Rheumatology News

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

A version of this article first appeared on WebMD.com.

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

A version of this article first appeared on WebMD.com.

Antibody levels may wane after 7 months for people who got the Pfizer-BioNTech vaccine, according to a new study published on the bioRxiv preprint server.

In the study, which hasn’t yet been peer-reviewed or formally published in a medical journal, researchers analyzed blood samples from 46 healthy young or middle-aged adults after receiving two doses, and then 6 months after the second dose.

“Our study shows vaccination with the Pfizer-BioNTech vaccine induces high levels of neutralizing antibodies against the original vaccine strain, but these levels drop by nearly 10-fold by 7 months,” the researchers told Reuters.

In about half of the adults, neutralizing antibodies were undetectable at 6 months after the second dose, particularly against coronavirus variants such as Delta, Beta, and Mu.

Neutralizing antibodies only make up part of the body’s immune defense against the virus, Reuters noted, but they are still “critically important” in protecting against coronavirus infections.

“These findings suggest that administering a booster dose at around 6 to 7 months following the initial immunization will likely enhance protection,” the study authors wrote.

BioNTech said a new vaccine formula will likely be needed by mid-2022 to protect against future mutations of the virus, according to the Financial Times.

“This year, [a different vaccine] is completely unneeded, but by mid-next year, it could be a different situation,” Ugur Sahin, MD, cofounder and CEO of BioNTech, told the news outlet.

Current variants, namely the Delta variant, are more contagious than the original coronavirus strain but not different enough to evade current vaccines, he said. But new strains may be able to evade boosters.

“This virus will stay, and the virus will further adapt,” Dr. Sahin said. “This is a continuous evolution, and that evolution has just started.”

A version of this article first appeared on WebMD.com.

Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.

That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.

The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),

Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.

Among the states, Delaware had the largest 5-year decrease, 2.38 percentage points, as its opioid prescribing rate dropped from 6.61% to 4.23% from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.

In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.

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Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.

That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.

The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),

Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.

Among the states, Delaware had the largest 5-year decrease, 2.38 percentage points, as its opioid prescribing rate dropped from 6.61% to 4.23% from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.

In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.

[email protected]

Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.

That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.

The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),

Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.

Among the states, Delaware had the largest 5-year decrease, 2.38 percentage points, as its opioid prescribing rate dropped from 6.61% to 4.23% from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.

In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.

[email protected]

Deucravacitinib, a novel inhibitor of tyrosine kinase 2 (TYK2), continues to demonstrate strong efficacy and acceptable safety after 52 weeks of follow-up, according to late-breaking data from two pivotal trials presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

From benefit reported on the two coprimary endpoints previously reported at 16 weeks, longer follow-up showed further gains out to 24 weeks and then persistent efficacy out to 52 weeks across these and multiple secondary endpoints, reported Richard Warren, MBChB, PhD, professor of dermatology and therapeutics, University of Manchester (England).

“This could be a unique oral therapy and an important treatment option for moderate to severe psoriasis,” Dr. Warren contended.

The multinational double-blind trials, called POETYK PSO-1 and PSO-2, enrolled 666 and 1,020 patients, respectively. The designs were similar. Patients with moderate to severe plaque psoriasis were randomly assigned in a 2:1:1 ratio to deucravacitinib (6 mg once daily), placebo, or apremilast (Otezla; 30 mg twice daily). At 16 weeks, those on placebo were switched to deucravacitinib.

For the coprimary endpoint of PASI 75 (75% clearance on the Psoriasis and Severity Index), the similar rate of response for deucravacitinib in the two studies (58.7%/53.6%) at week 16 was superior to the rates observed on both apremilast (35.1%/40.2%) and placebo (12.7%/9.4%).

By week 24, the proportion of deucravacitinib patients with a PASI 75 response had reached 69.3% and 58.7% in the POETYK PSO-1 and PSO-2 trials, respectively. The proportion of patients on apremilast with PASI 75 at this time point did not increase appreciably in one study and fell modestly in the other.

By week 52, the response rates achieved with deucravacitinib at week 24 were generally unchanged and nearly double those observed on apremilast.

The pattern of relative benefit on the other coprimary endpoint, which was a score of 0 or 1, signifying clear or almost clear skin on the static Physicians Global Assessment (sPGA), followed the same pattern. At week 16, 53.6% of patients had achieved sPGA 0/1. This was significantly higher than that observed on either apremilast or placebo, and this level of response was sustained through week 52.

When patients on placebo were switched to deucravacitinib at week 16, the PASI 75 response climbed quickly. There was complete catch-up by 32 weeks. In both groups, a PASI 75 response rate of about 65% or higher was maintained for the remainder of the study.

On a prespecified analysis, prior treatment exposure was not associated with any impact on the degree of response with deucravacitinib. This included a comparison between patients exposed to no prior biologic, one prior biologic, or two or more biologics, Dr. Warren reported.

Unlike patients in POETYK PSO-1, those with a PASI 75 response at 16 weeks in the POETYK PSO-2 trial were rerandomized to remain on deucravacitinib or switch to placebo. Designed to evaluate response durability, this analysis showed a relatively gradual decline in disease control.

“The median time to a loss of response was 12 weeks,” Dr. Warren said. He was referring in this case to the PASI 75 response, but the slope of decline was similar for sPGA score 0/1. At the end of 52 weeks, 31.3% of patients who had been rerandomized to placebo still maintained a PASI 75 while 80.4% of those who stayed on deucravacitinib still had PASI 75 clearance.

In the 52-week data from these two trials, several secondary endpoints have already been examined, and Dr. Warren said more analyses are coming. So far, the pattern of response has been similar for all endpoints.

