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Multidisciplinary approach touted for atopic dermatitis
researchers say.
“I think we really gained insight to how a more holistic approach benefited the patient,” Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said in an interview.
At the 2021 annual meeting of the International Society of Atopic Dermatitis, he and his colleagues described a pilot program to bring the specialists together at UCSD and Rady Children’s Hospital, San Diego.
Typically, children seeking care for atopic dermatitis see allergists and dermatologists separately for 10- to 15-minute appointments. The specialists sometimes prescribe treatments that conflict or are redundant with each other and may give contradictory instructions.
Instead, Dr. Eichenfield and colleagues designed a program bringing patients in for initial assessments lasting 1-1.5 hours. Patients typically started with visits to a clinical pharmacist, who assessed what medications had been prescribed and how much the patients were actually taking.
The patients then proceeded to separate appointments with an allergist and a dermatologist for evaluations. These specialists then met face to face to develop a treatment plan. At least one of the specialists would then present the plan to the patient and the patient’s family.
“We had a rich set of educational materials that were developed and put online that helped with shared decision-making and increased comfort level with appropriate skin care and medication,” Dr. Eichenfield said.
He and his colleagues assigned a physician assistant trained in both pediatric dermatology and pediatric allergy to coordinate the clinic. They designed combined pediatric dermatology and pediatric allergy fellowships for two fellows. “So, part of this program ended up allowing specially trained individuals who overlapped in fields that traditionally were separate,” said Dr. Eichenfield.
To see how well the approach worked, the researchers followed the progress of 23 patients who were already receiving treatment at one or both of the institutions.
- Eczema Area and Severity Index (EASI) scores decreased from visit 1 to visit 2 by a mean of 15.36 (P < .001), which correlates to a 56.36% average decrease.
- In 20 patients (89.96%), in EASI scores improved 50%.
- Thirteen patients (56.54%) achieved 75% improvement in EASI scores.
- Body surface area scores improved by a mean of 23.21% (P = .002).
- Validated Investigator Global Assessment scores decreased in 56.52% of patients to a clinically significant level.
The study did not include any control group, nor did the researchers report any details on how long the patients had been treated before the multidisciplinary program started or how their prescriptions changed.
Patients benefited from the comprehensive assessment of their symptoms, said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital. “Some had significant environmental allergies that might not have been a contributing factor to their atopic dermatitis,” he explained. “The complexities of comorbidities and atopic dermatitis influence the patient, even if one disease state isn’t necessarily directly causative of the other.”
In surveys, patients said they especially appreciated the increased time spent with their specialists. “No one’s ever spent an hour teaching us about eczema,” some commented. The approach motivated patients to take their home treatment more effectively, Dr. Eichenfield believed.
Primary care physicians did not participate in the multidisciplinary program, but the specialists communicated with them and shared electronic medical records with them, he said.
Without a control group, it is hard to say how much difference the multidisciplinary approach made, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview.
“What it does show is that there is significant improvement in a variety of endpoints within this multidisciplinary approach,” Dr. Silverberg said in an interview. “And so I have no doubt that this is valid and that a multidisciplinary approach would really improve, holistically, many aspects of patient care.”
Dr. Silverberg ran a multidisciplinary program at Northwestern University, Chicago, which included sleep medicine, endocrinology, gastroenterology, and other specialties as well as dermatology, allergy, and pharmacy.
However, Dr. Silverberg pointed out, a multidisciplinary approach is more expensive than standard care because when specialists spend more time with each patient, they see fewer patients per day. “So many health care systems or academic institutions are not as open as they should be to this kind of interdisciplinary care, which is why it’s so important to have outcome measures showing that this approach actually works.”
Dr. Eichenfield and Dr. Silverberg had no relevant disclosures.
A version of this article first appeared on Medscape.com.
researchers say.
“I think we really gained insight to how a more holistic approach benefited the patient,” Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said in an interview.
At the 2021 annual meeting of the International Society of Atopic Dermatitis, he and his colleagues described a pilot program to bring the specialists together at UCSD and Rady Children’s Hospital, San Diego.
Typically, children seeking care for atopic dermatitis see allergists and dermatologists separately for 10- to 15-minute appointments. The specialists sometimes prescribe treatments that conflict or are redundant with each other and may give contradictory instructions.
Instead, Dr. Eichenfield and colleagues designed a program bringing patients in for initial assessments lasting 1-1.5 hours. Patients typically started with visits to a clinical pharmacist, who assessed what medications had been prescribed and how much the patients were actually taking.
The patients then proceeded to separate appointments with an allergist and a dermatologist for evaluations. These specialists then met face to face to develop a treatment plan. At least one of the specialists would then present the plan to the patient and the patient’s family.
“We had a rich set of educational materials that were developed and put online that helped with shared decision-making and increased comfort level with appropriate skin care and medication,” Dr. Eichenfield said.
He and his colleagues assigned a physician assistant trained in both pediatric dermatology and pediatric allergy to coordinate the clinic. They designed combined pediatric dermatology and pediatric allergy fellowships for two fellows. “So, part of this program ended up allowing specially trained individuals who overlapped in fields that traditionally were separate,” said Dr. Eichenfield.
To see how well the approach worked, the researchers followed the progress of 23 patients who were already receiving treatment at one or both of the institutions.
- Eczema Area and Severity Index (EASI) scores decreased from visit 1 to visit 2 by a mean of 15.36 (P < .001), which correlates to a 56.36% average decrease.
- In 20 patients (89.96%), in EASI scores improved 50%.
- Thirteen patients (56.54%) achieved 75% improvement in EASI scores.
- Body surface area scores improved by a mean of 23.21% (P = .002).
- Validated Investigator Global Assessment scores decreased in 56.52% of patients to a clinically significant level.
The study did not include any control group, nor did the researchers report any details on how long the patients had been treated before the multidisciplinary program started or how their prescriptions changed.
Patients benefited from the comprehensive assessment of their symptoms, said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital. “Some had significant environmental allergies that might not have been a contributing factor to their atopic dermatitis,” he explained. “The complexities of comorbidities and atopic dermatitis influence the patient, even if one disease state isn’t necessarily directly causative of the other.”
In surveys, patients said they especially appreciated the increased time spent with their specialists. “No one’s ever spent an hour teaching us about eczema,” some commented. The approach motivated patients to take their home treatment more effectively, Dr. Eichenfield believed.
Primary care physicians did not participate in the multidisciplinary program, but the specialists communicated with them and shared electronic medical records with them, he said.
Without a control group, it is hard to say how much difference the multidisciplinary approach made, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview.
“What it does show is that there is significant improvement in a variety of endpoints within this multidisciplinary approach,” Dr. Silverberg said in an interview. “And so I have no doubt that this is valid and that a multidisciplinary approach would really improve, holistically, many aspects of patient care.”
Dr. Silverberg ran a multidisciplinary program at Northwestern University, Chicago, which included sleep medicine, endocrinology, gastroenterology, and other specialties as well as dermatology, allergy, and pharmacy.
However, Dr. Silverberg pointed out, a multidisciplinary approach is more expensive than standard care because when specialists spend more time with each patient, they see fewer patients per day. “So many health care systems or academic institutions are not as open as they should be to this kind of interdisciplinary care, which is why it’s so important to have outcome measures showing that this approach actually works.”
Dr. Eichenfield and Dr. Silverberg had no relevant disclosures.
A version of this article first appeared on Medscape.com.
researchers say.
“I think we really gained insight to how a more holistic approach benefited the patient,” Lawrence Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said in an interview.
At the 2021 annual meeting of the International Society of Atopic Dermatitis, he and his colleagues described a pilot program to bring the specialists together at UCSD and Rady Children’s Hospital, San Diego.
Typically, children seeking care for atopic dermatitis see allergists and dermatologists separately for 10- to 15-minute appointments. The specialists sometimes prescribe treatments that conflict or are redundant with each other and may give contradictory instructions.
Instead, Dr. Eichenfield and colleagues designed a program bringing patients in for initial assessments lasting 1-1.5 hours. Patients typically started with visits to a clinical pharmacist, who assessed what medications had been prescribed and how much the patients were actually taking.
The patients then proceeded to separate appointments with an allergist and a dermatologist for evaluations. These specialists then met face to face to develop a treatment plan. At least one of the specialists would then present the plan to the patient and the patient’s family.
“We had a rich set of educational materials that were developed and put online that helped with shared decision-making and increased comfort level with appropriate skin care and medication,” Dr. Eichenfield said.
He and his colleagues assigned a physician assistant trained in both pediatric dermatology and pediatric allergy to coordinate the clinic. They designed combined pediatric dermatology and pediatric allergy fellowships for two fellows. “So, part of this program ended up allowing specially trained individuals who overlapped in fields that traditionally were separate,” said Dr. Eichenfield.
To see how well the approach worked, the researchers followed the progress of 23 patients who were already receiving treatment at one or both of the institutions.
- Eczema Area and Severity Index (EASI) scores decreased from visit 1 to visit 2 by a mean of 15.36 (P < .001), which correlates to a 56.36% average decrease.
- In 20 patients (89.96%), in EASI scores improved 50%.
- Thirteen patients (56.54%) achieved 75% improvement in EASI scores.
- Body surface area scores improved by a mean of 23.21% (P = .002).
- Validated Investigator Global Assessment scores decreased in 56.52% of patients to a clinically significant level.
The study did not include any control group, nor did the researchers report any details on how long the patients had been treated before the multidisciplinary program started or how their prescriptions changed.
Patients benefited from the comprehensive assessment of their symptoms, said Dr. Eichenfield, also chief of pediatric and adolescent dermatology at Rady Children’s Hospital. “Some had significant environmental allergies that might not have been a contributing factor to their atopic dermatitis,” he explained. “The complexities of comorbidities and atopic dermatitis influence the patient, even if one disease state isn’t necessarily directly causative of the other.”
In surveys, patients said they especially appreciated the increased time spent with their specialists. “No one’s ever spent an hour teaching us about eczema,” some commented. The approach motivated patients to take their home treatment more effectively, Dr. Eichenfield believed.
Primary care physicians did not participate in the multidisciplinary program, but the specialists communicated with them and shared electronic medical records with them, he said.
Without a control group, it is hard to say how much difference the multidisciplinary approach made, Jonathan I. Silverberg, MD, PhD, MPH, associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, Washington, said in an interview.
“What it does show is that there is significant improvement in a variety of endpoints within this multidisciplinary approach,” Dr. Silverberg said in an interview. “And so I have no doubt that this is valid and that a multidisciplinary approach would really improve, holistically, many aspects of patient care.”
Dr. Silverberg ran a multidisciplinary program at Northwestern University, Chicago, which included sleep medicine, endocrinology, gastroenterology, and other specialties as well as dermatology, allergy, and pharmacy.
However, Dr. Silverberg pointed out, a multidisciplinary approach is more expensive than standard care because when specialists spend more time with each patient, they see fewer patients per day. “So many health care systems or academic institutions are not as open as they should be to this kind of interdisciplinary care, which is why it’s so important to have outcome measures showing that this approach actually works.”
Dr. Eichenfield and Dr. Silverberg had no relevant disclosures.
A version of this article first appeared on Medscape.com.
LGBTQ patients face unique skin risks
Dermatologists cautioned colleagues to in transgender people, who are especially vulnerable to acne because of hormone therapy.
The identities of sexual minorities “have a significant influence on many facets of health,” dermatologist Matthew Mansh, MD, of the University of Minnesota, Minneapolis, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.
In regard to skin cancer, he said, “there seems to be consistently higher rates of skin cancer and certain preventable risk behaviors like indoor tanning among sexual minority men.”
Dr. Mansh, codirector of the high-risk nonmelanoma skin cancer clinic at the University of Minnesota, highlighted a report, published in JAMA Dermatology in 2020, that used 2014-2018 U.S. survey data of over 870,000 adults to look at the association between sexual orientation and lifetime prevalence of skin cancer. The investigators found that gay and bisexual men had a higher lifetime prevalence of skin cancer compared with heterosexual men (adjusted odds ratio [aOR], 1.25; 95% confidence interval, 1.03-1.50; P = .02; and aOR, 1.46; 95% CI, 1.01-2.10; P = .04; for gay and bisexual men, respectively).
