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AAD unveils new guidelines for actinic keratosis management
. They also conditionally recommend the use of photodynamic therapy (PDT) and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.
Those are two of 18 recommendations made by 14 members of the multidisciplinary work group that convened to assemble the AAD’s first-ever guidelines on the management of AKs, which were published online April 2 in the Journal of the American Academy of Dermatology. The group, cochaired by Daniel B. Eisen, MD, professor of clinical dermatology at the University of California, Davis, and Todd E. Schlesinger, MD, medical director of the Dermatology and Laser Center of Charleston, S.C., conducted a systematic review to address five clinical questions on the management of AKs in adults. The questions were: What are the efficacy, effectiveness, and adverse effects of surgical and chemical peel treatments for AK; of topically applied agents for AK; of energy devices and other miscellaneous treatments for AK; and of combination therapy for the treatment of AK? And what are the special considerations to be taken into account when treating AK in immunocompromised individuals?
Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
“As a participant in the work group, I was impressed by the level of care and detail and the involvement of relevant stakeholders, including a patient advocate, as well as having the draft guidelines go out to the AAD membership at large, and evaluating every comment that came in,” Maryam Asgari, MD, MPH, professor of dermatology at Harvard University, Boston, said in an interview. “The academy sought stakeholder and leadership input in revising and revamping the guidelines. The AAD also made sure the work group had minimal conflicts of interest by requiring that the majority of experts convened did not have relevant financial conflicts of interest. That might not be the case in a publication such as a systematic review, where no threshold for financial conflict of interest for coauthorship is set.”
Of the 18 recommendations the work group made for patients with AKs, only four were ranked as “strong” based on the evidence reviewed, while the rest were ranked as “conditional.”
The strong recommendations include the use of UV protection, field treatment with 5-FU, field treatment with imiquimod, and the use of cryosurgery.
The first four conditional recommendations for patients with AKs include the use of diclofenac, treatment with cryosurgery over CO2 laser ablation, aminolevulinic acid (ALA)–red-light PDT, and 1- to 4-hour 5-ALA incubation time to enhance complete clearance with red-light PDT. The work group also conditionally recommends ALA-daylight PDT as less painful than but equally effective as ALA–red-light PDT.
In the clinical experience of Catherine M. DiGiorgio, MD, who was not involved in the guidelines, daylight PDT with ALA is a viable, cost-effective option. “Patients can come into the office, apply the ALA and then they go outside for 2 hours – not in direct sunlight but in a shady area,” Dr. DiGiorgio, a dermatologist who practices at the Boston Center for Facial Rejuvenation, said in an interview. “That’s a cost-effective treatment for patients who perhaps can’t afford some of the chemotherapy creams. I don’t think we’ve adopted ALA-daylight PDT here in the U.S. very much.”
The work group noted that topical 1% tirbanibulin ointment, a novel microtubule inhibitor, was approved for treatment of AKs on the face and scalp by the Food and Drug Administration after the guidelines had been put together.
Several trials of combination therapy were included in the review of evidence, prompting several recommendations. For example, the work group conditionally recommends combined 5-FU cream and cryosurgery over cryosurgery alone, based on moderate-quality evidence and conditionally recommends combined imiquimod and cryosurgery over cryosurgery alone based on low-quality evidence. In addition, the work group conditionally recommends against the use of 3% diclofenac in addition to cryosurgery, favoring cryosurgery alone based on low-quality evidence, and conditionally recommends against the use of imiquimod typically after ALA–blue-light PDT, based on moderate-quality data.
“The additional treatment with imiquimod was thought to add both expense and burden to the patient, which negates much of the perceived convenience of using PDT as a stand-alone treatment modality and which is not mitigated by the modest increase in lesion reduction,” the authors wrote.
The guidelines emphasize the importance of shared decision-making between patients and clinicians on the choice of therapy, a point that resonates with Dr. DiGiorgio. Success of a treatment can depend on whether a patient is willing to go through with it, she said. “Some patients don’t want to do a therapeutic topical like 5-FU. They prefer to come in and have cryotherapy done. Others prefer to not come in and have the cream at home and treat themselves.”
Assembling the guidelines exposed certain gaps in research, according to the work group. Of the 18 recommendations, seven were based on low-quality evidence, and there were not enough data to make guidelines for the treatment of AKs in immunocompromised individuals.
“I can’t tell you the number of times we in the committee sat back and said, ‘we need to have a randomized trial that looks at this, or compares this to that head on,’” Dr. Asgari said. Such limitations “give researchers direction for where the areas of study need to go to help us answer some of these management conundrums.”
She added that the new guidelines “give clinicians a leg to stand on” when an insurer pushes back on a recommended treatment for AK. “It gives you a way to have dialogue with insurers if you’re prescribing some of these treatments.”
The guidelines authors write that there is “strong theoretic rationale for the treatment of AK to prevent skin cancers” but acknowledge that only a few studies in the review “report the incidence of skin cancer as an outcome measure or have sufficient follow-up to viably measure carcinoma development.” In addition, “more long-term research is needed to validate our current understanding of skin cancer progression from AKs to keratinocyte carcinoma.”
