One of the most devastating complications in any endoscopic procedure is a perforation that may result in a life-threatening situation for the patient and abrupt termination of the intended procedure. The new AGA Clinical Practice Update on Endoscopic Management of Perforations in Gastrointestinal Tract: Expert Review offers a practical approach to prevent GI perforations, as well as detect subtle signs of and endoscopically manage them.

Best practice advice

• The area of perforation should be kept clean to prevent any spillage of gastrointestinal contents into the perforation by aspirating liquids and, if necessary, changing the patient position to bring the perforation into a nondependent location while minimizing insufflation of carbon dioxide to avoid compartment syndrome.
• Use of carbon dioxide for insufflation is encouraged for all endoscopic procedures, especially any endoscopic procedure with increased risk of perforation. If available, carbon dioxide should be used for all endoscopic procedures.
• All endoscopists should be aware of the procedures that carry an increased risk for perforation such as any dilation, foreign body removal, any per oral endoscopic myotomy (Zenker’s, esophageal, pyloric), stricture incision, thermal coagulation for hemostasis or tumor ablation, percutaneous endoscopic gastrostomy, ampullectomy, endoscopic mucosal resectio, endoscopic submucosal dissection, endoluminal stenting with self-expanding metal stent, full-thickness endoscopic resection, endoscopic retrograde cholangiopancreatography in surgically altered anatomy, endoscopic ultrasound (EUS)–guided biliary and pancreatic access, EUS-guided cystogastrostomy, and endoscopic gastroenterostomy using a lumen apposing metal stent.
• Urgent surgical consultation should be highly considered in all cases with perforation even when endoscopic repair is technically successful.

One of the most devastating complications in any endoscopic procedure is a perforation that may result in a life-threatening situation for the patient and abrupt termination of the intended procedure. The new AGA Clinical Practice Update on Endoscopic Management of Perforations in Gastrointestinal Tract: Expert Review offers a practical approach to prevent GI perforations, as well as detect subtle signs of and endoscopically manage them.

Best practice advice

• The area of perforation should be kept clean to prevent any spillage of gastrointestinal contents into the perforation by aspirating liquids and, if necessary, changing the patient position to bring the perforation into a nondependent location while minimizing insufflation of carbon dioxide to avoid compartment syndrome.
• Use of carbon dioxide for insufflation is encouraged for all endoscopic procedures, especially any endoscopic procedure with increased risk of perforation. If available, carbon dioxide should be used for all endoscopic procedures.
• All endoscopists should be aware of the procedures that carry an increased risk for perforation such as any dilation, foreign body removal, any per oral endoscopic myotomy (Zenker’s, esophageal, pyloric), stricture incision, thermal coagulation for hemostasis or tumor ablation, percutaneous endoscopic gastrostomy, ampullectomy, endoscopic mucosal resectio, endoscopic submucosal dissection, endoluminal stenting with self-expanding metal stent, full-thickness endoscopic resection, endoscopic retrograde cholangiopancreatography in surgically altered anatomy, endoscopic ultrasound (EUS)–guided biliary and pancreatic access, EUS-guided cystogastrostomy, and endoscopic gastroenterostomy using a lumen apposing metal stent.
• Urgent surgical consultation should be highly considered in all cases with perforation even when endoscopic repair is technically successful.

One of the most devastating complications in any endoscopic procedure is a perforation that may result in a life-threatening situation for the patient and abrupt termination of the intended procedure. The new AGA Clinical Practice Update on Endoscopic Management of Perforations in Gastrointestinal Tract: Expert Review offers a practical approach to prevent GI perforations, as well as detect subtle signs of and endoscopically manage them.

Best practice advice

• The area of perforation should be kept clean to prevent any spillage of gastrointestinal contents into the perforation by aspirating liquids and, if necessary, changing the patient position to bring the perforation into a nondependent location while minimizing insufflation of carbon dioxide to avoid compartment syndrome.
• Use of carbon dioxide for insufflation is encouraged for all endoscopic procedures, especially any endoscopic procedure with increased risk of perforation. If available, carbon dioxide should be used for all endoscopic procedures.
• All endoscopists should be aware of the procedures that carry an increased risk for perforation such as any dilation, foreign body removal, any per oral endoscopic myotomy (Zenker’s, esophageal, pyloric), stricture incision, thermal coagulation for hemostasis or tumor ablation, percutaneous endoscopic gastrostomy, ampullectomy, endoscopic mucosal resectio, endoscopic submucosal dissection, endoluminal stenting with self-expanding metal stent, full-thickness endoscopic resection, endoscopic retrograde cholangiopancreatography in surgically altered anatomy, endoscopic ultrasound (EUS)–guided biliary and pancreatic access, EUS-guided cystogastrostomy, and endoscopic gastroenterostomy using a lumen apposing metal stent.
• Urgent surgical consultation should be highly considered in all cases with perforation even when endoscopic repair is technically successful.

After an unexpected and challenging year and as the new year begins, there are some ways you can make a difference, without giving up assets you may need today.

• Beneficiary designation. Adding the AGA Research Foundation as a beneficiary of your retirement plan or other assets is simple and you don’t need to leave your home to complete the gift. Since the funds are granted after your lifetime, you can maintain your family budget today.
• Gift in your will. With as little as one sentence, you can create a brighter tomorrow at the AGA Research Foundation without parting with assets today. You can designate the AGA Research Foundation as the beneficiary of a specific asset or, as many of our donors do to ensure that their family is protected, as the recipient of a percentage of the total estate.
• Grant from your donor advised fund (DAF). This popular one-stop giving solution lets you care for multiple causes and organizations with minimal paperwork. Consider it a charitable savings account where money waits until you’re ready to distribute it. And when you use your existing DAF to recommend a grant, it means you can invest in our future without impacting your budget today.
• Distribution from your IRA. If you are 70½ years or older, you can use your IRA to make a gift directly to the AGA Research Foundation without having to pay income tax on the distribution. Beginning in the year you turn 72, you must take your required minimum distribution (RMD). You can use a gift from your IRA to satisfy all or part of your RMD.

Learn more at https://gastro.planmylegacy.org.

After an unexpected and challenging year and as the new year begins, there are some ways you can make a difference, without giving up assets you may need today.

• Beneficiary designation. Adding the AGA Research Foundation as a beneficiary of your retirement plan or other assets is simple and you don’t need to leave your home to complete the gift. Since the funds are granted after your lifetime, you can maintain your family budget today.
• Gift in your will. With as little as one sentence, you can create a brighter tomorrow at the AGA Research Foundation without parting with assets today. You can designate the AGA Research Foundation as the beneficiary of a specific asset or, as many of our donors do to ensure that their family is protected, as the recipient of a percentage of the total estate.
• Grant from your donor advised fund (DAF). This popular one-stop giving solution lets you care for multiple causes and organizations with minimal paperwork. Consider it a charitable savings account where money waits until you’re ready to distribute it. And when you use your existing DAF to recommend a grant, it means you can invest in our future without impacting your budget today.
• Distribution from your IRA. If you are 70½ years or older, you can use your IRA to make a gift directly to the AGA Research Foundation without having to pay income tax on the distribution. Beginning in the year you turn 72, you must take your required minimum distribution (RMD). You can use a gift from your IRA to satisfy all or part of your RMD.

Learn more at https://gastro.planmylegacy.org.

After an unexpected and challenging year and as the new year begins, there are some ways you can make a difference, without giving up assets you may need today.

• Beneficiary designation. Adding the AGA Research Foundation as a beneficiary of your retirement plan or other assets is simple and you don’t need to leave your home to complete the gift. Since the funds are granted after your lifetime, you can maintain your family budget today.
• Gift in your will. With as little as one sentence, you can create a brighter tomorrow at the AGA Research Foundation without parting with assets today. You can designate the AGA Research Foundation as the beneficiary of a specific asset or, as many of our donors do to ensure that their family is protected, as the recipient of a percentage of the total estate.
• Grant from your donor advised fund (DAF). This popular one-stop giving solution lets you care for multiple causes and organizations with minimal paperwork. Consider it a charitable savings account where money waits until you’re ready to distribute it. And when you use your existing DAF to recommend a grant, it means you can invest in our future without impacting your budget today.
• Distribution from your IRA. If you are 70½ years or older, you can use your IRA to make a gift directly to the AGA Research Foundation without having to pay income tax on the distribution. Beginning in the year you turn 72, you must take your required minimum distribution (RMD). You can use a gift from your IRA to satisfy all or part of your RMD.

Learn more at https://gastro.planmylegacy.org.

The clinical presentation of atopic dermatitis (AD) in skin of color varies widely, which may create a challenge for clinicians.

“We see very heterogenous and broad clinical presentations across the diverse patient populations that we see,” Andrew F. Alexis, MD, MPH, said at the Revolutionizing Atopic Dermatitis symposium. “Some of these differences might be related to population variations in skin barrier function, immunologic factors, genetic factors, and environmental factors, which all interplay to produce variations in the clinical presentation and overall impact of AD. Many nongenetic factors also contribute to differences that we see, including some socioeconomic and other factors that feed into health disparities.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, discussed four main clinical features of AD in skin of color.
 

Erythema is less visible because it is masked by pigment

“There can be some masking of the redness and alteration of that color such that it doesn’t look bright red as it would in the background of lightly pigmented skin,” Dr. Alexis said. “Instead, the [AD lesions] have shades of grayish-red or grayish-brown or reddish-brown. It’s important to recognize this clinical presentation and look carefully and assess the patient – not just visually but with palpation and take into consideration symptomatology so that you don’t fall into the trap of calling an AD lesion postinflammatory hyperpigmentation. It’s also helpful to isolate the islands of normal or nonlesional skin and contrast that with the areas of lesional skin, to get a sense of how active and inflamed the areas are. Palpation really helps to appreciate the elevation of the lesions that are involved.”

Follicular accentuation

Morphological variants common in skin of color include the follicular variant or micropapular variant of AD. “You might just see a collection of papules that are 1-2 mm in size and pruritic and in typical sites of predilection [for] eczema,” he said. Prurigo nodularis–like lesions or prurigo nodularis in association with AD are also seen more frequently in skin of color.

Lichenification

The lichenoid variant of AD is characterized by a violaceous hue and other features that resemble lichen planus and has been reported to be more common in individuals of African descent. A prospective study of about 1,000 patients with AD seen over 2 years at a dermatology clinic in southeastern Nigeria found that 54% of patients had papular lichenoid lesions. In addition, 51% had elevated blood eosinophil counts, especially those with severe disease.

Dr. Alexis added that psoriasiform features have been reported in studies of East Asian populations with AD. These plaques may be more well demarcated and have clinical and histologic features that resemble psoriasis.
 

Dyspigmentation

One common feature across the spectrum of patients with skin of color “is the risk of longstanding pigmentary sequelae in the form of hyperpigmentation or hypopigmentation,” said Dr. Alexis, who is also vice chair for diversity and inclusion for the department of dermatology at Weill Cornell Medicine. “In very severe longstanding areas with chronic excoriation to the point of breaking of the skin, eroding of the skin, causing permanent damage to the melanocytes, dyspigmentation that resembles vitiligo can be seen. We can also see hypopigmentation as a consequence of topical corticosteroids, particularly those that are class I or class II and are used for prolonged periods of time.”

Dr. Alexis noted that delays in treatment and undertreatment can contribute to a higher risk of pigmentary and other long-term sequelae. “New therapies show promise in improving outcomes in AD patients with skin of color. When it comes to therapeutic responses, there are some post hoc studies that have investigated potential differences in safety and efficacy of the agents that have been recently approved. We clearly need more data to better understand if there are potential racial or ethnic differences.”