Reporting on one as an example, Dr. Warren said that sPGA 0/1 for scalp psoriasis was achieved at week 16 by 70.3% of those randomly assigned to deucravacitinib versus 17.4% of those in the placebo arm. Among those switched from placebo to deucravacitinib at 16 weeks, the scalp response had caught up to that observed in those initiated on deucravacitinib by week 28. The response was sustained out to 52 weeks in both groups.

In the long-term trials, there have been no new safety concerns, according to Dr. Warren. He described this drug as “well tolerated,” adding that no significant laboratory abnormalities have been observed on long-term treatment. Although there has been a trend for increased risk of viral infections, such as herpes zoster, relative to apremilast, cases have so far been mild.

The Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has been approved for psoriatic arthritis, and numerous other JAK inhibitors are now in clinical trials for plaque psoriasis. These agents vary for their relative selectivity for JAK1, 2, and 3 kinases, but deucravacitinib is the first JAK inhibitor to reach clinical trials that target TYK2, which inhibits interleukin-23 and other cytokines implicated in the pathogenesis of plaque psoriasis.

“Deucravacitinib is very distinct from the other JAK inhibitors, and I think we are seeing this in the clinical studies,” Dr. Warren said. As a result of responses in the POETYK PRO trials that rival those achieved with monoclonal antibodies, he expects this drug, if approved, to be an important option for those with moderate to severe disease who prefer oral therapies.

Mark G. Lebwohl, MD, professor of dermatology and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York, shares this opinion. In an interview, he emphasized the unique mechanism of deucravacitinib and its clinical potential.

“Unlike other less specific JAK inhibitors, deucravacitinib has a unique binding site on TYK2, the regulatory domain of the molecule. This makes deucravacitinib more targeted and therefore safer than other JAK inhibitors,” said Dr. Lebwohl.

“After cyclosporine, which has many side effects, deucravacitinib is the most effective oral therapy we have for psoriasis and one of the safest,” he added.

The POETYK PSO-1 and PSO-2 trials received funding from Bristol-Myers Squibb. Dr. Warren has financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB, and Xenoport. Dr. Lebwohl has financial relationships with more than 20 pharmaceutical companies, including Bristol-Myers Squibb.

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

Deucravacitinib, a novel inhibitor of tyrosine kinase 2 (TYK2), continues to demonstrate strong efficacy and acceptable safety after 52 weeks of follow-up, according to late-breaking data from two pivotal trials presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

From benefit reported on the two coprimary endpoints previously reported at 16 weeks, longer follow-up showed further gains out to 24 weeks and then persistent efficacy out to 52 weeks across these and multiple secondary endpoints, reported Richard Warren, MBChB, PhD, professor of dermatology and therapeutics, University of Manchester (England).

“This could be a unique oral therapy and an important treatment option for moderate to severe psoriasis,” Dr. Warren contended.

The multinational double-blind trials, called POETYK PSO-1 and PSO-2, enrolled 666 and 1,020 patients, respectively. The designs were similar. Patients with moderate to severe plaque psoriasis were randomly assigned in a 2:1:1 ratio to deucravacitinib (6 mg once daily), placebo, or apremilast (Otezla; 30 mg twice daily). At 16 weeks, those on placebo were switched to deucravacitinib.

For the coprimary endpoint of PASI 75 (75% clearance on the Psoriasis and Severity Index), the similar rate of response for deucravacitinib in the two studies (58.7%/53.6%) at week 16 was superior to the rates observed on both apremilast (35.1%/40.2%) and placebo (12.7%/9.4%).

By week 24, the proportion of deucravacitinib patients with a PASI 75 response had reached 69.3% and 58.7% in the POETYK PSO-1 and PSO-2 trials, respectively. The proportion of patients on apremilast with PASI 75 at this time point did not increase appreciably in one study and fell modestly in the other.

By week 52, the response rates achieved with deucravacitinib at week 24 were generally unchanged and nearly double those observed on apremilast.

The pattern of relative benefit on the other coprimary endpoint, which was a score of 0 or 1, signifying clear or almost clear skin on the static Physicians Global Assessment (sPGA), followed the same pattern. At week 16, 53.6% of patients had achieved sPGA 0/1. This was significantly higher than that observed on either apremilast or placebo, and this level of response was sustained through week 52.

When patients on placebo were switched to deucravacitinib at week 16, the PASI 75 response climbed quickly. There was complete catch-up by 32 weeks. In both groups, a PASI 75 response rate of about 65% or higher was maintained for the remainder of the study.

On a prespecified analysis, prior treatment exposure was not associated with any impact on the degree of response with deucravacitinib. This included a comparison between patients exposed to no prior biologic, one prior biologic, or two or more biologics, Dr. Warren reported.

Unlike patients in POETYK PSO-1, those with a PASI 75 response at 16 weeks in the POETYK PSO-2 trial were rerandomized to remain on deucravacitinib or switch to placebo. Designed to evaluate response durability, this analysis showed a relatively gradual decline in disease control.

“The median time to a loss of response was 12 weeks,” Dr. Warren said. He was referring in this case to the PASI 75 response, but the slope of decline was similar for sPGA score 0/1. At the end of 52 weeks, 31.3% of patients who had been rerandomized to placebo still maintained a PASI 75 while 80.4% of those who stayed on deucravacitinib still had PASI 75 clearance.

In the 52-week data from these two trials, several secondary endpoints have already been examined, and Dr. Warren said more analyses are coming. So far, the pattern of response has been similar for all endpoints.

