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Topical ruxolitinib quickly relieves atopic dermatitis itch in Black patients
“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.
AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.
Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.
Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.
FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.
Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows:
- Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
- At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
- At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
- Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.
Ruxolitinib may be an alternative to systemic immunosuppressives
Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”
Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.
“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.
Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”
The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.
“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.
All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.
A version of this article first appeared on Medscape.com.
“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.
AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.
Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.
Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.
FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.
Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows:
- Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
- At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
- At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
- Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.
Ruxolitinib may be an alternative to systemic immunosuppressives
Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”
Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.
“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.
Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”
The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.
“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.
All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.
A version of this article first appeared on Medscape.com.
“Ruxolitinib cream monotherapy over 8 weeks was associated with rapid and considerable itch relief in Black or African American patients with AD and was well tolerated,” the study authors wrote in a poster presented at the annual meeting of the Society for Investigative Dermatology.
AD can behave differently in different racial groups and can be especially bothersome in Black patients. AD has a prevalence of about 20% in Black children and 5%-10% in Black adults. Black children are roughly twice as likely to be diagnosed with AD, and to have severe AD, than White children, according to the authors.
Lead author Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, and colleagues used pooled data from two identically designed phase 3 studies to describe the effects of the cream formulation of the Janus kinase (JAK) 1 and JAK 2 inhibitor ruxolitinib on itch in Black patients.
Topical ruxolitinib (Opzelura), 1.5%, was approved last September for treating AD in non-immunocompromised patients with mild to moderate AD, ages 12 years and older. In July 2022, it was approved for the treatment of nonsegmental vitiligo in the same age group.
FDA approval for AD was based on the results of the TRuE-AD1 and TRuE-AD2 double-blind randomized trials, which enrolled about 1,200 patients over age 12 with AD. These patients included 292 Black teenagers and adults between aged 12-71 years who had AD for 2 years or longer, with an Investigator’s Global Assessment (IGA) score of 2 or 3, with 3%-20% affected body surface area, excluding the scalp.
Of the 292 patients, those in the two treatment groups (n = 231) applied ruxolitinib cream twice a day for 8 weeks (0.75% in 118 patients and 1.5% in 113 patients) and 61 applied the vehicle. They used electronic diaries to record the worst level of itch they had experienced each day, from 0 (no itch) to 10 (worst imaginable itch). The main results were as follows:
- Mean itch numerical rating scale (NRS) scores at baseline were 5.3 and 5.4 for ruxolitinib cream 0.75% and 1.5%, respectively, and 5.7 for vehicle. Within about 12 hours of first application, mean itch NRS scores dropped –0.6 and –0.7 from baseline among those treated with ruxolitinib cream 0.75% and 1.5%, respectively, compared with –0.2 for those on the vehicle. At day 4, the decreases were –1.4 and –1.6 for ruxolitinib cream 0.75% and 1.5%, respectively, versus –0.6 for the vehicle (P = .026 and P = .005, respectively, vs. vehicle).
- At day 2, among the 187 patients with a baseline itch NRS score 4 or higher, more patients achieved 4-point or greater itch NRS improvement: 6.1% and 16.4% for ruxolitinib cream 0.75% and 1.5%, respectively versus 0% for vehicle. At day 7, the differences were 15.9% and 26.6% versus 3%, respectively. And by week 8, they increased to 30.1% and 43.2% versus 17.5% (P = .212 and P = .009), respectively.
- At week 2, 19% of patients in the 0.75% formulation group and 19.4% of patients in the 1.5% formulation group, compared with 5.3% in the vehicle group, reported no days of itch on question 1 of the Patient-Oriented Eczema Measure (POEM) questionnaire that evaluated various aspects of the disease over the previous week. By week 8, the differences grew to 34% and 30.8% versus 12.2%, respectively.
- Adverse events, reported by 14.4% and 22.1% of patients on 0.75% and 1.5% ruxolitinib, respectively, and by 32.8% of patients who received the vehicle, were headaches, upper respiratory tract infection, and application site pain.
Ruxolitinib may be an alternative to systemic immunosuppressives
Asked to comment on the results, Amy J. McMichael, MD, professor of dermatology at Wake Forest University School of Medicine, Winston-Salem, N.C., called itch “one of the major life disruptors in atopic dermatitis.”
Providers often assume that patients of different races respond similarly to treatment, but that is not always true, she noted in an email.
“This study proves ruxolitinib’s effectiveness in Black patients, who often have more severe atopic dermatitis signs and symptoms,” said Dr. McMichael, who was not involved in the study. “The fact that atopic dermatitis in patients of color has been singled out to examine efficacy is a great way to show that the findings are not just in those who have thinner plaques and potentially less longstanding thickening of the skin from scratching (lichenification),” she added.
Dr. McMichael welcomed the lack of systemic side effects and quick relief of itch with this treatment, noting that the effect on itch “is rare with other treatments and extremely rare with other topical medications.”
The effect of topical ruxolitinib on pruritus “was interesting and surprising because very few available topical medications can control itch,” she explained. “The strongest topical steroids can help with pruritus, but they have the risk for skin thinning (atrophy),” while topical ruxolitinib is not associated with skin atrophy.
“After topical steroids fail as first-line treatment, it is likely that more patients will be given this topical medication rather than be moved to immunosuppressive systemic medications,” she noted.
All study authors report relevant relationships with Incyte Corporation, which manufactures ruxolitinib and funded the study, and several authors report employment and shareholding interests in the company. Dr. McMichael reports no relevant relationship with the study.
A version of this article first appeared on Medscape.com.