Dr. Alexis reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Atopic dermatitis (AD) is highly heterogenous, with tremendous variations in extent, qualities of eczema, symptom complex, and physical presentation. Prior studies have reported disparities of care delivered to racial and ethnic minorities in the United States, as well as higher susceptibility to AD and odds of persistent disease into adulthood from child-onset AD. Recognizing some differences in presentation of AD in patients with skin of color is important as we select our therapeutic interventions, including assessing new treatments being added to our armamentarium. Erythema may be harder to notice in darker skin, but attempting to blanch the skin with pressure can help to assess the color and inflammation. Appreciating lichenoid changes, including papular and “micropapular” AD, and psoriasiform-like thickening in certain patients (reportedly more common in East Asian populations) are important as well. And dyspigmentation is an important aspect of the disease presentation and patient and parental concern, given both hypopigmentaton and hyperpigmentation commonly seen over the course of AD.

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

The clinical presentation of atopic dermatitis (AD) in skin of color varies widely, which may create a challenge for clinicians.

“We see very heterogenous and broad clinical presentations across the diverse patient populations that we see,” Andrew F. Alexis, MD, MPH, said at the Revolutionizing Atopic Dermatitis symposium. “Some of these differences might be related to population variations in skin barrier function, immunologic factors, genetic factors, and environmental factors, which all interplay to produce variations in the clinical presentation and overall impact of AD. Many nongenetic factors also contribute to differences that we see, including some socioeconomic and other factors that feed into health disparities.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, discussed four main clinical features of AD in skin of color.
 

Erythema is less visible because it is masked by pigment

“There can be some masking of the redness and alteration of that color such that it doesn’t look bright red as it would in the background of lightly pigmented skin,” Dr. Alexis said. “Instead, the [AD lesions] have shades of grayish-red or grayish-brown or reddish-brown. It’s important to recognize this clinical presentation and look carefully and assess the patient – not just visually but with palpation and take into consideration symptomatology so that you don’t fall into the trap of calling an AD lesion postinflammatory hyperpigmentation. It’s also helpful to isolate the islands of normal or nonlesional skin and contrast that with the areas of lesional skin, to get a sense of how active and inflamed the areas are. Palpation really helps to appreciate the elevation of the lesions that are involved.”

Follicular accentuation

Morphological variants common in skin of color include the follicular variant or micropapular variant of AD. “You might just see a collection of papules that are 1-2 mm in size and pruritic and in typical sites of predilection [for] eczema,” he said. Prurigo nodularis–like lesions or prurigo nodularis in association with AD are also seen more frequently in skin of color.

Lichenification

The lichenoid variant of AD is characterized by a violaceous hue and other features that resemble lichen planus and has been reported to be more common in individuals of African descent. A prospective study of about 1,000 patients with AD seen over 2 years at a dermatology clinic in southeastern Nigeria found that 54% of patients had papular lichenoid lesions. In addition, 51% had elevated blood eosinophil counts, especially those with severe disease.

Dr. Alexis added that psoriasiform features have been reported in studies of East Asian populations with AD. These plaques may be more well demarcated and have clinical and histologic features that resemble psoriasis.
 

Dyspigmentation

One common feature across the spectrum of patients with skin of color “is the risk of longstanding pigmentary sequelae in the form of hyperpigmentation or hypopigmentation,” said Dr. Alexis, who is also vice chair for diversity and inclusion for the department of dermatology at Weill Cornell Medicine. “In very severe longstanding areas with chronic excoriation to the point of breaking of the skin, eroding of the skin, causing permanent damage to the melanocytes, dyspigmentation that resembles vitiligo can be seen. We can also see hypopigmentation as a consequence of topical corticosteroids, particularly those that are class I or class II and are used for prolonged periods of time.”

Dr. Alexis noted that delays in treatment and undertreatment can contribute to a higher risk of pigmentary and other long-term sequelae. “New therapies show promise in improving outcomes in AD patients with skin of color. When it comes to therapeutic responses, there are some post hoc studies that have investigated potential differences in safety and efficacy of the agents that have been recently approved. We clearly need more data to better understand if there are potential racial or ethnic differences.”

Dr. Alexis reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Atopic dermatitis (AD) is highly heterogenous, with tremendous variations in extent, qualities of eczema, symptom complex, and physical presentation. Prior studies have reported disparities of care delivered to racial and ethnic minorities in the United States, as well as higher susceptibility to AD and odds of persistent disease into adulthood from child-onset AD. Recognizing some differences in presentation of AD in patients with skin of color is important as we select our therapeutic interventions, including assessing new treatments being added to our armamentarium. Erythema may be harder to notice in darker skin, but attempting to blanch the skin with pressure can help to assess the color and inflammation. Appreciating lichenoid changes, including papular and “micropapular” AD, and psoriasiform-like thickening in certain patients (reportedly more common in East Asian populations) are important as well. And dyspigmentation is an important aspect of the disease presentation and patient and parental concern, given both hypopigmentaton and hyperpigmentation commonly seen over the course of AD.

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

The clinical presentation of atopic dermatitis (AD) in skin of color varies widely, which may create a challenge for clinicians.

“We see very heterogenous and broad clinical presentations across the diverse patient populations that we see,” Andrew F. Alexis, MD, MPH, said at the Revolutionizing Atopic Dermatitis symposium. “Some of these differences might be related to population variations in skin barrier function, immunologic factors, genetic factors, and environmental factors, which all interplay to produce variations in the clinical presentation and overall impact of AD. Many nongenetic factors also contribute to differences that we see, including some socioeconomic and other factors that feed into health disparities.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, discussed four main clinical features of AD in skin of color.
 

Erythema is less visible because it is masked by pigment

“There can be some masking of the redness and alteration of that color such that it doesn’t look bright red as it would in the background of lightly pigmented skin,” Dr. Alexis said. “Instead, the [AD lesions] have shades of grayish-red or grayish-brown or reddish-brown. It’s important to recognize this clinical presentation and look carefully and assess the patient – not just visually but with palpation and take into consideration symptomatology so that you don’t fall into the trap of calling an AD lesion postinflammatory hyperpigmentation. It’s also helpful to isolate the islands of normal or nonlesional skin and contrast that with the areas of lesional skin, to get a sense of how active and inflamed the areas are. Palpation really helps to appreciate the elevation of the lesions that are involved.”

Follicular accentuation

Morphological variants common in skin of color include the follicular variant or micropapular variant of AD. “You might just see a collection of papules that are 1-2 mm in size and pruritic and in typical sites of predilection [for] eczema,” he said. Prurigo nodularis–like lesions or prurigo nodularis in association with AD are also seen more frequently in skin of color.

Lichenification

The lichenoid variant of AD is characterized by a violaceous hue and other features that resemble lichen planus and has been reported to be more common in individuals of African descent. A prospective study of about 1,000 patients with AD seen over 2 years at a dermatology clinic in southeastern Nigeria found that 54% of patients had papular lichenoid lesions. In addition, 51% had elevated blood eosinophil counts, especially those with severe disease.

Dr. Alexis added that psoriasiform features have been reported in studies of East Asian populations with AD. These plaques may be more well demarcated and have clinical and histologic features that resemble psoriasis.
 

Dyspigmentation

One common feature across the spectrum of patients with skin of color “is the risk of longstanding pigmentary sequelae in the form of hyperpigmentation or hypopigmentation,” said Dr. Alexis, who is also vice chair for diversity and inclusion for the department of dermatology at Weill Cornell Medicine. “In very severe longstanding areas with chronic excoriation to the point of breaking of the skin, eroding of the skin, causing permanent damage to the melanocytes, dyspigmentation that resembles vitiligo can be seen. We can also see hypopigmentation as a consequence of topical corticosteroids, particularly those that are class I or class II and are used for prolonged periods of time.”

Dr. Alexis noted that delays in treatment and undertreatment can contribute to a higher risk of pigmentary and other long-term sequelae. “New therapies show promise in improving outcomes in AD patients with skin of color. When it comes to therapeutic responses, there are some post hoc studies that have investigated potential differences in safety and efficacy of the agents that have been recently approved. We clearly need more data to better understand if there are potential racial or ethnic differences.”

Dr. Alexis reported no relevant financial relationships.

Commentary by Lawrence F. Eichenfield, MD

Atopic dermatitis (AD) is highly heterogenous, with tremendous variations in extent, qualities of eczema, symptom complex, and physical presentation. Prior studies have reported disparities of care delivered to racial and ethnic minorities in the United States, as well as higher susceptibility to AD and odds of persistent disease into adulthood from child-onset AD. Recognizing some differences in presentation of AD in patients with skin of color is important as we select our therapeutic interventions, including assessing new treatments being added to our armamentarium. Erythema may be harder to notice in darker skin, but attempting to blanch the skin with pressure can help to assess the color and inflammation. Appreciating lichenoid changes, including papular and “micropapular” AD, and psoriasiform-like thickening in certain patients (reportedly more common in East Asian populations) are important as well. And dyspigmentation is an important aspect of the disease presentation and patient and parental concern, given both hypopigmentaton and hyperpigmentation commonly seen over the course of AD.

Dr. Eichenfield is chief of pediatric and adolescent dermatology at Rady Children's Hospital-San Diego. He is vice chair of the department of dermatology and professor of dermatology and pediatrics at the University of California, San Diego. He disclosed that he has served as an investigator and/or consultant to AbbVie, Lilly, Pfizer, Regeneron, Sanofi-Genzyme, and Verrica.

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

This article was updated 6/18/22.

HIV testing centers across the United States showed reductions in testing of nearly 50% during the height of the COVID-19 pandemic in 2020, raising concerns of a subsequent increase in transmission by people unaware of their HIV-positive status.

“Testing strategies need to be ramped up to cover this decrease in testing while adapting to the continuing COVID-19 environment,” reported Deesha Patel, MPH, and colleagues with the Centers for Disease Control and Prevention’s division of HIV prevention, Atlanta, in research presented at the annual meeting of the United States Conference on HIV/AIDS.

According to their data from the National HIV Prevention Program Monitoring and Evaluation system, the number of CDC-funded HIV tests declined by more than 1 million in 2020 amid the COVID-19 restrictions, with 1,228,142 tests reported that year, compared with 2,301,669 tests in 2019, a reduction of 46.6%.

The number of persons who were newly diagnosed with HIV, based on the tests, declined by 29.7%, from 7,692 newly diagnosed in 2019 to 5,409 persons in 2020, the authors reported.

The reasons for the reduction in new HIV diagnoses in 2020 could be multifactorial, possibly reflecting not just the reduced rates of testing but also possibly lower rates of transmission because of the lockdowns and social distancing, Mr. Patel said in an interview.

“Both [of those] interpretations are plausible, and the reductions are likely due to a combination of reasons,” she said.

Of note, the percentage of tests that were positive did not show a decline and was in fact slightly higher in 2020 (0.4%), compared with 2019 (0.3%; rate ratio, 1.32). But the increase may reflect that those seeking testing during the pandemic were more likely to be symptomatic.

“It is plausible that the smaller pool of people getting tested represented those with a higher likelihood of receiving a positive HIV test, [for instance] having a recent exposure, exhibiting symptoms,” Mr. Patel explained. “Furthermore, it is possible that some health departments specifically focused outreach efforts to serve persons with increased potential for HIV acquisition, thus identifying a higher proportion of persons with HIV.”

The declines in testing are nevertheless of particular concern in light of recent pre-COVID data indicating that as many as 13% of people who were infected with HIV were unaware of their positive status, placing them at high risk of transmitting the virus.

And on a broader level, the declines could negatively affect the goal to eradicate HIV through the federal Ending the HIV Epidemic in the U.S. (EHE) initiative, which aims to reduce new HIV infections in the United States by 90% by 2030 through the scaling up of key HIV prevention and treatment strategies, Mr. Patel noted.

“The first pillar of EHE is to diagnose all people with HIV as early as possible, and to accomplish that, there needs to be sufficient HIV testing,” Mr. Patel explained. “With fewer HIV tests being conducted, there are missed opportunities to identify persons with newly diagnosed HIV, which affects the entire continuum of care, [including] linkage to medical care, receiving antiretroviral treatment, getting and keeping viral suppression, and reducing transmission.”
 

