⚡Opzelura In Pediatric AD, AI Melanoma Launch, and Cabtreo Vs Epiduo Forte

Good morning — it’s Saturday, May 31, and we’re covering new Phase 3 data for ruxolitinib cream in children with atopic dermatitis, an AI tool for melanoma detection launching in Europe, and more.

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Ruxolitinib (Opzelura), Incyte’s topical JAK1/2 inhibitor, showed rapid and significant efficacy in children with atopic dermatitis, according to results from the TRuE-AD3 Phase 3 trial published in JAAD.

Investigators randomized 330 children aged 2–11 years with mild to moderate atopic dermatitis to ruxolitinib cream (0.75% or 1.5%) or vehicle for 8 weeks.

Among those receiving the higher dose, 57% achieved clear or almost clear skin (IGA 0/1 with ≥2-point improvement) at Week 8, compared to 11% on vehicle. Similarly, 67% achieved at least a 75% reduction in eczema severity (EASI 75) versus 15% on vehicle. Improvements were evident as early as Week 2.

Ruxolitinib was well tolerated, with low rates of application site reactions (<5%), despite 64% of participants having facial involvement.

Limitations include the short 8-week duration and enrollment restricted to North America.

Now under FDA review for pediatric atopic dermatitis, ruxolitinib cream seeks to join tapinarof (Vtama) and roflumilast (Zoryve)—already approved down to ages 2 and 6, respectively—in a competitive yet underserved space as a fast-acting, nonsteroidal topical option.

> AI Melanoma Tool Dermalyser Secures CE Mark for European Launch: AI Medical Technology has received CE mark approval in Europe for Dermalyser, a smartphone-based AI-powered diagnostic tool for melanoma. The CE mark confirms compliance with EU health, safety, and performance standards, clearing the way for European market entry. Dermalyser uses a smartphone app paired with a dermatoscope to capture images of suspicious lesions, analyze them using AI, and return a clear yes/no result indicating evidence of melanoma. In a real-world trial across 36 Swedish primary care clinics, Dermalyser was evaluated on 253 lesions suspected of melanoma. It demonstrated strong performance, with 95% sensitivity and 85% specificity across all melanomas. For invasive melanomas, sensitivity and specificity rose to 100% and 93%, respectively. Following the app’s recommendations could have prevented unnecessary excision or referral in 140 of the 253 lesions. The study results were published in the British Journal of Dermatology in 2024. AI Medical Technology plans a U.S. rollout in 2027.

> Cabtreo Outperforms Epiduo Forte and Dyads in Moderate and Severe Acne: A new post hoc analysis stratified by baseline acne severity strengthens support for Cabtreo (clindamycin 1.2%/adapalene 0.15%/benzoyl peroxide 3.1%), the only FDA-approved triple-combination topical for acne. In pooled data from four randomized trials involving 1,787 participants, Cabtreo outperformed Epiduo Forte (adapalene 0.3%/benzoyl peroxide 2.5%) and three dyad combinations (pairings of two active ingredients) in moderate acne and generally showed greater efficacy in severe cases. Among participants with moderate acne (n=1,557), treatment success—defined as clear or almost clear skin (EGSS 0/1) with a ≥2-grade improvement—was achieved by 54% treated with Cabtreo versus 38% with Epiduo Forte and 20% with vehicle. In severe acne (n=230), Cabtreo and the clindamycin/adapalene dyad had the highest success rates (31% and 34%), compared to 20% with Epiduo Forte and 9% with vehicle. Cabtreo also generally provided greater reductions in inflammatory and noninflammatory lesions than Epiduo Forte, without increased adverse events. Limitations include the small sample size in the severe subgroup and exploratory statistical comparisons.

> Dupilumab Reduces Disease Severity in Pediatric Erythrodermic Atopic Dermatitis: A new post hoc analysis published in JAAD demonstrates the efficacy and safety of dupilumab in children aged 6 months to 11 years with erythrodermic atopic dermatitis. Patients received dupilumab or placebo alongside topical corticosteroids in two 16-week randomized trials (LIBERTY AD PRESCHOOL and PEDS), followed by a 52-week open-label extension (LIBERTY AD PED-OLE). Among 39 children, dupilumab reduced affected body surface area (BSA) by 58% at Week 16 compared to 19% with placebo, and Eczema Area and Severity Index (EASI) scores fell by 70% versus 21% (both P < 0.0001). Efficacy was sustained through Week 52, with BSA and EASI reductions of 68% and 69%, respectively. Results were consistent with outcomes in the broader pediatric trial population. No adverse events related to dupilumab were serious or led to treatment discontinuation. Despite the limited sample size, these findings support dupilumab’s use in pediatric erythrodermic atopic dermatitis.

> Shingrix Sustains High Efficacy Against Herpes Zoster in Final 11-Year Analysis: The final analysis of the ZOE-LTFU study confirms durable protection against herpes zoster with GSK’s adjuvanted recombinant zoster vaccine (Shingrix), lasting at least 11 years post-vaccination. The open-label study followed 7,273 participants initially enrolled in two pivotal Phase 3 trials (ZOE-50 and ZOE-70). Long-term follow-up (5 to 11 years post-vaccination) revealed an 80% vaccine efficacy against herpes zoster in adults aged ≥50 years. Efficacy against postherpetic neuralgia was 88%. Vaccine efficacy from one month after the second dose through year 11 was 88%, with protection sustained at 82% in the eleventh year. No vaccine-related serious adverse events were reported. Limitations include the use of a historical control for efficacy estimates and enrollment of only around half the original trial cohort in long-term follow-up. In comparison, Zostavax—a live attenuated vaccine and the first to be licensed for herpes zoster—showed declining efficacy from 51% to just 21% over similar periods (0–5 and 5–12 years), underscoring the superior long-term clinical benefit of Shingrix.

> Dual Kinase Inhibitor TLL-018 Clears Psoriasis In Early Trial: In a Phase 1 trial published in the British Journal of Dermatology, TLL-018—an investigational dual TYK2/JAK1 inhibitor—delivered high levels of skin clearance in moderate to severe psoriasis. The 12-week study randomized 73 patients to TLL-018 (10–30 mg BID) or placebo. At the highest dose, 71% achieved clear or almost clear skin (PGA 0/1), compared to 0% with placebo. Additionally, 48% of patients achieved at least a 90% reduction in disease severity (PASI 90). TLL-018 was well tolerated, with only one discontinuation due to mild facial swelling that resolved. The results approach those seen with deucravacitinib, a selective TYK2 inhibitor. TLL-018 recently completed Phase 2 evaluation.

Quizzes, cases, and perspectives to sharpen your clinical eye.

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