Dermatology News

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

Children with juvenile idiopathic arthritis (JIA) have nearly triple the risk of developing psoriasis after they begin therapy with tumor necrosis factor (TNF) inhibitors, according to preliminary research shared at the annual meeting of the Childhood Arthritis and Rheumatology Research Alliance (CARRA).

Previous retrospective research at the Children’s Hospital of Philadelphia had found similar results, so the goal of this study was to look at prospectively collected data from the CARRA registry that represented a broader patient population than that of a single institution, lead author Yongdong (Dan) Zhao, MD, PhD, assistant professor of rheumatology at the University of Washington, Seattle, and pediatric rheumatologist at Seattle Children’s Hospital, said in an interview.

“The take-home message is that we confirmed this finding, and everyone who prescribed this should be aware [of the risk] and also make the family aware because often the family just thinks this is eczema and they self-manage without reporting it to the physician,” Dr. Zhao said. He advised that physicians look for evidence of psoriasis at visits and, depending on the severity, be prepared with a management plan if needed.

The researchers analyzed data from patients with JIA enrolled in the CARRA registry during June 2015–January 2020. They excluded patients with a diagnosis of inflammatory bowel disease, psoriasis at or before their JIA diagnosis, or missing data regarding the timing of psoriasis diagnosis or starting TNF inhibitors.

Among 8,222 children (29% of whom were male), just over half (54%) had ever used TNF inhibitors. Most of the patients (76%) were White, and their average age at the time of JIA diagnosis was 7 years. Compared to those with no exposure to the drugs, patients who had ever been prescribed a TNF inhibitor were three times more likely to receive a diagnosis of psoriasis afterward (unadjusted hazard ratio [HR] = 3.01; P < .01). The risk dropped only slightly (HR = 2.93; P < .01) after adjustment for gender, race, family history of psoriasis, initial International League of Associations for Rheumatology classification category, and ever having taken methotrexate.

Overall median follow-up time for the cohort was 46.7 months. The overall incidence of psoriasis in the cohort was 5.28 cases per 1,000 person-years, which split into 3.24 cases for those never exposed to TNF inhibitors and 8.49 for those ever exposed. The incidence was similar (8.31 cases per 1,000 person-years) after only the first course of TNF inhibitors.

The risk appeared greatest for adalimumab, with an incidence of 12.2 cases per 1,000 person-years after a first course in TNF inhibitor-naive patients, compared to etanercept (6.31 cases) and infliximab (9.04 cases), which did not reach statistical significance. Incidence for cumulative exposure was greater for adalimumab: 13.17 cases per 1,000 person-years, compared to 5.19 cases for etanercept and 8.77 cases for infliximab.

TNF inhibitors are first-line biologic treatment for JIA and have a longer track record for safety and effectiveness than that of newer drugs, Dr. Zhao said. They’re also commonly used for children with psoriasis, said Pamela Weiss, MD, associate professor of pediatrics and epidemiology, at the University of Pennsylvania, Philadelphia, and clinical research director of rheumatology at Children’s Hospital of Philadelphia. She was not involved in the study.

“TNF inhibitors are an incredibly useful class of medications for children with arthritis, including psoriatic arthritis,” Dr. Weiss said in an interview. “I don’t think these findings impact the risk-benefit profile of TNF inhibitors as paradoxical psoriasis is a known side effect of the medication and something most of us already counsel our families and patients about before starting a TNF inhibitor medication.”

Dr. Zhao likewise did not think the findings changed these drugs’ benefit-risk profile as long as people are aware of it. If the psoriasis is mild, he said, it’s often possible to continue the TNF inhibitor therapy along with a topical medication for the psoriasis, “but if it’s really severe, or by patient preference, you may have to switch to a different TNF inhibitor or stop it,” he said. Occasionally, he has added an additional biologic to treat the psoriasis because the underlying JIA disease in the patient couldn’t be controlled without the TNF inhibitor.

Dr. Weiss similarly said that management will depend on the severity and on shared decision-making between the physician, patient, and family.

“If it’s a small area, it can often be managed with topical corticosteroids,” Dr. Weiss said. “If it involves a large area of the body or severely affects the scalp, then stopping the TNF inhibitor therapy and starting another therapy that targets a different pathway might be considered.”

The research was funded by CARRA. Dr. Zhao has received research funding from Bristol-Myers Squibb and has consulted for Novartis. Dr. Weiss has received consulting fees from Pfizer and Lilly.

Children with juvenile idiopathic arthritis (JIA) have nearly triple the risk of developing psoriasis after they begin therapy with tumor necrosis factor (TNF) inhibitors, according to preliminary research shared at the annual meeting of the Childhood Arthritis and Rheumatology Research Alliance (CARRA).

Previous retrospective research at the Children’s Hospital of Philadelphia had found similar results, so the goal of this study was to look at prospectively collected data from the CARRA registry that represented a broader patient population than that of a single institution, lead author Yongdong (Dan) Zhao, MD, PhD, assistant professor of rheumatology at the University of Washington, Seattle, and pediatric rheumatologist at Seattle Children’s Hospital, said in an interview.

“The take-home message is that we confirmed this finding, and everyone who prescribed this should be aware [of the risk] and also make the family aware because often the family just thinks this is eczema and they self-manage without reporting it to the physician,” Dr. Zhao said. He advised that physicians look for evidence of psoriasis at visits and, depending on the severity, be prepared with a management plan if needed.

The researchers analyzed data from patients with JIA enrolled in the CARRA registry during June 2015–January 2020. They excluded patients with a diagnosis of inflammatory bowel disease, psoriasis at or before their JIA diagnosis, or missing data regarding the timing of psoriasis diagnosis or starting TNF inhibitors.

Among 8,222 children (29% of whom were male), just over half (54%) had ever used TNF inhibitors. Most of the patients (76%) were White, and their average age at the time of JIA diagnosis was 7 years. Compared to those with no exposure to the drugs, patients who had ever been prescribed a TNF inhibitor were three times more likely to receive a diagnosis of psoriasis afterward (unadjusted hazard ratio [HR] = 3.01; P < .01). The risk dropped only slightly (HR = 2.93; P < .01) after adjustment for gender, race, family history of psoriasis, initial International League of Associations for Rheumatology classification category, and ever having taken methotrexate.

Overall median follow-up time for the cohort was 46.7 months. The overall incidence of psoriasis in the cohort was 5.28 cases per 1,000 person-years, which split into 3.24 cases for those never exposed to TNF inhibitors and 8.49 for those ever exposed. The incidence was similar (8.31 cases per 1,000 person-years) after only the first course of TNF inhibitors.

The risk appeared greatest for adalimumab, with an incidence of 12.2 cases per 1,000 person-years after a first course in TNF inhibitor-naive patients, compared to etanercept (6.31 cases) and infliximab (9.04 cases), which did not reach statistical significance. Incidence for cumulative exposure was greater for adalimumab: 13.17 cases per 1,000 person-years, compared to 5.19 cases for etanercept and 8.77 cases for infliximab.

TNF inhibitors are first-line biologic treatment for JIA and have a longer track record for safety and effectiveness than that of newer drugs, Dr. Zhao said. They’re also commonly used for children with psoriasis, said Pamela Weiss, MD, associate professor of pediatrics and epidemiology, at the University of Pennsylvania, Philadelphia, and clinical research director of rheumatology at Children’s Hospital of Philadelphia. She was not involved in the study.

“TNF inhibitors are an incredibly useful class of medications for children with arthritis, including psoriatic arthritis,” Dr. Weiss said in an interview. “I don’t think these findings impact the risk-benefit profile of TNF inhibitors as paradoxical psoriasis is a known side effect of the medication and something most of us already counsel our families and patients about before starting a TNF inhibitor medication.”

Dr. Zhao likewise did not think the findings changed these drugs’ benefit-risk profile as long as people are aware of it. If the psoriasis is mild, he said, it’s often possible to continue the TNF inhibitor therapy along with a topical medication for the psoriasis, “but if it’s really severe, or by patient preference, you may have to switch to a different TNF inhibitor or stop it,” he said. Occasionally, he has added an additional biologic to treat the psoriasis because the underlying JIA disease in the patient couldn’t be controlled without the TNF inhibitor.

Dr. Weiss similarly said that management will depend on the severity and on shared decision-making between the physician, patient, and family.

