A RECENT phase 3 clinical trial has shown promising results for ivarmacitinib, a selective oral JAK1 inhibitor, in treating moderate to severe atopic dermatitis (AD) in both adolescents and adults. This multicentre, double-blind, placebo-controlled study involved 336 patients aged 12 to 75 years, recruited from 53 sites across Canada and China between April 2021 and April 2022. Participants were randomly assigned to receive either 4 mg or 8 mg of ivarmacitinib or a placebo once daily for 16 weeks.
The results demonstrated significantly greater improvement in the ivarmacitinib groups compared to placebo. At 16 weeks, 36.3% of patients in the 4-mg group and 42.0% in the 8-mg group achieved clear or almost clear skin, with at least a two-grade improvement in their Investigator Global Assessment (IGA) scores. This was in stark contrast to just 9.0% of patients in the placebo group. Similarly, the proportion of patients reaching at least 75% improvement in the Eczema Area and Severity Index (EASI-75) was 54.0% for the 4-mg group and 66.1% for the 8-mg group, compared to only 21.6% in the placebo group.
Treatment-emergent adverse events were similar across all groups, occurring in approximately two-thirds of patients. Serious adverse events were rare, reported in fewer than 3% of participants in any group. These findings suggest that ivarmacitinib not only offers meaningful clinical benefits but also maintains a favourable safety profile.
In conclusion, this study supports ivarmacitinib as a potentially valuable treatment option for adolescents and adults living with moderate to severe AD. Its once-daily oral dosing, effectiveness, and manageable safety profile mark it as a promising new therapy in the evolving landscape of AD management.
Reference
Zhao Y et al. Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025;DOI:10.1001/jamadermatol.2025.0982.