Dr. DiGiorgio thinks about this differently. “I think treatment of AKs does prevent skin cancers,” she said. “We call them precancers as we’re treating our patients because we know a certain percentage of them can develop into skin cancers over time.”
The study was funded by internal funds from the AAD. Dr. Asgari disclosed that she serves as an investigator for Pfizer. Several of the other authors reported having financial disclosures.
Dr. DiGiorgio reported having no financial disclosures.
. They also conditionally recommend the use of photodynamic therapy (PDT) and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.
Those are two of 18 recommendations made by 14 members of the multidisciplinary work group that convened to assemble the AAD’s first-ever guidelines on the management of AKs, which were published online April 2 in the Journal of the American Academy of Dermatology. The group, cochaired by Daniel B. Eisen, MD, professor of clinical dermatology at the University of California, Davis, and Todd E. Schlesinger, MD, medical director of the Dermatology and Laser Center of Charleston, S.C., conducted a systematic review to address five clinical questions on the management of AKs in adults. The questions were: What are the efficacy, effectiveness, and adverse effects of surgical and chemical peel treatments for AK; of topically applied agents for AK; of energy devices and other miscellaneous treatments for AK; and of combination therapy for the treatment of AK? And what are the special considerations to be taken into account when treating AK in immunocompromised individuals?
Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
“As a participant in the work group, I was impressed by the level of care and detail and the involvement of relevant stakeholders, including a patient advocate, as well as having the draft guidelines go out to the AAD membership at large, and evaluating every comment that came in,” Maryam Asgari, MD, MPH, professor of dermatology at Harvard University, Boston, said in an interview. “The academy sought stakeholder and leadership input in revising and revamping the guidelines. The AAD also made sure the work group had minimal conflicts of interest by requiring that the majority of experts convened did not have relevant financial conflicts of interest. That might not be the case in a publication such as a systematic review, where no threshold for financial conflict of interest for coauthorship is set.”
Of the 18 recommendations the work group made for patients with AKs, only four were ranked as “strong” based on the evidence reviewed, while the rest were ranked as “conditional.”
The strong recommendations include the use of UV protection, field treatment with 5-FU, field treatment with imiquimod, and the use of cryosurgery.
The first four conditional recommendations for patients with AKs include the use of diclofenac, treatment with cryosurgery over CO2 laser ablation, aminolevulinic acid (ALA)–red-light PDT, and 1- to 4-hour 5-ALA incubation time to enhance complete clearance with red-light PDT. The work group also conditionally recommends ALA-daylight PDT as less painful than but equally effective as ALA–red-light PDT.
In the clinical experience of Catherine M. DiGiorgio, MD, who was not involved in the guidelines, daylight PDT with ALA is a viable, cost-effective option. “Patients can come into the office, apply the ALA and then they go outside for 2 hours – not in direct sunlight but in a shady area,” Dr. DiGiorgio, a dermatologist who practices at the Boston Center for Facial Rejuvenation, said in an interview. “That’s a cost-effective treatment for patients who perhaps can’t afford some of the chemotherapy creams. I don’t think we’ve adopted ALA-daylight PDT here in the U.S. very much.”
The work group noted that topical 1% tirbanibulin ointment, a novel microtubule inhibitor, was approved for treatment of AKs on the face and scalp by the Food and Drug Administration after the guidelines had been put together.
Several trials of combination therapy were included in the review of evidence, prompting several recommendations. For example, the work group conditionally recommends combined 5-FU cream and cryosurgery over cryosurgery alone, based on moderate-quality evidence and conditionally recommends combined imiquimod and cryosurgery over cryosurgery alone based on low-quality evidence. In addition, the work group conditionally recommends against the use of 3% diclofenac in addition to cryosurgery, favoring cryosurgery alone based on low-quality evidence, and conditionally recommends against the use of imiquimod typically after ALA–blue-light PDT, based on moderate-quality data.
“The additional treatment with imiquimod was thought to add both expense and burden to the patient, which negates much of the perceived convenience of using PDT as a stand-alone treatment modality and which is not mitigated by the modest increase in lesion reduction,” the authors wrote.
The guidelines emphasize the importance of shared decision-making between patients and clinicians on the choice of therapy, a point that resonates with Dr. DiGiorgio. Success of a treatment can depend on whether a patient is willing to go through with it, she said. “Some patients don’t want to do a therapeutic topical like 5-FU. They prefer to come in and have cryotherapy done. Others prefer to not come in and have the cream at home and treat themselves.”
Assembling the guidelines exposed certain gaps in research, according to the work group. Of the 18 recommendations, seven were based on low-quality evidence, and there were not enough data to make guidelines for the treatment of AKs in immunocompromised individuals.
“I can’t tell you the number of times we in the committee sat back and said, ‘we need to have a randomized trial that looks at this, or compares this to that head on,’” Dr. Asgari said. Such limitations “give researchers direction for where the areas of study need to go to help us answer some of these management conundrums.”