“If it’s a small area, it can often be managed with topical corticosteroids,” Dr. Weiss said. “If it involves a large area of the body or severely affects the scalp, then stopping the TNF inhibitor therapy and starting another therapy that targets a different pathway might be considered.”

The research was funded by CARRA. Dr. Zhao has received research funding from Bristol-Myers Squibb and has consulted for Novartis. Dr. Weiss has received consulting fees from Pfizer and Lilly.

Children with juvenile idiopathic arthritis (JIA) have nearly triple the risk of developing psoriasis after they begin therapy with tumor necrosis factor (TNF) inhibitors, according to preliminary research shared at the annual meeting of the Childhood Arthritis and Rheumatology Research Alliance (CARRA).

Previous retrospective research at the Children’s Hospital of Philadelphia had found similar results, so the goal of this study was to look at prospectively collected data from the CARRA registry that represented a broader patient population than that of a single institution, lead author Yongdong (Dan) Zhao, MD, PhD, assistant professor of rheumatology at the University of Washington, Seattle, and pediatric rheumatologist at Seattle Children’s Hospital, said in an interview.

“The take-home message is that we confirmed this finding, and everyone who prescribed this should be aware [of the risk] and also make the family aware because often the family just thinks this is eczema and they self-manage without reporting it to the physician,” Dr. Zhao said. He advised that physicians look for evidence of psoriasis at visits and, depending on the severity, be prepared with a management plan if needed.

The researchers analyzed data from patients with JIA enrolled in the CARRA registry during June 2015–January 2020. They excluded patients with a diagnosis of inflammatory bowel disease, psoriasis at or before their JIA diagnosis, or missing data regarding the timing of psoriasis diagnosis or starting TNF inhibitors.

Among 8,222 children (29% of whom were male), just over half (54%) had ever used TNF inhibitors. Most of the patients (76%) were White, and their average age at the time of JIA diagnosis was 7 years. Compared to those with no exposure to the drugs, patients who had ever been prescribed a TNF inhibitor were three times more likely to receive a diagnosis of psoriasis afterward (unadjusted hazard ratio [HR] = 3.01; P < .01). The risk dropped only slightly (HR = 2.93; P < .01) after adjustment for gender, race, family history of psoriasis, initial International League of Associations for Rheumatology classification category, and ever having taken methotrexate.

Overall median follow-up time for the cohort was 46.7 months. The overall incidence of psoriasis in the cohort was 5.28 cases per 1,000 person-years, which split into 3.24 cases for those never exposed to TNF inhibitors and 8.49 for those ever exposed. The incidence was similar (8.31 cases per 1,000 person-years) after only the first course of TNF inhibitors.

The risk appeared greatest for adalimumab, with an incidence of 12.2 cases per 1,000 person-years after a first course in TNF inhibitor-naive patients, compared to etanercept (6.31 cases) and infliximab (9.04 cases), which did not reach statistical significance. Incidence for cumulative exposure was greater for adalimumab: 13.17 cases per 1,000 person-years, compared to 5.19 cases for etanercept and 8.77 cases for infliximab.

TNF inhibitors are first-line biologic treatment for JIA and have a longer track record for safety and effectiveness than that of newer drugs, Dr. Zhao said. They’re also commonly used for children with psoriasis, said Pamela Weiss, MD, associate professor of pediatrics and epidemiology, at the University of Pennsylvania, Philadelphia, and clinical research director of rheumatology at Children’s Hospital of Philadelphia. She was not involved in the study.

“TNF inhibitors are an incredibly useful class of medications for children with arthritis, including psoriatic arthritis,” Dr. Weiss said in an interview. “I don’t think these findings impact the risk-benefit profile of TNF inhibitors as paradoxical psoriasis is a known side effect of the medication and something most of us already counsel our families and patients about before starting a TNF inhibitor medication.”

Dr. Zhao likewise did not think the findings changed these drugs’ benefit-risk profile as long as people are aware of it. If the psoriasis is mild, he said, it’s often possible to continue the TNF inhibitor therapy along with a topical medication for the psoriasis, “but if it’s really severe, or by patient preference, you may have to switch to a different TNF inhibitor or stop it,” he said. Occasionally, he has added an additional biologic to treat the psoriasis because the underlying JIA disease in the patient couldn’t be controlled without the TNF inhibitor.

Dr. Weiss similarly said that management will depend on the severity and on shared decision-making between the physician, patient, and family.

“If it’s a small area, it can often be managed with topical corticosteroids,” Dr. Weiss said. “If it involves a large area of the body or severely affects the scalp, then stopping the TNF inhibitor therapy and starting another therapy that targets a different pathway might be considered.”

The research was funded by CARRA. Dr. Zhao has received research funding from Bristol-Myers Squibb and has consulted for Novartis. Dr. Weiss has received consulting fees from Pfizer and Lilly.

An investigational novel cream containing a BRAF inhibitor appears to ameliorate the acneiform rash associated with epidermal growth factor receptor (EGFR) inhibitors such as cetuximab and panitumumab.

The results come from a first-in-human, phase 1 clinical trial conducted in 10 patients with metastatic colorectal cancer who were receiving treatment with either cetuximab or panitumumab and who developed a grade 1 or grade 2 rash while on treatment.

All were treated with the novel topical cream, dubbed LUTO14 (under development by Lutris Pharma).

For 6 of the 10 patients, the acneiform rash improved, according to investigator Mario Lacouture, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues.

The study was published online in Cancer Discovery.

“Based on preclinical modeling and early clinical trial testing, we conclude that improving a topmost adverse event of EGFR inhibitor therapy with topical LUT014 could allow [maintenance of] quality of life and dose intensity, thereby maximizing the antitumor effects [from EGFR inhibitor therapy] while locally inhibiting dose-limiting skin toxicities,” the investigators wrote.

The cream was well tolerated, and no dose-limiting toxicity or maximum tolerated dose was observed, although the cream did appear to be more effective at lower doses.

Rash is a common side effect of EGFR inhibitors. Previous studies have reported that 75%-90% of patients experience “some form of papulopustular, acneiform rash, which frequently leads to ... suboptimal anticancer treatment due to treatment interruptions, dose reductions, or permanent discontinuation of EGFR inhibitor therapy,” the investigators noted.
 

Paradoxical mechanism of action

How the novel cream containing a BRAF inhibitor helps ameliorate EGFR inhibitor–induced skin toxicity is complicated, but at a cellular level, the mechanism seems somewhat paradoxical, the team commented.

Skin toxicity experienced in the setting of EGFR inhibitor therapy is induced by inhibition of the mitogen-activated protein kinase (MAPK) pathway. Downstream inhibition of the MAPK pathway results in, among other effects, inflammatory changes in epithelial cells that mediate the acneiform rash on the skin.

In contrast, “BRAF inhibitors given systemically have an opposite effect on epithelial cells, resulting in paradoxical activation of the MAPK pathway,” the authors explained. They hypothesized that topical administration of BRAF inhibitors similarly activates the MAPK pathway in epithelial cells, although it was important to develop a specific BRAF inhibitor that would optimally induce paradoxical MAPK activation. That they managed to do so was shown when they evaluated LUT014 in cell culture systems.

The next phase of the study is designed to include approximately 120 patients recruited from centers in the United States and Israel. Interim results are expected by the end of 2021.

The study was funded by Lutris Pharma, the company developing LUT014.

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

An investigational novel cream containing a BRAF inhibitor appears to ameliorate the acneiform rash associated with epidermal growth factor receptor (EGFR) inhibitors such as cetuximab and panitumumab.

The results come from a first-in-human, phase 1 clinical trial conducted in 10 patients with metastatic colorectal cancer who were receiving treatment with either cetuximab or panitumumab and who developed a grade 1 or grade 2 rash while on treatment.

All were treated with the novel topical cream, dubbed LUTO14 (under development by Lutris Pharma).

For 6 of the 10 patients, the acneiform rash improved, according to investigator Mario Lacouture, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues.

The study was published online in Cancer Discovery.

“Based on preclinical modeling and early clinical trial testing, we conclude that improving a topmost adverse event of EGFR inhibitor therapy with topical LUT014 could allow [maintenance of] quality of life and dose intensity, thereby maximizing the antitumor effects [from EGFR inhibitor therapy] while locally inhibiting dose-limiting skin toxicities,” the investigators wrote.

The cream was well tolerated, and no dose-limiting toxicity or maximum tolerated dose was observed, although the cream did appear to be more effective at lower doses.

