Atopic Dermatitis

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

SAN DIEGO — Among patients with skin of color and moderate to severe atopic dermatitis (AD) who underwent 16 weeks of treatment with lebrikizumab, 68% achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75), interim results from a novel phase 3b trial showed.

Lebrikizumab, a novel monoclonal antibody being developed by Eli Lilly and Co, binds with high affinity to interleukin (IL)–13, thereby blocking the downstream effects of IL-13 with high potency, one of the study investigators, Jill S. Waibel, MD, a dermatologist in Miami, said at the annual meeting of the American Academy of Dermatology. Though the efficacy and safety of lebrikizumab to treat moderate to severe AD have been established in phase 3 studies, including subset analyses by race and ethnicity, “there is a paucity of data to guide the treatment of moderate-to-severe AD in populations traditionally under-represented in clinical trials, including patients with skin of color,” she said.

During a late-breaking abstract session, Dr. Waibel presented interim 16-week results from ADmirable, a phase 3b, open-label, 24-week study, was the first study to evaluate the safety and efficacy of lebrikizumab in adult and adolescents with skin of color and moderate to severe AD. At baseline and at 2 weeks, patients received a 500-mg loading dose of lebrikizumab. Through week 16, they received a 250-mg dose every 2 weeks. The study’s primary endpoint was the proportion of patients who achieved a 75% reduction in EASI-75 at week 16. “If they achieved the primary endpoint at week 16, they went to a 250-mg dose every 4 weeks,” Dr. Waibel said. “If they did not achieve that [primary endpoint] they stayed on the 250-mg dose every 2 weeks.”

The analysis included 50 patients with skin types IV, V, and VI who self-reported their race as Black or African American, American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander. They had chronic AD for at least 1 year, moderate to severe disease at baseline, a history of an inadequate response to topical medications, and were naive to biologics indicated for the treatment of AD.

Week 16 outcomes of interest were the EASI, the Investigator’s Global Assessment (IGA) of 0 or 1, the Pruritus Numerical Rating Scale (NRS), and PDCA-Derm, a scale developed by Eli Lilly and Co that was used to compare postinflammatory lesions to unaffected adjacent normal skin. All data for statistical analyses were summarized as observed.

At baseline, the mean age of the 50 patients was 42 years, 46% were women, their mean body mass index was 30.2, and the mean age at AD onset was 23 years. Most study participants (80%) were Black or African American, 14% were Asian, and 6% were American Indian or Alaska Native; 78% were not Hispanic or Latino and 22% were Hispanic or Latino. The mean EASI score was 28.1, the mean body surface area affected was 41.7%, and the mean Pruritus NRS score was 7.2 out of 11. According to the PDCA-Derm scale, 18% of patients had hypopigmented lesions, and 54% had hyperpigmented lesions.

After 16 weeks of treatment, 68% of patients achieved an EASI-75 response, whereas 46% achieved an EASI-90 response, Dr. Waibel reported at the meeting. In addition, 39% of patients achieved an IGA score of 0 or 1, 56% achieved a ≥ 4-point improvement on the Pruritus NRS, and 66% achieved a ≥ 3-point improvement on the Pruritus NRS. The PDCA-Derm score identified improvement in postinflammatory hyperpigmented lesions in 12 of 21 patients and improvement to normal skin tone in six of 21 patients.

“I have a large population [with skin of color in my practice],” Dr. Waibel said. “I usually tell my [patients with postinflammatory hyperpigmentation] that it takes 6 months to see improvement. In this study, we saw patients achieve improvement in skin tone in a 4-month time frame. PIH is sometimes more distressing than a primary condition, whether it’s acne or atopic dermatitis. In this case, it was surprisingly improved with lebrikizumab.”

No new safety signals or serious adverse events were observed. “This is very exciting because it’s the first time there has been a trial focusing on [patients with skin of color] with moderate to severe eczema in skin types IV-VI,” Dr. Waibel said.

In an interview, the study’s lead investigator, Andrew Alexis, MD, MPH, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York City, said that the interim results from this study “ add valuable, clinically relevant data on the treatment of moderate to severe AD in patient populations with skin of color.”

“An interesting finding,” he continued, “was that improvement in postinflammatory hyperpigmented lesions was seen in 12 of 21 patients and improvement to normal skin tone was observed in six of 21 patients at week 16. This is particularly relevant to patients with skin of color who frequently suffer from pigmentary changes in association with their AD.”

Lebrikizumab was approved in November 2023 in Europe for the treatment of moderate to severe AD in people aged 12 years or older and is currently under review by the Food and Drug Administration for treatment of AD. 

Both Dr. Waibel and Dr. Alexis disclosed numerous conflicts of interest from various pharmaceutical companies, including serving as a consultant and/or advisor to Eli Lilly and Co.
 

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Among patients with skin of color and moderate to severe atopic dermatitis (AD) who underwent 16 weeks of treatment with lebrikizumab, 68% achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75), interim results from a novel phase 3b trial showed.

Lebrikizumab, a novel monoclonal antibody being developed by Eli Lilly and Co, binds with high affinity to interleukin (IL)–13, thereby blocking the downstream effects of IL-13 with high potency, one of the study investigators, Jill S. Waibel, MD, a dermatologist in Miami, said at the annual meeting of the American Academy of Dermatology. Though the efficacy and safety of lebrikizumab to treat moderate to severe AD have been established in phase 3 studies, including subset analyses by race and ethnicity, “there is a paucity of data to guide the treatment of moderate-to-severe AD in populations traditionally under-represented in clinical trials, including patients with skin of color,” she said.

During a late-breaking abstract session, Dr. Waibel presented interim 16-week results from ADmirable, a phase 3b, open-label, 24-week study, was the first study to evaluate the safety and efficacy of lebrikizumab in adult and adolescents with skin of color and moderate to severe AD. At baseline and at 2 weeks, patients received a 500-mg loading dose of lebrikizumab. Through week 16, they received a 250-mg dose every 2 weeks. The study’s primary endpoint was the proportion of patients who achieved a 75% reduction in EASI-75 at week 16. “If they achieved the primary endpoint at week 16, they went to a 250-mg dose every 4 weeks,” Dr. Waibel said. “If they did not achieve that [primary endpoint] they stayed on the 250-mg dose every 2 weeks.”

The analysis included 50 patients with skin types IV, V, and VI who self-reported their race as Black or African American, American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander. They had chronic AD for at least 1 year, moderate to severe disease at baseline, a history of an inadequate response to topical medications, and were naive to biologics indicated for the treatment of AD.

