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Zoster vaccination does not appear to increase flare risk in patients with immune-mediated inflammatory disease
, according to research published in Arthritis & Rheumatology.
The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.
The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.
They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.
Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.
Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.
Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.
“Anytime you are vaccinating a patient with an autoimmune disease, especially one on a biologic, you always worry about the risk of flares,” said Dr. Bose. “Any time you tamper with the immune system, there is a risk of flares.”
The study serves as a clarification for the primary care setting, said Dr. Bose. “A lot of the time, the shingles vaccine is administered not by rheumatology but by primary care or through the pharmacy,” she said. “This study puts them [primary care physicians] at ease.”
Findings from the study reflect that most RZV vaccinations were administered in pharmacies.
One of the weaknesses of the study is that the investigators did not include patients younger than 50 years old, said Dr. Bose. “It would have been nice if they could have looked at younger patients,” she said. “We try to vaccinate all our [immunocompromised] adult patients, even the younger ones, because they are also at risk for shingles.”
Given that there are increasing options of medical therapies in rheumatology that are immunomodulatory, the subject of vaccination for patients is often one of discussion, added Dr. Bose.
Arthur Kavanaugh, MD, professor of medicine, University of California San Diego (UCSD), La Jolla, Calif., and director of the Center for Innovative Therapy in the UCSD Division of Rheumatology, Allergy, and Immunology, told this news organization that a strength of the study is its large numbers of patients but noted the shortcoming of using claims data. “Claims data has inherent limitations, such as the lack of detailed granular data on the patients,” wrote Dr. Kavanaugh, who was not involved with the study. He described this investigation as “really about the first evidence that I am aware of addressing this issue.”
No funding source was listed. One author disclosed having received research grants and consulting fees received from Pfizer and GSK for unrelated work; the other authors had no disclosures. Dr. Bose and Dr. Kavanaugh had no relevant disclosures.
, according to research published in Arthritis & Rheumatology.
The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.
The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.
They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.
Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.
Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.
Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.
“Anytime you are vaccinating a patient with an autoimmune disease, especially one on a biologic, you always worry about the risk of flares,” said Dr. Bose. “Any time you tamper with the immune system, there is a risk of flares.”
The study serves as a clarification for the primary care setting, said Dr. Bose. “A lot of the time, the shingles vaccine is administered not by rheumatology but by primary care or through the pharmacy,” she said. “This study puts them [primary care physicians] at ease.”
Findings from the study reflect that most RZV vaccinations were administered in pharmacies.
One of the weaknesses of the study is that the investigators did not include patients younger than 50 years old, said Dr. Bose. “It would have been nice if they could have looked at younger patients,” she said. “We try to vaccinate all our [immunocompromised] adult patients, even the younger ones, because they are also at risk for shingles.”
Given that there are increasing options of medical therapies in rheumatology that are immunomodulatory, the subject of vaccination for patients is often one of discussion, added Dr. Bose.
Arthur Kavanaugh, MD, professor of medicine, University of California San Diego (UCSD), La Jolla, Calif., and director of the Center for Innovative Therapy in the UCSD Division of Rheumatology, Allergy, and Immunology, told this news organization that a strength of the study is its large numbers of patients but noted the shortcoming of using claims data. “Claims data has inherent limitations, such as the lack of detailed granular data on the patients,” wrote Dr. Kavanaugh, who was not involved with the study. He described this investigation as “really about the first evidence that I am aware of addressing this issue.”
No funding source was listed. One author disclosed having received research grants and consulting fees received from Pfizer and GSK for unrelated work; the other authors had no disclosures. Dr. Bose and Dr. Kavanaugh had no relevant disclosures.
, according to research published in Arthritis & Rheumatology.
The authors of the study noted that individuals with IMIDs are at increased risk for herpes zoster and related complications, including postherpetic neuralgia, and that vaccination has been recommended for certain groups of patients with rheumatoid arthritis, inflammatory bowel disease, and psoriasis, by the American College of Rheumatology and other professional organizations for individuals aged 50 and older.
The study investigators used medical claims from IBM MarketScan, which provided data on patients aged 50-64 years, and data from the Centers for Medicare and Medicaid Services’ Medicare on patients aged 65 and older.
They defined presumed flares in three ways: hospitalization/emergency department visits for IMIDs, steroid treatment with a short-acting oral glucocorticoid, or treatment with a parenteral glucocorticoid injection. The investigators conducted a self-controlled case series (SCCS) analysis to examine any temporal link between the RZV and disease flares.
Among enrollees with IMIDs, 14.8% of the 55,654 patients in the MarketScan database and 43.2% of the 160,545 patients in the Medicare database received at least one dose of RZV during 2018-2019. The two-dose series completion within 6 months was 76.6% in the MarketScan group (age range, 50-64 years) and 85.4% among Medicare enrollees (age range, 65 years and older). In the SCCS analysis, 10% and 13% of patients developed flares in the control group as compared to 9%, and 11%-12% in the risk window following one or two doses of RZV among MarketScan and Medicare enrollees, respectively.
Based on these findings, the investigators concluded there was no statistically significant increase in flares subsequent to RZV administration for any IMID in either patients aged 50-64 years or patients aged 65 years and older following the first dose or second dose.
Nilanjana Bose, MD, a rheumatologist with Lonestar Rheumatology, Houston, Texas, who was not involved with the study, said that the research addresses a topic where there is uneasiness, namely vaccination in patients with IMIDs.
“Anytime you are vaccinating a patient with an autoimmune disease, especially one on a biologic, you always worry about the risk of flares,” said Dr. Bose. “Any time you tamper with the immune system, there is a risk of flares.”
The study serves as a clarification for the primary care setting, said Dr. Bose. “A lot of the time, the shingles vaccine is administered not by rheumatology but by primary care or through the pharmacy,” she said. “This study puts them [primary care physicians] at ease.”
Findings from the study reflect that most RZV vaccinations were administered in pharmacies.
One of the weaknesses of the study is that the investigators did not include patients younger than 50 years old, said Dr. Bose. “It would have been nice if they could have looked at younger patients,” she said. “We try to vaccinate all our [immunocompromised] adult patients, even the younger ones, because they are also at risk for shingles.”
Given that there are increasing options of medical therapies in rheumatology that are immunomodulatory, the subject of vaccination for patients is often one of discussion, added Dr. Bose.
Arthur Kavanaugh, MD, professor of medicine, University of California San Diego (UCSD), La Jolla, Calif., and director of the Center for Innovative Therapy in the UCSD Division of Rheumatology, Allergy, and Immunology, told this news organization that a strength of the study is its large numbers of patients but noted the shortcoming of using claims data. “Claims data has inherent limitations, such as the lack of detailed granular data on the patients,” wrote Dr. Kavanaugh, who was not involved with the study. He described this investigation as “really about the first evidence that I am aware of addressing this issue.”
No funding source was listed. One author disclosed having received research grants and consulting fees received from Pfizer and GSK for unrelated work; the other authors had no disclosures. Dr. Bose and Dr. Kavanaugh had no relevant disclosures.
Large study reaffirms rare risk of TNF inhibitor–induced psoriasis in patients with RA, IBD
according to a new study published in JAMA Dermatology.
Despite this finding, the authors of the large Danish nationwide cohort study noted that TNFi-induced psoriasis is still a rare adverse event. “Practitioners and patients should be aware and observant of the potential for TNFi-associated psoriasis during TNFi treatment but keep in mind that the absolute risk appears to be low,” David Thein, MB, of the department of dermatology at Bispebjerg Hospital, University of Copenhagen, and colleagues wrote in the study.
They analyzed 109,085 patients with RA and IBD enrolled in Danish national registries between 1995 and 2018 without a previous diagnosis of psoriasis, who received either TNFi (20,910 patients) or conventional treatments (108,024 patients) and were followed for 5 years. They were a mean of 50 years old when they started treatment, 62% were women, with 87.8% of patients in the TNFi group receiving prior conventional therapy and 1% of patients in the conventional therapy group receiving prior TNFi treatment.
The investigators assessed the risk of developing any psoriasis, nonpustular psoriasis, and pustular psoriasis in the two groups using ICD-10 codes as well as a record of two consecutive prescriptions for topical vitamin D analogs.
Overall, 1,471 patients (1.4%) developed psoriasis of any type; 1,332 had non-pustular psoriasis, 127 had palmoplantar pustulosis, and 12 had generalized pustulosis.
The incidence rate of developing any psoriasis was 3.0 per 1,000 patient-years (95% confidence interval, 2.9-3.2) for patients receiving conventional therapy and 7.8 per 1,000 patient-years (95% CI, 7.5-8.9) for patients receiving TNFi treatment. Compared with conventional treatment, the risk of developing nonpustular psoriasis was twofold higher among patients receiving TNFi treatment (hazard ratio, 2.12; 95% CI, 1.87-2.40; P < .001). The risk of developing pustular psoriasis was more than sixfold higher among those on a TNFi (HR, 6.50; 95% CI, 4.60-9.23; P < .001).
Dr. Thein and colleagues estimated that the exposure needed to harm 1 additional patient was 241 patient-years for any psoriasis type, 342 patient-years for nonpustular psoriasis, and 909 patient-years for pustular psoriasis, with an estimated absolute risk difference of 5 per 1,000 patient-years.
Best evidence to date on risk
Asked to comment on the study findings, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, said that he applauded the researchers for performing this well-designed study to determine the risk of TNF inhibitor–induced psoriasis in patients with RA and IBD.
The strengths of the study include excluding patients with a history of psoriasis to rule out disease recurrence and having a large comparator group of patients with IBD and RA who were taking medications other than TNF inhibitors, while one limitation was the potential accuracy of the ICD-10 codes used as the basis for diagnosing psoriasis. “It’s probably closer to the truth of what the true risk is compared to studies done in the past,” he said in an interview.
Dr. Fernandez noted that the results aren’t likely to change how dermatologists, rheumatologists, or gastroenterologists practice, but the message to stay the course in initially treating TNFi-induced psoriasis also holds value. “We don’t need to change anything in our clinical practice when it comes to TNF-alpha inhibitors.”
For patients with RA or IBD who develop TNFi-induced psoriasis with disease that is well controlled with TNFi treatment, keeping them on that treatment is a priority, Dr. Fernandez explained. “The first and foremost goal is, if the TNF inhibitor is working very well to control the disease that it was prescribed for, then you exhaust your efforts to try to control the psoriasis and allow those patients to stay on the TNF inhibitor.”
In his experience, most patients with RA and IBD who develop TNFi-induced psoriasis are controlled with topical medications. Switching to another TNFi is not recommended, he noted, as patients are “likely to have that reaction with any TNF inhibitor.”
However, Dr. Fernandez said that won’t be an option for all patients with RA and IBD. “In some patients you do simply have to stop the TNF inhibitor” and try an alternative treatment with a different mechanism of action.
The cause of TNFi-induced psoriasis is still not well understood. “There certainly is evidence to support that interferon alpha production by plasmacytoid dendritic cells is playing some role in this phenomenon,” but there is “more to the story” and unanswered questions remain, Dr. Fernandez said.
What’s most interesting about this phenomenon, he added, is that “patients can develop it at any time when exposed to a TNF inhibitor.” For instance, most patients develop drug reactions within 2-3 weeks of starting a treatment, but TNFi-induced psoriasis can appear after a single dose or several years after initiating treatment.
“Why so few patients, and why is there such variability in terms of how long they’re on the TNF inhibitor before the reaction occurs?” he asked. “That really points to ... some other trigger besides exposure to the TNF inhibitor needed for the initiation of this reaction.”
He noted that it would be valuable to identify triggers – or the most likely triggers – which would be challenging, but could “potentially impact clinical practice.”
The authors reported personal and institutional relationships in the form of personal and institutional research grants, honoraria, personal fees, investigator fees paid to university, consultancies, and speaker’s bureau positions for a variety of pharmaceutical companies, data companies, hospitals, and foundations. Dr. Fernandez reported he has nonbranded speaking, consulting, and research relationships with AbbVie and Novartis; and is a consultant for UCB, Bristol-Myers Squibb, and Boehringer Ingelheim on related products.
according to a new study published in JAMA Dermatology.
Despite this finding, the authors of the large Danish nationwide cohort study noted that TNFi-induced psoriasis is still a rare adverse event. “Practitioners and patients should be aware and observant of the potential for TNFi-associated psoriasis during TNFi treatment but keep in mind that the absolute risk appears to be low,” David Thein, MB, of the department of dermatology at Bispebjerg Hospital, University of Copenhagen, and colleagues wrote in the study.
They analyzed 109,085 patients with RA and IBD enrolled in Danish national registries between 1995 and 2018 without a previous diagnosis of psoriasis, who received either TNFi (20,910 patients) or conventional treatments (108,024 patients) and were followed for 5 years. They were a mean of 50 years old when they started treatment, 62% were women, with 87.8% of patients in the TNFi group receiving prior conventional therapy and 1% of patients in the conventional therapy group receiving prior TNFi treatment.
The investigators assessed the risk of developing any psoriasis, nonpustular psoriasis, and pustular psoriasis in the two groups using ICD-10 codes as well as a record of two consecutive prescriptions for topical vitamin D analogs.
Overall, 1,471 patients (1.4%) developed psoriasis of any type; 1,332 had non-pustular psoriasis, 127 had palmoplantar pustulosis, and 12 had generalized pustulosis.
The incidence rate of developing any psoriasis was 3.0 per 1,000 patient-years (95% confidence interval, 2.9-3.2) for patients receiving conventional therapy and 7.8 per 1,000 patient-years (95% CI, 7.5-8.9) for patients receiving TNFi treatment. Compared with conventional treatment, the risk of developing nonpustular psoriasis was twofold higher among patients receiving TNFi treatment (hazard ratio, 2.12; 95% CI, 1.87-2.40; P < .001). The risk of developing pustular psoriasis was more than sixfold higher among those on a TNFi (HR, 6.50; 95% CI, 4.60-9.23; P < .001).
Dr. Thein and colleagues estimated that the exposure needed to harm 1 additional patient was 241 patient-years for any psoriasis type, 342 patient-years for nonpustular psoriasis, and 909 patient-years for pustular psoriasis, with an estimated absolute risk difference of 5 per 1,000 patient-years.
Best evidence to date on risk
Asked to comment on the study findings, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, said that he applauded the researchers for performing this well-designed study to determine the risk of TNF inhibitor–induced psoriasis in patients with RA and IBD.
The strengths of the study include excluding patients with a history of psoriasis to rule out disease recurrence and having a large comparator group of patients with IBD and RA who were taking medications other than TNF inhibitors, while one limitation was the potential accuracy of the ICD-10 codes used as the basis for diagnosing psoriasis. “It’s probably closer to the truth of what the true risk is compared to studies done in the past,” he said in an interview.
Dr. Fernandez noted that the results aren’t likely to change how dermatologists, rheumatologists, or gastroenterologists practice, but the message to stay the course in initially treating TNFi-induced psoriasis also holds value. “We don’t need to change anything in our clinical practice when it comes to TNF-alpha inhibitors.”
For patients with RA or IBD who develop TNFi-induced psoriasis with disease that is well controlled with TNFi treatment, keeping them on that treatment is a priority, Dr. Fernandez explained. “The first and foremost goal is, if the TNF inhibitor is working very well to control the disease that it was prescribed for, then you exhaust your efforts to try to control the psoriasis and allow those patients to stay on the TNF inhibitor.”
In his experience, most patients with RA and IBD who develop TNFi-induced psoriasis are controlled with topical medications. Switching to another TNFi is not recommended, he noted, as patients are “likely to have that reaction with any TNF inhibitor.”
However, Dr. Fernandez said that won’t be an option for all patients with RA and IBD. “In some patients you do simply have to stop the TNF inhibitor” and try an alternative treatment with a different mechanism of action.
The cause of TNFi-induced psoriasis is still not well understood. “There certainly is evidence to support that interferon alpha production by plasmacytoid dendritic cells is playing some role in this phenomenon,” but there is “more to the story” and unanswered questions remain, Dr. Fernandez said.