FROM SID 2022
Cultural humility required to optimize treatment of eczema patients with skin of color
INDIANAPOLIS – Treating atopic dermatitis (AD) in children and adolescents with skin of color requires an acumen that extends well beyond the skin, said Candrice R. Heath, MD, at the annual meeting of the Society for Pediatric Dermatology.
This involves the practice of cultural humility, which Dr. Heath defined as a commitment to learn about all aspects of patients to truly understand them, including their race, access to health care, and socioeconomic status.
“We can continue to prioritize learning about all different types of skin tones and hair types, but we really have to commit to advocating for what our patients deserve in every way,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said during her presentation at the meeting.
“That means advocating for kids to have access to better housing and for increasing health literacy programs in our hospitals, so that all our patients can understand what’s happening and how to navigate the health system,” she said. “It also means increasing diversity in our clinical trials by taking a few extra moments with the patient and family of color who might be eligible to participate in a clinical trial. We have work to do.”
To illustrate her points, she discussed the case of a 6-year-old Black patient, whose parents bring him into the clinic complaining about dark marks on the skin. The areas are itchy and the doctor figures, “this is a slam dunk; this is AD,” Dr. Heath said. “You talk about the diagnosis, and you give your treatment plan.
“But the issue is, in the parking lot when the patient’s family leaves, they feel like you didn’t help them at all,” she continued. “You didn’t understand what they came in for. They didn’t receive a treatment for what they came in for, because the initial complaint was dark marks on the skin, which is postinflammatory hyperpigmentation. We know that patients are distressed by this.”
As evidence, she cited a cross-sectional study that assessed the impact of hyperpigmentation and hyperchromia on quality of life in adults, published in the Journal of the American Academy of Dermatology. People who reported the highest levels of distress were women, those with postinflammatory hyperpigmentation, those with fewer formal years of education, and those who had higher out-of-pocket spending on skin-enhancing products.
“So, when you see hyperpigmentation in your AD patients of color, acknowledge it; say, ‘I see this pigmentation change,’ ” Dr. Heath advised. “Talk about how controlling the AD with a topical steroid or other treatment option can have a positive impact on that.”
However, she added that sometimes patients have steroid phobia, possibly because they believe the topical steroids are causing the pigmentation changes, “especially in cases of hypopigmentation, so I take the time to reassure patients so that they will not be fearful about using the medication.”
Parents of patients with skin of color who have AD may harbor other “invisible” concerns during office visits, she continued, including prior experiences with dermatologists that may not have been positive, difficulty accessing pediatric dermatologists, or a general mistrust of the health care system.
“All of that is going on in the room with your patients, particularly those with skin of color and those who feel marginalized,” said Dr. Heath, who is also a faculty scholar at Temple University medical school’s office of health equity, diversity and inclusion. “Of course, we can’t fix everything. But we can commit to approaching our visits with cultural humility.”
For patients with skin of color, she pointed out, other upstream effects impact AD care and outcomes, including well-documented socioeconomic factors.
“One of the equalizing factors is that we as pediatric dermatologists can think about increasing our education regarding skin of color,” Dr. Heath said.
For example, an analysis of data from the 2002 to 2012 National Inpatient Sample found that the main risk factors for inpatient hospitalization for AD were being non-White, having lowest-quartile household income, and having Medicaid or no insurance, researchers reported in 2018.
A separate multicenter study of 1,437 mother-child pairs with known AD found that non-Hispanic Black children and Hispanic children had greater odds of persistent AD than non-Hispanic White children, according to a 2019 study. Another large prospective cohort study published in 2019 found that AD prevalence and persistence is highest in U.S. urban children who are female or Black, and urban children with AD are more likely to have poor quality of life and asthma.
A few months after that study was published, researchers reported results from an analysis of data from the 2007-2008 National Survey of Children’s Health, which found that children who perceive the neighborhood they lived in as unsafe, unsupportive, or underdeveloped had a higher prevalence of AD and a higher severity of AD. The same year, a study of the social and economic risk factors for moderate to severe AD found that Black children were more likely to come from homes with a lower household income, lower parental education attainment, lack of home ownership, and live between two residences, and have exposure to smoke.
“Disease recognition is one thing, but we also want everyone to be aware of these other factors,” she said, “because some patients do need a little bit more care and help to be able to access the medications that they need and gain access to us.”
Follicular, nummular eczema
In her clinical experience, the most common clinical variants of AD in patients with skin of color is follicular eczema. “Examine the patient, apply your hand to the affected area, and you can feel the papules beneath your fingertips,” she advised.
“That’s what I teach my residents and medical students,” she said. “If you are looking for erythema to seal your diagnosis of AD, it may not happen. You may see more of a violaceous hue and sometimes you may not find it at all, depending on the patient’s skin tone. If I find an area of normal appearing skin and then look back at the area of active skin disease, I go back and forth until I’m able to train my eye to be able to see those violaceous and erythematous hues more easily.”
Nummular eczema can also be a challenge in AD patients with skin of color.
“I like to listen to buzz words,” Dr. Heath said. “If a parent says, ‘my child has been diagnosed with ringworm multiple times,’ I zoom in on that. We know that kids can get tinea corporis, but usually not multiple times. I ask about all the things that can be associated with AD, and often we do see these nummular plaques on the skin and do some education about that. I also talk to their pediatrician or send information to that person so that they can be aware that nummular eczema is a form of AD.”
She noted that AD of the scalp may be confused with tinea capitis, especially in young Black children with moderate to severe AD. In her experience, triamcinolone 0.1% ointment works well for AD of the scalp.