Reporting on one as an example, Dr. Warren said that sPGA 0/1 for scalp psoriasis was achieved at week 16 by 70.3% of those randomly assigned to deucravacitinib versus 17.4% of those in the placebo arm. Among those switched from placebo to deucravacitinib at 16 weeks, the scalp response had caught up to that observed in those initiated on deucravacitinib by week 28. The response was sustained out to 52 weeks in both groups.

In the long-term trials, there have been no new safety concerns, according to Dr. Warren. He described this drug as “well tolerated,” adding that no significant laboratory abnormalities have been observed on long-term treatment. Although there has been a trend for increased risk of viral infections, such as herpes zoster, relative to apremilast, cases have so far been mild.

The Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has been approved for psoriatic arthritis, and numerous other JAK inhibitors are now in clinical trials for plaque psoriasis. These agents vary for their relative selectivity for JAK1, 2, and 3 kinases, but deucravacitinib is the first JAK inhibitor to reach clinical trials that target TYK2, which inhibits interleukin-23 and other cytokines implicated in the pathogenesis of plaque psoriasis.

“Deucravacitinib is very distinct from the other JAK inhibitors, and I think we are seeing this in the clinical studies,” Dr. Warren said. As a result of responses in the POETYK PRO trials that rival those achieved with monoclonal antibodies, he expects this drug, if approved, to be an important option for those with moderate to severe disease who prefer oral therapies.

Mark G. Lebwohl, MD, professor of dermatology and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York, shares this opinion. In an interview, he emphasized the unique mechanism of deucravacitinib and its clinical potential.

“Unlike other less specific JAK inhibitors, deucravacitinib has a unique binding site on TYK2, the regulatory domain of the molecule. This makes deucravacitinib more targeted and therefore safer than other JAK inhibitors,” said Dr. Lebwohl.

“After cyclosporine, which has many side effects, deucravacitinib is the most effective oral therapy we have for psoriasis and one of the safest,” he added.

The POETYK PSO-1 and PSO-2 trials received funding from Bristol-Myers Squibb. Dr. Warren has financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB, and Xenoport. Dr. Lebwohl has financial relationships with more than 20 pharmaceutical companies, including Bristol-Myers Squibb.

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

Deucravacitinib, a novel inhibitor of tyrosine kinase 2 (TYK2), continues to demonstrate strong efficacy and acceptable safety after 52 weeks of follow-up, according to late-breaking data from two pivotal trials presented at the virtual annual congress of the European Academy of Dermatology and Venereology.

From benefit reported on the two coprimary endpoints previously reported at 16 weeks, longer follow-up showed further gains out to 24 weeks and then persistent efficacy out to 52 weeks across these and multiple secondary endpoints, reported Richard Warren, MBChB, PhD, professor of dermatology and therapeutics, University of Manchester (England).

“This could be a unique oral therapy and an important treatment option for moderate to severe psoriasis,” Dr. Warren contended.

The multinational double-blind trials, called POETYK PSO-1 and PSO-2, enrolled 666 and 1,020 patients, respectively. The designs were similar. Patients with moderate to severe plaque psoriasis were randomly assigned in a 2:1:1 ratio to deucravacitinib (6 mg once daily), placebo, or apremilast (Otezla; 30 mg twice daily). At 16 weeks, those on placebo were switched to deucravacitinib.

For the coprimary endpoint of PASI 75 (75% clearance on the Psoriasis and Severity Index), the similar rate of response for deucravacitinib in the two studies (58.7%/53.6%) at week 16 was superior to the rates observed on both apremilast (35.1%/40.2%) and placebo (12.7%/9.4%).

By week 24, the proportion of deucravacitinib patients with a PASI 75 response had reached 69.3% and 58.7% in the POETYK PSO-1 and PSO-2 trials, respectively. The proportion of patients on apremilast with PASI 75 at this time point did not increase appreciably in one study and fell modestly in the other.

By week 52, the response rates achieved with deucravacitinib at week 24 were generally unchanged and nearly double those observed on apremilast.

The pattern of relative benefit on the other coprimary endpoint, which was a score of 0 or 1, signifying clear or almost clear skin on the static Physicians Global Assessment (sPGA), followed the same pattern. At week 16, 53.6% of patients had achieved sPGA 0/1. This was significantly higher than that observed on either apremilast or placebo, and this level of response was sustained through week 52.

When patients on placebo were switched to deucravacitinib at week 16, the PASI 75 response climbed quickly. There was complete catch-up by 32 weeks. In both groups, a PASI 75 response rate of about 65% or higher was maintained for the remainder of the study.

On a prespecified analysis, prior treatment exposure was not associated with any impact on the degree of response with deucravacitinib. This included a comparison between patients exposed to no prior biologic, one prior biologic, or two or more biologics, Dr. Warren reported.

Unlike patients in POETYK PSO-1, those with a PASI 75 response at 16 weeks in the POETYK PSO-2 trial were rerandomized to remain on deucravacitinib or switch to placebo. Designed to evaluate response durability, this analysis showed a relatively gradual decline in disease control.

“The median time to a loss of response was 12 weeks,” Dr. Warren said. He was referring in this case to the PASI 75 response, but the slope of decline was similar for sPGA score 0/1. At the end of 52 weeks, 31.3% of patients who had been rerandomized to placebo still maintained a PASI 75 while 80.4% of those who stayed on deucravacitinib still had PASI 75 clearance.

In the 52-week data from these two trials, several secondary endpoints have already been examined, and Dr. Warren said more analyses are coming. So far, the pattern of response has been similar for all endpoints.

Reporting on one as an example, Dr. Warren said that sPGA 0/1 for scalp psoriasis was achieved at week 16 by 70.3% of those randomly assigned to deucravacitinib versus 17.4% of those in the placebo arm. Among those switched from placebo to deucravacitinib at 16 weeks, the scalp response had caught up to that observed in those initiated on deucravacitinib by week 28. The response was sustained out to 52 weeks in both groups.