Week 16 outcomes of interest were the EASI, the Investigator’s Global Assessment (IGA) of 0 or 1, the Pruritus Numerical Rating Scale (NRS), and PDCA-Derm, a scale developed by Eli Lilly and Co that was used to compare postinflammatory lesions to unaffected adjacent normal skin. All data for statistical analyses were summarized as observed.

At baseline, the mean age of the 50 patients was 42 years, 46% were women, their mean body mass index was 30.2, and the mean age at AD onset was 23 years. Most study participants (80%) were Black or African American, 14% were Asian, and 6% were American Indian or Alaska Native; 78% were not Hispanic or Latino and 22% were Hispanic or Latino. The mean EASI score was 28.1, the mean body surface area affected was 41.7%, and the mean Pruritus NRS score was 7.2 out of 11. According to the PDCA-Derm scale, 18% of patients had hypopigmented lesions, and 54% had hyperpigmented lesions.

After 16 weeks of treatment, 68% of patients achieved an EASI-75 response, whereas 46% achieved an EASI-90 response, Dr. Waibel reported at the meeting. In addition, 39% of patients achieved an IGA score of 0 or 1, 56% achieved a ≥ 4-point improvement on the Pruritus NRS, and 66% achieved a ≥ 3-point improvement on the Pruritus NRS. The PDCA-Derm score identified improvement in postinflammatory hyperpigmented lesions in 12 of 21 patients and improvement to normal skin tone in six of 21 patients.

“I have a large population [with skin of color in my practice],” Dr. Waibel said. “I usually tell my [patients with postinflammatory hyperpigmentation] that it takes 6 months to see improvement. In this study, we saw patients achieve improvement in skin tone in a 4-month time frame. PIH is sometimes more distressing than a primary condition, whether it’s acne or atopic dermatitis. In this case, it was surprisingly improved with lebrikizumab.”

No new safety signals or serious adverse events were observed. “This is very exciting because it’s the first time there has been a trial focusing on [patients with skin of color] with moderate to severe eczema in skin types IV-VI,” Dr. Waibel said.

In an interview, the study’s lead investigator, Andrew Alexis, MD, MPH, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York City, said that the interim results from this study “ add valuable, clinically relevant data on the treatment of moderate to severe AD in patient populations with skin of color.”

“An interesting finding,” he continued, “was that improvement in postinflammatory hyperpigmented lesions was seen in 12 of 21 patients and improvement to normal skin tone was observed in six of 21 patients at week 16. This is particularly relevant to patients with skin of color who frequently suffer from pigmentary changes in association with their AD.”

Lebrikizumab was approved in November 2023 in Europe for the treatment of moderate to severe AD in people aged 12 years or older and is currently under review by the Food and Drug Administration for treatment of AD. 

Both Dr. Waibel and Dr. Alexis disclosed numerous conflicts of interest from various pharmaceutical companies, including serving as a consultant and/or advisor to Eli Lilly and Co.
 

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Among patients with skin of color and moderate to severe atopic dermatitis (AD) who underwent 16 weeks of treatment with lebrikizumab, 68% achieved a 75% reduction in the Eczema Area and Severity Index (EASI-75), interim results from a novel phase 3b trial showed.

Lebrikizumab, a novel monoclonal antibody being developed by Eli Lilly and Co, binds with high affinity to interleukin (IL)–13, thereby blocking the downstream effects of IL-13 with high potency, one of the study investigators, Jill S. Waibel, MD, a dermatologist in Miami, said at the annual meeting of the American Academy of Dermatology. Though the efficacy and safety of lebrikizumab to treat moderate to severe AD have been established in phase 3 studies, including subset analyses by race and ethnicity, “there is a paucity of data to guide the treatment of moderate-to-severe AD in populations traditionally under-represented in clinical trials, including patients with skin of color,” she said.

During a late-breaking abstract session, Dr. Waibel presented interim 16-week results from ADmirable, a phase 3b, open-label, 24-week study, was the first study to evaluate the safety and efficacy of lebrikizumab in adult and adolescents with skin of color and moderate to severe AD. At baseline and at 2 weeks, patients received a 500-mg loading dose of lebrikizumab. Through week 16, they received a 250-mg dose every 2 weeks. The study’s primary endpoint was the proportion of patients who achieved a 75% reduction in EASI-75 at week 16. “If they achieved the primary endpoint at week 16, they went to a 250-mg dose every 4 weeks,” Dr. Waibel said. “If they did not achieve that [primary endpoint] they stayed on the 250-mg dose every 2 weeks.”

The analysis included 50 patients with skin types IV, V, and VI who self-reported their race as Black or African American, American Indian or Alaska Native, Asian, and Native Hawaiian or Other Pacific Islander. They had chronic AD for at least 1 year, moderate to severe disease at baseline, a history of an inadequate response to topical medications, and were naive to biologics indicated for the treatment of AD.

Week 16 outcomes of interest were the EASI, the Investigator’s Global Assessment (IGA) of 0 or 1, the Pruritus Numerical Rating Scale (NRS), and PDCA-Derm, a scale developed by Eli Lilly and Co that was used to compare postinflammatory lesions to unaffected adjacent normal skin. All data for statistical analyses were summarized as observed.

At baseline, the mean age of the 50 patients was 42 years, 46% were women, their mean body mass index was 30.2, and the mean age at AD onset was 23 years. Most study participants (80%) were Black or African American, 14% were Asian, and 6% were American Indian or Alaska Native; 78% were not Hispanic or Latino and 22% were Hispanic or Latino. The mean EASI score was 28.1, the mean body surface area affected was 41.7%, and the mean Pruritus NRS score was 7.2 out of 11. According to the PDCA-Derm scale, 18% of patients had hypopigmented lesions, and 54% had hyperpigmented lesions.

After 16 weeks of treatment, 68% of patients achieved an EASI-75 response, whereas 46% achieved an EASI-90 response, Dr. Waibel reported at the meeting. In addition, 39% of patients achieved an IGA score of 0 or 1, 56% achieved a ≥ 4-point improvement on the Pruritus NRS, and 66% achieved a ≥ 3-point improvement on the Pruritus NRS. The PDCA-Derm score identified improvement in postinflammatory hyperpigmented lesions in 12 of 21 patients and improvement to normal skin tone in six of 21 patients.

“I have a large population [with skin of color in my practice],” Dr. Waibel said. “I usually tell my [patients with postinflammatory hyperpigmentation] that it takes 6 months to see improvement. In this study, we saw patients achieve improvement in skin tone in a 4-month time frame. PIH is sometimes more distressing than a primary condition, whether it’s acne or atopic dermatitis. In this case, it was surprisingly improved with lebrikizumab.”