Rash is a common side effect of EGFR inhibitors. Previous studies have reported that 75%-90% of patients experience “some form of papulopustular, acneiform rash, which frequently leads to ... suboptimal anticancer treatment due to treatment interruptions, dose reductions, or permanent discontinuation of EGFR inhibitor therapy,” the investigators noted.
 

Paradoxical mechanism of action

How the novel cream containing a BRAF inhibitor helps ameliorate EGFR inhibitor–induced skin toxicity is complicated, but at a cellular level, the mechanism seems somewhat paradoxical, the team commented.

Skin toxicity experienced in the setting of EGFR inhibitor therapy is induced by inhibition of the mitogen-activated protein kinase (MAPK) pathway. Downstream inhibition of the MAPK pathway results in, among other effects, inflammatory changes in epithelial cells that mediate the acneiform rash on the skin.

In contrast, “BRAF inhibitors given systemically have an opposite effect on epithelial cells, resulting in paradoxical activation of the MAPK pathway,” the authors explained. They hypothesized that topical administration of BRAF inhibitors similarly activates the MAPK pathway in epithelial cells, although it was important to develop a specific BRAF inhibitor that would optimally induce paradoxical MAPK activation. That they managed to do so was shown when they evaluated LUT014 in cell culture systems.

The next phase of the study is designed to include approximately 120 patients recruited from centers in the United States and Israel. Interim results are expected by the end of 2021.

The study was funded by Lutris Pharma, the company developing LUT014.

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

An investigational novel cream containing a BRAF inhibitor appears to ameliorate the acneiform rash associated with epidermal growth factor receptor (EGFR) inhibitors such as cetuximab and panitumumab.

The results come from a first-in-human, phase 1 clinical trial conducted in 10 patients with metastatic colorectal cancer who were receiving treatment with either cetuximab or panitumumab and who developed a grade 1 or grade 2 rash while on treatment.

All were treated with the novel topical cream, dubbed LUTO14 (under development by Lutris Pharma).

For 6 of the 10 patients, the acneiform rash improved, according to investigator Mario Lacouture, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues.

The study was published online in Cancer Discovery.

“Based on preclinical modeling and early clinical trial testing, we conclude that improving a topmost adverse event of EGFR inhibitor therapy with topical LUT014 could allow [maintenance of] quality of life and dose intensity, thereby maximizing the antitumor effects [from EGFR inhibitor therapy] while locally inhibiting dose-limiting skin toxicities,” the investigators wrote.

The cream was well tolerated, and no dose-limiting toxicity or maximum tolerated dose was observed, although the cream did appear to be more effective at lower doses.

Rash is a common side effect of EGFR inhibitors. Previous studies have reported that 75%-90% of patients experience “some form of papulopustular, acneiform rash, which frequently leads to ... suboptimal anticancer treatment due to treatment interruptions, dose reductions, or permanent discontinuation of EGFR inhibitor therapy,” the investigators noted.
 

Paradoxical mechanism of action

How the novel cream containing a BRAF inhibitor helps ameliorate EGFR inhibitor–induced skin toxicity is complicated, but at a cellular level, the mechanism seems somewhat paradoxical, the team commented.

Skin toxicity experienced in the setting of EGFR inhibitor therapy is induced by inhibition of the mitogen-activated protein kinase (MAPK) pathway. Downstream inhibition of the MAPK pathway results in, among other effects, inflammatory changes in epithelial cells that mediate the acneiform rash on the skin.

In contrast, “BRAF inhibitors given systemically have an opposite effect on epithelial cells, resulting in paradoxical activation of the MAPK pathway,” the authors explained. They hypothesized that topical administration of BRAF inhibitors similarly activates the MAPK pathway in epithelial cells, although it was important to develop a specific BRAF inhibitor that would optimally induce paradoxical MAPK activation. That they managed to do so was shown when they evaluated LUT014 in cell culture systems.

The next phase of the study is designed to include approximately 120 patients recruited from centers in the United States and Israel. Interim results are expected by the end of 2021.

The study was funded by Lutris Pharma, the company developing LUT014.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

On April 23, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate to severe atopic dermatitis (AD) who are eligible for systemic therapy.

The new opinion represents the final stages before the European Commission decides whether tralokinumab will be authorized for use throughout the European Union. The final decision should be made in the next few months.

If ultimately authorized, tralokinumab would become the first approved fully human monoclonal antibody targeting the interleukin-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with the inflammatory skin disease.

The EMA accepted the marketing application for tralokinumab back in June 2020. Submitted alongside the marketing application were data from the ECZTRA 1, 2, and 3 pivotal randomized, placebo-controlled trials.

In the ECZTRA trials, treatment with tralokinumab, either alone or with topical corticosteroids, was associated with significant improvements in the Investigator Global Assessment score of clear or almost clear skin and at least a 75% improvement in the Eczema Area and Severity Index score. Safety of tralokinumab in these trials was comparable with that reported with placebo.

Interim data from the open-label extension trial, ECZTEND, also showed that treatment with tralokinumab was associated with durable efficacy in adult patients with moderate to severe AD. Patients in this study were previously enrolled in the ECZTRA 1 and 2 parent trials and had received the IL-13 inhibitor for up to 2 years. Data from this trial were presented at the 2021 American Academy of Dermatology Virtual Meeting Experience.

Pending the European Commission’s final decision, the Marketing Authorization Application for use of tralokinumab in adults with moderate to severe AD will be valid in across all European Union member states in addition to Iceland, Norway, and Liechtenstein. Other regulatory filings for the drug are currently underway with health authorities from various countries worldwide.

Back in July 2020, the Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate to severe AD in adults. Data from the pivotal ECZTRA 1, 2, and ECZTRA 3 trials were submitted to the FDA.

The FDA expects to make a final decision in the second quarter of this year on whether to approve tralokinumab in the United States for the adult AD indication.

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

On April 23, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate to severe atopic dermatitis (AD) who are eligible for systemic therapy.

The new opinion represents the final stages before the European Commission decides whether tralokinumab will be authorized for use throughout the European Union. The final decision should be made in the next few months.

If ultimately authorized, tralokinumab would become the first approved fully human monoclonal antibody targeting the interleukin-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with the inflammatory skin disease.

The EMA accepted the marketing application for tralokinumab back in June 2020. Submitted alongside the marketing application were data from the ECZTRA 1, 2, and 3 pivotal randomized, placebo-controlled trials.

In the ECZTRA trials, treatment with tralokinumab, either alone or with topical corticosteroids, was associated with significant improvements in the Investigator Global Assessment score of clear or almost clear skin and at least a 75% improvement in the Eczema Area and Severity Index score. Safety of tralokinumab in these trials was comparable with that reported with placebo.

Interim data from the open-label extension trial, ECZTEND, also showed that treatment with tralokinumab was associated with durable efficacy in adult patients with moderate to severe AD. Patients in this study were previously enrolled in the ECZTRA 1 and 2 parent trials and had received the IL-13 inhibitor for up to 2 years. Data from this trial were presented at the 2021 American Academy of Dermatology Virtual Meeting Experience.

Pending the European Commission’s final decision, the Marketing Authorization Application for use of tralokinumab in adults with moderate to severe AD will be valid in across all European Union member states in addition to Iceland, Norway, and Liechtenstein. Other regulatory filings for the drug are currently underway with health authorities from various countries worldwide.

Back in July 2020, the Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate to severe AD in adults. Data from the pivotal ECZTRA 1, 2, and ECZTRA 3 trials were submitted to the FDA.

The FDA expects to make a final decision in the second quarter of this year on whether to approve tralokinumab in the United States for the adult AD indication.

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

On April 23, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion for the IL-13 inhibitor tralokinumab (Adtralza) for the treatment of adults with moderate to severe atopic dermatitis (AD) who are eligible for systemic therapy.

The new opinion represents the final stages before the European Commission decides whether tralokinumab will be authorized for use throughout the European Union. The final decision should be made in the next few months.

If ultimately authorized, tralokinumab would become the first approved fully human monoclonal antibody targeting the interleukin-13 cytokine, a key factor that drives the signs and symptoms of AD. Tralokinumab has previously shown to target IL-13 with high affinity and subsequently improve symptoms associated with the inflammatory skin disease.

The EMA accepted the marketing application for tralokinumab back in June 2020. Submitted alongside the marketing application were data from the ECZTRA 1, 2, and 3 pivotal randomized, placebo-controlled trials.