In the long-term trials, there have been no new safety concerns, according to Dr. Warren. He described this drug as “well tolerated,” adding that no significant laboratory abnormalities have been observed on long-term treatment. Although there has been a trend for increased risk of viral infections, such as herpes zoster, relative to apremilast, cases have so far been mild.

The Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR) has been approved for psoriatic arthritis, and numerous other JAK inhibitors are now in clinical trials for plaque psoriasis. These agents vary for their relative selectivity for JAK1, 2, and 3 kinases, but deucravacitinib is the first JAK inhibitor to reach clinical trials that target TYK2, which inhibits interleukin-23 and other cytokines implicated in the pathogenesis of plaque psoriasis.

“Deucravacitinib is very distinct from the other JAK inhibitors, and I think we are seeing this in the clinical studies,” Dr. Warren said. As a result of responses in the POETYK PRO trials that rival those achieved with monoclonal antibodies, he expects this drug, if approved, to be an important option for those with moderate to severe disease who prefer oral therapies.

Mark G. Lebwohl, MD, professor of dermatology and dean for clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York, shares this opinion. In an interview, he emphasized the unique mechanism of deucravacitinib and its clinical potential.

“Unlike other less specific JAK inhibitors, deucravacitinib has a unique binding site on TYK2, the regulatory domain of the molecule. This makes deucravacitinib more targeted and therefore safer than other JAK inhibitors,” said Dr. Lebwohl.

“After cyclosporine, which has many side effects, deucravacitinib is the most effective oral therapy we have for psoriasis and one of the safest,” he added.

The POETYK PSO-1 and PSO-2 trials received funding from Bristol-Myers Squibb. Dr. Warren has financial relationships with AbbVie, Almirall, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen, Leo Pharma, Novartis, Pfizer, Sanofi, UCB, and Xenoport. Dr. Lebwohl has financial relationships with more than 20 pharmaceutical companies, including Bristol-Myers Squibb.

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

A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly, compared with placebo.

Findings were published in the New England Journal of Medicine. 

COVID-related hospitalization or death from any cause occurred in 18 of 1,355 patients (1.3%) in the group getting 2,400 mg infusions of the study drug, compared with 62 (4.6%) of 1,341 in the matching placebo group, indicating a relative risk reduction of 71.3%; P < .001.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Fla., said in an interview that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes, or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”
 

Researchers seek lowest doses

This trial found that the effect was similar when researchers cut the doses in half. These outcomes occurred in 7 of 736 (1%) of patients given 1,200 mg of REGEN-COV and in 24 (3.2%) of 748 in the matching placebo group (relative risk reduction, 70.4%; P = .002).

Symptoms were resolved on average 4 days earlier with each REGEN-COV dose than with placebo (10 days vs. 14 days; P < .001 for both comparisons).

Dr. Weinreich said in an interview that trials will continue to find the lowest effective doses that can stand up to all evolving variants.

“This is one of those settings where you don’t want to underdose. You’ve got one shot at this,” he said. “We’d love to do lower doses. It would be more convenient and we could treat more patients, but if it generates more clinical failures or doesn’t work with certain variants, then you’ve done a huge disservice to the world.”

Also new in this study is that researchers tested not only seronegative patients, but patients at high risk regardless of blood antibody status, he said.

“It’s the first suggestion of data that if you’re breaking through a vaccine and you’re at high risk, the use of the cocktail is something to strongly consider because treatment early is better than treatment later,” Dr. Weinreich said.

In addition to efficacy, the phase 3 trial demonstrated the cocktail had a good safety profile. Serious adverse events occurred more often in the placebo group (4%) than in the 1,200-mg group (1.1%) and the 2,400-mg group (1.3%). Infusion reactions (grade 2 or higher) occurred in less than 0.3% of patients in all groups. 

William Fales, MD, state medical director for the Michigan Department of Health and Human Services, said the results confirm the promise of REGEN-COV for reducing hospitalizations and death in a peer-reviewed publication.
 

COVID-19 a moving target

However, Dr. Fales noted that COVID-19 is a moving target with emerging variants. The criteria for populations at high risk have also broadened since the start of the study, he said.

“A great example is pregnancy is now included as high risk, and that would have likely been a specific contraindication of patients in this clinical trial,” he said.

Dr. Fales said Michigan has been using both REGEN-COV and the Eli Lilly combination of bamlanivimab and etesevimab, which also has an emergency use authorization (EUA) from the Food and Drug Administration, with positive results.

REGEN-COV has an EUA to treat people who are at high risk of serious consequences from COVID-19, including those who are already infected (nonhospitalized) or those in certain postexposure prophylaxis settings.

“We’re seeing very low hospitalization rates and few deaths in a state that is predominately Delta,” Dr. Fales said. “So, this makes us feel that we’re doing the right thing and supports the current efforts around the country to make monoclonal antibody therapy available to high-risk patients.”  

Dr. Joshi noted that trial results have been emerging from other monoclonal antibody cocktails with different COVID-19 patient groups.

However, he said in an interview, “how much more effective they would be than this is something we’d have to look at, as 71% effectiveness in keeping people out of the hospital is pretty good for any treatment.”

“These are great numbers, but vaccination itself keeps you from getting the disease in the first place and not just for a short time period. This treatment is just that – a treatment. It gets you through that episode but it doesn’t mean you won’t get sick again. You don’t develop an immune response as you do with the vaccine,” he said.

Dr. Weinreich agreed: “This is not a substitute for a vaccine except for the small group who get the vaccine and their bodies can’t respond to it because they’re significantly immunocompromised.”