What’s most interesting about this phenomenon, he added, is that “patients can develop it at any time when exposed to a TNF inhibitor.” For instance, most patients develop drug reactions within 2-3 weeks of starting a treatment, but TNFi-induced psoriasis can appear after a single dose or several years after initiating treatment.
“Why so few patients, and why is there such variability in terms of how long they’re on the TNF inhibitor before the reaction occurs?” he asked. “That really points to ... some other trigger besides exposure to the TNF inhibitor needed for the initiation of this reaction.”
He noted that it would be valuable to identify triggers – or the most likely triggers – which would be challenging, but could “potentially impact clinical practice.”
The authors reported personal and institutional relationships in the form of personal and institutional research grants, honoraria, personal fees, investigator fees paid to university, consultancies, and speaker’s bureau positions for a variety of pharmaceutical companies, data companies, hospitals, and foundations. Dr. Fernandez reported he has nonbranded speaking, consulting, and research relationships with AbbVie and Novartis; and is a consultant for UCB, Bristol-Myers Squibb, and Boehringer Ingelheim on related products.
according to a new study published in JAMA Dermatology.
Despite this finding, the authors of the large Danish nationwide cohort study noted that TNFi-induced psoriasis is still a rare adverse event. “Practitioners and patients should be aware and observant of the potential for TNFi-associated psoriasis during TNFi treatment but keep in mind that the absolute risk appears to be low,” David Thein, MB, of the department of dermatology at Bispebjerg Hospital, University of Copenhagen, and colleagues wrote in the study.
They analyzed 109,085 patients with RA and IBD enrolled in Danish national registries between 1995 and 2018 without a previous diagnosis of psoriasis, who received either TNFi (20,910 patients) or conventional treatments (108,024 patients) and were followed for 5 years. They were a mean of 50 years old when they started treatment, 62% were women, with 87.8% of patients in the TNFi group receiving prior conventional therapy and 1% of patients in the conventional therapy group receiving prior TNFi treatment.
The investigators assessed the risk of developing any psoriasis, nonpustular psoriasis, and pustular psoriasis in the two groups using ICD-10 codes as well as a record of two consecutive prescriptions for topical vitamin D analogs.
Overall, 1,471 patients (1.4%) developed psoriasis of any type; 1,332 had non-pustular psoriasis, 127 had palmoplantar pustulosis, and 12 had generalized pustulosis.
The incidence rate of developing any psoriasis was 3.0 per 1,000 patient-years (95% confidence interval, 2.9-3.2) for patients receiving conventional therapy and 7.8 per 1,000 patient-years (95% CI, 7.5-8.9) for patients receiving TNFi treatment. Compared with conventional treatment, the risk of developing nonpustular psoriasis was twofold higher among patients receiving TNFi treatment (hazard ratio, 2.12; 95% CI, 1.87-2.40; P < .001). The risk of developing pustular psoriasis was more than sixfold higher among those on a TNFi (HR, 6.50; 95% CI, 4.60-9.23; P < .001).
Dr. Thein and colleagues estimated that the exposure needed to harm 1 additional patient was 241 patient-years for any psoriasis type, 342 patient-years for nonpustular psoriasis, and 909 patient-years for pustular psoriasis, with an estimated absolute risk difference of 5 per 1,000 patient-years.
Best evidence to date on risk
Asked to comment on the study findings, Anthony Fernandez, MD, PhD, director of medical dermatology at the Cleveland Clinic, said that he applauded the researchers for performing this well-designed study to determine the risk of TNF inhibitor–induced psoriasis in patients with RA and IBD.
The strengths of the study include excluding patients with a history of psoriasis to rule out disease recurrence and having a large comparator group of patients with IBD and RA who were taking medications other than TNF inhibitors, while one limitation was the potential accuracy of the ICD-10 codes used as the basis for diagnosing psoriasis. “It’s probably closer to the truth of what the true risk is compared to studies done in the past,” he said in an interview.
Dr. Fernandez noted that the results aren’t likely to change how dermatologists, rheumatologists, or gastroenterologists practice, but the message to stay the course in initially treating TNFi-induced psoriasis also holds value. “We don’t need to change anything in our clinical practice when it comes to TNF-alpha inhibitors.”
For patients with RA or IBD who develop TNFi-induced psoriasis with disease that is well controlled with TNFi treatment, keeping them on that treatment is a priority, Dr. Fernandez explained. “The first and foremost goal is, if the TNF inhibitor is working very well to control the disease that it was prescribed for, then you exhaust your efforts to try to control the psoriasis and allow those patients to stay on the TNF inhibitor.”
In his experience, most patients with RA and IBD who develop TNFi-induced psoriasis are controlled with topical medications. Switching to another TNFi is not recommended, he noted, as patients are “likely to have that reaction with any TNF inhibitor.”
However, Dr. Fernandez said that won’t be an option for all patients with RA and IBD. “In some patients you do simply have to stop the TNF inhibitor” and try an alternative treatment with a different mechanism of action.
The cause of TNFi-induced psoriasis is still not well understood. “There certainly is evidence to support that interferon alpha production by plasmacytoid dendritic cells is playing some role in this phenomenon,” but there is “more to the story” and unanswered questions remain, Dr. Fernandez said.
What’s most interesting about this phenomenon, he added, is that “patients can develop it at any time when exposed to a TNF inhibitor.” For instance, most patients develop drug reactions within 2-3 weeks of starting a treatment, but TNFi-induced psoriasis can appear after a single dose or several years after initiating treatment.
“Why so few patients, and why is there such variability in terms of how long they’re on the TNF inhibitor before the reaction occurs?” he asked. “That really points to ... some other trigger besides exposure to the TNF inhibitor needed for the initiation of this reaction.”
He noted that it would be valuable to identify triggers – or the most likely triggers – which would be challenging, but could “potentially impact clinical practice.”
The authors reported personal and institutional relationships in the form of personal and institutional research grants, honoraria, personal fees, investigator fees paid to university, consultancies, and speaker’s bureau positions for a variety of pharmaceutical companies, data companies, hospitals, and foundations. Dr. Fernandez reported he has nonbranded speaking, consulting, and research relationships with AbbVie and Novartis; and is a consultant for UCB, Bristol-Myers Squibb, and Boehringer Ingelheim on related products.
FROM JAMA DERMATOLOGY
Compulsivity contributes to poor outcomes in body-focused repetitive behaviors
Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.
In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.
Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.
“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.
The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.
However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.
The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.
Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.
In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.
Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.
“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.
The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.
However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.
The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.
Although body-focused repetitive behaviors (BFRBs), specifically trichotillomania and skin-picking disorder, are similar in clinical presentation to aspects of obsessive-compulsive disorder (OCD), the role of compulsivity in TTM and SPD has not been well studied, wrote Jon E. Grant, MD, of the University of Chicago and colleagues.
In a study published in the Journal of Psychiatric Research, the authors recruited 69 women and 22 men who met DSM-5 criteria for TTM and SPD. Participants completed diagnostic interviews, symptom inventories, and measures of disability/functioning. Compulsivity was measured using the 15-item Cambridge-Chicago Compulsivity Trait Scale (CHI-T). The average age of the participants was 30.9 years; 48 had TTM, 37 had SPD, and 2 had both conditions.
Overall, total CHI-T scores were significantly correlated with worse disability and quality of life, based on the Quality of Life Inventory (P = .0278) and the Sheehan Disability Scale (P = .0085) but not with severity of TTM or SPD symptoms. TTM and SPD symptoms were assessed using the Massachusetts General Hospital Hair Pulling Scale and the Skin Picking Symptom Symptom Assessment Scale.
“In the current study, we did not find a link between conventional symptom severity measures for BFRBs and disability or quality of life, whereas trans-diagnostic compulsivity did correlate with these clinically important parameters,” the researchers wrote in their discussion. “These findings might suggest the current symptom measures for BFRBs are not including an important aspect of the disease and that a fuller understanding of these symptoms requires measurement of compulsivity. Including validated measures of compulsivity in clinical trials of therapy or medication would also seem to be important for future work,” they said.
The study findings were limited by several factors including the use of a community sample that may not generalize to a clinical setting, the researchers noted. Other limitations include the cross-sectional design, which prevents conclusions about causality, the lack of a control group, and the relatively small sample size, they said.
However, the study is the first known to use a validated compulsivity measure to assess BFRBs, and the results suggest a clinically relevant impact of compulsivity on both psychosocial dysfunction and poor quality of life in this patient population, with possible implications for treatment, the researchers wrote.
The study received no outside funding. Lead author Dr. Grant disclosed research grants from Otsuka and Biohaven Pharmaceuticals, yearly compensation from Springer Publishing for acting as editor in chief of the Journal of Gambling Studies, and royalties from Oxford University Press, American Psychiatric Publishing, Norton Press, and McGraw Hill.
FROM THE JOURNAL OF PSYCHIATRIC RESEARCH
U.K. survey: Dermatologists want training in prescribing antipsychotics for delusional infestation
GLASGOW – that also indicated there is a clear demand for training in prescribing these drugs.
Delusional infestation is a rare disorder characterized by an individual’s belief that his or her skin, body, or immediate environment is infested by small, living pathogens, despite a lack of any medical evidence. Most of these patients require antipsychotic medication to alleviate symptoms.
The survey of almost 80 dermatologists found that almost 90% had not prescribed antipsychotics in the previous month for patients with psychodermatology conditions and that the most common barrier to prescribing was lack of experience with the drugs.
This was reflected in only 10% of survey respondents who said they were “happy to” prescribe antipsychotics without consulting either dermatology or psychiatric colleagues, and less than half having attended a related course.
Yet the research, presented at the annual meeting of the British Association of Dermatologists, indicated that more than 75% of respondents would attend such a course to increase their confidence.
This finding, said study presenter Ling Li, MD, Churchill Hospital, Oxford (England) University Hospitals NHS Foundation Trust, shows that there is a “clear demand for training, particularly among all the registrars [residents] who we surveyed.”
Dr. Li noted that the UK’s Joint Royal Colleges of Physicians Training Board’s latest curriculum for dermatology training highlights psychocutaneous medicine as a key area, and “that will include antipsychotic medication.”
The BAD also recently published guidelines for the management of adults with delusional infestation, which includes a recommendation to conduct a survey on attitudes toward antipsychotic prescribing for the condition among U.K. dermatologists.
Heeding that call, Dr. Li and colleagues sent an email containing a 10-question online survey to members of the BAD and the British Society for Medical Dermatology. Questions covered familiarity with antipsychotics and frequency of prescribing, confidence around antipsychotics, and current training and future needs. Responses were received between February through April 2021.
Among the 79 respondents, 51 (65%) were consultants and 20 (25%) were dermatology registrars, with the remainder dermatology clinical fellows, foundation doctors, or other doctors. A total of 31 respondents had an average of more than 50 visits with patients per week, 18 had an average of 41-50 patient visits, and 13 had an average of 31-40 visits per week; the remainder had an average of 11-30 visits per week.
Most of the respondents (39) said they had seen 2-5 patients with psychodermatology conditions in the last 6 months, while 17 said they had seen 1 patient, 13 said they had seen more than 10 patients, and 6 said they had seen 6-10 patients (4 had seen none and 1 could not remember).
The most commonly prescribed antipsychotics for psychodermatology patients in the past 6 months were risperidone (Risperdal; prescribed by five respondents), followed by olanzapine (Zyprexa; by four respondents). Seventy respondents had not prescribed any antipsychotics.
Asked about how confident they felt about prescribing antipsychotic medication for patients with delusional infestation, 8 (10%) said they were happy to prescribe independently, while 42 (54%) said they were not at all confident. Another 10 (13%) respondents said they would be happy to prescribe the medications after liaising with a dermatology colleague, while 17 (22%) said they would prefer to consult with the psychiatry team.
The most common barrier to prescribing antipsychotic medications was a lack of experience with the drugs, cited by 66 respondents, followed by concerns over drug monitoring, cited by 43 respondents.
In addition, 42 respondents highlighted concerns over adverse effects, 36 cited lack of experience in psychodermatology clinics, and 19 cited lack of experience in discussing psychodermatologic conditions with patients. Other barriers mentioned by the respondents included difficulties with patient acceptance of a psychiatric medication prescribed by a dermatologist.
An audience member went further, saying that clinicians have been told not to “confront” such patients and that the temptation is therefore to cloak the discussion of antipsychotics in nonthreatening language so that it is more acceptable to the patient.
However, under the U.K. system, a letter with the results of the consultation, including information that an antipsychotic has been prescribed, must be sent to the patient’s family doctor along with a copy that goes to the patient. “The situation is almost impossible,” the audience member said, adding that there “must be some arrangement where in certain circumstances dermatologists could be allowed not to write to the patient” or alternatively, “write an entirely different letter” to the family doctor.
Session cochair Susannah Baron, MD, a consultant dermatologist at St. John’s Institute of Dermatology, Guy’s and St. Thomas’ Hospital, London, said that, in these situations, it is “really helpful to talk about doses” with patients.
She explained that she uses the analogy of aspirin, which has different effects depending on the dose given, giving pain relief at high doses but primarily an antiplatelet effect at low doses.
In the case of an antipsychotic, it is helpful to explain to the patient that “you don’t think they’re psychotic, and you’re prescribing it in a very low dose, because what it can do is help with their symptoms,” Dr. Baron added. “You have to be very open because if you’re not, they go to the pharmacy, and the pharmacist says: ‘Why are you on an antipsychotic?’ ”
Further results from the survey revealed that 56 (71%) respondents did not have access to a specialist psychodermatology clinic, whereas 36 (46%) had not yet attended a psychodermatology course.
Despite these responses, 60 (77%) respondents said they would be interested in attending a training course for prescribing antipsychotics, which included all 20 of the registrars who took part in the survey. a psychodermatologist at Frimley Health Foundation Trust, Windsor, England, and lead author of the BAD guidelines, commented from the audience that the survey results were “sort of what we expected.”
She explained that the intention of the authors when developing the guidelines “was to be able to help our junior colleagues and our peers to be able to feel competent to discuss antipsychotics with patients with delusional infestation and also initiate management.”
Dr. Ahmed added: “Why we’re encouraging our colleagues to prescribe antipsychotics is the longer you leave this type of psychotic illness untreated, the worse the prognosis.”
No funding or relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
GLASGOW – that also indicated there is a clear demand for training in prescribing these drugs.
Delusional infestation is a rare disorder characterized by an individual’s belief that his or her skin, body, or immediate environment is infested by small, living pathogens, despite a lack of any medical evidence. Most of these patients require antipsychotic medication to alleviate symptoms.
The survey of almost 80 dermatologists found that almost 90% had not prescribed antipsychotics in the previous month for patients with psychodermatology conditions and that the most common barrier to prescribing was lack of experience with the drugs.
This was reflected in only 10% of survey respondents who said they were “happy to” prescribe antipsychotics without consulting either dermatology or psychiatric colleagues, and less than half having attended a related course.
Yet the research, presented at the annual meeting of the British Association of Dermatologists, indicated that more than 75% of respondents would attend such a course to increase their confidence.
This finding, said study presenter Ling Li, MD, Churchill Hospital, Oxford (England) University Hospitals NHS Foundation Trust, shows that there is a “clear demand for training, particularly among all the registrars [residents] who we surveyed.”
Dr. Li noted that the UK’s Joint Royal Colleges of Physicians Training Board’s latest curriculum for dermatology training highlights psychocutaneous medicine as a key area, and “that will include antipsychotic medication.”
The BAD also recently published guidelines for the management of adults with delusional infestation, which includes a recommendation to conduct a survey on attitudes toward antipsychotic prescribing for the condition among U.K. dermatologists.
Heeding that call, Dr. Li and colleagues sent an email containing a 10-question online survey to members of the BAD and the British Society for Medical Dermatology. Questions covered familiarity with antipsychotics and frequency of prescribing, confidence around antipsychotics, and current training and future needs. Responses were received between February through April 2021.
Among the 79 respondents, 51 (65%) were consultants and 20 (25%) were dermatology registrars, with the remainder dermatology clinical fellows, foundation doctors, or other doctors. A total of 31 respondents had an average of more than 50 visits with patients per week, 18 had an average of 41-50 patient visits, and 13 had an average of 31-40 visits per week; the remainder had an average of 11-30 visits per week.
