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Long-Term Efficacy of Baricitinib for Severe Alopecia Areata
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Researchers examined the impact of baricitinib withdrawal and retreatment on hair regrowth in patients with severe alopecia areata.
Although baricitinib has demonstrated efficacy for treating patients with severe alopecia areata, withdrawal of therapy resulted in hair loss for almost all patients, indicating the need for continued therapy to maintain hair regrowth, according to one study.1
Results of the randomized, placebo-controlled, phase 3 BRAVE-AA1 clinical trial were published in JAMA Dermatology.
“Treatment withdrawal was dictated by the clinical trial design, which was distinctly different from clinical practice, in which the duration and/or depth of response and other parameters (baseline disease severity or chronicity) broadly inform treatment decisions but may be especially important in guiding decisions to adjust the dose, interrupt therapy, or discontinue treatment,” wrote the researchers of the study.
Baricitinib is an oral Janus kinase (JAK) inhibitor that has been found to be more effective than established therapies for moderate to severe alopecia areata.2 However, alopecia areata is a relapsing condition, in which maintenance therapy after successful regrowth may be necessary.1
The study reported results from the BRAVE-AA1 clinical trial, an adaptive phase 2 to 3 double-blind, parallel-group, randomized, placebo-controlled trial. This trial included a randomized withdrawal substudy to assess the outcomes of discontinuing treatment in patients who initially responded to baricitinib.
Participants were adults aged 18 to 60 years (men) and 18 to 70 years (women) with severe alopecia areata, defined by a Severity of Alopecia Tool (SALT) score of 50 or greater, indicating at least 50% scalp hair loss. Additionally, the duration of the current alopecia areata episode had to be longer than 6 months but less than 8 years, with no spontaneous improvement over the 6 months before screening.
Furthermore, participants were randomized 3:2:2 to receive baricitinib 4 mg, baricitinib 2 mg, or placebo once daily for 52 weeks.
After 52 weeks of treatment, patients who achieved a SALT score of 20 or less were eligible for the randomized withdrawal substudy, in which responders were randomized 3:1 to continue their current dose of baricitinib or switch to placebo.
The primary outcome was the proportion of patients maintaining a SALT score of 20 or less through week 152.
A total of 654 patients received treatment, with a mean (SD) age of 37.1 (13) years, including 383 (58.6%) women. At week 52, 10 of 39 responders receiving baricitinib 2 mg and 30 of 115 responders receiving baricitinib 4 mg were randomized to placebo.
At 4 and 8 weeks of treatment withdrawal, 0% and 10% to 11% of patients lost treatment benefit regardless of dose, respectively. By week 152, 80% of patients lost benefit compared with 7% of patients who continued baricitinib.
Additionally, 63% of patients taking baricitinib 2 mg and 87.5% of patients taking baricitinib 4 mg achieved a SALT score of 20 or less after treatment within the follow-up observation periods.
However, the researchers noted some limitations in their findings. As the study progressed, patient visits were scheduled at longer intervals. This may have delayed the detection of hair loss, resulting in patients potentially losing more hair before retreatment was initiated.
Additionally, the lack of quality of life data limits the understanding of the broader psychological and social impacts of hair loss and regrowth on patients. Small sample sizes for certain subgroups further restrict the ability to draw definitive conclusions. Moreover, the study's approach to treatment withdrawal may not reflect real-world clinical practice, where more personalized decision-making occurs based on individual patient responses.
Despite these limitations, the researchers believe the study provides valuable insights into the effectiveness of baricitinib for treating severe alopecia areata, suggesting that further research is needed to refine treatment approaches, understand long-term outcomes, and improve the quality of life for patients dealing with this chronic condition.
References
1. King B, Ko J, Kwon O, et al. Baricitinib withdrawal and retreatment in patients with severe alopecia areata: the BRAVE-AA1 randomized clinical trial. JAMA Dermatol. Published online August 14, 2024. doi:10.1001/jamadermatol.2024.2734
2. Santoro C. Review finds JAK inhibitors more effective for moderate to severe AA compared with established therapies. AJMC®. March 13, 2024. Accessed August 29, 2024. https://www.ajmc.com/view/review-finds-jak-inhibitors-more-effective-for-moderate-to-severe-aa-compared-with-established-therapies