No new safety signals or serious adverse events were observed. “This is very exciting because it’s the first time there has been a trial focusing on [patients with skin of color] with moderate to severe eczema in skin types IV-VI,” Dr. Waibel said.

In an interview, the study’s lead investigator, Andrew Alexis, MD, MPH, vice chair for diversity and inclusion in the department of dermatology and professor of clinical dermatology at Weill Cornell Medicine, New York City, said that the interim results from this study “ add valuable, clinically relevant data on the treatment of moderate to severe AD in patient populations with skin of color.”

“An interesting finding,” he continued, “was that improvement in postinflammatory hyperpigmented lesions was seen in 12 of 21 patients and improvement to normal skin tone was observed in six of 21 patients at week 16. This is particularly relevant to patients with skin of color who frequently suffer from pigmentary changes in association with their AD.”

Lebrikizumab was approved in November 2023 in Europe for the treatment of moderate to severe AD in people aged 12 years or older and is currently under review by the Food and Drug Administration for treatment of AD. 

Both Dr. Waibel and Dr. Alexis disclosed numerous conflicts of interest from various pharmaceutical companies, including serving as a consultant and/or advisor to Eli Lilly and Co.
 

A version of this article appeared on Medscape.com.
 

SAN DIEGO — Treatment with topical roflumilast, 0.05%, approved at a higher concentration for treating psoriasis, showed high levels of improvement in about a quarter of children aged 2-5 years with mild to moderate atopic dermatitis (AD), according to the results of a phase 3 study reported at the annual meeting of the American Academy of Dermatology.

Among patients treated with roflumilast cream, 0.05%, 25.4% reached the primary endpoint of “clear” or “almost clear” plus a two-grade improvement from baseline at week 4 vs 10.7% among those in the vehicle group (P < .0001) in a phase 3 randomized controlled trial of children. The findings were released in a late-breaker session at the meeting.

Roflumilast cream, 0.3% (Zoryve), is approved by the Food and Drug Administration (FDA) for treating psoriasis in patients 6 years and older, and lower doses are being evaluated for AD: 0.15% for adults and children ages 6 and older, and 0.05% for ages 2-5. Roflumilast is a phosphodiesterase-4 inhibitor. In 2023, the FDA accepted a supplemental drug application from the manufacturer, Arcutis, for roflumilast, 0.15%, for treating AD in patients ages 6 and older, based on the results from two recently published phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2.

The study of younger children, INTEGUMENT-PED, recruited 652 patients aged 2-5 with mild to moderate AD, with a Validated Investigator Global Assessment scale for AD (vlGA-AD) score of 2 or 3, a mean body surface area of 22% overall (range, 3%-82%), and an Eczema Area and Severity Index (EASI) score of at least 5. Of the patients enrolled, 437 were assigned to 0.05% roflumilast cream, applied once a day for 4 weeks (mean age, 3.3 years; 51.6% male; 67.4% White; 15.6% Black; 8.5% Asian; 8.5% other or more than one race; 80.5% not Latino/Hispanic). The remaining 215 children were assigned to vehicle cream and had similar characteristics.

About 52% of the patients in both groups had an inadequate response, intolerance, or contraindications to topical corticosteroids (and about 17% for topical calcineurin inhibitors and about 9% for crisaborole).

The proportions of patients who reached “clear” (0) or “almost clear” (1) on the vlGA-AD scale were 35.4% and 14.6%, respectively, at week 4 (P < .0001) for roflumilast and vehicle, respectively, according to the lead author of the study, Lawrence M. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, who presented the results at the meeting. In addition, 39.4% and 20.6% achieved an EASI-75 (a secondary endpoint), respectively (P < .0001), and itch also improved within 24 hours of starting treatment.

With regard to safety, 29.7% of patients taking roflumilast had treatment-emergent adverse effects (including upper respiratory tract infections in 4.1%) vs 21.9% of those in the vehicle arm (including upper respiratory tract infections in 1.4%). Reports of pain at the administration site were low (1.6% for roflumilast vs 1.9% for vehicle). Only one patient, a 2-year-old girl, had a treatment-emergent serious adverse event. The child, who was in the roflumilast group, had cellulitis involving noneczematous skin and was treated with antibiotics in the hospital for 3 days. The event was not attributed to roflumilast, which was stopped for 5 days, according to Dr. Eichenfield.

In an interview, Fairfield, Connecticut–based dermatologist Brittany Craiglow, MD, who was not involved in the study, said topical roflumilast would be an “important” new treatment because there are still few nonsteroidal options for the treatment of AD in children under 12. “The excellent local tolerability combined with early improvements in itch and skin clearance will make this a particularly attractive option, if approved,” she said.

Dr. Eichenfield disclosed multiple relationships with various drugmakers. He and several other study authors are investigators and/or consultants for Arcutis and received grants/research funding and/or honoraria. Two authors are Arcutis employees. Other disclosure information for the authors was not immediately available. Dr. Craiglow had no disclosures.

A version of this article appeared on Medscape.com .

SAN DIEGO — Treatment with topical roflumilast, 0.05%, approved at a higher concentration for treating psoriasis, showed high levels of improvement in about a quarter of children aged 2-5 years with mild to moderate atopic dermatitis (AD), according to the results of a phase 3 study reported at the annual meeting of the American Academy of Dermatology.

Among patients treated with roflumilast cream, 0.05%, 25.4% reached the primary endpoint of “clear” or “almost clear” plus a two-grade improvement from baseline at week 4 vs 10.7% among those in the vehicle group (P < .0001) in a phase 3 randomized controlled trial of children. The findings were released in a late-breaker session at the meeting.

Roflumilast cream, 0.3% (Zoryve), is approved by the Food and Drug Administration (FDA) for treating psoriasis in patients 6 years and older, and lower doses are being evaluated for AD: 0.15% for adults and children ages 6 and older, and 0.05% for ages 2-5. Roflumilast is a phosphodiesterase-4 inhibitor. In 2023, the FDA accepted a supplemental drug application from the manufacturer, Arcutis, for roflumilast, 0.15%, for treating AD in patients ages 6 and older, based on the results from two recently published phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2.