The results from this paper “are one piece of a large, multistudy, phase 3 program that basically spans from prophylaxis all the way to hospitalization and pretty much the gamut – all of them – have worked. All of these studies have shown dramatic improvement in whatever the definitive regulatory endpoint is,” Dr. Weinreich said.

He said discussions are ongoing for full regulatory approval in the United States and for expanding the EUA for other populations, including pre-exposure prophylaxis, “which the [United Kingdom’s] authority has already granted us but the FDA has not.”

The study is funded by Regeneron and the Department of Health & Human Services. Dr. Weinreich is a vice president of Regeneron. Dr. Joshi reported no relevant financial relationships. Dr. Fales holds stock in Eli Lilly.

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

A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly, compared with placebo.

Findings were published in the New England Journal of Medicine. 

COVID-related hospitalization or death from any cause occurred in 18 of 1,355 patients (1.3%) in the group getting 2,400 mg infusions of the study drug, compared with 62 (4.6%) of 1,341 in the matching placebo group, indicating a relative risk reduction of 71.3%; P < .001.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Fla., said in an interview that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes, or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”
 

Researchers seek lowest doses

This trial found that the effect was similar when researchers cut the doses in half. These outcomes occurred in 7 of 736 (1%) of patients given 1,200 mg of REGEN-COV and in 24 (3.2%) of 748 in the matching placebo group (relative risk reduction, 70.4%; P = .002).

Symptoms were resolved on average 4 days earlier with each REGEN-COV dose than with placebo (10 days vs. 14 days; P < .001 for both comparisons).

Dr. Weinreich said in an interview that trials will continue to find the lowest effective doses that can stand up to all evolving variants.

“This is one of those settings where you don’t want to underdose. You’ve got one shot at this,” he said. “We’d love to do lower doses. It would be more convenient and we could treat more patients, but if it generates more clinical failures or doesn’t work with certain variants, then you’ve done a huge disservice to the world.”

Also new in this study is that researchers tested not only seronegative patients, but patients at high risk regardless of blood antibody status, he said.

“It’s the first suggestion of data that if you’re breaking through a vaccine and you’re at high risk, the use of the cocktail is something to strongly consider because treatment early is better than treatment later,” Dr. Weinreich said.

In addition to efficacy, the phase 3 trial demonstrated the cocktail had a good safety profile. Serious adverse events occurred more often in the placebo group (4%) than in the 1,200-mg group (1.1%) and the 2,400-mg group (1.3%). Infusion reactions (grade 2 or higher) occurred in less than 0.3% of patients in all groups. 

William Fales, MD, state medical director for the Michigan Department of Health and Human Services, said the results confirm the promise of REGEN-COV for reducing hospitalizations and death in a peer-reviewed publication.
 

COVID-19 a moving target

However, Dr. Fales noted that COVID-19 is a moving target with emerging variants. The criteria for populations at high risk have also broadened since the start of the study, he said.

“A great example is pregnancy is now included as high risk, and that would have likely been a specific contraindication of patients in this clinical trial,” he said.

Dr. Fales said Michigan has been using both REGEN-COV and the Eli Lilly combination of bamlanivimab and etesevimab, which also has an emergency use authorization (EUA) from the Food and Drug Administration, with positive results.

REGEN-COV has an EUA to treat people who are at high risk of serious consequences from COVID-19, including those who are already infected (nonhospitalized) or those in certain postexposure prophylaxis settings.

“We’re seeing very low hospitalization rates and few deaths in a state that is predominately Delta,” Dr. Fales said. “So, this makes us feel that we’re doing the right thing and supports the current efforts around the country to make monoclonal antibody therapy available to high-risk patients.”  

Dr. Joshi noted that trial results have been emerging from other monoclonal antibody cocktails with different COVID-19 patient groups.

However, he said in an interview, “how much more effective they would be than this is something we’d have to look at, as 71% effectiveness in keeping people out of the hospital is pretty good for any treatment.”

“These are great numbers, but vaccination itself keeps you from getting the disease in the first place and not just for a short time period. This treatment is just that – a treatment. It gets you through that episode but it doesn’t mean you won’t get sick again. You don’t develop an immune response as you do with the vaccine,” he said.

Dr. Weinreich agreed: “This is not a substitute for a vaccine except for the small group who get the vaccine and their bodies can’t respond to it because they’re significantly immunocompromised.”

The results from this paper “are one piece of a large, multistudy, phase 3 program that basically spans from prophylaxis all the way to hospitalization and pretty much the gamut – all of them – have worked. All of these studies have shown dramatic improvement in whatever the definitive regulatory endpoint is,” Dr. Weinreich said.

He said discussions are ongoing for full regulatory approval in the United States and for expanding the EUA for other populations, including pre-exposure prophylaxis, “which the [United Kingdom’s] authority has already granted us but the FDA has not.”

The study is funded by Regeneron and the Department of Health & Human Services. Dr. Weinreich is a vice president of Regeneron. Dr. Joshi reported no relevant financial relationships. Dr. Fales holds stock in Eli Lilly.

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

A monoclonal antibody combination of casirivimab and imdevimab (REGEN-COV) significantly reduced the risk of COVID-19–related hospitalizations and death from any cause in the phase 3 portion of an adaptive trial of outpatients.

Researchers, led by David Weinreich, MD, MBA, executive vice president of the drug cocktail’s manufacturer Regeneron, found in the randomized trial that the combination also resolved symptoms and reduced the SARS-CoV-2 viral load more quickly, compared with placebo.

Findings were published in the New England Journal of Medicine. 