She concluded her presentation by noting that there is no easy solution to treating AD in young patients with skin of color. “It’s way more than just eczema. We can help people see AD in a different way. My goal is to see the value in challenging ourselves to understand the impact of what happens outside of the exam room on these patients.”
Dr. Heath disclosed that she has served as a consultant for several pharmaceutical companies, including Regeneron, Janssen, Arcutis, Johnson and Johnson, Cassiopea, and Lilly.
INDIANAPOLIS – Treating atopic dermatitis (AD) in children and adolescents with skin of color requires an acumen that extends well beyond the skin, said Candrice R. Heath, MD, at the annual meeting of the Society for Pediatric Dermatology.
This involves the practice of cultural humility, which Dr. Heath defined as a commitment to learn about all aspects of patients to truly understand them, including their race, access to health care, and socioeconomic status.
“We can continue to prioritize learning about all different types of skin tones and hair types, but we really have to commit to advocating for what our patients deserve in every way,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said during her presentation at the meeting.
“That means advocating for kids to have access to better housing and for increasing health literacy programs in our hospitals, so that all our patients can understand what’s happening and how to navigate the health system,” she said. “It also means increasing diversity in our clinical trials by taking a few extra moments with the patient and family of color who might be eligible to participate in a clinical trial. We have work to do.”
To illustrate her points, she discussed the case of a 6-year-old Black patient, whose parents bring him into the clinic complaining about dark marks on the skin. The areas are itchy and the doctor figures, “this is a slam dunk; this is AD,” Dr. Heath said. “You talk about the diagnosis, and you give your treatment plan.
“But the issue is, in the parking lot when the patient’s family leaves, they feel like you didn’t help them at all,” she continued. “You didn’t understand what they came in for. They didn’t receive a treatment for what they came in for, because the initial complaint was dark marks on the skin, which is postinflammatory hyperpigmentation. We know that patients are distressed by this.”
As evidence, she cited a cross-sectional study that assessed the impact of hyperpigmentation and hyperchromia on quality of life in adults, published in the Journal of the American Academy of Dermatology. People who reported the highest levels of distress were women, those with postinflammatory hyperpigmentation, those with fewer formal years of education, and those who had higher out-of-pocket spending on skin-enhancing products.
“So, when you see hyperpigmentation in your AD patients of color, acknowledge it; say, ‘I see this pigmentation change,’ ” Dr. Heath advised. “Talk about how controlling the AD with a topical steroid or other treatment option can have a positive impact on that.”
However, she added that sometimes patients have steroid phobia, possibly because they believe the topical steroids are causing the pigmentation changes, “especially in cases of hypopigmentation, so I take the time to reassure patients so that they will not be fearful about using the medication.”
Parents of patients with skin of color who have AD may harbor other “invisible” concerns during office visits, she continued, including prior experiences with dermatologists that may not have been positive, difficulty accessing pediatric dermatologists, or a general mistrust of the health care system.
“All of that is going on in the room with your patients, particularly those with skin of color and those who feel marginalized,” said Dr. Heath, who is also a faculty scholar at Temple University medical school’s office of health equity, diversity and inclusion. “Of course, we can’t fix everything. But we can commit to approaching our visits with cultural humility.”
For patients with skin of color, she pointed out, other upstream effects impact AD care and outcomes, including well-documented socioeconomic factors.
“One of the equalizing factors is that we as pediatric dermatologists can think about increasing our education regarding skin of color,” Dr. Heath said.
For example, an analysis of data from the 2002 to 2012 National Inpatient Sample found that the main risk factors for inpatient hospitalization for AD were being non-White, having lowest-quartile household income, and having Medicaid or no insurance, researchers reported in 2018.
A separate multicenter study of 1,437 mother-child pairs with known AD found that non-Hispanic Black children and Hispanic children had greater odds of persistent AD than non-Hispanic White children, according to a 2019 study. Another large prospective cohort study published in 2019 found that AD prevalence and persistence is highest in U.S. urban children who are female or Black, and urban children with AD are more likely to have poor quality of life and asthma.
A few months after that study was published, researchers reported results from an analysis of data from the 2007-2008 National Survey of Children’s Health, which found that children who perceive the neighborhood they lived in as unsafe, unsupportive, or underdeveloped had a higher prevalence of AD and a higher severity of AD. The same year, a study of the social and economic risk factors for moderate to severe AD found that Black children were more likely to come from homes with a lower household income, lower parental education attainment, lack of home ownership, and live between two residences, and have exposure to smoke.
“Disease recognition is one thing, but we also want everyone to be aware of these other factors,” she said, “because some patients do need a little bit more care and help to be able to access the medications that they need and gain access to us.”
Follicular, nummular eczema
In her clinical experience, the most common clinical variants of AD in patients with skin of color is follicular eczema. “Examine the patient, apply your hand to the affected area, and you can feel the papules beneath your fingertips,” she advised.
“That’s what I teach my residents and medical students,” she said. “If you are looking for erythema to seal your diagnosis of AD, it may not happen. You may see more of a violaceous hue and sometimes you may not find it at all, depending on the patient’s skin tone. If I find an area of normal appearing skin and then look back at the area of active skin disease, I go back and forth until I’m able to train my eye to be able to see those violaceous and erythematous hues more easily.”
Nummular eczema can also be a challenge in AD patients with skin of color.
“I like to listen to buzz words,” Dr. Heath said. “If a parent says, ‘my child has been diagnosed with ringworm multiple times,’ I zoom in on that. We know that kids can get tinea corporis, but usually not multiple times. I ask about all the things that can be associated with AD, and often we do see these nummular plaques on the skin and do some education about that. I also talk to their pediatrician or send information to that person so that they can be aware that nummular eczema is a form of AD.”