She added that the new guidelines “give clinicians a leg to stand on” when an insurer pushes back on a recommended treatment for AK. “It gives you a way to have dialogue with insurers if you’re prescribing some of these treatments.”
The guidelines authors write that there is “strong theoretic rationale for the treatment of AK to prevent skin cancers” but acknowledge that only a few studies in the review “report the incidence of skin cancer as an outcome measure or have sufficient follow-up to viably measure carcinoma development.” In addition, “more long-term research is needed to validate our current understanding of skin cancer progression from AKs to keratinocyte carcinoma.”
Dr. DiGiorgio thinks about this differently. “I think treatment of AKs does prevent skin cancers,” she said. “We call them precancers as we’re treating our patients because we know a certain percentage of them can develop into skin cancers over time.”
The study was funded by internal funds from the AAD. Dr. Asgari disclosed that she serves as an investigator for Pfizer. Several of the other authors reported having financial disclosures.
Dr. DiGiorgio reported having no financial disclosures.
. They also conditionally recommend the use of photodynamic therapy (PDT) and diclofenac for the treatment of AK, both individually and as part of combination therapy regimens.
Those are two of 18 recommendations made by 14 members of the multidisciplinary work group that convened to assemble the AAD’s first-ever guidelines on the management of AKs, which were published online April 2 in the Journal of the American Academy of Dermatology. The group, cochaired by Daniel B. Eisen, MD, professor of clinical dermatology at the University of California, Davis, and Todd E. Schlesinger, MD, medical director of the Dermatology and Laser Center of Charleston, S.C., conducted a systematic review to address five clinical questions on the management of AKs in adults. The questions were: What are the efficacy, effectiveness, and adverse effects of surgical and chemical peel treatments for AK; of topically applied agents for AK; of energy devices and other miscellaneous treatments for AK; and of combination therapy for the treatment of AK? And what are the special considerations to be taken into account when treating AK in immunocompromised individuals?
Next, the work group applied the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing the certainty of the evidence and formulating and grading clinical recommendations based on relevant randomized trials in the medical literature.
“As a participant in the work group, I was impressed by the level of care and detail and the involvement of relevant stakeholders, including a patient advocate, as well as having the draft guidelines go out to the AAD membership at large, and evaluating every comment that came in,” Maryam Asgari, MD, MPH, professor of dermatology at Harvard University, Boston, said in an interview. “The academy sought stakeholder and leadership input in revising and revamping the guidelines. The AAD also made sure the work group had minimal conflicts of interest by requiring that the majority of experts convened did not have relevant financial conflicts of interest. That might not be the case in a publication such as a systematic review, where no threshold for financial conflict of interest for coauthorship is set.”
Of the 18 recommendations the work group made for patients with AKs, only four were ranked as “strong” based on the evidence reviewed, while the rest were ranked as “conditional.”
The strong recommendations include the use of UV protection, field treatment with 5-FU, field treatment with imiquimod, and the use of cryosurgery.
The first four conditional recommendations for patients with AKs include the use of diclofenac, treatment with cryosurgery over CO2 laser ablation, aminolevulinic acid (ALA)–red-light PDT, and 1- to 4-hour 5-ALA incubation time to enhance complete clearance with red-light PDT. The work group also conditionally recommends ALA-daylight PDT as less painful than but equally effective as ALA–red-light PDT.
In the clinical experience of Catherine M. DiGiorgio, MD, who was not involved in the guidelines, daylight PDT with ALA is a viable, cost-effective option. “Patients can come into the office, apply the ALA and then they go outside for 2 hours – not in direct sunlight but in a shady area,” Dr. DiGiorgio, a dermatologist who practices at the Boston Center for Facial Rejuvenation, said in an interview. “That’s a cost-effective treatment for patients who perhaps can’t afford some of the chemotherapy creams. I don’t think we’ve adopted ALA-daylight PDT here in the U.S. very much.”
The work group noted that topical 1% tirbanibulin ointment, a novel microtubule inhibitor, was approved for treatment of AKs on the face and scalp by the Food and Drug Administration after the guidelines had been put together.
Several trials of combination therapy were included in the review of evidence, prompting several recommendations. For example, the work group conditionally recommends combined 5-FU cream and cryosurgery over cryosurgery alone, based on moderate-quality evidence and conditionally recommends combined imiquimod and cryosurgery over cryosurgery alone based on low-quality evidence. In addition, the work group conditionally recommends against the use of 3% diclofenac in addition to cryosurgery, favoring cryosurgery alone based on low-quality evidence, and conditionally recommends against the use of imiquimod typically after ALA–blue-light PDT, based on moderate-quality data.
“The additional treatment with imiquimod was thought to add both expense and burden to the patient, which negates much of the perceived convenience of using PDT as a stand-alone treatment modality and which is not mitigated by the modest increase in lesion reduction,” the authors wrote.
