they like seeing each other. In addition, the teachers make videos to send home and they are currently working on one to demystify masks. “We’re working on normalizing masks and showing children that when you put the mask on, you’re still there underneath.”

The center has existed for 48 years. There have been struggles for some of the children who attend; some of the parents have been hospitalized with the virus, and some work on the front line and so parents may be living away from a child.

“We’ve seen more challenging behaviors during this time, more tantrums, toileting issues, night awakenings, and more fragility. But as the new normal takes hold, things are settling in. Parents have been good about getting new routines and it helps if parents can handle their own stress,” Dr. Klein said. She also pointed out that for parents working at home while caring for their children, this can be particularly difficult on a young child. “The child knows the parent is home, but isn’t spending time with him, and he sees it as a rejection.”

Margaret Adams, MD, is a child psychiatrist in Maryland who works with very young children and their parents. She says that some of the children are thriving with the extra attention from their parents. “I often have seen difficulties with readjustment to the routine of separations to day care after a family vacation of a week, or sometimes even a weekend, even for those young ones who seem to love the social aspects of day care. I think it is likely a big impact will come upon return, depending on the developmental stage of the child,” Dr. Adams noted.

Despite the hardships of the moment, all three experts expressed hopefulness about the future for these children.

“Young children are super-resilient and that’s the blessing of this,” Dr. Galanti said. “I think they will be okay.”

Emma is home for now with her parents, who are expecting another child soon. Her mother notes: “The days are long and balancing work is an impossible challenge, but being with Emma has been a total blessing, and when would I ever have this much time to spend with my kid? She’s at such a fun age – so curious and adventurous – it’s amazing to watch her language and skills progress. I wish we weren’t in the midst of a pandemic, but Emma is definitely the bright spot.”
 

Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University Press, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore. Dr. Miller has no disclosures.

Most married couples vowed to stay with their partners during sickness and health, but none of us vowed to remain trapped with our loved ones behind the same four walls, all day, every day, for an unknown period of time. We didn’t sign up for this! Some romantics may be titillated by the prospect, while more independent partners may panic at the mere thought of spending all day and night with their loved ones.

AbleStock.com

Because of the swift implementation of the lifestyle-altering restrictions, couples did not have ample time to mentally and physically prepare. A lack of preparation and loss of control heightens our emotions. It can make couples more susceptible to engage in unhealthy styles of communication and destructive behaviors that are harmful to their relationships.

There are psychological reasons that “absence makes the heart grow fonder.” Distance from your partner is not just a clever way to make your partner appreciate and desire you more. It is human nature to habituate to what is part of your daily life. For instance, when your partner is away from you while on a work trip, you may find the first night or two alone relaxing; but by day 3, you begin to miss your partner’s hugs and kisses, smell, and touch. And after many days apart, you may even miss the incessant nagging that secretly motivates you. Physical distance from our partners essentially gives us the ability to long for and appreciate each other. Our brains are wired to pay more attention to things that are novel and exciting and less interested in what is in our everyday lives.

Separation gives us the ability to miss our partners, while quarantine does the complete opposite.

To avoid contemplating how to murder one’s spouse before quarantine ends, partners can strengthen their relationships by using the strategies I’ve outlined below, which are loosely based on dialectical behavior therapy (DBT). These strategies can be useful for anyone – providers and patients alike – going through these struggles.

Dialectical behavior therapy was developed by psychologist Marsha Linehan PhD, to help regulate emotions for people diagnosed with borderline personality disorder. These skills help to identify thoughts and feelings, to accept one’s inner emotional world and outward behaviors. The idea is that, once you can recognize and accept, then change is possible. The “dialectic” in dialectical behavior therapy implies that one is attempting to find a balance between acceptance and change. All of us can benefit from these skills, especially emotionally volatile couples who are trapped together in quarantine.
 

Radically accept what is uncertain in your lives

Radical acceptance is a practice used in DBT in situations that are out of our control, such as the COVID-19 pandemic. Radically accept that you and your partner are trapped in quarantine without attempting to place blame on our government, your spouse, your boss, and even yourself. Radical acceptance is exactly what the name implies. Accept your current situation for what it is and not what you hoped it to be.

Accept the unknown and unanswered questions such as when will this quarantine end? Will there be a summer camp? Will I get back to my office this summer? Will my children even return to school in the fall? The acceptance of what is out of your control will ultimately decrease your mental time spent worrying and obsessing about the uncertainties of your post-quarantine life and instead provide you more time to be present with your spouse.

Remain mindful during all communication with your spouse. To stay in the moment, you need to be aware of your bodily reactions to distress and notice when your heart rate increases, breathing becomes more shallow, stomach muscles tighten, and when your thoughts become more negative. Mindfulness skills enable us to use physiological changes in our body to become aware of our emotions. You can use your partner’s nonverbal body language and tone of voice to gauge that person’s emotional reactivity.

The practice of mindfulness leads to an increased emotional intelligence. The goal is to have enough self-awareness and emotional understanding of your partner and enough empathy to know when a conversation is becoming too emotionally charged and to let it go and back off. Mindfulness is not nagging your partner to remember to change the heating unit filters with a reminder of what happened years ago when this wasn’t done promptly – without first checking in to make sure your partner is emotionally ready for this type of conversation.

When we have strong emotions, we are using the more primitive parts of our brain that induce a fight or flight reaction. These emotional reactions overshadow the more advanced prefrontal region of our brain that stores our rational thoughts and reasoning skills, a concept identified by psychologist Daniel Goleman as “emotional hijacking.”
 

Use distress tolerance skills to deal with negative emotions

Distress tolerance is an individual’s ability to manage feelings in response to stress. Distress tolerance skills are aimed at helping one manage intense emotions without worsening a situation by engaging in behaviors that are destructive and may exacerbate the problem. The goal is to tolerate the stress while with your partner and not respond negatively or in a way that is harmful to the integrity of your relationship.

To prioritize your relationship, this may mean that you choose not to react negatively when your partner makes a passive-aggressive comment on how you spent your day during quarantine since you still have a pile of laundry on your bedroom floor and overflowing dishes in the kitchen sink. A high level of distress tolerance will enable you to not overreact or withdraw from your spouse when flooded with emotions of anger or sadness.

Distraction techniques are a type of distress tolerance skill. You can engage in activities that keep you distracted and require your full attention. When things get heated between you and your spouse during quarantine, try to obtain some distance from each other to cool down and engage in an activity that involves your full concentration.

Many of us have been surprised by our hidden talents that were discovered during the quarantine. Use the time away from your partner to distract yourself with your new passion for writing, baking, organizing, and even your newfound love of balloon artistry. Do an activity that engages your mind and provides you the necessary physical and mental time away from your partner to deescalate. You can always revisit the initial cause of the conflict when both you and your partner are not emotionally charged. You can also distract yourself with self-soothing tactics such as taking a warm bath or a reading good book. Perhaps distract yourself by giving back to others and spending time planning a drive-by surprise party for your sister’s birthday next month. It can be helpful to distract yourself by comparing yourself to others less fortunate than you or a time in your life when you and your partner were struggling much worse than now, to provide perspective. The goal is not to add to your distress but instead, provide yourself a sense of perspective.
 

Use interpersonal effectiveness skills to establish a healthy relationship

Be gentle in all your communications with your partner, think about your spouse’s perspective, show empathy and interest in what your partner has to say by your verbal communication or body language, such as maintaining eye contact, and offer recognitional cues, such as “uh-huh” and “oh, really.” Avoid communication that is at all invalidating. Never start a sentence with “YOU” while having heated conversations with your spouse; instead, use “I feel” statements. This type of communication avoids the blame game that gets many couples into trouble.

Instead, communicate how you feel while not necessarily blaming your spouse but rather expressing your emotions. This will ultimately lead to less defensive communication from your partner. Remember that not all communication is for the sole purpose of communicating. Much of the time, communication is used as an attempt for one partner to connect with the other partner. Couples may say that they have difficulty with communication when it is not the communication that is the issue but instead the underlying disconnect of the couple.

This disconnect usually manifests while couples are communicating, and therefore, can be misconstrued as solely a communication issue by the couple. When your partner asks you to stop staring at your phone during dinner, it is not necessarily that your spouse is attempting to control you or wants to engage in some deep conversation, but more likely a bid to try to connect with you. Your partner is attempting to tell you that he or she feels disconnected, misses you, and wants to reconnect.
 

Provide validation and acceptance to your partner

Focus on your partner’s strengths and accept the weaknesses. Accept that your partner is scattered, disorganized, and takes at least 20 minutes to find the phone and keys every morning. Remember that during your courtship days, you found your partner’s flighty attributes to be endearing. Do the same for your strengths and weaknesses.

Accept that the pandemic is unpredictable and that you may need to strengthen your ability to be flexible and more adaptable. This will ultimately lead to feeling less disappointment by your partner and more accepting of shortcomings. Acceptance of your imperfections will improve your sense of worth and confidence and lessen negative emotions, such as guilt, regret, and shame.

Accept the fact that, as similar as we all are, we use different methods to recharge ourselves. Remember that you may require time with others, including your spouse, to feel invigorated. In contrast, your spouse needs alone time without distractions to reboot mentally and prepare for the following day. In the pre-pandemic world, if there were a mismatch in what a couple needed to feel rejuvenated, they could independently compensate and search for fulfillment outside of the home. Before stay-at-home orders were rolled out throughout the country, spouses had ample opportunities to spend time away from their partners at work, dinner with friends, or while squeezing in a 7 p.m. yoga sculpt class – barely getting home in time to kiss our children goodnight – with a few minutes to spare to engage in mundane conversation with our partners before our nighttime routine of TV commenced. Unfortunately, COVID-19 has made it very hard for couples to carve out that time for compensatory activities outside of the home.

Remember that you are a team

Remind yourself of the reason why you initially fell in love with your partner. Teammates do not keep score or compete with one another. They support each other when one player is not feeling well, and they make sacrifices for the betterment of the team.

Your marriage vows included “through sickness and health” and now should include “through quarantine.”

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

Most married couples vowed to stay with their partners during sickness and health, but none of us vowed to remain trapped with our loved ones behind the same four walls, all day, every day, for an unknown period of time. We didn’t sign up for this! Some romantics may be titillated by the prospect, while more independent partners may panic at the mere thought of spending all day and night with their loved ones.

AbleStock.com

Because of the swift implementation of the lifestyle-altering restrictions, couples did not have ample time to mentally and physically prepare. A lack of preparation and loss of control heightens our emotions. It can make couples more susceptible to engage in unhealthy styles of communication and destructive behaviors that are harmful to their relationships.

There are psychological reasons that “absence makes the heart grow fonder.” Distance from your partner is not just a clever way to make your partner appreciate and desire you more. It is human nature to habituate to what is part of your daily life. For instance, when your partner is away from you while on a work trip, you may find the first night or two alone relaxing; but by day 3, you begin to miss your partner’s hugs and kisses, smell, and touch. And after many days apart, you may even miss the incessant nagging that secretly motivates you. Physical distance from our partners essentially gives us the ability to long for and appreciate each other. Our brains are wired to pay more attention to things that are novel and exciting and less interested in what is in our everyday lives.

Separation gives us the ability to miss our partners, while quarantine does the complete opposite.

To avoid contemplating how to murder one’s spouse before quarantine ends, partners can strengthen their relationships by using the strategies I’ve outlined below, which are loosely based on dialectical behavior therapy (DBT). These strategies can be useful for anyone – providers and patients alike – going through these struggles.

Dialectical behavior therapy was developed by psychologist Marsha Linehan PhD, to help regulate emotions for people diagnosed with borderline personality disorder. These skills help to identify thoughts and feelings, to accept one’s inner emotional world and outward behaviors. The idea is that, once you can recognize and accept, then change is possible. The “dialectic” in dialectical behavior therapy implies that one is attempting to find a balance between acceptance and change. All of us can benefit from these skills, especially emotionally volatile couples who are trapped together in quarantine.
 

Radically accept what is uncertain in your lives

Radical acceptance is a practice used in DBT in situations that are out of our control, such as the COVID-19 pandemic. Radically accept that you and your partner are trapped in quarantine without attempting to place blame on our government, your spouse, your boss, and even yourself. Radical acceptance is exactly what the name implies. Accept your current situation for what it is and not what you hoped it to be.

Accept the unknown and unanswered questions such as when will this quarantine end? Will there be a summer camp? Will I get back to my office this summer? Will my children even return to school in the fall? The acceptance of what is out of your control will ultimately decrease your mental time spent worrying and obsessing about the uncertainties of your post-quarantine life and instead provide you more time to be present with your spouse.

Remain mindful during all communication with your spouse. To stay in the moment, you need to be aware of your bodily reactions to distress and notice when your heart rate increases, breathing becomes more shallow, stomach muscles tighten, and when your thoughts become more negative. Mindfulness skills enable us to use physiological changes in our body to become aware of our emotions. You can use your partner’s nonverbal body language and tone of voice to gauge that person’s emotional reactivity.

The practice of mindfulness leads to an increased emotional intelligence. The goal is to have enough self-awareness and emotional understanding of your partner and enough empathy to know when a conversation is becoming too emotionally charged and to let it go and back off. Mindfulness is not nagging your partner to remember to change the heating unit filters with a reminder of what happened years ago when this wasn’t done promptly – without first checking in to make sure your partner is emotionally ready for this type of conversation.