She noted that AD of the scalp may be confused with tinea capitis, especially in young Black children with moderate to severe AD. In her experience, triamcinolone 0.1% ointment works well for AD of the scalp.
She concluded her presentation by noting that there is no easy solution to treating AD in young patients with skin of color. “It’s way more than just eczema. We can help people see AD in a different way. My goal is to see the value in challenging ourselves to understand the impact of what happens outside of the exam room on these patients.”
Dr. Heath disclosed that she has served as a consultant for several pharmaceutical companies, including Regeneron, Janssen, Arcutis, Johnson and Johnson, Cassiopea, and Lilly.
INDIANAPOLIS – Treating atopic dermatitis (AD) in children and adolescents with skin of color requires an acumen that extends well beyond the skin, said Candrice R. Heath, MD, at the annual meeting of the Society for Pediatric Dermatology.
This involves the practice of cultural humility, which Dr. Heath defined as a commitment to learn about all aspects of patients to truly understand them, including their race, access to health care, and socioeconomic status.
“We can continue to prioritize learning about all different types of skin tones and hair types, but we really have to commit to advocating for what our patients deserve in every way,” Dr. Heath, director of pediatric dermatology at Temple University, Philadelphia, said during her presentation at the meeting.
“That means advocating for kids to have access to better housing and for increasing health literacy programs in our hospitals, so that all our patients can understand what’s happening and how to navigate the health system,” she said. “It also means increasing diversity in our clinical trials by taking a few extra moments with the patient and family of color who might be eligible to participate in a clinical trial. We have work to do.”
To illustrate her points, she discussed the case of a 6-year-old Black patient, whose parents bring him into the clinic complaining about dark marks on the skin. The areas are itchy and the doctor figures, “this is a slam dunk; this is AD,” Dr. Heath said. “You talk about the diagnosis, and you give your treatment plan.
“But the issue is, in the parking lot when the patient’s family leaves, they feel like you didn’t help them at all,” she continued. “You didn’t understand what they came in for. They didn’t receive a treatment for what they came in for, because the initial complaint was dark marks on the skin, which is postinflammatory hyperpigmentation. We know that patients are distressed by this.”
As evidence, she cited a cross-sectional study that assessed the impact of hyperpigmentation and hyperchromia on quality of life in adults, published in the Journal of the American Academy of Dermatology. People who reported the highest levels of distress were women, those with postinflammatory hyperpigmentation, those with fewer formal years of education, and those who had higher out-of-pocket spending on skin-enhancing products.
“So, when you see hyperpigmentation in your AD patients of color, acknowledge it; say, ‘I see this pigmentation change,’ ” Dr. Heath advised. “Talk about how controlling the AD with a topical steroid or other treatment option can have a positive impact on that.”
However, she added that sometimes patients have steroid phobia, possibly because they believe the topical steroids are causing the pigmentation changes, “especially in cases of hypopigmentation, so I take the time to reassure patients so that they will not be fearful about using the medication.”
Parents of patients with skin of color who have AD may harbor other “invisible” concerns during office visits, she continued, including prior experiences with dermatologists that may not have been positive, difficulty accessing pediatric dermatologists, or a general mistrust of the health care system.
“All of that is going on in the room with your patients, particularly those with skin of color and those who feel marginalized,” said Dr. Heath, who is also a faculty scholar at Temple University medical school’s office of health equity, diversity and inclusion. “Of course, we can’t fix everything. But we can commit to approaching our visits with cultural humility.”
For patients with skin of color, she pointed out, other upstream effects impact AD care and outcomes, including well-documented socioeconomic factors.
“One of the equalizing factors is that we as pediatric dermatologists can think about increasing our education regarding skin of color,” Dr. Heath said.
For example, an analysis of data from the 2002 to 2012 National Inpatient Sample found that the main risk factors for inpatient hospitalization for AD were being non-White, having lowest-quartile household income, and having Medicaid or no insurance, researchers reported in 2018.
A separate multicenter study of 1,437 mother-child pairs with known AD found that non-Hispanic Black children and Hispanic children had greater odds of persistent AD than non-Hispanic White children, according to a 2019 study. Another large prospective cohort study published in 2019 found that AD prevalence and persistence is highest in U.S. urban children who are female or Black, and urban children with AD are more likely to have poor quality of life and asthma.
A few months after that study was published, researchers reported results from an analysis of data from the 2007-2008 National Survey of Children’s Health, which found that children who perceive the neighborhood they lived in as unsafe, unsupportive, or underdeveloped had a higher prevalence of AD and a higher severity of AD. The same year, a study of the social and economic risk factors for moderate to severe AD found that Black children were more likely to come from homes with a lower household income, lower parental education attainment, lack of home ownership, and live between two residences, and have exposure to smoke.
“Disease recognition is one thing, but we also want everyone to be aware of these other factors,” she said, “because some patients do need a little bit more care and help to be able to access the medications that they need and gain access to us.”
Follicular, nummular eczema
In her clinical experience, the most common clinical variants of AD in patients with skin of color is follicular eczema. “Examine the patient, apply your hand to the affected area, and you can feel the papules beneath your fingertips,” she advised.
“That’s what I teach my residents and medical students,” she said. “If you are looking for erythema to seal your diagnosis of AD, it may not happen. You may see more of a violaceous hue and sometimes you may not find it at all, depending on the patient’s skin tone. If I find an area of normal appearing skin and then look back at the area of active skin disease, I go back and forth until I’m able to train my eye to be able to see those violaceous and erythematous hues more easily.”