The guidelines emphasize the importance of shared decision-making between patients and clinicians on the choice of therapy, a point that resonates with Dr. DiGiorgio. Success of a treatment can depend on whether a patient is willing to go through with it, she said. “Some patients don’t want to do a therapeutic topical like 5-FU. They prefer to come in and have cryotherapy done. Others prefer to not come in and have the cream at home and treat themselves.”
Assembling the guidelines exposed certain gaps in research, according to the work group. Of the 18 recommendations, seven were based on low-quality evidence, and there were not enough data to make guidelines for the treatment of AKs in immunocompromised individuals.
“I can’t tell you the number of times we in the committee sat back and said, ‘we need to have a randomized trial that looks at this, or compares this to that head on,’” Dr. Asgari said. Such limitations “give researchers direction for where the areas of study need to go to help us answer some of these management conundrums.”
She added that the new guidelines “give clinicians a leg to stand on” when an insurer pushes back on a recommended treatment for AK. “It gives you a way to have dialogue with insurers if you’re prescribing some of these treatments.”
The guidelines authors write that there is “strong theoretic rationale for the treatment of AK to prevent skin cancers” but acknowledge that only a few studies in the review “report the incidence of skin cancer as an outcome measure or have sufficient follow-up to viably measure carcinoma development.” In addition, “more long-term research is needed to validate our current understanding of skin cancer progression from AKs to keratinocyte carcinoma.”
Dr. DiGiorgio thinks about this differently. “I think treatment of AKs does prevent skin cancers,” she said. “We call them precancers as we’re treating our patients because we know a certain percentage of them can develop into skin cancers over time.”
The study was funded by internal funds from the AAD. Dr. Asgari disclosed that she serves as an investigator for Pfizer. Several of the other authors reported having financial disclosures.
Dr. DiGiorgio reported having no financial disclosures.
FROM JAAD
Atopic dermatitis genes vary with ethnicity
patients, researchers say.
The finding moves researchers another step forward in the effort to figure out which patients are most at risk for the disease and who will respond best to which treatments.
“Because atopic dermatitis is considered a complex trait, we think if there is any method to detect AD gene variations simultaneously, it could be possible to prevent the development of AD and then the atopic march,” said Eung Ho Choi, MD, PhD, a dermatology professor at Yonsei University, Wonju, South Korea.
He presented the finding at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting.
Atopic dermatitis is not caused by a single genetic mutation. But genetic factors play an important role, with about 75% concordance between monozygotic twins versus only 23% for dizygotic twins.
“Genetic biomarkers are needed in predicting the occurrence, severity, and treatment response,” as well as determining the prognosis of atopic dermatitis “and applying it to precision medicine,” Dr. Choi said.
Researchers have identified multiple genetic variations related to atopic dermatitis. One of the most significant genetic contributions found so far is the filaggrin gene variation, which can produce a defective skin barrier, Dr. Choi said. Others are involved in the immune response.
Although variations in the filaggrin gene (FLG ) are the most reliable genetic predictor of atopic dermatitis in Korean patients, they are less common in Korean patients than in Northwestern Europeans, Chinese, and Japanese patients. In Korean patients, the most common reported mutations of this gene are 3321delA and K4022X, Dr. Choi said.
To find out what other gene variants are important in Korean patients with atopic dermatitis, Dr. Choi and his colleagues developed the reverse blot hybridization assay (REBA) to detect skin barrier variations in the FLG, SPINK5 and KLK7 genes, and genes involved in immune response variations, KDR, IL-5RA, IL-9, DEFB1 (Defensin Beta 1), IL-12RB1 (interleukin-12 receptor subunit beta 1), and IL-12RB2.
They compared the prevalence of these variations in 279 Koreans with atopic dermatitis to the prevalence in 224 healthy people without atopic dermatitis and found that the odds ratio for atopic dermatitis increased with the number of these variants: People with three or four variants had a 3.75 times greater risk of AD, and those with 5 or more variants had a 10.3 times greater risk. The number of variants did not correlate to the severity of the disease, however.
The filaggrin variation was present in 13.9% of those with atopic dermatitis. About a quarter (28%) of the patients with AD who had this variation had impetigo, 15% had eczema herpeticum, and 5% had prurigo nodularis. By comparison, 14% of the patients with AD who did not have this variation had impetigo, and 5% had eczema herpeticum, but 19% had prurigo nodularis.
In a separate study, Dr. Choi and his colleagues identified a mutation in IL-17RA, present in 8.1% of 332 patients with AD compared with 3.3% of 245 controls. The patients with IL-17RA mutations all had extrinsic AD.
The variation was associated with longer disease duration, more frequent keratosis pilaris, higher blood eosinophil counts, higher serum total immunoglobulin E (IgE) levels, higher house dust mite allergen-specific IgE levels, and a greater need for systemic treatment than patients without the IL-17RA mutation.
Such findings are important for progress in treating atopic dermatitis because the mechanism differs among patients, said Emma Guttman-Yassky, MD, PhD, director of the Center for Excellence in Eczema and professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York.
“It’s not one size fits all in atopic dermatitis, and we need better biomarkers that will be able to tell us which treatment will work best for each patient,” she said in an interview.