When we have strong emotions, we are using the more primitive parts of our brain that induce a fight or flight reaction. These emotional reactions overshadow the more advanced prefrontal region of our brain that stores our rational thoughts and reasoning skills, a concept identified by psychologist Daniel Goleman as “emotional hijacking.”
 

Use distress tolerance skills to deal with negative emotions

Distress tolerance is an individual’s ability to manage feelings in response to stress. Distress tolerance skills are aimed at helping one manage intense emotions without worsening a situation by engaging in behaviors that are destructive and may exacerbate the problem. The goal is to tolerate the stress while with your partner and not respond negatively or in a way that is harmful to the integrity of your relationship.

To prioritize your relationship, this may mean that you choose not to react negatively when your partner makes a passive-aggressive comment on how you spent your day during quarantine since you still have a pile of laundry on your bedroom floor and overflowing dishes in the kitchen sink. A high level of distress tolerance will enable you to not overreact or withdraw from your spouse when flooded with emotions of anger or sadness.

Distraction techniques are a type of distress tolerance skill. You can engage in activities that keep you distracted and require your full attention. When things get heated between you and your spouse during quarantine, try to obtain some distance from each other to cool down and engage in an activity that involves your full concentration.

Many of us have been surprised by our hidden talents that were discovered during the quarantine. Use the time away from your partner to distract yourself with your new passion for writing, baking, organizing, and even your newfound love of balloon artistry. Do an activity that engages your mind and provides you the necessary physical and mental time away from your partner to deescalate. You can always revisit the initial cause of the conflict when both you and your partner are not emotionally charged. You can also distract yourself with self-soothing tactics such as taking a warm bath or a reading good book. Perhaps distract yourself by giving back to others and spending time planning a drive-by surprise party for your sister’s birthday next month. It can be helpful to distract yourself by comparing yourself to others less fortunate than you or a time in your life when you and your partner were struggling much worse than now, to provide perspective. The goal is not to add to your distress but instead, provide yourself a sense of perspective.
 

Use interpersonal effectiveness skills to establish a healthy relationship

Be gentle in all your communications with your partner, think about your spouse’s perspective, show empathy and interest in what your partner has to say by your verbal communication or body language, such as maintaining eye contact, and offer recognitional cues, such as “uh-huh” and “oh, really.” Avoid communication that is at all invalidating. Never start a sentence with “YOU” while having heated conversations with your spouse; instead, use “I feel” statements. This type of communication avoids the blame game that gets many couples into trouble.

Instead, communicate how you feel while not necessarily blaming your spouse but rather expressing your emotions. This will ultimately lead to less defensive communication from your partner. Remember that not all communication is for the sole purpose of communicating. Much of the time, communication is used as an attempt for one partner to connect with the other partner. Couples may say that they have difficulty with communication when it is not the communication that is the issue but instead the underlying disconnect of the couple.

This disconnect usually manifests while couples are communicating, and therefore, can be misconstrued as solely a communication issue by the couple. When your partner asks you to stop staring at your phone during dinner, it is not necessarily that your spouse is attempting to control you or wants to engage in some deep conversation, but more likely a bid to try to connect with you. Your partner is attempting to tell you that he or she feels disconnected, misses you, and wants to reconnect.
 

Provide validation and acceptance to your partner

Focus on your partner’s strengths and accept the weaknesses. Accept that your partner is scattered, disorganized, and takes at least 20 minutes to find the phone and keys every morning. Remember that during your courtship days, you found your partner’s flighty attributes to be endearing. Do the same for your strengths and weaknesses.

Accept that the pandemic is unpredictable and that you may need to strengthen your ability to be flexible and more adaptable. This will ultimately lead to feeling less disappointment by your partner and more accepting of shortcomings. Acceptance of your imperfections will improve your sense of worth and confidence and lessen negative emotions, such as guilt, regret, and shame.

Accept the fact that, as similar as we all are, we use different methods to recharge ourselves. Remember that you may require time with others, including your spouse, to feel invigorated. In contrast, your spouse needs alone time without distractions to reboot mentally and prepare for the following day. In the pre-pandemic world, if there were a mismatch in what a couple needed to feel rejuvenated, they could independently compensate and search for fulfillment outside of the home. Before stay-at-home orders were rolled out throughout the country, spouses had ample opportunities to spend time away from their partners at work, dinner with friends, or while squeezing in a 7 p.m. yoga sculpt class – barely getting home in time to kiss our children goodnight – with a few minutes to spare to engage in mundane conversation with our partners before our nighttime routine of TV commenced. Unfortunately, COVID-19 has made it very hard for couples to carve out that time for compensatory activities outside of the home.

Remember that you are a team

Remind yourself of the reason why you initially fell in love with your partner. Teammates do not keep score or compete with one another. They support each other when one player is not feeling well, and they make sacrifices for the betterment of the team.

Your marriage vows included “through sickness and health” and now should include “through quarantine.”

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

Most married couples vowed to stay with their partners during sickness and health, but none of us vowed to remain trapped with our loved ones behind the same four walls, all day, every day, for an unknown period of time. We didn’t sign up for this! Some romantics may be titillated by the prospect, while more independent partners may panic at the mere thought of spending all day and night with their loved ones.

AbleStock.com

Because of the swift implementation of the lifestyle-altering restrictions, couples did not have ample time to mentally and physically prepare. A lack of preparation and loss of control heightens our emotions. It can make couples more susceptible to engage in unhealthy styles of communication and destructive behaviors that are harmful to their relationships.

There are psychological reasons that “absence makes the heart grow fonder.” Distance from your partner is not just a clever way to make your partner appreciate and desire you more. It is human nature to habituate to what is part of your daily life. For instance, when your partner is away from you while on a work trip, you may find the first night or two alone relaxing; but by day 3, you begin to miss your partner’s hugs and kisses, smell, and touch. And after many days apart, you may even miss the incessant nagging that secretly motivates you. Physical distance from our partners essentially gives us the ability to long for and appreciate each other. Our brains are wired to pay more attention to things that are novel and exciting and less interested in what is in our everyday lives.

Separation gives us the ability to miss our partners, while quarantine does the complete opposite.

To avoid contemplating how to murder one’s spouse before quarantine ends, partners can strengthen their relationships by using the strategies I’ve outlined below, which are loosely based on dialectical behavior therapy (DBT). These strategies can be useful for anyone – providers and patients alike – going through these struggles.

Dialectical behavior therapy was developed by psychologist Marsha Linehan PhD, to help regulate emotions for people diagnosed with borderline personality disorder. These skills help to identify thoughts and feelings, to accept one’s inner emotional world and outward behaviors. The idea is that, once you can recognize and accept, then change is possible. The “dialectic” in dialectical behavior therapy implies that one is attempting to find a balance between acceptance and change. All of us can benefit from these skills, especially emotionally volatile couples who are trapped together in quarantine.
 

Radically accept what is uncertain in your lives

Radical acceptance is a practice used in DBT in situations that are out of our control, such as the COVID-19 pandemic. Radically accept that you and your partner are trapped in quarantine without attempting to place blame on our government, your spouse, your boss, and even yourself. Radical acceptance is exactly what the name implies. Accept your current situation for what it is and not what you hoped it to be.

Accept the unknown and unanswered questions such as when will this quarantine end? Will there be a summer camp? Will I get back to my office this summer? Will my children even return to school in the fall? The acceptance of what is out of your control will ultimately decrease your mental time spent worrying and obsessing about the uncertainties of your post-quarantine life and instead provide you more time to be present with your spouse.

Remain mindful during all communication with your spouse. To stay in the moment, you need to be aware of your bodily reactions to distress and notice when your heart rate increases, breathing becomes more shallow, stomach muscles tighten, and when your thoughts become more negative. Mindfulness skills enable us to use physiological changes in our body to become aware of our emotions. You can use your partner’s nonverbal body language and tone of voice to gauge that person’s emotional reactivity.

The practice of mindfulness leads to an increased emotional intelligence. The goal is to have enough self-awareness and emotional understanding of your partner and enough empathy to know when a conversation is becoming too emotionally charged and to let it go and back off. Mindfulness is not nagging your partner to remember to change the heating unit filters with a reminder of what happened years ago when this wasn’t done promptly – without first checking in to make sure your partner is emotionally ready for this type of conversation.

When we have strong emotions, we are using the more primitive parts of our brain that induce a fight or flight reaction. These emotional reactions overshadow the more advanced prefrontal region of our brain that stores our rational thoughts and reasoning skills, a concept identified by psychologist Daniel Goleman as “emotional hijacking.”
 

Use distress tolerance skills to deal with negative emotions

Distress tolerance is an individual’s ability to manage feelings in response to stress. Distress tolerance skills are aimed at helping one manage intense emotions without worsening a situation by engaging in behaviors that are destructive and may exacerbate the problem. The goal is to tolerate the stress while with your partner and not respond negatively or in a way that is harmful to the integrity of your relationship.

To prioritize your relationship, this may mean that you choose not to react negatively when your partner makes a passive-aggressive comment on how you spent your day during quarantine since you still have a pile of laundry on your bedroom floor and overflowing dishes in the kitchen sink. A high level of distress tolerance will enable you to not overreact or withdraw from your spouse when flooded with emotions of anger or sadness.

Distraction techniques are a type of distress tolerance skill. You can engage in activities that keep you distracted and require your full attention. When things get heated between you and your spouse during quarantine, try to obtain some distance from each other to cool down and engage in an activity that involves your full concentration.

Many of us have been surprised by our hidden talents that were discovered during the quarantine. Use the time away from your partner to distract yourself with your new passion for writing, baking, organizing, and even your newfound love of balloon artistry. Do an activity that engages your mind and provides you the necessary physical and mental time away from your partner to deescalate. You can always revisit the initial cause of the conflict when both you and your partner are not emotionally charged. You can also distract yourself with self-soothing tactics such as taking a warm bath or a reading good book. Perhaps distract yourself by giving back to others and spending time planning a drive-by surprise party for your sister’s birthday next month. It can be helpful to distract yourself by comparing yourself to others less fortunate than you or a time in your life when you and your partner were struggling much worse than now, to provide perspective. The goal is not to add to your distress but instead, provide yourself a sense of perspective.
 

Use interpersonal effectiveness skills to establish a healthy relationship

Be gentle in all your communications with your partner, think about your spouse’s perspective, show empathy and interest in what your partner has to say by your verbal communication or body language, such as maintaining eye contact, and offer recognitional cues, such as “uh-huh” and “oh, really.” Avoid communication that is at all invalidating. Never start a sentence with “YOU” while having heated conversations with your spouse; instead, use “I feel” statements. This type of communication avoids the blame game that gets many couples into trouble.

Instead, communicate how you feel while not necessarily blaming your spouse but rather expressing your emotions. This will ultimately lead to less defensive communication from your partner. Remember that not all communication is for the sole purpose of communicating. Much of the time, communication is used as an attempt for one partner to connect with the other partner. Couples may say that they have difficulty with communication when it is not the communication that is the issue but instead the underlying disconnect of the couple.

This disconnect usually manifests while couples are communicating, and therefore, can be misconstrued as solely a communication issue by the couple. When your partner asks you to stop staring at your phone during dinner, it is not necessarily that your spouse is attempting to control you or wants to engage in some deep conversation, but more likely a bid to try to connect with you. Your partner is attempting to tell you that he or she feels disconnected, misses you, and wants to reconnect.
 

Provide validation and acceptance to your partner

Focus on your partner’s strengths and accept the weaknesses. Accept that your partner is scattered, disorganized, and takes at least 20 minutes to find the phone and keys every morning. Remember that during your courtship days, you found your partner’s flighty attributes to be endearing. Do the same for your strengths and weaknesses.

Accept that the pandemic is unpredictable and that you may need to strengthen your ability to be flexible and more adaptable. This will ultimately lead to feeling less disappointment by your partner and more accepting of shortcomings. Acceptance of your imperfections will improve your sense of worth and confidence and lessen negative emotions, such as guilt, regret, and shame.

Accept the fact that, as similar as we all are, we use different methods to recharge ourselves. Remember that you may require time with others, including your spouse, to feel invigorated. In contrast, your spouse needs alone time without distractions to reboot mentally and prepare for the following day. In the pre-pandemic world, if there were a mismatch in what a couple needed to feel rejuvenated, they could independently compensate and search for fulfillment outside of the home. Before stay-at-home orders were rolled out throughout the country, spouses had ample opportunities to spend time away from their partners at work, dinner with friends, or while squeezing in a 7 p.m. yoga sculpt class – barely getting home in time to kiss our children goodnight – with a few minutes to spare to engage in mundane conversation with our partners before our nighttime routine of TV commenced. Unfortunately, COVID-19 has made it very hard for couples to carve out that time for compensatory activities outside of the home.

Remember that you are a team

Remind yourself of the reason why you initially fell in love with your partner. Teammates do not keep score or compete with one another. They support each other when one player is not feeling well, and they make sacrifices for the betterment of the team.

Your marriage vows included “through sickness and health” and now should include “through quarantine.”