In the ECZTRA trials, treatment with tralokinumab, either alone or with topical corticosteroids, was associated with significant improvements in the Investigator Global Assessment score of clear or almost clear skin and at least a 75% improvement in the Eczema Area and Severity Index score. Safety of tralokinumab in these trials was comparable with that reported with placebo.

Interim data from the open-label extension trial, ECZTEND, also showed that treatment with tralokinumab was associated with durable efficacy in adult patients with moderate to severe AD. Patients in this study were previously enrolled in the ECZTRA 1 and 2 parent trials and had received the IL-13 inhibitor for up to 2 years. Data from this trial were presented at the 2021 American Academy of Dermatology Virtual Meeting Experience.

Pending the European Commission’s final decision, the Marketing Authorization Application for use of tralokinumab in adults with moderate to severe AD will be valid in across all European Union member states in addition to Iceland, Norway, and Liechtenstein. Other regulatory filings for the drug are currently underway with health authorities from various countries worldwide.

Back in July 2020, the Food and Drug Administration accepted a Biologics License Application for tralokinumab for the treatment of moderate to severe AD in adults. Data from the pivotal ECZTRA 1, 2, and ECZTRA 3 trials were submitted to the FDA.

The FDA expects to make a final decision in the second quarter of this year on whether to approve tralokinumab in the United States for the adult AD indication.

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

After a steep rise in the beginning of the COVID-19 pandemic and a slow decline that started in the summer, telehealth consults in dermatology remain far elevated over those provided prior to the COVID-19 pandemic. But it is not clear whether the current rate will fall further, be sustained, or even climb again, according to data presented and opinions expressed in a forum on this topic at the American Academy of Dermatology Virtual Meeting Experience.

There are many unknowns, not least of which is future reimbursement from the Centers for Medicare & Medicaid Services and other third-party payers, according to several participants in a scientific session devoted to this topic. The CARES Act, which was passed in the early stages of the pandemic, provided only a temporary increase in reimbursement for telehealth. Postpandemic payments for telehealth services are yet undetermined.

Many of the assembled experts are convinced that teledermatology will continue to be offered at far higher rates than prior to the pandemic, but many issues, including physician acceptance of this approach remain unresolved. This was reflected in an AAD survey of members conducted in June 2020.

“Seventy percent of dermatologists responded that teledermatology will continue, but only 58% reported that they intend to offer it,” after the pandemic, reported Jules Lipoff, MD, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who is one of the authors of the paper that reported the results.

The low relative proportion of dermatologists planning to participate in teledermatology might at least in part reflect uncertainty about reimbursement, according to Dr. Lipoff, who is the outgoing chair of the AAD teledermatology task force

Many dermatologists might find it difficult to opt out of telehealth. In some types of care, such as follow-up visits, a combination of patient demand and institutional policy, particularly if reimbursement is adequate, might compel or at least strongly incentivize teledermatology services.

“Now that telemedicine has gotten out there, we will never go back to what once was normal practice,” Dr. Lipoff predicted. According to Dr. Lipoff, there was a great deal of data even prior to the pandemic to conclude that mobile dermatology is “an acceptable equivalent” for delivering many types of dermatologic care.

The rapid evolution in telemedicine is remarkable. According to the results of the AAD survey, 14.1% of dermatologists had experience with teledermatology prior to the COVID-19 pandemic, which increased to 96.9% by June, 2020, when the survey was conducted. Nearly 600 dermatologists completed the survey, for a 13.6% response rate.

At the beginning of the pandemic, the CARES act, along with other pandemic legislation and policy changes, changed the landscape of telemedicine by providing reimbursement commensurate with in-office visits, modifying HIPAA regulations, and permitting reciprocal licensing to allow physicians to provide care to patients who had moved out of the state. While these were among the factors that facilitated the phenomenal growth in telemedicine, nearly all of these changes were temporary or are subject to revision.

“Reimbursement [for telehealth] was very low prior to the pandemic,” noted Elizabeth K. Jones, MD, assistant professor of dermatology, Thomas Jefferson University, Philadelphia. While many physicians and policy makers were convinced that reimbursement levels had to be increased temporarily to provide medical care when in-office visits were unsafe, Dr. Jones said it is unlikely that pandemic reimbursement rates will be preserved. But recent statements from the CMS foreshadow lower rates for most video and telephone consults, she added.

Reimbursement is not the only consideration. George Han, MD, PhD, chief of teledermatology at the Icahn School of Medicine at Mount Sinai, New York, spoke about the frustration of using imperfect tools. He, like many dermatologists, have become familiar with the difficulty of making a definitive diagnosis from transmitted images of skin lesions.

As long as patients communicate with personal computers and phones under variable lighting conditions, this problem might never go away, but suboptimal quality images do not necessarily preclude other types of consults, particularly follow-up visits, according to Dr. Han, who is also system medical director for dermatology at Mount Sinai Health System.

“Now that patients know about teledermatology, they are for it,” he said. He suggested that increased efficiency of follow-up using telemedicine for both patients and physicians might increase the frequency with which these types of visits are scheduled. Citing evidence that follow-up visits increase patient retention rates, Dr. Han sees these visits among the routine uses of telemedicine when the pandemic is over.

At the height of the pandemic, teledermatology was employed broadly, but after the pandemic, Dr. Han and others predict a narrower focus. Some consults, such as those for acne or other conditions reasonably treated on the basis of patient history, appear to lend themselves to telemedicine. Others, such as a skin check for malignancy, might not.

As the role of telemedicine is sorted out and finds its equilibrium in a postpandemic world, Dr. Lipoff pointed out the need to consider populations without good-quality internet access. Without specific strategies to ensure these patients are not forgotten, he warned of “wealthier patients consuming more than their fair share” of health care resources, further widening an existing disparity.

“Is telemedicine here to stay? It is clear that, yes, it is in some way,” said Dr. Lipoff, who sees no reason for dermatology to be an exception.
 

Dr. Lipoff reported a financial relationship with AcneAway. The other investigators reported no potential conflicts of interest related to telemedicine.

After a steep rise in the beginning of the COVID-19 pandemic and a slow decline that started in the summer, telehealth consults in dermatology remain far elevated over those provided prior to the COVID-19 pandemic. But it is not clear whether the current rate will fall further, be sustained, or even climb again, according to data presented and opinions expressed in a forum on this topic at the American Academy of Dermatology Virtual Meeting Experience.

There are many unknowns, not least of which is future reimbursement from the Centers for Medicare & Medicaid Services and other third-party payers, according to several participants in a scientific session devoted to this topic. The CARES Act, which was passed in the early stages of the pandemic, provided only a temporary increase in reimbursement for telehealth. Postpandemic payments for telehealth services are yet undetermined.

Many of the assembled experts are convinced that teledermatology will continue to be offered at far higher rates than prior to the pandemic, but many issues, including physician acceptance of this approach remain unresolved. This was reflected in an AAD survey of members conducted in June 2020.

“Seventy percent of dermatologists responded that teledermatology will continue, but only 58% reported that they intend to offer it,” after the pandemic, reported Jules Lipoff, MD, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who is one of the authors of the paper that reported the results.

The low relative proportion of dermatologists planning to participate in teledermatology might at least in part reflect uncertainty about reimbursement, according to Dr. Lipoff, who is the outgoing chair of the AAD teledermatology task force

Many dermatologists might find it difficult to opt out of telehealth. In some types of care, such as follow-up visits, a combination of patient demand and institutional policy, particularly if reimbursement is adequate, might compel or at least strongly incentivize teledermatology services.

“Now that telemedicine has gotten out there, we will never go back to what once was normal practice,” Dr. Lipoff predicted. According to Dr. Lipoff, there was a great deal of data even prior to the pandemic to conclude that mobile dermatology is “an acceptable equivalent” for delivering many types of dermatologic care.

The rapid evolution in telemedicine is remarkable. According to the results of the AAD survey, 14.1% of dermatologists had experience with teledermatology prior to the COVID-19 pandemic, which increased to 96.9% by June, 2020, when the survey was conducted. Nearly 600 dermatologists completed the survey, for a 13.6% response rate.

At the beginning of the pandemic, the CARES act, along with other pandemic legislation and policy changes, changed the landscape of telemedicine by providing reimbursement commensurate with in-office visits, modifying HIPAA regulations, and permitting reciprocal licensing to allow physicians to provide care to patients who had moved out of the state. While these were among the factors that facilitated the phenomenal growth in telemedicine, nearly all of these changes were temporary or are subject to revision.