When compared with heterosexual women, risk among bisexual women was lower (aOR, 0.75; 95% CI, 0.60-0.95; P = .02), but not among lesbian women (aOR, 1.01; 95% CI, 0.77-1.33; P = .95, respectively).
Other studies have reached similar conclusions, Dr. Mansh said, although there’s been fairly little research in this area. What could explain these differences? Factors such as smoking, age, and alcohol use affect skin cancer risk, he said, but these studies control for those variables. Instead, he noted, it’s useful to look at studies of ultraviolet exposure.
For example, he highlighted a study published in JAMA Dermatology in 2015, which examined 12-month indoor-tanning rates and skin cancer prevalence by sexual orientation, using data from California and national health interview surveys. The study found that compared with heterosexual men, “sexual minority men had higher rates of indoor tanning by roughly three- to sixfold,” said Dr. Mansh, the lead author. “And this was among respondents who were adults over age 18. People between the ages of 18 and 34 years are important from a skin cancer perspective as it’s well established that exposure to tanning beds at a younger age is most associated with an increased risk of skin cancer.”
Sexual minority men were also significantly more likely to report having skin cancer, compared with heterosexual men.
In the study, sexual minority women had about half the odds of engaging in indoor tanning compared with heterosexual women, and were less likely to report having been diagnosed with nonmelanoma skin cancer, he added.
Other studies suggest that gay and bisexual men live in neighborhoods with more indoor tanning salons and that they may spend more time in the sun outside too, he said. Some research suggests motivations for tanning include social pressure and the desire to improve appearance, he added.
Overall, “we may be able to use these data to add more appropriate screening and recommendations for these patients, which are sorely lacking in dermatology,” and to design targeted behavioral interventions, said Dr. Mansh, codirector of the dermatology gender care clinic at the University of Minnesota.
What can dermatologists do now? In an interview, dermatologist Jon Klint Peebles, MD, of the mid-Atlantic Permanente Medical Group, in Largo, Md., suggested that colleagues ask patients questions about indoor tanning frequency, the motivations for tanning, exposure to outdoor ultraviolet radiation, sunscreen use, and use of photoprotective clothing.
Hormone therapy and acne
In a related presentation at the meeting, Howa Yeung, MD, of the department of dermatology, Emory University, Atlanta, said that in transgender people, estrogen therapy can actually reduce sebum production and often improves acne, while testosterone therapy frequently has the opposite effect.
“We’ve seen some pretty tough cases of acne in transmasculine patients in my practice,” said Dr. Yeung, who highlighted a recently published study that tracked 988 transgender patients in Boston who underwent testosterone therapy. Nearly a third were diagnosed with acne, compared with 6% prior to hormone therapy, and those at the highest risk were aged 18-21.
The prevalence of acne was 25% 2 years after initiation of hormone therapy. “Acne remains a very common issue and not just at the beginning of treatment,” he said.
In 2020, Dr. Yeung and colleagues reported the results of a survey of 696 transgender patients in California and Georgia; most were treated with hormone therapy. They found that 14% of transmasculine patients reported currently having moderate to severe acne diagnosed by a physician, compared with 1% of transfeminine patients.
Dr. Yeung noted that another survey of transmasculine persons who had received testosterone found that those who had moderate to severe acne were more likely to suffer from depression and anxiety than were those who had never had acne (aOR, 2.4; 95% CI, 1.1-5.4; P = .001, for depression; and aOR, 2.7; 95% CI, 1.2-6.3; P = .002, for anxiety).
Acne treatments in transmasculine patients are complicated by the fact that hormone treatments for acne can have feminizing effects, Dr. Yeung said, adding that it’s not clear how clascoterone, a new anti-androgen topical therapy for acne, will affect them. For now, many patients will require isotretinoin for treating acne.
Dr. Peebles cautioned that with isotretinoin, “we still do not yet have solid data on the optimal dosing or duration in the context of testosterone-induced acne, as well as what individual factors may be predictive of treatment success or failure. It is also important to be aware of any planned surgical procedures, whether as part of gender-affirming care or otherwise, given that some surgeons may view isotretinoin as a barrier for some procedures, despite limited data to support this.”
Both Dr. Peebles and Dr. Yeung noted that the iPledge risk management program for isotretinoin patients who may become pregnant is problematic. “A trans man who is assigned female at birth and identifies as a man and has a uterus and ovaries must be registered as a female with reproductive potential,” Dr. Yeung said.
“While the program remains inherently discriminatory, it is important to have an honest conversation with patients about these issues in a sensitive way,” Dr. Peebles noted. “Luckily, there is substantial momentum building around modifying iPLEDGE to become more inclusive. While the mechanics are complicated and involve a variety of entities and advocacy initiatives, we are optimistic that major changes are in the pipeline.”
Dr. Mansh, Dr. Yeung, and Dr. Peebles reported no disclosures.
Dermatologists cautioned colleagues to in transgender people, who are especially vulnerable to acne because of hormone therapy.
The identities of sexual minorities “have a significant influence on many facets of health,” dermatologist Matthew Mansh, MD, of the University of Minnesota, Minneapolis, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.
In regard to skin cancer, he said, “there seems to be consistently higher rates of skin cancer and certain preventable risk behaviors like indoor tanning among sexual minority men.”
Dr. Mansh, codirector of the high-risk nonmelanoma skin cancer clinic at the University of Minnesota, highlighted a report, published in JAMA Dermatology in 2020, that used 2014-2018 U.S. survey data of over 870,000 adults to look at the association between sexual orientation and lifetime prevalence of skin cancer. The investigators found that gay and bisexual men had a higher lifetime prevalence of skin cancer compared with heterosexual men (adjusted odds ratio [aOR], 1.25; 95% confidence interval, 1.03-1.50; P = .02; and aOR, 1.46; 95% CI, 1.01-2.10; P = .04; for gay and bisexual men, respectively).
When compared with heterosexual women, risk among bisexual women was lower (aOR, 0.75; 95% CI, 0.60-0.95; P = .02), but not among lesbian women (aOR, 1.01; 95% CI, 0.77-1.33; P = .95, respectively).
Other studies have reached similar conclusions, Dr. Mansh said, although there’s been fairly little research in this area. What could explain these differences? Factors such as smoking, age, and alcohol use affect skin cancer risk, he said, but these studies control for those variables. Instead, he noted, it’s useful to look at studies of ultraviolet exposure.
For example, he highlighted a study published in JAMA Dermatology in 2015, which examined 12-month indoor-tanning rates and skin cancer prevalence by sexual orientation, using data from California and national health interview surveys. The study found that compared with heterosexual men, “sexual minority men had higher rates of indoor tanning by roughly three- to sixfold,” said Dr. Mansh, the lead author. “And this was among respondents who were adults over age 18. People between the ages of 18 and 34 years are important from a skin cancer perspective as it’s well established that exposure to tanning beds at a younger age is most associated with an increased risk of skin cancer.”
Sexual minority men were also significantly more likely to report having skin cancer, compared with heterosexual men.
In the study, sexual minority women had about half the odds of engaging in indoor tanning compared with heterosexual women, and were less likely to report having been diagnosed with nonmelanoma skin cancer, he added.
Other studies suggest that gay and bisexual men live in neighborhoods with more indoor tanning salons and that they may spend more time in the sun outside too, he said. Some research suggests motivations for tanning include social pressure and the desire to improve appearance, he added.
Overall, “we may be able to use these data to add more appropriate screening and recommendations for these patients, which are sorely lacking in dermatology,” and to design targeted behavioral interventions, said Dr. Mansh, codirector of the dermatology gender care clinic at the University of Minnesota.
What can dermatologists do now? In an interview, dermatologist Jon Klint Peebles, MD, of the mid-Atlantic Permanente Medical Group, in Largo, Md., suggested that colleagues ask patients questions about indoor tanning frequency, the motivations for tanning, exposure to outdoor ultraviolet radiation, sunscreen use, and use of photoprotective clothing.
Hormone therapy and acne
In a related presentation at the meeting, Howa Yeung, MD, of the department of dermatology, Emory University, Atlanta, said that in transgender people, estrogen therapy can actually reduce sebum production and often improves acne, while testosterone therapy frequently has the opposite effect.
“We’ve seen some pretty tough cases of acne in transmasculine patients in my practice,” said Dr. Yeung, who highlighted a recently published study that tracked 988 transgender patients in Boston who underwent testosterone therapy. Nearly a third were diagnosed with acne, compared with 6% prior to hormone therapy, and those at the highest risk were aged 18-21.
The prevalence of acne was 25% 2 years after initiation of hormone therapy. “Acne remains a very common issue and not just at the beginning of treatment,” he said.
In 2020, Dr. Yeung and colleagues reported the results of a survey of 696 transgender patients in California and Georgia; most were treated with hormone therapy. They found that 14% of transmasculine patients reported currently having moderate to severe acne diagnosed by a physician, compared with 1% of transfeminine patients.
Dr. Yeung noted that another survey of transmasculine persons who had received testosterone found that those who had moderate to severe acne were more likely to suffer from depression and anxiety than were those who had never had acne (aOR, 2.4; 95% CI, 1.1-5.4; P = .001, for depression; and aOR, 2.7; 95% CI, 1.2-6.3; P = .002, for anxiety).
Acne treatments in transmasculine patients are complicated by the fact that hormone treatments for acne can have feminizing effects, Dr. Yeung said, adding that it’s not clear how clascoterone, a new anti-androgen topical therapy for acne, will affect them. For now, many patients will require isotretinoin for treating acne.
Dr. Peebles cautioned that with isotretinoin, “we still do not yet have solid data on the optimal dosing or duration in the context of testosterone-induced acne, as well as what individual factors may be predictive of treatment success or failure. It is also important to be aware of any planned surgical procedures, whether as part of gender-affirming care or otherwise, given that some surgeons may view isotretinoin as a barrier for some procedures, despite limited data to support this.”
Both Dr. Peebles and Dr. Yeung noted that the iPledge risk management program for isotretinoin patients who may become pregnant is problematic. “A trans man who is assigned female at birth and identifies as a man and has a uterus and ovaries must be registered as a female with reproductive potential,” Dr. Yeung said.
“While the program remains inherently discriminatory, it is important to have an honest conversation with patients about these issues in a sensitive way,” Dr. Peebles noted. “Luckily, there is substantial momentum building around modifying iPLEDGE to become more inclusive. While the mechanics are complicated and involve a variety of entities and advocacy initiatives, we are optimistic that major changes are in the pipeline.”
Dr. Mansh, Dr. Yeung, and Dr. Peebles reported no disclosures.
Dermatologists cautioned colleagues to in transgender people, who are especially vulnerable to acne because of hormone therapy.
The identities of sexual minorities “have a significant influence on many facets of health,” dermatologist Matthew Mansh, MD, of the University of Minnesota, Minneapolis, said in a presentation at the American Academy of Dermatology Virtual Meeting Experience.
In regard to skin cancer, he said, “there seems to be consistently higher rates of skin cancer and certain preventable risk behaviors like indoor tanning among sexual minority men.”
Dr. Mansh, codirector of the high-risk nonmelanoma skin cancer clinic at the University of Minnesota, highlighted a report, published in JAMA Dermatology in 2020, that used 2014-2018 U.S. survey data of over 870,000 adults to look at the association between sexual orientation and lifetime prevalence of skin cancer. The investigators found that gay and bisexual men had a higher lifetime prevalence of skin cancer compared with heterosexual men (adjusted odds ratio [aOR], 1.25; 95% confidence interval, 1.03-1.50; P = .02; and aOR, 1.46; 95% CI, 1.01-2.10; P = .04; for gay and bisexual men, respectively).
When compared with heterosexual women, risk among bisexual women was lower (aOR, 0.75; 95% CI, 0.60-0.95; P = .02), but not among lesbian women (aOR, 1.01; 95% CI, 0.77-1.33; P = .95, respectively).