At the local level: Adaptations allowed for continued testing

In a separate report presented at the meeting detailing the experiences at a more local level, Joseph Olsen, MPH, and colleagues with CrescentCare, New Orleans, described a similar reduction of HIV testing in 2020 of 49% in their system, compared with the previous year, down from 7,952 rapid HIV tests in 2019 to 4,034 in 2020.

However, through efforts to continue to provide services during the pandemic, the program was able to link 182 patients to HIV care in 2020, which was up from 172 in 2019.

In addition to offering the rapid HIV testing in conjunction with COVID-19 testing at their urgent care centers, the center adapted to the pandemic’s challenges with strategies including a new at-home testing program; providing testing at a hotel shelter for the homeless; and testing as part of walk-in testing with a syringe access component.

Mr. Olsen credited the swift program adaptations with maintaining testing during the time of crisis.

“Without [those] measures, it would have been a near-zero number of tests provided,” he said in an interview. “It would have been easy to blame the pandemic and not try to find innovations to deliver services, but I credit our incredibly motivated team for wanting to make sure every possible resource was available.”

But now there are signs of possible fallout from the testing reductions that did occur, Mr. Olsen said.

“We are already seeing the increase with other sexually transmitted infections [STIs], and I expect that we will see this with HIV as well,” he said.

In response, clinicians should use diligence in providing HIV testing, Mr. Olsen asserted.

“The take-home message for clinicians is that anyone having sex should get tested for HIV. It’s as easy as that!” he said.

“If they are getting tested for any other STI, make sure an HIV panel is added and discussed. If someone is pregnant, make sure an HIV panel is added and discussed. If someone has never had an HIV test before in their life – and I would add if they haven’t had an HIV test since March of 2020 – make sure an HIV panel is added/discussed,” he said. “Doing this for everyone also reduces stigma around testing. It’s not because any one person or group or risk behavior is being targeted, it is just good public health practice.”

The authors disclosed no relevant financial relationships. Mr. Patel noted that the findings and conclusions of her poster are those of the authors and do not necessarily represent the official position of the CDC.

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

HIV testing centers across the United States showed reductions in testing of nearly 50% during the height of the COVID-19 pandemic in 2020, raising concerns of a subsequent increase in transmission by people unaware of their HIV-positive status.

“Testing strategies need to be ramped up to cover this decrease in testing while adapting to the continuing COVID-19 environment,” reported Deesha Patel, MPH, and colleagues with the Centers for Disease Control and Prevention’s division of HIV prevention, Atlanta, in research presented at the annual meeting of the United States Conference on HIV/AIDS.

According to their data from the National HIV Prevention Program Monitoring and Evaluation system, the number of CDC-funded HIV tests declined by more than 1 million in 2020 amid the COVID-19 restrictions, with 1,228,142 tests reported that year, compared with 2,301,669 tests in 2019, a reduction of 46.6%.

The number of persons who were newly diagnosed with HIV, based on the tests, declined by 29.7%, from 7,692 newly diagnosed in 2019 to 5,409 persons in 2020, the authors reported.

The reasons for the reduction in new HIV diagnoses in 2020 could be multifactorial, possibly reflecting not just the reduced rates of testing but also possibly lower rates of transmission because of the lockdowns and social distancing, Mr. Patel said in an interview.

“Both [of those] interpretations are plausible, and the reductions are likely due to a combination of reasons,” she said.

Of note, the percentage of tests that were positive did not show a decline and was in fact slightly higher in 2020 (0.4%), compared with 2019 (0.3%; rate ratio, 1.32). But the increase may reflect that those seeking testing during the pandemic were more likely to be symptomatic.

“It is plausible that the smaller pool of people getting tested represented those with a higher likelihood of receiving a positive HIV test, [for instance] having a recent exposure, exhibiting symptoms,” Mr. Patel explained. “Furthermore, it is possible that some health departments specifically focused outreach efforts to serve persons with increased potential for HIV acquisition, thus identifying a higher proportion of persons with HIV.”

The declines in testing are nevertheless of particular concern in light of recent pre-COVID data indicating that as many as 13% of people who were infected with HIV were unaware of their positive status, placing them at high risk of transmitting the virus.

And on a broader level, the declines could negatively affect the goal to eradicate HIV through the federal Ending the HIV Epidemic in the U.S. (EHE) initiative, which aims to reduce new HIV infections in the United States by 90% by 2030 through the scaling up of key HIV prevention and treatment strategies, Mr. Patel noted.

“The first pillar of EHE is to diagnose all people with HIV as early as possible, and to accomplish that, there needs to be sufficient HIV testing,” Mr. Patel explained. “With fewer HIV tests being conducted, there are missed opportunities to identify persons with newly diagnosed HIV, which affects the entire continuum of care, [including] linkage to medical care, receiving antiretroviral treatment, getting and keeping viral suppression, and reducing transmission.”
 

At the local level: Adaptations allowed for continued testing

In a separate report presented at the meeting detailing the experiences at a more local level, Joseph Olsen, MPH, and colleagues with CrescentCare, New Orleans, described a similar reduction of HIV testing in 2020 of 49% in their system, compared with the previous year, down from 7,952 rapid HIV tests in 2019 to 4,034 in 2020.

However, through efforts to continue to provide services during the pandemic, the program was able to link 182 patients to HIV care in 2020, which was up from 172 in 2019.

In addition to offering the rapid HIV testing in conjunction with COVID-19 testing at their urgent care centers, the center adapted to the pandemic’s challenges with strategies including a new at-home testing program; providing testing at a hotel shelter for the homeless; and testing as part of walk-in testing with a syringe access component.

Mr. Olsen credited the swift program adaptations with maintaining testing during the time of crisis.

“Without [those] measures, it would have been a near-zero number of tests provided,” he said in an interview. “It would have been easy to blame the pandemic and not try to find innovations to deliver services, but I credit our incredibly motivated team for wanting to make sure every possible resource was available.”

But now there are signs of possible fallout from the testing reductions that did occur, Mr. Olsen said.

“We are already seeing the increase with other sexually transmitted infections [STIs], and I expect that we will see this with HIV as well,” he said.

In response, clinicians should use diligence in providing HIV testing, Mr. Olsen asserted.

“The take-home message for clinicians is that anyone having sex should get tested for HIV. It’s as easy as that!” he said.

“If they are getting tested for any other STI, make sure an HIV panel is added and discussed. If someone is pregnant, make sure an HIV panel is added and discussed. If someone has never had an HIV test before in their life – and I would add if they haven’t had an HIV test since March of 2020 – make sure an HIV panel is added/discussed,” he said. “Doing this for everyone also reduces stigma around testing. It’s not because any one person or group or risk behavior is being targeted, it is just good public health practice.”

The authors disclosed no relevant financial relationships. Mr. Patel noted that the findings and conclusions of her poster are those of the authors and do not necessarily represent the official position of the CDC.

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

HIV testing centers across the United States showed reductions in testing of nearly 50% during the height of the COVID-19 pandemic in 2020, raising concerns of a subsequent increase in transmission by people unaware of their HIV-positive status.

“Testing strategies need to be ramped up to cover this decrease in testing while adapting to the continuing COVID-19 environment,” reported Deesha Patel, MPH, and colleagues with the Centers for Disease Control and Prevention’s division of HIV prevention, Atlanta, in research presented at the annual meeting of the United States Conference on HIV/AIDS.

According to their data from the National HIV Prevention Program Monitoring and Evaluation system, the number of CDC-funded HIV tests declined by more than 1 million in 2020 amid the COVID-19 restrictions, with 1,228,142 tests reported that year, compared with 2,301,669 tests in 2019, a reduction of 46.6%.

The number of persons who were newly diagnosed with HIV, based on the tests, declined by 29.7%, from 7,692 newly diagnosed in 2019 to 5,409 persons in 2020, the authors reported.

The reasons for the reduction in new HIV diagnoses in 2020 could be multifactorial, possibly reflecting not just the reduced rates of testing but also possibly lower rates of transmission because of the lockdowns and social distancing, Mr. Patel said in an interview.

“Both [of those] interpretations are plausible, and the reductions are likely due to a combination of reasons,” she said.

Of note, the percentage of tests that were positive did not show a decline and was in fact slightly higher in 2020 (0.4%), compared with 2019 (0.3%; rate ratio, 1.32). But the increase may reflect that those seeking testing during the pandemic were more likely to be symptomatic.

“It is plausible that the smaller pool of people getting tested represented those with a higher likelihood of receiving a positive HIV test, [for instance] having a recent exposure, exhibiting symptoms,” Mr. Patel explained. “Furthermore, it is possible that some health departments specifically focused outreach efforts to serve persons with increased potential for HIV acquisition, thus identifying a higher proportion of persons with HIV.”

The declines in testing are nevertheless of particular concern in light of recent pre-COVID data indicating that as many as 13% of people who were infected with HIV were unaware of their positive status, placing them at high risk of transmitting the virus.

And on a broader level, the declines could negatively affect the goal to eradicate HIV through the federal Ending the HIV Epidemic in the U.S. (EHE) initiative, which aims to reduce new HIV infections in the United States by 90% by 2030 through the scaling up of key HIV prevention and treatment strategies, Mr. Patel noted.

“The first pillar of EHE is to diagnose all people with HIV as early as possible, and to accomplish that, there needs to be sufficient HIV testing,” Mr. Patel explained. “With fewer HIV tests being conducted, there are missed opportunities to identify persons with newly diagnosed HIV, which affects the entire continuum of care, [including] linkage to medical care, receiving antiretroviral treatment, getting and keeping viral suppression, and reducing transmission.”
 

At the local level: Adaptations allowed for continued testing

In a separate report presented at the meeting detailing the experiences at a more local level, Joseph Olsen, MPH, and colleagues with CrescentCare, New Orleans, described a similar reduction of HIV testing in 2020 of 49% in their system, compared with the previous year, down from 7,952 rapid HIV tests in 2019 to 4,034 in 2020.

However, through efforts to continue to provide services during the pandemic, the program was able to link 182 patients to HIV care in 2020, which was up from 172 in 2019.

In addition to offering the rapid HIV testing in conjunction with COVID-19 testing at their urgent care centers, the center adapted to the pandemic’s challenges with strategies including a new at-home testing program; providing testing at a hotel shelter for the homeless; and testing as part of walk-in testing with a syringe access component.

Mr. Olsen credited the swift program adaptations with maintaining testing during the time of crisis.

“Without [those] measures, it would have been a near-zero number of tests provided,” he said in an interview. “It would have been easy to blame the pandemic and not try to find innovations to deliver services, but I credit our incredibly motivated team for wanting to make sure every possible resource was available.”

But now there are signs of possible fallout from the testing reductions that did occur, Mr. Olsen said.

“We are already seeing the increase with other sexually transmitted infections [STIs], and I expect that we will see this with HIV as well,” he said.

In response, clinicians should use diligence in providing HIV testing, Mr. Olsen asserted.

“The take-home message for clinicians is that anyone having sex should get tested for HIV. It’s as easy as that!” he said.

“If they are getting tested for any other STI, make sure an HIV panel is added and discussed. If someone is pregnant, make sure an HIV panel is added and discussed. If someone has never had an HIV test before in their life – and I would add if they haven’t had an HIV test since March of 2020 – make sure an HIV panel is added/discussed,” he said. “Doing this for everyone also reduces stigma around testing. It’s not because any one person or group or risk behavior is being targeted, it is just good public health practice.”

The authors disclosed no relevant financial relationships. Mr. Patel noted that the findings and conclusions of her poster are those of the authors and do not necessarily represent the official position of the CDC.

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

Responses to abrocitinib treatment among patients with moderate to severe atopic dermatitis (AD) showed dose-dependent consistency across age groups and was comparable in patients aged 51 years and older, results from a post hoc analysis of four trials showed.