“Reimbursement [for telehealth] was very low prior to the pandemic,” noted Elizabeth K. Jones, MD, assistant professor of dermatology, Thomas Jefferson University, Philadelphia. While many physicians and policy makers were convinced that reimbursement levels had to be increased temporarily to provide medical care when in-office visits were unsafe, Dr. Jones said it is unlikely that pandemic reimbursement rates will be preserved. But recent statements from the CMS foreshadow lower rates for most video and telephone consults, she added.

Reimbursement is not the only consideration. George Han, MD, PhD, chief of teledermatology at the Icahn School of Medicine at Mount Sinai, New York, spoke about the frustration of using imperfect tools. He, like many dermatologists, have become familiar with the difficulty of making a definitive diagnosis from transmitted images of skin lesions.

As long as patients communicate with personal computers and phones under variable lighting conditions, this problem might never go away, but suboptimal quality images do not necessarily preclude other types of consults, particularly follow-up visits, according to Dr. Han, who is also system medical director for dermatology at Mount Sinai Health System.

“Now that patients know about teledermatology, they are for it,” he said. He suggested that increased efficiency of follow-up using telemedicine for both patients and physicians might increase the frequency with which these types of visits are scheduled. Citing evidence that follow-up visits increase patient retention rates, Dr. Han sees these visits among the routine uses of telemedicine when the pandemic is over.

At the height of the pandemic, teledermatology was employed broadly, but after the pandemic, Dr. Han and others predict a narrower focus. Some consults, such as those for acne or other conditions reasonably treated on the basis of patient history, appear to lend themselves to telemedicine. Others, such as a skin check for malignancy, might not.

As the role of telemedicine is sorted out and finds its equilibrium in a postpandemic world, Dr. Lipoff pointed out the need to consider populations without good-quality internet access. Without specific strategies to ensure these patients are not forgotten, he warned of “wealthier patients consuming more than their fair share” of health care resources, further widening an existing disparity.

“Is telemedicine here to stay? It is clear that, yes, it is in some way,” said Dr. Lipoff, who sees no reason for dermatology to be an exception.
 

Dr. Lipoff reported a financial relationship with AcneAway. The other investigators reported no potential conflicts of interest related to telemedicine.

After a steep rise in the beginning of the COVID-19 pandemic and a slow decline that started in the summer, telehealth consults in dermatology remain far elevated over those provided prior to the COVID-19 pandemic. But it is not clear whether the current rate will fall further, be sustained, or even climb again, according to data presented and opinions expressed in a forum on this topic at the American Academy of Dermatology Virtual Meeting Experience.

There are many unknowns, not least of which is future reimbursement from the Centers for Medicare & Medicaid Services and other third-party payers, according to several participants in a scientific session devoted to this topic. The CARES Act, which was passed in the early stages of the pandemic, provided only a temporary increase in reimbursement for telehealth. Postpandemic payments for telehealth services are yet undetermined.

Many of the assembled experts are convinced that teledermatology will continue to be offered at far higher rates than prior to the pandemic, but many issues, including physician acceptance of this approach remain unresolved. This was reflected in an AAD survey of members conducted in June 2020.

“Seventy percent of dermatologists responded that teledermatology will continue, but only 58% reported that they intend to offer it,” after the pandemic, reported Jules Lipoff, MD, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who is one of the authors of the paper that reported the results.

The low relative proportion of dermatologists planning to participate in teledermatology might at least in part reflect uncertainty about reimbursement, according to Dr. Lipoff, who is the outgoing chair of the AAD teledermatology task force

Many dermatologists might find it difficult to opt out of telehealth. In some types of care, such as follow-up visits, a combination of patient demand and institutional policy, particularly if reimbursement is adequate, might compel or at least strongly incentivize teledermatology services.

“Now that telemedicine has gotten out there, we will never go back to what once was normal practice,” Dr. Lipoff predicted. According to Dr. Lipoff, there was a great deal of data even prior to the pandemic to conclude that mobile dermatology is “an acceptable equivalent” for delivering many types of dermatologic care.

The rapid evolution in telemedicine is remarkable. According to the results of the AAD survey, 14.1% of dermatologists had experience with teledermatology prior to the COVID-19 pandemic, which increased to 96.9% by June, 2020, when the survey was conducted. Nearly 600 dermatologists completed the survey, for a 13.6% response rate.

At the beginning of the pandemic, the CARES act, along with other pandemic legislation and policy changes, changed the landscape of telemedicine by providing reimbursement commensurate with in-office visits, modifying HIPAA regulations, and permitting reciprocal licensing to allow physicians to provide care to patients who had moved out of the state. While these were among the factors that facilitated the phenomenal growth in telemedicine, nearly all of these changes were temporary or are subject to revision.

“Reimbursement [for telehealth] was very low prior to the pandemic,” noted Elizabeth K. Jones, MD, assistant professor of dermatology, Thomas Jefferson University, Philadelphia. While many physicians and policy makers were convinced that reimbursement levels had to be increased temporarily to provide medical care when in-office visits were unsafe, Dr. Jones said it is unlikely that pandemic reimbursement rates will be preserved. But recent statements from the CMS foreshadow lower rates for most video and telephone consults, she added.

Reimbursement is not the only consideration. George Han, MD, PhD, chief of teledermatology at the Icahn School of Medicine at Mount Sinai, New York, spoke about the frustration of using imperfect tools. He, like many dermatologists, have become familiar with the difficulty of making a definitive diagnosis from transmitted images of skin lesions.

As long as patients communicate with personal computers and phones under variable lighting conditions, this problem might never go away, but suboptimal quality images do not necessarily preclude other types of consults, particularly follow-up visits, according to Dr. Han, who is also system medical director for dermatology at Mount Sinai Health System.

“Now that patients know about teledermatology, they are for it,” he said. He suggested that increased efficiency of follow-up using telemedicine for both patients and physicians might increase the frequency with which these types of visits are scheduled. Citing evidence that follow-up visits increase patient retention rates, Dr. Han sees these visits among the routine uses of telemedicine when the pandemic is over.

At the height of the pandemic, teledermatology was employed broadly, but after the pandemic, Dr. Han and others predict a narrower focus. Some consults, such as those for acne or other conditions reasonably treated on the basis of patient history, appear to lend themselves to telemedicine. Others, such as a skin check for malignancy, might not.

As the role of telemedicine is sorted out and finds its equilibrium in a postpandemic world, Dr. Lipoff pointed out the need to consider populations without good-quality internet access. Without specific strategies to ensure these patients are not forgotten, he warned of “wealthier patients consuming more than their fair share” of health care resources, further widening an existing disparity.

“Is telemedicine here to stay? It is clear that, yes, it is in some way,” said Dr. Lipoff, who sees no reason for dermatology to be an exception.
 

Dr. Lipoff reported a financial relationship with AcneAway. The other investigators reported no potential conflicts of interest related to telemedicine.

A cohort study of psoriasis patients in Denmark found that a nonmedical switch from brand name adalimumab to adalimumab biosimilars was not associated with drug retention at 1 year. And another study, a small, single-center retrospective study of patients with hidradenitis suppurativa (HS), found that administration of infliximab and biosimilar infliximab were associated with similar and significant improvement in disease.

Both studies were published online in April in JAMA Dermatology and add to mounting evidence that biosimilars may be interchangeable in certain dermatologic conditions.

“Biosimilars are an exciting innovation in the field,” Joseph Zahn, MD, assistant professor of dermatology at George Washington University, Washington, said in an interview. “Their efficacy and price point will allow patients greater access to effective treatment.” To date, biosimilars approved in the United States that could be prescribed by dermatologists include those for rituximab, etanercept, adalimumab, and infliximab.

In the trial from Denmark, Nikolai Loft, MD, of the University of Copenhagen and colleagues evaluated outcomes following a mandatory medical switch from the brand name adalimumab, referred to as adalimumab originator, to adalimumab biosimilars among 726 individuals who were enrolled in a Danish nationwide registry of patients treated with biologics since 2007. The primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator.

The study population consisted of 348 patients with at least 2 years of exposure to adalimumab who had switched from originator to adalimumab biosimilars (a mean age of 52 and 72% male) and 378 patients who served as the adalimumab cohort (a mean age of 51 and 71% male). When the researchers compared the 1-year drug retention rates between the adalimumab biosimilar cohort and the adalimumab originator cohort, the rates were similar (92% vs. 92.1%, respectively).

