Efficacy and Safety of Baricitinib in Patients with Severe Alopecia Areata over 52 Weeks of Continuous Therapy in Two Phase III Trials (BRAVE-AA1 and BRAVE-AA2)

• DOI: 10.1007/s40257-023-00764-w
• Publication Date: 2023-03-01T03:02:40Z
• Authors: Ohsang Kwon; Maryanne M. Senna; Rodney Sinclair; Taisuke Ito; Yves Dutronc; Chen-Yen Lin; Guanglei Yu; Chiara Chiasserini; Jill McCollam; Wen-Shuo Wu; Brett King
• Keywords: Adult; Alopecia Areata; Humans; COVID-19; Janus Kinase Inhibitors; Original Research Article; 3. Good health; COVID-19 Drug Treatment

The oral Janus kinase (JAK) inhibitor baricitinib has demonstrated efficacy for severe alopecia areata (AA) over 36 weeks. There are limited data on the longer-term treatment of AA.The aim this study was to evaluate and safety AA in adults with ≥50% scalp hair loss through 52 weeks continuous therapy two phase III trials (BRAVE-AA1 BRAVE-AA2).Patients randomized at baseline BRAVE-AA1 (N = 465) BRAVE-AA2 390) retained their allocation Week 52. Efficacy outcomes included proportion patients achieving a Severity Alopecia Tool (SALT) score ≤ 20 (≤ 20% loss). Data were censored after permanent discontinuation or if collected remotely due coronavirus disease 2019 (COVID-19) pandemic.Response rates regrowth increased 52-week period. Of treated 4 mg 2 mg, respectively, 40.9% 21.2% 36.8% 24.4% achieved SALT most frequent treatment-emergent adverse events upper respiratory tract infection, headache, nasopharyngitis, acne, urinary creatine phosphokinase elevation, COVID-19 infection.There no comparisons placebo.Efficacy continuously improved weeks, indicating that long-term may be necessary observe maximum clinical benefit. new signals.ClinicalTrials.gov NCT03570749 NCT03899259. Safety Baricitinib Patients Severe Areata: Week-52 Results from BRAVE-AA2.Alopecia is an autoimmune causes patchy scalp, face, body. approved treat several countries, based results studies, BRAVE-AA2. In these least 50% Long-term important AA, can take longer some disease. Therefore, we assessed course therapy. study, report 465 390 goal reduce less by BRAVE-AA1, who took had missing Similarly, BRAVE-AA2, common effects reported during period infection. indicate continues improve without any concerns taking baricitinib.