Baricitinib Confirmed Safe and Efficacious for Treating Alopecia Areata

A recent study has indicated the safety and efficacy of using baricitinib to treat severe alopecia areata in adults, using results from two Phase III trials over at least 152 weeks and up to 4 years of treatment.

Baricitinib is an oral selective Janus kinase (JAK) inhibitor that has been approved for many countries for several rheumatologic and dermatologic disorders, as well as for COVID-19. Estimates put the number of individuals exposed to baricitinib at well over 780,000.1

“The long-term data from the integrated safety analysis of patients with severe AA in the BRAVE-AA1 and BRAVE-AA2 clinical trials, spanning up to 4 years, reinforce the established safety profile of baricitinib over an extended period,” wrote Brett King, MD, PhD, department of dermatology, Yale School of Medicine, and colleagues. “Importantly, the rates of [adverse events of special interest] AESIs have remained stable, falling within the expected background rates for the general AA population.”1

The BRAVE-AAI and BRAVE-AA2 clinical trials were ongoing randomized, double-blind, parallel-group, placebo-controlled trials which included 654 and 546 participants respectively. Participants were gauged based on the Severity of Alopecia Tool (SALT) score; participants were included if they had a score of 50 or higher (range, 0 [no scalp hair loss] to 100 [complete scalp hair loss]). Patients were randomized 2:2:3 to receive a daily dose of either placebo, 2 mg baricitinib, or 4 mg baricitinib. The primary outcome was a score of 20 or less at week 36.2

This study included two integrated datasets from the BRAVE-AA trials; extended BARI AA, which includes patients continuously treated with baricitinib 2 or 4 mg from baseline to data cutoff, and all BARI AA, which includes all available data during baricitinib exposure for all patients who received one or more doses at any time from randomization or switch from placebo, up to 30 days after the final dose.1

King and colleagues indicated that safety outcomes for the trials included treatment-emergent adverse effects (TEAEs), AESIs, abnormal changes in laboratory test results, mean change from baseline in lipid parameters, and concomitant use of lipid-lowering medications. AESIs included serious infection, herpes simplex and zoster, opportunistic infection, tuberculosis, major adverse cardiovascular events (MACEs), deep vein thrombosis, pulmonary embolism, malignancy, non-melanoma skin cancer (NMSC) and gastrointestinal perforation.1

The team notes that Extended BARI AA had 948 participants, while All BARI AA included 1303. The mean age of All BARI AA was 37.5 years, and the mean and median SALT score were 85.8 and 97.0, respectively. 1

TEAEs were reported in 274 and 449 patients receiving baricitinib 2 mg and 4 mg respectively in Extended BARI AA, and in 1028 patients in All BARI AA. The most common TEAEs, occurring in ≥3% of patients in All BARI AA, were COVID-19, upper respiratory tract infection, headache, nasopharyngitis, acne, urinary tract infection, and creatine phosphokinase increase. The only AESIs reported included herpes zoster and simplex, the incidence of which remained stable over time, and seven malignancies.1

The team indicates that this safety analysis brought up no new concerns or signals. The majority of TEAEs were moderate to mild, and the incidence rates of TEAEs and AEs leading to discontinuations were low, as well as being consistent with previously reported data from the BRAVE-AA trials.1

“The BRAVE-AA1 and BRAVE-AA2 trials are ongoing and will continue to monitor patients for up to 200 weeks,” King and colleagues wrote.1

References

1. King B, Mostaghimi A, Shimomura Y, et al. Safety of baricitinib in adults with severe alopecia areata from two phase III trials over a median of 2.3 years and up to 4 years of treatment. American Journal of Clinical Dermatology. Published online April 11, 2025. doi:10.1007/s40257-025-00932-0

2. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. New England Journal of Medicine. 2022;386(18):1687-1699. doi:10.1056/nejmoa2110343