Most of the respondents (39) said they had seen 2-5 patients with psychodermatology conditions in the last 6 months, while 17 said they had seen 1 patient, 13 said they had seen more than 10 patients, and 6 said they had seen 6-10 patients (4 had seen none and 1 could not remember).
The most commonly prescribed antipsychotics for psychodermatology patients in the past 6 months were risperidone (Risperdal; prescribed by five respondents), followed by olanzapine (Zyprexa; by four respondents). Seventy respondents had not prescribed any antipsychotics.
Asked about how confident they felt about prescribing antipsychotic medication for patients with delusional infestation, 8 (10%) said they were happy to prescribe independently, while 42 (54%) said they were not at all confident. Another 10 (13%) respondents said they would be happy to prescribe the medications after liaising with a dermatology colleague, while 17 (22%) said they would prefer to consult with the psychiatry team.
The most common barrier to prescribing antipsychotic medications was a lack of experience with the drugs, cited by 66 respondents, followed by concerns over drug monitoring, cited by 43 respondents.
In addition, 42 respondents highlighted concerns over adverse effects, 36 cited lack of experience in psychodermatology clinics, and 19 cited lack of experience in discussing psychodermatologic conditions with patients. Other barriers mentioned by the respondents included difficulties with patient acceptance of a psychiatric medication prescribed by a dermatologist.
An audience member went further, saying that clinicians have been told not to “confront” such patients and that the temptation is therefore to cloak the discussion of antipsychotics in nonthreatening language so that it is more acceptable to the patient.
However, under the U.K. system, a letter with the results of the consultation, including information that an antipsychotic has been prescribed, must be sent to the patient’s family doctor along with a copy that goes to the patient. “The situation is almost impossible,” the audience member said, adding that there “must be some arrangement where in certain circumstances dermatologists could be allowed not to write to the patient” or alternatively, “write an entirely different letter” to the family doctor.
Session cochair Susannah Baron, MD, a consultant dermatologist at St. John’s Institute of Dermatology, Guy’s and St. Thomas’ Hospital, London, said that, in these situations, it is “really helpful to talk about doses” with patients.
She explained that she uses the analogy of aspirin, which has different effects depending on the dose given, giving pain relief at high doses but primarily an antiplatelet effect at low doses.
In the case of an antipsychotic, it is helpful to explain to the patient that “you don’t think they’re psychotic, and you’re prescribing it in a very low dose, because what it can do is help with their symptoms,” Dr. Baron added. “You have to be very open because if you’re not, they go to the pharmacy, and the pharmacist says: ‘Why are you on an antipsychotic?’ ”
Further results from the survey revealed that 56 (71%) respondents did not have access to a specialist psychodermatology clinic, whereas 36 (46%) had not yet attended a psychodermatology course.
Despite these responses, 60 (77%) respondents said they would be interested in attending a training course for prescribing antipsychotics, which included all 20 of the registrars who took part in the survey. a psychodermatologist at Frimley Health Foundation Trust, Windsor, England, and lead author of the BAD guidelines, commented from the audience that the survey results were “sort of what we expected.”
She explained that the intention of the authors when developing the guidelines “was to be able to help our junior colleagues and our peers to be able to feel competent to discuss antipsychotics with patients with delusional infestation and also initiate management.”
Dr. Ahmed added: “Why we’re encouraging our colleagues to prescribe antipsychotics is the longer you leave this type of psychotic illness untreated, the worse the prognosis.”
No funding or relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
GLASGOW – that also indicated there is a clear demand for training in prescribing these drugs.
Delusional infestation is a rare disorder characterized by an individual’s belief that his or her skin, body, or immediate environment is infested by small, living pathogens, despite a lack of any medical evidence. Most of these patients require antipsychotic medication to alleviate symptoms.
The survey of almost 80 dermatologists found that almost 90% had not prescribed antipsychotics in the previous month for patients with psychodermatology conditions and that the most common barrier to prescribing was lack of experience with the drugs.
This was reflected in only 10% of survey respondents who said they were “happy to” prescribe antipsychotics without consulting either dermatology or psychiatric colleagues, and less than half having attended a related course.
Yet the research, presented at the annual meeting of the British Association of Dermatologists, indicated that more than 75% of respondents would attend such a course to increase their confidence.
This finding, said study presenter Ling Li, MD, Churchill Hospital, Oxford (England) University Hospitals NHS Foundation Trust, shows that there is a “clear demand for training, particularly among all the registrars [residents] who we surveyed.”
Dr. Li noted that the UK’s Joint Royal Colleges of Physicians Training Board’s latest curriculum for dermatology training highlights psychocutaneous medicine as a key area, and “that will include antipsychotic medication.”
The BAD also recently published guidelines for the management of adults with delusional infestation, which includes a recommendation to conduct a survey on attitudes toward antipsychotic prescribing for the condition among U.K. dermatologists.
Heeding that call, Dr. Li and colleagues sent an email containing a 10-question online survey to members of the BAD and the British Society for Medical Dermatology. Questions covered familiarity with antipsychotics and frequency of prescribing, confidence around antipsychotics, and current training and future needs. Responses were received between February through April 2021.
Among the 79 respondents, 51 (65%) were consultants and 20 (25%) were dermatology registrars, with the remainder dermatology clinical fellows, foundation doctors, or other doctors. A total of 31 respondents had an average of more than 50 visits with patients per week, 18 had an average of 41-50 patient visits, and 13 had an average of 31-40 visits per week; the remainder had an average of 11-30 visits per week.
Most of the respondents (39) said they had seen 2-5 patients with psychodermatology conditions in the last 6 months, while 17 said they had seen 1 patient, 13 said they had seen more than 10 patients, and 6 said they had seen 6-10 patients (4 had seen none and 1 could not remember).
The most commonly prescribed antipsychotics for psychodermatology patients in the past 6 months were risperidone (Risperdal; prescribed by five respondents), followed by olanzapine (Zyprexa; by four respondents). Seventy respondents had not prescribed any antipsychotics.
Asked about how confident they felt about prescribing antipsychotic medication for patients with delusional infestation, 8 (10%) said they were happy to prescribe independently, while 42 (54%) said they were not at all confident. Another 10 (13%) respondents said they would be happy to prescribe the medications after liaising with a dermatology colleague, while 17 (22%) said they would prefer to consult with the psychiatry team.
The most common barrier to prescribing antipsychotic medications was a lack of experience with the drugs, cited by 66 respondents, followed by concerns over drug monitoring, cited by 43 respondents.
In addition, 42 respondents highlighted concerns over adverse effects, 36 cited lack of experience in psychodermatology clinics, and 19 cited lack of experience in discussing psychodermatologic conditions with patients. Other barriers mentioned by the respondents included difficulties with patient acceptance of a psychiatric medication prescribed by a dermatologist.
An audience member went further, saying that clinicians have been told not to “confront” such patients and that the temptation is therefore to cloak the discussion of antipsychotics in nonthreatening language so that it is more acceptable to the patient.
However, under the U.K. system, a letter with the results of the consultation, including information that an antipsychotic has been prescribed, must be sent to the patient’s family doctor along with a copy that goes to the patient. “The situation is almost impossible,” the audience member said, adding that there “must be some arrangement where in certain circumstances dermatologists could be allowed not to write to the patient” or alternatively, “write an entirely different letter” to the family doctor.
Session cochair Susannah Baron, MD, a consultant dermatologist at St. John’s Institute of Dermatology, Guy’s and St. Thomas’ Hospital, London, said that, in these situations, it is “really helpful to talk about doses” with patients.
She explained that she uses the analogy of aspirin, which has different effects depending on the dose given, giving pain relief at high doses but primarily an antiplatelet effect at low doses.
In the case of an antipsychotic, it is helpful to explain to the patient that “you don’t think they’re psychotic, and you’re prescribing it in a very low dose, because what it can do is help with their symptoms,” Dr. Baron added. “You have to be very open because if you’re not, they go to the pharmacy, and the pharmacist says: ‘Why are you on an antipsychotic?’ ”
Further results from the survey revealed that 56 (71%) respondents did not have access to a specialist psychodermatology clinic, whereas 36 (46%) had not yet attended a psychodermatology course.
Despite these responses, 60 (77%) respondents said they would be interested in attending a training course for prescribing antipsychotics, which included all 20 of the registrars who took part in the survey. a psychodermatologist at Frimley Health Foundation Trust, Windsor, England, and lead author of the BAD guidelines, commented from the audience that the survey results were “sort of what we expected.”
She explained that the intention of the authors when developing the guidelines “was to be able to help our junior colleagues and our peers to be able to feel competent to discuss antipsychotics with patients with delusional infestation and also initiate management.”
Dr. Ahmed added: “Why we’re encouraging our colleagues to prescribe antipsychotics is the longer you leave this type of psychotic illness untreated, the worse the prognosis.”
No funding or relevant financial relationships were declared.
A version of this article first appeared on Medscape.com.
AT BAD 2022
Eczema severity, time spent on management strongly associated with overall disease burden
. However, AD severity and spending 11 hours or more per week managing the condition did correlate with higher overall disease burden.
“Research has documented the disease burden of AD, including its visible nature and the effect on itch and sleep, but knowledge gaps remain,” Aaron M. Drucker, MD, of the division of dermatology at the University of Toronto, and colleagues wrote in the study published online in JAMA Dermatology. “Gaps include a poor understanding of symptoms other than itch, patients’ treatment experience, and how different elements of burden of disease interact.”
Dr. Drucker and colleagues collected data from an externally led patient-focused drug development survey on AD, a 32-item questionnaire that was administered electronically between Aug. 1, 2019, and Oct. 11, 2019. Respondents were asked to rate the overall impact of their AD in the past months and the specific elements of disease burden on a 1-5 scale, with 1 meaning no impact, and 5 meaning a significant impact. They were also asked to rate current mood changes and mood changes at the worst point of AD on a 4-point scale that ranged from “not present” to “severe.” The researchers used multivariable ordinal regression to examine associations between demographic and clinical variables and patient-reported overall AD impact scores.
Survey results
Of the 1,065 respondents, 33% were aged 18-34 years, 50% were aged 35-50 years, 17% were aged 65 years or older, and 83% were female. Nearly half (45%) reported having moderate AD, while 28% had severe AD. When asked about the overall disease burden of AD symptoms in the past month, 30% reported a significant impact on life, 28% reported a moderate impact score, 21% reported a high impact score, 18% reported a low impact score, and 3% of respondents reported no impact.
In the multivariable proportional odds analysis, moderate AD (odds ratio [OR], 4.13) and severe AD (OR, 13.63) were both associated with greater disease burden compared with mild AD. Also, spending 11 or more hours per week managing AD symptoms was associated with greater disease burden compared with 0 to 4 hours (an OR of 2.67 for 11-20 hours per week spent managing AD and OR of 5.34 for 21 or more hours per week spent managing AD).
Correlations between specific impact domains such as sleep, cognitive thinking, and physical activity and overall AD impact scores ranged from weak to moderate, and no individual aspect of disease burden correlated strongly with overall impact scores. The researchers observed similar results after they stratified the analysis by age, current severity, and time spent managing AD.
In other findings, 40% of study participants reported mild changes in mood related to their AD, 30% reported moderate changes, 9% reported severe changes, while the remainder reported no changes in mood. The variable most strongly associated with current mood changes was having severe AD at the time of the survey (OR 5.29).
Understanding of disease burden ‘limited’
“Atopic dermatitis is associated with an immense clinical burden,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “However, our understanding of disease burden from the patient perspective is limited,” he added.
“Interestingly, no single specific element of disease burden was strongly correlated with overall burden, further supporting the complex, multidimensional nature” of the impact of AD, he said, noting that the study “highlights the need for clinicians to look beyond the skin when it comes to AD and underscores the need for additional research to better understand the patient and caregiver perspective.”
Zelma Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was also asked to comment on the study, noted that aside from the well discussed impact and burden of itch and its impact on sleep loss, much remains to be learned about the full impact of AD, particularly among adults.
“For example, it is commonly accepted and expected that patients with more severe AD likely experience higher disease burden, but are there other factors that can influence this risk?” she asked. “Can we explain the high impact of AD disease aside from the level of disease severity, particularly among adults with AD?”
The study, she added, “is important because it provides additional insights into those possible factors, including ‘time spent managing their disease’ and ‘associated depression.’ In particular, understanding the association between ‘time spent managing their disease’ and higher disease burden is critical because, in my opinion, it emphasizes the need to develop better strategies for improving the care of patients with AD including the development of more efficacious and safer treatment strategies.”
Dr. Drucker and colleagues acknowledged certain limitations of the analysis, including its cross-sectional design, the potential for selection bias, and the fact that it did not use the patient-oriented outcome measure or the dermatology life quality index. “Further work to address the complex burden of AD, including strategies to reduce time spent managing AD, and understanding the fullness of the patient experience is needed,” they concluded.
The work was supported in part by a grant from the National Eczema Association (NEA). Dr. Drucker reported that he receives compensation from the British Journal of Dermatology (as reviewer and section editor), American Academy of Dermatology (guidelines writer), and NEA (grant reviewer). Coauthors representing the NEA and other patient organizations including the Allergy & Asthma Network, Asthma and Allergy Foundation of America, Global Parents for Eczema Research, and International Topical Steroid Awareness Network received organizational grants (Pfizer) and sponsorship funding for these analyses from AbbVie, Eli Lilly, Incyte, LEO Pharma, Regeneron Pharmaceuticals, and Sanofi Genzyme.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, EPI Health, Incyte, L’Oréal, the NEA, Pfizer, Regeneron, Sanofi, and UCB.
Dr. Chiesa Fuxench disclosed that she has received research grants from Lilly, LEO Pharma, Regeneron, Sanofi, Tioga, and Vanda for work related to AD She has served as consultant for the Asthma and Allergy Foundation of America, NEA, AbbVie, Incyte Corporation, and Pfizer; and received honoraria for CME work in AD sponsored by education grants from Regeneron/Sanofi and Pfizer.
. However, AD severity and spending 11 hours or more per week managing the condition did correlate with higher overall disease burden.
“Research has documented the disease burden of AD, including its visible nature and the effect on itch and sleep, but knowledge gaps remain,” Aaron M. Drucker, MD, of the division of dermatology at the University of Toronto, and colleagues wrote in the study published online in JAMA Dermatology. “Gaps include a poor understanding of symptoms other than itch, patients’ treatment experience, and how different elements of burden of disease interact.”
Dr. Drucker and colleagues collected data from an externally led patient-focused drug development survey on AD, a 32-item questionnaire that was administered electronically between Aug. 1, 2019, and Oct. 11, 2019. Respondents were asked to rate the overall impact of their AD in the past months and the specific elements of disease burden on a 1-5 scale, with 1 meaning no impact, and 5 meaning a significant impact. They were also asked to rate current mood changes and mood changes at the worst point of AD on a 4-point scale that ranged from “not present” to “severe.” The researchers used multivariable ordinal regression to examine associations between demographic and clinical variables and patient-reported overall AD impact scores.
Survey results
Of the 1,065 respondents, 33% were aged 18-34 years, 50% were aged 35-50 years, 17% were aged 65 years or older, and 83% were female. Nearly half (45%) reported having moderate AD, while 28% had severe AD. When asked about the overall disease burden of AD symptoms in the past month, 30% reported a significant impact on life, 28% reported a moderate impact score, 21% reported a high impact score, 18% reported a low impact score, and 3% of respondents reported no impact.
In the multivariable proportional odds analysis, moderate AD (odds ratio [OR], 4.13) and severe AD (OR, 13.63) were both associated with greater disease burden compared with mild AD. Also, spending 11 or more hours per week managing AD symptoms was associated with greater disease burden compared with 0 to 4 hours (an OR of 2.67 for 11-20 hours per week spent managing AD and OR of 5.34 for 21 or more hours per week spent managing AD).
Correlations between specific impact domains such as sleep, cognitive thinking, and physical activity and overall AD impact scores ranged from weak to moderate, and no individual aspect of disease burden correlated strongly with overall impact scores. The researchers observed similar results after they stratified the analysis by age, current severity, and time spent managing AD.