Abrocitinib (Cibinqo) is an oral, once-daily, Janus kinase 1 selective inhibitor that has shown good efficacy and safety as monotherapy or combined with topical therapy for treatment of patients with moderate to severe AD. The agent was approved in mid-December in Europe for the treatment of moderate to severe AD in adults who are candidates for systemic therapy and is currently under review by the Food and Drug Administration.

“We know that responses to, and adverse events associated with, systemic therapies may vary among patients of different ages,” Andrew F. Alexis, MD, MPH, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “The efficacy and safety of abrocitinib monotherapy were previously evaluated in adolescent and adult subpopulations from controlled clinical trials in patients with moderate to severe AD. The objective of the current study was to assess the impact of age on short-term responses to abrocitinib treatment in patients with moderate to severe AD.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, and colleagues performed a post hoc analysis across four randomized, double-blind studies that was stratified by age group: 12-17 years, 18-40 years, 41-50 years, and 51 years and older. Efficacy data were assessed separately for patients in the monotherapy pool and in the JADE COMPARE trial. The monotherapy pool included patients from one phase 2b study and two phase 3 studies who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo monotherapy for 12 weeks (JADE-MONO-1 and JADE-MONO-2).

The JADE COMPARE pool included patients who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo, plus medicated topical therapy for 16 weeks. Data from patients in all four trials were pooled for the analysis of treatment-emergent adverse events. Efficacy points analyzed were the Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear), a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75), or Peak Pruritus Numeric Rating Scale score (PP-NRS4) at week 12 for the monotherapy pool and at week 16 for COMPARE.

In the monotherapy pool, the proportions of patients ages 12-17 years, 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response at 12 weeks were 31.3%, 40.2%, 43.8%, and 50.8% (abrocitinib 200 mg); 22%, 23.7%, 22.4%, and 40.8% (abrocitinib 100 mg); and 8.7%, 8%, 3.3%, and 10% (placebo).

In JADE COMPARE, the proportions of patients aged 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response were 50%, 53.2%, and 34.8% (abrocitinib 200 mg); 36.9%, 37.1%, and 26.1% (abrocitinib 100 mg); and 12%, 11.8%, and 16.7% (placebo) at 16 weeks. Similar trends were observed for EASI-75 and PP-NRS4 responses at 12 weeks.

Across all age groups, the most common treatment-emergent adverse events were infections/infestations and gastrointestinal effects; most cases were mild or moderate. Nausea was more frequent in the two younger age groups and was dose related: For abrocitinib 200 mg and abrocitinib 100 mg, respectively, the rates of nausea were 18.8% and 7.8% in patients aged 12-17 years; 17.1% and 6.4% in patients aged 18-40 years; and 7.1% and 3.3% in patients aged 51 and older.

“Efficacy responses in patients 51 years of age and older were comparable to those in other age groups,” concluded Dr. Alexis, vice chair for diversity and inclusion in the department of dermatology at Weill Cornell. “The safety profile was consistent across age ranges and was similar to that reported previously.”

The investigators found that treatment response to abrocitinib “in the absence or presence of medicated topical therapy was fairly consistent across age groups, showed similar dose-dependency, and importantly, did not show reduced efficacy in older adults as measured by lesional severity, extent, and itch at 4 months,” said Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study.

“Furthermore, the safety profile was consistent across all adults, though notably, nausea was more common among younger age groups, highlighting an area of future investigation,” he added. “Overall, these data show that abrocitinib is associated with similar short-term responses across adulthood and underscore the importance of the JAK-STAT pathway in the underlying pathophysiology of AD in different age groups. It will be interesting to see how these data reflect the real-world setting with both short- and long-term outcomes in a heterogeneous patient population.”

In the interview, Dr. Chovatiya said, “the next frontier in personalized therapy for AD involves deeper clinical phenotyping of our patients and a better understanding of how efficacy and safety vary across patient groups.” For example, he noted, “AD in earlier versus later adulthood may be associated with different clinical signs, symptoms, comorbidities, and other measures of patient burden, and thus, may be associated with different treatment responses to systemic therapy.”  

Dr. Alexis disclosed that he has served as an adviser to, or has received consulting fees from, Leo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Beiersdorf, Valeant, L’Oréal, BMS, Bausch Health, UCB, Vyne, Arcutis, Janssen, Allergan, Almirall, AbbVie, Sol-Gel, and Amgen.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme.

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

Responses to abrocitinib treatment among patients with moderate to severe atopic dermatitis (AD) showed dose-dependent consistency across age groups and was comparable in patients aged 51 years and older, results from a post hoc analysis of four trials showed.

Abrocitinib (Cibinqo) is an oral, once-daily, Janus kinase 1 selective inhibitor that has shown good efficacy and safety as monotherapy or combined with topical therapy for treatment of patients with moderate to severe AD. The agent was approved in mid-December in Europe for the treatment of moderate to severe AD in adults who are candidates for systemic therapy and is currently under review by the Food and Drug Administration.

“We know that responses to, and adverse events associated with, systemic therapies may vary among patients of different ages,” Andrew F. Alexis, MD, MPH, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “The efficacy and safety of abrocitinib monotherapy were previously evaluated in adolescent and adult subpopulations from controlled clinical trials in patients with moderate to severe AD. The objective of the current study was to assess the impact of age on short-term responses to abrocitinib treatment in patients with moderate to severe AD.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, and colleagues performed a post hoc analysis across four randomized, double-blind studies that was stratified by age group: 12-17 years, 18-40 years, 41-50 years, and 51 years and older. Efficacy data were assessed separately for patients in the monotherapy pool and in the JADE COMPARE trial. The monotherapy pool included patients from one phase 2b study and two phase 3 studies who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo monotherapy for 12 weeks (JADE-MONO-1 and JADE-MONO-2).

The JADE COMPARE pool included patients who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo, plus medicated topical therapy for 16 weeks. Data from patients in all four trials were pooled for the analysis of treatment-emergent adverse events. Efficacy points analyzed were the Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear), a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75), or Peak Pruritus Numeric Rating Scale score (PP-NRS4) at week 12 for the monotherapy pool and at week 16 for COMPARE.

In the monotherapy pool, the proportions of patients ages 12-17 years, 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response at 12 weeks were 31.3%, 40.2%, 43.8%, and 50.8% (abrocitinib 200 mg); 22%, 23.7%, 22.4%, and 40.8% (abrocitinib 100 mg); and 8.7%, 8%, 3.3%, and 10% (placebo).

In JADE COMPARE, the proportions of patients aged 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response were 50%, 53.2%, and 34.8% (abrocitinib 200 mg); 36.9%, 37.1%, and 26.1% (abrocitinib 100 mg); and 12%, 11.8%, and 16.7% (placebo) at 16 weeks. Similar trends were observed for EASI-75 and PP-NRS4 responses at 12 weeks.

Across all age groups, the most common treatment-emergent adverse events were infections/infestations and gastrointestinal effects; most cases were mild or moderate. Nausea was more frequent in the two younger age groups and was dose related: For abrocitinib 200 mg and abrocitinib 100 mg, respectively, the rates of nausea were 18.8% and 7.8% in patients aged 12-17 years; 17.1% and 6.4% in patients aged 18-40 years; and 7.1% and 3.3% in patients aged 51 and older.

“Efficacy responses in patients 51 years of age and older were comparable to those in other age groups,” concluded Dr. Alexis, vice chair for diversity and inclusion in the department of dermatology at Weill Cornell. “The safety profile was consistent across age ranges and was similar to that reported previously.”

The investigators found that treatment response to abrocitinib “in the absence or presence of medicated topical therapy was fairly consistent across age groups, showed similar dose-dependency, and importantly, did not show reduced efficacy in older adults as measured by lesional severity, extent, and itch at 4 months,” said Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study.

“Furthermore, the safety profile was consistent across all adults, though notably, nausea was more common among younger age groups, highlighting an area of future investigation,” he added. “Overall, these data show that abrocitinib is associated with similar short-term responses across adulthood and underscore the importance of the JAK-STAT pathway in the underlying pathophysiology of AD in different age groups. It will be interesting to see how these data reflect the real-world setting with both short- and long-term outcomes in a heterogeneous patient population.”

In the interview, Dr. Chovatiya said, “the next frontier in personalized therapy for AD involves deeper clinical phenotyping of our patients and a better understanding of how efficacy and safety vary across patient groups.” For example, he noted, “AD in earlier versus later adulthood may be associated with different clinical signs, symptoms, comorbidities, and other measures of patient burden, and thus, may be associated with different treatment responses to systemic therapy.”  

Dr. Alexis disclosed that he has served as an adviser to, or has received consulting fees from, Leo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Beiersdorf, Valeant, L’Oréal, BMS, Bausch Health, UCB, Vyne, Arcutis, Janssen, Allergan, Almirall, AbbVie, Sol-Gel, and Amgen.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme.

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

Responses to abrocitinib treatment among patients with moderate to severe atopic dermatitis (AD) showed dose-dependent consistency across age groups and was comparable in patients aged 51 years and older, results from a post hoc analysis of four trials showed.

Abrocitinib (Cibinqo) is an oral, once-daily, Janus kinase 1 selective inhibitor that has shown good efficacy and safety as monotherapy or combined with topical therapy for treatment of patients with moderate to severe AD. The agent was approved in mid-December in Europe for the treatment of moderate to severe AD in adults who are candidates for systemic therapy and is currently under review by the Food and Drug Administration.

“We know that responses to, and adverse events associated with, systemic therapies may vary among patients of different ages,” Andrew F. Alexis, MD, MPH, said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “The efficacy and safety of abrocitinib monotherapy were previously evaluated in adolescent and adult subpopulations from controlled clinical trials in patients with moderate to severe AD. The objective of the current study was to assess the impact of age on short-term responses to abrocitinib treatment in patients with moderate to severe AD.”

Dr. Alexis, professor of clinical dermatology at Weill Cornell Medicine, New York, and colleagues performed a post hoc analysis across four randomized, double-blind studies that was stratified by age group: 12-17 years, 18-40 years, 41-50 years, and 51 years and older. Efficacy data were assessed separately for patients in the monotherapy pool and in the JADE COMPARE trial. The monotherapy pool included patients from one phase 2b study and two phase 3 studies who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo monotherapy for 12 weeks (JADE-MONO-1 and JADE-MONO-2).

The JADE COMPARE pool included patients who received abrocitinib 200 mg, abrocitinib 100 mg, or placebo, plus medicated topical therapy for 16 weeks. Data from patients in all four trials were pooled for the analysis of treatment-emergent adverse events. Efficacy points analyzed were the Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear), a 75% reduction from baseline in the Eczema Area and Severity Index (EASI-75), or Peak Pruritus Numeric Rating Scale score (PP-NRS4) at week 12 for the monotherapy pool and at week 16 for COMPARE.

In the monotherapy pool, the proportions of patients ages 12-17 years, 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response at 12 weeks were 31.3%, 40.2%, 43.8%, and 50.8% (abrocitinib 200 mg); 22%, 23.7%, 22.4%, and 40.8% (abrocitinib 100 mg); and 8.7%, 8%, 3.3%, and 10% (placebo).

In JADE COMPARE, the proportions of patients aged 18-40 years, 41-50 years, and 51 years and older who achieved an IGA 0/1 response were 50%, 53.2%, and 34.8% (abrocitinib 200 mg); 36.9%, 37.1%, and 26.1% (abrocitinib 100 mg); and 12%, 11.8%, and 16.7% (placebo) at 16 weeks. Similar trends were observed for EASI-75 and PP-NRS4 responses at 12 weeks.

Across all age groups, the most common treatment-emergent adverse events were infections/infestations and gastrointestinal effects; most cases were mild or moderate. Nausea was more frequent in the two younger age groups and was dose related: For abrocitinib 200 mg and abrocitinib 100 mg, respectively, the rates of nausea were 18.8% and 7.8% in patients aged 12-17 years; 17.1% and 6.4% in patients aged 18-40 years; and 7.1% and 3.3% in patients aged 51 and older.