Nummular eczema can also be a challenge in AD patients with skin of color.
“I like to listen to buzz words,” Dr. Heath said. “If a parent says, ‘my child has been diagnosed with ringworm multiple times,’ I zoom in on that. We know that kids can get tinea corporis, but usually not multiple times. I ask about all the things that can be associated with AD, and often we do see these nummular plaques on the skin and do some education about that. I also talk to their pediatrician or send information to that person so that they can be aware that nummular eczema is a form of AD.”
She noted that AD of the scalp may be confused with tinea capitis, especially in young Black children with moderate to severe AD. In her experience, triamcinolone 0.1% ointment works well for AD of the scalp.
She concluded her presentation by noting that there is no easy solution to treating AD in young patients with skin of color. “It’s way more than just eczema. We can help people see AD in a different way. My goal is to see the value in challenging ourselves to understand the impact of what happens outside of the exam room on these patients.”
Dr. Heath disclosed that she has served as a consultant for several pharmaceutical companies, including Regeneron, Janssen, Arcutis, Johnson and Johnson, Cassiopea, and Lilly.
AT SPD 2022
Atopic dermatitis and infectious cutaneous disorders: What is the link?
Key clinical point: Risk for cutaneous infectious diseases is significantly higher in adults and children with atopic dermatitis (AD) than individuals without AD, with the risk for molluscum contagiosum being the highest.
Major finding: Patients with AD vs individuals without AD were at a significantly greater risk for molluscum contagiosum (adjusted odds ratio [aOR] 5.237), followed by impetigo (aOR 2.852), chickenpox (aOR 2.251), otitis media (aOR 2.243), eczema herpeticum (aOR 1.292), viral warts (aOR 1.105), and viral conjunctivitis (aOR 1.099; all P < .001) with molluscum contagiosum having the highest comorbidity (1.06%) and shortest onset duration (77.42 days).
Study details: Findings are from a nationwide population-based study including 70,205 patients with AD and individuals without AD.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Han J-H et al. Evaluation of atopic dermatitis and cutaneous infectious disorders using sequential pattern mining: A nationwide population-based cohort study. J Clin Med. 2022;11(12):3422 (Jun 14). Doi: 10.3390/jcm11123422
Key clinical point: Risk for cutaneous infectious diseases is significantly higher in adults and children with atopic dermatitis (AD) than individuals without AD, with the risk for molluscum contagiosum being the highest.
Major finding: Patients with AD vs individuals without AD were at a significantly greater risk for molluscum contagiosum (adjusted odds ratio [aOR] 5.237), followed by impetigo (aOR 2.852), chickenpox (aOR 2.251), otitis media (aOR 2.243), eczema herpeticum (aOR 1.292), viral warts (aOR 1.105), and viral conjunctivitis (aOR 1.099; all P < .001) with molluscum contagiosum having the highest comorbidity (1.06%) and shortest onset duration (77.42 days).
Study details: Findings are from a nationwide population-based study including 70,205 patients with AD and individuals without AD.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Han J-H et al. Evaluation of atopic dermatitis and cutaneous infectious disorders using sequential pattern mining: A nationwide population-based cohort study. J Clin Med. 2022;11(12):3422 (Jun 14). Doi: 10.3390/jcm11123422
Key clinical point: Risk for cutaneous infectious diseases is significantly higher in adults and children with atopic dermatitis (AD) than individuals without AD, with the risk for molluscum contagiosum being the highest.
Major finding: Patients with AD vs individuals without AD were at a significantly greater risk for molluscum contagiosum (adjusted odds ratio [aOR] 5.237), followed by impetigo (aOR 2.852), chickenpox (aOR 2.251), otitis media (aOR 2.243), eczema herpeticum (aOR 1.292), viral warts (aOR 1.105), and viral conjunctivitis (aOR 1.099; all P < .001) with molluscum contagiosum having the highest comorbidity (1.06%) and shortest onset duration (77.42 days).
Study details: Findings are from a nationwide population-based study including 70,205 patients with AD and individuals without AD.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Han J-H et al. Evaluation of atopic dermatitis and cutaneous infectious disorders using sequential pattern mining: A nationwide population-based cohort study. J Clin Med. 2022;11(12):3422 (Jun 14). Doi: 10.3390/jcm11123422
Exposure to antibiotics in early life not linked to atopic dermatitis onset in childhood or adolescence
Key clinical point: Exposure to antibiotics in early life was not associated with an increased risk of development of atopic dermatitis (AD) from 1 year of life up to adolescence.
Major finding: Antibiotic exposure vs no exposure during the first 6 months of life (adjusted hazard ratio [aHR] 1.05; 95% CI 0.97-1.12), first year of life (aHR 1.02; 95% CI 0.97-1.07), and first 2 years of life (aHR 1.01; 95% CI 0.94-1.10) was not associated with an increased risk of development of AD.
Study details: Findings are from a retrospective study including 73,816 children aged 0-14 years, of which 34,202 were exposed to antibiotics.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Cantarutti A et al. Early-life exposure to antibiotics and subsequent development of atopic dermatitis. Expert Rev Clin Pharmacol. 2022 (Jun 20). Doi: 10.1080/17512433.2022.2092471
Key clinical point: Exposure to antibiotics in early life was not associated with an increased risk of development of atopic dermatitis (AD) from 1 year of life up to adolescence.