In other findings, 40% of study participants reported mild changes in mood related to their AD, 30% reported moderate changes, 9% reported severe changes, while the remainder reported no changes in mood. The variable most strongly associated with current mood changes was having severe AD at the time of the survey (OR 5.29).
Understanding of disease burden ‘limited’
“Atopic dermatitis is associated with an immense clinical burden,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “However, our understanding of disease burden from the patient perspective is limited,” he added.
“Interestingly, no single specific element of disease burden was strongly correlated with overall burden, further supporting the complex, multidimensional nature” of the impact of AD, he said, noting that the study “highlights the need for clinicians to look beyond the skin when it comes to AD and underscores the need for additional research to better understand the patient and caregiver perspective.”
Zelma Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was also asked to comment on the study, noted that aside from the well discussed impact and burden of itch and its impact on sleep loss, much remains to be learned about the full impact of AD, particularly among adults.
“For example, it is commonly accepted and expected that patients with more severe AD likely experience higher disease burden, but are there other factors that can influence this risk?” she asked. “Can we explain the high impact of AD disease aside from the level of disease severity, particularly among adults with AD?”
The study, she added, “is important because it provides additional insights into those possible factors, including ‘time spent managing their disease’ and ‘associated depression.’ In particular, understanding the association between ‘time spent managing their disease’ and higher disease burden is critical because, in my opinion, it emphasizes the need to develop better strategies for improving the care of patients with AD including the development of more efficacious and safer treatment strategies.”
Dr. Drucker and colleagues acknowledged certain limitations of the analysis, including its cross-sectional design, the potential for selection bias, and the fact that it did not use the patient-oriented outcome measure or the dermatology life quality index. “Further work to address the complex burden of AD, including strategies to reduce time spent managing AD, and understanding the fullness of the patient experience is needed,” they concluded.
The work was supported in part by a grant from the National Eczema Association (NEA). Dr. Drucker reported that he receives compensation from the British Journal of Dermatology (as reviewer and section editor), American Academy of Dermatology (guidelines writer), and NEA (grant reviewer). Coauthors representing the NEA and other patient organizations including the Allergy & Asthma Network, Asthma and Allergy Foundation of America, Global Parents for Eczema Research, and International Topical Steroid Awareness Network received organizational grants (Pfizer) and sponsorship funding for these analyses from AbbVie, Eli Lilly, Incyte, LEO Pharma, Regeneron Pharmaceuticals, and Sanofi Genzyme.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, EPI Health, Incyte, L’Oréal, the NEA, Pfizer, Regeneron, Sanofi, and UCB.
Dr. Chiesa Fuxench disclosed that she has received research grants from Lilly, LEO Pharma, Regeneron, Sanofi, Tioga, and Vanda for work related to AD She has served as consultant for the Asthma and Allergy Foundation of America, NEA, AbbVie, Incyte Corporation, and Pfizer; and received honoraria for CME work in AD sponsored by education grants from Regeneron/Sanofi and Pfizer.
. However, AD severity and spending 11 hours or more per week managing the condition did correlate with higher overall disease burden.
“Research has documented the disease burden of AD, including its visible nature and the effect on itch and sleep, but knowledge gaps remain,” Aaron M. Drucker, MD, of the division of dermatology at the University of Toronto, and colleagues wrote in the study published online in JAMA Dermatology. “Gaps include a poor understanding of symptoms other than itch, patients’ treatment experience, and how different elements of burden of disease interact.”
Dr. Drucker and colleagues collected data from an externally led patient-focused drug development survey on AD, a 32-item questionnaire that was administered electronically between Aug. 1, 2019, and Oct. 11, 2019. Respondents were asked to rate the overall impact of their AD in the past months and the specific elements of disease burden on a 1-5 scale, with 1 meaning no impact, and 5 meaning a significant impact. They were also asked to rate current mood changes and mood changes at the worst point of AD on a 4-point scale that ranged from “not present” to “severe.” The researchers used multivariable ordinal regression to examine associations between demographic and clinical variables and patient-reported overall AD impact scores.
Survey results
Of the 1,065 respondents, 33% were aged 18-34 years, 50% were aged 35-50 years, 17% were aged 65 years or older, and 83% were female. Nearly half (45%) reported having moderate AD, while 28% had severe AD. When asked about the overall disease burden of AD symptoms in the past month, 30% reported a significant impact on life, 28% reported a moderate impact score, 21% reported a high impact score, 18% reported a low impact score, and 3% of respondents reported no impact.
In the multivariable proportional odds analysis, moderate AD (odds ratio [OR], 4.13) and severe AD (OR, 13.63) were both associated with greater disease burden compared with mild AD. Also, spending 11 or more hours per week managing AD symptoms was associated with greater disease burden compared with 0 to 4 hours (an OR of 2.67 for 11-20 hours per week spent managing AD and OR of 5.34 for 21 or more hours per week spent managing AD).
Correlations between specific impact domains such as sleep, cognitive thinking, and physical activity and overall AD impact scores ranged from weak to moderate, and no individual aspect of disease burden correlated strongly with overall impact scores. The researchers observed similar results after they stratified the analysis by age, current severity, and time spent managing AD.
In other findings, 40% of study participants reported mild changes in mood related to their AD, 30% reported moderate changes, 9% reported severe changes, while the remainder reported no changes in mood. The variable most strongly associated with current mood changes was having severe AD at the time of the survey (OR 5.29).
Understanding of disease burden ‘limited’
“Atopic dermatitis is associated with an immense clinical burden,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “However, our understanding of disease burden from the patient perspective is limited,” he added.
“Interestingly, no single specific element of disease burden was strongly correlated with overall burden, further supporting the complex, multidimensional nature” of the impact of AD, he said, noting that the study “highlights the need for clinicians to look beyond the skin when it comes to AD and underscores the need for additional research to better understand the patient and caregiver perspective.”
Zelma Chiesa Fuxench, MD, MSCE, assistant professor of dermatology at the University of Pennsylvania, Philadelphia, who was also asked to comment on the study, noted that aside from the well discussed impact and burden of itch and its impact on sleep loss, much remains to be learned about the full impact of AD, particularly among adults.
“For example, it is commonly accepted and expected that patients with more severe AD likely experience higher disease burden, but are there other factors that can influence this risk?” she asked. “Can we explain the high impact of AD disease aside from the level of disease severity, particularly among adults with AD?”
The study, she added, “is important because it provides additional insights into those possible factors, including ‘time spent managing their disease’ and ‘associated depression.’ In particular, understanding the association between ‘time spent managing their disease’ and higher disease burden is critical because, in my opinion, it emphasizes the need to develop better strategies for improving the care of patients with AD including the development of more efficacious and safer treatment strategies.”
Dr. Drucker and colleagues acknowledged certain limitations of the analysis, including its cross-sectional design, the potential for selection bias, and the fact that it did not use the patient-oriented outcome measure or the dermatology life quality index. “Further work to address the complex burden of AD, including strategies to reduce time spent managing AD, and understanding the fullness of the patient experience is needed,” they concluded.
The work was supported in part by a grant from the National Eczema Association (NEA). Dr. Drucker reported that he receives compensation from the British Journal of Dermatology (as reviewer and section editor), American Academy of Dermatology (guidelines writer), and NEA (grant reviewer). Coauthors representing the NEA and other patient organizations including the Allergy & Asthma Network, Asthma and Allergy Foundation of America, Global Parents for Eczema Research, and International Topical Steroid Awareness Network received organizational grants (Pfizer) and sponsorship funding for these analyses from AbbVie, Eli Lilly, Incyte, LEO Pharma, Regeneron Pharmaceuticals, and Sanofi Genzyme.
Dr. Chovatiya disclosed that he has served as an advisory board member, consultant, speaker, and/or investigator for AbbVie, Arcutis, Arena, Beiersdorf, Bristol Myers Squibb, Dermavant, Eli Lilly and Company, EPI Health, Incyte, L’Oréal, the NEA, Pfizer, Regeneron, Sanofi, and UCB.
Dr. Chiesa Fuxench disclosed that she has received research grants from Lilly, LEO Pharma, Regeneron, Sanofi, Tioga, and Vanda for work related to AD She has served as consultant for the Asthma and Allergy Foundation of America, NEA, AbbVie, Incyte Corporation, and Pfizer; and received honoraria for CME work in AD sponsored by education grants from Regeneron/Sanofi and Pfizer.
FROM JAMA DERMATOLOGY
Study explores gender differences in pediatric melanoma
INDIANAPOLIS – .
In addition, male gender was independently associated with increased mortality, but age was not.
Those are key findings from a retrospective cohort analysis of nearly 5,000 records from the National Cancer Database.
“There are multiple studies from primarily adult populations showing females with melanoma have a different presentation and better outcomes than males,” co-first author Rebecca M. Thiede, MD, a dermatologist at the University of Arizona, Tucson, said in an interview with this news organization in advance of the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session. “However, because melanoma is so rare in younger patients, little is known about gender differences in presentation and survival in pediatric and adolescent patients. To our knowledge, this is one of the largest studies to date in this population, and the first to explore gender differences in detail in pediatric and adolescent patients with melanoma.”
Working with co-first author Sabrina Dahak, a fourth-year medical student at the University of Arizona, Phoenix, Dr. Thiede and colleagues retrospectively analyzed the National Cancer Database to identify biopsy-confirmed invasive primary cutaneous melanoma cases diagnosed in patients 0-21 years of age between 2004 and 2018. The search yielded 4,645 cases, and the researchers used American Academy of Pediatrics definitions to categorize the patients by age, from infancy (birth to 2 years), to childhood (3-10 years), early adolescence (11-14 years), middle adolescence (15-17 years), and late adolescence (18-21 years). They used the Kaplan Meier analysis to determine overall survival and multivariate Cox regression to determine independent survival predictors.
Of the 4,645 pediatric melanoma cases, 63.4% were in females and 36.6% were in males, a difference that was significant (P < .001). Dr. Thiede and colleagues also observed a significant relationship between primary site and gender (P < .001). Primary sites included the trunk (34.3% of females vs. 32.9% of males, respectively), head and neck (16.4% vs. 30.9%), upper extremities (19.5% vs. 16%), lower extremities (27.9% vs. 16.5%), and “unspecified” (1.9% vs. 3.7%).
Females had higher rates of superficial spreading melanoma while males were affected by nodular melanoma more often. For example, the median Breslow depth was higher for males (1.05 mm; interquartile range [IQR] 0.50-2.31) than for females (0.80 mm; IQR, 0.40-1.67; P < .001).
Although females accounted for a higher percentage of cases than males overall, from birth to 17 years, a higher percentage of males than females were found to have later stage of melanoma at time of diagnosis: Females were more likely to be diagnosed with stage I disease (67.8%) than were males (53.6%), and males were more likely than were females to be diagnosed with stages II (15.9% vs. 12.3%), III (27.1% vs. 18.3%), and IV disease (3.3% vs. 1.6%; P < .001 for all).
In other findings, the 5- and 10-year overall survival rates were higher for females (95.9% and 93.9%, respectively) than for males (92.0% vs. 86.7%, respectively; P < .001). However, by age group, overall survival rates were similar between females and males among infants, children, and those in early adolescence – but not for those in middle adolescence (96.7% vs. 91.9%; P < .001) or late adolescence (95.7% vs. 90.4%; P < .001).
When the researchers adjusted for confounding variables, male gender was independently associated with an increased risk of death (adjusted hazard ratio 1.37; P < .001), but age was not.
“It was particularly surprising to see that even at such a young age, there is a significant difference in overall survival between males and females, where females have better outcomes than males,” Dr. Thiede said. “When examining pediatric and adolescent patients, it is essential to maintain cutaneous melanoma on the differential,” she advised. “It is important for clinicians to perform a thorough exam at annual visits particularly for those at high risk for melanoma to catch this rare but potentially devastating diagnosis.”
She acknowledged certain limitations of the study, including its reliance on one database, “as comparing multiple databases would strengthen the conclusions,” she said. “There was some missing data present in our dataset, and a large percentage of the histologic subtypes were unspecified, both of which are common issues with cancer registries. An additional limitation is related to the low death rates in adolescent and pediatric patients, which may impact the analysis related to survival and independent predictors of survival.”
Asked to comment on the study results, Carrie C. Coughlin, MD, who directs the section of pediatric dermatology Washington University/St. Louis Children’s Hospital, said that the finding that males were more likely to present with stage II or higher disease compared with females “could be related to their finding that females had more superficial spreading melanomas, whereas males had more nodular melanoma.” Those differences “could influence how providers evaluate melanocytic lesions in children,” she added.
Dr. Coughlin, who directs the pediatric dermatology fellowship at Washington University/St. Louis Children’s Hospital, said it was “interesting” that the authors found no association between older age and an increased risk of death. “It would be helpful to have more data about melanoma subtype, including information about Spitz or Spitzoid melanomas,” she said. “Also, knowing the distribution of melanoma across the age categories could provide more insight into their data.”
Ms. Dahak received an award from the National Cancer Institute to fund travel for presentation of this study at the SPD meeting. No other financial conflicts were reported by the researchers. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.
INDIANAPOLIS – .
In addition, male gender was independently associated with increased mortality, but age was not.
Those are key findings from a retrospective cohort analysis of nearly 5,000 records from the National Cancer Database.
“There are multiple studies from primarily adult populations showing females with melanoma have a different presentation and better outcomes than males,” co-first author Rebecca M. Thiede, MD, a dermatologist at the University of Arizona, Tucson, said in an interview with this news organization in advance of the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session. “However, because melanoma is so rare in younger patients, little is known about gender differences in presentation and survival in pediatric and adolescent patients. To our knowledge, this is one of the largest studies to date in this population, and the first to explore gender differences in detail in pediatric and adolescent patients with melanoma.”
Working with co-first author Sabrina Dahak, a fourth-year medical student at the University of Arizona, Phoenix, Dr. Thiede and colleagues retrospectively analyzed the National Cancer Database to identify biopsy-confirmed invasive primary cutaneous melanoma cases diagnosed in patients 0-21 years of age between 2004 and 2018. The search yielded 4,645 cases, and the researchers used American Academy of Pediatrics definitions to categorize the patients by age, from infancy (birth to 2 years), to childhood (3-10 years), early adolescence (11-14 years), middle adolescence (15-17 years), and late adolescence (18-21 years). They used the Kaplan Meier analysis to determine overall survival and multivariate Cox regression to determine independent survival predictors.
Of the 4,645 pediatric melanoma cases, 63.4% were in females and 36.6% were in males, a difference that was significant (P < .001). Dr. Thiede and colleagues also observed a significant relationship between primary site and gender (P < .001). Primary sites included the trunk (34.3% of females vs. 32.9% of males, respectively), head and neck (16.4% vs. 30.9%), upper extremities (19.5% vs. 16%), lower extremities (27.9% vs. 16.5%), and “unspecified” (1.9% vs. 3.7%).
Females had higher rates of superficial spreading melanoma while males were affected by nodular melanoma more often. For example, the median Breslow depth was higher for males (1.05 mm; interquartile range [IQR] 0.50-2.31) than for females (0.80 mm; IQR, 0.40-1.67; P < .001).
Although females accounted for a higher percentage of cases than males overall, from birth to 17 years, a higher percentage of males than females were found to have later stage of melanoma at time of diagnosis: Females were more likely to be diagnosed with stage I disease (67.8%) than were males (53.6%), and males were more likely than were females to be diagnosed with stages II (15.9% vs. 12.3%), III (27.1% vs. 18.3%), and IV disease (3.3% vs. 1.6%; P < .001 for all).
In other findings, the 5- and 10-year overall survival rates were higher for females (95.9% and 93.9%, respectively) than for males (92.0% vs. 86.7%, respectively; P < .001). However, by age group, overall survival rates were similar between females and males among infants, children, and those in early adolescence – but not for those in middle adolescence (96.7% vs. 91.9%; P < .001) or late adolescence (95.7% vs. 90.4%; P < .001).
When the researchers adjusted for confounding variables, male gender was independently associated with an increased risk of death (adjusted hazard ratio 1.37; P < .001), but age was not.