The hazard ratios for other outcomes were similar as well. Specifically, the crude hazard ratios were 1.02 (P = .94) for all causes of drug discontinuation, 0.82 (P = .60) for insufficient effect, and 1.41 (P = .50) for adverse events (AEs) in the adalimumab biosimilar cohort, compared with the adalimumab originator cohort.

“Overall, results for any AEs were contradicting, but certain AEs were more prevalent in the adalimumab biosimilar cohort,” the authors wrote. Dermatologic AEs and AEs in the “other” category “were more prevalent, which could be attributable to more patients experiencing injection site reactions as a result of larger volumes and differences in excipients and syringes in the adalimumab biosimilars and the adalimumab originator.” Other potential explanations they offered were the nocebo effect and greater awareness of AEs among practitioners and patients.

“This study concludes that, when switched to a biosimilar medication, patients do not have worse control of their psoriasis nor do they switch to other medications,” Dr. Zahn, who was asked to comment about these results, said in the interview. “However, there was a trend toward a higher number of side effects in the biosimilar group. The main takeaway point from this study is that biosimilars of adalimumab seem to be relatively interchangeable in patients with psoriasis without loss of efficacy or significant increase in side effects that lead to a medication change for the patient.”

The researchers acknowledged certain limitations of their study, including the fact that it was limited to Danish patients and that individual AEs could not be examined. “Moreover, the surveillance of AEs is not as vigilant as in clinical trials, and AEs are most likely underreported,” they wrote. “Although no major differences were found when switching from adalimumab originator to adalimumab biosimilar versions, it was not possible to assess the performance of individual adalimumab biosimilar versions in this study.”

In the second study, Christopher Sayed, MD, associate professor of dermatology, University of North Carolina, Chapel Hill, and colleagues retrospectively evaluated the effectiveness of infliximab-abda versus infliximab administration in the treatment of 34 patients with HS who were cared for at the university’s dermatology clinic. Patients were treated with either agent for at least 10 weeks. The infliximab treatment group consisted of 20 patients with a mean age of 42 years who were mostly female (17; 85%), while the infliximab-abda treatment group included 14 patients with a mean age of 36 years who also were mostly female (13; 93%).

Both groups received loading doses of 10 mg/kg at weeks 0, 2, and 6, and treatment was continued with a maintenance dose administered every 4-8 weeks. The patients were followed between February 2016 and June 2020 and the primary outcome measure was Hidradenitis Suppurative Clinical Response (HiSCR), which was defined as at least a 50% decrease in inflammatory nodule count without any increase in the number of abscesses or draining sinuses.

The researchers found that 71% of patients in the infliximab-abda treatment group achieved a HiSCR, compared with 60% of their counterparts in the infliximab treatment group, a difference that did not reach statistical significance (P = .47). Three patients in the infliximab treatment group experienced AEs, compared with none in the infliximab-abda treatment group.

“The data are promising,” Dr. Zahn said. “Although this is a small study with a limited number of patients, it suggests that this particular biosimilar may be a reasonable or possibly even equivalent alternative to infliximab. A larger, prospective trial will be needed before we can be sure the results are equivalent.”

Dr. Sayed and colleagues noted certain limitations of their study, including the retrospective design and the use of concomitant medications by some participants. “There is also a risk of selection bias because copay and medication assistance programs are not available for infliximab-abda for patients with HS,” they wrote.

In an editorial accompanying the two studies, Mark Lebwohl, MD, professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, wrote that the introduction of biosimilars have been justified by “the hope that lower costs” will increase availability of treatments to patients with moderate to severe psoriasis. “Inroads in the U.S. market, however, have been limited,” he added, and there is concern that they “may be used to prevent access to newer interleukin-17 blockers and interleukin-23 blockers for which biosimilars are available and that do not carry the boxed warnings found on tumor necrosis factor blockers.”

Dr. Loft reported receiving personal fees from Eli Lilly and Janssen outside of the submitted work. Many of his coauthors reporting having numerous financial conflicts of interest with the pharmaceutical industry. The HS study was supported by a public health service research award from the National Institutes of Health. Dr. Sayed reported receiving personal fees or personal fees paid to the institution from AbbVie, Novartis, Chemocentryx, GlaxoSmithKline, Incyte, InflaRx, and UCB. No other disclosures were reported. Dr. Lebwohl disclosed receiving research funds from companies including AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Incyte; and receiving personal fees from multiple companies, outside of the submitted work. Dr. Zahn reported having no disclosures.

dbrunk@mdedge.com

A cohort study of psoriasis patients in Denmark found that a nonmedical switch from brand name adalimumab to adalimumab biosimilars was not associated with drug retention at 1 year. And another study, a small, single-center retrospective study of patients with hidradenitis suppurativa (HS), found that administration of infliximab and biosimilar infliximab were associated with similar and significant improvement in disease.

Both studies were published online in April in JAMA Dermatology and add to mounting evidence that biosimilars may be interchangeable in certain dermatologic conditions.

“Biosimilars are an exciting innovation in the field,” Joseph Zahn, MD, assistant professor of dermatology at George Washington University, Washington, said in an interview. “Their efficacy and price point will allow patients greater access to effective treatment.” To date, biosimilars approved in the United States that could be prescribed by dermatologists include those for rituximab, etanercept, adalimumab, and infliximab.

In the trial from Denmark, Nikolai Loft, MD, of the University of Copenhagen and colleagues evaluated outcomes following a mandatory medical switch from the brand name adalimumab, referred to as adalimumab originator, to adalimumab biosimilars among 726 individuals who were enrolled in a Danish nationwide registry of patients treated with biologics since 2007. The primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator.

The study population consisted of 348 patients with at least 2 years of exposure to adalimumab who had switched from originator to adalimumab biosimilars (a mean age of 52 and 72% male) and 378 patients who served as the adalimumab cohort (a mean age of 51 and 71% male). When the researchers compared the 1-year drug retention rates between the adalimumab biosimilar cohort and the adalimumab originator cohort, the rates were similar (92% vs. 92.1%, respectively).

The hazard ratios for other outcomes were similar as well. Specifically, the crude hazard ratios were 1.02 (P = .94) for all causes of drug discontinuation, 0.82 (P = .60) for insufficient effect, and 1.41 (P = .50) for adverse events (AEs) in the adalimumab biosimilar cohort, compared with the adalimumab originator cohort.

“Overall, results for any AEs were contradicting, but certain AEs were more prevalent in the adalimumab biosimilar cohort,” the authors wrote. Dermatologic AEs and AEs in the “other” category “were more prevalent, which could be attributable to more patients experiencing injection site reactions as a result of larger volumes and differences in excipients and syringes in the adalimumab biosimilars and the adalimumab originator.” Other potential explanations they offered were the nocebo effect and greater awareness of AEs among practitioners and patients.

“This study concludes that, when switched to a biosimilar medication, patients do not have worse control of their psoriasis nor do they switch to other medications,” Dr. Zahn, who was asked to comment about these results, said in the interview. “However, there was a trend toward a higher number of side effects in the biosimilar group. The main takeaway point from this study is that biosimilars of adalimumab seem to be relatively interchangeable in patients with psoriasis without loss of efficacy or significant increase in side effects that lead to a medication change for the patient.”

The researchers acknowledged certain limitations of their study, including the fact that it was limited to Danish patients and that individual AEs could not be examined. “Moreover, the surveillance of AEs is not as vigilant as in clinical trials, and AEs are most likely underreported,” they wrote. “Although no major differences were found when switching from adalimumab originator to adalimumab biosimilar versions, it was not possible to assess the performance of individual adalimumab biosimilar versions in this study.”

In the second study, Christopher Sayed, MD, associate professor of dermatology, University of North Carolina, Chapel Hill, and colleagues retrospectively evaluated the effectiveness of infliximab-abda versus infliximab administration in the treatment of 34 patients with HS who were cared for at the university’s dermatology clinic. Patients were treated with either agent for at least 10 weeks. The infliximab treatment group consisted of 20 patients with a mean age of 42 years who were mostly female (17; 85%), while the infliximab-abda treatment group included 14 patients with a mean age of 36 years who also were mostly female (13; 93%).