“Efficacy responses in patients 51 years of age and older were comparable to those in other age groups,” concluded Dr. Alexis, vice chair for diversity and inclusion in the department of dermatology at Weill Cornell. “The safety profile was consistent across age ranges and was similar to that reported previously.”

The investigators found that treatment response to abrocitinib “in the absence or presence of medicated topical therapy was fairly consistent across age groups, showed similar dose-dependency, and importantly, did not show reduced efficacy in older adults as measured by lesional severity, extent, and itch at 4 months,” said Raj Chovatiya, MD, PhD, assistant professor of dermatology at Northwestern University, Chicago, who was asked to comment on the study.

“Furthermore, the safety profile was consistent across all adults, though notably, nausea was more common among younger age groups, highlighting an area of future investigation,” he added. “Overall, these data show that abrocitinib is associated with similar short-term responses across adulthood and underscore the importance of the JAK-STAT pathway in the underlying pathophysiology of AD in different age groups. It will be interesting to see how these data reflect the real-world setting with both short- and long-term outcomes in a heterogeneous patient population.”

In the interview, Dr. Chovatiya said, “the next frontier in personalized therapy for AD involves deeper clinical phenotyping of our patients and a better understanding of how efficacy and safety vary across patient groups.” For example, he noted, “AD in earlier versus later adulthood may be associated with different clinical signs, symptoms, comorbidities, and other measures of patient burden, and thus, may be associated with different treatment responses to systemic therapy.”  

Dr. Alexis disclosed that he has served as an adviser to, or has received consulting fees from, Leo, Galderma, Pfizer, Sanofi-Regeneron, Dermavant, Beiersdorf, Valeant, L’Oréal, BMS, Bausch Health, UCB, Vyne, Arcutis, Janssen, Allergan, Almirall, AbbVie, Sol-Gel, and Amgen.

Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for AbbVie, Arena, Arcutis, Incyte, Pfizer, Regeneron, and Sanofi-Genzyme.

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

Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.

The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.

In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.

Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.

By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.

The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.

However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.

In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
 

Accepting simple intervention could have great impact

This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.

“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.

Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.

“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.  

However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.

“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.

Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.

Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.

The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.

Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.

The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.

In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.

Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.

By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.

The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.

However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.

In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
 

Accepting simple intervention could have great impact

This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.

“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.

Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.

“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.  

However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.

“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.

Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.

Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.

The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.

Delayed umbilical cord clamping for at least 60 seconds after birth significantly reduced death or disability in infants of less than 30 weeks’ gestation, according to data from nearly 1,500 infants.

The burden of disability and mortality for babies born before 30 weeks’ gestation remains high, especially in low- and middle-income countries, wrote Kristy P. Robledo, PhD, of the University of Sydney, Australia, and colleagues. Delayed clamping of the umbilical cord is a simple procedure that may improve mortality in this population, but more research is needed; recommended times to delayed clamping range from 30 seconds to 3 minutes, they noted.

In a study published in The Lancet Child & Adolescent Health, the researchers randomized 767 very preterm infants to delayed clamping at least 60 seconds after birth and 764 to immediate clamping. Of these, 384 were multiple births (who were individually randomized), 862 were male, and 505 were born before 27 weeks’ gestation. The primary outcome was death or disability at 2 years of age. Major disability was defined as cerebral palsy, severe visual loss, deafness requiring a hearing aid or cochlear implants, major language or speech problems, or cognitive delay at 2 years corrected age. The median time to clamping was 60 seconds in the delayed group and 5 seconds in the immediate group.

Primary outcome data were available for 1,419 infants. Death or major disability occurred in 29% of infants assigned to delayed clamping compared to 34% of those assigned to immediate clamping (relative risk 0.83, P = .010). The infants were part of the APTS Childhood Follow-Up Study, an open-label superiority trial conducted in Australia and New Zealand.

By age 2 years, 8% of infants in the delayed group and 11% of those in the immediate group had died; 23% and 26%, respectively, met criteria for major disability. The impact of delayed clamping translates to a 30% reduction in relative risk of mortality at 2 years of age, but no significant impact on major disability, the researchers wrote.

The findings were limited by several factors including the unblinded study design, lack of data on heart rate or time to first breath, and the clamping prior to 60 seconds in 26% of infants in the delayed group based on clinical concerns for these specific infants, the researchers noted.

However, the results were strengthened by the large size, low risk of bias, and specific primary outcome, they said. The data support findings from recent systematic reviews and highlight the need for further trials to evaluate delayed clamping at different time points, with larger populations, inclusion of time to first breath and heart rate, and improved measures of disability, the researchers added.

In clinical practice, “Given that aiming to delay cord clamping for 60 seconds or more improved 2-year outcomes and short-term hematological measures with no evidence of significant harm, it seems reasonable to conclude that delayed clamping is appropriate as standard care in very preterm infants,” they concluded.
 

Accepting simple intervention could have great impact

This study is important in light of the overwhelming burden of preterm birth on the health care system and society as a whole, Lisette D. Tanner, MD, of Emory University, Atlanta, said in an interview.

“Preterm birth is associated with billions in health care costs each year, and a large portion of that money is directed to the complications associated with preterm birth, such as early intervention services, educational support, and ongoing medical care,” Dr. Tanner said. “This study is particularly timely, as we are quickly approaching 2030, the deadline for achieving the United Nations Sustainable Development Goal of ending preventable deaths of newborns and children under 5 years of age,” she said. The goal involves “all countries aiming to reduce neonatal mortality to at least as low as 12 per 1,000 live births and under-5 mortality to at least as low as 25 per 1,000 live births. Effective treatments to reduce infant and child mortality would make strong inroads toward this goal,” she explained.

Dr. Tanner said she was not surprised by the findings because previous studies have shown similar results. “However, the large, multicenter nature of this study provides additional weight to recommendations to delay cord clamping as standard practice,” she said.

“The findings of this study support the recommendations of a number of large organizations,” said Dr. Tanner. “The World Health Organization recommends that the umbilical cord not be clamped earlier than 1 minute after birth in term or preterm infants who do not require positive pressure ventilation. The American College of Obstetricians and Gynecologists and the American Academy of Pediatrics now recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30–60 seconds after birth,” she said. “The Royal College of Obstetricians and Gynaecologists also recommends deferring umbilical cord clamping for healthy term and preterm infants for at least 2 minutes after birth,” she added.  

However, “the delay in adoption of this guidelines in practice appears to be related to some concerns regarding universal adoption of this approach,” Dr. Tanner noted. “Some clinicians have suggested that delayed cord clamping could delay vital neonatal resuscitative efforts, leading to worse neonatal outcomes, but this concern has not been borne out in the data, as all guidelines specifically state that this intervention is for vigorous newborns,” she said. “In fact, in preterm infants, delayed cord clamping is associated with improved transitional circulation, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage,” Dr. Tanner emphasized. “Additionally, concerns persist that delayed cord clamping could lead to excessive transfusion with resultant polycythemia. Again, no data have supported this claim to date,” she said.

“Finally, some clinicians are concerned that delayed clamping could lead to delay in addressing maternal complications of birth such as hemorrhage, but studies have shown the opposite; delayed umbilical cord clamping has not been associated with an increased risk of postpartum hemorrhage or increased blood loss at delivery, nor has it been with a difference in the need for blood transfusion,” said Dr. Tanner.

Ideally, practitioners will become more comfortable in delaying cord clamping as a routine practice as more data demonstrating the safety and benefit of this easy intervention are disseminated, she said.

Additional research delineating which gestational ages benefit most from delayed cord clamping would help direct education efforts to implement this intervention, Dr. Tanner noted.

The study was funded by the Australian National Health and Medical Research Council. The researchers and Dr. Tanner had no financial conflicts to disclose.

A home-based tunneled peritoneal catheter (PeCa) drainage system provided significant relief for patients with refractory ascites who were not candidates for transjugular intrahepatic portosystemic shunt (TIPS).

For these patients, the current standard of care is repeated large volume paracentesis, but this can require frequent hospital trips that can be costly and onerous.

The PeCa system consists of one part that lays in the peritoneal cavity, then a tunnel through subcutaneous tissue and an external port where the patient can connect drainage bags. It has been tested and found to provide relief for patients with malignant ascites, but there is little data available for patients with cirrhosis, according to Tammo Lambert Tergast, MD, who presented the study at the annual meeting of the American Association for the Study of Liver Diseases. Dr. Tergast is a resident in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School.

“Patients with refractory ascites have a very high risk for rehospitalization, AKI [acute kidney injury], and death. Our data indicate that PeCa could be a valuable new treatment option for patients with refractory ascites and contraindication for TIPS. However, the risk for hyponatremia and AKI has to be considered and further explored,” said Dr. Tergast during his presentation.

The researchers retrospectively analyzed outcomes in 152 patients with refractory ascites who received a PeCa implant and 71 patients who received standard of care (SOC), which included repeated large volume paracentesis and albumin. The median explant-free survival was 74 days, and just under 50% were explant free at 90 days.

52 patients had the PeCa system removed: 54% because of an infection, 15% because of liver transplant, 12% because of dysfunction, and 10% because of accidental removal.

Factors associated with 90-day survival included PeCa (hazard ratio, 0.52; P = .05) and each point of Model for End-Stage Liver Disease (MELD) score (HR, 1.16; P = .001). There was a trend toward a higher incidence of hyponatremia in the PeCa group (P = .09).

Hospitalizations were more common in the PeCa group (P = .035), but there was no significant difference in mortality between the two groups. Reasons for hospitalization included spontaneous bacterial peritonitis (SBP; 18% in PeCa vs. 8% of SOC), hyponatremia (10% vs. 0%), and infections other than SBP (4% and 16%).

A propensity score–matched analysis that included age, history of SBP, platelet count, serum albumin levels, and MELD score found no significant differences between the two groups, but there were trends in the PeCa group towards higher 90-day survival (P = .16) and a higher frequency of acute kidney injury (P = .08).

Although the appropriate patient population for the system would be small, “once you get to refractory ascites, management of these individuals is really, really challenging, especially people that had contraindications to a TIPS procedure. Anything that you can do to improve their quality of life and help with management is definitely desired,” said Nancy Reau, MD, who was asked to comment on the study. Dr. Reau is chief of the section of hepatology at Rush University Medical Center, Chicago.

The study found little difference in infection risk between the PeCa and standard of care group, but there was a trend toward more hyponatremia in the PeCa group. That could be caused by reduced contact with the health system, according to Dr. Reau, since physicians may be keeping an eye on electrolytes, diuretics, and other factors during paracentesis visits. “But as long as you’re setting up home nursing or some other way to make sure that you’re managing them appropriately, that should be something that is overcome with awareness,” said Dr. Reau.

During the question-and-answer following the presentation, Dr. Tergast was asked about the heightened frequency of hospitalizations in the PeCa group. He posited that the observation may be caused by the retrospective nature of the study. His center is a tertiary care center, which accepts referrals from all over Germany. When a problem occurs with a PeCa, patients often get referred back to the tertiary center, leading to a higher number of hospitalizations observed in that group. “So this might be a bias in the analysis,” he said.

“I think if we can optimize the treatment after discharge, we can also minimize the rehospitalization in these patients. Rehospitalization rate because of ascites was quite low,” said Dr. Tergast.

Dr. Tergast and Dr. Reau have no relevant financial disclosures.

A home-based tunneled peritoneal catheter (PeCa) drainage system provided significant relief for patients with refractory ascites who were not candidates for transjugular intrahepatic portosystemic shunt (TIPS).

For these patients, the current standard of care is repeated large volume paracentesis, but this can require frequent hospital trips that can be costly and onerous.

The PeCa system consists of one part that lays in the peritoneal cavity, then a tunnel through subcutaneous tissue and an external port where the patient can connect drainage bags. It has been tested and found to provide relief for patients with malignant ascites, but there is little data available for patients with cirrhosis, according to Tammo Lambert Tergast, MD, who presented the study at the annual meeting of the American Association for the Study of Liver Diseases. Dr. Tergast is a resident in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School.