Dr. Abraham is a psychiatrist in private practice in Philadelphia. She has no disclosures.

The US Food and Drug Administration (FDA) issued an emergency use authorization on May 1 for remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

The investigational antiviral drug, manufactured by Gilead Sciences Inc., was shown in a preliminary analysis of a National Institutes of Health (NIH) clinical trial to shorten recovery time in some patients, according to information presented during a White House press conference earlier this week. However, the results of the trial have not been published and little is known about how safe and effective it is in treating people in the hospital with COVID-19.

The emergency use authorization (EUA) designation means remdesivir can be distributed in the United States and administered intravenously by healthcare providers, as appropriate to treat severe disease. Those with severe disease, the FDA said in a press release, are patients with low blood oxygen levels or those who need oxygen therapy or more intensive support such as a mechanical ventilator.

“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

The FDA writes, “Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”

The drug must be administered intravenously and the optimal dosing and duration are not yet known, the company said in a press release issued May 1.

In addition, Gilead advises that infusion-related reactions and liver transaminase elevations have been seen in patients treated with the drug.

“If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy,” the company said.

Before granting the emergency use authorization, the FDA had allowed for study of the drug in clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by Gilead.

“The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance,” the FDA said.


This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) issued an emergency use authorization on May 1 for remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

The investigational antiviral drug, manufactured by Gilead Sciences Inc., was shown in a preliminary analysis of a National Institutes of Health (NIH) clinical trial to shorten recovery time in some patients, according to information presented during a White House press conference earlier this week. However, the results of the trial have not been published and little is known about how safe and effective it is in treating people in the hospital with COVID-19.

The emergency use authorization (EUA) designation means remdesivir can be distributed in the United States and administered intravenously by healthcare providers, as appropriate to treat severe disease. Those with severe disease, the FDA said in a press release, are patients with low blood oxygen levels or those who need oxygen therapy or more intensive support such as a mechanical ventilator.

“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

The FDA writes, “Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”

The drug must be administered intravenously and the optimal dosing and duration are not yet known, the company said in a press release issued May 1.

In addition, Gilead advises that infusion-related reactions and liver transaminase elevations have been seen in patients treated with the drug.

“If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy,” the company said.

Before granting the emergency use authorization, the FDA had allowed for study of the drug in clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by Gilead.

“The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance,” the FDA said.


This article first appeared on Medscape.com.

The US Food and Drug Administration (FDA) issued an emergency use authorization on May 1 for remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease.

The investigational antiviral drug, manufactured by Gilead Sciences Inc., was shown in a preliminary analysis of a National Institutes of Health (NIH) clinical trial to shorten recovery time in some patients, according to information presented during a White House press conference earlier this week. However, the results of the trial have not been published and little is known about how safe and effective it is in treating people in the hospital with COVID-19.

The emergency use authorization (EUA) designation means remdesivir can be distributed in the United States and administered intravenously by healthcare providers, as appropriate to treat severe disease. Those with severe disease, the FDA said in a press release, are patients with low blood oxygen levels or those who need oxygen therapy or more intensive support such as a mechanical ventilator.

“There’s tremendous interest among all parties to identify and arm ourselves with medicines to combat COVID-19, and through our Coronavirus Treatment Acceleration Program, the FDA is working around-the-clock and using every tool at our disposal to speed these efforts,” FDA Commissioner Stephen M. Hahn, MD, said in a statement.

The FDA writes, “Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”

The drug must be administered intravenously and the optimal dosing and duration are not yet known, the company said in a press release issued May 1.

In addition, Gilead advises that infusion-related reactions and liver transaminase elevations have been seen in patients treated with the drug.

“If signs and symptoms of a clinically significant infusion reaction occur, immediately discontinue administration of remdesivir and initiate appropriate treatment. Patients should have appropriate clinical and laboratory monitoring to aid in early detection of any potential adverse events. Monitor renal and hepatic function prior to initiating and daily during therapy with remdesivir; additionally monitor serum chemistries and hematology daily during therapy,” the company said.

Before granting the emergency use authorization, the FDA had allowed for study of the drug in clinical trials, as well as expanded access use for individual patients and through a multipatient expanded access program coordinated by Gilead.

“The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance,” the FDA said.


This article first appeared on Medscape.com.

Ustekinumab or a tumor necrosis factor inhibitor (TNFi) are better used alone than with methotrexate in the treatment of psoriatic arthritis suggest the results of PsABio (A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis), a large, ongoing, prospective observational study.

The percentages of patients achieving multiple psoriatic arthritis disease activity outcome measures at 6 months were higher if biologic monotherapy was used rather than a biologic in combination with methotrexate.

For example, minimal disease activity (MDA) was achieved by 27.5% of patients taking ustekinumab as monotherapy and by 32.1% of those taking a TNFi alone. When methotrexate was used in combination, the respective percentages of patients achieving MDA were 23.7% and 27.8%.

A similar pattern was seen for very-low disease activity (VLDA), with 9.8% of patients in the ustekinumab monotherapy arm and 12% of those in the TNFi monotherapy arm achieving this target, compared with 5.7% and 5.4% when these drugs were combined with methotrexate.

MDA is defined as meeting five or more cutoffs for seven domains of disease activity, and VLDA for all seven: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area Severity Index 1 or less or body surface area involved 3% or less, 0-1 tender entheseal points, Health Assessment Questionnaire score of 0.5 or less, patient global disease activity visual analog scale score of 20 or lower, and patient pain visual analog scale score of 15 or lower.

Other outcome measures used that showed no advantage of adding methotrexate to these biologics were the Clinical Disease Activity in Psoriatic Arthritis low disease activity and remission scores, the patient acceptable symptoms rate of the 12-item Psoriatic Arthritis Impact of Disease Questionnaire, and improvement in skin involvement.

“Patients were no more likely to achieve lower disease activity or a remission target having received methotrexate than they did just on the biologic drug on its own,” Stefan Siebert, MBBCh, PhD, one of the PsABio investigators, said in an interview.

Dr. Siebert, who is clinical senior lecturer in inflammation and rheumatology at the University of Glasgow (Scotland), was scheduled to present the findings at the British Society for Rheumatology annual conference. The meeting was canceled because of the ongoing COVID-19 crisis. Abstracts and ePosters from the meeting have since been released in a supplement to Rheumatology and via the BSR’s conference app.
 

First data for ustekinumab

“There certainly doesn’t appear to be any added benefit from using methotrexate on a group level in patients getting ustekinumab and TNF inhibitors,” Dr. Siebert said. “We’ve looked at everything,” he emphasized, and “none of the single domains or composite measures were improved by the addition of methotrexate. I think we knew that for TNF inhibitors, but the key thing is we’ve never known that for ustekinumab, and this is the first study to show that.”

Indeed, the findings match up with those from the SEAM-PsA (Etanercept and Methotrexate in Subjects with Psoriatic Arthritis) study in which patients who were treated with the TNFi etanercept as monotherapy did much better than those given the TNFi in combination with methotrexate or methotrexate alone. While not a randomized trial, PsABio now shows that the same is true for ustekinumab.

Obviously, there are some clear differences between a clinical trial and an observational study such as PsABio. For one thing, there was no randomization and patients taking methotrexate were presumably doing so for good reason, Dr. Siebert said. Secondly, there was no methotrexate-only arm.

PsABio recruited patients who were starting treatment with either ustekinumab or a new TNFi as first-, second-, or third-line biologic disease-modifying antirheumatic therapy (DMARD). “These are all people starting on a biologic, so they’ve already got severe disease and have failed methotrexate on some level. So everything we’ve done is biologic without methotrexate or biologic with methotrexate,” Dr. Siebert explained. Patients may not have been taking methotrexate for a variety of reasons, such as inefficacy or side effects, so PsABio “doesn’t tell us anything about methotrexate on its own.”

Time to rethink ingrained methotrexate use

The rationale for using methotrexate in combination with biologics in psoriatic arthritis comes from its long-standing use in rheumatoid arthritis. Much of what is advocated in guidelines comes from experience in RA, Dr. Siebert said.

“In rheumatoid arthritis, we know that the TNF inhibitors work much better if you use methotrexate, that’s a given,” he noted. “We’ve been trained that you have to have methotrexate to have a biologic. However, PsABio, together with other studies, show that you don’t have to, and you should have a good reason to add methotrexate.”

Individual patients may still benefit from methotrexate use, but the decision to treat all patients the same is not supported by the current evidence. “It’s good that it shows that, actually, once you get someone on a decent biologic, it’s working: It’s doing what it ‘says on the tin’ for a lot of patients. I really think that is the key message, here, that you don’t have to; this reassures clinicians and actually makes them think ‘should this patient be on methotrexate?’ ” Dr. Siebert said.

The PsABio study was funded by Janssen. Dr. Siebert has acted as a consultant to and received research funding from Janssen, UCB, Pfizer, Boehringer Ingelheim, Novartis, and Celgene. He has also acted as a consultant for AbbVie and received research support from Bristol-Myers Squibb.

SOURCE: Siebert S et al. Rheumatology. 2020;59(Suppl 2). doi: 10.1093/rheumatology/keaa110.023, Abstract O24.

Ustekinumab or a tumor necrosis factor inhibitor (TNFi) are better used alone than with methotrexate in the treatment of psoriatic arthritis suggest the results of PsABio (A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis), a large, ongoing, prospective observational study.

The percentages of patients achieving multiple psoriatic arthritis disease activity outcome measures at 6 months were higher if biologic monotherapy was used rather than a biologic in combination with methotrexate.

For example, minimal disease activity (MDA) was achieved by 27.5% of patients taking ustekinumab as monotherapy and by 32.1% of those taking a TNFi alone. When methotrexate was used in combination, the respective percentages of patients achieving MDA were 23.7% and 27.8%.

A similar pattern was seen for very-low disease activity (VLDA), with 9.8% of patients in the ustekinumab monotherapy arm and 12% of those in the TNFi monotherapy arm achieving this target, compared with 5.7% and 5.4% when these drugs were combined with methotrexate.

MDA is defined as meeting five or more cutoffs for seven domains of disease activity, and VLDA for all seven: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area Severity Index 1 or less or body surface area involved 3% or less, 0-1 tender entheseal points, Health Assessment Questionnaire score of 0.5 or less, patient global disease activity visual analog scale score of 20 or lower, and patient pain visual analog scale score of 15 or lower.

Other outcome measures used that showed no advantage of adding methotrexate to these biologics were the Clinical Disease Activity in Psoriatic Arthritis low disease activity and remission scores, the patient acceptable symptoms rate of the 12-item Psoriatic Arthritis Impact of Disease Questionnaire, and improvement in skin involvement.

“Patients were no more likely to achieve lower disease activity or a remission target having received methotrexate than they did just on the biologic drug on its own,” Stefan Siebert, MBBCh, PhD, one of the PsABio investigators, said in an interview.

Dr. Siebert, who is clinical senior lecturer in inflammation and rheumatology at the University of Glasgow (Scotland), was scheduled to present the findings at the British Society for Rheumatology annual conference. The meeting was canceled because of the ongoing COVID-19 crisis. Abstracts and ePosters from the meeting have since been released in a supplement to Rheumatology and via the BSR’s conference app.
 

First data for ustekinumab

“There certainly doesn’t appear to be any added benefit from using methotrexate on a group level in patients getting ustekinumab and TNF inhibitors,” Dr. Siebert said. “We’ve looked at everything,” he emphasized, and “none of the single domains or composite measures were improved by the addition of methotrexate. I think we knew that for TNF inhibitors, but the key thing is we’ve never known that for ustekinumab, and this is the first study to show that.”

Indeed, the findings match up with those from the SEAM-PsA (Etanercept and Methotrexate in Subjects with Psoriatic Arthritis) study in which patients who were treated with the TNFi etanercept as monotherapy did much better than those given the TNFi in combination with methotrexate or methotrexate alone. While not a randomized trial, PsABio now shows that the same is true for ustekinumab.

Obviously, there are some clear differences between a clinical trial and an observational study such as PsABio. For one thing, there was no randomization and patients taking methotrexate were presumably doing so for good reason, Dr. Siebert said. Secondly, there was no methotrexate-only arm.

PsABio recruited patients who were starting treatment with either ustekinumab or a new TNFi as first-, second-, or third-line biologic disease-modifying antirheumatic therapy (DMARD). “These are all people starting on a biologic, so they’ve already got severe disease and have failed methotrexate on some level. So everything we’ve done is biologic without methotrexate or biologic with methotrexate,” Dr. Siebert explained. Patients may not have been taking methotrexate for a variety of reasons, such as inefficacy or side effects, so PsABio “doesn’t tell us anything about methotrexate on its own.”

Time to rethink ingrained methotrexate use

The rationale for using methotrexate in combination with biologics in psoriatic arthritis comes from its long-standing use in rheumatoid arthritis. Much of what is advocated in guidelines comes from experience in RA, Dr. Siebert said.

“In rheumatoid arthritis, we know that the TNF inhibitors work much better if you use methotrexate, that’s a given,” he noted. “We’ve been trained that you have to have methotrexate to have a biologic. However, PsABio, together with other studies, show that you don’t have to, and you should have a good reason to add methotrexate.”