Both groups received loading doses of 10 mg/kg at weeks 0, 2, and 6, and treatment was continued with a maintenance dose administered every 4-8 weeks. The patients were followed between February 2016 and June 2020 and the primary outcome measure was Hidradenitis Suppurative Clinical Response (HiSCR), which was defined as at least a 50% decrease in inflammatory nodule count without any increase in the number of abscesses or draining sinuses.

The researchers found that 71% of patients in the infliximab-abda treatment group achieved a HiSCR, compared with 60% of their counterparts in the infliximab treatment group, a difference that did not reach statistical significance (P = .47). Three patients in the infliximab treatment group experienced AEs, compared with none in the infliximab-abda treatment group.

“The data are promising,” Dr. Zahn said. “Although this is a small study with a limited number of patients, it suggests that this particular biosimilar may be a reasonable or possibly even equivalent alternative to infliximab. A larger, prospective trial will be needed before we can be sure the results are equivalent.”

Dr. Sayed and colleagues noted certain limitations of their study, including the retrospective design and the use of concomitant medications by some participants. “There is also a risk of selection bias because copay and medication assistance programs are not available for infliximab-abda for patients with HS,” they wrote.

In an editorial accompanying the two studies, Mark Lebwohl, MD, professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, wrote that the introduction of biosimilars have been justified by “the hope that lower costs” will increase availability of treatments to patients with moderate to severe psoriasis. “Inroads in the U.S. market, however, have been limited,” he added, and there is concern that they “may be used to prevent access to newer interleukin-17 blockers and interleukin-23 blockers for which biosimilars are available and that do not carry the boxed warnings found on tumor necrosis factor blockers.”

Dr. Loft reported receiving personal fees from Eli Lilly and Janssen outside of the submitted work. Many of his coauthors reporting having numerous financial conflicts of interest with the pharmaceutical industry. The HS study was supported by a public health service research award from the National Institutes of Health. Dr. Sayed reported receiving personal fees or personal fees paid to the institution from AbbVie, Novartis, Chemocentryx, GlaxoSmithKline, Incyte, InflaRx, and UCB. No other disclosures were reported. Dr. Lebwohl disclosed receiving research funds from companies including AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Incyte; and receiving personal fees from multiple companies, outside of the submitted work. Dr. Zahn reported having no disclosures.

dbrunk@mdedge.com

A cohort study of psoriasis patients in Denmark found that a nonmedical switch from brand name adalimumab to adalimumab biosimilars was not associated with drug retention at 1 year. And another study, a small, single-center retrospective study of patients with hidradenitis suppurativa (HS), found that administration of infliximab and biosimilar infliximab were associated with similar and significant improvement in disease.

Both studies were published online in April in JAMA Dermatology and add to mounting evidence that biosimilars may be interchangeable in certain dermatologic conditions.

“Biosimilars are an exciting innovation in the field,” Joseph Zahn, MD, assistant professor of dermatology at George Washington University, Washington, said in an interview. “Their efficacy and price point will allow patients greater access to effective treatment.” To date, biosimilars approved in the United States that could be prescribed by dermatologists include those for rituximab, etanercept, adalimumab, and infliximab.

In the trial from Denmark, Nikolai Loft, MD, of the University of Copenhagen and colleagues evaluated outcomes following a mandatory medical switch from the brand name adalimumab, referred to as adalimumab originator, to adalimumab biosimilars among 726 individuals who were enrolled in a Danish nationwide registry of patients treated with biologics since 2007. The primary outcome was 1-year drug retention in patients switching to adalimumab biosimilars compared with patients treated with adalimumab originator.

The study population consisted of 348 patients with at least 2 years of exposure to adalimumab who had switched from originator to adalimumab biosimilars (a mean age of 52 and 72% male) and 378 patients who served as the adalimumab cohort (a mean age of 51 and 71% male). When the researchers compared the 1-year drug retention rates between the adalimumab biosimilar cohort and the adalimumab originator cohort, the rates were similar (92% vs. 92.1%, respectively).

The hazard ratios for other outcomes were similar as well. Specifically, the crude hazard ratios were 1.02 (P = .94) for all causes of drug discontinuation, 0.82 (P = .60) for insufficient effect, and 1.41 (P = .50) for adverse events (AEs) in the adalimumab biosimilar cohort, compared with the adalimumab originator cohort.

“Overall, results for any AEs were contradicting, but certain AEs were more prevalent in the adalimumab biosimilar cohort,” the authors wrote. Dermatologic AEs and AEs in the “other” category “were more prevalent, which could be attributable to more patients experiencing injection site reactions as a result of larger volumes and differences in excipients and syringes in the adalimumab biosimilars and the adalimumab originator.” Other potential explanations they offered were the nocebo effect and greater awareness of AEs among practitioners and patients.

“This study concludes that, when switched to a biosimilar medication, patients do not have worse control of their psoriasis nor do they switch to other medications,” Dr. Zahn, who was asked to comment about these results, said in the interview. “However, there was a trend toward a higher number of side effects in the biosimilar group. The main takeaway point from this study is that biosimilars of adalimumab seem to be relatively interchangeable in patients with psoriasis without loss of efficacy or significant increase in side effects that lead to a medication change for the patient.”

The researchers acknowledged certain limitations of their study, including the fact that it was limited to Danish patients and that individual AEs could not be examined. “Moreover, the surveillance of AEs is not as vigilant as in clinical trials, and AEs are most likely underreported,” they wrote. “Although no major differences were found when switching from adalimumab originator to adalimumab biosimilar versions, it was not possible to assess the performance of individual adalimumab biosimilar versions in this study.”

In the second study, Christopher Sayed, MD, associate professor of dermatology, University of North Carolina, Chapel Hill, and colleagues retrospectively evaluated the effectiveness of infliximab-abda versus infliximab administration in the treatment of 34 patients with HS who were cared for at the university’s dermatology clinic. Patients were treated with either agent for at least 10 weeks. The infliximab treatment group consisted of 20 patients with a mean age of 42 years who were mostly female (17; 85%), while the infliximab-abda treatment group included 14 patients with a mean age of 36 years who also were mostly female (13; 93%).

Both groups received loading doses of 10 mg/kg at weeks 0, 2, and 6, and treatment was continued with a maintenance dose administered every 4-8 weeks. The patients were followed between February 2016 and June 2020 and the primary outcome measure was Hidradenitis Suppurative Clinical Response (HiSCR), which was defined as at least a 50% decrease in inflammatory nodule count without any increase in the number of abscesses or draining sinuses.

The researchers found that 71% of patients in the infliximab-abda treatment group achieved a HiSCR, compared with 60% of their counterparts in the infliximab treatment group, a difference that did not reach statistical significance (P = .47). Three patients in the infliximab treatment group experienced AEs, compared with none in the infliximab-abda treatment group.

“The data are promising,” Dr. Zahn said. “Although this is a small study with a limited number of patients, it suggests that this particular biosimilar may be a reasonable or possibly even equivalent alternative to infliximab. A larger, prospective trial will be needed before we can be sure the results are equivalent.”

Dr. Sayed and colleagues noted certain limitations of their study, including the retrospective design and the use of concomitant medications by some participants. “There is also a risk of selection bias because copay and medication assistance programs are not available for infliximab-abda for patients with HS,” they wrote.

In an editorial accompanying the two studies, Mark Lebwohl, MD, professor of dermatology, Icahn School of Medicine at Mount Sinai, New York, wrote that the introduction of biosimilars have been justified by “the hope that lower costs” will increase availability of treatments to patients with moderate to severe psoriasis. “Inroads in the U.S. market, however, have been limited,” he added, and there is concern that they “may be used to prevent access to newer interleukin-17 blockers and interleukin-23 blockers for which biosimilars are available and that do not carry the boxed warnings found on tumor necrosis factor blockers.”

Dr. Loft reported receiving personal fees from Eli Lilly and Janssen outside of the submitted work. Many of his coauthors reporting having numerous financial conflicts of interest with the pharmaceutical industry. The HS study was supported by a public health service research award from the National Institutes of Health. Dr. Sayed reported receiving personal fees or personal fees paid to the institution from AbbVie, Novartis, Chemocentryx, GlaxoSmithKline, Incyte, InflaRx, and UCB. No other disclosures were reported. Dr. Lebwohl disclosed receiving research funds from companies including AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, and Incyte; and receiving personal fees from multiple companies, outside of the submitted work. Dr. Zahn reported having no disclosures.

dbrunk@mdedge.com

The remarkable efficacy of biologics for moderate to severe psoriasis has led some to ask if biologics should be used for milder cases.