Major finding: Antibiotic exposure vs no exposure during the first 6 months of life (adjusted hazard ratio [aHR] 1.05; 95% CI 0.97-1.12), first year of life (aHR 1.02; 95% CI 0.97-1.07), and first 2 years of life (aHR 1.01; 95% CI 0.94-1.10) was not associated with an increased risk of development of AD.
Study details: Findings are from a retrospective study including 73,816 children aged 0-14 years, of which 34,202 were exposed to antibiotics.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Cantarutti A et al. Early-life exposure to antibiotics and subsequent development of atopic dermatitis. Expert Rev Clin Pharmacol. 2022 (Jun 20). Doi: 10.1080/17512433.2022.2092471
Key clinical point: Exposure to antibiotics in early life was not associated with an increased risk of development of atopic dermatitis (AD) from 1 year of life up to adolescence.
Major finding: Antibiotic exposure vs no exposure during the first 6 months of life (adjusted hazard ratio [aHR] 1.05; 95% CI 0.97-1.12), first year of life (aHR 1.02; 95% CI 0.97-1.07), and first 2 years of life (aHR 1.01; 95% CI 0.94-1.10) was not associated with an increased risk of development of AD.
Study details: Findings are from a retrospective study including 73,816 children aged 0-14 years, of which 34,202 were exposed to antibiotics.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Cantarutti A et al. Early-life exposure to antibiotics and subsequent development of atopic dermatitis. Expert Rev Clin Pharmacol. 2022 (Jun 20). Doi: 10.1080/17512433.2022.2092471
Pediatric atopic dermatitis: Food allergy common but AD rarely triggered by food
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Pediatric atopic dermatitis: Food allergy common but AD rarely triggered by food
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Key clinical point: Although food allergy (FA) is common among pediatric patients with atopic dermatitis (AD), immunoglobulin E (IgE) mediates the majority of instances and very few patients report food-triggered AD (FTAD), cautioning against unnecessary dietary restrictions.
Major finding: IgE-mediated FA was common in the overall cohort (55%) irrespective of the severity of AD (mild, 60%; moderate, 45%; severe, 57%), whereas FTAD was rare (3%) and diagnosed in only 2%, 6%, and 4% of patients with mild, moderate, and severe AD, respectively. In patients with AD only, more patients developed IgE-mediated FA vs FTAD (29% vs 5%).
Study details: Findings are from a retrospective study including 372 pediatric patients with AD, of which 29% had moderate AD and 18% had severe AD.
Disclosures: This study was funded by University of Wisconsin-Madison. The authors declared no conflicts of interest.
Source: Li JC et al. Prevalence of food allergy diagnosis in pediatric patients with atopic dermatitis referred to allergy and/or dermatology subspecialty clinics. J Allergy Clin Immunol Pract. 2022 (Jun 8). Doi: 10.1016/j.jaip.2022.05.028
Identifying factors associated with AD severity
Key clinical point: Age, sex, body mass index (BMI), onset age of atopic dermatitis (AD), smoking habits, presence of palmar hyperlinearity, and other atopic diseases determine the disease severity in patients with AD.
Major finding: Compared with patients with mild AD, those with severe AD were usually older (P = .020) and male (P = .002) with an early onset age of AD (<2 years; P = .004), higher BMI (P < .000), history of smoking (P = .012), concomitant asthma (P = .001), palmar hyperlinearity (P = .013), hand dermatitis (P = .020), history of contact allergy (P = .042), and higher immunoglobulin E levels (P < .0001).
Study details: Findings are from a single-center, cross-sectional observational study including 502 Finnish patients with AD, of which 146, 231, and 125 patients had mild, moderate, and severe AD, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Salava A et al. Factors associated with severity of atopic dermatitis - a Finnish cross-sectional study. J Eur Acad Dermatol Venereol. 2022 (Jun 29). Doi: 10.1111/jdv.18378
Key clinical point: Age, sex, body mass index (BMI), onset age of atopic dermatitis (AD), smoking habits, presence of palmar hyperlinearity, and other atopic diseases determine the disease severity in patients with AD.
Major finding: Compared with patients with mild AD, those with severe AD were usually older (P = .020) and male (P = .002) with an early onset age of AD (<2 years; P = .004), higher BMI (P < .000), history of smoking (P = .012), concomitant asthma (P = .001), palmar hyperlinearity (P = .013), hand dermatitis (P = .020), history of contact allergy (P = .042), and higher immunoglobulin E levels (P < .0001).
Study details: Findings are from a single-center, cross-sectional observational study including 502 Finnish patients with AD, of which 146, 231, and 125 patients had mild, moderate, and severe AD, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Salava A et al. Factors associated with severity of atopic dermatitis - a Finnish cross-sectional study. J Eur Acad Dermatol Venereol. 2022 (Jun 29). Doi: 10.1111/jdv.18378
Key clinical point: Age, sex, body mass index (BMI), onset age of atopic dermatitis (AD), smoking habits, presence of palmar hyperlinearity, and other atopic diseases determine the disease severity in patients with AD.
Major finding: Compared with patients with mild AD, those with severe AD were usually older (P = .020) and male (P = .002) with an early onset age of AD (<2 years; P = .004), higher BMI (P < .000), history of smoking (P = .012), concomitant asthma (P = .001), palmar hyperlinearity (P = .013), hand dermatitis (P = .020), history of contact allergy (P = .042), and higher immunoglobulin E levels (P < .0001).
Study details: Findings are from a single-center, cross-sectional observational study including 502 Finnish patients with AD, of which 146, 231, and 125 patients had mild, moderate, and severe AD, respectively.