“Patients with refractory ascites have a very high risk for rehospitalization, AKI [acute kidney injury], and death. Our data indicate that PeCa could be a valuable new treatment option for patients with refractory ascites and contraindication for TIPS. However, the risk for hyponatremia and AKI has to be considered and further explored,” said Dr. Tergast during his presentation.

The researchers retrospectively analyzed outcomes in 152 patients with refractory ascites who received a PeCa implant and 71 patients who received standard of care (SOC), which included repeated large volume paracentesis and albumin. The median explant-free survival was 74 days, and just under 50% were explant free at 90 days.

52 patients had the PeCa system removed: 54% because of an infection, 15% because of liver transplant, 12% because of dysfunction, and 10% because of accidental removal.

Factors associated with 90-day survival included PeCa (hazard ratio, 0.52; P = .05) and each point of Model for End-Stage Liver Disease (MELD) score (HR, 1.16; P = .001). There was a trend toward a higher incidence of hyponatremia in the PeCa group (P = .09).

Hospitalizations were more common in the PeCa group (P = .035), but there was no significant difference in mortality between the two groups. Reasons for hospitalization included spontaneous bacterial peritonitis (SBP; 18% in PeCa vs. 8% of SOC), hyponatremia (10% vs. 0%), and infections other than SBP (4% and 16%).

A propensity score–matched analysis that included age, history of SBP, platelet count, serum albumin levels, and MELD score found no significant differences between the two groups, but there were trends in the PeCa group towards higher 90-day survival (P = .16) and a higher frequency of acute kidney injury (P = .08).

Although the appropriate patient population for the system would be small, “once you get to refractory ascites, management of these individuals is really, really challenging, especially people that had contraindications to a TIPS procedure. Anything that you can do to improve their quality of life and help with management is definitely desired,” said Nancy Reau, MD, who was asked to comment on the study. Dr. Reau is chief of the section of hepatology at Rush University Medical Center, Chicago.

The study found little difference in infection risk between the PeCa and standard of care group, but there was a trend toward more hyponatremia in the PeCa group. That could be caused by reduced contact with the health system, according to Dr. Reau, since physicians may be keeping an eye on electrolytes, diuretics, and other factors during paracentesis visits. “But as long as you’re setting up home nursing or some other way to make sure that you’re managing them appropriately, that should be something that is overcome with awareness,” said Dr. Reau.

During the question-and-answer following the presentation, Dr. Tergast was asked about the heightened frequency of hospitalizations in the PeCa group. He posited that the observation may be caused by the retrospective nature of the study. His center is a tertiary care center, which accepts referrals from all over Germany. When a problem occurs with a PeCa, patients often get referred back to the tertiary center, leading to a higher number of hospitalizations observed in that group. “So this might be a bias in the analysis,” he said.

“I think if we can optimize the treatment after discharge, we can also minimize the rehospitalization in these patients. Rehospitalization rate because of ascites was quite low,” said Dr. Tergast.

Dr. Tergast and Dr. Reau have no relevant financial disclosures.

A home-based tunneled peritoneal catheter (PeCa) drainage system provided significant relief for patients with refractory ascites who were not candidates for transjugular intrahepatic portosystemic shunt (TIPS).

For these patients, the current standard of care is repeated large volume paracentesis, but this can require frequent hospital trips that can be costly and onerous.

The PeCa system consists of one part that lays in the peritoneal cavity, then a tunnel through subcutaneous tissue and an external port where the patient can connect drainage bags. It has been tested and found to provide relief for patients with malignant ascites, but there is little data available for patients with cirrhosis, according to Tammo Lambert Tergast, MD, who presented the study at the annual meeting of the American Association for the Study of Liver Diseases. Dr. Tergast is a resident in the department of gastroenterology, hepatology, and endocrinology at Hannover (Germany) Medical School.

“Patients with refractory ascites have a very high risk for rehospitalization, AKI [acute kidney injury], and death. Our data indicate that PeCa could be a valuable new treatment option for patients with refractory ascites and contraindication for TIPS. However, the risk for hyponatremia and AKI has to be considered and further explored,” said Dr. Tergast during his presentation.

The researchers retrospectively analyzed outcomes in 152 patients with refractory ascites who received a PeCa implant and 71 patients who received standard of care (SOC), which included repeated large volume paracentesis and albumin. The median explant-free survival was 74 days, and just under 50% were explant free at 90 days.

52 patients had the PeCa system removed: 54% because of an infection, 15% because of liver transplant, 12% because of dysfunction, and 10% because of accidental removal.

Factors associated with 90-day survival included PeCa (hazard ratio, 0.52; P = .05) and each point of Model for End-Stage Liver Disease (MELD) score (HR, 1.16; P = .001). There was a trend toward a higher incidence of hyponatremia in the PeCa group (P = .09).

Hospitalizations were more common in the PeCa group (P = .035), but there was no significant difference in mortality between the two groups. Reasons for hospitalization included spontaneous bacterial peritonitis (SBP; 18% in PeCa vs. 8% of SOC), hyponatremia (10% vs. 0%), and infections other than SBP (4% and 16%).

A propensity score–matched analysis that included age, history of SBP, platelet count, serum albumin levels, and MELD score found no significant differences between the two groups, but there were trends in the PeCa group towards higher 90-day survival (P = .16) and a higher frequency of acute kidney injury (P = .08).

Although the appropriate patient population for the system would be small, “once you get to refractory ascites, management of these individuals is really, really challenging, especially people that had contraindications to a TIPS procedure. Anything that you can do to improve their quality of life and help with management is definitely desired,” said Nancy Reau, MD, who was asked to comment on the study. Dr. Reau is chief of the section of hepatology at Rush University Medical Center, Chicago.

The study found little difference in infection risk between the PeCa and standard of care group, but there was a trend toward more hyponatremia in the PeCa group. That could be caused by reduced contact with the health system, according to Dr. Reau, since physicians may be keeping an eye on electrolytes, diuretics, and other factors during paracentesis visits. “But as long as you’re setting up home nursing or some other way to make sure that you’re managing them appropriately, that should be something that is overcome with awareness,” said Dr. Reau.

During the question-and-answer following the presentation, Dr. Tergast was asked about the heightened frequency of hospitalizations in the PeCa group. He posited that the observation may be caused by the retrospective nature of the study. His center is a tertiary care center, which accepts referrals from all over Germany. When a problem occurs with a PeCa, patients often get referred back to the tertiary center, leading to a higher number of hospitalizations observed in that group. “So this might be a bias in the analysis,” he said.

“I think if we can optimize the treatment after discharge, we can also minimize the rehospitalization in these patients. Rehospitalization rate because of ascites was quite low,” said Dr. Tergast.

Dr. Tergast and Dr. Reau have no relevant financial disclosures.

Diabetes mellitus (DM) is associated with Parkinson’s disease (PD) development, as well as more severe symptoms and more rapid disease progression, new research suggests.

In a systematic review, patients with type 2 diabetes were 34% more likely to develop PD than those without comorbid DM. In addition, patients with both conditions had significantly worse scores on the Unified Parkinson’s Disease Rating Scale (UPDRS) and worse cognitive performance.

Together, the results suggest that “DM may be a facilitating factor of neurodegeneration,” wrote the investigators, led by Gennaro Pagano, MD, PhD, expert medical director at Roche Pharma Research and Early Development, in Basel, Switzerland.

The findings were published in a recent issue of the Journal of Parkinson’s Disease.
 

Unanswered questions

Researchers have long proposed a potential relationship between diabetes and PD. However, case-control studies have yielded conflicting results about this relationship – and previous systematic reviews have failed to clarify the question.

In the current systematic review and meta-analysis, investigators identified relevant studies in databases such as MEDLINE/PubMed, Cochrane CENTRAL, and Scopus.

Eligible studies reported prevalence of DM in patients with PD, reported incidence of PD in those with and those without DM, and analyzed Parkinson’s phenotype and progression in those with and those without DM.

The researchers identified 3,829 articles in their initial search, evaluated 90 articles in detail, and included 43 studies in their analysis. Study quality was judged to be moderate or good, and the investigators did not find significant publication bias.

Twenty-one studies that encompassed 11,396 patients were examined to determine prevalence of DM in PD. This prevalence was calculated to be 10.02%, which is similar to the global prevalence of 9.3% reported in 2019.

The researchers also analyzed 12 cohort studies that included 17,797,221 patients to calculate risk for PD in patients with comorbid diabetes. The pooled summary odds ratio for incident PD among patients with type 2 diabetes was 1.34.

The evaluation of the effect of diabetes on PD severity was based on 10 studies that included 603 patients with both diseases. Because data on motor symptoms were not available for all studies, the researchers considered Hoehn and Yahr stage, UPDRS score, and cognitive impairment.

Patients with both conditions had a worse Hoehn and Yahr stage (standardized mean difference, 0.36; P < .001), and higher UPDRS score (SMD, 0.60; P < .001). In 7 of the 10 studies, diabetes was associated with worse cognitive performance in patients with PD.
 

Mechanisms uncertain

The mechanisms of the effect of diabetes on risk for and severity of PD are uncertain, but the researchers have developed hypotheses.

“Overlapping mechanisms between insulin resistance, mitochondrial dysfunction, oxidative stress, and alpha-synuclein expression could influence the development of the neurodegeneration process,” they wrote.

Because the current analysis demonstrated a trend toward more pronounced cognitive decline in patients with the comorbidities, clinicians should pay particular attention to the progression of motor and cognitive symptoms in patients with these diseases, the investigators noted.

“Additional studies are needed in order to better define the clinical phenotype of PD-DM patients and explore the role of antidiabetic drugs on PD progression,” they wrote.

They add that future studies also are needed to evaluate whether antidiabetic drugs might reduce risk for PD in these patients.

The investigators noted several limitations of their research. In many of the studies they examined, for example, diagnostic criteria of type 2 diabetes and PD were based only on medical records or self-reported health questionnaires. The diagnoses were rarely confirmed.

In addition, not all studies clearly stated that their populations presented with type 2 diabetes. Finally, patients with diabetes may be at increased risk for cardiovascular death, which could affect follow-up related to the development of PD, the investigators noted.

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

Diabetes mellitus (DM) is associated with Parkinson’s disease (PD) development, as well as more severe symptoms and more rapid disease progression, new research suggests.

In a systematic review, patients with type 2 diabetes were 34% more likely to develop PD than those without comorbid DM. In addition, patients with both conditions had significantly worse scores on the Unified Parkinson’s Disease Rating Scale (UPDRS) and worse cognitive performance.

Together, the results suggest that “DM may be a facilitating factor of neurodegeneration,” wrote the investigators, led by Gennaro Pagano, MD, PhD, expert medical director at Roche Pharma Research and Early Development, in Basel, Switzerland.

The findings were published in a recent issue of the Journal of Parkinson’s Disease.
 

Unanswered questions

Researchers have long proposed a potential relationship between diabetes and PD. However, case-control studies have yielded conflicting results about this relationship – and previous systematic reviews have failed to clarify the question.

In the current systematic review and meta-analysis, investigators identified relevant studies in databases such as MEDLINE/PubMed, Cochrane CENTRAL, and Scopus.

Eligible studies reported prevalence of DM in patients with PD, reported incidence of PD in those with and those without DM, and analyzed Parkinson’s phenotype and progression in those with and those without DM.

The researchers identified 3,829 articles in their initial search, evaluated 90 articles in detail, and included 43 studies in their analysis. Study quality was judged to be moderate or good, and the investigators did not find significant publication bias.

Twenty-one studies that encompassed 11,396 patients were examined to determine prevalence of DM in PD. This prevalence was calculated to be 10.02%, which is similar to the global prevalence of 9.3% reported in 2019.