Individual patients may still benefit from methotrexate use, but the decision to treat all patients the same is not supported by the current evidence. “It’s good that it shows that, actually, once you get someone on a decent biologic, it’s working: It’s doing what it ‘says on the tin’ for a lot of patients. I really think that is the key message, here, that you don’t have to; this reassures clinicians and actually makes them think ‘should this patient be on methotrexate?’ ” Dr. Siebert said.

The PsABio study was funded by Janssen. Dr. Siebert has acted as a consultant to and received research funding from Janssen, UCB, Pfizer, Boehringer Ingelheim, Novartis, and Celgene. He has also acted as a consultant for AbbVie and received research support from Bristol-Myers Squibb.

SOURCE: Siebert S et al. Rheumatology. 2020;59(Suppl 2). doi: 10.1093/rheumatology/keaa110.023, Abstract O24.

Ustekinumab or a tumor necrosis factor inhibitor (TNFi) are better used alone than with methotrexate in the treatment of psoriatic arthritis suggest the results of PsABio (A Study on Assessment of STELARA and Tumor Necrosis Factor Alpha Inhibitor Therapies in Participants With Psoriatic Arthritis), a large, ongoing, prospective observational study.

The percentages of patients achieving multiple psoriatic arthritis disease activity outcome measures at 6 months were higher if biologic monotherapy was used rather than a biologic in combination with methotrexate.

For example, minimal disease activity (MDA) was achieved by 27.5% of patients taking ustekinumab as monotherapy and by 32.1% of those taking a TNFi alone. When methotrexate was used in combination, the respective percentages of patients achieving MDA were 23.7% and 27.8%.

A similar pattern was seen for very-low disease activity (VLDA), with 9.8% of patients in the ustekinumab monotherapy arm and 12% of those in the TNFi monotherapy arm achieving this target, compared with 5.7% and 5.4% when these drugs were combined with methotrexate.

MDA is defined as meeting five or more cutoffs for seven domains of disease activity, and VLDA for all seven: 0-1 tender joints, 0-1 swollen joints, Psoriasis Area Severity Index 1 or less or body surface area involved 3% or less, 0-1 tender entheseal points, Health Assessment Questionnaire score of 0.5 or less, patient global disease activity visual analog scale score of 20 or lower, and patient pain visual analog scale score of 15 or lower.

Other outcome measures used that showed no advantage of adding methotrexate to these biologics were the Clinical Disease Activity in Psoriatic Arthritis low disease activity and remission scores, the patient acceptable symptoms rate of the 12-item Psoriatic Arthritis Impact of Disease Questionnaire, and improvement in skin involvement.

“Patients were no more likely to achieve lower disease activity or a remission target having received methotrexate than they did just on the biologic drug on its own,” Stefan Siebert, MBBCh, PhD, one of the PsABio investigators, said in an interview.

Dr. Siebert, who is clinical senior lecturer in inflammation and rheumatology at the University of Glasgow (Scotland), was scheduled to present the findings at the British Society for Rheumatology annual conference. The meeting was canceled because of the ongoing COVID-19 crisis. Abstracts and ePosters from the meeting have since been released in a supplement to Rheumatology and via the BSR’s conference app.
 

First data for ustekinumab

“There certainly doesn’t appear to be any added benefit from using methotrexate on a group level in patients getting ustekinumab and TNF inhibitors,” Dr. Siebert said. “We’ve looked at everything,” he emphasized, and “none of the single domains or composite measures were improved by the addition of methotrexate. I think we knew that for TNF inhibitors, but the key thing is we’ve never known that for ustekinumab, and this is the first study to show that.”

Indeed, the findings match up with those from the SEAM-PsA (Etanercept and Methotrexate in Subjects with Psoriatic Arthritis) study in which patients who were treated with the TNFi etanercept as monotherapy did much better than those given the TNFi in combination with methotrexate or methotrexate alone. While not a randomized trial, PsABio now shows that the same is true for ustekinumab.

Obviously, there are some clear differences between a clinical trial and an observational study such as PsABio. For one thing, there was no randomization and patients taking methotrexate were presumably doing so for good reason, Dr. Siebert said. Secondly, there was no methotrexate-only arm.

PsABio recruited patients who were starting treatment with either ustekinumab or a new TNFi as first-, second-, or third-line biologic disease-modifying antirheumatic therapy (DMARD). “These are all people starting on a biologic, so they’ve already got severe disease and have failed methotrexate on some level. So everything we’ve done is biologic without methotrexate or biologic with methotrexate,” Dr. Siebert explained. Patients may not have been taking methotrexate for a variety of reasons, such as inefficacy or side effects, so PsABio “doesn’t tell us anything about methotrexate on its own.”

Time to rethink ingrained methotrexate use

The rationale for using methotrexate in combination with biologics in psoriatic arthritis comes from its long-standing use in rheumatoid arthritis. Much of what is advocated in guidelines comes from experience in RA, Dr. Siebert said.

“In rheumatoid arthritis, we know that the TNF inhibitors work much better if you use methotrexate, that’s a given,” he noted. “We’ve been trained that you have to have methotrexate to have a biologic. However, PsABio, together with other studies, show that you don’t have to, and you should have a good reason to add methotrexate.”

Individual patients may still benefit from methotrexate use, but the decision to treat all patients the same is not supported by the current evidence. “It’s good that it shows that, actually, once you get someone on a decent biologic, it’s working: It’s doing what it ‘says on the tin’ for a lot of patients. I really think that is the key message, here, that you don’t have to; this reassures clinicians and actually makes them think ‘should this patient be on methotrexate?’ ” Dr. Siebert said.

The PsABio study was funded by Janssen. Dr. Siebert has acted as a consultant to and received research funding from Janssen, UCB, Pfizer, Boehringer Ingelheim, Novartis, and Celgene. He has also acted as a consultant for AbbVie and received research support from Bristol-Myers Squibb.

SOURCE: Siebert S et al. Rheumatology. 2020;59(Suppl 2). doi: 10.1093/rheumatology/keaa110.023, Abstract O24.

Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.

On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.

Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.

The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.

“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”

CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.

“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”

Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”

Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*

“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”

Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.

“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”

The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.

[email protected]

*Correction, 5/5/2020: An earlier version of this story misstated Dr. Samuel Jones' affiliation.  He is the chair of the Health Affairs Committee at the American College of Cardiology. 

Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.

On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.

Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.

The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.

“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”

CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.

“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”

Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”

Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*

“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”

Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.

“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”

The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.

[email protected]

*Correction, 5/5/2020: An earlier version of this story misstated Dr. Samuel Jones' affiliation.  He is the chair of the Health Affairs Committee at the American College of Cardiology. 

Physicians who are conducting telephone visits during the COVID-19 pandemic will be paid at a higher rate, more closely aligning the rates with payments for face-to-face visits.

On April 30, officials at the Centers for Medicare & Medicaid Services announced the temporary telephone visit rate change and expanded the scope of services that are eligible telephone visits to include many behavioral health and patient education services.

Rates for telephone visits will jump from $14-$41 per visit to about $46-$110. The pay increase is retroactive to March 1, 2020.

The move was welcomed by the American College of Physicians, but the organization said more needs to be done in order help maintain the financial stability of physician practices.

“ACP has repeatedly requested this change from CMS as the country has been dealing with the COVID-19 national emergency, and we are heartened that they have heard our concerns,” ACP President Jacqueline Fincher, MD, said in a statement. “More still needs to be done to ensure that physician practices are able to remain operational and care for their patients, but this change in payment policy addresses one of the biggest issues facing physicians as they struggle to make up for lost revenue and provide appropriate care to patients.”

CMS also is expanding payment availability for audio-only telemedicine services by waiving the video requirement for certain evaluation and management services. The move is aimed at reaching Medicare beneficiaries who may not have access to video technology or choose not to use it.

“This is a major victory for medicine that will enable physicians to care for their patients, especially their elderly patients with chronic conditions who may not have access to audio-visual technology or high-speed Internet,” Patrice Harris, MD, president of the American Medical Association, said in a statement. “This change will help patients address their health challenges that existed before COVID-19.”

Shawn Martin, senior vice president at the American Academy of Family Physicians, said his group is pleased to see CMS roll out this change and noted that it is especially important for patients with underlying health conditions. “This is the only connectivity they may have with a health care system for their ongoing health care needs.”

Samuel Jones, MD, chair of the Health Affairs Committee at the American College of Cardiology, highlighted the expansion and coverage of audio-only telemedicine appointments as a huge plus for patient access.*

“There was a huge hunger to say, ‘Can we just have improvement in the reimbursement for telephone, which is providing a good service, our patients our asking for it,’ and we were able to get that,” Dr. Jones said in an interview. “It really was, I think, a good thing for patient care.”

Dr. Jones also suggested that the temporary policy be extended after the COVID-19 crisis is over.

“Telemedicine is here to stay,” he said. “But if all of these relaxations suddenly go away with a snap of the finger, or if the reimbursement [is lowered], if all that changes as soon as this emergency declaration is over, we are going to have a hard time.”

The pay increase for telephone services was part of a broader package of increased regulatory flexibility CMS rolled out, including expanding the types of providers who can order a COVID-19 test.

[email protected]

*Correction, 5/5/2020: An earlier version of this story misstated Dr. Samuel Jones' affiliation.  He is the chair of the Health Affairs Committee at the American College of Cardiology. 

During his shift at a COVID-19 drive-through triage screening area set up outside the University of Arkansas for Medical Sciences in Little Rock, Robert Hopkins Jr., MD, noticed a woman bowled over in the front seat of her car.

Courtesy Dr. Robert Hopkins, Jr.

A nurse practitioner had just informed her that she had met the criteria for undergoing testing for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

“She was very upset and was crying nearly inconsolably,” said Dr. Hopkins, who directs the division of general internal medicine at the University of Arkansas Medical Sciences College of Medicine. “I went over and visited with her for a few minutes. She was scared to death that we [had] told her she was going to die. In her mind, if she had COVID-19 that meant a death sentence, and if we were testing her that meant she was likely to not survive.”

Dr. Hopkins tried his best to put testing in perspective for the woman. “At least she came to a level of comfort and realized that we were doing this for her, that this was not a death sentence, that this was not her fault,” he said. “She was worried about infecting her kids and her grandkids and ending up in the hospital and being a burden. Being able to spend that few minutes with her and help to bring down her level of anxiety – I think that’s where we need to put our efforts as physicians right now, helping people understand, ‘Yes, this is serious. Yes, we need to continue to social distance. Yes, we need to be cautious. But, we will get through this if we all work together to do so.’ ”

Prior to the COVID-19 pandemic, Dr. Hopkins spent part of his time seeing patients in the university’s main hospital, but most of it in an outpatient clinic where he and about 20 other primary care physicians care for patients and precept medical residents. Now, medical residents have been deployed to other services, primarily in the hospital, and he and his physician colleagues are conducting 80%-90% of patient visits by video conferencing or by telephone. It’s a whole new world.

“We’ve gone from a relatively traditional inpatient/outpatient practice where we’re seeing patients face to face to doing some face-to-face visits, but an awful lot of what we do now is in the technology domain,” said Dr. Hopkins, who also assisted with health care relief efforts during hurricanes Rita and Katrina.

“A group of six of us has been redeployed to assist with the surge unit for the inpatient facility, so our outpatient duties are being taken on by some of our partners.”

He also pitches in at the drive-through COVID-19 screening clinic, which was set up on March 27 and operates between 8 a.m. and 8 p.m., 7 days a week. “We’re able to measure people’s temperature, take a quick screening history, decide whether their risk is such that we need to do a COVID-19 PCR [polymerase chain reaction] test,” he said. “Then we make a determination of whether they need to go home on quarantine awaiting those results, or if they don’t have anything that needs to be evaluated, or whether they need to be triaged to an urgent care setting or to the emergency department.”

To minimize his risk of acquiring COVID-19, he follows personal hygiene practices recommended by the Centers for Disease Control and Prevention. He also places his work shoes in a shoebox, which he keeps in his car. “I put them on when I get to the parking deck at work, do my work, and then I put them in the shoebox, slip on another pair of shoes and drive home so I’m not tracking in things I potentially had on me,” said Dr. Hopkins, who is married and a father to two college-aged sons and a daughter in fourth grade. “When I get home I immediately shower, and then I exercise or have dinner with my family.”

Despite the longer-than-usual work hours and upheaval to the traditional medical practice model brought on by the pandemic, Dr. Hopkins, a self-described “glass half full person,” said that he does his best to keep watch over his patients and colleagues. “I’m trying to keep an eye out on my team members – physicians, nurses, medical assistants, and folks at the front desk – trying to make sure that people are getting rest, trying to make sure that people are not overcommitting,” he said. “Because if we’re not all working together and working for the long term, we’re going to be in trouble. This is not going to be a sprint; this is going to be a marathon for us to get through.”

To keep mentally centered, he engages in at least 40 minutes of exercise each day on his bicycle or on the elliptical machine at home. Dr. Hopkins hopes that the current efforts to redeploy resources, expand clinician skill sets, and forge relationships with colleagues in other disciplines will carry over into the delivery of health care when COVID-19 is a distant memory. “I hope that some of those relationships are going to continue and result in better care for all of our patients,” he said.
 