The study of younger children, INTEGUMENT-PED, recruited 652 patients aged 2-5 with mild to moderate AD, with a Validated Investigator Global Assessment scale for AD (vlGA-AD) score of 2 or 3, a mean body surface area of 22% overall (range, 3%-82%), and an Eczema Area and Severity Index (EASI) score of at least 5. Of the patients enrolled, 437 were assigned to 0.05% roflumilast cream, applied once a day for 4 weeks (mean age, 3.3 years; 51.6% male; 67.4% White; 15.6% Black; 8.5% Asian; 8.5% other or more than one race; 80.5% not Latino/Hispanic). The remaining 215 children were assigned to vehicle cream and had similar characteristics.

About 52% of the patients in both groups had an inadequate response, intolerance, or contraindications to topical corticosteroids (and about 17% for topical calcineurin inhibitors and about 9% for crisaborole).

The proportions of patients who reached “clear” (0) or “almost clear” (1) on the vlGA-AD scale were 35.4% and 14.6%, respectively, at week 4 (P < .0001) for roflumilast and vehicle, respectively, according to the lead author of the study, Lawrence M. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, who presented the results at the meeting. In addition, 39.4% and 20.6% achieved an EASI-75 (a secondary endpoint), respectively (P < .0001), and itch also improved within 24 hours of starting treatment.

With regard to safety, 29.7% of patients taking roflumilast had treatment-emergent adverse effects (including upper respiratory tract infections in 4.1%) vs 21.9% of those in the vehicle arm (including upper respiratory tract infections in 1.4%). Reports of pain at the administration site were low (1.6% for roflumilast vs 1.9% for vehicle). Only one patient, a 2-year-old girl, had a treatment-emergent serious adverse event. The child, who was in the roflumilast group, had cellulitis involving noneczematous skin and was treated with antibiotics in the hospital for 3 days. The event was not attributed to roflumilast, which was stopped for 5 days, according to Dr. Eichenfield.

In an interview, Fairfield, Connecticut–based dermatologist Brittany Craiglow, MD, who was not involved in the study, said topical roflumilast would be an “important” new treatment because there are still few nonsteroidal options for the treatment of AD in children under 12. “The excellent local tolerability combined with early improvements in itch and skin clearance will make this a particularly attractive option, if approved,” she said.

Dr. Eichenfield disclosed multiple relationships with various drugmakers. He and several other study authors are investigators and/or consultants for Arcutis and received grants/research funding and/or honoraria. Two authors are Arcutis employees. Other disclosure information for the authors was not immediately available. Dr. Craiglow had no disclosures.

A version of this article appeared on Medscape.com .

SAN DIEGO — Treatment with topical roflumilast, 0.05%, approved at a higher concentration for treating psoriasis, showed high levels of improvement in about a quarter of children aged 2-5 years with mild to moderate atopic dermatitis (AD), according to the results of a phase 3 study reported at the annual meeting of the American Academy of Dermatology.

Among patients treated with roflumilast cream, 0.05%, 25.4% reached the primary endpoint of “clear” or “almost clear” plus a two-grade improvement from baseline at week 4 vs 10.7% among those in the vehicle group (P < .0001) in a phase 3 randomized controlled trial of children. The findings were released in a late-breaker session at the meeting.

Roflumilast cream, 0.3% (Zoryve), is approved by the Food and Drug Administration (FDA) for treating psoriasis in patients 6 years and older, and lower doses are being evaluated for AD: 0.15% for adults and children ages 6 and older, and 0.05% for ages 2-5. Roflumilast is a phosphodiesterase-4 inhibitor. In 2023, the FDA accepted a supplemental drug application from the manufacturer, Arcutis, for roflumilast, 0.15%, for treating AD in patients ages 6 and older, based on the results from two recently published phase 3 trials, INTEGUMENT-1 and INTEGUMENT-2.

The study of younger children, INTEGUMENT-PED, recruited 652 patients aged 2-5 with mild to moderate AD, with a Validated Investigator Global Assessment scale for AD (vlGA-AD) score of 2 or 3, a mean body surface area of 22% overall (range, 3%-82%), and an Eczema Area and Severity Index (EASI) score of at least 5. Of the patients enrolled, 437 were assigned to 0.05% roflumilast cream, applied once a day for 4 weeks (mean age, 3.3 years; 51.6% male; 67.4% White; 15.6% Black; 8.5% Asian; 8.5% other or more than one race; 80.5% not Latino/Hispanic). The remaining 215 children were assigned to vehicle cream and had similar characteristics.

About 52% of the patients in both groups had an inadequate response, intolerance, or contraindications to topical corticosteroids (and about 17% for topical calcineurin inhibitors and about 9% for crisaborole).

The proportions of patients who reached “clear” (0) or “almost clear” (1) on the vlGA-AD scale were 35.4% and 14.6%, respectively, at week 4 (P < .0001) for roflumilast and vehicle, respectively, according to the lead author of the study, Lawrence M. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, who presented the results at the meeting. In addition, 39.4% and 20.6% achieved an EASI-75 (a secondary endpoint), respectively (P < .0001), and itch also improved within 24 hours of starting treatment.

With regard to safety, 29.7% of patients taking roflumilast had treatment-emergent adverse effects (including upper respiratory tract infections in 4.1%) vs 21.9% of those in the vehicle arm (including upper respiratory tract infections in 1.4%). Reports of pain at the administration site were low (1.6% for roflumilast vs 1.9% for vehicle). Only one patient, a 2-year-old girl, had a treatment-emergent serious adverse event. The child, who was in the roflumilast group, had cellulitis involving noneczematous skin and was treated with antibiotics in the hospital for 3 days. The event was not attributed to roflumilast, which was stopped for 5 days, according to Dr. Eichenfield.

In an interview, Fairfield, Connecticut–based dermatologist Brittany Craiglow, MD, who was not involved in the study, said topical roflumilast would be an “important” new treatment because there are still few nonsteroidal options for the treatment of AD in children under 12. “The excellent local tolerability combined with early improvements in itch and skin clearance will make this a particularly attractive option, if approved,” she said.

Dr. Eichenfield disclosed multiple relationships with various drugmakers. He and several other study authors are investigators and/or consultants for Arcutis and received grants/research funding and/or honoraria. Two authors are Arcutis employees. Other disclosure information for the authors was not immediately available. Dr. Craiglow had no disclosures.

A version of this article appeared on Medscape.com .

Key clinical point: Increased cytokine S100A8/9 expression on the skin surface in infants with a high risk for atopic dermatitis (AD) at 2 months with filaggrin wild genotype (FLGwt), but not filaggrin loss-of-function mutations (FLGmut), is predictive of AD development and persistence in the first year of life.

