Efficacy and safety of the oral Janus kinase inhibitor baricitinib in the treatment of adults with alopecia areata: Phase 2 results from a randomized controlled study

Abstract

Background: There are no treatments approved by the Food and Drug Administration for alopecia areata.Objective: To evaluate the efficacy and safety of baricitinib in patients with $50% scalp hair loss in a phase 2 study of adults with alopecia areata (BRAVE-AA1).Methods: Patients were randomized 1:1:1:1 to receive placebo or baricitinib 1 mg, 2 mg, or 4 mg once daily. Two consecutive interim analyses were performed after all patients completed weeks 12 and 36 or had discontinued treatment prior to these time points. The primary endpoint was the proportion of patients achieving a Severity of Alopecia Tool (SALT) score #20 at week 36. Logistic regression was used with nonresponder imputation for missing data.Results: A total of 110 patients were randomized (placebo, 28; baricitinib 1-mg, 28; 2-mg, 27; 4-mg, 27). The baricitinib 1-mg dose was dropped after the first interim analysis based on lower SALT 30 response rate. At week 36, the proportion of patients achieving a SALT score of #20 was significantly greater in baricitinib 2-mg (33.3%, P = .016) and 4-mg (51.9%, P = .001) groups versus placebo (3.6%). Baricitinib was well tolerated with no new safety findings.Limitations: Small sample size limits generalizability of results. Conclusion:These results support the efficacy and safety of baricitinib in patients with $50% scalp hair loss.

The efficacy and safety of JAK inhibitors for alopecia areata: A systematic review and meta-analysis of prospective studies

“…The remaining 151 potentially relevant reports were reviewed in full text. After detailed evaluation of these reports, 14 studies (5 RCTs and 9 non-RCTs) ( Kennedy Crispin et al, 2016 ; Mackay-Wiggan et al, 2016 ; Almutairi et al, 2018 ; Jabbari et al, 2018 ; Liu et al, 2018 ; Olsen et al, 2020 ; King et al, 2021a ; AlMarzoug et al, 2021 ; King et al, 2021b ; Lai et al, 2021 ; Peeva et al, 2021 ; King et al, 2022 ), enrolling a total of 1,845 patients, were included for analysis ( Figure 1 ).…”

An overview of JAK/STAT pathways and JAK inhibition in alopecia areata

“…Favorable results from the BRAVE-AA1 and BRAVE-AA2 trials led to the first-in-disease systemic FDA-approved treatment for AA. On June 13 th 2022, the FDA approved a once-daily regimen of baricitinib (Olumiant) available as 1 mg, 2 mg, or 4 mg tablets for adults with severe AA ( 87 ). Approved FDA labeling of Olumiant includes boxed warnings for potential serious adverse effects.…”

Application of Baricitinib in Dermatology

“…A Phase II randomized controlled study where baricitinib was used to treat adult AA showed that 33.3% and 51.9% of patients with AA had alopecia tool scores of <20 at 36 weeks after oral administration of 2 mg and 4 mg dose, respectively, and baricitinib was well-tolerated. 29 One case report of a patient with AA, who lost all of her hair after a local injection of triamcinolone acetonide, showed that 97% of the scalp hair, eyebrows, and eyelashes regrew after receiving 2 mg baricitinib treatment. This patient received treatment for 13 months without any adverse effects.…”