Other studies have reached similar conclusions, Dr. Mansh said, although there’s been fairly little research in this area. What could explain these differences? Factors such as smoking, age, and alcohol use affect skin cancer risk, he said, but these studies control for those variables. Instead, he noted, it’s useful to look at studies of ultraviolet exposure.
For example, he highlighted a study published in JAMA Dermatology in 2015, which examined 12-month indoor-tanning rates and skin cancer prevalence by sexual orientation, using data from California and national health interview surveys. The study found that compared with heterosexual men, “sexual minority men had higher rates of indoor tanning by roughly three- to sixfold,” said Dr. Mansh, the lead author. “And this was among respondents who were adults over age 18. People between the ages of 18 and 34 years are important from a skin cancer perspective as it’s well established that exposure to tanning beds at a younger age is most associated with an increased risk of skin cancer.”
Sexual minority men were also significantly more likely to report having skin cancer, compared with heterosexual men.
In the study, sexual minority women had about half the odds of engaging in indoor tanning compared with heterosexual women, and were less likely to report having been diagnosed with nonmelanoma skin cancer, he added.
Other studies suggest that gay and bisexual men live in neighborhoods with more indoor tanning salons and that they may spend more time in the sun outside too, he said. Some research suggests motivations for tanning include social pressure and the desire to improve appearance, he added.
Overall, “we may be able to use these data to add more appropriate screening and recommendations for these patients, which are sorely lacking in dermatology,” and to design targeted behavioral interventions, said Dr. Mansh, codirector of the dermatology gender care clinic at the University of Minnesota.
What can dermatologists do now? In an interview, dermatologist Jon Klint Peebles, MD, of the mid-Atlantic Permanente Medical Group, in Largo, Md., suggested that colleagues ask patients questions about indoor tanning frequency, the motivations for tanning, exposure to outdoor ultraviolet radiation, sunscreen use, and use of photoprotective clothing.
Hormone therapy and acne
In a related presentation at the meeting, Howa Yeung, MD, of the department of dermatology, Emory University, Atlanta, said that in transgender people, estrogen therapy can actually reduce sebum production and often improves acne, while testosterone therapy frequently has the opposite effect.
“We’ve seen some pretty tough cases of acne in transmasculine patients in my practice,” said Dr. Yeung, who highlighted a recently published study that tracked 988 transgender patients in Boston who underwent testosterone therapy. Nearly a third were diagnosed with acne, compared with 6% prior to hormone therapy, and those at the highest risk were aged 18-21.
The prevalence of acne was 25% 2 years after initiation of hormone therapy. “Acne remains a very common issue and not just at the beginning of treatment,” he said.
In 2020, Dr. Yeung and colleagues reported the results of a survey of 696 transgender patients in California and Georgia; most were treated with hormone therapy. They found that 14% of transmasculine patients reported currently having moderate to severe acne diagnosed by a physician, compared with 1% of transfeminine patients.
Dr. Yeung noted that another survey of transmasculine persons who had received testosterone found that those who had moderate to severe acne were more likely to suffer from depression and anxiety than were those who had never had acne (aOR, 2.4; 95% CI, 1.1-5.4; P = .001, for depression; and aOR, 2.7; 95% CI, 1.2-6.3; P = .002, for anxiety).
Acne treatments in transmasculine patients are complicated by the fact that hormone treatments for acne can have feminizing effects, Dr. Yeung said, adding that it’s not clear how clascoterone, a new anti-androgen topical therapy for acne, will affect them. For now, many patients will require isotretinoin for treating acne.
Dr. Peebles cautioned that with isotretinoin, “we still do not yet have solid data on the optimal dosing or duration in the context of testosterone-induced acne, as well as what individual factors may be predictive of treatment success or failure. It is also important to be aware of any planned surgical procedures, whether as part of gender-affirming care or otherwise, given that some surgeons may view isotretinoin as a barrier for some procedures, despite limited data to support this.”
Both Dr. Peebles and Dr. Yeung noted that the iPledge risk management program for isotretinoin patients who may become pregnant is problematic. “A trans man who is assigned female at birth and identifies as a man and has a uterus and ovaries must be registered as a female with reproductive potential,” Dr. Yeung said.
“While the program remains inherently discriminatory, it is important to have an honest conversation with patients about these issues in a sensitive way,” Dr. Peebles noted. “Luckily, there is substantial momentum building around modifying iPLEDGE to become more inclusive. While the mechanics are complicated and involve a variety of entities and advocacy initiatives, we are optimistic that major changes are in the pipeline.”
Dr. Mansh, Dr. Yeung, and Dr. Peebles reported no disclosures.
FROM AAD VMX 2021
TNF inhibitors linked to threefold increased risk of psoriasis in JIA patients
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.
FROM CARRA 2021
Psoriasis associated with an increased risk of COVID-19 in real-world study
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.
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.
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.
FROM AAD VMX 2021
Debate: Should biologics be used for milder cases of psoriasis?
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 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 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.
Tofacitinib: Small study shows big cutaneous sarcoidosis response
Researchers are reporting impressive results in a small, , and all patients improved by an average of 83% via a scoring system.
“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.
Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.
“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.
“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”
Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.
Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.
The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.
In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”
Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.
In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.
She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”
The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.
This article was updated 5/5/21.
Researchers are reporting impressive results in a small, , and all patients improved by an average of 83% via a scoring system.
“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.
Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.
“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.
“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”
Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.
Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.
The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.
In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”
Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.
In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.
She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”
The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.
This article was updated 5/5/21.
Researchers are reporting impressive results in a small, , and all patients improved by an average of 83% via a scoring system.
“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.
Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.
“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.
“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”
Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.
Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.
The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.
In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”
Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.
In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.
She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”
The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.
This article was updated 5/5/21.
REPORTING FROM AAD VMX 2021
Topical anticholinergic for axillary hyperhidrosis shows fewer side effects
according to 48-week safety and outcome data.
A structural analogue of glycopyrrolate working through the same mechanism, sofpironium bromide was developed as a retrometabolic agent. This means it is rapidly transformed into an inactive metabolite after application, reducing risk of systemic effects, study investigator Stacy Smith, MD, explained in the late-breaking research session at the American Academy of Dermatology Virtual Meeting Experience.
The anticholinergic glycopyrrolate, which currently is the most commonly used therapy for hyperhidrosis, is absorbed through the skin and excreted through the urine. The systemic exposure to the active agent after topical application explains the substantial risk of adverse effects, said Dr. Smith, a clinician and researcher affiliated with the California Dermatology and Clinical Research Institute, Encinitas.
In contrast,“sofpironium bromide is the ideal topical medication, because it has strong activity at the application site but then reduced systemic activity due to the retrometabolism,” Dr. Smith said.
The 52-week data from the open-label, phase 3 trial supports the premise. In this study of 299 patients randomized to the 5% (102 patients) or 15% (197 patients) topical sofpironium bromide gel formulations, most anticholinergic adverse events were mild or moderate and transient, with complaints concentrated in the first 3 months of the trial.
“The retrometabolic pathway seems to work,” Dr. Smith said. He acknowledged that the treatment-naive patients who entered the study “had to get used to the drug over time,” but the data “show they did.”
The phase 3 trial of sofpironium bromide, which is already approved to treat axillary hyperhidrosis in Japan, did not have a placebo control. It was focused primarily on safety, but outcomes were assessed with the Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax).
At least a 1-point improvement in the 7-point HDSM-Ax scale, which is considered clinically meaningful, was achieved by 86.1% and 85.8% of those treated with the 5% and 15% gels, respectively. A 2-point or greater improvement at the end of the study was observed in 69.4% and 61.9%, respectively.
“The medication works well and there was improved efficacy over time. About two-thirds of the patients had at least a 2-point improvement in the HDSM-Ax score at the end of 48 weeks,” Dr. Smith reported.
While response rates climbed over the course of the study, rates of adverse events fell markedly.
After 2 weeks of treatment, the proportions of patients with a treatment-related adverse event were 6% and just under 15% for the 5% and 15% topical-gel groups, respectively. At each 2-week interval when reassessed, the rates fell. By week 12, the rates were less than 2% and about 4% in the two groups, respectively.
The discontinuation rates overall for anticholinergic side effects were 3% and 8.1% for the lower and higher doses. Blurred vision accounted for the vast majority of these discontinuations in both groups. The other discontinuations, which included those for dry mouth, urinary retention, and mydriasis, occurred in one patient each. Again, discontinuations were most common in the first few months of the study.
For the total study population, mild (10.8% vs. 24%) and moderate (10.8% vs. 20.3%) side effects accounted for almost all side effects with the lower and higher doses of the topical drug. Only one patient in the low-dose group had a severe adverse event. At 6.1%, the proportion of the high-dose group with a severe adverse event was higher, but none of the adverse events were considered serious. All were transient.
These rates of adverse events are lower than those reported historically with effective doses of glycopyrrolate, Dr. Smith said.
The data presented by Dr. Smith are part of a phase 3 pivotal trials program designed to gain FDA approval. Going forward, these trials, which are enrolling patients as young as 9 years old, are expected to focus on clinical development of the 15% gel, he added.
The gel is delivered with a metered-dose pump that has an applicator, according to Brickell Biotech, the company developing the treatment in the United States. The 5% formulation was approved in Japan in September 2020, for the treatment of primary axillary hyperhidrosis.
In an interview, David M. Pariser, MD, professor of dermatology, Eastern Virginia Medical School, Norfolk, said that he believes that this drug has could be helpful if the pivotal studies confirm efficacy with a lower risk of adverse events relative to glycopyrrolate. “If it is true that, in phase 3, placebo-controlled trials, there are fewer systemic anticholinergic effects, then this drug will be very useful,” said Dr. Pariser, cofounder of the International Hyperhidrosis Society and an investigator on a previously published dose-ranging, phase 2 study of sofpironium bromide.
The trial was sponsored by Brickell Biotech, which compensated Dr. Smith and other coauthors for their participation. Dr. Pariser has financial relationships with multiple pharmaceutical companies with dermatologic products, including Brickell Biotech.
This article was updated 4/26/21.
according to 48-week safety and outcome data.
A structural analogue of glycopyrrolate working through the same mechanism, sofpironium bromide was developed as a retrometabolic agent. This means it is rapidly transformed into an inactive metabolite after application, reducing risk of systemic effects, study investigator Stacy Smith, MD, explained in the late-breaking research session at the American Academy of Dermatology Virtual Meeting Experience.
The anticholinergic glycopyrrolate, which currently is the most commonly used therapy for hyperhidrosis, is absorbed through the skin and excreted through the urine. The systemic exposure to the active agent after topical application explains the substantial risk of adverse effects, said Dr. Smith, a clinician and researcher affiliated with the California Dermatology and Clinical Research Institute, Encinitas.
In contrast,“sofpironium bromide is the ideal topical medication, because it has strong activity at the application site but then reduced systemic activity due to the retrometabolism,” Dr. Smith said.
The 52-week data from the open-label, phase 3 trial supports the premise. In this study of 299 patients randomized to the 5% (102 patients) or 15% (197 patients) topical sofpironium bromide gel formulations, most anticholinergic adverse events were mild or moderate and transient, with complaints concentrated in the first 3 months of the trial.
“The retrometabolic pathway seems to work,” Dr. Smith said. He acknowledged that the treatment-naive patients who entered the study “had to get used to the drug over time,” but the data “show they did.”
The phase 3 trial of sofpironium bromide, which is already approved to treat axillary hyperhidrosis in Japan, did not have a placebo control. It was focused primarily on safety, but outcomes were assessed with the Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax).
At least a 1-point improvement in the 7-point HDSM-Ax scale, which is considered clinically meaningful, was achieved by 86.1% and 85.8% of those treated with the 5% and 15% gels, respectively. A 2-point or greater improvement at the end of the study was observed in 69.4% and 61.9%, respectively.
“The medication works well and there was improved efficacy over time. About two-thirds of the patients had at least a 2-point improvement in the HDSM-Ax score at the end of 48 weeks,” Dr. Smith reported.
While response rates climbed over the course of the study, rates of adverse events fell markedly.