"We are in dire need of hugs"

MaryAnn Dakkak, MD, is another primary care physician whose work week looks drastically different from how it looked before the pandemic. Typically, Dr. Dakkak, a family physician at Boston University, practices a mix of clinic-based family medicine and obstetrics, and works in inpatient medicine 6 weeks a year. Currently, she is leading a COVID-19 team full time at Boston Medical Center, a 300-bed safety-net hospital located on the campus of Boston University Medical Center.

Courtesy Dr. MaryAnn Dakkak

COVID-19 has also shaken up her life at home.

When Dr. Dakkak volunteered to take on her new role, the first thing that came to her mind was how making the switch would affect the well-being of her 8-year-old son and 10-year-old daughter.

“I thought, ‘How do I get my children somewhere where I don’t have to worry about them?’ ” Dr. Dakkak said.

She floated the idea with her husband of flying their children out to stay with her recently retired parents, who live outside of Sacramento, Calif., until the pandemic eases up. “I was thinking to myself, ‘Am I overreacting? Is the pandemic not going to be that bad?’ because the rest of the country seemed to be in some amount of denial,” she said. “So, I called my dad, who’s a retired pediatric anesthesiologist. He’s from Egypt so he’s done crisis medicine in his time. He encouraged me to send the kids.”

On the same day that Dr. Dakkak began her first 12-hour COVID-19 shift at the hospital, her husband and children boarded a plane to California, where the kids remain in the care of her parents. Her husband returned after staying there for 2 weeks. “Every day when I’m working, I validate my decision,” she said. “When I first started, I worked 5 nights in a row, had 2 days off, and then worked 6 nights in a row. I was busy so I didn’t think about [being away from my kids], but at the same time I was grateful that I didn’t have to come home and worry about homeschooling the kids or infecting them.”

She checks in with them as she can via cell phone or FaceTime. “My son has been very honest,” Dr. Dakkak said. “He says, ‘FaceTime makes me miss you more, and I don’t like it,’ which I understand. I’ll call my mom, and if they want to talk to me, they’ll talk to me. If they don’t want to talk to me, I’m okay. This is about them being healthy and safe. I sent them a care package a few days ago with cards and some workbooks. I’m optimistic that in June I can at least see them if not bring them home.”

Dr. Dakkak describes leading a COVID-19 team as a grueling experience that challenges her medical know-how nearly every day, with seemingly ever-changing algorithms. “Our knowledge of this disease is five steps behind, and changing at lightning speed,” said Dr. Dakkak, who completed a fellowship in surgical and high-risk obstetrics. “It’s hard to balance continuing to teach evidence-based medicine for everything else in medicine [with continuing] to practice minimal and ever-changing evidence-based COVID medicine. We just don’t know enough [about the virus] yet. This is nothing like we were taught in medical school. Everyone has elevated d-dimers with COVID-19, and we don’t get CT pulmonary angiograms [CTPAs] on all of them; we wouldn’t physically be able to. Some patients have d-dimers in the thousands, and only some are stable to get CTPAs. We are also finding pulmonary embolisms. Now we’re basing our algorithm on anticoagulation due to d-dimers because sometimes you can’t always do a CTPA even if you want to. On the other hand, we have people who are coming into the hospital too late. We’ve had a few who have come in after having days of stroke symptoms. I worry about our patients at home who hesitate to come in when they really should.”

Sometimes she feels sad for the medical residents on her team because their instinct is to go in and check on each patient, “but I don’t want them to get exposed,” she said. “So, we check in by phone, or if they need a physical check-in, we minimize the check-ins; only one of us goes in. I’m more willing to put myself in the room than to put them in the room. I also feel for them because they came into medicine for the humanity of medicine – not the charting or the ordering of medicine. I also worry about the acuity and sadness they’re seeing. This is a rough introduction to medicine for them.”

When interviewed for this story in late April, Dr. Dakkak had kept track of her intubated COVID-19 patients. “Most of my patients get to go home without having been intubated, but those aren’t the ones I worry about,” she said. “I have two patients I have been watching. One of them has just been extubated and I’m still worried about him, but I’m hoping he’s going to be fine. The other one is the first pregnant woman we intubated. She is now extubated, doing really well, and went home. Her fetus is doing well, never had any issues while she was intubated. Those cases make me happy. They were both under the age of 35. It is nice to follow those intubations and find that the majority are doing okay.”

The first patient she had cared for who died was a young man “who was always in good spirits,” she recalled. “We called his brother right before intubating him. After intubation, his oxygen saturation didn’t jump up, which made me worry a bit.” About a week later, the young man died. “I kept thinking, ‘We intubated him when he was still comfortable talking. Should I have put it off and had him call more people to say goodbye? Should I have known that he wasn’t going to wake up?’ ” said Dr. Dakkak, who is also women’s health director at Manet Community Health Centers. “A lot of us have worked on our end-of-life discussions in the past month, just being able to tell somebody, ‘This might be your last time to call family. Call family and talk to whoever you want.’ Guilt isn’t the right word, but it’s unsettling if I’m the last person a patient talks to. I feel that, if that’s the case, then I didn’t do a good enough job trying to get them to their family or friends. If I am worried about a patient’s clinical status declining, I tell families now, when I call them, ‘I hope I’m wrong; I hope they don’t need to be intubated, but I think this is the time to talk.’ ”

To keep herself grounded during off hours, Dr. Dakkak spends time resting, checking in with her family, journaling “to get a lot of feelings out,” gardening, hiking, and joining Zoom chats with friends. Once recentered, she draws from a sense of obligation to others as she prepares for her next shift caring for COVID-19 patients.

“I have a lot of love for the world that I get to expend by doing this hard work,” she said. “I love humanity and I love humanity in times of crisis. The interactions I have with patients and their families are still central to why I do this work. I love my medical teams, and I would never want to let them down. It is nice to feel the sense of teamwork across the hospital. The nurses that I sit with and experience this with are amazing. I keep saying that the only thing I want to do when this pandemic is over is hug everyone. I think we are in dire need of hugs.”
 

Finding light in the darkness

Internist Katie Jobbins, DO, also has worked in a professional role that was created because of COVID-19.

Shortly before Dr. Jobbins was deployed to Baystate Medical Center in Springfield, Ma., for 2 weeks in April of 2020 to help clinicians with an anticipated surge of COVID-19 cases, she encountered a patient who walked into Baystate’s High Street Health Center.

“I think I have COVID-19,” the patient proclaimed to her, at the outpatient clinic that serves mostly inner-city, Medicaid patients.

Prior to becoming an ambulatory internist, Dr. Jobbins was a surgical resident. “So I went into that mode of ‘I need to do this, this, and this,’ ” she said. “I went through a checklist in my head to make sure I was prepared to take care of the patient.”

She applied that same systems approach during her redeployment assignment in the tertiary care hospital, which typically involved 10-hour shifts overseeing internal medicine residents in a medical telemetry unit. “We would take care of people under investigation for COVID-19, but we were not assigned to the actual COVID unit,” said Dr. Jobbins, who is also associate program director for the internal medicine residency program at the University of Massachusetts Medical School–Baystate Springfield. “They tried to redeploy other people to those units who had special training, and we were trying to back fill into where those people that got moved to the COVID units or the ICU units were actually working. We were taking more of the medical side of the floors.”

Even so, one patient on the unit was suspected of having COVID-19, so Dr. Jobbins suited up with personal protective equipment and conducted a thorough exam with residents waiting outside the patient’s room, a safe distance away. “I explained everything I found on the exam to the residents, trying to give them some educational benefit, even though they couldn’t physically examine the patient because we’re trying to protect them since they’re in training,” she said. “It was anxiety provoking, on some level, knowing that there’s a potential risk of exposure [to the virus], but knowing that Baystate Health has gone to extraordinary measures to make sure we have the correct PPE and support us is reassuring. I knew I had the right equipment and the right tools to take care of the patient, which calmed my nerves and made me feel like I could do the job. That’s the most important thing as a physician during this time: knowing that you have people supporting you who have your back at all times.”

Like Dr. Dakkak, Dr. Jobbins had to make some adjustments to her interaction with her family.

Before she began the deployment, Dr. Jobbins engaged in a frank discussion with her husband and her two young boys about the risks she faced working in a hospital caring for patients with COVID-19. “My husband and I made sure our wills were up to date, and we talked about what we would do if either of us got the virus,” she said. To minimize the potential risk of transmitting the virus to her loved ones during the two-week deployment, she considered living away from her family in a nearby home owned by her father, but decided against that and to “take it day by day.” Following her hospital shifts, Dr. Jobbins changed into a fresh set of clothes before leaving the hospital. Once she arrived home, she showered to reduce the risk of possibly becoming a vector to her family.

She had to tell her kids: “You can’t kiss me right now.”

“As much as it’s hard for them to understand, we had a conversation [in which I explained] ‘This is a virus. It will go away eventually, but it’s a virus we’re fighting.’ It’s interesting to watch a 3-year-old try to process that and take his play samurai sword or Marvel toys and decide he’s going to run around the neighborhood and try to kill the virus.”

At the High Street Health Center, Dr. Jobbins and her colleagues have transitioned to conducting most patient encounters via telephone or video appointments. “We have tried to maintain as much continuity for our patients to address their chronic medical needs through these visits, such as hypertension management and diabetes care,” she said. “We have begun a rigorous screening process to triage and treat patients suspicious for COVID-19 through telehealth in hopes of keeping them safe and in their own homes. We also continue to see patients for nonrespiratory urgent care needs in person once they have screened negative for COVID-19.”

“In terms of the inpatient setting, we’ve noticed that a lot of people are choosing not to go to the hospital now, unless they’re extremely ill,” Dr. Jobbins noted. “We’re going to need to find a balance with when do people truly need to go to the hospital and when do they not? What can we manage as an outpatient versus having someone go to the emergency department? That’s really the role of the primary care physician. We need to help people understand, ‘You don’t need to go to the ED for everything, but here are the things you really need to go for.’ ”

“It will be interesting to see what health care looks like in 6 months or a year. I’m excited to see where we land,” Dr. Jobbins added.


 

Hopes for the Future of Telemedicine

When the practice of medicine enters a post–COVID-19 era, Dr. Jobbins hopes that telemedicine will be incorporated more into the delivery of patient care. “I’ve found that many of my patients who often are no-shows to the inpatient version of their visits have had a higher success rate of follow-through when we do the telephone visits,” she said. “It’s been very successful. I hope that the insurance companies and [Centers for Medicare & Medicaid] will continue to reimburse this as they see this is a benefit to our patients.

Courtesy Dr. Robert Hopkins, Jr.

Dr. Hopkins is also hopeful that physicians will be able to successfully see patients via telemedicine in the postpandemic world.

“For the ups and downs we’ve had with telemedicine, I’d love for us to be able to enhance the positives and incorporate that into our practice going forward. If we can reach our patients and help treat them where they are, rather than them having to come to us, that may be a plus,” he said.

In the meantime, Dr. Jobbins presses on as the curve of COVID-19 cases flattens in Western Massachusetts and remains grateful that she chose to practice medicine.

“The commitment I have to being an educator in addition to being a physician is part of why I keep doing this,” Dr. Jobbins said. “I find this to be one of the most fulfilling jobs and careers you could ever have: being there for people when they need you the most. That’s really what a physician’s job is: being there for people when a family member has passed away or when they just need to talk because they’re having anxiety. At the end of the day, if we can impart that to those we work with and bring in a positive attitude, it’s infectious and it makes people see this is a reason we keep doing what we’re doing.”

She’s also been heartened by the kindness of strangers during this pandemic, from those who made and donated face shields when they were in short supply, to those who delivered food to the hospital as a gesture of thanks.

“I had a patient who made homemade masks and sent them to my office,” she said. “There’s obviously good and bad during this time, but I get hope from seeing all of the good things that are coming out of this, the whole idea of finding the light in the darkness.”

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During his shift at a COVID-19 drive-through triage screening area set up outside the University of Arkansas for Medical Sciences in Little Rock, Robert Hopkins Jr., MD, noticed a woman bowled over in the front seat of her car.

Courtesy Dr. Robert Hopkins, Jr.

A nurse practitioner had just informed her that she had met the criteria for undergoing testing for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

“She was very upset and was crying nearly inconsolably,” said Dr. Hopkins, who directs the division of general internal medicine at the University of Arkansas Medical Sciences College of Medicine. “I went over and visited with her for a few minutes. She was scared to death that we [had] told her she was going to die. In her mind, if she had COVID-19 that meant a death sentence, and if we were testing her that meant she was likely to not survive.”

Dr. Hopkins tried his best to put testing in perspective for the woman. “At least she came to a level of comfort and realized that we were doing this for her, that this was not a death sentence, that this was not her fault,” he said. “She was worried about infecting her kids and her grandkids and ending up in the hospital and being a burden. Being able to spend that few minutes with her and help to bring down her level of anxiety – I think that’s where we need to put our efforts as physicians right now, helping people understand, ‘Yes, this is serious. Yes, we need to continue to social distance. Yes, we need to be cautious. But, we will get through this if we all work together to do so.’ ”

Prior to the COVID-19 pandemic, Dr. Hopkins spent part of his time seeing patients in the university’s main hospital, but most of it in an outpatient clinic where he and about 20 other primary care physicians care for patients and precept medical residents. Now, medical residents have been deployed to other services, primarily in the hospital, and he and his physician colleagues are conducting 80%-90% of patient visits by video conferencing or by telephone. It’s a whole new world.