“It was particularly surprising to see that even at such a young age, there is a significant difference in overall survival between males and females, where females have better outcomes than males,” Dr. Thiede said. “When examining pediatric and adolescent patients, it is essential to maintain cutaneous melanoma on the differential,” she advised. “It is important for clinicians to perform a thorough exam at annual visits particularly for those at high risk for melanoma to catch this rare but potentially devastating diagnosis.”
She acknowledged certain limitations of the study, including its reliance on one database, “as comparing multiple databases would strengthen the conclusions,” she said. “There was some missing data present in our dataset, and a large percentage of the histologic subtypes were unspecified, both of which are common issues with cancer registries. An additional limitation is related to the low death rates in adolescent and pediatric patients, which may impact the analysis related to survival and independent predictors of survival.”
Asked to comment on the study results, Carrie C. Coughlin, MD, who directs the section of pediatric dermatology Washington University/St. Louis Children’s Hospital, said that the finding that males were more likely to present with stage II or higher disease compared with females “could be related to their finding that females had more superficial spreading melanomas, whereas males had more nodular melanoma.” Those differences “could influence how providers evaluate melanocytic lesions in children,” she added.
Dr. Coughlin, who directs the pediatric dermatology fellowship at Washington University/St. Louis Children’s Hospital, said it was “interesting” that the authors found no association between older age and an increased risk of death. “It would be helpful to have more data about melanoma subtype, including information about Spitz or Spitzoid melanomas,” she said. “Also, knowing the distribution of melanoma across the age categories could provide more insight into their data.”
Ms. Dahak received an award from the National Cancer Institute to fund travel for presentation of this study at the SPD meeting. No other financial conflicts were reported by the researchers. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.
INDIANAPOLIS – .
In addition, male gender was independently associated with increased mortality, but age was not.
Those are key findings from a retrospective cohort analysis of nearly 5,000 records from the National Cancer Database.
“There are multiple studies from primarily adult populations showing females with melanoma have a different presentation and better outcomes than males,” co-first author Rebecca M. Thiede, MD, a dermatologist at the University of Arizona, Tucson, said in an interview with this news organization in advance of the annual meeting of the Society for Pediatric Dermatology, where the abstract was presented during a poster session. “However, because melanoma is so rare in younger patients, little is known about gender differences in presentation and survival in pediatric and adolescent patients. To our knowledge, this is one of the largest studies to date in this population, and the first to explore gender differences in detail in pediatric and adolescent patients with melanoma.”
Working with co-first author Sabrina Dahak, a fourth-year medical student at the University of Arizona, Phoenix, Dr. Thiede and colleagues retrospectively analyzed the National Cancer Database to identify biopsy-confirmed invasive primary cutaneous melanoma cases diagnosed in patients 0-21 years of age between 2004 and 2018. The search yielded 4,645 cases, and the researchers used American Academy of Pediatrics definitions to categorize the patients by age, from infancy (birth to 2 years), to childhood (3-10 years), early adolescence (11-14 years), middle adolescence (15-17 years), and late adolescence (18-21 years). They used the Kaplan Meier analysis to determine overall survival and multivariate Cox regression to determine independent survival predictors.
Of the 4,645 pediatric melanoma cases, 63.4% were in females and 36.6% were in males, a difference that was significant (P < .001). Dr. Thiede and colleagues also observed a significant relationship between primary site and gender (P < .001). Primary sites included the trunk (34.3% of females vs. 32.9% of males, respectively), head and neck (16.4% vs. 30.9%), upper extremities (19.5% vs. 16%), lower extremities (27.9% vs. 16.5%), and “unspecified” (1.9% vs. 3.7%).
Females had higher rates of superficial spreading melanoma while males were affected by nodular melanoma more often. For example, the median Breslow depth was higher for males (1.05 mm; interquartile range [IQR] 0.50-2.31) than for females (0.80 mm; IQR, 0.40-1.67; P < .001).
Although females accounted for a higher percentage of cases than males overall, from birth to 17 years, a higher percentage of males than females were found to have later stage of melanoma at time of diagnosis: Females were more likely to be diagnosed with stage I disease (67.8%) than were males (53.6%), and males were more likely than were females to be diagnosed with stages II (15.9% vs. 12.3%), III (27.1% vs. 18.3%), and IV disease (3.3% vs. 1.6%; P < .001 for all).
In other findings, the 5- and 10-year overall survival rates were higher for females (95.9% and 93.9%, respectively) than for males (92.0% vs. 86.7%, respectively; P < .001). However, by age group, overall survival rates were similar between females and males among infants, children, and those in early adolescence – but not for those in middle adolescence (96.7% vs. 91.9%; P < .001) or late adolescence (95.7% vs. 90.4%; P < .001).
When the researchers adjusted for confounding variables, male gender was independently associated with an increased risk of death (adjusted hazard ratio 1.37; P < .001), but age was not.
“It was particularly surprising to see that even at such a young age, there is a significant difference in overall survival between males and females, where females have better outcomes than males,” Dr. Thiede said. “When examining pediatric and adolescent patients, it is essential to maintain cutaneous melanoma on the differential,” she advised. “It is important for clinicians to perform a thorough exam at annual visits particularly for those at high risk for melanoma to catch this rare but potentially devastating diagnosis.”
She acknowledged certain limitations of the study, including its reliance on one database, “as comparing multiple databases would strengthen the conclusions,” she said. “There was some missing data present in our dataset, and a large percentage of the histologic subtypes were unspecified, both of which are common issues with cancer registries. An additional limitation is related to the low death rates in adolescent and pediatric patients, which may impact the analysis related to survival and independent predictors of survival.”
Asked to comment on the study results, Carrie C. Coughlin, MD, who directs the section of pediatric dermatology Washington University/St. Louis Children’s Hospital, said that the finding that males were more likely to present with stage II or higher disease compared with females “could be related to their finding that females had more superficial spreading melanomas, whereas males had more nodular melanoma.” Those differences “could influence how providers evaluate melanocytic lesions in children,” she added.
Dr. Coughlin, who directs the pediatric dermatology fellowship at Washington University/St. Louis Children’s Hospital, said it was “interesting” that the authors found no association between older age and an increased risk of death. “It would be helpful to have more data about melanoma subtype, including information about Spitz or Spitzoid melanomas,” she said. “Also, knowing the distribution of melanoma across the age categories could provide more insight into their data.”
Ms. Dahak received an award from the National Cancer Institute to fund travel for presentation of this study at the SPD meeting. No other financial conflicts were reported by the researchers. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance (PeDRA) and the International Immunosuppression and Transplant Skin Cancer Collaborative.
AT SPD 2022
Ruxolitinib found to benefit adolescents with vitiligo up to one year
INDIANAPOLIS – and a higher proportion responded at week 52, results from a pooled analysis of phase 3 data showed.
Currently, there is no treatment approved by the Food and Drug Administration to repigment patients with vitiligo, but the cream formulation of the Janus kinase inhibitor ruxolitinib was shown to be effective and have a favorable safety profile in patients aged 12 years and up in the phase 3 clinical trials, TRuE-V1 and TruE-V2. “We know that about half of patients will develop vitiligo by the age of 20, so there is a significant need to have treatments available for the pediatric population,” lead study author David Rosmarin, MD, told this news organization in advance of the annual meeting of the Society for Pediatric Dermatology.
In September 2021, topical ruxolitinib (Opzelura) was approved by the FDA for treating atopic dermatitis in nonimmunocompromised patients aged 12 years and older. The manufacturer, Incyte, has submitted an application for approval to the agency for treating vitiligo in patients ages 12 years and older based on 24-week results; the FDA is expected to make a decision by July 18.
For the current study, presented during a poster session at the meeting, Dr. Rosmarin, of the department of dermatology at Tufts Medical Center, Boston, and colleagues pooled efficacy and safety data for adolescent patients aged 12-17 years from the TRuE-V studies, which enrolled patients 12 years of age and older diagnosed with nonsegmental vitiligo with depigmentation covering up to 10% of total body surface area (BSA), including facial and total Vitiligo Area Scoring Index (F-VASI/T-VASI) scores of ≥ 0.5/≥ 3. Investigators randomized patients 2:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 24 weeks, after which all patients could apply 1.5% ruxolitinib cream through week 52. Efficacy endpoints included the proportions of patients who achieved at least 75%, 50%, and 90% improvement from baseline in F-VASI scores (F-VASI75, F-VASI50, F-VASI90); the proportion of patients who achieved at least a 50% improvement from baseline in T-VASI (T-VASI50); the proportion of patients who achieved a Vitiligo Noticeability Scale (VNS) rating of 4 or 5; and percentage change from baseline in facial BSA (F-BSA). Safety and tolerability were also assessed.
For the pooled analysis, Dr. Rosmarin and colleagues reported results on 72 adolescents: 55 who received ruxolitinib cream and 17 who received vehicle. At week 24, 32.1% of adolescents treated with ruxolitinib cream achieved F-VASI75, compared with none of those in the vehicle group. Further, response rates at week 52 for patients who applied ruxolitinib cream from day 1 were as follows: F-VASI75, 48.0%; F-VASI50, 70.0%; F-VASI90, 24.0%; T-VASI50, 60.0%; VNS score of 4/5, 56.0%; and F-BSA mean percentage change from baseline, –41.9%.
Efficacy at week 52 among crossover patients (after 28 weeks of ruxolitinib cream) was consistent with week 24 data in patients who applied ruxolitinib cream from day 1.
“As we know that repigmentation takes time, about half of the patients achieved the F-VASI75 at the 52-week endpoint,” said Dr. Rosmarin, who is also vice-chair for research and education at Tufts Medical Center, Boston. “Particularly remarkable is that 60% of adolescents achieved a T-VASI50 [50% or more repigmentation of the whole body at the year mark] and over half the patients described their vitiligo as a lot less noticeable or no longer noticeable at the year mark.”
In terms of safety, treatment-related adverse events occurred in 12.9% of patients treated with ruxolitinib (no information was available on the specific events). Serious adverse events occurred in 1.4% of patients; none were considered related to treatment.
“Overall, these results are quite impressive,” Dr. Rosmarin said. “While it can be very challenging to repigment patients with vitiligo, ruxolitinib cream provides an effective option which can help many of my patients.” He acknowledged certain limitations of the analysis, including the fact that the TRuE-V studies were conducted during the COVID-19 pandemic, “which may have contributed to patients being lost to follow-up. Also, the majority of the patients had skin phototypes 1-3.”
Carrie C. Coughlin, MD, who was asked to comment on the study, said that patients with vitiligo need treatment options that are well-studied and covered by insurance. “This study is a great step forward in developing medications for this underserved patient population,” said Dr. Coughlin, who directs the section of pediatric dermatology at Washington University/St. Louis Children’s Hospital.
However, she continued, “the authors mention approximately 13% of patients had a treatment-related adverse reaction, but the abstract does not delineate these reactions.” In addition, the study was limited to children who had less than or equal to 10% body surface area involvement of vitiligo, she noted, adding that “more work is needed to learn about safety of application to larger surface areas.”
Going forward, “it will be important to learn the durability of response,” said Dr. Coughlin, who is also assistant professor of dermatology at Washington University in St. Louis. “Does the vitiligo return if patients stop applying the ruxolitinib cream?”
Dr. Rosmarin disclosed that he has received honoraria as a consultant for Incyte, AbbVie, Abcuro, AltruBio, Arena, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio. He has also received research support from Incyte, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Galderma, Janssen, Lilly, Merck, Novartis, Pfizer, and Regeneron; and has served as a paid speaker for Incyte, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Incyte, Janssen, Lilly, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance and the International Immunosuppression and Transplant Skin Cancer Collaborative.
INDIANAPOLIS – and a higher proportion responded at week 52, results from a pooled analysis of phase 3 data showed.
Currently, there is no treatment approved by the Food and Drug Administration to repigment patients with vitiligo, but the cream formulation of the Janus kinase inhibitor ruxolitinib was shown to be effective and have a favorable safety profile in patients aged 12 years and up in the phase 3 clinical trials, TRuE-V1 and TruE-V2. “We know that about half of patients will develop vitiligo by the age of 20, so there is a significant need to have treatments available for the pediatric population,” lead study author David Rosmarin, MD, told this news organization in advance of the annual meeting of the Society for Pediatric Dermatology.
In September 2021, topical ruxolitinib (Opzelura) was approved by the FDA for treating atopic dermatitis in nonimmunocompromised patients aged 12 years and older. The manufacturer, Incyte, has submitted an application for approval to the agency for treating vitiligo in patients ages 12 years and older based on 24-week results; the FDA is expected to make a decision by July 18.
For the current study, presented during a poster session at the meeting, Dr. Rosmarin, of the department of dermatology at Tufts Medical Center, Boston, and colleagues pooled efficacy and safety data for adolescent patients aged 12-17 years from the TRuE-V studies, which enrolled patients 12 years of age and older diagnosed with nonsegmental vitiligo with depigmentation covering up to 10% of total body surface area (BSA), including facial and total Vitiligo Area Scoring Index (F-VASI/T-VASI) scores of ≥ 0.5/≥ 3. Investigators randomized patients 2:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 24 weeks, after which all patients could apply 1.5% ruxolitinib cream through week 52. Efficacy endpoints included the proportions of patients who achieved at least 75%, 50%, and 90% improvement from baseline in F-VASI scores (F-VASI75, F-VASI50, F-VASI90); the proportion of patients who achieved at least a 50% improvement from baseline in T-VASI (T-VASI50); the proportion of patients who achieved a Vitiligo Noticeability Scale (VNS) rating of 4 or 5; and percentage change from baseline in facial BSA (F-BSA). Safety and tolerability were also assessed.
For the pooled analysis, Dr. Rosmarin and colleagues reported results on 72 adolescents: 55 who received ruxolitinib cream and 17 who received vehicle. At week 24, 32.1% of adolescents treated with ruxolitinib cream achieved F-VASI75, compared with none of those in the vehicle group. Further, response rates at week 52 for patients who applied ruxolitinib cream from day 1 were as follows: F-VASI75, 48.0%; F-VASI50, 70.0%; F-VASI90, 24.0%; T-VASI50, 60.0%; VNS score of 4/5, 56.0%; and F-BSA mean percentage change from baseline, –41.9%.
Efficacy at week 52 among crossover patients (after 28 weeks of ruxolitinib cream) was consistent with week 24 data in patients who applied ruxolitinib cream from day 1.
“As we know that repigmentation takes time, about half of the patients achieved the F-VASI75 at the 52-week endpoint,” said Dr. Rosmarin, who is also vice-chair for research and education at Tufts Medical Center, Boston. “Particularly remarkable is that 60% of adolescents achieved a T-VASI50 [50% or more repigmentation of the whole body at the year mark] and over half the patients described their vitiligo as a lot less noticeable or no longer noticeable at the year mark.”
In terms of safety, treatment-related adverse events occurred in 12.9% of patients treated with ruxolitinib (no information was available on the specific events). Serious adverse events occurred in 1.4% of patients; none were considered related to treatment.
“Overall, these results are quite impressive,” Dr. Rosmarin said. “While it can be very challenging to repigment patients with vitiligo, ruxolitinib cream provides an effective option which can help many of my patients.” He acknowledged certain limitations of the analysis, including the fact that the TRuE-V studies were conducted during the COVID-19 pandemic, “which may have contributed to patients being lost to follow-up. Also, the majority of the patients had skin phototypes 1-3.”
Carrie C. Coughlin, MD, who was asked to comment on the study, said that patients with vitiligo need treatment options that are well-studied and covered by insurance. “This study is a great step forward in developing medications for this underserved patient population,” said Dr. Coughlin, who directs the section of pediatric dermatology at Washington University/St. Louis Children’s Hospital.
However, she continued, “the authors mention approximately 13% of patients had a treatment-related adverse reaction, but the abstract does not delineate these reactions.” In addition, the study was limited to children who had less than or equal to 10% body surface area involvement of vitiligo, she noted, adding that “more work is needed to learn about safety of application to larger surface areas.”
Going forward, “it will be important to learn the durability of response,” said Dr. Coughlin, who is also assistant professor of dermatology at Washington University in St. Louis. “Does the vitiligo return if patients stop applying the ruxolitinib cream?”