After 2 weeks of treatment, the proportions of patients with a treatment-related adverse event were 6% and just under 15% for the 5% and 15% topical-gel groups, respectively. At each 2-week interval when reassessed, the rates fell. By week 12, the rates were less than 2% and about 4% in the two groups, respectively.
The discontinuation rates overall for anticholinergic side effects were 3% and 8.1% for the lower and higher doses. Blurred vision accounted for the vast majority of these discontinuations in both groups. The other discontinuations, which included those for dry mouth, urinary retention, and mydriasis, occurred in one patient each. Again, discontinuations were most common in the first few months of the study.
For the total study population, mild (10.8% vs. 24%) and moderate (10.8% vs. 20.3%) side effects accounted for almost all side effects with the lower and higher doses of the topical drug. Only one patient in the low-dose group had a severe adverse event. At 6.1%, the proportion of the high-dose group with a severe adverse event was higher, but none of the adverse events were considered serious. All were transient.
These rates of adverse events are lower than those reported historically with effective doses of glycopyrrolate, Dr. Smith said.
The data presented by Dr. Smith are part of a phase 3 pivotal trials program designed to gain FDA approval. Going forward, these trials, which are enrolling patients as young as 9 years old, are expected to focus on clinical development of the 15% gel, he added.
The gel is delivered with a metered-dose pump that has an applicator, according to Brickell Biotech, the company developing the treatment in the United States. The 5% formulation was approved in Japan in September 2020, for the treatment of primary axillary hyperhidrosis.
In an interview, David M. Pariser, MD, professor of dermatology, Eastern Virginia Medical School, Norfolk, said that he believes that this drug has could be helpful if the pivotal studies confirm efficacy with a lower risk of adverse events relative to glycopyrrolate. “If it is true that, in phase 3, placebo-controlled trials, there are fewer systemic anticholinergic effects, then this drug will be very useful,” said Dr. Pariser, cofounder of the International Hyperhidrosis Society and an investigator on a previously published dose-ranging, phase 2 study of sofpironium bromide.
The trial was sponsored by Brickell Biotech, which compensated Dr. Smith and other coauthors for their participation. Dr. Pariser has financial relationships with multiple pharmaceutical companies with dermatologic products, including Brickell Biotech.
This article was updated 4/26/21.
according to 48-week safety and outcome data.
A structural analogue of glycopyrrolate working through the same mechanism, sofpironium bromide was developed as a retrometabolic agent. This means it is rapidly transformed into an inactive metabolite after application, reducing risk of systemic effects, study investigator Stacy Smith, MD, explained in the late-breaking research session at the American Academy of Dermatology Virtual Meeting Experience.
The anticholinergic glycopyrrolate, which currently is the most commonly used therapy for hyperhidrosis, is absorbed through the skin and excreted through the urine. The systemic exposure to the active agent after topical application explains the substantial risk of adverse effects, said Dr. Smith, a clinician and researcher affiliated with the California Dermatology and Clinical Research Institute, Encinitas.
In contrast,“sofpironium bromide is the ideal topical medication, because it has strong activity at the application site but then reduced systemic activity due to the retrometabolism,” Dr. Smith said.
The 52-week data from the open-label, phase 3 trial supports the premise. In this study of 299 patients randomized to the 5% (102 patients) or 15% (197 patients) topical sofpironium bromide gel formulations, most anticholinergic adverse events were mild or moderate and transient, with complaints concentrated in the first 3 months of the trial.
“The retrometabolic pathway seems to work,” Dr. Smith said. He acknowledged that the treatment-naive patients who entered the study “had to get used to the drug over time,” but the data “show they did.”
The phase 3 trial of sofpironium bromide, which is already approved to treat axillary hyperhidrosis in Japan, did not have a placebo control. It was focused primarily on safety, but outcomes were assessed with the Hyperhidrosis Disease Severity Measure–Axillary (HDSM-Ax).
At least a 1-point improvement in the 7-point HDSM-Ax scale, which is considered clinically meaningful, was achieved by 86.1% and 85.8% of those treated with the 5% and 15% gels, respectively. A 2-point or greater improvement at the end of the study was observed in 69.4% and 61.9%, respectively.
“The medication works well and there was improved efficacy over time. About two-thirds of the patients had at least a 2-point improvement in the HDSM-Ax score at the end of 48 weeks,” Dr. Smith reported.
While response rates climbed over the course of the study, rates of adverse events fell markedly.
After 2 weeks of treatment, the proportions of patients with a treatment-related adverse event were 6% and just under 15% for the 5% and 15% topical-gel groups, respectively. At each 2-week interval when reassessed, the rates fell. By week 12, the rates were less than 2% and about 4% in the two groups, respectively.
The discontinuation rates overall for anticholinergic side effects were 3% and 8.1% for the lower and higher doses. Blurred vision accounted for the vast majority of these discontinuations in both groups. The other discontinuations, which included those for dry mouth, urinary retention, and mydriasis, occurred in one patient each. Again, discontinuations were most common in the first few months of the study.
For the total study population, mild (10.8% vs. 24%) and moderate (10.8% vs. 20.3%) side effects accounted for almost all side effects with the lower and higher doses of the topical drug. Only one patient in the low-dose group had a severe adverse event. At 6.1%, the proportion of the high-dose group with a severe adverse event was higher, but none of the adverse events were considered serious. All were transient.
These rates of adverse events are lower than those reported historically with effective doses of glycopyrrolate, Dr. Smith said.
The data presented by Dr. Smith are part of a phase 3 pivotal trials program designed to gain FDA approval. Going forward, these trials, which are enrolling patients as young as 9 years old, are expected to focus on clinical development of the 15% gel, he added.
The gel is delivered with a metered-dose pump that has an applicator, according to Brickell Biotech, the company developing the treatment in the United States. The 5% formulation was approved in Japan in September 2020, for the treatment of primary axillary hyperhidrosis.
In an interview, David M. Pariser, MD, professor of dermatology, Eastern Virginia Medical School, Norfolk, said that he believes that this drug has could be helpful if the pivotal studies confirm efficacy with a lower risk of adverse events relative to glycopyrrolate. “If it is true that, in phase 3, placebo-controlled trials, there are fewer systemic anticholinergic effects, then this drug will be very useful,” said Dr. Pariser, cofounder of the International Hyperhidrosis Society and an investigator on a previously published dose-ranging, phase 2 study of sofpironium bromide.
The trial was sponsored by Brickell Biotech, which compensated Dr. Smith and other coauthors for their participation. Dr. Pariser has financial relationships with multiple pharmaceutical companies with dermatologic products, including Brickell Biotech.
This article was updated 4/26/21.
FROM AAD VMX 2021
Pigmented palmar lesions
Fortunately, the dermoscopy images of these 2 small palmar lesions showed a pattern of pigmentation that aligned in the furrows and was consistent with benign palmar nevi.
It is not uncommon to have nevi on the palms or soles of the feet, so it is important to distinguish between acral lentiginous melanoma (ALM) and benign nevi. ALM is the least common form of melanoma. In contrast to other types of melanoma, it is not considered secondary to excessive sun exposure. Clinically, ALM presents with irregular, enlarging pigmentation that follows, or crosses, the raised ridges of the palms or soles.1 The pigmented areas can progress to ulcerated or bleeding lesions. As with other melanomas, early diagnosis and removal is important to optimize prognosis.
Removal of lesions suspicious for ALM can be achieved in several ways: deep shave biopsy, punch excision if the lesion is small, excision with narrow margins, or, if the lesion is large, by a selective punch biopsy of the most suspicious portion of the lesion (typically the thickest and most irregular area). Larger diameter lesions that are raised and irregular are more worrisome than this patient’s 2-mm macular lesions.
In this case, the patient was reassured that the lesions did not require excision. She was advised to continue to monitor her lesions for growth or changes over time and to return for evaluation, as needed. She was also counseled regarding the American Cancer Society’s ABCDE rules (Asymmetry, Border irregularity, Color, Diameter, Elevation or Evolving) regarding melanomas.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque
1. Hall KH, Rapini RP. Acral lentiginous melanoma. In: StatPearls [Internet]. StatPearls Publishing; 2020. Accessed April 5, 2021. https://www.ncbi.nlm.nih.gov/books/NBK559113/
Fortunately, the dermoscopy images of these 2 small palmar lesions showed a pattern of pigmentation that aligned in the furrows and was consistent with benign palmar nevi.
It is not uncommon to have nevi on the palms or soles of the feet, so it is important to distinguish between acral lentiginous melanoma (ALM) and benign nevi. ALM is the least common form of melanoma. In contrast to other types of melanoma, it is not considered secondary to excessive sun exposure. Clinically, ALM presents with irregular, enlarging pigmentation that follows, or crosses, the raised ridges of the palms or soles.1 The pigmented areas can progress to ulcerated or bleeding lesions. As with other melanomas, early diagnosis and removal is important to optimize prognosis.
Removal of lesions suspicious for ALM can be achieved in several ways: deep shave biopsy, punch excision if the lesion is small, excision with narrow margins, or, if the lesion is large, by a selective punch biopsy of the most suspicious portion of the lesion (typically the thickest and most irregular area). Larger diameter lesions that are raised and irregular are more worrisome than this patient’s 2-mm macular lesions.
In this case, the patient was reassured that the lesions did not require excision. She was advised to continue to monitor her lesions for growth or changes over time and to return for evaluation, as needed. She was also counseled regarding the American Cancer Society’s ABCDE rules (Asymmetry, Border irregularity, Color, Diameter, Elevation or Evolving) regarding melanomas.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque
Fortunately, the dermoscopy images of these 2 small palmar lesions showed a pattern of pigmentation that aligned in the furrows and was consistent with benign palmar nevi.
It is not uncommon to have nevi on the palms or soles of the feet, so it is important to distinguish between acral lentiginous melanoma (ALM) and benign nevi. ALM is the least common form of melanoma. In contrast to other types of melanoma, it is not considered secondary to excessive sun exposure. Clinically, ALM presents with irregular, enlarging pigmentation that follows, or crosses, the raised ridges of the palms or soles.1 The pigmented areas can progress to ulcerated or bleeding lesions. As with other melanomas, early diagnosis and removal is important to optimize prognosis.
Removal of lesions suspicious for ALM can be achieved in several ways: deep shave biopsy, punch excision if the lesion is small, excision with narrow margins, or, if the lesion is large, by a selective punch biopsy of the most suspicious portion of the lesion (typically the thickest and most irregular area). Larger diameter lesions that are raised and irregular are more worrisome than this patient’s 2-mm macular lesions.
In this case, the patient was reassured that the lesions did not require excision. She was advised to continue to monitor her lesions for growth or changes over time and to return for evaluation, as needed. She was also counseled regarding the American Cancer Society’s ABCDE rules (Asymmetry, Border irregularity, Color, Diameter, Elevation or Evolving) regarding melanomas.
Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque
1. Hall KH, Rapini RP. Acral lentiginous melanoma. In: StatPearls [Internet]. StatPearls Publishing; 2020. Accessed April 5, 2021. https://www.ncbi.nlm.nih.gov/books/NBK559113/
1. Hall KH, Rapini RP. Acral lentiginous melanoma. In: StatPearls [Internet]. StatPearls Publishing; 2020. Accessed April 5, 2021. https://www.ncbi.nlm.nih.gov/books/NBK559113/
Boosting the presence of darker skin in rheumatology education
Studies are flagging racial and ethnic disparities in rheumatology training materials, pointing to a need to boost representation of darker skin tones and better educate physicians in evaluating this cohort.
Not enough is known about these disparities in rheumatology education, despite the fact that minorities make up 40% of the population in the United States.
The problem starts with books and references used in medical schools, Lynn McKinley-Grant, MD, immediate past president of the Skin of Color Society and associate professor of dermatology at Howard University, Washington, said in an interview. “In the medical literature there has been a dearth of images in skin of color in all specialties,” she said. With an increased diversity in the U.S. population, there is a need for health care providers to be able to recognize disease patterns in all skin types.” If a physician is training at an institution where there are not many patients of color in the community, the rheumatologists are even more limited in terms of their clinical experience.