“We’ve gone from a relatively traditional inpatient/outpatient practice where we’re seeing patients face to face to doing some face-to-face visits, but an awful lot of what we do now is in the technology domain,” said Dr. Hopkins, who also assisted with health care relief efforts during hurricanes Rita and Katrina.

“A group of six of us has been redeployed to assist with the surge unit for the inpatient facility, so our outpatient duties are being taken on by some of our partners.”

He also pitches in at the drive-through COVID-19 screening clinic, which was set up on March 27 and operates between 8 a.m. and 8 p.m., 7 days a week. “We’re able to measure people’s temperature, take a quick screening history, decide whether their risk is such that we need to do a COVID-19 PCR [polymerase chain reaction] test,” he said. “Then we make a determination of whether they need to go home on quarantine awaiting those results, or if they don’t have anything that needs to be evaluated, or whether they need to be triaged to an urgent care setting or to the emergency department.”

To minimize his risk of acquiring COVID-19, he follows personal hygiene practices recommended by the Centers for Disease Control and Prevention. He also places his work shoes in a shoebox, which he keeps in his car. “I put them on when I get to the parking deck at work, do my work, and then I put them in the shoebox, slip on another pair of shoes and drive home so I’m not tracking in things I potentially had on me,” said Dr. Hopkins, who is married and a father to two college-aged sons and a daughter in fourth grade. “When I get home I immediately shower, and then I exercise or have dinner with my family.”

Despite the longer-than-usual work hours and upheaval to the traditional medical practice model brought on by the pandemic, Dr. Hopkins, a self-described “glass half full person,” said that he does his best to keep watch over his patients and colleagues. “I’m trying to keep an eye out on my team members – physicians, nurses, medical assistants, and folks at the front desk – trying to make sure that people are getting rest, trying to make sure that people are not overcommitting,” he said. “Because if we’re not all working together and working for the long term, we’re going to be in trouble. This is not going to be a sprint; this is going to be a marathon for us to get through.”

To keep mentally centered, he engages in at least 40 minutes of exercise each day on his bicycle or on the elliptical machine at home. Dr. Hopkins hopes that the current efforts to redeploy resources, expand clinician skill sets, and forge relationships with colleagues in other disciplines will carry over into the delivery of health care when COVID-19 is a distant memory. “I hope that some of those relationships are going to continue and result in better care for all of our patients,” he said.
 

"We are in dire need of hugs"

MaryAnn Dakkak, MD, is another primary care physician whose work week looks drastically different from how it looked before the pandemic. Typically, Dr. Dakkak, a family physician at Boston University, practices a mix of clinic-based family medicine and obstetrics, and works in inpatient medicine 6 weeks a year. Currently, she is leading a COVID-19 team full time at Boston Medical Center, a 300-bed safety-net hospital located on the campus of Boston University Medical Center.

Courtesy Dr. MaryAnn Dakkak

COVID-19 has also shaken up her life at home.

When Dr. Dakkak volunteered to take on her new role, the first thing that came to her mind was how making the switch would affect the well-being of her 8-year-old son and 10-year-old daughter.

“I thought, ‘How do I get my children somewhere where I don’t have to worry about them?’ ” Dr. Dakkak said.

She floated the idea with her husband of flying their children out to stay with her recently retired parents, who live outside of Sacramento, Calif., until the pandemic eases up. “I was thinking to myself, ‘Am I overreacting? Is the pandemic not going to be that bad?’ because the rest of the country seemed to be in some amount of denial,” she said. “So, I called my dad, who’s a retired pediatric anesthesiologist. He’s from Egypt so he’s done crisis medicine in his time. He encouraged me to send the kids.”

On the same day that Dr. Dakkak began her first 12-hour COVID-19 shift at the hospital, her husband and children boarded a plane to California, where the kids remain in the care of her parents. Her husband returned after staying there for 2 weeks. “Every day when I’m working, I validate my decision,” she said. “When I first started, I worked 5 nights in a row, had 2 days off, and then worked 6 nights in a row. I was busy so I didn’t think about [being away from my kids], but at the same time I was grateful that I didn’t have to come home and worry about homeschooling the kids or infecting them.”

She checks in with them as she can via cell phone or FaceTime. “My son has been very honest,” Dr. Dakkak said. “He says, ‘FaceTime makes me miss you more, and I don’t like it,’ which I understand. I’ll call my mom, and if they want to talk to me, they’ll talk to me. If they don’t want to talk to me, I’m okay. This is about them being healthy and safe. I sent them a care package a few days ago with cards and some workbooks. I’m optimistic that in June I can at least see them if not bring them home.”

Dr. Dakkak describes leading a COVID-19 team as a grueling experience that challenges her medical know-how nearly every day, with seemingly ever-changing algorithms. “Our knowledge of this disease is five steps behind, and changing at lightning speed,” said Dr. Dakkak, who completed a fellowship in surgical and high-risk obstetrics. “It’s hard to balance continuing to teach evidence-based medicine for everything else in medicine [with continuing] to practice minimal and ever-changing evidence-based COVID medicine. We just don’t know enough [about the virus] yet. This is nothing like we were taught in medical school. Everyone has elevated d-dimers with COVID-19, and we don’t get CT pulmonary angiograms [CTPAs] on all of them; we wouldn’t physically be able to. Some patients have d-dimers in the thousands, and only some are stable to get CTPAs. We are also finding pulmonary embolisms. Now we’re basing our algorithm on anticoagulation due to d-dimers because sometimes you can’t always do a CTPA even if you want to. On the other hand, we have people who are coming into the hospital too late. We’ve had a few who have come in after having days of stroke symptoms. I worry about our patients at home who hesitate to come in when they really should.”

Sometimes she feels sad for the medical residents on her team because their instinct is to go in and check on each patient, “but I don’t want them to get exposed,” she said. “So, we check in by phone, or if they need a physical check-in, we minimize the check-ins; only one of us goes in. I’m more willing to put myself in the room than to put them in the room. I also feel for them because they came into medicine for the humanity of medicine – not the charting or the ordering of medicine. I also worry about the acuity and sadness they’re seeing. This is a rough introduction to medicine for them.”

When interviewed for this story in late April, Dr. Dakkak had kept track of her intubated COVID-19 patients. “Most of my patients get to go home without having been intubated, but those aren’t the ones I worry about,” she said. “I have two patients I have been watching. One of them has just been extubated and I’m still worried about him, but I’m hoping he’s going to be fine. The other one is the first pregnant woman we intubated. She is now extubated, doing really well, and went home. Her fetus is doing well, never had any issues while she was intubated. Those cases make me happy. They were both under the age of 35. It is nice to follow those intubations and find that the majority are doing okay.”

The first patient she had cared for who died was a young man “who was always in good spirits,” she recalled. “We called his brother right before intubating him. After intubation, his oxygen saturation didn’t jump up, which made me worry a bit.” About a week later, the young man died. “I kept thinking, ‘We intubated him when he was still comfortable talking. Should I have put it off and had him call more people to say goodbye? Should I have known that he wasn’t going to wake up?’ ” said Dr. Dakkak, who is also women’s health director at Manet Community Health Centers. “A lot of us have worked on our end-of-life discussions in the past month, just being able to tell somebody, ‘This might be your last time to call family. Call family and talk to whoever you want.’ Guilt isn’t the right word, but it’s unsettling if I’m the last person a patient talks to. I feel that, if that’s the case, then I didn’t do a good enough job trying to get them to their family or friends. If I am worried about a patient’s clinical status declining, I tell families now, when I call them, ‘I hope I’m wrong; I hope they don’t need to be intubated, but I think this is the time to talk.’ ”

To keep herself grounded during off hours, Dr. Dakkak spends time resting, checking in with her family, journaling “to get a lot of feelings out,” gardening, hiking, and joining Zoom chats with friends. Once recentered, she draws from a sense of obligation to others as she prepares for her next shift caring for COVID-19 patients.

“I have a lot of love for the world that I get to expend by doing this hard work,” she said. “I love humanity and I love humanity in times of crisis. The interactions I have with patients and their families are still central to why I do this work. I love my medical teams, and I would never want to let them down. It is nice to feel the sense of teamwork across the hospital. The nurses that I sit with and experience this with are amazing. I keep saying that the only thing I want to do when this pandemic is over is hug everyone. I think we are in dire need of hugs.”
 

Finding light in the darkness

Internist Katie Jobbins, DO, also has worked in a professional role that was created because of COVID-19.

Shortly before Dr. Jobbins was deployed to Baystate Medical Center in Springfield, Ma., for 2 weeks in April of 2020 to help clinicians with an anticipated surge of COVID-19 cases, she encountered a patient who walked into Baystate’s High Street Health Center.

“I think I have COVID-19,” the patient proclaimed to her, at the outpatient clinic that serves mostly inner-city, Medicaid patients.

Prior to becoming an ambulatory internist, Dr. Jobbins was a surgical resident. “So I went into that mode of ‘I need to do this, this, and this,’ ” she said. “I went through a checklist in my head to make sure I was prepared to take care of the patient.”

She applied that same systems approach during her redeployment assignment in the tertiary care hospital, which typically involved 10-hour shifts overseeing internal medicine residents in a medical telemetry unit. “We would take care of people under investigation for COVID-19, but we were not assigned to the actual COVID unit,” said Dr. Jobbins, who is also associate program director for the internal medicine residency program at the University of Massachusetts Medical School–Baystate Springfield. “They tried to redeploy other people to those units who had special training, and we were trying to back fill into where those people that got moved to the COVID units or the ICU units were actually working. We were taking more of the medical side of the floors.”

Even so, one patient on the unit was suspected of having COVID-19, so Dr. Jobbins suited up with personal protective equipment and conducted a thorough exam with residents waiting outside the patient’s room, a safe distance away. “I explained everything I found on the exam to the residents, trying to give them some educational benefit, even though they couldn’t physically examine the patient because we’re trying to protect them since they’re in training,” she said. “It was anxiety provoking, on some level, knowing that there’s a potential risk of exposure [to the virus], but knowing that Baystate Health has gone to extraordinary measures to make sure we have the correct PPE and support us is reassuring. I knew I had the right equipment and the right tools to take care of the patient, which calmed my nerves and made me feel like I could do the job. That’s the most important thing as a physician during this time: knowing that you have people supporting you who have your back at all times.”

Like Dr. Dakkak, Dr. Jobbins had to make some adjustments to her interaction with her family.

Before she began the deployment, Dr. Jobbins engaged in a frank discussion with her husband and her two young boys about the risks she faced working in a hospital caring for patients with COVID-19. “My husband and I made sure our wills were up to date, and we talked about what we would do if either of us got the virus,” she said. To minimize the potential risk of transmitting the virus to her loved ones during the two-week deployment, she considered living away from her family in a nearby home owned by her father, but decided against that and to “take it day by day.” Following her hospital shifts, Dr. Jobbins changed into a fresh set of clothes before leaving the hospital. Once she arrived home, she showered to reduce the risk of possibly becoming a vector to her family.

She had to tell her kids: “You can’t kiss me right now.”

“As much as it’s hard for them to understand, we had a conversation [in which I explained] ‘This is a virus. It will go away eventually, but it’s a virus we’re fighting.’ It’s interesting to watch a 3-year-old try to process that and take his play samurai sword or Marvel toys and decide he’s going to run around the neighborhood and try to kill the virus.”

At the High Street Health Center, Dr. Jobbins and her colleagues have transitioned to conducting most patient encounters via telephone or video appointments. “We have tried to maintain as much continuity for our patients to address their chronic medical needs through these visits, such as hypertension management and diabetes care,” she said. “We have begun a rigorous screening process to triage and treat patients suspicious for COVID-19 through telehealth in hopes of keeping them safe and in their own homes. We also continue to see patients for nonrespiratory urgent care needs in person once they have screened negative for COVID-19.”

“In terms of the inpatient setting, we’ve noticed that a lot of people are choosing not to go to the hospital now, unless they’re extremely ill,” Dr. Jobbins noted. “We’re going to need to find a balance with when do people truly need to go to the hospital and when do they not? What can we manage as an outpatient versus having someone go to the emergency department? That’s really the role of the primary care physician. We need to help people understand, ‘You don’t need to go to the ED for everything, but here are the things you really need to go for.’ ”

“It will be interesting to see what health care looks like in 6 months or a year. I’m excited to see where we land,” Dr. Jobbins added.


 

Hopes for the Future of Telemedicine

When the practice of medicine enters a post–COVID-19 era, Dr. Jobbins hopes that telemedicine will be incorporated more into the delivery of patient care. “I’ve found that many of my patients who often are no-shows to the inpatient version of their visits have had a higher success rate of follow-through when we do the telephone visits,” she said. “It’s been very successful. I hope that the insurance companies and [Centers for Medicare & Medicaid] will continue to reimburse this as they see this is a benefit to our patients.

Courtesy Dr. Robert Hopkins, Jr.

Dr. Hopkins is also hopeful that physicians will be able to successfully see patients via telemedicine in the postpandemic world.