The issue was tackled in a debate at the American Academy of Dermatology Virtual Meeting Experience.

Taking the con side, Kenneth Gordon, MD, professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee, argued that, with the high cost of biologics, availability of many alternatives, and other issues, “we should just say no. ... There is no good reason that we need to expand the use of biologics in patients with limited disease.”

On the pro side, Richard Langley, MD, professor of dermatology at Dalhousie University Halifax, N.S, argued for a nuanced approach. He noted that patients with smaller patches of disease can be just as miserable as patients who hit traditional benchmarks of increased severity, such as high body surface area involvement – especially if those small areas are in sensitive locations like the scalp, palms, or genitals.

The decision to use a biologic should hinge on how badly patients and their quality of life are affected, not on “some artificial and limiting definition” of severity, Dr. Langley said.

Dr. Gordon didn’t disagree, noting that current use criteria include objective measures as well as disease in sensitive areas and failure of alternative treatments.

Rather, he was concerned about “expanding the definition of who is eligible beyond these criteria ... to chase every last bit of” disease. “I don’t think we have” a good rationale for that approach, he said.

Cost is the most important issue, Dr. Gordon said.

With more biologics on the way and prices continuing to go up, “there is going to a be a huge challenge to our use of these expensive medicines over the next few years” from payers. “It is important that we use them smartly in order to make sure we are able to use them for people with severe disease” who really need them. If “we start using biologics for all our patients with psoriasis,” it will be a “cost disaster,” Dr. Gordon said.

In addition, topicals and home phototherapy can be effective as long as patients adhere to them, as can alternative systemic agents, such as methotrexate and apremilast.

Often with biologics, “the issue is mainly convenience” rather than a fundamental problem with the alternatives, and despite the good safety record in trials, “chasing the last bit” of psoriasis with a biologic “is not necessarily” without risk for the patient, Dr. Gordon said.

Still, there can be a “pretty significant disconnect” between how patients perceive their psoriasis and “what physicians are thinking and prescribing” for it based on objective measures, Dr. Langley noted. Sometimes patients who have limited disease but are in significant distress aren’t even receiving treatment or are only given another cream to add to their collection of ones that haven’t worked.

One problem with traditional severity classifications is that they don’t generally take patients’ subjective experience into account, he added. There’s also been a lack of standardization to the point that dermatologists, researchers, and payers can sometimes disagree over severity in a given patient.

There’s movement toward better incorporation of patient experience into severity considerations, but for now at least, a designation of mild psoriasis can underestimate the true severity of disease, Dr. Langley said.

Dr. Gordon and Dr. Langley reported receiving honoraria and/or research support from many pharmaceutical companies, including AbbVie, Pfizer, and Lilly.

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

The remarkable efficacy of biologics for moderate to severe psoriasis has led some to ask if biologics should be used for milder cases.

The issue was tackled in a debate at the American Academy of Dermatology Virtual Meeting Experience.

Taking the con side, Kenneth Gordon, MD, professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee, argued that, with the high cost of biologics, availability of many alternatives, and other issues, “we should just say no. ... There is no good reason that we need to expand the use of biologics in patients with limited disease.”

On the pro side, Richard Langley, MD, professor of dermatology at Dalhousie University Halifax, N.S, argued for a nuanced approach. He noted that patients with smaller patches of disease can be just as miserable as patients who hit traditional benchmarks of increased severity, such as high body surface area involvement – especially if those small areas are in sensitive locations like the scalp, palms, or genitals.

The decision to use a biologic should hinge on how badly patients and their quality of life are affected, not on “some artificial and limiting definition” of severity, Dr. Langley said.

Dr. Gordon didn’t disagree, noting that current use criteria include objective measures as well as disease in sensitive areas and failure of alternative treatments.

Rather, he was concerned about “expanding the definition of who is eligible beyond these criteria ... to chase every last bit of” disease. “I don’t think we have” a good rationale for that approach, he said.

Cost is the most important issue, Dr. Gordon said.

With more biologics on the way and prices continuing to go up, “there is going to a be a huge challenge to our use of these expensive medicines over the next few years” from payers. “It is important that we use them smartly in order to make sure we are able to use them for people with severe disease” who really need them. If “we start using biologics for all our patients with psoriasis,” it will be a “cost disaster,” Dr. Gordon said.

In addition, topicals and home phototherapy can be effective as long as patients adhere to them, as can alternative systemic agents, such as methotrexate and apremilast.

Often with biologics, “the issue is mainly convenience” rather than a fundamental problem with the alternatives, and despite the good safety record in trials, “chasing the last bit” of psoriasis with a biologic “is not necessarily” without risk for the patient, Dr. Gordon said.

Still, there can be a “pretty significant disconnect” between how patients perceive their psoriasis and “what physicians are thinking and prescribing” for it based on objective measures, Dr. Langley noted. Sometimes patients who have limited disease but are in significant distress aren’t even receiving treatment or are only given another cream to add to their collection of ones that haven’t worked.

One problem with traditional severity classifications is that they don’t generally take patients’ subjective experience into account, he added. There’s also been a lack of standardization to the point that dermatologists, researchers, and payers can sometimes disagree over severity in a given patient.

There’s movement toward better incorporation of patient experience into severity considerations, but for now at least, a designation of mild psoriasis can underestimate the true severity of disease, Dr. Langley said.

Dr. Gordon and Dr. Langley reported receiving honoraria and/or research support from many pharmaceutical companies, including AbbVie, Pfizer, and Lilly.

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

The remarkable efficacy of biologics for moderate to severe psoriasis has led some to ask if biologics should be used for milder cases.

The issue was tackled in a debate at the American Academy of Dermatology Virtual Meeting Experience.

Taking the con side, Kenneth Gordon, MD, professor and chair of dermatology at the Medical College of Wisconsin, Milwaukee, argued that, with the high cost of biologics, availability of many alternatives, and other issues, “we should just say no. ... There is no good reason that we need to expand the use of biologics in patients with limited disease.”

On the pro side, Richard Langley, MD, professor of dermatology at Dalhousie University Halifax, N.S, argued for a nuanced approach. He noted that patients with smaller patches of disease can be just as miserable as patients who hit traditional benchmarks of increased severity, such as high body surface area involvement – especially if those small areas are in sensitive locations like the scalp, palms, or genitals.

The decision to use a biologic should hinge on how badly patients and their quality of life are affected, not on “some artificial and limiting definition” of severity, Dr. Langley said.

Dr. Gordon didn’t disagree, noting that current use criteria include objective measures as well as disease in sensitive areas and failure of alternative treatments.

Rather, he was concerned about “expanding the definition of who is eligible beyond these criteria ... to chase every last bit of” disease. “I don’t think we have” a good rationale for that approach, he said.

Cost is the most important issue, Dr. Gordon said.

With more biologics on the way and prices continuing to go up, “there is going to a be a huge challenge to our use of these expensive medicines over the next few years” from payers. “It is important that we use them smartly in order to make sure we are able to use them for people with severe disease” who really need them. If “we start using biologics for all our patients with psoriasis,” it will be a “cost disaster,” Dr. Gordon said.

In addition, topicals and home phototherapy can be effective as long as patients adhere to them, as can alternative systemic agents, such as methotrexate and apremilast.

Often with biologics, “the issue is mainly convenience” rather than a fundamental problem with the alternatives, and despite the good safety record in trials, “chasing the last bit” of psoriasis with a biologic “is not necessarily” without risk for the patient, Dr. Gordon said.

Still, there can be a “pretty significant disconnect” between how patients perceive their psoriasis and “what physicians are thinking and prescribing” for it based on objective measures, Dr. Langley noted. Sometimes patients who have limited disease but are in significant distress aren’t even receiving treatment or are only given another cream to add to their collection of ones that haven’t worked.

One problem with traditional severity classifications is that they don’t generally take patients’ subjective experience into account, he added. There’s also been a lack of standardization to the point that dermatologists, researchers, and payers can sometimes disagree over severity in a given patient.

There’s movement toward better incorporation of patient experience into severity considerations, but for now at least, a designation of mild psoriasis can underestimate the true severity of disease, Dr. Langley said.

Dr. Gordon and Dr. Langley reported receiving honoraria and/or research support from many pharmaceutical companies, including AbbVie, Pfizer, and Lilly.

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