This lack of training in diagnosis of disease has serious clinical repercussions, as seen in COVID cases, Dr. McKinley-Grant noted. “You end up not being able to recognize early erythema, jaundice, anemia, or hypoxemia because those conditions are a different color or pattern in the darker skin types. This can lead to errors in treatment, diagnosis, and medical care, resulting in increased morbidity and mortality.”
Studies point to education gaps
A team of researchers from Washington University in St. Louis called attention to this issue at the American College of Rhematology’s Convergence 2020 conference.
“Patients of color with lupus are especially vulnerable as they often carry a greater disease burden, yet studies show that individuals with darker skin tones are underrepresented in medical educational materials,” Vijay Kannuthurai, MD, and colleagues wrote in their study abstract. The team surveyed 132 providers in St. Louis, Mo., on their confidence in evaluating any rash, and rashes in patients with lupus and varied skin tones.
Participating clinicians, mostly rheumatologists, dermatologists, or internists, had a higher confidence level in diagnosing any rash versus lupus rashes, but were considerably less confident in diagnosing lupus rash on darker skin, compared with those on fair skin. This represents “a disparity between provider confidence and the patient population lupus traditionally affects,” the investigators concluded.
Another recent study found evidence of disparities in clinical education resources. “The lack of dark skin representation among rheumatology educational materials contributes to the implicit bias and structural racism present in medical education by promoting White-only models of disease,” lead author Adrienne Strait, a medical student at the University of California, San Francisco, said in an interview. “Given that rheumatic diseases disproportionately impact racial and ethnic minorities, we felt it was important to examine the representation of these groups within rheumatology training resources.”
She and her colleagues gathered images of rheumatic diseases from four major databases: the American College of Rheumatology’s Image Library, UpToDate, the New England Journal of Medicine Images in Clinical Medicine and Clinical Cases filtered by “Rheumatology,” and the 9th edition of Kelley’s Textbook of Rheumatology. They used Fitzpatrick’s skin phototypes to independently code images depicting skin as “light” (skin types I-IV), “dark” (skin types V-VI), or “indeterminate,” focusing on systemic lupus erythematosus (SLE) and rheumatoid arthritis, two conditions with a known connection to racial and ethnic health disparities.
Taking into account the high incidence of sarcoidosis and SLE in Black patients when compared with White patients, the investigators did a secondary analysis that excluded these cases.
Among 1,043 patient images studied, just 13.4% represented dark skin, compared with 84% that represented light skin. More than 2% represented an indeterminate skin color. Comparing dark-skin representation in the clinical images and SLE images with the representation of Asian, Native American, and Black individuals in the United States and within lupus cases nationally, the investigators found significant underrepresentation of dark skin.
Only 4.2% of RA images had dark-skin representation, making RA one of the diseases with the lowest representation in the study, along with juvenile idiopathic arthritis, the spondyloarthropathies, and Kawasaki disease. “Representation of dark skin in SLE was also lower than the proportion of Black individuals in SLE studies,” the investigators noted. Overall, representation of dark skin in SLE images was just 22.6%. Sarcoidosis comparatively had the largest representation of dark-skin images (69.6%, n = 32).
“Excluding sarcoidosis and SLE images, the overall representation of dark skin was 9.4% (n = 84), which was significantly lower than the proportion of Asian, Native American, and Black individuals within the U.S. Census population,” according to Ms. Strait and her associates. UpToDate contained the largest proportion of images of dark skin respective to other databases, whereas Kelley’s Textbook had the smallest.
Actionable steps
Many physicians are willing to improve upon their skills in identifying conditions on darker skin, as the study by Dr. Kannuthurai and associates suggests. Overall, 93% of the survey’s participants wanted to learn more about rashes in patients of color. “Future educational interventions may help practitioners improve their confidence when diagnosing rashes in lupus patients” with darker skin, they suggested.
Ms. Strait and her colleagues recommended a series of actionable steps to improve diversity and equity of dark skin tone representation in rheumatology curricula.
Editors of educational resources, for example, should make image diversity a priority for those diseases that are most commonly associated with cutaneous manifestations, such as SLE, vasculitis, inflammatory myopathies, systemic sclerosis, sarcoidosis, and psoriasis. They also called for educators in academic rheumatology programs to collaborate to improve diversity in resources used at the undergraduate and graduate medical education level.
Efforts should take place at the local, regional, and national level to publicly discuss and educate clinicians about rheumatic diseases in individuals of color. Speakers at rheumatology conferences should strive to educate learners about presentations of rheumatic diseases in individuals of color. The ACR in the meantime could establish a task force to enhance racial and ethnic diversity in their image library and other published resources.
“These steps may improve provider recognition and diagnosis of rheumatic disease manifestations in skin of color, which may in turn reduce health disparities among racial and ethnic minority groups,” Ms. Strait said.
Beth L. Jonas, MD, chair of the ACR’s Committee on Rheumatology Training and Workforce Issues, called the findings of this study “timely and important.” The researchers highlighted a deficiency in rheumatology training materials that needs addressing, she said in an interview. “I definitely agree that ACR needs to be mindful of this. There’s no doubt that we need to take these recommendations and move along these lines.”
The ACR took a first step in 2020 with the creation of a diversity, equity, and inclusion committee. “We are undergoing a college-wide look at what we do, with an eye toward inclusion. There is a strong interest in addressing health disparities and being an equitable and inclusive community of rheumatology health care professionals,” said Dr. Jonas, chief of the University of North Carolina at Chapel Hill’s division of rheumatology, allergy, and immunology.
The American Academy of Dermatology is also working to improve the image library with images of disease in skin of color. “Everyone’s jumping on this now,” Dr. McKinley-Grant observed. The medical profession can’t afford not to. It’s a life-threatening issue when rheumatoid arthritis and other diseases in people of color aren’t diagnosed early and correctly, she added.
Technologies seek to reduce bias
While many organizations are taking steps to improve representation of darker skin images, VisualDx has taken the lead on this, she said. “They’ve been doing this for years now. There are over 14,000 images of disease in skin of color, including all the rheumatologic diseases. There’s a mobile app and desktop decision support system, and it is very popular. A majority of medical schools have this as a library resource, and hospital systems license it for EHR integration.” Doctors can also get it individually. This enables them to share images and handouts of a diagnosis and select images of patients of color, said Dr. McKinley-Grant, who uses the VisualDx smartphone app DermExpert, which is an app for nondermatologists that features an image library of skin lesions, including darker-skin images.
ProjectIMPACT, powered by VisualDx, is another effort to support reducing health care bias in darker skin. The project is a collaboration between the New England Journal of Medicine Group and the Skin Of Color Society. According to Dr. McKinley-Grant, the organizers are building awareness of the importance of reducing the educational and clinical gaps in diagnosing patients of color and trying to get students and educators to pledge to take meaningful steps and to have real-world impact.
This isn’t just exclusive to dermatology and rheumatology – it involves all medical specialties, she stressed.
ProjectIMPACT isn’t just a resource for physicians, she continued. Librarians can also use it to develop more resources on skin of color.
The Skin Of Color Society and VisualDx have also partnered with the NEJM Group to develop a comprehensive virtual series on the impact of skin color and ethnicity on clinical research. The four-part series addresses structural racism and racial bias in medicine, hair disorders in people of color, pigmentary disorders, keloids, COVID-19 comorbidities, and cutaneous manifestations of systemic diseases in children and adults.
Nuances of recognizing disease
As a medical student, Dr. McKinley-Grant said she was fortunate to attend the Albert Schweitzer Hospital in Lambarene, Gabon, on a fellowship. For 3 months, she gained a wealth of experience examining only African patients with brown skin.
In her other training in medicine, “I’ve been at institutions with diverse populations, in Boston, New York, and Washington,” learning more about all different skin pigments.
This type of training should be more widely available, especially now, with COVID-19 producing new manifestations of skin lesions, she emphasized. Such efforts involve a diversification of images physicians are being trained on so that they can recognize the same disease in a person of color.
“Doctors have to be able to recognize different colors, different shades of brown and shades of white. Not all white skin is the same color,” she noted. In looking at a rash or lesion, “you have to learn how to discern differences in the background color of the skin, which is determined by melanin in the skin (Fitzpatrick skin types I-VI) and by what’s going on in the blood, such as how much oxygen and hemoglobin the patient has in their blood.” Inflammation and infection (erythema) will appear more violaceous in IV-VI skin types, for example.
At the University of North Carolina at Chapel Hill, a group of students and faculty have created a dermatology image library to address the deficiency in the availability of images for teaching purposes. “Our medical students recognized the gap and started this,” Dr. Jonas said. Julie Mervak, MD, assistant professor of dermatology, is spearheading this effort, with students Linnea Westerkam and Anuj Pranav Sanghvi.
“I understand that others around the country are working on similar initiatives,” Dr. Jonas said.
None of the sources for this story had any relevant disclosures.
Studies are flagging racial and ethnic disparities in rheumatology training materials, pointing to a need to boost representation of darker skin tones and better educate physicians in evaluating this cohort.
Not enough is known about these disparities in rheumatology education, despite the fact that minorities make up 40% of the population in the United States.
The problem starts with books and references used in medical schools, Lynn McKinley-Grant, MD, immediate past president of the Skin of Color Society and associate professor of dermatology at Howard University, Washington, said in an interview. “In the medical literature there has been a dearth of images in skin of color in all specialties,” she said. With an increased diversity in the U.S. population, there is a need for health care providers to be able to recognize disease patterns in all skin types.” If a physician is training at an institution where there are not many patients of color in the community, the rheumatologists are even more limited in terms of their clinical experience.
This lack of training in diagnosis of disease has serious clinical repercussions, as seen in COVID cases, Dr. McKinley-Grant noted. “You end up not being able to recognize early erythema, jaundice, anemia, or hypoxemia because those conditions are a different color or pattern in the darker skin types. This can lead to errors in treatment, diagnosis, and medical care, resulting in increased morbidity and mortality.”
Studies point to education gaps
A team of researchers from Washington University in St. Louis called attention to this issue at the American College of Rhematology’s Convergence 2020 conference.
“Patients of color with lupus are especially vulnerable as they often carry a greater disease burden, yet studies show that individuals with darker skin tones are underrepresented in medical educational materials,” Vijay Kannuthurai, MD, and colleagues wrote in their study abstract. The team surveyed 132 providers in St. Louis, Mo., on their confidence in evaluating any rash, and rashes in patients with lupus and varied skin tones.
Participating clinicians, mostly rheumatologists, dermatologists, or internists, had a higher confidence level in diagnosing any rash versus lupus rashes, but were considerably less confident in diagnosing lupus rash on darker skin, compared with those on fair skin. This represents “a disparity between provider confidence and the patient population lupus traditionally affects,” the investigators concluded.
Another recent study found evidence of disparities in clinical education resources. “The lack of dark skin representation among rheumatology educational materials contributes to the implicit bias and structural racism present in medical education by promoting White-only models of disease,” lead author Adrienne Strait, a medical student at the University of California, San Francisco, said in an interview. “Given that rheumatic diseases disproportionately impact racial and ethnic minorities, we felt it was important to examine the representation of these groups within rheumatology training resources.”
She and her colleagues gathered images of rheumatic diseases from four major databases: the American College of Rheumatology’s Image Library, UpToDate, the New England Journal of Medicine Images in Clinical Medicine and Clinical Cases filtered by “Rheumatology,” and the 9th edition of Kelley’s Textbook of Rheumatology. They used Fitzpatrick’s skin phototypes to independently code images depicting skin as “light” (skin types I-IV), “dark” (skin types V-VI), or “indeterminate,” focusing on systemic lupus erythematosus (SLE) and rheumatoid arthritis, two conditions with a known connection to racial and ethnic health disparities.
Taking into account the high incidence of sarcoidosis and SLE in Black patients when compared with White patients, the investigators did a secondary analysis that excluded these cases.
Among 1,043 patient images studied, just 13.4% represented dark skin, compared with 84% that represented light skin. More than 2% represented an indeterminate skin color. Comparing dark-skin representation in the clinical images and SLE images with the representation of Asian, Native American, and Black individuals in the United States and within lupus cases nationally, the investigators found significant underrepresentation of dark skin.