Major finding: Increased S100A8/9 titers detected in skin swabs of the antecubital fossa at 8 weeks in infants with FLGwt, but not in those with FLGmut, were associated with AD development in the first year of life (P = .033) and AD persistence of between 6 and 12 months of age (P < .001).

Study details: This single-center study included 86 infants from the STOP AD trial who had at least one parent with a history of AD, asthma, or allergic rhinitis and had either FLGwt or FLGmut.

Disclosures: The cost of the sample analysis was funded by Janssen R&D and Johnson & Johnson Santé Beauté France and the product used in the study was provided by Johnson & Johnson Santé Beauté France. Six authors declared being employees of or having other ties with the Johnson & Johnson family of companies and others. Two authors are coauthors on a patent application in relation to the STOP-AD study. No declaration of conflicting interests was made by CNC.

Source: Stamatas GN, Sato T, Ni Chaoimh C, et al. Early skin inflammatory biomarker is predictive of development and persistence of atopic dermatitis in infants. J Allergy Clin Immunol. 2024 (Mar 7). doi: 10.1016/j.jaci.2024.02.018 Source

Key clinical point: Increased cytokine S100A8/9 expression on the skin surface in infants with a high risk for atopic dermatitis (AD) at 2 months with filaggrin wild genotype (FLGwt), but not filaggrin loss-of-function mutations (FLGmut), is predictive of AD development and persistence in the first year of life.

Major finding: Increased S100A8/9 titers detected in skin swabs of the antecubital fossa at 8 weeks in infants with FLGwt, but not in those with FLGmut, were associated with AD development in the first year of life (P = .033) and AD persistence of between 6 and 12 months of age (P < .001).

Study details: This single-center study included 86 infants from the STOP AD trial who had at least one parent with a history of AD, asthma, or allergic rhinitis and had either FLGwt or FLGmut.

Disclosures: The cost of the sample analysis was funded by Janssen R&D and Johnson & Johnson Santé Beauté France and the product used in the study was provided by Johnson & Johnson Santé Beauté France. Six authors declared being employees of or having other ties with the Johnson & Johnson family of companies and others. Two authors are coauthors on a patent application in relation to the STOP-AD study. No declaration of conflicting interests was made by CNC.

Source: Stamatas GN, Sato T, Ni Chaoimh C, et al. Early skin inflammatory biomarker is predictive of development and persistence of atopic dermatitis in infants. J Allergy Clin Immunol. 2024 (Mar 7). doi: 10.1016/j.jaci.2024.02.018 Source

Key clinical point: Increased cytokine S100A8/9 expression on the skin surface in infants with a high risk for atopic dermatitis (AD) at 2 months with filaggrin wild genotype (FLGwt), but not filaggrin loss-of-function mutations (FLGmut), is predictive of AD development and persistence in the first year of life.

Major finding: Increased S100A8/9 titers detected in skin swabs of the antecubital fossa at 8 weeks in infants with FLGwt, but not in those with FLGmut, were associated with AD development in the first year of life (P = .033) and AD persistence of between 6 and 12 months of age (P < .001).

Study details: This single-center study included 86 infants from the STOP AD trial who had at least one parent with a history of AD, asthma, or allergic rhinitis and had either FLGwt or FLGmut.

Disclosures: The cost of the sample analysis was funded by Janssen R&D and Johnson & Johnson Santé Beauté France and the product used in the study was provided by Johnson & Johnson Santé Beauté France. Six authors declared being employees of or having other ties with the Johnson & Johnson family of companies and others. Two authors are coauthors on a patent application in relation to the STOP-AD study. No declaration of conflicting interests was made by CNC.

Source: Stamatas GN, Sato T, Ni Chaoimh C, et al. Early skin inflammatory biomarker is predictive of development and persistence of atopic dermatitis in infants. J Allergy Clin Immunol. 2024 (Mar 7). doi: 10.1016/j.jaci.2024.02.018 Source

Key clinical point: Safety is the most valued treatment attribute for adults with moderate-to-severe atopic dermatitis (AD), followed by the mode of administration, whereas monitoring requirements is the least critical attribute.

Major finding: The risk for severe adverse events emerged as the most important attribute (coefficient 0.42; 95% CI 0.36-0.49), followed by the ease of treatment administration with daily oral pills vs biweekly injections (coefficient 0.41, 95% CI 0.35-0.48). Avoiding monitoring for severe adverse events was the least critical attribute (coefficient 0.02; 95% CI −0.03 to 0.07).

Study details: This study included 713 adults with moderate-to-severe AD having Patient-Oriented Eczema Measure scores > 7 or current or prior exposure to systemic treatment who completed the online discrete choice experiment survey for treatment preferences in AD.

Disclosures: This study was sponsored by LEO Pharma. Five authors declared being employees of LEO Pharma or EY Economics Denmark, a paid vendor of LEO Pharma. Some authors declared serving as advisors, consultants, etc., for or receiving research grants, etc., from LEO Pharma and others.

Source: Ameen M, Alhusayen R, Brandi H, et al. Patient preferences in the treatment of moderate-to-severe atopic dermatitis. Acta Derm Venereol. 2024 (Feb 21). doi: 10.2340/actadv.v104.19454 Source

Key clinical point: Safety is the most valued treatment attribute for adults with moderate-to-severe atopic dermatitis (AD), followed by the mode of administration, whereas monitoring requirements is the least critical attribute.

Major finding: The risk for severe adverse events emerged as the most important attribute (coefficient 0.42; 95% CI 0.36-0.49), followed by the ease of treatment administration with daily oral pills vs biweekly injections (coefficient 0.41, 95% CI 0.35-0.48). Avoiding monitoring for severe adverse events was the least critical attribute (coefficient 0.02; 95% CI −0.03 to 0.07).

Study details: This study included 713 adults with moderate-to-severe AD having Patient-Oriented Eczema Measure scores > 7 or current or prior exposure to systemic treatment who completed the online discrete choice experiment survey for treatment preferences in AD.

Disclosures: This study was sponsored by LEO Pharma. Five authors declared being employees of LEO Pharma or EY Economics Denmark, a paid vendor of LEO Pharma. Some authors declared serving as advisors, consultants, etc., for or receiving research grants, etc., from LEO Pharma and others.

Source: Ameen M, Alhusayen R, Brandi H, et al. Patient preferences in the treatment of moderate-to-severe atopic dermatitis. Acta Derm Venereol. 2024 (Feb 21). doi: 10.2340/actadv.v104.19454 Source

Key clinical point: Safety is the most valued treatment attribute for adults with moderate-to-severe atopic dermatitis (AD), followed by the mode of administration, whereas monitoring requirements is the least critical attribute.

