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).
Baricitinib, an oral, selective Janus kinase (JAK)1/JAK2 inhibitor, is being studied for moderate-to-severe atopic dermatitis (AD) in adults.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.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.At Week 16, the proportion of patients achieving EASI75 was 8%, 13%, and 30% (P
Authors: Eric L Simpson, Seth Forman, Jonathan I Silverberg, Matthew Zirwas, Emanual Maverakis, George Han, Emma Guttman-Yassky, Daniel Marnell, Robert Bissonnette, Jill Waibel, Fabio P Nunes, Amy M DeLozier, Robinette Angle, Margaret Gamalo, Katrin Holzwarth, Orin Goldblum, Jinglin Zhong, Jonathan Janes, Kim Papp