Only 4.2% of RA images had dark-skin representation, making RA one of the diseases with the lowest representation in the study, along with juvenile idiopathic arthritis, the spondyloarthropathies, and Kawasaki disease. “Representation of dark skin in SLE was also lower than the proportion of Black individuals in SLE studies,” the investigators noted. Overall, representation of dark skin in SLE images was just 22.6%. Sarcoidosis comparatively had the largest representation of dark-skin images (69.6%, n = 32).
“Excluding sarcoidosis and SLE images, the overall representation of dark skin was 9.4% (n = 84), which was significantly lower than the proportion of Asian, Native American, and Black individuals within the U.S. Census population,” according to Ms. Strait and her associates. UpToDate contained the largest proportion of images of dark skin respective to other databases, whereas Kelley’s Textbook had the smallest.
Actionable steps
Many physicians are willing to improve upon their skills in identifying conditions on darker skin, as the study by Dr. Kannuthurai and associates suggests. Overall, 93% of the survey’s participants wanted to learn more about rashes in patients of color. “Future educational interventions may help practitioners improve their confidence when diagnosing rashes in lupus patients” with darker skin, they suggested.
Ms. Strait and her colleagues recommended a series of actionable steps to improve diversity and equity of dark skin tone representation in rheumatology curricula.
Editors of educational resources, for example, should make image diversity a priority for those diseases that are most commonly associated with cutaneous manifestations, such as SLE, vasculitis, inflammatory myopathies, systemic sclerosis, sarcoidosis, and psoriasis. They also called for educators in academic rheumatology programs to collaborate to improve diversity in resources used at the undergraduate and graduate medical education level.
Efforts should take place at the local, regional, and national level to publicly discuss and educate clinicians about rheumatic diseases in individuals of color. Speakers at rheumatology conferences should strive to educate learners about presentations of rheumatic diseases in individuals of color. The ACR in the meantime could establish a task force to enhance racial and ethnic diversity in their image library and other published resources.
“These steps may improve provider recognition and diagnosis of rheumatic disease manifestations in skin of color, which may in turn reduce health disparities among racial and ethnic minority groups,” Ms. Strait said.
Beth L. Jonas, MD, chair of the ACR’s Committee on Rheumatology Training and Workforce Issues, called the findings of this study “timely and important.” The researchers highlighted a deficiency in rheumatology training materials that needs addressing, she said in an interview. “I definitely agree that ACR needs to be mindful of this. There’s no doubt that we need to take these recommendations and move along these lines.”
The ACR took a first step in 2020 with the creation of a diversity, equity, and inclusion committee. “We are undergoing a college-wide look at what we do, with an eye toward inclusion. There is a strong interest in addressing health disparities and being an equitable and inclusive community of rheumatology health care professionals,” said Dr. Jonas, chief of the University of North Carolina at Chapel Hill’s division of rheumatology, allergy, and immunology.
The American Academy of Dermatology is also working to improve the image library with images of disease in skin of color. “Everyone’s jumping on this now,” Dr. McKinley-Grant observed. The medical profession can’t afford not to. It’s a life-threatening issue when rheumatoid arthritis and other diseases in people of color aren’t diagnosed early and correctly, she added.
Technologies seek to reduce bias
While many organizations are taking steps to improve representation of darker skin images, VisualDx has taken the lead on this, she said. “They’ve been doing this for years now. There are over 14,000 images of disease in skin of color, including all the rheumatologic diseases. There’s a mobile app and desktop decision support system, and it is very popular. A majority of medical schools have this as a library resource, and hospital systems license it for EHR integration.” Doctors can also get it individually. This enables them to share images and handouts of a diagnosis and select images of patients of color, said Dr. McKinley-Grant, who uses the VisualDx smartphone app DermExpert, which is an app for nondermatologists that features an image library of skin lesions, including darker-skin images.
ProjectIMPACT, powered by VisualDx, is another effort to support reducing health care bias in darker skin. The project is a collaboration between the New England Journal of Medicine Group and the Skin Of Color Society. According to Dr. McKinley-Grant, the organizers are building awareness of the importance of reducing the educational and clinical gaps in diagnosing patients of color and trying to get students and educators to pledge to take meaningful steps and to have real-world impact.
This isn’t just exclusive to dermatology and rheumatology – it involves all medical specialties, she stressed.
ProjectIMPACT isn’t just a resource for physicians, she continued. Librarians can also use it to develop more resources on skin of color.
The Skin Of Color Society and VisualDx have also partnered with the NEJM Group to develop a comprehensive virtual series on the impact of skin color and ethnicity on clinical research. The four-part series addresses structural racism and racial bias in medicine, hair disorders in people of color, pigmentary disorders, keloids, COVID-19 comorbidities, and cutaneous manifestations of systemic diseases in children and adults.
Nuances of recognizing disease
As a medical student, Dr. McKinley-Grant said she was fortunate to attend the Albert Schweitzer Hospital in Lambarene, Gabon, on a fellowship. For 3 months, she gained a wealth of experience examining only African patients with brown skin.
In her other training in medicine, “I’ve been at institutions with diverse populations, in Boston, New York, and Washington,” learning more about all different skin pigments.
This type of training should be more widely available, especially now, with COVID-19 producing new manifestations of skin lesions, she emphasized. Such efforts involve a diversification of images physicians are being trained on so that they can recognize the same disease in a person of color.
“Doctors have to be able to recognize different colors, different shades of brown and shades of white. Not all white skin is the same color,” she noted. In looking at a rash or lesion, “you have to learn how to discern differences in the background color of the skin, which is determined by melanin in the skin (Fitzpatrick skin types I-VI) and by what’s going on in the blood, such as how much oxygen and hemoglobin the patient has in their blood.” Inflammation and infection (erythema) will appear more violaceous in IV-VI skin types, for example.
At the University of North Carolina at Chapel Hill, a group of students and faculty have created a dermatology image library to address the deficiency in the availability of images for teaching purposes. “Our medical students recognized the gap and started this,” Dr. Jonas said. Julie Mervak, MD, assistant professor of dermatology, is spearheading this effort, with students Linnea Westerkam and Anuj Pranav Sanghvi.
“I understand that others around the country are working on similar initiatives,” Dr. Jonas said.
None of the sources for this story had any relevant disclosures.
Studies are flagging racial and ethnic disparities in rheumatology training materials, pointing to a need to boost representation of darker skin tones and better educate physicians in evaluating this cohort.
Not enough is known about these disparities in rheumatology education, despite the fact that minorities make up 40% of the population in the United States.
The problem starts with books and references used in medical schools, Lynn McKinley-Grant, MD, immediate past president of the Skin of Color Society and associate professor of dermatology at Howard University, Washington, said in an interview. “In the medical literature there has been a dearth of images in skin of color in all specialties,” she said. With an increased diversity in the U.S. population, there is a need for health care providers to be able to recognize disease patterns in all skin types.” If a physician is training at an institution where there are not many patients of color in the community, the rheumatologists are even more limited in terms of their clinical experience.
This lack of training in diagnosis of disease has serious clinical repercussions, as seen in COVID cases, Dr. McKinley-Grant noted. “You end up not being able to recognize early erythema, jaundice, anemia, or hypoxemia because those conditions are a different color or pattern in the darker skin types. This can lead to errors in treatment, diagnosis, and medical care, resulting in increased morbidity and mortality.”
Studies point to education gaps
A team of researchers from Washington University in St. Louis called attention to this issue at the American College of Rhematology’s Convergence 2020 conference.
“Patients of color with lupus are especially vulnerable as they often carry a greater disease burden, yet studies show that individuals with darker skin tones are underrepresented in medical educational materials,” Vijay Kannuthurai, MD, and colleagues wrote in their study abstract. The team surveyed 132 providers in St. Louis, Mo., on their confidence in evaluating any rash, and rashes in patients with lupus and varied skin tones.
Participating clinicians, mostly rheumatologists, dermatologists, or internists, had a higher confidence level in diagnosing any rash versus lupus rashes, but were considerably less confident in diagnosing lupus rash on darker skin, compared with those on fair skin. This represents “a disparity between provider confidence and the patient population lupus traditionally affects,” the investigators concluded.
Another recent study found evidence of disparities in clinical education resources. “The lack of dark skin representation among rheumatology educational materials contributes to the implicit bias and structural racism present in medical education by promoting White-only models of disease,” lead author Adrienne Strait, a medical student at the University of California, San Francisco, said in an interview. “Given that rheumatic diseases disproportionately impact racial and ethnic minorities, we felt it was important to examine the representation of these groups within rheumatology training resources.”
She and her colleagues gathered images of rheumatic diseases from four major databases: the American College of Rheumatology’s Image Library, UpToDate, the New England Journal of Medicine Images in Clinical Medicine and Clinical Cases filtered by “Rheumatology,” and the 9th edition of Kelley’s Textbook of Rheumatology. They used Fitzpatrick’s skin phototypes to independently code images depicting skin as “light” (skin types I-IV), “dark” (skin types V-VI), or “indeterminate,” focusing on systemic lupus erythematosus (SLE) and rheumatoid arthritis, two conditions with a known connection to racial and ethnic health disparities.
Taking into account the high incidence of sarcoidosis and SLE in Black patients when compared with White patients, the investigators did a secondary analysis that excluded these cases.
Among 1,043 patient images studied, just 13.4% represented dark skin, compared with 84% that represented light skin. More than 2% represented an indeterminate skin color. Comparing dark-skin representation in the clinical images and SLE images with the representation of Asian, Native American, and Black individuals in the United States and within lupus cases nationally, the investigators found significant underrepresentation of dark skin.
Only 4.2% of RA images had dark-skin representation, making RA one of the diseases with the lowest representation in the study, along with juvenile idiopathic arthritis, the spondyloarthropathies, and Kawasaki disease. “Representation of dark skin in SLE was also lower than the proportion of Black individuals in SLE studies,” the investigators noted. Overall, representation of dark skin in SLE images was just 22.6%. Sarcoidosis comparatively had the largest representation of dark-skin images (69.6%, n = 32).
“Excluding sarcoidosis and SLE images, the overall representation of dark skin was 9.4% (n = 84), which was significantly lower than the proportion of Asian, Native American, and Black individuals within the U.S. Census population,” according to Ms. Strait and her associates. UpToDate contained the largest proportion of images of dark skin respective to other databases, whereas Kelley’s Textbook had the smallest.
Actionable steps
Many physicians are willing to improve upon their skills in identifying conditions on darker skin, as the study by Dr. Kannuthurai and associates suggests. Overall, 93% of the survey’s participants wanted to learn more about rashes in patients of color. “Future educational interventions may help practitioners improve their confidence when diagnosing rashes in lupus patients” with darker skin, they suggested.
Ms. Strait and her colleagues recommended a series of actionable steps to improve diversity and equity of dark skin tone representation in rheumatology curricula.
Editors of educational resources, for example, should make image diversity a priority for those diseases that are most commonly associated with cutaneous manifestations, such as SLE, vasculitis, inflammatory myopathies, systemic sclerosis, sarcoidosis, and psoriasis. They also called for educators in academic rheumatology programs to collaborate to improve diversity in resources used at the undergraduate and graduate medical education level.
Efforts should take place at the local, regional, and national level to publicly discuss and educate clinicians about rheumatic diseases in individuals of color. Speakers at rheumatology conferences should strive to educate learners about presentations of rheumatic diseases in individuals of color. The ACR in the meantime could establish a task force to enhance racial and ethnic diversity in their image library and other published resources.
“These steps may improve provider recognition and diagnosis of rheumatic disease manifestations in skin of color, which may in turn reduce health disparities among racial and ethnic minority groups,” Ms. Strait said.
Beth L. Jonas, MD, chair of the ACR’s Committee on Rheumatology Training and Workforce Issues, called the findings of this study “timely and important.” The researchers highlighted a deficiency in rheumatology training materials that needs addressing, she said in an interview. “I definitely agree that ACR needs to be mindful of this. There’s no doubt that we need to take these recommendations and move along these lines.”
