Baricitinib Shows Real-World Effectiveness in Severe Alopecia Areata Hair Loss

Baricitinib (Olumiant; Eli Lilly) demonstrated meaningful efficacy and a favorable safety profile in adults with severe alopecia areata in a real-world prospective study, with more than half of patients achieving substantial hair regrowth within 1 year of treatment.¹ The findings, published in the Journal of Dermatologic Treatment, help bridge an evidence gap between randomized clinical trials and everyday dermatology practice, where long-standing disease, prior treatment failures, and comorbidities are common.

This year, the therapy has provided promising data, with notable findings highlighted in the phase 3 BRAVE-AA-PEDS study (NCT05723198), which showed significant scalp, eyelash, and eyebrow hair regrowth at 52 weeks in adolescents with severe alopecia areata.²

The new prospective observational study followed 48 adults with severe alopecia areata for 12 months to assess real-world effectiveness, safety, and predictors of response to baricitinib, a Janus kinase (JAK) inhibitor approved for severe alopecia areata.¹ The primary end point was achievement of a Severity of Alopecia Tool (SALT) score below 20%, sustained across at least 2 assessments separated by 12 weeks within the first year of therapy.

Participants had a mean (SD) age of 37.0 (16.0) years, and two-thirds were female (66.7%), reflecting the female predominance often seen in specialty alopecia areata cohorts. Disease burden was substantial: the mean disease duration prior to baricitinib initiation was 10.6 (9.9) years, and baseline scalp hair loss was severe, with a mean SALT score of 66.9 (32.7). Nearly one-third of patients (35.4%) had alopecia totalis or universalis, and 60.4% had eyebrow or eyelash involvement.

Comorbid autoimmune and inflammatory conditions were frequent, including hypothyroidism (22.9%), atopic dermatitis (18.8%), and psoriasis (10.4%). All patients had previously received topical and systemic corticosteroids, and many had cycled through additional therapies, such as intralesional corticosteroids (77.1%), topical minoxidil (83.3%), oral minoxidil (54.2%), methotrexate (33.3%), and even prior JAK inhibition with tofacitinib (20.8%), underscoring the refractory nature of disease in this cohort.

Most patients (87.5%) initiated baricitinib at the recommended dose of 4 mg/day, whereas 12.5% started at 2 mg/day. Dose adjustments occurred in select cases due to adverse events or inadequate response, with several patients requiring escalation back to 4 mg/day to achieve clinical improvement.

Over the 12-month follow-up, mean SALT scores declined significantly, from 67% at baseline to 22% at month 12 (P < .001), with the greatest improvements occurring within the first 6 months of therapy. The proportion of patients achieving the primary end point (SALT < 20) increased steadily, reaching 58.3% by months 9 and 12. A complete response (SALT < 10) was observed in 37.5% of patients.

Patients exhibited heterogeneous response patterns: 29.5% were classified as early responders, 25.0% as gradual responders, 9.1% as late responders, and 36.4% as nonresponders. Overall, 63.6% achieved a clinically meaningful response within the first year, whereas more than one-third failed to achieve even a 30% reduction in baseline SALT score. Notably, eyebrow and eyelash regrowth improved significantly during treatment (P < .01).

Univariate analyses showed that younger age, shorter disease duration, lower baseline SALT scores, and higher baseline erythrocyte sedimentation rate (ESR) were associated with higher complete response rates (P < .05). In multivariate analysis, lower baseline SALT score (P = .036) and shorter disease duration (P = .05) emerged as independent predictors of complete response, while ESR showed a borderline association. Prior exposure to tofacitinib was not significantly associated with outcomes.

Baricitinib was generally well-tolerated. Acne was the most common adverse event (17.6%), followed by dyslipidemia (7.8%). Asthenia, elevated liver enzymes, and weight gain each occurred in fewer than 4% of patients, and 51.0% reported no adverse events. No serious adverse events were observed.

Taken together, these real-world data reinforce baricitinib as an effective and safe option for severe alopecia areata, particularly when initiated earlier in the disease course and in patients with lower baseline severity. The findings emphasize the importance of timely intervention and careful patient selection to optimize outcomes in routine clinical practice.

"Early treatment initiation, particularly in those with lower baseline SALT scores and elevated ESR, was associated with improved clinical outcomes," the authors wrote. "These findings highlight the relevance of timely intervention and appropriate patient selection. Further large, multicenter prospective studies with extended follow-up are warranted to better characterize long-term outcomes, particularly in patients exhibiting a partial response during the first year."

References

1. Muñoz-Barba D, García-Moronta C, Haselgruber-de Francisco S, Sánchez-Díaz M, Arias-Santiago S. Effectiveness and safety of baricitinib in alopecia areata: a prospective cohort study. J Dermatolog Treat. 2025;36(1):2583877. doi:10.1080/09546634.2025.2583877
2. McNulty R. Baricitinib leads to significant hair regrowth in adolescents with severe alopecia areata. AJMC®. November 5, 2025. Accessed December 23, 2025. https://www.ajmc.com/view/baricitinib-leads-to-significant-hair-regrowth-in-adolescents-with-severe-alopecia-areata