Long-Term Efficacy and Safety of Baricitinib in Patients With Severe Alopecia Areata: 104-Week Results From BRAVE-AA1 and BRAVE-AA2

The document presents the results of two Phase 3 trials (BRAVE-AA1 and BRAVE-AA2) on the long-term efficacy and safety of baricitinib, a drug used for severe alopecia areata (AA). The study found that continuous monotherapy with baricitinib over 104 weeks maintained efficacy, with 90.7% of patients treated with 4mg and 89.2% of patients treated with 2mg maintaining clinical response at Week 104. The study also found that long-term treatment is necessary to observe maximum benefit. The most common treatment-emergent adverse events (TEAEs) were COVID-19, upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, and creatine phosphokinase increase. The study concluded that long-term therapy may be necessary for disease control in severe AA, and continuous baricitinib treatment over 104 weeks showed cumulative benefit on hair regrowth and improved quality of life. There were few discontinuations and no new safety signals over the long-term observation period.