COVID-related hospitalization or death from any cause occurred in 18 of 1,355 patients (1.3%) in the group getting 2,400 mg infusions of the study drug, compared with 62 (4.6%) of 1,341 in the matching placebo group, indicating a relative risk reduction of 71.3%; P < .001.

Sunil Joshi, MD, president of the Duval County Medical Society Foundation and an immunologist in Jacksonville, Fla., said in an interview that these findings confirm benefits of REGEN-COV and are very good news for a patient group that includes those age 65 and older with high blood pressure, diabetes, or obesity; and for people not vaccinated, who are all at high risk of hospitalization or death if they get COVID-19.

“Vaccines are critically important,” he said, “but if you were to be infected and know that there’s a way to keep yourself out of the hospital, this is very good news.”
 

Researchers seek lowest doses

This trial found that the effect was similar when researchers cut the doses in half. These outcomes occurred in 7 of 736 (1%) of patients given 1,200 mg of REGEN-COV and in 24 (3.2%) of 748 in the matching placebo group (relative risk reduction, 70.4%; P = .002).

Symptoms were resolved on average 4 days earlier with each REGEN-COV dose than with placebo (10 days vs. 14 days; P < .001 for both comparisons).

Dr. Weinreich said in an interview that trials will continue to find the lowest effective doses that can stand up to all evolving variants.

“This is one of those settings where you don’t want to underdose. You’ve got one shot at this,” he said. “We’d love to do lower doses. It would be more convenient and we could treat more patients, but if it generates more clinical failures or doesn’t work with certain variants, then you’ve done a huge disservice to the world.”

Also new in this study is that researchers tested not only seronegative patients, but patients at high risk regardless of blood antibody status, he said.

“It’s the first suggestion of data that if you’re breaking through a vaccine and you’re at high risk, the use of the cocktail is something to strongly consider because treatment early is better than treatment later,” Dr. Weinreich said.

In addition to efficacy, the phase 3 trial demonstrated the cocktail had a good safety profile. Serious adverse events occurred more often in the placebo group (4%) than in the 1,200-mg group (1.1%) and the 2,400-mg group (1.3%). Infusion reactions (grade 2 or higher) occurred in less than 0.3% of patients in all groups. 

William Fales, MD, state medical director for the Michigan Department of Health and Human Services, said the results confirm the promise of REGEN-COV for reducing hospitalizations and death in a peer-reviewed publication.
 

COVID-19 a moving target

However, Dr. Fales noted that COVID-19 is a moving target with emerging variants. The criteria for populations at high risk have also broadened since the start of the study, he said.

“A great example is pregnancy is now included as high risk, and that would have likely been a specific contraindication of patients in this clinical trial,” he said.

Dr. Fales said Michigan has been using both REGEN-COV and the Eli Lilly combination of bamlanivimab and etesevimab, which also has an emergency use authorization (EUA) from the Food and Drug Administration, with positive results.

REGEN-COV has an EUA to treat people who are at high risk of serious consequences from COVID-19, including those who are already infected (nonhospitalized) or those in certain postexposure prophylaxis settings.

“We’re seeing very low hospitalization rates and few deaths in a state that is predominately Delta,” Dr. Fales said. “So, this makes us feel that we’re doing the right thing and supports the current efforts around the country to make monoclonal antibody therapy available to high-risk patients.”  

Dr. Joshi noted that trial results have been emerging from other monoclonal antibody cocktails with different COVID-19 patient groups.

However, he said in an interview, “how much more effective they would be than this is something we’d have to look at, as 71% effectiveness in keeping people out of the hospital is pretty good for any treatment.”

“These are great numbers, but vaccination itself keeps you from getting the disease in the first place and not just for a short time period. This treatment is just that – a treatment. It gets you through that episode but it doesn’t mean you won’t get sick again. You don’t develop an immune response as you do with the vaccine,” he said.

Dr. Weinreich agreed: “This is not a substitute for a vaccine except for the small group who get the vaccine and their bodies can’t respond to it because they’re significantly immunocompromised.”

The results from this paper “are one piece of a large, multistudy, phase 3 program that basically spans from prophylaxis all the way to hospitalization and pretty much the gamut – all of them – have worked. All of these studies have shown dramatic improvement in whatever the definitive regulatory endpoint is,” Dr. Weinreich said.

He said discussions are ongoing for full regulatory approval in the United States and for expanding the EUA for other populations, including pre-exposure prophylaxis, “which the [United Kingdom’s] authority has already granted us but the FDA has not.”

The study is funded by Regeneron and the Department of Health & Human Services. Dr. Weinreich is a vice president of Regeneron. Dr. Joshi reported no relevant financial relationships. Dr. Fales holds stock in Eli Lilly.

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

After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.

Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.

Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.

What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.

Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.

What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.

How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.

The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.

The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.

The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).

Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.

What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.

Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.

Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.

How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.

During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.

What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.

Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.

Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.

Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.

[email protected]

After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.

Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.

Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.

What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.

Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.

What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.

How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.

The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.

The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.

The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).

Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.

What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.

Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.

Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.

How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.

During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.

What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.

Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.

Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.

Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.

[email protected]

After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.

“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.

Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.

Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.

What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.

Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.

What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.

How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.

The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.

The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.

The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).

Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.

What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.

Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.

Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.

How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.

During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.

What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.

Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.

Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.

Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.

[email protected]

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.

Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.

A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.

RichLegg/E+

Big jump during pandemic

The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.

The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).

Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.

Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.

There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.

The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
 

How telehealth was used

Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.

Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.

Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).

Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
 

Virtual consults with peers

Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.

Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.

The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

The number of physicians who have chosen early retirement or have left medicine because of the COVID-19 pandemic may be considerably lower than previously thought, results of a new study suggest.

The research letter in the Journal of the American Medical Association, based on Medicare claims data, stated that “practice interruption rates were similar before and during the COVID-19 pandemic, except for a spike in April 2020.”

