26691 Rapid and concurrent improvements in the signs and symptoms of atopic dermatitis with baricitinib in the phase 3 study, BREEZE-AD5

Abstract

Baricitinib (BARI), an oral selective Janus kinase (JAK)1/JAK2 inhibitor, was evaluated in adult patients with moderate-to-severe atopic dermatitis (AD) who were intolerant or inadequate responders to topical therapy in the US- and Canadian-based placebo (PBO)-controlled Phase 3 trial, BREEZE-AD5 (NCT03435081). The objective of this analysis was to assess the onset and magnitude of changes across all disease dimensions (clinician-based and patient-reported outcomes) for the first 4 weeks of treatment in this monotherapy trial. Patients (N = 440) were randomized 1:1:1 to once-daily PBO or BARI (1-mg or 2-mg). At baseline, topical and systemic AD therapies were not allowed but could be used for rescue; data after rescue or discontinuation were considered missing. Least-squares mean change from baseline to Week 1 through Week 4 were compared between treatments using mixed model repeated measure analysis for the following: Eczema Area and Severity Index (EASI), Itch Numeric Rating Scale (NRS), Skin Pain NRS, AD Sleep Scale (ADSS) Item 2 (frequency of nighttime awakenings), Dermatology Life Quality Index (DLQI), and Patient Oriented Eczema Measure (POEM). Statistically significant improvements (P ˂ .05) in EASI, Itch NRS, Skin Pain NRS, ADSS Item 2, POEM, and DLQI were observed by Week 1 for both BARI doses compared with PBO. Statistically significant improvements (P ˂ .05) were maintained to Week 4 for both BARI doses, except with BARI 1 mg vs PBO for ADSS Item 2 (P = .055). BARI resulted in rapid and concurrent improvements in EASI, itch, sleep disturbance, DLQI, and POEM, with statistically significant improvements seen by Week 1.