Dr. Rosmarin disclosed that he has received honoraria as a consultant for Incyte, AbbVie, Abcuro, AltruBio, Arena, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio. He has also received research support from Incyte, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Galderma, Janssen, Lilly, Merck, Novartis, Pfizer, and Regeneron; and has served as a paid speaker for Incyte, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Incyte, Janssen, Lilly, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance and the International Immunosuppression and Transplant Skin Cancer Collaborative.
INDIANAPOLIS – and a higher proportion responded at week 52, results from a pooled analysis of phase 3 data showed.
Currently, there is no treatment approved by the Food and Drug Administration to repigment patients with vitiligo, but the cream formulation of the Janus kinase inhibitor ruxolitinib was shown to be effective and have a favorable safety profile in patients aged 12 years and up in the phase 3 clinical trials, TRuE-V1 and TruE-V2. “We know that about half of patients will develop vitiligo by the age of 20, so there is a significant need to have treatments available for the pediatric population,” lead study author David Rosmarin, MD, told this news organization in advance of the annual meeting of the Society for Pediatric Dermatology.
In September 2021, topical ruxolitinib (Opzelura) was approved by the FDA for treating atopic dermatitis in nonimmunocompromised patients aged 12 years and older. The manufacturer, Incyte, has submitted an application for approval to the agency for treating vitiligo in patients ages 12 years and older based on 24-week results; the FDA is expected to make a decision by July 18.
For the current study, presented during a poster session at the meeting, Dr. Rosmarin, of the department of dermatology at Tufts Medical Center, Boston, and colleagues pooled efficacy and safety data for adolescent patients aged 12-17 years from the TRuE-V studies, which enrolled patients 12 years of age and older diagnosed with nonsegmental vitiligo with depigmentation covering up to 10% of total body surface area (BSA), including facial and total Vitiligo Area Scoring Index (F-VASI/T-VASI) scores of ≥ 0.5/≥ 3. Investigators randomized patients 2:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 24 weeks, after which all patients could apply 1.5% ruxolitinib cream through week 52. Efficacy endpoints included the proportions of patients who achieved at least 75%, 50%, and 90% improvement from baseline in F-VASI scores (F-VASI75, F-VASI50, F-VASI90); the proportion of patients who achieved at least a 50% improvement from baseline in T-VASI (T-VASI50); the proportion of patients who achieved a Vitiligo Noticeability Scale (VNS) rating of 4 or 5; and percentage change from baseline in facial BSA (F-BSA). Safety and tolerability were also assessed.
For the pooled analysis, Dr. Rosmarin and colleagues reported results on 72 adolescents: 55 who received ruxolitinib cream and 17 who received vehicle. At week 24, 32.1% of adolescents treated with ruxolitinib cream achieved F-VASI75, compared with none of those in the vehicle group. Further, response rates at week 52 for patients who applied ruxolitinib cream from day 1 were as follows: F-VASI75, 48.0%; F-VASI50, 70.0%; F-VASI90, 24.0%; T-VASI50, 60.0%; VNS score of 4/5, 56.0%; and F-BSA mean percentage change from baseline, –41.9%.
Efficacy at week 52 among crossover patients (after 28 weeks of ruxolitinib cream) was consistent with week 24 data in patients who applied ruxolitinib cream from day 1.
“As we know that repigmentation takes time, about half of the patients achieved the F-VASI75 at the 52-week endpoint,” said Dr. Rosmarin, who is also vice-chair for research and education at Tufts Medical Center, Boston. “Particularly remarkable is that 60% of adolescents achieved a T-VASI50 [50% or more repigmentation of the whole body at the year mark] and over half the patients described their vitiligo as a lot less noticeable or no longer noticeable at the year mark.”
In terms of safety, treatment-related adverse events occurred in 12.9% of patients treated with ruxolitinib (no information was available on the specific events). Serious adverse events occurred in 1.4% of patients; none were considered related to treatment.
“Overall, these results are quite impressive,” Dr. Rosmarin said. “While it can be very challenging to repigment patients with vitiligo, ruxolitinib cream provides an effective option which can help many of my patients.” He acknowledged certain limitations of the analysis, including the fact that the TRuE-V studies were conducted during the COVID-19 pandemic, “which may have contributed to patients being lost to follow-up. Also, the majority of the patients had skin phototypes 1-3.”
Carrie C. Coughlin, MD, who was asked to comment on the study, said that patients with vitiligo need treatment options that are well-studied and covered by insurance. “This study is a great step forward in developing medications for this underserved patient population,” said Dr. Coughlin, who directs the section of pediatric dermatology at Washington University/St. Louis Children’s Hospital.
However, she continued, “the authors mention approximately 13% of patients had a treatment-related adverse reaction, but the abstract does not delineate these reactions.” In addition, the study was limited to children who had less than or equal to 10% body surface area involvement of vitiligo, she noted, adding that “more work is needed to learn about safety of application to larger surface areas.”
Going forward, “it will be important to learn the durability of response,” said Dr. Coughlin, who is also assistant professor of dermatology at Washington University in St. Louis. “Does the vitiligo return if patients stop applying the ruxolitinib cream?”
Dr. Rosmarin disclosed that he has received honoraria as a consultant for Incyte, AbbVie, Abcuro, AltruBio, Arena, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Concert, CSL Behring, Dermavant, Dermira, Janssen, Kyowa Kirin, Lilly, Novartis, Pfizer, Regeneron, Revolo Biotherapeutics, Sanofi, Sun Pharmaceuticals, UCB, and VielaBio. He has also received research support from Incyte, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Dermira, Galderma, Janssen, Lilly, Merck, Novartis, Pfizer, and Regeneron; and has served as a paid speaker for Incyte, AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Incyte, Janssen, Lilly, Novartis, Pfizer, Regeneron, and Sanofi. Dr. Coughlin is on the board of the Pediatric Dermatology Research Alliance and the International Immunosuppression and Transplant Skin Cancer Collaborative.
AT SPD 2022
Baricitinib’s approval for alopecia areata: Considerations for starting patients on treatment
On June 13, the FDA approved baricitinib, a Janus kinase inhibitor (Olumiant, Lilly), for severe AA, and two other options may not be far behind. Pfizer and Concert Pharmaceuticals have JAK inhibitors in late-stage development for AA. JAK inhibitors, including baricitinib, are already on the market for treating rheumatoid arthritis and other autoimmune diseases.
Meanwhile, dermatologists have been fielding calls from hopeful patients and sorting out who should get the treatment, how to advise patients on risks and benefits, and what tests should be used before and after starting treatment.
Uptake for new systemic drugs, such as biologics, can be slow in dermatology, noted Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, as some doctors like to stick with what they know.
He told this news organization that he hopes that uptake for baricitinib is quicker, as it is the only approved oral systemic treatment for patients with severe alopecia areata, which affects about 300,000 people a year in the United States. Other treatments, including steroid injections in the scalp, have lacked efficacy and convenience.
Beyond the physical effects, the mental toll of patchy hair clumps and missing brows and lashes can be devastating for patients with alopecia areata.
Fielding patient inquiries
Word of the FDA approval spread fast, and calls and emails are coming into dermatologists’ offices and clinics from interested patients.
Physicians should be ready for patients with any kind of hair loss, not just severe alopecia areata, to ask about the drug, Dr. Friedman said. Some patients contacting him don’t fit the indication, which “highlights how disabling hair loss” is for people, considering that, in general, “people see this and think it is for them.”
Baricitinib is not a new drug, but a drug with a new indication. It had already been approved for treating moderate to severe RA in patients who have had an inadequate response to one or more tumor necrosis factor blockers, and for treating COVID-19 in certain hospitalized adults.
Boxed warning
Patients may ask about the boxed warning in the baricitinib label about the increased risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Natasha A. Mesinkovska, MD, PhD, an investigator in the clinical trials that led to FDA approval of baricitinib and the chief scientific officer at the National Alopecia Areata Foundation, told this news organization that several aspects of the label are important to point out.
One is that the warning is for all the JAK inhibitors used to treat RA and other inflammatory conditions, not just baricitinib. Also, the warning is based mostly on data on patients with RA who, she noted, have substantial comorbidities and have been taking toxic immunosuppressive medications. The RA population is also typically many years older than the alopecia areata population.
“Whether the warnings apply to the alopecia areata patients is as yet unclear,” said Dr. Mesinkovska, who is also an associate professor of dermatology at the University of California, Irvine.
Patients are also asking about how well it works.
In one of the two trials that led up to the FDA approval, which enrolled patients with at least 50% scalp hair loss for over 6 months, 22% of the patients who received 2 mg of baricitinib and 35% of those who received 4 mg saw adequate hair coverage (at least 80%) at week 36, compared with 5% on placebo. In the second trial, 17% of those who received 2 mg and 32% who received 4 mg saw adequate hair coverage, compared with 3% on placebo.
Common side effects associated with baricitinib, according to the FDA, are lower respiratory tract infections, headache, acne, high cholesterol, increased creatinine phosphokinase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, herpes zoster (shingles), and weight gain.
The risk-benefit discussions with patients should also include potential benefits beyond hair regrowth on the scalp. Loss of hair in the ears and nose can affect hearing and allergies, Dr. Mesinkovska said.
“About 30%-50% with alopecia areata, depending on age group or part of the world, will have allergies,” she said.
Patients should also know that baricitinib will need to be taken “for a very long time,” Dr. Mesinkovska noted. It’s possible that could be forever and that stopping the medication at any point may result in hair falling out again, she says, but duration will vary from case to case.
The good news is that it has been well tolerated. “We give a lot of medications for acne like doxycycline and other antibiotics and people have more stomach problems and angst with those than with [baricitinib],” she said.
Regrowth takes time
Benjamin Ungar, MD, a dermatologist at the Alopecia Center of Excellence at Mount Sinai, New York, told this news organization that an important message for patients is that hair regrowth takes time. For some other skin conditions, patients start treatment and see almost instant improvement.
“That is not the case for alopecia areata,” he said. “The expectation is that it will take months for regrowth in general.”
He said he hasn’t started prescribing baricitinib yet, but plans to do so soon.
“Obviously, I’ll have conversations with patients about it, but it’s a medication I’m going to be using, definitely. I have no reservations,” Dr. Ungar said.
After initial testing, physicians may find that some patients might not be ideal candidates, he added. People with liver disease, a history of blood clots, abnormal blood counts, or low neutrophils are among those who may not be the best candidates for baricitinib.
For most with severe alopecia areata, though, baricitinib provides hope.
“Treatment options have been not readily available, often inaccessible, ineffective, often dangerous,” he said. “There’s a treatment now that can be accessed, generally is safe and is effective for many people.”
Be up front with patients about the unknown
Additionally, it’s important to tell patients what is not yet known, the experts interviewed say.
“Alopecia areata is a chronic disease. We don’t have long-term data on the patient population yet,” Dr. Friedman said.
Also unknown is how easy it will be for physicians to get insurance to reimburse for baricitinib, which, at the end of June, was priced at about $5,000 a month for the 4-mg dose. FDA approval was important in that regard. Previously, some claims had been rejected for drugs used off label for AA.
“We dermatologists know how much it affects patients,” Dr. Mesinkovska said. “As long as we stick by what we know and convey to insurers how much it affects people’s lives, they should cover it.”
Another unknown is what other drugs can be taken with baricitinib. In clinical trials, it was used alone, she said. Currently, concomitant use of other immune suppressants – such as methotrexate or prednisone – is not recommended. But it remains to be seen what other medications will be safe to use at the same time as more long-term data are available.
Lynne J. Goldberg, MD, professor of dermatology, pathology, and laboratory medicine, Boston University, and director of the Hair Clinic at Boston Medical Center, said that she received a slew of emails from patients asking about baricitinib, but most of them did not have alopecia areata and were not candidates for this treatment.
She said that nurses in her clinic have been instructed on what to tell patients about which patients the drug is meant to treat, side effects, and benefits.
Access won’t be immediate
Dr. Goldberg said the drug’s approval does not mean immediate access. The patient has to come in, discuss the treatment, and get lab tests first. “It’s not a casual drug. This is a potent immunosuppressant drug. You need lab tests and once you start it you need blood tests every 3 months to stay on it.”
Those tests may vary by physician, but people will generally need a standard blood count and a comprehensive metabolic panel and lipid panel. “There’s nothing esoteric,” she said.
She added that physicians will need to check for presence of infections including tuberculosis and hepatitis B and C before prescribing, just as they would before they start prescribing a biologic.
“You don’t want to reactivate something,” she noted.
But, Dr. Goldberg added, the benefits for all who have been either living with only patches of hair or no hair or who put on a wig or hat every day are “life changing.”
Dr. Mesinkovska is on the advisory boards and runs trials for Eli Lilly, Pfizer, and Concert Pharmaceuticals. Dr. Friedman, Dr. Goldberg, and Dr. Ungar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On June 13, the FDA approved baricitinib, a Janus kinase inhibitor (Olumiant, Lilly), for severe AA, and two other options may not be far behind. Pfizer and Concert Pharmaceuticals have JAK inhibitors in late-stage development for AA. JAK inhibitors, including baricitinib, are already on the market for treating rheumatoid arthritis and other autoimmune diseases.
Meanwhile, dermatologists have been fielding calls from hopeful patients and sorting out who should get the treatment, how to advise patients on risks and benefits, and what tests should be used before and after starting treatment.
Uptake for new systemic drugs, such as biologics, can be slow in dermatology, noted Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, as some doctors like to stick with what they know.
He told this news organization that he hopes that uptake for baricitinib is quicker, as it is the only approved oral systemic treatment for patients with severe alopecia areata, which affects about 300,000 people a year in the United States. Other treatments, including steroid injections in the scalp, have lacked efficacy and convenience.
Beyond the physical effects, the mental toll of patchy hair clumps and missing brows and lashes can be devastating for patients with alopecia areata.
Fielding patient inquiries
Word of the FDA approval spread fast, and calls and emails are coming into dermatologists’ offices and clinics from interested patients.
Physicians should be ready for patients with any kind of hair loss, not just severe alopecia areata, to ask about the drug, Dr. Friedman said. Some patients contacting him don’t fit the indication, which “highlights how disabling hair loss” is for people, considering that, in general, “people see this and think it is for them.”
Baricitinib is not a new drug, but a drug with a new indication. It had already been approved for treating moderate to severe RA in patients who have had an inadequate response to one or more tumor necrosis factor blockers, and for treating COVID-19 in certain hospitalized adults.
Boxed warning
Patients may ask about the boxed warning in the baricitinib label about the increased risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Natasha A. Mesinkovska, MD, PhD, an investigator in the clinical trials that led to FDA approval of baricitinib and the chief scientific officer at the National Alopecia Areata Foundation, told this news organization that several aspects of the label are important to point out.
One is that the warning is for all the JAK inhibitors used to treat RA and other inflammatory conditions, not just baricitinib. Also, the warning is based mostly on data on patients with RA who, she noted, have substantial comorbidities and have been taking toxic immunosuppressive medications. The RA population is also typically many years older than the alopecia areata population.
“Whether the warnings apply to the alopecia areata patients is as yet unclear,” said Dr. Mesinkovska, who is also an associate professor of dermatology at the University of California, Irvine.
Patients are also asking about how well it works.
In one of the two trials that led up to the FDA approval, which enrolled patients with at least 50% scalp hair loss for over 6 months, 22% of the patients who received 2 mg of baricitinib and 35% of those who received 4 mg saw adequate hair coverage (at least 80%) at week 36, compared with 5% on placebo. In the second trial, 17% of those who received 2 mg and 32% who received 4 mg saw adequate hair coverage, compared with 3% on placebo.
Common side effects associated with baricitinib, according to the FDA, are lower respiratory tract infections, headache, acne, high cholesterol, increased creatinine phosphokinase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, herpes zoster (shingles), and weight gain.
The risk-benefit discussions with patients should also include potential benefits beyond hair regrowth on the scalp. Loss of hair in the ears and nose can affect hearing and allergies, Dr. Mesinkovska said.
“About 30%-50% with alopecia areata, depending on age group or part of the world, will have allergies,” she said.
