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) - Supplement
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 <.001, 2 mg vs. placebo) and those with a vIGA-AD 0/1 were 5%, 13%, and 24% (P <.001, 2 mg vs. placebo), for placebo, baricitinib 1 mg, and 2 mg, respectively. Safety findings were similar to other baricitinib AD studies. 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.