The researchers also analyzed 12 cohort studies that included 17,797,221 patients to calculate risk for PD in patients with comorbid diabetes. The pooled summary odds ratio for incident PD among patients with type 2 diabetes was 1.34.

The evaluation of the effect of diabetes on PD severity was based on 10 studies that included 603 patients with both diseases. Because data on motor symptoms were not available for all studies, the researchers considered Hoehn and Yahr stage, UPDRS score, and cognitive impairment.

Patients with both conditions had a worse Hoehn and Yahr stage (standardized mean difference, 0.36; P < .001), and higher UPDRS score (SMD, 0.60; P < .001). In 7 of the 10 studies, diabetes was associated with worse cognitive performance in patients with PD.
 

Mechanisms uncertain

The mechanisms of the effect of diabetes on risk for and severity of PD are uncertain, but the researchers have developed hypotheses.

“Overlapping mechanisms between insulin resistance, mitochondrial dysfunction, oxidative stress, and alpha-synuclein expression could influence the development of the neurodegeneration process,” they wrote.

Because the current analysis demonstrated a trend toward more pronounced cognitive decline in patients with the comorbidities, clinicians should pay particular attention to the progression of motor and cognitive symptoms in patients with these diseases, the investigators noted.

“Additional studies are needed in order to better define the clinical phenotype of PD-DM patients and explore the role of antidiabetic drugs on PD progression,” they wrote.

They add that future studies also are needed to evaluate whether antidiabetic drugs might reduce risk for PD in these patients.

The investigators noted several limitations of their research. In many of the studies they examined, for example, diagnostic criteria of type 2 diabetes and PD were based only on medical records or self-reported health questionnaires. The diagnoses were rarely confirmed.

In addition, not all studies clearly stated that their populations presented with type 2 diabetes. Finally, patients with diabetes may be at increased risk for cardiovascular death, which could affect follow-up related to the development of PD, the investigators noted.

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

Diabetes mellitus (DM) is associated with Parkinson’s disease (PD) development, as well as more severe symptoms and more rapid disease progression, new research suggests.

In a systematic review, patients with type 2 diabetes were 34% more likely to develop PD than those without comorbid DM. In addition, patients with both conditions had significantly worse scores on the Unified Parkinson’s Disease Rating Scale (UPDRS) and worse cognitive performance.

Together, the results suggest that “DM may be a facilitating factor of neurodegeneration,” wrote the investigators, led by Gennaro Pagano, MD, PhD, expert medical director at Roche Pharma Research and Early Development, in Basel, Switzerland.

The findings were published in a recent issue of the Journal of Parkinson’s Disease.
 

Unanswered questions

Researchers have long proposed a potential relationship between diabetes and PD. However, case-control studies have yielded conflicting results about this relationship – and previous systematic reviews have failed to clarify the question.

In the current systematic review and meta-analysis, investigators identified relevant studies in databases such as MEDLINE/PubMed, Cochrane CENTRAL, and Scopus.

Eligible studies reported prevalence of DM in patients with PD, reported incidence of PD in those with and those without DM, and analyzed Parkinson’s phenotype and progression in those with and those without DM.

The researchers identified 3,829 articles in their initial search, evaluated 90 articles in detail, and included 43 studies in their analysis. Study quality was judged to be moderate or good, and the investigators did not find significant publication bias.

Twenty-one studies that encompassed 11,396 patients were examined to determine prevalence of DM in PD. This prevalence was calculated to be 10.02%, which is similar to the global prevalence of 9.3% reported in 2019.

The researchers also analyzed 12 cohort studies that included 17,797,221 patients to calculate risk for PD in patients with comorbid diabetes. The pooled summary odds ratio for incident PD among patients with type 2 diabetes was 1.34.

The evaluation of the effect of diabetes on PD severity was based on 10 studies that included 603 patients with both diseases. Because data on motor symptoms were not available for all studies, the researchers considered Hoehn and Yahr stage, UPDRS score, and cognitive impairment.

Patients with both conditions had a worse Hoehn and Yahr stage (standardized mean difference, 0.36; P < .001), and higher UPDRS score (SMD, 0.60; P < .001). In 7 of the 10 studies, diabetes was associated with worse cognitive performance in patients with PD.
 

Mechanisms uncertain

The mechanisms of the effect of diabetes on risk for and severity of PD are uncertain, but the researchers have developed hypotheses.

“Overlapping mechanisms between insulin resistance, mitochondrial dysfunction, oxidative stress, and alpha-synuclein expression could influence the development of the neurodegeneration process,” they wrote.

Because the current analysis demonstrated a trend toward more pronounced cognitive decline in patients with the comorbidities, clinicians should pay particular attention to the progression of motor and cognitive symptoms in patients with these diseases, the investigators noted.

“Additional studies are needed in order to better define the clinical phenotype of PD-DM patients and explore the role of antidiabetic drugs on PD progression,” they wrote.

They add that future studies also are needed to evaluate whether antidiabetic drugs might reduce risk for PD in these patients.

The investigators noted several limitations of their research. In many of the studies they examined, for example, diagnostic criteria of type 2 diabetes and PD were based only on medical records or self-reported health questionnaires. The diagnoses were rarely confirmed.

In addition, not all studies clearly stated that their populations presented with type 2 diabetes. Finally, patients with diabetes may be at increased risk for cardiovascular death, which could affect follow-up related to the development of PD, the investigators noted.

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

Adult atopic dermatitis (AD) patients with sleep disorders had higher levels of the inflammatory biomarker C-reactive protein (CRP), as well as a higher risk of developing adverse cardiovascular outcomes and mortality, results from a large cohort analysis showed.

“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”

To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.

The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).

To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”

Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).

“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.

Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”

“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”

Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.

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

Adult atopic dermatitis (AD) patients with sleep disorders had higher levels of the inflammatory biomarker C-reactive protein (CRP), as well as a higher risk of developing adverse cardiovascular outcomes and mortality, results from a large cohort analysis showed.

“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”

To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.

The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).

To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”

Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).

“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.

Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”

“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”

Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.

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

Adult atopic dermatitis (AD) patients with sleep disorders had higher levels of the inflammatory biomarker C-reactive protein (CRP), as well as a higher risk of developing adverse cardiovascular outcomes and mortality, results from a large cohort analysis showed.

“The implications of these findings are vast,” presenting author Varsha Parthasarathy said during a late-breaking abstract session at the Revolutionizing Atopic Dermatitis virtual symposium. “Poor sleep quality is known to be associated with increased inflammatory markers such as IL-6, IL-17, and CRP, so it is interesting to see this reflected in AD patients with versus without sleep disturbance. Additionally, we know that CRP is a driver of inflammation and is strongly associated with cardiovascular complications such as heart attack and stroke. Therefore, CRP may be a useful prognostic marker in AD patients with sleep disturbances.”

To examine the comorbidity burden of sleep disorders in AD patients and associate findings with inflammatory CRP and cardiovascular comorbidities, Mr. Parthasarathy, a medical student and itch fellow in the department of dermatology at the Johns Hopkins University School of Medicine, Baltimore, and colleagues drew from TriNetX, a health care network of approximately 73 million de-identified medical records in 53 organizations. The years of study were 2015 to 2021. The researchers limited the analysis to adults with at least two instances of International Classification of Diseases, Tenth Revision (ICD-10) code L28 for AD, to capture a population with true AD. Controls were adults without AD who presented for general checkup and were matched to AD patients by age, race, and sex.

The study population consisted of 120,480 AD patients and matched controls. Their mean age was 36 years, 61% were female, and 26% were Black. Compared with controls, AD patients had an increased risk of developing general sleep disorders over the 6-year period (relative risk, 1.10), as well as obstructive sleep apnea (RR, 1.13), insomnia (RR, 1.10), hypersomnia (RR, 1.24), sleep-related movement disorders (RR, 1.36), restless legs syndrome (RR, 1.25), sleep deprivation (RR, 1.36), and unspecified sleep disorders (RR, 1.22).

To examine the association of sleep disturbance with the inflammatory biomarker CRP, the researchers measured CRP levels between these patient groups. They found a substantially higher CRP in AD patients compared with controls (21.2 mg/L vs. 7.6 mg/L, respectively; P < .0001). This finding “is suggestive of a higher level of inflammation in these patients,” Mr. Parthasarathy said. Interestingly, he added, they also found a higher CRP level in AD patients with sleep disturbances compared to AD patients without sleep disturbances (23.3 vs. 20.6 mg/L; P = .02), “also pointing to a higher inflammatory burden in AD patients whose sleep was affected.”

Compared to matched AD patients without sleep disorders, AD patients with sleep disorders were more likely to develop obesity (RR, 2.65), hyperlipidemia (RR, 2.18), type 2 diabetes (RR, 2.45), metabolic syndrome (RR, 4.16), atherosclerosis (RR, 2.42), peripheral vascular disease (RR, 2.47), stroke (RR, 2.37), venous thromboembolism (RR, 2.93), and mortality (hazard ratio, 1.24).

“There is a consequence of not treating patients with atopic dermatitis, especially those patients with sleep disturbance,” the study’s primary author, Shawn G. Kwatra, MD, associate professor of dermatology at Johns Hopkins, told this news organization. “Chronic inflammation can lead to the development of comorbidities, so it is important to offer patients early treatment to reduce their overall inflammation.” He said that he was most surprised by the degree of increased inflammation in the blood of AD as compared to healthy controls. “This likely plays a part in the development of several comorbidities,” he said.

Mr. Parthasarathy acknowledged certain limitations of the study, including the inability to infer causal relationships, as uncontrolled factors may be present. “Additionally, sampling of only patients that have had medical encounters limits the generalizability of the findings,” she said. “However, findings in this large cohort study suggest that clinicians should seek to identify sleep disorders in AD patients and screen for cardiac comorbidities secondary to inflammation in this patient population.”

“There is increased data to suggest that adults with AD, particularly those with more severe disease, may be at an increased risk of cardiovascular disease and the results from [this study] further support the concept of AD as systemic disease,” said Zelma C. Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study. She cited the large population-based, retrospective design and use of two instances of ICD codes for AD to confirm diagnosis as key strengths of the research. “However, it is unclear if for each patient CRP levels were measured at one single timepoint,” Dr. Chiesa Fuxench said. “For future studies, it would be interesting to see if these levels fluctuate with time and if persistently elevated levels are associated with worse cardiovascular outcomes in this population. More data is needed to better understand the relationship better atopic dermatitis disease severity, impact on sleep, and how this relates to increased systemic inflammation and worse cardiovascular outcomes in this population.”

Dr. Kwatra disclosed support by the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health under Award Number K23AR077073-01A1 and previous funding by the Dermatology Foundation and Skin of Color Society. Dr. Kwatra is also an advisory board member/consultant for AbbVie, Celldex Therapeutics, Galderma, Incyte Corporation, Johnson & Johnson, Novartis Pharmaceuticals Corporation, Pfizer, Regeneron Pharmaceuticals, Sanofi, and Kiniksa Pharmaceuticals and has served as an investigator for Galderma, Pfizer, and Sanofi. Dr. Chiesa Fuxench disclosed research grants from several pharmaceutical companies for work related to AD. She has also served as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, AbbVie, Incyte Corporation, and Pfizer.

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

New research provides more evidence that antipsychotics that raise prolactin levels are tied to a significantly increased risk for breast cancer.

The relative risk for breast cancer was 62% higher in women who took category 1 antipsychotic medications associated with high prolactin levels. These include haloperidol (Haldol), paliperidone (Invega), and risperidone (Risperdal). Additionally, the risk was 54% higher in those taking category 2 antipsychotics that have mid-range effects on prolactin. These include iloperidone (Fanapt), lurasidone (Latuda), and olanzapine (Zyprexa).

In contrast, category 3 antipsychotics which have a lesser effect on prolactin levels were not associated with any increase in breast cancer risk. These drugs include aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (multiple brands), quetiapine (Seroquel), and ziprasidone (Geodon).

