JAMA Dermatol

Investigational oral JAK inhibitor effective for moderate to severe atopic dermatitis in phase 3 trial

May 9, 2025

Once-daily ivarmacitinib offers a promising new treatment option for patients with moderate to severe atopic dermatitis (AD), demonstrating significant improvements in skin condition and patient-reported outcomes.

Study details: This multicenter, double-blind, placebo-controlled phase 3 trial (NCT04875169) evaluated the efficacy and safety of ivarmacitinib, a selective JAK1 inhibitor, in 336 patients aged 12 to 75 years with moderate to severe AD. Participants were randomized to receive either 4 mg or 8 mg of ivarmacitinib or placebo once daily for 16 weeks. The primary endpoints were achieving an Investigator Global Assessment (IGA) score of 0 or 1 with at least a 2-grade improvement from baseline and a 75% improvement in the Eczema Area and Severity Index (EASI-75) at week 16.

Results: By week 16, the IGA response rate was 42% in the 8 mg group and 36% in the 4 mg group, compared with 9% in the placebo group (P<.001). The EASI-75 response rate was 66% for the 8 mg group and 54% for the 4 mg group vs. 22% for placebo. Significant improvements were also observed in secondary endpoints, including itch severity and quality of life measures. Rates of treatment-emergent adverse events were 69.0% in the 4-mg group, 66.1% in the 8-mg group, and 64.9% in the placebo group. For serious treatment-emergent adverse events, rates were 2.7%, 1.8%, and 2.7%, respectively.

Source:

Zhao Y, et al. (2025, April 30). JAMA Dermatol. Ivarmacitinib for Moderate to Severe Atopic Dermatitis in Adults and Adolescents: A Phase 3 Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40305055/