By contrast, in a Physicians Foundation Survey conducted in August 2020, 8% of physicians said they had closed their practices as a result of COVID, and 4% of the respondents said they planned to leave their practices within the next 12 months.

Similarly, a Jackson Physician Search survey in the fourth quarter of 2020 found that 54% of physicians surveyed had changed their employment plans. Of those doctors, 21% said they might hang up their white coat for early retirement. That works out to about 11% of the respondents.

The JAMA study’s authors analyzed the Medicare claims data from Jan. 1, 2019, to Dec. 30, 2020, to see how many physicians with Medicare patients had stopped filing claims for a period during those 2 years.

If a doctor had ceased submitting claims and then resumed filing them within 6 months after the last billing month, the lapse in filing was defined as “interruption with return.” If a physician stopped filing claims to Medicare and did not resume within 6 months, the gap in filing was called “interruption without return.”

In April 2020, 6.9% of physicians billing Medicare had a practice interruption, compared to 1.4% in 2019. But only 1.1% of physicians stopped practice in April 2020 and did not return, compared with 0.33% in 2019.

Physicians aged 55 or older had higher rates of interruption both with and without return than younger doctors did. The change in interruption rates for older doctors was 7.2% vs. 3.9% for younger physicians. The change in older physicians’ interruption-without-return rate was 1.3% vs. 0.34% for younger colleagues.

“Female physicians, specialists, physicians in smaller practices, those not in a health professional shortage area, and those practicing in a metropolitan area experienced greater increases in practice interruption rates in April 2020 vs. April 2019,” the study states. “But those groups typically had higher rates of return, so the overall changes in practice interruptions without return were similar across characteristics other than age.”
 

Significance for retirement rate

Discussing these results, the authors stressed that practice interruptions without return can’t necessarily be attributed to retirement, and that practice interruptions with return don’t necessarily signify that doctors had been furloughed from their practices.

Also, they said, “this measure of practice interruption likely misses meaningful interruptions that lasted for less than a month or did not involve complete cessation in treating Medicare patients.”

Nevertheless, “the study does capture a signal of some doctors probably retiring,” Jonathan Weiner, DPH, professor of health policy and management at the Johns Hopkins Bloomberg School of Public Health, said in an interview.

But he added, “Some of those people who interrupted their practices and didn’t return may still come back. And there are probably a lot of other doctors who are leaving or changing practices that they didn’t capture.” For example, it’s possible that some doctors who went to work for other health care organizations stopped billing under their own names.

In Dr. Weiner’s view, the true percentage of physicians who have retired since the start of the pandemic is probably somewhere between the portion of doctors who interrupted their practice without return, according to the JAMA study, and the percentage of physicians who said they had closed their practices in the Physicians Foundation survey.
 

No mass exodus seen

Michael Belkin, JD, divisional vice president of recruiting for Merritt Hawkins, a physician search firm, said in an interview that the real number may be closer to the interruption-without-return figure in the JAMA study.

While many physician practices were disrupted in spring of 2020, he said, “it really didn’t result in a mass exodus [from health care]. We’re not talking to a lot of candidates who retired or walked away from their practices. We are talking to candidates who slowed down last year and then realized that they wanted to get back into medicine. And now they’re actively looking.”

One change in job candidates’ attitude, Mr. Belkin said, is that, because of COVID-19–related burnout, their quality of life is more important to them.

“They want to know, ‘What’s the culture of the employer like? What did they do last year during COVID? How did they handle it? Have they put together any protocols for the next pandemic?’ “
 

Demand for doctors has returned

In the summer of 2020, there was a major drop in physician recruitment by hospitals and health systems, partly because of fewer patient visits and procedures. But demand for doctors has bounced back over the past year, Mr. Belkin noted. One reason is the pent-up need for care among patients who avoided health care providers in 2020.

Another reason is that some employed doctors – particularly older physicians – have slowed down. Many doctors prefer to work remotely 1 or 2 days a week, providing telehealth visits to patients. That has led to a loss of productivity in many health care organizations and, consequently, a need to hire additional physicians.

Nevertheless, not many doctors are heading for the exit earlier than physicians did before COVID-19.

“They may work reduced hours,” Mr. Belkin said. “But the sense from a physician’s perspective is that this is all they know. For them to walk away from their life in medicine, from who they are, is problematic. So they’re continuing to practice, but at a reduced capacity.”

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

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

It took years for Elle Moxley to get a diagnosis that explained her crippling gastrointestinal pain, digestion problems, fatigue, and hot, red rashes. And after learning in 2016 that she had Crohn’s disease, a chronic inflammation of the digestive tract, she spent more than 4 years trying medications before getting her disease under control with a biologic drug called Remicade.

So Ms. Moxley, 33, was dismayed to receive a notice from her insurer in January that Remicade would no longer be covered as a preferred drug on her plan. Another drug, Inflectra, which the Food and Drug Administration says has no meaningful clinical differences from Remicade, is now preferred. It is a “biosimilar” drug.

“I felt very powerless,” said Ms. Moxley, who recently started a job as a public relations coordinator for Kansas City (Mo.) Public Schools. “I have this decision being made for me and my doctor that’s not in my best interest, and it might knock me out of remission.”

After Ms. Moxley’s first Inflectra infusion in July, she developed a painful rash. It went away after a few days, but she said she continues to feel extremely fatigued and experiences gastrointestinal pain, constipation, diarrhea and nausea.

Many medical professionals look to biosimilar drugs as a way to increase competition and give consumers cheaper options, much as generic drugs do, and they point to the more robust use of these products in Europe to cut costs.