In addition to genetic biomarkers, she and her colleagues are analyzing proteins involved in inflammation. They are using adhesive tape strips to harvest these markers, a less invasive approach than skin biopsies.
A version of this article first appeared on Medscape.com.
patients, researchers say.
The finding moves researchers another step forward in the effort to figure out which patients are most at risk for the disease and who will respond best to which treatments.
“Because atopic dermatitis is considered a complex trait, we think if there is any method to detect AD gene variations simultaneously, it could be possible to prevent the development of AD and then the atopic march,” said Eung Ho Choi, MD, PhD, a dermatology professor at Yonsei University, Wonju, South Korea.
He presented the finding at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting.
Atopic dermatitis is not caused by a single genetic mutation. But genetic factors play an important role, with about 75% concordance between monozygotic twins versus only 23% for dizygotic twins.
“Genetic biomarkers are needed in predicting the occurrence, severity, and treatment response,” as well as determining the prognosis of atopic dermatitis “and applying it to precision medicine,” Dr. Choi said.
Researchers have identified multiple genetic variations related to atopic dermatitis. One of the most significant genetic contributions found so far is the filaggrin gene variation, which can produce a defective skin barrier, Dr. Choi said. Others are involved in the immune response.
Although variations in the filaggrin gene (FLG ) are the most reliable genetic predictor of atopic dermatitis in Korean patients, they are less common in Korean patients than in Northwestern Europeans, Chinese, and Japanese patients. In Korean patients, the most common reported mutations of this gene are 3321delA and K4022X, Dr. Choi said.
To find out what other gene variants are important in Korean patients with atopic dermatitis, Dr. Choi and his colleagues developed the reverse blot hybridization assay (REBA) to detect skin barrier variations in the FLG, SPINK5 and KLK7 genes, and genes involved in immune response variations, KDR, IL-5RA, IL-9, DEFB1 (Defensin Beta 1), IL-12RB1 (interleukin-12 receptor subunit beta 1), and IL-12RB2.
They compared the prevalence of these variations in 279 Koreans with atopic dermatitis to the prevalence in 224 healthy people without atopic dermatitis and found that the odds ratio for atopic dermatitis increased with the number of these variants: People with three or four variants had a 3.75 times greater risk of AD, and those with 5 or more variants had a 10.3 times greater risk. The number of variants did not correlate to the severity of the disease, however.
The filaggrin variation was present in 13.9% of those with atopic dermatitis. About a quarter (28%) of the patients with AD who had this variation had impetigo, 15% had eczema herpeticum, and 5% had prurigo nodularis. By comparison, 14% of the patients with AD who did not have this variation had impetigo, and 5% had eczema herpeticum, but 19% had prurigo nodularis.
In a separate study, Dr. Choi and his colleagues identified a mutation in IL-17RA, present in 8.1% of 332 patients with AD compared with 3.3% of 245 controls. The patients with IL-17RA mutations all had extrinsic AD.
The variation was associated with longer disease duration, more frequent keratosis pilaris, higher blood eosinophil counts, higher serum total immunoglobulin E (IgE) levels, higher house dust mite allergen-specific IgE levels, and a greater need for systemic treatment than patients without the IL-17RA mutation.
Such findings are important for progress in treating atopic dermatitis because the mechanism differs among patients, said Emma Guttman-Yassky, MD, PhD, director of the Center for Excellence in Eczema and professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York.
“It’s not one size fits all in atopic dermatitis, and we need better biomarkers that will be able to tell us which treatment will work best for each patient,” she said in an interview.
In addition to genetic biomarkers, she and her colleagues are analyzing proteins involved in inflammation. They are using adhesive tape strips to harvest these markers, a less invasive approach than skin biopsies.
A version of this article first appeared on Medscape.com.
patients, researchers say.
The finding moves researchers another step forward in the effort to figure out which patients are most at risk for the disease and who will respond best to which treatments.
“Because atopic dermatitis is considered a complex trait, we think if there is any method to detect AD gene variations simultaneously, it could be possible to prevent the development of AD and then the atopic march,” said Eung Ho Choi, MD, PhD, a dermatology professor at Yonsei University, Wonju, South Korea.
He presented the finding at the International Society of Atopic Dermatitis (ISAD) 2021 Annual Meeting.
Atopic dermatitis is not caused by a single genetic mutation. But genetic factors play an important role, with about 75% concordance between monozygotic twins versus only 23% for dizygotic twins.
“Genetic biomarkers are needed in predicting the occurrence, severity, and treatment response,” as well as determining the prognosis of atopic dermatitis “and applying it to precision medicine,” Dr. Choi said.
Researchers have identified multiple genetic variations related to atopic dermatitis. One of the most significant genetic contributions found so far is the filaggrin gene variation, which can produce a defective skin barrier, Dr. Choi said. Others are involved in the immune response.
Although variations in the filaggrin gene (FLG ) are the most reliable genetic predictor of atopic dermatitis in Korean patients, they are less common in Korean patients than in Northwestern Europeans, Chinese, and Japanese patients. In Korean patients, the most common reported mutations of this gene are 3321delA and K4022X, Dr. Choi said.
