Baricitinib Efficacy Through 4 Years in Responders and Safety up to 5 Years in Adults with Severe Alopecia Areata: Final Results from BRAVE-AA1 and BRAVE-AA2.
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INTRODUCTION: Long-term efficacy and safety data are imperative for therapies used to treat severe alopecia areata (AA) because the disease is chronic, loss of response can be devastating to patients, and the safety profile needs to support long-term therapy. Baricitinib, a selective JAK inhibitor, has been approved for severe AA in adults and is being studied in pediatric patients. This study evaluates the final long-term efficacy and safety of baricitinib in adults with severe AA. METHODS: Efficacy was assessed for patients randomized to baricitinib 4 mg or 2 mg who achieved response (Severity of Alopecia Tool [SALT] score ≤ 20) at Week 52 (4 mg, N = 133; 2 mg, N = 72) and stayed on the same dose through Week 200. Proportions of patients maintaining a SALT score ≤ 20 and achieving a Clinician-Reported Outcome Measure for Eyebrow/Eyelash (EB/EL) Hair Loss™ score of 0 or 1 with ≥ 2-point improvement from baseline were reported using the modified last-observation-carried-forward method. Safety is reported as incidence rates (IR) per 100 patient-years at risk for the All BARI AA group (N = 1303) and Extended BARI AA group (N = 948) through 248 weeks of exposure RESULTS: For baricitinib 4 mg and 2 mg, respectively, among Week 52 responders, 115/133 (86.5%) and 61/72 (84.7%) maintained a SALT score ≤ 20 at Week 200. Regrowth of EB/EL hair continued beyond Week 52 and was maintained through Week 200. In up to 5 years of exposure with baricitinib, the IR for serious infections, nonmelanoma skin cancer malignancies, deep vein thrombosis/pulmonary embolism, and major adverse cardiovascular events remained low relative to background rates. No deaths occurred, and adverse event rates remained stable over time. CONCLUSIONS: Within this population, ~ 85% of responders maintained SALT scores ≤ 20 through approximately 4 years with continued benefit for EB/EL. Baricitinib's safety profile remained consistent over 5 years of treatment, in line with prior BRAVE program findings. TRIAL REGISTRATION NUMBER: BRAVE-AA1, ClinicalTrials.gov number, NCT03570749, start date, September 24, 2018; BRAVE-AA2, ClinicalTrials.gov number, NCT03899259, start date, July 8, 2019.