Major finding: The risk for severe adverse events emerged as the most important attribute (coefficient 0.42; 95% CI 0.36-0.49), followed by the ease of treatment administration with daily oral pills vs biweekly injections (coefficient 0.41, 95% CI 0.35-0.48). Avoiding monitoring for severe adverse events was the least critical attribute (coefficient 0.02; 95% CI −0.03 to 0.07).

Study details: This study included 713 adults with moderate-to-severe AD having Patient-Oriented Eczema Measure scores > 7 or current or prior exposure to systemic treatment who completed the online discrete choice experiment survey for treatment preferences in AD.

Disclosures: This study was sponsored by LEO Pharma. Five authors declared being employees of LEO Pharma or EY Economics Denmark, a paid vendor of LEO Pharma. Some authors declared serving as advisors, consultants, etc., for or receiving research grants, etc., from LEO Pharma and others.

Source: Ameen M, Alhusayen R, Brandi H, et al. Patient preferences in the treatment of moderate-to-severe atopic dermatitis. Acta Derm Venereol. 2024 (Feb 21). doi: 10.2340/actadv.v104.19454 Source

Key clinical point: Abrocitinib is safe and effective in patients with atopic dermatitis (AD) in daily practice, regardless of their previous inadequate response to upadacitinib or dupilumab.

Major finding: At week 28, 57.6% of patients achieved a ≥75% reduction in the Eczema Area and Severity Index (EASI) scores. At week 16, no significant difference was observed in the EASI scores between nonresponders and patients naive or responsive to upadacitinib or dupilumab (all P > .05). Most adverse events (81.6%) were mild in severity.

Study details: This multicenter prospective study included 103 patients with AD from the BioDay registry who did or did not exhibit adequate response to previous dupilumab or upadacitinib treatment and received abrocitinib for ≤28 weeks.

Disclosures: The BioDay registry was sponsored by Eli Lilly, Sanofi Genzyme, Leo Pharma, AbbVie, and Pfizer. Seven authors reported being consultants, speakers, etc., for or having other ties with various sources, including the aforementioned organizations. The other authors had nothing to disclose.

Source: Kamphuis E, Boesjes CM, Loman L, et al. Real-world experience of abrocitinib treatment in patients with atopic dermatitis and hand eczema: Up to 28-week results from the BioDay Registry. Acta Derm Venereol. 2024 (Feb 7). Doi: 10.2340/actadv.v104.19454 Source

Key clinical point: Abrocitinib is safe and effective in patients with atopic dermatitis (AD) in daily practice, regardless of their previous inadequate response to upadacitinib or dupilumab.

Major finding: At week 28, 57.6% of patients achieved a ≥75% reduction in the Eczema Area and Severity Index (EASI) scores. At week 16, no significant difference was observed in the EASI scores between nonresponders and patients naive or responsive to upadacitinib or dupilumab (all P > .05). Most adverse events (81.6%) were mild in severity.

Study details: This multicenter prospective study included 103 patients with AD from the BioDay registry who did or did not exhibit adequate response to previous dupilumab or upadacitinib treatment and received abrocitinib for ≤28 weeks.

Disclosures: The BioDay registry was sponsored by Eli Lilly, Sanofi Genzyme, Leo Pharma, AbbVie, and Pfizer. Seven authors reported being consultants, speakers, etc., for or having other ties with various sources, including the aforementioned organizations. The other authors had nothing to disclose.

Source: Kamphuis E, Boesjes CM, Loman L, et al. Real-world experience of abrocitinib treatment in patients with atopic dermatitis and hand eczema: Up to 28-week results from the BioDay Registry. Acta Derm Venereol. 2024 (Feb 7). Doi: 10.2340/actadv.v104.19454 Source

Key clinical point: Abrocitinib is safe and effective in patients with atopic dermatitis (AD) in daily practice, regardless of their previous inadequate response to upadacitinib or dupilumab.

Major finding: At week 28, 57.6% of patients achieved a ≥75% reduction in the Eczema Area and Severity Index (EASI) scores. At week 16, no significant difference was observed in the EASI scores between nonresponders and patients naive or responsive to upadacitinib or dupilumab (all P > .05). Most adverse events (81.6%) were mild in severity.

Study details: This multicenter prospective study included 103 patients with AD from the BioDay registry who did or did not exhibit adequate response to previous dupilumab or upadacitinib treatment and received abrocitinib for ≤28 weeks.

Disclosures: The BioDay registry was sponsored by Eli Lilly, Sanofi Genzyme, Leo Pharma, AbbVie, and Pfizer. Seven authors reported being consultants, speakers, etc., for or having other ties with various sources, including the aforementioned organizations. The other authors had nothing to disclose.

Source: Kamphuis E, Boesjes CM, Loman L, et al. Real-world experience of abrocitinib treatment in patients with atopic dermatitis and hand eczema: Up to 28-week results from the BioDay Registry. Acta Derm Venereol. 2024 (Feb 7). Doi: 10.2340/actadv.v104.19454 Source

Key clinical point: Atopic dermatitis (AD) does not have a significant association with the development of photodermatoses, including photosensitivity, photoallergy, and contact allergy.

Major finding: Of the phototested patients, 23 had a history of AD, of whom 52.2% were photosensitive and 34.8% were photopatch test-positive. Phototested patients with and without AD showed no significant differences in terms of the development of photosensitivity (P = .61), photoallergy (P = .25), or contact allergy (P = .74).

Study details: Findings are from a 10-year retrospective cohort study including 101 patients with or without a history of AD who were tested for sensitivity to UV-A, UV-B, and visible light, followed by photopatch or contact patch testing if photoallergy or simple contact dermatitis was suspected.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Afvari S and Zippin JH. Photodermatoses in patients with atopic dermatitis: A 10-year retrospective cohort study. J Am Acad Dermatol. 2024 (Feb 18). doi: 10.1016/j.jaad.2024.01.032 Source

Key clinical point: Atopic dermatitis (AD) does not have a significant association with the development of photodermatoses, including photosensitivity, photoallergy, and contact allergy.

Major finding: Of the phototested patients, 23 had a history of AD, of whom 52.2% were photosensitive and 34.8% were photopatch test-positive. Phototested patients with and without AD showed no significant differences in terms of the development of photosensitivity (P = .61), photoallergy (P = .25), or contact allergy (P = .74).