The ACR took a first step in 2020 with the creation of a diversity, equity, and inclusion committee. “We are undergoing a college-wide look at what we do, with an eye toward inclusion. There is a strong interest in addressing health disparities and being an equitable and inclusive community of rheumatology health care professionals,” said Dr. Jonas, chief of the University of North Carolina at Chapel Hill’s division of rheumatology, allergy, and immunology.
The American Academy of Dermatology is also working to improve the image library with images of disease in skin of color. “Everyone’s jumping on this now,” Dr. McKinley-Grant observed. The medical profession can’t afford not to. It’s a life-threatening issue when rheumatoid arthritis and other diseases in people of color aren’t diagnosed early and correctly, she added.
Technologies seek to reduce bias
While many organizations are taking steps to improve representation of darker skin images, VisualDx has taken the lead on this, she said. “They’ve been doing this for years now. There are over 14,000 images of disease in skin of color, including all the rheumatologic diseases. There’s a mobile app and desktop decision support system, and it is very popular. A majority of medical schools have this as a library resource, and hospital systems license it for EHR integration.” Doctors can also get it individually. This enables them to share images and handouts of a diagnosis and select images of patients of color, said Dr. McKinley-Grant, who uses the VisualDx smartphone app DermExpert, which is an app for nondermatologists that features an image library of skin lesions, including darker-skin images.
ProjectIMPACT, powered by VisualDx, is another effort to support reducing health care bias in darker skin. The project is a collaboration between the New England Journal of Medicine Group and the Skin Of Color Society. According to Dr. McKinley-Grant, the organizers are building awareness of the importance of reducing the educational and clinical gaps in diagnosing patients of color and trying to get students and educators to pledge to take meaningful steps and to have real-world impact.
This isn’t just exclusive to dermatology and rheumatology – it involves all medical specialties, she stressed.
ProjectIMPACT isn’t just a resource for physicians, she continued. Librarians can also use it to develop more resources on skin of color.
The Skin Of Color Society and VisualDx have also partnered with the NEJM Group to develop a comprehensive virtual series on the impact of skin color and ethnicity on clinical research. The four-part series addresses structural racism and racial bias in medicine, hair disorders in people of color, pigmentary disorders, keloids, COVID-19 comorbidities, and cutaneous manifestations of systemic diseases in children and adults.
Nuances of recognizing disease
As a medical student, Dr. McKinley-Grant said she was fortunate to attend the Albert Schweitzer Hospital in Lambarene, Gabon, on a fellowship. For 3 months, she gained a wealth of experience examining only African patients with brown skin.
In her other training in medicine, “I’ve been at institutions with diverse populations, in Boston, New York, and Washington,” learning more about all different skin pigments.
This type of training should be more widely available, especially now, with COVID-19 producing new manifestations of skin lesions, she emphasized. Such efforts involve a diversification of images physicians are being trained on so that they can recognize the same disease in a person of color.
“Doctors have to be able to recognize different colors, different shades of brown and shades of white. Not all white skin is the same color,” she noted. In looking at a rash or lesion, “you have to learn how to discern differences in the background color of the skin, which is determined by melanin in the skin (Fitzpatrick skin types I-VI) and by what’s going on in the blood, such as how much oxygen and hemoglobin the patient has in their blood.” Inflammation and infection (erythema) will appear more violaceous in IV-VI skin types, for example.
At the University of North Carolina at Chapel Hill, a group of students and faculty have created a dermatology image library to address the deficiency in the availability of images for teaching purposes. “Our medical students recognized the gap and started this,” Dr. Jonas said. Julie Mervak, MD, assistant professor of dermatology, is spearheading this effort, with students Linnea Westerkam and Anuj Pranav Sanghvi.
“I understand that others around the country are working on similar initiatives,” Dr. Jonas said.
None of the sources for this story had any relevant disclosures.
Most patients with chronic inflammatory diseases have sufficient response to COVID-19 vaccination
Glucocorticoids and B-cell–depleting therapies are trouble spots
Although most patients with chronic inflammatory diseases mounted immune responses after two doses of mRNA-based COVID-19 vaccines, glucocorticoids and B-cell–depleting therapies markedly reduced the response, according to a recently published preprint of a new study.
The study, published on MedRxiv and not yet peer reviewed, involved a prospective look at 133 patients with chronic inflammatory disease (CID) and 53 patients with healthy immune systems at Washington University, St. Louis, and the University of California, San Francisco. It is regarded as the largest and most detailed study yet in how vaccines perform in people with immune-mediated inflammatory disease. The patients were enrolled between December 2020 and March 2021, and the most common diseases were inflammatory bowel disease (32%), rheumatoid arthritis (29%), spondyloarthritis (15%), and systemic lupus erythematosus (11%).
A ‘modest’ reduction in antibody response
Senior author Alfred Kim, MD, PhD, of the department of medicine at Washington University, said the overall results so far are encouraging.
“Most patients with an autoimmune disease that are on immunosuppression can mount antibody responses,” he said. “We’re seeing the majority of our subjects respond.”
The immune-healthy controls and most of the patients with CID had a robust immune response against the spike protein, although the CID group had a mean reduction in antibody titers that was three times lower than the controls (P = .0092). The CID group similarly had a 2.7-fold reduction in preventing neutralization, or halting the virus’ ability to infect (P < .0001), researchers reported.
This reduction in response is “modest,” he said.
“Is the level of reduction going to be detrimental for protection? Time will tell,” he said, adding that researchers anticipate that it won’t have a critical effect on protection because responses tended to be within the range of the immunocompetent controls, who themselves had wildly varied antibody titers across a 20-fold range. “ ‘Optimal’ isn’t necessarily the same as ‘sufficient.’ ”
Type of medication has big impact on antibody titers
But there was a wide variety of effects on the immune response depending on the medication. Glucorticoids resulted in a response that was 10 times lower than the immune-healthy controls, as well as fewer circulating plasmablasts after vaccination. Researchers found that 98% of controls were seropositive for antibody, compared with 92% of those with CID who were not taking prednisone, and 65% of CID patients on prednisone (P = .0006 and .0115, respectively). Prevention of neutralization of the virus was similarly reduced in those groups, compared with the controls. Dr. Kim noted this was a small sample size, with about 15 patients. These effects were seen regardless of the dose.
“We would’ve anticipated this would have been dose dependent, so this was a little bit surprising,” Dr. Kim said.
B-cell–depleting therapies, such as rituximab (Rituxan) and ocrelizumab (Ocrevus), reduced antibody titers by 36 times, compared with controls (P < .0001), with a similar reduction in preventing infection (P = .0066), the researchers found. The reduction in antibody titers was the most pronounced among those who had received B-cell–depleting therapies within the previous 6 months. Dr. Kim noted this was a small sample size, with about 10 patients.
CID study subjects taking an antimetabolite, including methotrexate, had an average of a two- to threefold reduction in antibody titers and in neutralization (P = .0006). This reduction was greatest with methotrexate, researchers found (P = .0027).
JAK inhibitors also significantly reduced antibody titers (P = .0066), but the reduction in neutralization of the virus was not significant. In addition, researchers found a reduction in antibody titers, the prevention of viral infection, and circulating plasmablasts among those on tumor necrosis factor (TNF) inhibitors, compared with controls, but these were insignificant statistically except for virus neutralization.
Dr. Kim said he hopes the glucocorticoid data spur physicians to try harder to wean patients off the drugs, when possible, in keeping with recommendations already in place.
“The general culture in rheumatology has been very lax about the need to reduce glucocorticoids,” he said. “This reinvigorates that call.” Questions about possible drug holidays from glucocorticoids remain, regarding how long a holiday would be needed, he said. He noted that many patients on glucocorticoids nonetheless mounted responses.
Those on B-cell–depleting therapies present a “much more difficult” question, he said. Some patients possibly could wait a bit longer than their normal, every-6-month schedule, but it’s an individual decision, he said. Since a booster of influenza vaccine has been found to enhance the response even within the 6-month window among ocrelizumab patients, a booster of COVID-19 vaccine might also help, although this remains to be studied.
The study group has already increased its sample size and is looking at adverse reactions and long-term immune responses, Dr. Kim said.
Encouraging, rather than discouraging, results
Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic in Ohio, said the findings shouldn’t discourage clinicians from encouraging vaccination.
“There’s still a preponderance of people who will develop a robust antibody vaccine response,” he said.
He cautioned that the findings look only at antibodies to the spike protein and at plasmablasts. The reduction in these titers is “of concern,” he said, but “we don’t really know with certainty what are the effects of these drugs, and these data are on the overall biologic protective effect of the vaccine. There’s much more to a vaccine response than anti–spike protein and plasmablasts,” including cell-mediated immune response.
For an individual patient, the findings “mean a lot,” he said.
“I think that people who are on significant prednisone and B-cell–depleting agents, I think you have to share with them that there’s a reasonable chance that you’re not going to be making a response similar to healthy people,” he said. “Thus, even with your vaccine, we’re not going to cut you loose to do things that are violating social distancing and group settings. … Should you be hugging your grandchildren if you’re a rituximab vaccine recipient? I think I would wait until we have a little bit more data.”
Kevin Winthrop, MD, MPH, professor of ophthalmology at Oregon Health & Science University, Portland, where he studies vaccinations in the immunocompromised, said that glucocorticoids tend to have little effect on vaccinations generally at low doses.
When effects are seen they can be difficult to interpret, he said.
“It’s hard to extricate that from the effect of the underlying disease,” he said. The drug can be a proxy for worse disease control.
Although it’s a small study, it’s reassuring that overall the responses were similar to healthy controls.
For B-cell–depleting therapies, his usual guidance is to not give vaccine until a patient is at least 3 months out from their last dose, and not to restart until at least 2 weeks after vaccination.
“It’s not surprising that some of these DMARDs [disease-modifying antirheumatic drugs] do negatively affect vaccine response, particularly B-cell–depletion therapy. We need to do some studies to find a way to overcome that, or optimize delivery of the vaccine.”
Dr. Kim reported participating in consulting, advisory board, or speaker’s bureau for Alexion, Aurinia, Annexon Biosciences, Exagen Diagnostics, and GlaxoSmithKline, and receiving funding under a sponsored research agreement unrelated to the data in the paper from GlaxoSmithKline. Dr. Winthrop reported receiving consulting fees from Pfizer, AbbVie, UCB, Eli Lilly, Galapagos, GlaxoSmithKline, Roche, Gilead, Bristol-Myers Squibb, Regeneron, Sanofi, AstraZeneca, Novartis, and research grants from Bristol-Myers Squibb and Pfizer. Dr. Calabrese reported no relevant disclosures.
Glucocorticoids and B-cell–depleting therapies are trouble spots
Glucocorticoids and B-cell–depleting therapies are trouble spots
Although most patients with chronic inflammatory diseases mounted immune responses after two doses of mRNA-based COVID-19 vaccines, glucocorticoids and B-cell–depleting therapies markedly reduced the response, according to a recently published preprint of a new study.
The study, published on MedRxiv and not yet peer reviewed, involved a prospective look at 133 patients with chronic inflammatory disease (CID) and 53 patients with healthy immune systems at Washington University, St. Louis, and the University of California, San Francisco. It is regarded as the largest and most detailed study yet in how vaccines perform in people with immune-mediated inflammatory disease. The patients were enrolled between December 2020 and March 2021, and the most common diseases were inflammatory bowel disease (32%), rheumatoid arthritis (29%), spondyloarthritis (15%), and systemic lupus erythematosus (11%).
A ‘modest’ reduction in antibody response
Senior author Alfred Kim, MD, PhD, of the department of medicine at Washington University, said the overall results so far are encouraging.
“Most patients with an autoimmune disease that are on immunosuppression can mount antibody responses,” he said. “We’re seeing the majority of our subjects respond.”
The immune-healthy controls and most of the patients with CID had a robust immune response against the spike protein, although the CID group had a mean reduction in antibody titers that was three times lower than the controls (P = .0092). The CID group similarly had a 2.7-fold reduction in preventing neutralization, or halting the virus’ ability to infect (P < .0001), researchers reported.
