Baricitinib in patients with moderate-to-severe atopic dermatitis: Results from a randomized monotherapy Phase 3 trial in the United States and Canada (BREEZE-AD5).

Abstract Background Baricitinib, an oral, selective Janus kinase (JAK)1/JAK2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults. Objective To evaluate the efficacy and safety of baricitinib monotherapy in a North American Phase 3 trial (BREEZE-AD5/NCT03435081) of adults with moderate-to-severe AD who responded inadequately or were intolerant to topical therapy. Methods Patients (N=440) were randomized 1:1:1 to once-daily placebo or baricitinib (1 mg or 2 mg). The primary endpoint was the proportion of patients achieving ≥75% reduction in the Eczema Area and Severity Index (EASI75) at Week 16. A key secondary endpoint was the proportion of patients achieving a validated Investigator Global Assessment for AD (vIGA-AD™) score of 0 (clear)/1(almost clear) with ≥2-point improvement. Results At Week 16, the proportion of patients achieving EASI75 was 8%, 13%, and 30% (P Limitations Short-term clinical trial results may not be generalizable to real-world settings. Conclusion Baricitinib was efficacious for patients with moderate-to-severe AD with no new safety findings over 16 weeks.