Study details: Findings are from a 10-year retrospective cohort study including 101 patients with or without a history of AD who were tested for sensitivity to UV-A, UV-B, and visible light, followed by photopatch or contact patch testing if photoallergy or simple contact dermatitis was suspected.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Afvari S and Zippin JH. Photodermatoses in patients with atopic dermatitis: A 10-year retrospective cohort study. J Am Acad Dermatol. 2024 (Feb 18). doi: 10.1016/j.jaad.2024.01.032 Source

Key clinical point: Atopic dermatitis (AD) does not have a significant association with the development of photodermatoses, including photosensitivity, photoallergy, and contact allergy.

Major finding: Of the phototested patients, 23 had a history of AD, of whom 52.2% were photosensitive and 34.8% were photopatch test-positive. Phototested patients with and without AD showed no significant differences in terms of the development of photosensitivity (P = .61), photoallergy (P = .25), or contact allergy (P = .74).

Study details: Findings are from a 10-year retrospective cohort study including 101 patients with or without a history of AD who were tested for sensitivity to UV-A, UV-B, and visible light, followed by photopatch or contact patch testing if photoallergy or simple contact dermatitis was suspected.

Disclosures: This study did not receive any funding. The authors declared no conflicts of interest.

Source: Afvari S and Zippin JH. Photodermatoses in patients with atopic dermatitis: A 10-year retrospective cohort study. J Am Acad Dermatol. 2024 (Feb 18). doi: 10.1016/j.jaad.2024.01.032 Source

Key clinical point: Dupilumab led to rapid and significant improvements in atopic dermatitis (AD) signs and symptoms in children, including those who failed to attain clear or almost clear skin according to Investigator's Global Assessment (IGA).

Major finding: At week 16, the composite endpoint, including ≥50% improvement in Eczema Area and Severity Index scores, was achieved by significantly more children receiving dupilumab vs placebo in the overall group (77.7% vs 24.6%; P < .0001) and the subgroup with an IGA score > 1 (68.9% vs 21.5%; P < .0001). Significant improvements were observed as early as week 2.

Study details: This post hoc analysis of LIBERTY AD PRESCHOOL (Part B) included 162 children age 6 months to 5 years with moderate-to-severe AD who were randomized to receive dupilumab or placebo and low-potency topical corticosteroids, of whom 136 had an IGA score > 1.

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors reported being employees of or owning stocks or stock options in Sanofi or Regeneron. The remaining authors reported receiving grants from or having other ties with Sanofi, Regeneron, or others.

Source: Cork MJ, Lockshin B, Pinter A, et al. Clinically meaningful responses to dupilumab among children aged 6 months to 5 years with moderate-to-severe atopic dermatitis who did not achieve clear or almost clear skin according to the investigator's global assessment: A post hoc analysis of a phase 3 trial. Acta Derm Venereol. 2024 (Feb 12). doi: 10.2340/actadv.v104.13467 Source

Key clinical point: Dupilumab led to rapid and significant improvements in atopic dermatitis (AD) signs and symptoms in children, including those who failed to attain clear or almost clear skin according to Investigator's Global Assessment (IGA).

Major finding: At week 16, the composite endpoint, including ≥50% improvement in Eczema Area and Severity Index scores, was achieved by significantly more children receiving dupilumab vs placebo in the overall group (77.7% vs 24.6%; P < .0001) and the subgroup with an IGA score > 1 (68.9% vs 21.5%; P < .0001). Significant improvements were observed as early as week 2.

Study details: This post hoc analysis of LIBERTY AD PRESCHOOL (Part B) included 162 children age 6 months to 5 years with moderate-to-severe AD who were randomized to receive dupilumab or placebo and low-potency topical corticosteroids, of whom 136 had an IGA score > 1.

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors reported being employees of or owning stocks or stock options in Sanofi or Regeneron. The remaining authors reported receiving grants from or having other ties with Sanofi, Regeneron, or others.

Source: Cork MJ, Lockshin B, Pinter A, et al. Clinically meaningful responses to dupilumab among children aged 6 months to 5 years with moderate-to-severe atopic dermatitis who did not achieve clear or almost clear skin according to the investigator's global assessment: A post hoc analysis of a phase 3 trial. Acta Derm Venereol. 2024 (Feb 12). doi: 10.2340/actadv.v104.13467 Source

Key clinical point: Dupilumab led to rapid and significant improvements in atopic dermatitis (AD) signs and symptoms in children, including those who failed to attain clear or almost clear skin according to Investigator's Global Assessment (IGA).

Major finding: At week 16, the composite endpoint, including ≥50% improvement in Eczema Area and Severity Index scores, was achieved by significantly more children receiving dupilumab vs placebo in the overall group (77.7% vs 24.6%; P < .0001) and the subgroup with an IGA score > 1 (68.9% vs 21.5%; P < .0001). Significant improvements were observed as early as week 2.

Study details: This post hoc analysis of LIBERTY AD PRESCHOOL (Part B) included 162 children age 6 months to 5 years with moderate-to-severe AD who were randomized to receive dupilumab or placebo and low-potency topical corticosteroids, of whom 136 had an IGA score > 1.

Disclosures: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. Three authors reported being employees of or owning stocks or stock options in Sanofi or Regeneron. The remaining authors reported receiving grants from or having other ties with Sanofi, Regeneron, or others.

Source: Cork MJ, Lockshin B, Pinter A, et al. Clinically meaningful responses to dupilumab among children aged 6 months to 5 years with moderate-to-severe atopic dermatitis who did not achieve clear or almost clear skin according to the investigator's global assessment: A post hoc analysis of a phase 3 trial. Acta Derm Venereol. 2024 (Feb 12). doi: 10.2340/actadv.v104.13467 Source

Key clinical point: Both the age of onset and persistence of atopic dermatitis (AD) are differentially associated with the expression and progression of other atopic diseases during childhood.

Major finding: Children who developed AD at 1 year of age (persistent AD) showed significantly higher rates of food allergy (P = .004), asthma (P < .001), and self-reported rhinitis (P < .001) during childhood compared with children without AD at age 1 year (none/intermittent AD [never had AD or had an intermittent course] or late-onset AD [onset from 4-6 years of age]).

Study details: This study included 285 children from the Childhood Origins of ASThma cohort with a history of physician-diagnosed asthma or respiratory allergies who were followed up to 18 years of age and categorized based on AD phenotypes into none/intermittent (n = 180), late-onset (n = 38), or persistent (n = 67) AD groups.

Disclosures: This study was funded by the US National Institutes of Health (NIH) and the US National Heart, Lung, and Blood Institute. Two authors declared receiving funding from or having other ties with various sources, including NIH.