Yet the United States has been slower to adopt biosimilar drugs since the first such medicine was approved in 2015. That’s partly because of concerns raised by patients like Moxley and their doctors, but also because brand-name biologics have kept biosimilars from entering the market. The companies behind the brand-name drugs have used legal actions to extend the life of their patents and incentives that make offering the brand biologic more attractive than offering a biosimilar on a formulary, listing which drugs are covered on an insurance plan.

“It distorts the market and makes it so that patients can’t get access,” said Jinoos Yazdany, MD, MPH, a professor of medicine and chief of the rheumatology division at Zuckerberg San Francisco General Hospital.

The FDA has approved 31 biosimilar medications since 2015, but only about 60% have made it to market, according to an analysis by NORC, a research organization at the University of Chicago.

Remicade’s manufacturer, Johnson & Johnson, and Pfizer, which makes the Remicade biosimilar Inflectra, have been embroiled in a long-running lawsuit over Pfizer’s claims that Johnson & Johnson tried to choke off competition through exclusionary contracts with insurers and other anticompetitive actions. In July, the companies settled the case on undisclosed terms.

In a statement, Pfizer said it would continue to sell Inflectra in the United States but noted ongoing challenges: “Pfizer has begun to see progress in the overall biosimilars marketplace in the U.S. However, changes in policy at a government level and acceptance of biosimilars among key stakeholders are critical to deliver more meaningful uptake so patients and the health care system at large can benefit from the cost savings these medicines may deliver.”

Johnson & Johnson said it is committed to making Remicade available to patients who choose it, which “compels us to compete responsibly on both price and value.”

Biologic medicines, which are generally grown from living organisms such as animal cells or bacteria, are more complex and expensive to manufacture than drugs made from chemicals. In recent years, biologic drugs have become a mainstay of treatment for autoimmune conditions like Crohn’s disease and rheumatoid arthritis, as well as certain cancers and diabetes, among other conditions.

Other drugmakers can’t exactly reproduce these biologic drugs by following chemical recipes as they do for generic versions of conventional drugs.

Instead, biosimilar versions of biologic drugs are generally made from the same types of materials as the original biologics and must be “highly similar” to them to be approved by the FDA. They must have no clinically meaningful differences from the biologic drug, and be just as safe, pure and potent. More than a decade after Congress created an approval pathway for biosimilars, they are widely accepted as safe and effective alternatives to brand biologics.

Medical experts hope that as biosimilars become more widely used they will increasingly provide a brake on drug spending.

From 2015 to 2019, drug spending overall grew 6.1%, while spending on biologics grew more than twice as much – 14.6% – according to a report by IQVIA, a health care analytics company. In 2019, biologics accounted for 43% of drug spending in the United States

Biosimilars provide a roughly 30% discount over brand biologics in the United States but have the potential to reduce spending by more than $100 billion in the next 5 years, the IQVIA analysis found.

In a survey of 602 physicians who prescribe biologic medications, more than three-quarters said they believed biosimilars are just as safe and effective as their biologic counterparts, according to NORC.

But they were less comfortable with switching patients from a brand biologic to a biosimilar. While about half said they were very likely to prescribe a biosimilar to a patient just starting biologic therapy, only 31% said they were very likely to prescribe a biosimilar to a patient already doing well on a brand biologic.

It can be challenging to find a treatment regimen that works for patients with complicated chronic conditions, and physicians and patients often don’t want to rock the boat once that is achieved.

In Ms. Moxley’s case, for example, before her condition stabilized on Remicade, she tried a conventional pill called Lialda, the biologic drug Humira and a lower dose of Remicade.

Some doctors and patients raise concerns that switching between these drugs might cause patients to develop antibodies that cause the drugs to lose effectiveness. They want to see more research about the effects of such switches.

“We haven’t seen enough studies about patients going from the biologic to the biosimilar and bouncing back and forth,” said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “We don’t want our patients to be guinea pigs.”

Manufacturers of biologic and biosimilar drugs have participated in advertising, exhibit or sponsorship opportunities with the American College of Rheumatology, according to ACR spokesperson Jocelyn Givens.

But studies show a one-time switch from Remicade to a biosimilar like Inflectra does not cause side effects or the development of antibodies, said Ross Maltz, MD, a pediatric gastroenterologist at Nationwide Children’s Hospital in Columbus, Ohio, and former member of the Crohn’s & Colitis Foundation’s National Scientific Advisory Committee. Studies may be conducted by researchers with extensive ties to the industry and funded by drugmakers.

Situations like Ms. Moxley’s are unusual, said Kristine Grow, senior vice president of communications at AHIP, an insurer trade group.

“For patients who have been taking a brand-name biologic for some time, health insurance providers do not typically encourage them to switch to a biosimilar because of a formulary change, and most plans exclude these patients from any changes in cost sharing due to formulary changes,” she said.

Drugmakers can seek approval from the FDA of their biosimilar as interchangeable with a biologic drug, allowing pharmacists, subject to state law, to switch a physician’s prescription from the brand drug, as they often do with generic drugs.

However, the FDA has approved only one biosimilar (Semglee, a form of insulin) as interchangeable with a biologic (Lantus).

Like Ms. Moxley, many other patients using biologics get copay assistance from drug companies, but the money often isn’t enough to cover the full cost. In her old job as a radio reporter, Ms. Moxley said, she hit the $7,000 maximum annual out-of-pocket spending limit for her plan by May.

In her new job, Ms. Moxley has an individual plan with a $4,000 maximum out-of-pocket limit, which she expects to blow past once again within months.

But she received good news recently: Her new plan will cover Remicade.

“I’m still concerned that I will have developed antibodies since my last dose,” she said. “But it feels like a step in the direction of good health again.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.