32237 Clinician and patient evaluation of improvement for eyebrow and eyelashes hair loss during baricitinib phase 3 trials BRAVE-AA1 and BRAVE-AA2

Abstract

Baricitinib is an oral, selective Janus kinase (JAK)1/JAK2 inhibitor in development for severe alopecia areata (AA). Here, we present and describe the similarity between clinician-reported outcome (ClinRO) and patient-reported outcome (PRO) improvement on Eyebrow (EB) Hair Loss and Eyelash (EL) Hair Loss scales from phase 3, independent, randomized, double-blind, placebo-controlled AA trials, BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259). Adults with severe AA (Severity of Alopecia Tool score ≥50) were randomized 3:2:2 to once-daily baricitinib 4- mg, baricitinib 2- mg, or placebo. ClinRO and PRO scale scores were 0 (full coverage), 1 (minimal gaps/even distribution), 2 (significant gaps/uneven distribution), and 3 (no notable hair). We evaluated the proportions of patients achieving ClinRO or PRO 0-1 scores with ≥2-point improvement from baseline at Week 36 for EB and EL among those with baseline scores ≥2. In BRAVE-AA1 and BRAVE-AA2, respectively, 654 and 546 patients were randomized, and 598 (91.4%) and 490 (89.7%) completed up to Week 36. EB and EL hair regrowth improvements with both ClinRO and PROs were observed at Week 12, and response rates increased over time. At Week 36, for baricitinib 4- mg/baricitinib-2 mg/placebo, the proportions of patients with 0-1 scores for ClinRO and PRO, respectively, for eyebrows were 31.4%/19.1%/3.2% and 32.1%/16.3%/3.1% in BRAVE-AA1, and 34.8%/11.5%/4.5% and 35.8%/14.8% /4.7% in BRAVE-AA2, and for eyelashes were 33.5%/13.5%/3.1% and 29.8%/19.6%/2.0% in BRAVE-AA1 and 34.3%/10.1%/5.6% and 34.6%/18.9%/1.1% in BRAVE-AA2. Baricitinib demonstrated efficacy in EB and EL hair regrowth. Response rates were similar between the ClinRO and PRO measures for EB and EL improvement and consistent across trials.