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Salava A et al. Factors associated with severity of atopic dermatitis - a Finnish cross-sectional study. J Eur Acad Dermatol Venereol. 2022 (Jun 29). Doi: 10.1111/jdv.18378
Difamilast shows promise as long-term therapeutic option for atopic dermatitis
Key clinical point: A 52-week long treatment with difamilast ointment was well tolerated and reduced the severity of atopic dermatitis (AD) in Japanese adult and pediatric patients.
Major finding: Overall, 72.3% of adult patients and 89.0% of pediatric patients experienced treatment-emergent adverse events (TEAE) of mostly mild or moderate severity, and only 7.8% of adult patients and 3.5% of pediatric patients discontinued treatment due to TEAE. At week 52, 55.4% of adult patients and 73.5% of pediatric patients achieved ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from a long-term, open-label, phase 3 study including 166 adult (15-70 years) and 200 pediatric (2-14 years) patients with AD who initiated a 52-week treatment with 0.3% or 1% difamilast ointment.
Disclosures: This study was supported by Otsuka Pharmaceutical Co., Ltd. Three authors declared being employees of Otsuka Pharmaceutical, and the other author declared receiving consulting fees, funding, grant support, and honoraria from several sources, including Otsuka Pharmaceutical.
Source: Saeki H et al. Difamilast ointment in Japanese adult and pediatric patients with atopic dermatitis: A phase III, long-term, open-label study. Dermatol Ther (Heidelb). 2022;12:1589-1601 (Jun 18). Doi: 10.1007/s13555-022-00751-9
Key clinical point: A 52-week long treatment with difamilast ointment was well tolerated and reduced the severity of atopic dermatitis (AD) in Japanese adult and pediatric patients.
Major finding: Overall, 72.3% of adult patients and 89.0% of pediatric patients experienced treatment-emergent adverse events (TEAE) of mostly mild or moderate severity, and only 7.8% of adult patients and 3.5% of pediatric patients discontinued treatment due to TEAE. At week 52, 55.4% of adult patients and 73.5% of pediatric patients achieved ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from a long-term, open-label, phase 3 study including 166 adult (15-70 years) and 200 pediatric (2-14 years) patients with AD who initiated a 52-week treatment with 0.3% or 1% difamilast ointment.
Disclosures: This study was supported by Otsuka Pharmaceutical Co., Ltd. Three authors declared being employees of Otsuka Pharmaceutical, and the other author declared receiving consulting fees, funding, grant support, and honoraria from several sources, including Otsuka Pharmaceutical.
Source: Saeki H et al. Difamilast ointment in Japanese adult and pediatric patients with atopic dermatitis: A phase III, long-term, open-label study. Dermatol Ther (Heidelb). 2022;12:1589-1601 (Jun 18). Doi: 10.1007/s13555-022-00751-9
Key clinical point: A 52-week long treatment with difamilast ointment was well tolerated and reduced the severity of atopic dermatitis (AD) in Japanese adult and pediatric patients.
Major finding: Overall, 72.3% of adult patients and 89.0% of pediatric patients experienced treatment-emergent adverse events (TEAE) of mostly mild or moderate severity, and only 7.8% of adult patients and 3.5% of pediatric patients discontinued treatment due to TEAE. At week 52, 55.4% of adult patients and 73.5% of pediatric patients achieved ≥75% improvement in the Eczema Area and Severity Index.
Study details: Findings are from a long-term, open-label, phase 3 study including 166 adult (15-70 years) and 200 pediatric (2-14 years) patients with AD who initiated a 52-week treatment with 0.3% or 1% difamilast ointment.
Disclosures: This study was supported by Otsuka Pharmaceutical Co., Ltd. Three authors declared being employees of Otsuka Pharmaceutical, and the other author declared receiving consulting fees, funding, grant support, and honoraria from several sources, including Otsuka Pharmaceutical.
Source: Saeki H et al. Difamilast ointment in Japanese adult and pediatric patients with atopic dermatitis: A phase III, long-term, open-label study. Dermatol Ther (Heidelb). 2022;12:1589-1601 (Jun 18). Doi: 10.1007/s13555-022-00751-9
Atopic dermatitis: Upadacitinib-induced acne does not pose a significant safety risk
Key clinical point: Acne caused by upadacitinib in adolescents and adults with moderate-to-severe atopic dermatitis (AD) is typically mild or moderate in severity and may not be considered a significant safety risk.
Major finding: Acne of mostly mild or moderate severity was reported by a higher proportion of patients receiving 15 mg upadacitinib (9.8%) and 30 mg upadacitinib (15.2%) vs placebo (2.2%), with no intervention required in 40.5% and 46.6% of patients receiving 15 and 30 mg upadacitinib, respectively. The improvement in quality-of-life scores was proportional to the decrease in AD severity and was similar in patients with or without acne.
Study details: Findings are from a post hoc integrated analysis of 3 phase 3 trials including 2583 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (15 or 30 mg) or placebo as monotherapy or with concomitant topical corticosteroids.
Disclosures: This study was funded by AbbVie, Inc. Five authors declared being employees or stockholders of AbbVie. The other authors reported ties with various sources, including AbbVie.
Source: Mendes-Bastos P et al. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 (Jun 14). Doi: 10.1016/j.jaad.2022.06.012
Key clinical point: Acne caused by upadacitinib in adolescents and adults with moderate-to-severe atopic dermatitis (AD) is typically mild or moderate in severity and may not be considered a significant safety risk.
Major finding: Acne of mostly mild or moderate severity was reported by a higher proportion of patients receiving 15 mg upadacitinib (9.8%) and 30 mg upadacitinib (15.2%) vs placebo (2.2%), with no intervention required in 40.5% and 46.6% of patients receiving 15 and 30 mg upadacitinib, respectively. The improvement in quality-of-life scores was proportional to the decrease in AD severity and was similar in patients with or without acne.