To find out what other gene variants are important in Korean patients with atopic dermatitis, Dr. Choi and his colleagues developed the reverse blot hybridization assay (REBA) to detect skin barrier variations in the FLG, SPINK5 and KLK7 genes, and genes involved in immune response variations, KDR, IL-5RA, IL-9, DEFB1 (Defensin Beta 1), IL-12RB1 (interleukin-12 receptor subunit beta 1), and IL-12RB2.
They compared the prevalence of these variations in 279 Koreans with atopic dermatitis to the prevalence in 224 healthy people without atopic dermatitis and found that the odds ratio for atopic dermatitis increased with the number of these variants: People with three or four variants had a 3.75 times greater risk of AD, and those with 5 or more variants had a 10.3 times greater risk. The number of variants did not correlate to the severity of the disease, however.
The filaggrin variation was present in 13.9% of those with atopic dermatitis. About a quarter (28%) of the patients with AD who had this variation had impetigo, 15% had eczema herpeticum, and 5% had prurigo nodularis. By comparison, 14% of the patients with AD who did not have this variation had impetigo, and 5% had eczema herpeticum, but 19% had prurigo nodularis.
In a separate study, Dr. Choi and his colleagues identified a mutation in IL-17RA, present in 8.1% of 332 patients with AD compared with 3.3% of 245 controls. The patients with IL-17RA mutations all had extrinsic AD.
The variation was associated with longer disease duration, more frequent keratosis pilaris, higher blood eosinophil counts, higher serum total immunoglobulin E (IgE) levels, higher house dust mite allergen-specific IgE levels, and a greater need for systemic treatment than patients without the IL-17RA mutation.
Such findings are important for progress in treating atopic dermatitis because the mechanism differs among patients, said Emma Guttman-Yassky, MD, PhD, director of the Center for Excellence in Eczema and professor and chair of dermatology at the Icahn School of Medicine at Mount Sinai, New York.
“It’s not one size fits all in atopic dermatitis, and we need better biomarkers that will be able to tell us which treatment will work best for each patient,” she said in an interview.
In addition to genetic biomarkers, she and her colleagues are analyzing proteins involved in inflammation. They are using adhesive tape strips to harvest these markers, a less invasive approach than skin biopsies.
A version of this article first appeared on Medscape.com.
Checkpoint inhibitor skin side effects more common in women
of 235 patients at Dana Farber Cancer Center, Boston.
Overall, 62.4% of the 93 women in the review and 48.6% of the 142 men experienced confirmed skin reactions, for an odds ratio (OR) of 2.11 for women compared with men (P = .01).
“Clinicians should consider these results in counseling female patients regarding an elevated risk of dermatologic adverse events” when taking checkpoint inhibitors, said investigators led by Harvard University medical student Jordan Said, who presented the results at the American Academy of Dermatology Virtual Meeting Experience.
Autoimmune-like adverse events are common with checkpoint inhibitors. Dermatologic side effects occur in about half of people receiving monotherapy and more than that among patients receiving combination therapy.
Skin reactions can include psoriasiform dermatitis, lichenoid reactions, vitiligo, and bullous pemphigoid and may require hospitalization and prolonged steroid treatment.
Not much is known about risk factors for these reactions. A higher incidence among women has been previously reported. A 2019 study found a higher risk for pneumonitis and endocrinopathy, including hypophysitis, among women who underwent treatment for non–small cell lung cancer or metastatic melanoma.
The 2019 study found that the risk was higher among premenopausal women than postmenopausal women, which led some to suggest that estrogen may play a role.
The results of the Dana Farber review argue against that notion. In their review, the investigators found that the risk was similarly elevated among the 27 premenopausal women (OR, 1.97; P = .40) and the 66 postmenopausal women (OR, 2.17, P = .05). In the study, women who were aged 52 years or older at the start of treatment were considered to be postmenopausal.
“This suggests that factors beyond sex hormones are likely contributory” to the difference in risk between men and women. It’s known that women are at higher risk for autoimmune disease overall, which might be related to the increased odds of autoimmune-like reactions, and it may be that sex-related differences in innate and adoptive immunity are at work, Mr. Said noted.
When asked for comment, Douglas Johnson, MD, assistant professor of hematology/oncology at Vanderbilt University, Nashville, Tenn., said that although some studies have reported a greater risk for side effects among women, others have not. “Additional research is needed to determine the interactions between sex and effects of immune checkpoint inhibitors, as well as many other possible triggers of immune-related adverse events,” he said.
“Continued work in this area will be so important to help determine how to best counsel women and to ensure early recognition and intervention for dermatologic side effects,” said Bernice Kwong, MD, director of the Supportive Dermato-Oncology Program at Stanford (Calif.) University.
The patients in the review were treated from 2011 to 2016 and underwent at least monthly evaluations by their medical teams. They were taking either nivolumab, pembrolizumab, or ipilimumab or a nivolumab/ipilimumab combination.