“For the ups and downs we’ve had with telemedicine, I’d love for us to be able to enhance the positives and incorporate that into our practice going forward. If we can reach our patients and help treat them where they are, rather than them having to come to us, that may be a plus,” he said.

In the meantime, Dr. Jobbins presses on as the curve of COVID-19 cases flattens in Western Massachusetts and remains grateful that she chose to practice medicine.

“The commitment I have to being an educator in addition to being a physician is part of why I keep doing this,” Dr. Jobbins said. “I find this to be one of the most fulfilling jobs and careers you could ever have: being there for people when they need you the most. That’s really what a physician’s job is: being there for people when a family member has passed away or when they just need to talk because they’re having anxiety. At the end of the day, if we can impart that to those we work with and bring in a positive attitude, it’s infectious and it makes people see this is a reason we keep doing what we’re doing.”

She’s also been heartened by the kindness of strangers during this pandemic, from those who made and donated face shields when they were in short supply, to those who delivered food to the hospital as a gesture of thanks.

“I had a patient who made homemade masks and sent them to my office,” she said. “There’s obviously good and bad during this time, but I get hope from seeing all of the good things that are coming out of this, the whole idea of finding the light in the darkness.”

[email protected]

During his shift at a COVID-19 drive-through triage screening area set up outside the University of Arkansas for Medical Sciences in Little Rock, Robert Hopkins Jr., MD, noticed a woman bowled over in the front seat of her car.

Courtesy Dr. Robert Hopkins, Jr.

A nurse practitioner had just informed her that she had met the criteria for undergoing testing for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

“She was very upset and was crying nearly inconsolably,” said Dr. Hopkins, who directs the division of general internal medicine at the University of Arkansas Medical Sciences College of Medicine. “I went over and visited with her for a few minutes. She was scared to death that we [had] told her she was going to die. In her mind, if she had COVID-19 that meant a death sentence, and if we were testing her that meant she was likely to not survive.”

Dr. Hopkins tried his best to put testing in perspective for the woman. “At least she came to a level of comfort and realized that we were doing this for her, that this was not a death sentence, that this was not her fault,” he said. “She was worried about infecting her kids and her grandkids and ending up in the hospital and being a burden. Being able to spend that few minutes with her and help to bring down her level of anxiety – I think that’s where we need to put our efforts as physicians right now, helping people understand, ‘Yes, this is serious. Yes, we need to continue to social distance. Yes, we need to be cautious. But, we will get through this if we all work together to do so.’ ”

Prior to the COVID-19 pandemic, Dr. Hopkins spent part of his time seeing patients in the university’s main hospital, but most of it in an outpatient clinic where he and about 20 other primary care physicians care for patients and precept medical residents. Now, medical residents have been deployed to other services, primarily in the hospital, and he and his physician colleagues are conducting 80%-90% of patient visits by video conferencing or by telephone. It’s a whole new world.

“We’ve gone from a relatively traditional inpatient/outpatient practice where we’re seeing patients face to face to doing some face-to-face visits, but an awful lot of what we do now is in the technology domain,” said Dr. Hopkins, who also assisted with health care relief efforts during hurricanes Rita and Katrina.

“A group of six of us has been redeployed to assist with the surge unit for the inpatient facility, so our outpatient duties are being taken on by some of our partners.”

He also pitches in at the drive-through COVID-19 screening clinic, which was set up on March 27 and operates between 8 a.m. and 8 p.m., 7 days a week. “We’re able to measure people’s temperature, take a quick screening history, decide whether their risk is such that we need to do a COVID-19 PCR [polymerase chain reaction] test,” he said. “Then we make a determination of whether they need to go home on quarantine awaiting those results, or if they don’t have anything that needs to be evaluated, or whether they need to be triaged to an urgent care setting or to the emergency department.”

To minimize his risk of acquiring COVID-19, he follows personal hygiene practices recommended by the Centers for Disease Control and Prevention. He also places his work shoes in a shoebox, which he keeps in his car. “I put them on when I get to the parking deck at work, do my work, and then I put them in the shoebox, slip on another pair of shoes and drive home so I’m not tracking in things I potentially had on me,” said Dr. Hopkins, who is married and a father to two college-aged sons and a daughter in fourth grade. “When I get home I immediately shower, and then I exercise or have dinner with my family.”

Despite the longer-than-usual work hours and upheaval to the traditional medical practice model brought on by the pandemic, Dr. Hopkins, a self-described “glass half full person,” said that he does his best to keep watch over his patients and colleagues. “I’m trying to keep an eye out on my team members – physicians, nurses, medical assistants, and folks at the front desk – trying to make sure that people are getting rest, trying to make sure that people are not overcommitting,” he said. “Because if we’re not all working together and working for the long term, we’re going to be in trouble. This is not going to be a sprint; this is going to be a marathon for us to get through.”

To keep mentally centered, he engages in at least 40 minutes of exercise each day on his bicycle or on the elliptical machine at home. Dr. Hopkins hopes that the current efforts to redeploy resources, expand clinician skill sets, and forge relationships with colleagues in other disciplines will carry over into the delivery of health care when COVID-19 is a distant memory. “I hope that some of those relationships are going to continue and result in better care for all of our patients,” he said.
 

"We are in dire need of hugs"

MaryAnn Dakkak, MD, is another primary care physician whose work week looks drastically different from how it looked before the pandemic. Typically, Dr. Dakkak, a family physician at Boston University, practices a mix of clinic-based family medicine and obstetrics, and works in inpatient medicine 6 weeks a year. Currently, she is leading a COVID-19 team full time at Boston Medical Center, a 300-bed safety-net hospital located on the campus of Boston University Medical Center.

Courtesy Dr. MaryAnn Dakkak

COVID-19 has also shaken up her life at home.

When Dr. Dakkak volunteered to take on her new role, the first thing that came to her mind was how making the switch would affect the well-being of her 8-year-old son and 10-year-old daughter.

“I thought, ‘How do I get my children somewhere where I don’t have to worry about them?’ ” Dr. Dakkak said.

She floated the idea with her husband of flying their children out to stay with her recently retired parents, who live outside of Sacramento, Calif., until the pandemic eases up. “I was thinking to myself, ‘Am I overreacting? Is the pandemic not going to be that bad?’ because the rest of the country seemed to be in some amount of denial,” she said. “So, I called my dad, who’s a retired pediatric anesthesiologist. He’s from Egypt so he’s done crisis medicine in his time. He encouraged me to send the kids.”

On the same day that Dr. Dakkak began her first 12-hour COVID-19 shift at the hospital, her husband and children boarded a plane to California, where the kids remain in the care of her parents. Her husband returned after staying there for 2 weeks. “Every day when I’m working, I validate my decision,” she said. “When I first started, I worked 5 nights in a row, had 2 days off, and then worked 6 nights in a row. I was busy so I didn’t think about [being away from my kids], but at the same time I was grateful that I didn’t have to come home and worry about homeschooling the kids or infecting them.”

She checks in with them as she can via cell phone or FaceTime. “My son has been very honest,” Dr. Dakkak said. “He says, ‘FaceTime makes me miss you more, and I don’t like it,’ which I understand. I’ll call my mom, and if they want to talk to me, they’ll talk to me. If they don’t want to talk to me, I’m okay. This is about them being healthy and safe. I sent them a care package a few days ago with cards and some workbooks. I’m optimistic that in June I can at least see them if not bring them home.”

Dr. Dakkak describes leading a COVID-19 team as a grueling experience that challenges her medical know-how nearly every day, with seemingly ever-changing algorithms. “Our knowledge of this disease is five steps behind, and changing at lightning speed,” said Dr. Dakkak, who completed a fellowship in surgical and high-risk obstetrics. “It’s hard to balance continuing to teach evidence-based medicine for everything else in medicine [with continuing] to practice minimal and ever-changing evidence-based COVID medicine. We just don’t know enough [about the virus] yet. This is nothing like we were taught in medical school. Everyone has elevated d-dimers with COVID-19, and we don’t get CT pulmonary angiograms [CTPAs] on all of them; we wouldn’t physically be able to. Some patients have d-dimers in the thousands, and only some are stable to get CTPAs. We are also finding pulmonary embolisms. Now we’re basing our algorithm on anticoagulation due to d-dimers because sometimes you can’t always do a CTPA even if you want to. On the other hand, we have people who are coming into the hospital too late. We’ve had a few who have come in after having days of stroke symptoms. I worry about our patients at home who hesitate to come in when they really should.”

Sometimes she feels sad for the medical residents on her team because their instinct is to go in and check on each patient, “but I don’t want them to get exposed,” she said. “So, we check in by phone, or if they need a physical check-in, we minimize the check-ins; only one of us goes in. I’m more willing to put myself in the room than to put them in the room. I also feel for them because they came into medicine for the humanity of medicine – not the charting or the ordering of medicine. I also worry about the acuity and sadness they’re seeing. This is a rough introduction to medicine for them.”

When interviewed for this story in late April, Dr. Dakkak had kept track of her intubated COVID-19 patients. “Most of my patients get to go home without having been intubated, but those aren’t the ones I worry about,” she said. “I have two patients I have been watching. One of them has just been extubated and I’m still worried about him, but I’m hoping he’s going to be fine. The other one is the first pregnant woman we intubated. She is now extubated, doing really well, and went home. Her fetus is doing well, never had any issues while she was intubated. Those cases make me happy. They were both under the age of 35. It is nice to follow those intubations and find that the majority are doing okay.”

The first patient she had cared for who died was a young man “who was always in good spirits,” she recalled. “We called his brother right before intubating him. After intubation, his oxygen saturation didn’t jump up, which made me worry a bit.” About a week later, the young man died. “I kept thinking, ‘We intubated him when he was still comfortable talking. Should I have put it off and had him call more people to say goodbye? Should I have known that he wasn’t going to wake up?’ ” said Dr. Dakkak, who is also women’s health director at Manet Community Health Centers. “A lot of us have worked on our end-of-life discussions in the past month, just being able to tell somebody, ‘This might be your last time to call family. Call family and talk to whoever you want.’ Guilt isn’t the right word, but it’s unsettling if I’m the last person a patient talks to. I feel that, if that’s the case, then I didn’t do a good enough job trying to get them to their family or friends. If I am worried about a patient’s clinical status declining, I tell families now, when I call them, ‘I hope I’m wrong; I hope they don’t need to be intubated, but I think this is the time to talk.’ ”

To keep herself grounded during off hours, Dr. Dakkak spends time resting, checking in with her family, journaling “to get a lot of feelings out,” gardening, hiking, and joining Zoom chats with friends. Once recentered, she draws from a sense of obligation to others as she prepares for her next shift caring for COVID-19 patients.

“I have a lot of love for the world that I get to expend by doing this hard work,” she said. “I love humanity and I love humanity in times of crisis. The interactions I have with patients and their families are still central to why I do this work. I love my medical teams, and I would never want to let them down. It is nice to feel the sense of teamwork across the hospital. The nurses that I sit with and experience this with are amazing. I keep saying that the only thing I want to do when this pandemic is over is hug everyone. I think we are in dire need of hugs.”
 

Finding light in the darkness

Internist Katie Jobbins, DO, also has worked in a professional role that was created because of COVID-19.

Shortly before Dr. Jobbins was deployed to Baystate Medical Center in Springfield, Ma., for 2 weeks in April of 2020 to help clinicians with an anticipated surge of COVID-19 cases, she encountered a patient who walked into Baystate’s High Street Health Center.

“I think I have COVID-19,” the patient proclaimed to her, at the outpatient clinic that serves mostly inner-city, Medicaid patients.

Prior to becoming an ambulatory internist, Dr. Jobbins was a surgical resident. “So I went into that mode of ‘I need to do this, this, and this,’ ” she said. “I went through a checklist in my head to make sure I was prepared to take care of the patient.”

She applied that same systems approach during her redeployment assignment in the tertiary care hospital, which typically involved 10-hour shifts overseeing internal medicine residents in a medical telemetry unit. “We would take care of people under investigation for COVID-19, but we were not assigned to the actual COVID unit,” said Dr. Jobbins, who is also associate program director for the internal medicine residency program at the University of Massachusetts Medical School–Baystate Springfield. “They tried to redeploy other people to those units who had special training, and we were trying to back fill into where those people that got moved to the COVID units or the ICU units were actually working. We were taking more of the medical side of the floors.”

Even so, one patient on the unit was suspected of having COVID-19, so Dr. Jobbins suited up with personal protective equipment and conducted a thorough exam with residents waiting outside the patient’s room, a safe distance away. “I explained everything I found on the exam to the residents, trying to give them some educational benefit, even though they couldn’t physically examine the patient because we’re trying to protect them since they’re in training,” she said. “It was anxiety provoking, on some level, knowing that there’s a potential risk of exposure [to the virus], but knowing that Baystate Health has gone to extraordinary measures to make sure we have the correct PPE and support us is reassuring. I knew I had the right equipment and the right tools to take care of the patient, which calmed my nerves and made me feel like I could do the job. That’s the most important thing as a physician during this time: knowing that you have people supporting you who have your back at all times.”

Like Dr. Dakkak, Dr. Jobbins had to make some adjustments to her interaction with her family.

