Top-line results from phase III study (BREEZE-AD4) of baricitinib with topical corticosteroids in patients with moderate to severe atopic dermatitis not controlled with cyclosporine.- Eli Lilly

Eli Lilly and Company and Incyte announced that baricitinib met the primary endpoint in BREEZE-AD4, an investigational Phase III, randomized, placebo-controlled study evaluating the safety and efficacy of baricitinib in combination with topical corticosteroids (TCS) for the treatment of adult patients with moderate to severe atopic dermatitis (AD) who were inadequate responders, intolerant or had contraindication to treatment with cyclosporine. The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16. BREEZE-AD4 is a multicenter, double-blind, randomized, placebo-controlled study conducted outside of the U.S. The study evaluated the efficacy and safety of the 1-mg, 2-mg and 4-mg doses of baricitinib in combination with TCS in patients with moderate to severe AD who have experienced failure to cyclosporine or are intolerant to—or have contraindication to cyclosporine. In this study, the 4-mg dose of baricitinib plus TCS met the primary endpoint as defined by the proportion of participants achieving EASI75 at Week 16. The safety profile was consistent with the known safety findings of baricitinib in AD. The most common treatment-emergent adverse events (TEAEs) included nasopharyngitis, headache, and influenza. No venous thromboembolic events (VTEs) or deaths were reported in the trial. Lilly recently submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate to severe atopic dermatitis and plans to submit for approval in the U.S. and Japan in 2020. Full results from the BREEZE-AD4 study will be disclosed at future scientific venues and in peer-reviewed journals.