This reduction in response is “modest,” he said.
“Is the level of reduction going to be detrimental for protection? Time will tell,” he said, adding that researchers anticipate that it won’t have a critical effect on protection because responses tended to be within the range of the immunocompetent controls, who themselves had wildly varied antibody titers across a 20-fold range. “ ‘Optimal’ isn’t necessarily the same as ‘sufficient.’ ”
Type of medication has big impact on antibody titers
But there was a wide variety of effects on the immune response depending on the medication. Glucorticoids resulted in a response that was 10 times lower than the immune-healthy controls, as well as fewer circulating plasmablasts after vaccination. Researchers found that 98% of controls were seropositive for antibody, compared with 92% of those with CID who were not taking prednisone, and 65% of CID patients on prednisone (P = .0006 and .0115, respectively). Prevention of neutralization of the virus was similarly reduced in those groups, compared with the controls. Dr. Kim noted this was a small sample size, with about 15 patients. These effects were seen regardless of the dose.
“We would’ve anticipated this would have been dose dependent, so this was a little bit surprising,” Dr. Kim said.
B-cell–depleting therapies, such as rituximab (Rituxan) and ocrelizumab (Ocrevus), reduced antibody titers by 36 times, compared with controls (P < .0001), with a similar reduction in preventing infection (P = .0066), the researchers found. The reduction in antibody titers was the most pronounced among those who had received B-cell–depleting therapies within the previous 6 months. Dr. Kim noted this was a small sample size, with about 10 patients.
CID study subjects taking an antimetabolite, including methotrexate, had an average of a two- to threefold reduction in antibody titers and in neutralization (P = .0006). This reduction was greatest with methotrexate, researchers found (P = .0027).
JAK inhibitors also significantly reduced antibody titers (P = .0066), but the reduction in neutralization of the virus was not significant. In addition, researchers found a reduction in antibody titers, the prevention of viral infection, and circulating plasmablasts among those on tumor necrosis factor (TNF) inhibitors, compared with controls, but these were insignificant statistically except for virus neutralization.
Dr. Kim said he hopes the glucocorticoid data spur physicians to try harder to wean patients off the drugs, when possible, in keeping with recommendations already in place.
“The general culture in rheumatology has been very lax about the need to reduce glucocorticoids,” he said. “This reinvigorates that call.” Questions about possible drug holidays from glucocorticoids remain, regarding how long a holiday would be needed, he said. He noted that many patients on glucocorticoids nonetheless mounted responses.
Those on B-cell–depleting therapies present a “much more difficult” question, he said. Some patients possibly could wait a bit longer than their normal, every-6-month schedule, but it’s an individual decision, he said. Since a booster of influenza vaccine has been found to enhance the response even within the 6-month window among ocrelizumab patients, a booster of COVID-19 vaccine might also help, although this remains to be studied.
The study group has already increased its sample size and is looking at adverse reactions and long-term immune responses, Dr. Kim said.
Encouraging, rather than discouraging, results
Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic in Ohio, said the findings shouldn’t discourage clinicians from encouraging vaccination.
“There’s still a preponderance of people who will develop a robust antibody vaccine response,” he said.
He cautioned that the findings look only at antibodies to the spike protein and at plasmablasts. The reduction in these titers is “of concern,” he said, but “we don’t really know with certainty what are the effects of these drugs, and these data are on the overall biologic protective effect of the vaccine. There’s much more to a vaccine response than anti–spike protein and plasmablasts,” including cell-mediated immune response.
For an individual patient, the findings “mean a lot,” he said.
“I think that people who are on significant prednisone and B-cell–depleting agents, I think you have to share with them that there’s a reasonable chance that you’re not going to be making a response similar to healthy people,” he said. “Thus, even with your vaccine, we’re not going to cut you loose to do things that are violating social distancing and group settings. … Should you be hugging your grandchildren if you’re a rituximab vaccine recipient? I think I would wait until we have a little bit more data.”
Kevin Winthrop, MD, MPH, professor of ophthalmology at Oregon Health & Science University, Portland, where he studies vaccinations in the immunocompromised, said that glucocorticoids tend to have little effect on vaccinations generally at low doses.
When effects are seen they can be difficult to interpret, he said.
“It’s hard to extricate that from the effect of the underlying disease,” he said. The drug can be a proxy for worse disease control.
Although it’s a small study, it’s reassuring that overall the responses were similar to healthy controls.
For B-cell–depleting therapies, his usual guidance is to not give vaccine until a patient is at least 3 months out from their last dose, and not to restart until at least 2 weeks after vaccination.
“It’s not surprising that some of these DMARDs [disease-modifying antirheumatic drugs] do negatively affect vaccine response, particularly B-cell–depletion therapy. We need to do some studies to find a way to overcome that, or optimize delivery of the vaccine.”
Dr. Kim reported participating in consulting, advisory board, or speaker’s bureau for Alexion, Aurinia, Annexon Biosciences, Exagen Diagnostics, and GlaxoSmithKline, and receiving funding under a sponsored research agreement unrelated to the data in the paper from GlaxoSmithKline. Dr. Winthrop reported receiving consulting fees from Pfizer, AbbVie, UCB, Eli Lilly, Galapagos, GlaxoSmithKline, Roche, Gilead, Bristol-Myers Squibb, Regeneron, Sanofi, AstraZeneca, Novartis, and research grants from Bristol-Myers Squibb and Pfizer. Dr. Calabrese reported no relevant disclosures.
Although most patients with chronic inflammatory diseases mounted immune responses after two doses of mRNA-based COVID-19 vaccines, glucocorticoids and B-cell–depleting therapies markedly reduced the response, according to a recently published preprint of a new study.
The study, published on MedRxiv and not yet peer reviewed, involved a prospective look at 133 patients with chronic inflammatory disease (CID) and 53 patients with healthy immune systems at Washington University, St. Louis, and the University of California, San Francisco. It is regarded as the largest and most detailed study yet in how vaccines perform in people with immune-mediated inflammatory disease. The patients were enrolled between December 2020 and March 2021, and the most common diseases were inflammatory bowel disease (32%), rheumatoid arthritis (29%), spondyloarthritis (15%), and systemic lupus erythematosus (11%).
A ‘modest’ reduction in antibody response
Senior author Alfred Kim, MD, PhD, of the department of medicine at Washington University, said the overall results so far are encouraging.
“Most patients with an autoimmune disease that are on immunosuppression can mount antibody responses,” he said. “We’re seeing the majority of our subjects respond.”
The immune-healthy controls and most of the patients with CID had a robust immune response against the spike protein, although the CID group had a mean reduction in antibody titers that was three times lower than the controls (P = .0092). The CID group similarly had a 2.7-fold reduction in preventing neutralization, or halting the virus’ ability to infect (P < .0001), researchers reported.
This reduction in response is “modest,” he said.
“Is the level of reduction going to be detrimental for protection? Time will tell,” he said, adding that researchers anticipate that it won’t have a critical effect on protection because responses tended to be within the range of the immunocompetent controls, who themselves had wildly varied antibody titers across a 20-fold range. “ ‘Optimal’ isn’t necessarily the same as ‘sufficient.’ ”
Type of medication has big impact on antibody titers
But there was a wide variety of effects on the immune response depending on the medication. Glucorticoids resulted in a response that was 10 times lower than the immune-healthy controls, as well as fewer circulating plasmablasts after vaccination. Researchers found that 98% of controls were seropositive for antibody, compared with 92% of those with CID who were not taking prednisone, and 65% of CID patients on prednisone (P = .0006 and .0115, respectively). Prevention of neutralization of the virus was similarly reduced in those groups, compared with the controls. Dr. Kim noted this was a small sample size, with about 15 patients. These effects were seen regardless of the dose.
“We would’ve anticipated this would have been dose dependent, so this was a little bit surprising,” Dr. Kim said.
B-cell–depleting therapies, such as rituximab (Rituxan) and ocrelizumab (Ocrevus), reduced antibody titers by 36 times, compared with controls (P < .0001), with a similar reduction in preventing infection (P = .0066), the researchers found. The reduction in antibody titers was the most pronounced among those who had received B-cell–depleting therapies within the previous 6 months. Dr. Kim noted this was a small sample size, with about 10 patients.
CID study subjects taking an antimetabolite, including methotrexate, had an average of a two- to threefold reduction in antibody titers and in neutralization (P = .0006). This reduction was greatest with methotrexate, researchers found (P = .0027).
JAK inhibitors also significantly reduced antibody titers (P = .0066), but the reduction in neutralization of the virus was not significant. In addition, researchers found a reduction in antibody titers, the prevention of viral infection, and circulating plasmablasts among those on tumor necrosis factor (TNF) inhibitors, compared with controls, but these were insignificant statistically except for virus neutralization.
Dr. Kim said he hopes the glucocorticoid data spur physicians to try harder to wean patients off the drugs, when possible, in keeping with recommendations already in place.
“The general culture in rheumatology has been very lax about the need to reduce glucocorticoids,” he said. “This reinvigorates that call.” Questions about possible drug holidays from glucocorticoids remain, regarding how long a holiday would be needed, he said. He noted that many patients on glucocorticoids nonetheless mounted responses.
Those on B-cell–depleting therapies present a “much more difficult” question, he said. Some patients possibly could wait a bit longer than their normal, every-6-month schedule, but it’s an individual decision, he said. Since a booster of influenza vaccine has been found to enhance the response even within the 6-month window among ocrelizumab patients, a booster of COVID-19 vaccine might also help, although this remains to be studied.
The study group has already increased its sample size and is looking at adverse reactions and long-term immune responses, Dr. Kim said.
Encouraging, rather than discouraging, results
Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic in Ohio, said the findings shouldn’t discourage clinicians from encouraging vaccination.
“There’s still a preponderance of people who will develop a robust antibody vaccine response,” he said.
He cautioned that the findings look only at antibodies to the spike protein and at plasmablasts. The reduction in these titers is “of concern,” he said, but “we don’t really know with certainty what are the effects of these drugs, and these data are on the overall biologic protective effect of the vaccine. There’s much more to a vaccine response than anti–spike protein and plasmablasts,” including cell-mediated immune response.
For an individual patient, the findings “mean a lot,” he said.
“I think that people who are on significant prednisone and B-cell–depleting agents, I think you have to share with them that there’s a reasonable chance that you’re not going to be making a response similar to healthy people,” he said. “Thus, even with your vaccine, we’re not going to cut you loose to do things that are violating social distancing and group settings. … Should you be hugging your grandchildren if you’re a rituximab vaccine recipient? I think I would wait until we have a little bit more data.”
Kevin Winthrop, MD, MPH, professor of ophthalmology at Oregon Health & Science University, Portland, where he studies vaccinations in the immunocompromised, said that glucocorticoids tend to have little effect on vaccinations generally at low doses.
When effects are seen they can be difficult to interpret, he said.
“It’s hard to extricate that from the effect of the underlying disease,” he said. The drug can be a proxy for worse disease control.
Although it’s a small study, it’s reassuring that overall the responses were similar to healthy controls.
For B-cell–depleting therapies, his usual guidance is to not give vaccine until a patient is at least 3 months out from their last dose, and not to restart until at least 2 weeks after vaccination.
“It’s not surprising that some of these DMARDs [disease-modifying antirheumatic drugs] do negatively affect vaccine response, particularly B-cell–depletion therapy. We need to do some studies to find a way to overcome that, or optimize delivery of the vaccine.”
Dr. Kim reported participating in consulting, advisory board, or speaker’s bureau for Alexion, Aurinia, Annexon Biosciences, Exagen Diagnostics, and GlaxoSmithKline, and receiving funding under a sponsored research agreement unrelated to the data in the paper from GlaxoSmithKline. Dr. Winthrop reported receiving consulting fees from Pfizer, AbbVie, UCB, Eli Lilly, Galapagos, GlaxoSmithKline, Roche, Gilead, Bristol-Myers Squibb, Regeneron, Sanofi, AstraZeneca, Novartis, and research grants from Bristol-Myers Squibb and Pfizer. Dr. Calabrese reported no relevant disclosures.
FROM MEDRXIV