Patients should also know that baricitinib will need to be taken “for a very long time,” Dr. Mesinkovska noted. It’s possible that could be forever and that stopping the medication at any point may result in hair falling out again, she says, but duration will vary from case to case.
The good news is that it has been well tolerated. “We give a lot of medications for acne like doxycycline and other antibiotics and people have more stomach problems and angst with those than with [baricitinib],” she said.
Regrowth takes time
Benjamin Ungar, MD, a dermatologist at the Alopecia Center of Excellence at Mount Sinai, New York, told this news organization that an important message for patients is that hair regrowth takes time. For some other skin conditions, patients start treatment and see almost instant improvement.
“That is not the case for alopecia areata,” he said. “The expectation is that it will take months for regrowth in general.”
He said he hasn’t started prescribing baricitinib yet, but plans to do so soon.
“Obviously, I’ll have conversations with patients about it, but it’s a medication I’m going to be using, definitely. I have no reservations,” Dr. Ungar said.
After initial testing, physicians may find that some patients might not be ideal candidates, he added. People with liver disease, a history of blood clots, abnormal blood counts, or low neutrophils are among those who may not be the best candidates for baricitinib.
For most with severe alopecia areata, though, baricitinib provides hope.
“Treatment options have been not readily available, often inaccessible, ineffective, often dangerous,” he said. “There’s a treatment now that can be accessed, generally is safe and is effective for many people.”
Be up front with patients about the unknown
Additionally, it’s important to tell patients what is not yet known, the experts interviewed say.
“Alopecia areata is a chronic disease. We don’t have long-term data on the patient population yet,” Dr. Friedman said.
Also unknown is how easy it will be for physicians to get insurance to reimburse for baricitinib, which, at the end of June, was priced at about $5,000 a month for the 4-mg dose. FDA approval was important in that regard. Previously, some claims had been rejected for drugs used off label for AA.
“We dermatologists know how much it affects patients,” Dr. Mesinkovska said. “As long as we stick by what we know and convey to insurers how much it affects people’s lives, they should cover it.”
Another unknown is what other drugs can be taken with baricitinib. In clinical trials, it was used alone, she said. Currently, concomitant use of other immune suppressants – such as methotrexate or prednisone – is not recommended. But it remains to be seen what other medications will be safe to use at the same time as more long-term data are available.
Lynne J. Goldberg, MD, professor of dermatology, pathology, and laboratory medicine, Boston University, and director of the Hair Clinic at Boston Medical Center, said that she received a slew of emails from patients asking about baricitinib, but most of them did not have alopecia areata and were not candidates for this treatment.
She said that nurses in her clinic have been instructed on what to tell patients about which patients the drug is meant to treat, side effects, and benefits.
Access won’t be immediate
Dr. Goldberg said the drug’s approval does not mean immediate access. The patient has to come in, discuss the treatment, and get lab tests first. “It’s not a casual drug. This is a potent immunosuppressant drug. You need lab tests and once you start it you need blood tests every 3 months to stay on it.”
Those tests may vary by physician, but people will generally need a standard blood count and a comprehensive metabolic panel and lipid panel. “There’s nothing esoteric,” she said.
She added that physicians will need to check for presence of infections including tuberculosis and hepatitis B and C before prescribing, just as they would before they start prescribing a biologic.
“You don’t want to reactivate something,” she noted.
But, Dr. Goldberg added, the benefits for all who have been either living with only patches of hair or no hair or who put on a wig or hat every day are “life changing.”
Dr. Mesinkovska is on the advisory boards and runs trials for Eli Lilly, Pfizer, and Concert Pharmaceuticals. Dr. Friedman, Dr. Goldberg, and Dr. Ungar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
On June 13, the FDA approved baricitinib, a Janus kinase inhibitor (Olumiant, Lilly), for severe AA, and two other options may not be far behind. Pfizer and Concert Pharmaceuticals have JAK inhibitors in late-stage development for AA. JAK inhibitors, including baricitinib, are already on the market for treating rheumatoid arthritis and other autoimmune diseases.
Meanwhile, dermatologists have been fielding calls from hopeful patients and sorting out who should get the treatment, how to advise patients on risks and benefits, and what tests should be used before and after starting treatment.
Uptake for new systemic drugs, such as biologics, can be slow in dermatology, noted Adam Friedman, MD, professor and chair of dermatology, George Washington University, Washington, as some doctors like to stick with what they know.
He told this news organization that he hopes that uptake for baricitinib is quicker, as it is the only approved oral systemic treatment for patients with severe alopecia areata, which affects about 300,000 people a year in the United States. Other treatments, including steroid injections in the scalp, have lacked efficacy and convenience.
Beyond the physical effects, the mental toll of patchy hair clumps and missing brows and lashes can be devastating for patients with alopecia areata.
Fielding patient inquiries
Word of the FDA approval spread fast, and calls and emails are coming into dermatologists’ offices and clinics from interested patients.
Physicians should be ready for patients with any kind of hair loss, not just severe alopecia areata, to ask about the drug, Dr. Friedman said. Some patients contacting him don’t fit the indication, which “highlights how disabling hair loss” is for people, considering that, in general, “people see this and think it is for them.”
Baricitinib is not a new drug, but a drug with a new indication. It had already been approved for treating moderate to severe RA in patients who have had an inadequate response to one or more tumor necrosis factor blockers, and for treating COVID-19 in certain hospitalized adults.
Boxed warning
Patients may ask about the boxed warning in the baricitinib label about the increased risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Natasha A. Mesinkovska, MD, PhD, an investigator in the clinical trials that led to FDA approval of baricitinib and the chief scientific officer at the National Alopecia Areata Foundation, told this news organization that several aspects of the label are important to point out.
One is that the warning is for all the JAK inhibitors used to treat RA and other inflammatory conditions, not just baricitinib. Also, the warning is based mostly on data on patients with RA who, she noted, have substantial comorbidities and have been taking toxic immunosuppressive medications. The RA population is also typically many years older than the alopecia areata population.
“Whether the warnings apply to the alopecia areata patients is as yet unclear,” said Dr. Mesinkovska, who is also an associate professor of dermatology at the University of California, Irvine.
Patients are also asking about how well it works.
In one of the two trials that led up to the FDA approval, which enrolled patients with at least 50% scalp hair loss for over 6 months, 22% of the patients who received 2 mg of baricitinib and 35% of those who received 4 mg saw adequate hair coverage (at least 80%) at week 36, compared with 5% on placebo. In the second trial, 17% of those who received 2 mg and 32% who received 4 mg saw adequate hair coverage, compared with 3% on placebo.
Common side effects associated with baricitinib, according to the FDA, are lower respiratory tract infections, headache, acne, high cholesterol, increased creatinine phosphokinase, urinary tract infection, liver enzyme elevations, folliculitis, fatigue, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, herpes zoster (shingles), and weight gain.
The risk-benefit discussions with patients should also include potential benefits beyond hair regrowth on the scalp. Loss of hair in the ears and nose can affect hearing and allergies, Dr. Mesinkovska said.
“About 30%-50% with alopecia areata, depending on age group or part of the world, will have allergies,” she said.
Patients should also know that baricitinib will need to be taken “for a very long time,” Dr. Mesinkovska noted. It’s possible that could be forever and that stopping the medication at any point may result in hair falling out again, she says, but duration will vary from case to case.
The good news is that it has been well tolerated. “We give a lot of medications for acne like doxycycline and other antibiotics and people have more stomach problems and angst with those than with [baricitinib],” she said.
Regrowth takes time
Benjamin Ungar, MD, a dermatologist at the Alopecia Center of Excellence at Mount Sinai, New York, told this news organization that an important message for patients is that hair regrowth takes time. For some other skin conditions, patients start treatment and see almost instant improvement.
“That is not the case for alopecia areata,” he said. “The expectation is that it will take months for regrowth in general.”
He said he hasn’t started prescribing baricitinib yet, but plans to do so soon.
“Obviously, I’ll have conversations with patients about it, but it’s a medication I’m going to be using, definitely. I have no reservations,” Dr. Ungar said.
After initial testing, physicians may find that some patients might not be ideal candidates, he added. People with liver disease, a history of blood clots, abnormal blood counts, or low neutrophils are among those who may not be the best candidates for baricitinib.
For most with severe alopecia areata, though, baricitinib provides hope.
“Treatment options have been not readily available, often inaccessible, ineffective, often dangerous,” he said. “There’s a treatment now that can be accessed, generally is safe and is effective for many people.”
Be up front with patients about the unknown
Additionally, it’s important to tell patients what is not yet known, the experts interviewed say.
“Alopecia areata is a chronic disease. We don’t have long-term data on the patient population yet,” Dr. Friedman said.
Also unknown is how easy it will be for physicians to get insurance to reimburse for baricitinib, which, at the end of June, was priced at about $5,000 a month for the 4-mg dose. FDA approval was important in that regard. Previously, some claims had been rejected for drugs used off label for AA.
“We dermatologists know how much it affects patients,” Dr. Mesinkovska said. “As long as we stick by what we know and convey to insurers how much it affects people’s lives, they should cover it.”
Another unknown is what other drugs can be taken with baricitinib. In clinical trials, it was used alone, she said. Currently, concomitant use of other immune suppressants – such as methotrexate or prednisone – is not recommended. But it remains to be seen what other medications will be safe to use at the same time as more long-term data are available.
Lynne J. Goldberg, MD, professor of dermatology, pathology, and laboratory medicine, Boston University, and director of the Hair Clinic at Boston Medical Center, said that she received a slew of emails from patients asking about baricitinib, but most of them did not have alopecia areata and were not candidates for this treatment.
She said that nurses in her clinic have been instructed on what to tell patients about which patients the drug is meant to treat, side effects, and benefits.
Access won’t be immediate
Dr. Goldberg said the drug’s approval does not mean immediate access. The patient has to come in, discuss the treatment, and get lab tests first. “It’s not a casual drug. This is a potent immunosuppressant drug. You need lab tests and once you start it you need blood tests every 3 months to stay on it.”
Those tests may vary by physician, but people will generally need a standard blood count and a comprehensive metabolic panel and lipid panel. “There’s nothing esoteric,” she said.
She added that physicians will need to check for presence of infections including tuberculosis and hepatitis B and C before prescribing, just as they would before they start prescribing a biologic.
“You don’t want to reactivate something,” she noted.
But, Dr. Goldberg added, the benefits for all who have been either living with only patches of hair or no hair or who put on a wig or hat every day are “life changing.”
Dr. Mesinkovska is on the advisory boards and runs trials for Eli Lilly, Pfizer, and Concert Pharmaceuticals. Dr. Friedman, Dr. Goldberg, and Dr. Ungar reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nail dystrophy and foot pain
These findings are consistent with a type of heritable keratoderma called pachyonychia congenita (also called twenty-nails dystrophy). It is easy to mistake this unusual cause of thickening nails with a more common cause: onychomycosis.
Pachyonychia congenita describes a set of disorders driven by heritable defects in 1 of 5 keratin genes. The disorder is often transmitted in an autosomal dominant fashion, although a third of patients are thought to have a spontaneous mutation.1 These gene changes can cause 1 or multiple dystrophic nails, thickened nail beds, natal teeth, thick plantar or palmar nodules or plaques, and hearing difficulties. Some patients may have symptoms at birth, while other patients do not develop symptoms until later in life.1
There is currently no cure for pachyonychia congenita. Patients with suspected heritable keratoderma benefit from referral to Medical Genetics and a dermatologist who is comfortable treating keratodermas. Patients can obtain free genetic testing, educational material, and additional resources through pachyonychia.org.
This patient was prescribed topical urea 40% cream that was to be applied to the feet nightly, until the nodules became less painful. He was also evaluated for pressure-offloading orthotics. Nails may be treated with topical urea lacquer nightly until patients are satisfied with the appearance, although this patient chose to forgo the lacquer.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Smith FJD, Hansen CD, Hull PR, et al. Pachyonychia congenita. In: Adam MP, Mirzaa GM, Pagon RA, et al., eds. GeneReviews. Seattle (WA): University of Washington, Seattle; 2006. Updated November 30, 2017. Accessed June 27, 2022. https://www.ncbi.nlm.nih.gov/books/NBK1280/
These findings are consistent with a type of heritable keratoderma called pachyonychia congenita (also called twenty-nails dystrophy). It is easy to mistake this unusual cause of thickening nails with a more common cause: onychomycosis.
Pachyonychia congenita describes a set of disorders driven by heritable defects in 1 of 5 keratin genes. The disorder is often transmitted in an autosomal dominant fashion, although a third of patients are thought to have a spontaneous mutation.1 These gene changes can cause 1 or multiple dystrophic nails, thickened nail beds, natal teeth, thick plantar or palmar nodules or plaques, and hearing difficulties. Some patients may have symptoms at birth, while other patients do not develop symptoms until later in life.1
There is currently no cure for pachyonychia congenita. Patients with suspected heritable keratoderma benefit from referral to Medical Genetics and a dermatologist who is comfortable treating keratodermas. Patients can obtain free genetic testing, educational material, and additional resources through pachyonychia.org.
This patient was prescribed topical urea 40% cream that was to be applied to the feet nightly, until the nodules became less painful. He was also evaluated for pressure-offloading orthotics. Nails may be treated with topical urea lacquer nightly until patients are satisfied with the appearance, although this patient chose to forgo the lacquer.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
These findings are consistent with a type of heritable keratoderma called pachyonychia congenita (also called twenty-nails dystrophy). It is easy to mistake this unusual cause of thickening nails with a more common cause: onychomycosis.
Pachyonychia congenita describes a set of disorders driven by heritable defects in 1 of 5 keratin genes. The disorder is often transmitted in an autosomal dominant fashion, although a third of patients are thought to have a spontaneous mutation.1 These gene changes can cause 1 or multiple dystrophic nails, thickened nail beds, natal teeth, thick plantar or palmar nodules or plaques, and hearing difficulties. Some patients may have symptoms at birth, while other patients do not develop symptoms until later in life.1
There is currently no cure for pachyonychia congenita. Patients with suspected heritable keratoderma benefit from referral to Medical Genetics and a dermatologist who is comfortable treating keratodermas. Patients can obtain free genetic testing, educational material, and additional resources through pachyonychia.org.
This patient was prescribed topical urea 40% cream that was to be applied to the feet nightly, until the nodules became less painful. He was also evaluated for pressure-offloading orthotics. Nails may be treated with topical urea lacquer nightly until patients are satisfied with the appearance, although this patient chose to forgo the lacquer.
Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).
1. Smith FJD, Hansen CD, Hull PR, et al. Pachyonychia congenita. In: Adam MP, Mirzaa GM, Pagon RA, et al., eds. GeneReviews. Seattle (WA): University of Washington, Seattle; 2006. Updated November 30, 2017. Accessed June 27, 2022. https://www.ncbi.nlm.nih.gov/books/NBK1280/
1. Smith FJD, Hansen CD, Hull PR, et al. Pachyonychia congenita. In: Adam MP, Mirzaa GM, Pagon RA, et al., eds. GeneReviews. Seattle (WA): University of Washington, Seattle; 2006. Updated November 30, 2017. Accessed June 27, 2022. https://www.ncbi.nlm.nih.gov/books/NBK1280/
Skin reactions after COVID-19 vaccination have six patterns
Skin manifestations of COVID-19 were among the topics presented in several sessions at the 49th Congress of the Spanish Academy of Dermatology and Venereology. Specialists agreed that fewer skin changes associated with this virus have been seen with the latest variants of SARS-CoV-2. They highlighted the results of the most remarkable research on this topic that were presented in this forum.
In the study, which was carried out by Spanish dermatologists with the support of the AEDV, researchers analyzed skin reactions associated with the COVID-19 vaccine.
Study author Cristina Galván, MD, a dermatologist at the University Hospital of Móstoles, Madrid, said, of the dermatological manifestations caused as a reaction to these vaccines.”
The study was carried out during the first months of COVID-19 vaccination, Dr. Galván told this news organization. It was proposed as a continuation of a COVID skin study that was published in the British Journal of Dermatology. That study documented the first classification of skin lesions associated with COVID-19. Dr. Galván is the lead author of the latter study.
