Three Years on Baricitinib Preserved Hair Regrowth in Severe Alopecia Areata

For patients with severe alopecia areata, regaining lost hair is only one part of the equation—keeping it for the long term is another matter entirely. New 3-year data from a pair of phase 3 trials now offer some reassurance on that front, showing that most patients who responded to baricitinib within the first year of treatment held onto their gains, and many deepened them with continued therapy.

Background: The Case for Long-Term Data in a Chronic Condition

Alopecia areata affects approximately 2% of the global population over a lifetime, making it the most prevalent autoimmune condition and the second most common form of hair loss after androgenetic alopecia.² The burden extends well beyond physical appearance: a systematic review found that roughly 70% of people with alopecia areata meet criteria for a lifetime psychiatric disorder, most commonly depression or anxiety. First onset typically occurs in the third or fourth decade of life, and an earlier age of onset is associated with a greater lifetime risk of extensive disease—factors that amplify the clinical stakes of finding treatments that work not just initially, but over the long term.

Alopecia areata is a chronic autoimmune condition with a low rate of spontaneous remission—approximately 4% among those with severe disease. High relapse rates following treatment withdrawal have reinforced the clinical need for sustained therapy and, by extension, for evidence demonstrating its safety and efficacy over time. Baricitinib, an oral Janus kinase (JAK) inhibitor, became the first systemic treatment approved globally for adults with severe alopecia areata. Earlier results from the BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) trials had shown baricitinib to be effective through 104 weeks; the current analysis extended follow-up to 152 weeks to evaluate whether those results persisted.¹

Who Was Studied: Patient Demographics and Enrollment

The long-term analysis drew from both trials, which together enrolled patients at 169 sites across 10 countries. The analysis focused on adults with a Severity of Alopecia Tool (SALT) score of 50 or greater at baseline—indicating at least 50% scalp hair loss—who had achieved a SALT score of 20 or lower at week 52 and continued on the same dose through week 152. The long-term efficacy population comprised 129 patients receiving baricitinib 4 mg and 67 patients receiving baricitinib 2 mg.

In the 4 mg group, the mean age was 37 years, and 62% of patients were female; 39% had entered the trial with a baseline SALT score of 95 or higher, indicating very severe disease. In the 2 mg group, the mean age was 38 years, and 70% were female; 34% had a baseline SALT score of 95 or higher. The mean duration of the current alopecia areata episode was approximately 3 years in both groups.

Primary Efficacy Outcomes: Deep and Durable Scalp Regrowth

Among week-52 responders who continued on the same dose, 115 of 129 patients (89.1%) in the 4 mg group and 56 of 67 patients (83.6%) in the 2 mg group maintained a SALT score of 20 or lower at week 152. The mean SALT score at week 152 was 3.2 for the 4 mg group (median, 1) and 4.3 for the 2 mg group (median, 2).

Patients also achieved progressively deeper levels of scalp coverage with sustained treatment. By week 152, 79.1% of patients in the 4 mg group and 70.1% in the 2 mg group had reached a SALT score of 10 or lower, representing no more than 10% remaining scalp hair loss. Eyebrow and eyelash regrowth also continued to improve beyond week 52, and patient-reported outcomes were consistent with clinician assessments throughout.

The authors noted that "patients stably maintained and extended their regrowth across scalp, eyebrows, and eyelashes" with continued baricitinib treatment—findings they described as supporting the drug's suitability for long-term management of severe alopecia areata.

Loss of Response and Safety Profile Over 152 Weeks

Despite the high overall maintenance rates, approximately 13% of patients experienced disease worsening by week 152, defined as a SALT score above 20. Among those who lost response, the median absolute SALT score was 32.5 in the 4 mg group and 34 in the 2 mg group. Patients who lost response tended to have had more severe disease at baseline and a longer duration of their current alopecia areata episode, suggesting these characteristics may confer greater vulnerability to treatment flare.

Safety data drawn from 1303 patients across 2789.7 total patient-years of exposure showed no new safety signals compared with the prior 104-week analysis. There were no deaths. Incidence rates for serious infections, major cardiovascular events, and venous thromboembolism remained unchanged. Three additional malignancies were reported—endometrial cancer (stage I), breast cancer, and malignant melanoma—but the overall incidence rate for malignancy did not increase.

Limitations to Consider

The analysis was restricted to patients who achieved a SALT score of 20 or lower by week 52 and continued on the same dose. It did not capture outcomes for patients who showed partial improvement at week 52 but did not meet that response threshold for continued treatment at that dose. The relatively small number of patients who experienced treatment flares also limited the ability to characterize contributing clinical factors.

References

1. Senna M, Mostaghimi A, Sinclair R, et al. Maintenance of long-term efficacy with continuous baricitinib treatment in patients with severe alopecia areata: 3-year results from BRAVE-AA1 and BRAVE-AA2. J Am Acad Dermatol. 2026;94(4):1126-1133.
2. Villasante Fricke AC, Miteva M. Epidemiology and burden of alopecia areata: a systematic review. Clin Cosmet Investig Dermatol. 2015;8:397-403. doi:10.2147/CCID.S53985