Before she began the deployment, Dr. Jobbins engaged in a frank discussion with her husband and her two young boys about the risks she faced working in a hospital caring for patients with COVID-19. “My husband and I made sure our wills were up to date, and we talked about what we would do if either of us got the virus,” she said. To minimize the potential risk of transmitting the virus to her loved ones during the two-week deployment, she considered living away from her family in a nearby home owned by her father, but decided against that and to “take it day by day.” Following her hospital shifts, Dr. Jobbins changed into a fresh set of clothes before leaving the hospital. Once she arrived home, she showered to reduce the risk of possibly becoming a vector to her family.

She had to tell her kids: “You can’t kiss me right now.”

“As much as it’s hard for them to understand, we had a conversation [in which I explained] ‘This is a virus. It will go away eventually, but it’s a virus we’re fighting.’ It’s interesting to watch a 3-year-old try to process that and take his play samurai sword or Marvel toys and decide he’s going to run around the neighborhood and try to kill the virus.”

At the High Street Health Center, Dr. Jobbins and her colleagues have transitioned to conducting most patient encounters via telephone or video appointments. “We have tried to maintain as much continuity for our patients to address their chronic medical needs through these visits, such as hypertension management and diabetes care,” she said. “We have begun a rigorous screening process to triage and treat patients suspicious for COVID-19 through telehealth in hopes of keeping them safe and in their own homes. We also continue to see patients for nonrespiratory urgent care needs in person once they have screened negative for COVID-19.”

“In terms of the inpatient setting, we’ve noticed that a lot of people are choosing not to go to the hospital now, unless they’re extremely ill,” Dr. Jobbins noted. “We’re going to need to find a balance with when do people truly need to go to the hospital and when do they not? What can we manage as an outpatient versus having someone go to the emergency department? That’s really the role of the primary care physician. We need to help people understand, ‘You don’t need to go to the ED for everything, but here are the things you really need to go for.’ ”

“It will be interesting to see what health care looks like in 6 months or a year. I’m excited to see where we land,” Dr. Jobbins added.


 

Hopes for the Future of Telemedicine

When the practice of medicine enters a post–COVID-19 era, Dr. Jobbins hopes that telemedicine will be incorporated more into the delivery of patient care. “I’ve found that many of my patients who often are no-shows to the inpatient version of their visits have had a higher success rate of follow-through when we do the telephone visits,” she said. “It’s been very successful. I hope that the insurance companies and [Centers for Medicare & Medicaid] will continue to reimburse this as they see this is a benefit to our patients.

Courtesy Dr. Robert Hopkins, Jr.

Dr. Hopkins is also hopeful that physicians will be able to successfully see patients via telemedicine in the postpandemic world.

“For the ups and downs we’ve had with telemedicine, I’d love for us to be able to enhance the positives and incorporate that into our practice going forward. If we can reach our patients and help treat them where they are, rather than them having to come to us, that may be a plus,” he said.

In the meantime, Dr. Jobbins presses on as the curve of COVID-19 cases flattens in Western Massachusetts and remains grateful that she chose to practice medicine.

“The commitment I have to being an educator in addition to being a physician is part of why I keep doing this,” Dr. Jobbins said. “I find this to be one of the most fulfilling jobs and careers you could ever have: being there for people when they need you the most. That’s really what a physician’s job is: being there for people when a family member has passed away or when they just need to talk because they’re having anxiety. At the end of the day, if we can impart that to those we work with and bring in a positive attitude, it’s infectious and it makes people see this is a reason we keep doing what we’re doing.”

She’s also been heartened by the kindness of strangers during this pandemic, from those who made and donated face shields when they were in short supply, to those who delivered food to the hospital as a gesture of thanks.

“I had a patient who made homemade masks and sent them to my office,” she said. “There’s obviously good and bad during this time, but I get hope from seeing all of the good things that are coming out of this, the whole idea of finding the light in the darkness.”

[email protected]

Out-of-hospital cardiac arrests increased 58% during the peak of the COVID-19 outbreak in the hard-hit region of Lombardy, Italy, compared with the same period last year, a new analysis shows.

During the first 40 days of the outbreak beginning Feb. 21, four provinces in northern Italy reported 362 cases of out-of-hospital cardiac arrest compared with 229 during the same period in 2019.

The increases in these provinces varied in magnitude from 18% in Mantua, where there were 1,688 confirmed COVID-19 cases, to 187% in Lodi, which had 2,116 COVID-19 cases. The Cremona province, which had the highest number of COVID-19 cases at 3,869, saw a 143% increase in out-of-hospital cardiac arrests.

The mortality rate in the field was 14.9 percentage points higher in 2020 than in 2019 among patients in whom resuscitation was attempted by emergency medical services (EMS), Enrico Baldi, MD, University of Pavia, Italy, and colleagues reported in a letter April 29 in the New England Journal of Medicine.

“The sex and age of the patients were similar in the 2020 and 2019 periods, but in 2020, the incidence of out-of-hospital cardiac arrest due to a medical cause was 6.5 percentage points higher, the incidence of out-of-hospital cardiac arrest at home was 7.3 percentage points higher, and the incidence of unwitnessed cardiac arrest was 11.3 percentage points higher,” the authors wrote.

Patients were also less likely to receive cardiopulmonary resuscitation from bystanders in 2020 vs 2019 (–15.6 percentage points) and were more likely to die before reaching the hospital when resuscitation was attempted by EMS (+14.9 percentage points).

Among all patients, the death rate in the field increased 11.4 percentage points during the outbreak, from 77.3% in 2019 to 88.7% in 2020.

The cumulative incidence of out-of-hospital cardiac arrest in 2020 was “strongly associated” with the cumulative incidence of COVID-19 (Spearman rank correlation coefficient, 0.87; 95% confidence interval, 0.83-0.91) and the spike in cases “followed the time course of the COVID-19 outbreak,” the researchers noted.

A total of 103 patients, who arrested out of hospital and were diagnosed with or suspected of having COVID-19, “account for 77.4% of the increase in cases of out-of-hospital cardiac arrest observed in these provinces in 2020,” the investigators noted.

As the pandemic has taken hold, hospitals and physicians across the United States are also voicing concerns about the drop in the number of patients presenting with myocardial infarction (MI) or stroke.

Nearly one-third of Americans (29%) report having delayed or avoided medical care because of concerns of catching COVID-19, according to a new poll released April 28 from the American College of Emergency Physicians (ACEP) and Morning Consult, a global data research firm.

Despite many emergency departments reporting a decline in patient volume, 74% of respondents said they were worried about hospital wait times and overcrowding. Another 59% expressed concerns about being turned away from the hospital or doctor’s office.

At the same time, the survey found strong support for emergency physicians and 73% of respondents said they were concerned about overstressing the health care system.

The drop-off in Americans seeking care for MI and strokes nationally prompted eight professional societies – including ACEP, the American Heart Association, and the Association of Black Cardiologists – to issue a joint statement urging those experiencing symptoms to call 911 and seek care for these life-threatening events.

The authors have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Out-of-hospital cardiac arrests increased 58% during the peak of the COVID-19 outbreak in the hard-hit region of Lombardy, Italy, compared with the same period last year, a new analysis shows.

During the first 40 days of the outbreak beginning Feb. 21, four provinces in northern Italy reported 362 cases of out-of-hospital cardiac arrest compared with 229 during the same period in 2019.

The increases in these provinces varied in magnitude from 18% in Mantua, where there were 1,688 confirmed COVID-19 cases, to 187% in Lodi, which had 2,116 COVID-19 cases. The Cremona province, which had the highest number of COVID-19 cases at 3,869, saw a 143% increase in out-of-hospital cardiac arrests.

The mortality rate in the field was 14.9 percentage points higher in 2020 than in 2019 among patients in whom resuscitation was attempted by emergency medical services (EMS), Enrico Baldi, MD, University of Pavia, Italy, and colleagues reported in a letter April 29 in the New England Journal of Medicine.

“The sex and age of the patients were similar in the 2020 and 2019 periods, but in 2020, the incidence of out-of-hospital cardiac arrest due to a medical cause was 6.5 percentage points higher, the incidence of out-of-hospital cardiac arrest at home was 7.3 percentage points higher, and the incidence of unwitnessed cardiac arrest was 11.3 percentage points higher,” the authors wrote.

Patients were also less likely to receive cardiopulmonary resuscitation from bystanders in 2020 vs 2019 (–15.6 percentage points) and were more likely to die before reaching the hospital when resuscitation was attempted by EMS (+14.9 percentage points).

Among all patients, the death rate in the field increased 11.4 percentage points during the outbreak, from 77.3% in 2019 to 88.7% in 2020.

The cumulative incidence of out-of-hospital cardiac arrest in 2020 was “strongly associated” with the cumulative incidence of COVID-19 (Spearman rank correlation coefficient, 0.87; 95% confidence interval, 0.83-0.91) and the spike in cases “followed the time course of the COVID-19 outbreak,” the researchers noted.

A total of 103 patients, who arrested out of hospital and were diagnosed with or suspected of having COVID-19, “account for 77.4% of the increase in cases of out-of-hospital cardiac arrest observed in these provinces in 2020,” the investigators noted.

As the pandemic has taken hold, hospitals and physicians across the United States are also voicing concerns about the drop in the number of patients presenting with myocardial infarction (MI) or stroke.

Nearly one-third of Americans (29%) report having delayed or avoided medical care because of concerns of catching COVID-19, according to a new poll released April 28 from the American College of Emergency Physicians (ACEP) and Morning Consult, a global data research firm.

Despite many emergency departments reporting a decline in patient volume, 74% of respondents said they were worried about hospital wait times and overcrowding. Another 59% expressed concerns about being turned away from the hospital or doctor’s office.

At the same time, the survey found strong support for emergency physicians and 73% of respondents said they were concerned about overstressing the health care system.

The drop-off in Americans seeking care for MI and strokes nationally prompted eight professional societies – including ACEP, the American Heart Association, and the Association of Black Cardiologists – to issue a joint statement urging those experiencing symptoms to call 911 and seek care for these life-threatening events.

The authors have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

Out-of-hospital cardiac arrests increased 58% during the peak of the COVID-19 outbreak in the hard-hit region of Lombardy, Italy, compared with the same period last year, a new analysis shows.

During the first 40 days of the outbreak beginning Feb. 21, four provinces in northern Italy reported 362 cases of out-of-hospital cardiac arrest compared with 229 during the same period in 2019.

The increases in these provinces varied in magnitude from 18% in Mantua, where there were 1,688 confirmed COVID-19 cases, to 187% in Lodi, which had 2,116 COVID-19 cases. The Cremona province, which had the highest number of COVID-19 cases at 3,869, saw a 143% increase in out-of-hospital cardiac arrests.

The mortality rate in the field was 14.9 percentage points higher in 2020 than in 2019 among patients in whom resuscitation was attempted by emergency medical services (EMS), Enrico Baldi, MD, University of Pavia, Italy, and colleagues reported in a letter April 29 in the New England Journal of Medicine.

“The sex and age of the patients were similar in the 2020 and 2019 periods, but in 2020, the incidence of out-of-hospital cardiac arrest due to a medical cause was 6.5 percentage points higher, the incidence of out-of-hospital cardiac arrest at home was 7.3 percentage points higher, and the incidence of unwitnessed cardiac arrest was 11.3 percentage points higher,” the authors wrote.

Patients were also less likely to receive cardiopulmonary resuscitation from bystanders in 2020 vs 2019 (–15.6 percentage points) and were more likely to die before reaching the hospital when resuscitation was attempted by EMS (+14.9 percentage points).

Among all patients, the death rate in the field increased 11.4 percentage points during the outbreak, from 77.3% in 2019 to 88.7% in 2020.

The cumulative incidence of out-of-hospital cardiac arrest in 2020 was “strongly associated” with the cumulative incidence of COVID-19 (Spearman rank correlation coefficient, 0.87; 95% confidence interval, 0.83-0.91) and the spike in cases “followed the time course of the COVID-19 outbreak,” the researchers noted.

A total of 103 patients, who arrested out of hospital and were diagnosed with or suspected of having COVID-19, “account for 77.4% of the increase in cases of out-of-hospital cardiac arrest observed in these provinces in 2020,” the investigators noted.

As the pandemic has taken hold, hospitals and physicians across the United States are also voicing concerns about the drop in the number of patients presenting with myocardial infarction (MI) or stroke.

Nearly one-third of Americans (29%) report having delayed or avoided medical care because of concerns of catching COVID-19, according to a new poll released April 28 from the American College of Emergency Physicians (ACEP) and Morning Consult, a global data research firm.

Despite many emergency departments reporting a decline in patient volume, 74% of respondents said they were worried about hospital wait times and overcrowding. Another 59% expressed concerns about being turned away from the hospital or doctor’s office.

At the same time, the survey found strong support for emergency physicians and 73% of respondents said they were concerned about overstressing the health care system.

The drop-off in Americans seeking care for MI and strokes nationally prompted eight professional societies – including ACEP, the American Heart Association, and the Association of Black Cardiologists – to issue a joint statement urging those experiencing symptoms to call 911 and seek care for these life-threatening events.

The authors have disclosed no relevant financial relationships.

A version of this article originally appeared on Medscape.com.