The median age of the men in the study was 65 years; the median age of women was 60 years. Almost 98% of the participants were White. The majority received one to three infusions, most commonly with pembrolizumab monotherapy.
No funding for the study was reported. Mr. Said has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
of 235 patients at Dana Farber Cancer Center, Boston.
Overall, 62.4% of the 93 women in the review and 48.6% of the 142 men experienced confirmed skin reactions, for an odds ratio (OR) of 2.11 for women compared with men (P = .01).
“Clinicians should consider these results in counseling female patients regarding an elevated risk of dermatologic adverse events” when taking checkpoint inhibitors, said investigators led by Harvard University medical student Jordan Said, who presented the results at the American Academy of Dermatology Virtual Meeting Experience.
Autoimmune-like adverse events are common with checkpoint inhibitors. Dermatologic side effects occur in about half of people receiving monotherapy and more than that among patients receiving combination therapy.
Skin reactions can include psoriasiform dermatitis, lichenoid reactions, vitiligo, and bullous pemphigoid and may require hospitalization and prolonged steroid treatment.
Not much is known about risk factors for these reactions. A higher incidence among women has been previously reported. A 2019 study found a higher risk for pneumonitis and endocrinopathy, including hypophysitis, among women who underwent treatment for non–small cell lung cancer or metastatic melanoma.
The 2019 study found that the risk was higher among premenopausal women than postmenopausal women, which led some to suggest that estrogen may play a role.
The results of the Dana Farber review argue against that notion. In their review, the investigators found that the risk was similarly elevated among the 27 premenopausal women (OR, 1.97; P = .40) and the 66 postmenopausal women (OR, 2.17, P = .05). In the study, women who were aged 52 years or older at the start of treatment were considered to be postmenopausal.
“This suggests that factors beyond sex hormones are likely contributory” to the difference in risk between men and women. It’s known that women are at higher risk for autoimmune disease overall, which might be related to the increased odds of autoimmune-like reactions, and it may be that sex-related differences in innate and adoptive immunity are at work, Mr. Said noted.
When asked for comment, Douglas Johnson, MD, assistant professor of hematology/oncology at Vanderbilt University, Nashville, Tenn., said that although some studies have reported a greater risk for side effects among women, others have not. “Additional research is needed to determine the interactions between sex and effects of immune checkpoint inhibitors, as well as many other possible triggers of immune-related adverse events,” he said.
“Continued work in this area will be so important to help determine how to best counsel women and to ensure early recognition and intervention for dermatologic side effects,” said Bernice Kwong, MD, director of the Supportive Dermato-Oncology Program at Stanford (Calif.) University.
The patients in the review were treated from 2011 to 2016 and underwent at least monthly evaluations by their medical teams. They were taking either nivolumab, pembrolizumab, or ipilimumab or a nivolumab/ipilimumab combination.
The median age of the men in the study was 65 years; the median age of women was 60 years. Almost 98% of the participants were White. The majority received one to three infusions, most commonly with pembrolizumab monotherapy.
No funding for the study was reported. Mr. Said has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
of 235 patients at Dana Farber Cancer Center, Boston.
Overall, 62.4% of the 93 women in the review and 48.6% of the 142 men experienced confirmed skin reactions, for an odds ratio (OR) of 2.11 for women compared with men (P = .01).
“Clinicians should consider these results in counseling female patients regarding an elevated risk of dermatologic adverse events” when taking checkpoint inhibitors, said investigators led by Harvard University medical student Jordan Said, who presented the results at the American Academy of Dermatology Virtual Meeting Experience.
Autoimmune-like adverse events are common with checkpoint inhibitors. Dermatologic side effects occur in about half of people receiving monotherapy and more than that among patients receiving combination therapy.
Skin reactions can include psoriasiform dermatitis, lichenoid reactions, vitiligo, and bullous pemphigoid and may require hospitalization and prolonged steroid treatment.
Not much is known about risk factors for these reactions. A higher incidence among women has been previously reported. A 2019 study found a higher risk for pneumonitis and endocrinopathy, including hypophysitis, among women who underwent treatment for non–small cell lung cancer or metastatic melanoma.
The 2019 study found that the risk was higher among premenopausal women than postmenopausal women, which led some to suggest that estrogen may play a role.
The results of the Dana Farber review argue against that notion. In their review, the investigators found that the risk was similarly elevated among the 27 premenopausal women (OR, 1.97; P = .40) and the 66 postmenopausal women (OR, 2.17, P = .05). In the study, women who were aged 52 years or older at the start of treatment were considered to be postmenopausal.
“This suggests that factors beyond sex hormones are likely contributory” to the difference in risk between men and women. It’s known that women are at higher risk for autoimmune disease overall, which might be related to the increased odds of autoimmune-like reactions, and it may be that sex-related differences in innate and adoptive immunity are at work, Mr. Said noted.
When asked for comment, Douglas Johnson, MD, assistant professor of hematology/oncology at Vanderbilt University, Nashville, Tenn., said that although some studies have reported a greater risk for side effects among women, others have not. “Additional research is needed to determine the interactions between sex and effects of immune checkpoint inhibitors, as well as many other possible triggers of immune-related adverse events,” he said.