While the “absolute” breast cancer risk for these drugs is unclear, “we can make the case that high circulating prolactin levels are associated with breast cancer risk. This follows what is already known about prolactin from prior studies, notably the nurses’ health studies,” Tahir Rahman, MD, associate professor of psychiatry, Washington University School of Medicine, St. Louis, told this news organization.

“We don’t want to alarm patients taking antipsychotic drugs for life-threatening mental health problems, but we also think it is time for doctors to track prolactin levels and vigilantly monitor their patients who are being treated with antipsychotics,” Dr. Rahman added in a news release.

The study was published online Dec. 3 in the Journal of Clinical Psychopharmacology.
 

Test prolactin levels

Using administrative claims data, the researchers evaluated breast cancer risk in women aged 18-64 exposed to antipsychotic medications compared with anticonvulsants and/or lithium. 

They identified 914 cases of invasive breast cancer among 540,737 women.

Roughly 52% of the study population filled at least one prescription for a category 3 antipsychotic agent, whereas 15% filled at least one prescription for a category 1 agent; 49% of women filled at least one prescription for an anticonvulsant medication during the study period.

Exposure to all antipsychotics was independently associated with a 35% increased risk for breast cancer (adjusted hazard ratio, 1.35; 95% CI, 1.14-1.61), the study team found.

Compared with anticonvulsants or lithium, the risk for breast cancer was significantly increased for high prolactin (category 1) antipsychotics (adjusted hazard ratio, 1.62; 95% CI, 1.30-2.03) and for mid-prolactin (category 2) drugs (aHR 1.54; 95% CI, 1.19-1.99), with no increased risk for category 3 antipsychotics.

“Our research is obviously of interest for preventing breast cancer in antipsychotic-treated patients. Checking a blood prolactin level is cheap and easy [and a high level is] fairly simple to mitigate,” said Dr. Rahman.
 

A matter of debate

Reached for comment, Christoph Correll, MD, professor of psychiatry and molecular medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said, “The potential elevation of breast cancer risk depending on the dose and time of treatment with antipsychotic medications with varying degrees of prolactin-raising properties has been a topic of research and matter of debate.”

This new study “adds another data point indicating that antipsychotics that are associated on average with a higher prolactin-raising effect than other antipsychotics may increase the risk of breast cancer in women to some degree,” said Dr. Correll, who was not involved with the study.

However, he cautioned that “naturalistic data are always vulnerable to residual confounding, for example, unmeasured effects that could also at least partially explain the results, and the follow-up time of only 4 years (maximum 6 years) in this study was relatively short.

“Nevertheless, given availability of many different antipsychotics with varying degrees of prolactin-raising potential, in women requiring antipsychotic treatment, less prolactin-raising antipsychotics may be preferable,” Dr. Correll said.

“In women receiving prolactin-raising antipsychotics for medium- and longer-term maintenance therapy, prolactin levels should be monitored,” he added.

When an elevated prolactin level is detected, this should be addressed “either via dose reduction, a switch to an alternative antipsychotic that does not raise prolactin levels significantly, or the addition of a partial or full D2 agonist when the prolactin-raising antipsychotic should be continued based on individualized risk assessment,” Dr. Correll advised.

This work was supported by an award from the Alvin J. Siteman Cancer Center; the National Cancer Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health; the Taylor Family Institute for Innovative Psychiatric Research; and the Center for Brain Research in Mood Disorders. The authors have disclosed no relevant financial relationships. Dr. Correll has received royalties from UpToDate and is a stock option holder of LB Pharma.

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

New research provides more evidence that antipsychotics that raise prolactin levels are tied to a significantly increased risk for breast cancer.

The relative risk for breast cancer was 62% higher in women who took category 1 antipsychotic medications associated with high prolactin levels. These include haloperidol (Haldol), paliperidone (Invega), and risperidone (Risperdal). Additionally, the risk was 54% higher in those taking category 2 antipsychotics that have mid-range effects on prolactin. These include iloperidone (Fanapt), lurasidone (Latuda), and olanzapine (Zyprexa).

In contrast, category 3 antipsychotics which have a lesser effect on prolactin levels were not associated with any increase in breast cancer risk. These drugs include aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (multiple brands), quetiapine (Seroquel), and ziprasidone (Geodon).

While the “absolute” breast cancer risk for these drugs is unclear, “we can make the case that high circulating prolactin levels are associated with breast cancer risk. This follows what is already known about prolactin from prior studies, notably the nurses’ health studies,” Tahir Rahman, MD, associate professor of psychiatry, Washington University School of Medicine, St. Louis, told this news organization.

“We don’t want to alarm patients taking antipsychotic drugs for life-threatening mental health problems, but we also think it is time for doctors to track prolactin levels and vigilantly monitor their patients who are being treated with antipsychotics,” Dr. Rahman added in a news release.

The study was published online Dec. 3 in the Journal of Clinical Psychopharmacology.
 

Test prolactin levels

Using administrative claims data, the researchers evaluated breast cancer risk in women aged 18-64 exposed to antipsychotic medications compared with anticonvulsants and/or lithium. 

They identified 914 cases of invasive breast cancer among 540,737 women.

Roughly 52% of the study population filled at least one prescription for a category 3 antipsychotic agent, whereas 15% filled at least one prescription for a category 1 agent; 49% of women filled at least one prescription for an anticonvulsant medication during the study period.

Exposure to all antipsychotics was independently associated with a 35% increased risk for breast cancer (adjusted hazard ratio, 1.35; 95% CI, 1.14-1.61), the study team found.

Compared with anticonvulsants or lithium, the risk for breast cancer was significantly increased for high prolactin (category 1) antipsychotics (adjusted hazard ratio, 1.62; 95% CI, 1.30-2.03) and for mid-prolactin (category 2) drugs (aHR 1.54; 95% CI, 1.19-1.99), with no increased risk for category 3 antipsychotics.

“Our research is obviously of interest for preventing breast cancer in antipsychotic-treated patients. Checking a blood prolactin level is cheap and easy [and a high level is] fairly simple to mitigate,” said Dr. Rahman.
 

A matter of debate

Reached for comment, Christoph Correll, MD, professor of psychiatry and molecular medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said, “The potential elevation of breast cancer risk depending on the dose and time of treatment with antipsychotic medications with varying degrees of prolactin-raising properties has been a topic of research and matter of debate.”

This new study “adds another data point indicating that antipsychotics that are associated on average with a higher prolactin-raising effect than other antipsychotics may increase the risk of breast cancer in women to some degree,” said Dr. Correll, who was not involved with the study.

However, he cautioned that “naturalistic data are always vulnerable to residual confounding, for example, unmeasured effects that could also at least partially explain the results, and the follow-up time of only 4 years (maximum 6 years) in this study was relatively short.

“Nevertheless, given availability of many different antipsychotics with varying degrees of prolactin-raising potential, in women requiring antipsychotic treatment, less prolactin-raising antipsychotics may be preferable,” Dr. Correll said.

“In women receiving prolactin-raising antipsychotics for medium- and longer-term maintenance therapy, prolactin levels should be monitored,” he added.

When an elevated prolactin level is detected, this should be addressed “either via dose reduction, a switch to an alternative antipsychotic that does not raise prolactin levels significantly, or the addition of a partial or full D2 agonist when the prolactin-raising antipsychotic should be continued based on individualized risk assessment,” Dr. Correll advised.

This work was supported by an award from the Alvin J. Siteman Cancer Center; the National Cancer Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health; the Taylor Family Institute for Innovative Psychiatric Research; and the Center for Brain Research in Mood Disorders. The authors have disclosed no relevant financial relationships. Dr. Correll has received royalties from UpToDate and is a stock option holder of LB Pharma.

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

New research provides more evidence that antipsychotics that raise prolactin levels are tied to a significantly increased risk for breast cancer.

The relative risk for breast cancer was 62% higher in women who took category 1 antipsychotic medications associated with high prolactin levels. These include haloperidol (Haldol), paliperidone (Invega), and risperidone (Risperdal). Additionally, the risk was 54% higher in those taking category 2 antipsychotics that have mid-range effects on prolactin. These include iloperidone (Fanapt), lurasidone (Latuda), and olanzapine (Zyprexa).

In contrast, category 3 antipsychotics which have a lesser effect on prolactin levels were not associated with any increase in breast cancer risk. These drugs include aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), cariprazine (Vraylar), clozapine (multiple brands), quetiapine (Seroquel), and ziprasidone (Geodon).

While the “absolute” breast cancer risk for these drugs is unclear, “we can make the case that high circulating prolactin levels are associated with breast cancer risk. This follows what is already known about prolactin from prior studies, notably the nurses’ health studies,” Tahir Rahman, MD, associate professor of psychiatry, Washington University School of Medicine, St. Louis, told this news organization.

“We don’t want to alarm patients taking antipsychotic drugs for life-threatening mental health problems, but we also think it is time for doctors to track prolactin levels and vigilantly monitor their patients who are being treated with antipsychotics,” Dr. Rahman added in a news release.

The study was published online Dec. 3 in the Journal of Clinical Psychopharmacology.
 

Test prolactin levels

Using administrative claims data, the researchers evaluated breast cancer risk in women aged 18-64 exposed to antipsychotic medications compared with anticonvulsants and/or lithium. 

They identified 914 cases of invasive breast cancer among 540,737 women.

Roughly 52% of the study population filled at least one prescription for a category 3 antipsychotic agent, whereas 15% filled at least one prescription for a category 1 agent; 49% of women filled at least one prescription for an anticonvulsant medication during the study period.

Exposure to all antipsychotics was independently associated with a 35% increased risk for breast cancer (adjusted hazard ratio, 1.35; 95% CI, 1.14-1.61), the study team found.

Compared with anticonvulsants or lithium, the risk for breast cancer was significantly increased for high prolactin (category 1) antipsychotics (adjusted hazard ratio, 1.62; 95% CI, 1.30-2.03) and for mid-prolactin (category 2) drugs (aHR 1.54; 95% CI, 1.19-1.99), with no increased risk for category 3 antipsychotics.

“Our research is obviously of interest for preventing breast cancer in antipsychotic-treated patients. Checking a blood prolactin level is cheap and easy [and a high level is] fairly simple to mitigate,” said Dr. Rahman.
 

A matter of debate

Reached for comment, Christoph Correll, MD, professor of psychiatry and molecular medicine, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, said, “The potential elevation of breast cancer risk depending on the dose and time of treatment with antipsychotic medications with varying degrees of prolactin-raising properties has been a topic of research and matter of debate.”

This new study “adds another data point indicating that antipsychotics that are associated on average with a higher prolactin-raising effect than other antipsychotics may increase the risk of breast cancer in women to some degree,” said Dr. Correll, who was not involved with the study.

However, he cautioned that “naturalistic data are always vulnerable to residual confounding, for example, unmeasured effects that could also at least partially explain the results, and the follow-up time of only 4 years (maximum 6 years) in this study was relatively short.

“Nevertheless, given availability of many different antipsychotics with varying degrees of prolactin-raising potential, in women requiring antipsychotic treatment, less prolactin-raising antipsychotics may be preferable,” Dr. Correll said.

“In women receiving prolactin-raising antipsychotics for medium- and longer-term maintenance therapy, prolactin levels should be monitored,” he added.

When an elevated prolactin level is detected, this should be addressed “either via dose reduction, a switch to an alternative antipsychotic that does not raise prolactin levels significantly, or the addition of a partial or full D2 agonist when the prolactin-raising antipsychotic should be continued based on individualized risk assessment,” Dr. Correll advised.

This work was supported by an award from the Alvin J. Siteman Cancer Center; the National Cancer Institute and the National Center for Advancing Translational Sciences of the National Institutes of Health; the Taylor Family Institute for Innovative Psychiatric Research; and the Center for Brain Research in Mood Disorders. The authors have disclosed no relevant financial relationships. Dr. Correll has received royalties from UpToDate and is a stock option holder of LB Pharma.

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