Source: Taki MH, Lee KE, Gangnon R, et al. Atopic dermatitis phenotypes impact expression of atopic diseases despite similar mononuclear cell cytokine responses. J Allergy Clin Immunol. 2024 (Mar 2). doi: 10.1016/j.jaci.2024.02.015 Source

Key clinical point: Both the age of onset and persistence of atopic dermatitis (AD) are differentially associated with the expression and progression of other atopic diseases during childhood.

Major finding: Children who developed AD at 1 year of age (persistent AD) showed significantly higher rates of food allergy (P = .004), asthma (P < .001), and self-reported rhinitis (P < .001) during childhood compared with children without AD at age 1 year (none/intermittent AD [never had AD or had an intermittent course] or late-onset AD [onset from 4-6 years of age]).

Study details: This study included 285 children from the Childhood Origins of ASThma cohort with a history of physician-diagnosed asthma or respiratory allergies who were followed up to 18 years of age and categorized based on AD phenotypes into none/intermittent (n = 180), late-onset (n = 38), or persistent (n = 67) AD groups.

Disclosures: This study was funded by the US National Institutes of Health (NIH) and the US National Heart, Lung, and Blood Institute. Two authors declared receiving funding from or having other ties with various sources, including NIH.

Source: Taki MH, Lee KE, Gangnon R, et al. Atopic dermatitis phenotypes impact expression of atopic diseases despite similar mononuclear cell cytokine responses. J Allergy Clin Immunol. 2024 (Mar 2). doi: 10.1016/j.jaci.2024.02.015 Source

Key clinical point: Both the age of onset and persistence of atopic dermatitis (AD) are differentially associated with the expression and progression of other atopic diseases during childhood.

Major finding: Children who developed AD at 1 year of age (persistent AD) showed significantly higher rates of food allergy (P = .004), asthma (P < .001), and self-reported rhinitis (P < .001) during childhood compared with children without AD at age 1 year (none/intermittent AD [never had AD or had an intermittent course] or late-onset AD [onset from 4-6 years of age]).

Study details: This study included 285 children from the Childhood Origins of ASThma cohort with a history of physician-diagnosed asthma or respiratory allergies who were followed up to 18 years of age and categorized based on AD phenotypes into none/intermittent (n = 180), late-onset (n = 38), or persistent (n = 67) AD groups.

Disclosures: This study was funded by the US National Institutes of Health (NIH) and the US National Heart, Lung, and Blood Institute. Two authors declared receiving funding from or having other ties with various sources, including NIH.

Source: Taki MH, Lee KE, Gangnon R, et al. Atopic dermatitis phenotypes impact expression of atopic diseases despite similar mononuclear cell cytokine responses. J Allergy Clin Immunol. 2024 (Mar 2). doi: 10.1016/j.jaci.2024.02.015 Source

Key clinical point: Children who later developed atopic dermatitis (AD) had a delayed maturation of the skin microbiome and increased levels of proinflammatory stratum corneum biomarkers before AD onset.

Major finding: Children who did vs did not develop AD later had significantly increased levels of stratum corneum biomarkers (thymus and activation-regulated chemokine, interleukin-18, monocyte chemoattractant protein-1, interleukin-22, etc.; all P ≤ .01) and greater variance over time in the most abundant 14 core amplicon sequence variants (P = .04), indicating delayed establishment of a stable skin microbiome.

Study details: This study longitudinally analyzed the epidermal biomarker levels and microbiome profiles of 50 children who were at a high risk for AD from a previous randomized study, of whom 26% of children developed AD up to month 24.

Disclosures: This study was supported by the BIOMAP project, LA ROCHE-POSAY Laboratoire Pharmaceutique, France, and others. Four authors declared receiving institutional research grants, honoraria for consulting, etc., from or having other ties with various sources.

Source: Fonfara M, Hartmann J, Stölzl D, et al. Stratum corneum and microbial biomarkers precede and characterize childhood atopic dermatitis. J Eur Acad Dermatol Venereol. 2024 (Feb 29). doi: 10.1111/jdv.19932 Source

Key clinical point: Children who later developed atopic dermatitis (AD) had a delayed maturation of the skin microbiome and increased levels of proinflammatory stratum corneum biomarkers before AD onset.

Major finding: Children who did vs did not develop AD later had significantly increased levels of stratum corneum biomarkers (thymus and activation-regulated chemokine, interleukin-18, monocyte chemoattractant protein-1, interleukin-22, etc.; all P ≤ .01) and greater variance over time in the most abundant 14 core amplicon sequence variants (P = .04), indicating delayed establishment of a stable skin microbiome.

Study details: This study longitudinally analyzed the epidermal biomarker levels and microbiome profiles of 50 children who were at a high risk for AD from a previous randomized study, of whom 26% of children developed AD up to month 24.

Disclosures: This study was supported by the BIOMAP project, LA ROCHE-POSAY Laboratoire Pharmaceutique, France, and others. Four authors declared receiving institutional research grants, honoraria for consulting, etc., from or having other ties with various sources.

Source: Fonfara M, Hartmann J, Stölzl D, et al. Stratum corneum and microbial biomarkers precede and characterize childhood atopic dermatitis. J Eur Acad Dermatol Venereol. 2024 (Feb 29). doi: 10.1111/jdv.19932 Source

Key clinical point: Children who later developed atopic dermatitis (AD) had a delayed maturation of the skin microbiome and increased levels of proinflammatory stratum corneum biomarkers before AD onset.

Major finding: Children who did vs did not develop AD later had significantly increased levels of stratum corneum biomarkers (thymus and activation-regulated chemokine, interleukin-18, monocyte chemoattractant protein-1, interleukin-22, etc.; all P ≤ .01) and greater variance over time in the most abundant 14 core amplicon sequence variants (P = .04), indicating delayed establishment of a stable skin microbiome.

Study details: This study longitudinally analyzed the epidermal biomarker levels and microbiome profiles of 50 children who were at a high risk for AD from a previous randomized study, of whom 26% of children developed AD up to month 24.

Disclosures: This study was supported by the BIOMAP project, LA ROCHE-POSAY Laboratoire Pharmaceutique, France, and others. Four authors declared receiving institutional research grants, honoraria for consulting, etc., from or having other ties with various sources.

Source: Fonfara M, Hartmann J, Stölzl D, et al. Stratum corneum and microbial biomarkers precede and characterize childhood atopic dermatitis. J Eur Acad Dermatol Venereol. 2024 (Feb 29). doi: 10.1111/jdv.19932 Source