“Continued work in this area will be so important to help determine how to best counsel women and to ensure early recognition and intervention for dermatologic side effects,” said Bernice Kwong, MD, director of the Supportive Dermato-Oncology Program at Stanford (Calif.) University.
The patients in the review were treated from 2011 to 2016 and underwent at least monthly evaluations by their medical teams. They were taking either nivolumab, pembrolizumab, or ipilimumab or a nivolumab/ipilimumab combination.
The median age of the men in the study was 65 years; the median age of women was 60 years. Almost 98% of the participants were White. The majority received one to three infusions, most commonly with pembrolizumab monotherapy.
No funding for the study was reported. Mr. Said has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Brown plaque on the arm
Due to its size, 2 shave biopsies targeting the most concerning portions of the lesion were performed; the results were consistent with a lichenoid keratosis (LK), also known as lichen planus-like keratosis.
LK is a benign solitary lesion that mimics basal cell carcinoma, squamous cell carcinoma, and superficial spreading or amelanotic melanoma.1 One theory suggests that LK is a solar lentigo or actinic keratosis undergoing attack from the immune system. Lesions most often manifest as a pink, gray, or brown macule to thin papule on the trunk or extremities. Itching or mild pain may be present. Dermoscopy can help distinguish an LK from malignancy but overlapping features of fine dark regression structures (called peppering, as seen in this case) should prompt further evaluation.
LKs are great mimics and biopsy is key to distinguishing them from cancer. In this case, shave biopsies were performed in the thickest and most characteristic portions of the lesion. Punch or incisional biopsies also would have been appropriate, but any result would have been a partial result. If the result had come back as an atypical melanocytic lesion, a complete excision would have been necessary to make sure the pathology reflected the entirety of the lesion.
Armed with the knowledge that the LK was benign, the patient in this case was scheduled for a follow-up visit for cryotherapy to remove the residual lesion.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Maor D, Ondhia C, Yu LL, et al. Lichenoid keratosis is frequently misdiagnosed as basal cell carcinoma. Clin Exp Dermatol. 2017;42:663-666. doi: 10.1111/ced.13178
Due to its size, 2 shave biopsies targeting the most concerning portions of the lesion were performed; the results were consistent with a lichenoid keratosis (LK), also known as lichen planus-like keratosis.
LK is a benign solitary lesion that mimics basal cell carcinoma, squamous cell carcinoma, and superficial spreading or amelanotic melanoma.1 One theory suggests that LK is a solar lentigo or actinic keratosis undergoing attack from the immune system. Lesions most often manifest as a pink, gray, or brown macule to thin papule on the trunk or extremities. Itching or mild pain may be present. Dermoscopy can help distinguish an LK from malignancy but overlapping features of fine dark regression structures (called peppering, as seen in this case) should prompt further evaluation.
LKs are great mimics and biopsy is key to distinguishing them from cancer. In this case, shave biopsies were performed in the thickest and most characteristic portions of the lesion. Punch or incisional biopsies also would have been appropriate, but any result would have been a partial result. If the result had come back as an atypical melanocytic lesion, a complete excision would have been necessary to make sure the pathology reflected the entirety of the lesion.
Armed with the knowledge that the LK was benign, the patient in this case was scheduled for a follow-up visit for cryotherapy to remove the residual lesion.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
Due to its size, 2 shave biopsies targeting the most concerning portions of the lesion were performed; the results were consistent with a lichenoid keratosis (LK), also known as lichen planus-like keratosis.
LK is a benign solitary lesion that mimics basal cell carcinoma, squamous cell carcinoma, and superficial spreading or amelanotic melanoma.1 One theory suggests that LK is a solar lentigo or actinic keratosis undergoing attack from the immune system. Lesions most often manifest as a pink, gray, or brown macule to thin papule on the trunk or extremities. Itching or mild pain may be present. Dermoscopy can help distinguish an LK from malignancy but overlapping features of fine dark regression structures (called peppering, as seen in this case) should prompt further evaluation.
LKs are great mimics and biopsy is key to distinguishing them from cancer. In this case, shave biopsies were performed in the thickest and most characteristic portions of the lesion. Punch or incisional biopsies also would have been appropriate, but any result would have been a partial result. If the result had come back as an atypical melanocytic lesion, a complete excision would have been necessary to make sure the pathology reflected the entirety of the lesion.
Armed with the knowledge that the LK was benign, the patient in this case was scheduled for a follow-up visit for cryotherapy to remove the residual lesion.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Maor D, Ondhia C, Yu LL, et al. Lichenoid keratosis is frequently misdiagnosed as basal cell carcinoma. Clin Exp Dermatol. 2017;42:663-666. doi: 10.1111/ced.13178
1. Maor D, Ondhia C, Yu LL, et al. Lichenoid keratosis is frequently misdiagnosed as basal cell carcinoma. Clin Exp Dermatol. 2017;42:663-666. doi: 10.1111/ced.13178
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