Study details: Findings are from a post hoc integrated analysis of 3 phase 3 trials including 2583 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (15 or 30 mg) or placebo as monotherapy or with concomitant topical corticosteroids.
Disclosures: This study was funded by AbbVie, Inc. Five authors declared being employees or stockholders of AbbVie. The other authors reported ties with various sources, including AbbVie.
Source: Mendes-Bastos P et al. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 (Jun 14). Doi: 10.1016/j.jaad.2022.06.012
Key clinical point: Acne caused by upadacitinib in adolescents and adults with moderate-to-severe atopic dermatitis (AD) is typically mild or moderate in severity and may not be considered a significant safety risk.
Major finding: Acne of mostly mild or moderate severity was reported by a higher proportion of patients receiving 15 mg upadacitinib (9.8%) and 30 mg upadacitinib (15.2%) vs placebo (2.2%), with no intervention required in 40.5% and 46.6% of patients receiving 15 and 30 mg upadacitinib, respectively. The improvement in quality-of-life scores was proportional to the decrease in AD severity and was similar in patients with or without acne.
Study details: Findings are from a post hoc integrated analysis of 3 phase 3 trials including 2583 patients with moderate-to-severe AD who were randomly assigned to receive upadacitinib (15 or 30 mg) or placebo as monotherapy or with concomitant topical corticosteroids.
Disclosures: This study was funded by AbbVie, Inc. Five authors declared being employees or stockholders of AbbVie. The other authors reported ties with various sources, including AbbVie.
Source: Mendes-Bastos P et al. Characterization of acne associated with upadacitinib treatment in patients with moderate-to-severe atopic dermatitis: A post hoc integrated analysis of 3 phase 3 randomized, double-blind, placebo-controlled trials. J Am Acad Dermatol. 2022 (Jun 14). Doi: 10.1016/j.jaad.2022.06.012
Atopic dermatitis: Improvement in disease severity and skin barrier function with dupilumab
Key clinical point: Dupilumab was more effective than topical corticosteroids (TCS) and cyclosporine in reducing the severity of atopic dermatitis (AD) and transepidermal water loss (TEWL), both in eczematous lesions and nonlesioned skin.
Major finding: At week 16, a higher proportion of patients receiving dupilumab vs cyclosporine or TCS achieved 50% improvement in the Eczema Area and Severity Index (EASI-50; 81.8% vs 28.6% or 40.0% respectively; P = .004). TEWL reduced with both dupilumab (P < .001) and TCS (P = .047) in eczematous lesions and with dupilumab in nonlesioned skin (P = .006) with dupilumab treatment being associated with achievement of EASI-50 (odds ratio 10.67; P = .026) and 50% improvement in TEWL (P = .004).
Study details: Findings are from a prospective, observational study including 46 patients with AD who received TCS (n = 10), cyclosporine (n = 14), or dupilumab (n = 22).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Montero-Vilchez T et al. Dupilumab improves skin barrier function in adults with atopic dermatitis: A prospective observational study. J Clin Med. 2022;11(12):3341 (Jun 10). Doi: 10.3390/jcm11123341
Key clinical point: Dupilumab was more effective than topical corticosteroids (TCS) and cyclosporine in reducing the severity of atopic dermatitis (AD) and transepidermal water loss (TEWL), both in eczematous lesions and nonlesioned skin.
Major finding: At week 16, a higher proportion of patients receiving dupilumab vs cyclosporine or TCS achieved 50% improvement in the Eczema Area and Severity Index (EASI-50; 81.8% vs 28.6% or 40.0% respectively; P = .004). TEWL reduced with both dupilumab (P < .001) and TCS (P = .047) in eczematous lesions and with dupilumab in nonlesioned skin (P = .006) with dupilumab treatment being associated with achievement of EASI-50 (odds ratio 10.67; P = .026) and 50% improvement in TEWL (P = .004).
Study details: Findings are from a prospective, observational study including 46 patients with AD who received TCS (n = 10), cyclosporine (n = 14), or dupilumab (n = 22).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Montero-Vilchez T et al. Dupilumab improves skin barrier function in adults with atopic dermatitis: A prospective observational study. J Clin Med. 2022;11(12):3341 (Jun 10). Doi: 10.3390/jcm11123341
Key clinical point: Dupilumab was more effective than topical corticosteroids (TCS) and cyclosporine in reducing the severity of atopic dermatitis (AD) and transepidermal water loss (TEWL), both in eczematous lesions and nonlesioned skin.
Major finding: At week 16, a higher proportion of patients receiving dupilumab vs cyclosporine or TCS achieved 50% improvement in the Eczema Area and Severity Index (EASI-50; 81.8% vs 28.6% or 40.0% respectively; P = .004). TEWL reduced with both dupilumab (P < .001) and TCS (P = .047) in eczematous lesions and with dupilumab in nonlesioned skin (P = .006) with dupilumab treatment being associated with achievement of EASI-50 (odds ratio 10.67; P = .026) and 50% improvement in TEWL (P = .004).
Study details: Findings are from a prospective, observational study including 46 patients with AD who received TCS (n = 10), cyclosporine (n = 14), or dupilumab (n = 22).
Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.
Source: Montero-Vilchez T et al. Dupilumab improves skin barrier function in adults with atopic dermatitis: A prospective observational study. J Clin Med. 2022;11(12):3341 (Jun 10). Doi: 10.3390/jcm11123341