“The objectives of this study were to characterize and classify skin reactions after vaccination, identify their chronology, and analyze the associations with a series of antecedents: dermatological and allergic diseases, previous SARS-CoV-2 infection, and skin reactions associated with COVID-19,” said Dr. Galván. The study was a team effort, she added.
“It was conducted between Feb. 15 and May 12, 2021, and information was gathered on 405 reactions that appeared during the 21 days after any dose of the COVID-19 vaccines approved at that time in Spain: the Pfizer/BioNTech, Moderna, and University of Oxford/AstraZeneca vaccines,” she added.
Dr. Galván explained that the study shows very clear patterns and investigators reached conclusions that match those of other groups that have investigated this topic. “Six reaction patterns were described according to their frequency. The first is the ‘COVID-19 arm,’ which consists of a local reaction at the injection site and occurs almost exclusively in women and in 70% of cases after inoculation with the Moderna serum. It is a manifestation that resolves well and does not always recur in subsequent doses. More than half are of delayed onset: biopsied patients show signs of a delayed hypersensitivity reaction. In line with all the publications in this regard, it was found that this reaction is not a reason to skip or delay a dose.”
Herpes zoster reactivation
The second pattern is urticarial, which, according to the specialist, occurs with equal frequency after the administration of all vaccines and is well controlled with antihistamines. “This is a very nonspecific pattern, which does not prevent it from still being frequent. It was not associated with drug intake.
“The morbilliform pattern is more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. It affects the trunk and extremities, and up to a quarter of the cases required systemic corticosteroids. The papulovesicular and pityriasis rosea–like patterns are equally frequent in all vaccines. The latter is found in a younger age group. Finally, there is the purpuric pattern, more localized in the extremities and more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. On biopsy, this pattern showed small-vessel vasculitis.”
Less frequently, reactivations or de novo onset of different dermatologic diseases were found. “Varicella-zoster virus reactivations were observed with a frequency of 13.8%, being more common after the Pfizer/BioNTech vaccine,” said Dr. Galván. “Other studies have corroborated this increase in herpes zoster, although it has been seen that the absolute number is low, so the benefits of the vaccine outweigh this eventual complication. At the same time and along the same lines, vaccination against herpes zoster is recommended for those over 50 years of age.”
Another fact revealed by the study is that these reactions were not significantly more severe in people with dermatologic diseases, those with previous infection, or those with skin manifestation associated with COVID-19.
Dr. Galván highlighted that, except for the COVID-19 arm, these patterns were among those associated with the disease, “which supports [the idea] that it does not demonstrate that the host’s immune reaction to the infection was playing a role.”
Women and young people
“As for pseudoperniosis, it is poorly represented in our series: 0.7% compared to 2% in the American registry. Although neither the SARS-CoV-2–pseudoperniosis association nor its pathophysiology is clear, the idea is that if this manifestation is related to the host’s immune response during infection, pseudoperniosis after vaccination could also be linked to the immune response to the vaccine,” said Dr. Galván.
Many of these reactions are more intense in women. “Before starting to use these vaccines, we already knew that messenger RNA vaccines (a powerful activator of innate immunity) induce frequent reactions, that adjuvants and excipients (polyethylene glycol and polysorbate) also generate them, and that other factors influence reactogenicity, among those of us of the same age and sex, reactions being more frequent in younger people and in women,” said Dr. Galván. “This may be one of the reasons why the COVID-19 arm is so much more prevalent in the female population and that 80% of all reactions that were collected were in women.”
In relation to the fact that manifestations differed, depending on the type of inoculated serum, Dr. Galván said, “Some reactions are just as common after any of the vaccines. However, others are not, as is the case with the COVID-19 arm for the Moderna vaccine or reactivations of the herpes virus, more frequent after the Pfizer/BioNTech vaccine.
“Undoubtedly, behind these differences are particularities in the immune reaction caused by each of the vaccines and their composition, including the excipients,” she said.
Regarding the fact that these reactions were the same throughout the vaccine regimen or that they varied in intensity, depending on the dose, Dr. Galván said, “In our study, as in those carried out by other groups, there were no significant differences in terms of frequency after the first and second doses. One thing to keep in mind is that, due to the temporary design of our study and the time at which it was conducted, it was not possible to collect reactions after second doses of AstraZeneca.
“Manifestations have generally been mild and well controlled. Many of them did not recur after the second dose, and the vast majority did not prevent completion of the vaccination scheme, but we must not lose sight of the fact that 20% of these manifestations were assessed by the dermatologist as serious or very serious,” Dr. Galván added.
Regarding the next steps planned for this line of research, Dr. Galván commented, “We are awaiting the evolution of the reported cases and the reactions that may arise, although for now, our group does not have any open studies. The most important thing now is to be alert and report the data observed in the pharmacovigilance systems, in open registries, and in scientific literature to generate evidence.”
Dr. Galván has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Skin manifestations of COVID-19 were among the topics presented in several sessions at the 49th Congress of the Spanish Academy of Dermatology and Venereology. Specialists agreed that fewer skin changes associated with this virus have been seen with the latest variants of SARS-CoV-2. They highlighted the results of the most remarkable research on this topic that were presented in this forum.
In the study, which was carried out by Spanish dermatologists with the support of the AEDV, researchers analyzed skin reactions associated with the COVID-19 vaccine.
Study author Cristina Galván, MD, a dermatologist at the University Hospital of Móstoles, Madrid, said, of the dermatological manifestations caused as a reaction to these vaccines.”
The study was carried out during the first months of COVID-19 vaccination, Dr. Galván told this news organization. It was proposed as a continuation of a COVID skin study that was published in the British Journal of Dermatology. That study documented the first classification of skin lesions associated with COVID-19. Dr. Galván is the lead author of the latter study.
“The objectives of this study were to characterize and classify skin reactions after vaccination, identify their chronology, and analyze the associations with a series of antecedents: dermatological and allergic diseases, previous SARS-CoV-2 infection, and skin reactions associated with COVID-19,” said Dr. Galván. The study was a team effort, she added.
“It was conducted between Feb. 15 and May 12, 2021, and information was gathered on 405 reactions that appeared during the 21 days after any dose of the COVID-19 vaccines approved at that time in Spain: the Pfizer/BioNTech, Moderna, and University of Oxford/AstraZeneca vaccines,” she added.
Dr. Galván explained that the study shows very clear patterns and investigators reached conclusions that match those of other groups that have investigated this topic. “Six reaction patterns were described according to their frequency. The first is the ‘COVID-19 arm,’ which consists of a local reaction at the injection site and occurs almost exclusively in women and in 70% of cases after inoculation with the Moderna serum. It is a manifestation that resolves well and does not always recur in subsequent doses. More than half are of delayed onset: biopsied patients show signs of a delayed hypersensitivity reaction. In line with all the publications in this regard, it was found that this reaction is not a reason to skip or delay a dose.”
Herpes zoster reactivation
The second pattern is urticarial, which, according to the specialist, occurs with equal frequency after the administration of all vaccines and is well controlled with antihistamines. “This is a very nonspecific pattern, which does not prevent it from still being frequent. It was not associated with drug intake.
“The morbilliform pattern is more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. It affects the trunk and extremities, and up to a quarter of the cases required systemic corticosteroids. The papulovesicular and pityriasis rosea–like patterns are equally frequent in all vaccines. The latter is found in a younger age group. Finally, there is the purpuric pattern, more localized in the extremities and more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. On biopsy, this pattern showed small-vessel vasculitis.”
Less frequently, reactivations or de novo onset of different dermatologic diseases were found. “Varicella-zoster virus reactivations were observed with a frequency of 13.8%, being more common after the Pfizer/BioNTech vaccine,” said Dr. Galván. “Other studies have corroborated this increase in herpes zoster, although it has been seen that the absolute number is low, so the benefits of the vaccine outweigh this eventual complication. At the same time and along the same lines, vaccination against herpes zoster is recommended for those over 50 years of age.”
Another fact revealed by the study is that these reactions were not significantly more severe in people with dermatologic diseases, those with previous infection, or those with skin manifestation associated with COVID-19.
Dr. Galván highlighted that, except for the COVID-19 arm, these patterns were among those associated with the disease, “which supports [the idea] that it does not demonstrate that the host’s immune reaction to the infection was playing a role.”
Women and young people
“As for pseudoperniosis, it is poorly represented in our series: 0.7% compared to 2% in the American registry. Although neither the SARS-CoV-2–pseudoperniosis association nor its pathophysiology is clear, the idea is that if this manifestation is related to the host’s immune response during infection, pseudoperniosis after vaccination could also be linked to the immune response to the vaccine,” said Dr. Galván.
Many of these reactions are more intense in women. “Before starting to use these vaccines, we already knew that messenger RNA vaccines (a powerful activator of innate immunity) induce frequent reactions, that adjuvants and excipients (polyethylene glycol and polysorbate) also generate them, and that other factors influence reactogenicity, among those of us of the same age and sex, reactions being more frequent in younger people and in women,” said Dr. Galván. “This may be one of the reasons why the COVID-19 arm is so much more prevalent in the female population and that 80% of all reactions that were collected were in women.”
In relation to the fact that manifestations differed, depending on the type of inoculated serum, Dr. Galván said, “Some reactions are just as common after any of the vaccines. However, others are not, as is the case with the COVID-19 arm for the Moderna vaccine or reactivations of the herpes virus, more frequent after the Pfizer/BioNTech vaccine.
“Undoubtedly, behind these differences are particularities in the immune reaction caused by each of the vaccines and their composition, including the excipients,” she said.
Regarding the fact that these reactions were the same throughout the vaccine regimen or that they varied in intensity, depending on the dose, Dr. Galván said, “In our study, as in those carried out by other groups, there were no significant differences in terms of frequency after the first and second doses. One thing to keep in mind is that, due to the temporary design of our study and the time at which it was conducted, it was not possible to collect reactions after second doses of AstraZeneca.
“Manifestations have generally been mild and well controlled. Many of them did not recur after the second dose, and the vast majority did not prevent completion of the vaccination scheme, but we must not lose sight of the fact that 20% of these manifestations were assessed by the dermatologist as serious or very serious,” Dr. Galván added.
Regarding the next steps planned for this line of research, Dr. Galván commented, “We are awaiting the evolution of the reported cases and the reactions that may arise, although for now, our group does not have any open studies. The most important thing now is to be alert and report the data observed in the pharmacovigilance systems, in open registries, and in scientific literature to generate evidence.”
Dr. Galván has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Skin manifestations of COVID-19 were among the topics presented in several sessions at the 49th Congress of the Spanish Academy of Dermatology and Venereology. Specialists agreed that fewer skin changes associated with this virus have been seen with the latest variants of SARS-CoV-2. They highlighted the results of the most remarkable research on this topic that were presented in this forum.
In the study, which was carried out by Spanish dermatologists with the support of the AEDV, researchers analyzed skin reactions associated with the COVID-19 vaccine.
Study author Cristina Galván, MD, a dermatologist at the University Hospital of Móstoles, Madrid, said, of the dermatological manifestations caused as a reaction to these vaccines.”
The study was carried out during the first months of COVID-19 vaccination, Dr. Galván told this news organization. It was proposed as a continuation of a COVID skin study that was published in the British Journal of Dermatology. That study documented the first classification of skin lesions associated with COVID-19. Dr. Galván is the lead author of the latter study.
“The objectives of this study were to characterize and classify skin reactions after vaccination, identify their chronology, and analyze the associations with a series of antecedents: dermatological and allergic diseases, previous SARS-CoV-2 infection, and skin reactions associated with COVID-19,” said Dr. Galván. The study was a team effort, she added.
“It was conducted between Feb. 15 and May 12, 2021, and information was gathered on 405 reactions that appeared during the 21 days after any dose of the COVID-19 vaccines approved at that time in Spain: the Pfizer/BioNTech, Moderna, and University of Oxford/AstraZeneca vaccines,” she added.
Dr. Galván explained that the study shows very clear patterns and investigators reached conclusions that match those of other groups that have investigated this topic. “Six reaction patterns were described according to their frequency. The first is the ‘COVID-19 arm,’ which consists of a local reaction at the injection site and occurs almost exclusively in women and in 70% of cases after inoculation with the Moderna serum. It is a manifestation that resolves well and does not always recur in subsequent doses. More than half are of delayed onset: biopsied patients show signs of a delayed hypersensitivity reaction. In line with all the publications in this regard, it was found that this reaction is not a reason to skip or delay a dose.”
Herpes zoster reactivation
The second pattern is urticarial, which, according to the specialist, occurs with equal frequency after the administration of all vaccines and is well controlled with antihistamines. “This is a very nonspecific pattern, which does not prevent it from still being frequent. It was not associated with drug intake.
“The morbilliform pattern is more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. It affects the trunk and extremities, and up to a quarter of the cases required systemic corticosteroids. The papulovesicular and pityriasis rosea–like patterns are equally frequent in all vaccines. The latter is found in a younger age group. Finally, there is the purpuric pattern, more localized in the extremities and more frequent after the Pfizer/BioNTech and AstraZeneca vaccines. On biopsy, this pattern showed small-vessel vasculitis.”
Less frequently, reactivations or de novo onset of different dermatologic diseases were found. “Varicella-zoster virus reactivations were observed with a frequency of 13.8%, being more common after the Pfizer/BioNTech vaccine,” said Dr. Galván. “Other studies have corroborated this increase in herpes zoster, although it has been seen that the absolute number is low, so the benefits of the vaccine outweigh this eventual complication. At the same time and along the same lines, vaccination against herpes zoster is recommended for those over 50 years of age.”
Another fact revealed by the study is that these reactions were not significantly more severe in people with dermatologic diseases, those with previous infection, or those with skin manifestation associated with COVID-19.
Dr. Galván highlighted that, except for the COVID-19 arm, these patterns were among those associated with the disease, “which supports [the idea] that it does not demonstrate that the host’s immune reaction to the infection was playing a role.”
Women and young people
“As for pseudoperniosis, it is poorly represented in our series: 0.7% compared to 2% in the American registry. Although neither the SARS-CoV-2–pseudoperniosis association nor its pathophysiology is clear, the idea is that if this manifestation is related to the host’s immune response during infection, pseudoperniosis after vaccination could also be linked to the immune response to the vaccine,” said Dr. Galván.
Many of these reactions are more intense in women. “Before starting to use these vaccines, we already knew that messenger RNA vaccines (a powerful activator of innate immunity) induce frequent reactions, that adjuvants and excipients (polyethylene glycol and polysorbate) also generate them, and that other factors influence reactogenicity, among those of us of the same age and sex, reactions being more frequent in younger people and in women,” said Dr. Galván. “This may be one of the reasons why the COVID-19 arm is so much more prevalent in the female population and that 80% of all reactions that were collected were in women.”
In relation to the fact that manifestations differed, depending on the type of inoculated serum, Dr. Galván said, “Some reactions are just as common after any of the vaccines. However, others are not, as is the case with the COVID-19 arm for the Moderna vaccine or reactivations of the herpes virus, more frequent after the Pfizer/BioNTech vaccine.
“Undoubtedly, behind these differences are particularities in the immune reaction caused by each of the vaccines and their composition, including the excipients,” she said.
Regarding the fact that these reactions were the same throughout the vaccine regimen or that they varied in intensity, depending on the dose, Dr. Galván said, “In our study, as in those carried out by other groups, there were no significant differences in terms of frequency after the first and second doses. One thing to keep in mind is that, due to the temporary design of our study and the time at which it was conducted, it was not possible to collect reactions after second doses of AstraZeneca.
“Manifestations have generally been mild and well controlled. Many of them did not recur after the second dose, and the vast majority did not prevent completion of the vaccination scheme, but we must not lose sight of the fact that 20% of these manifestations were assessed by the dermatologist as serious or very serious,” Dr. Galván added.
Regarding the next steps planned for this line of research, Dr. Galván commented, “We are awaiting the evolution of the reported cases and the reactions that may arise, although for now, our group does not have any open studies. The most important thing now is to be alert and report the data observed in the pharmacovigilance systems, in open registries, and in scientific literature to generate evidence.”
Dr. Galván has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.