Baricitinib Effective, Safe Over 52 Weeks for Severe Alopecia Areata

Baricitinib is safe and efficacious over 52 weeks as a treatment for severe alopecia areata, according to recent real-world findings, aligning with clinical trial results.1

These conclusions regarding baricitinib’s treatment of alopecia areata resulted from an analysis written by a team of investigators led by Carlo A. Vignolia. Vignolia works at the dermatology unit at IRCCS Humanitas Research Hospital in Milan.

Vignolia et al. noted that although recent research has been limited by shorter lengths of follow-up, findings have supported baricitinib as an option for alopecia treatment in real-world clinical settings.2 Nonetheless, given variable responses among patients, treatment of alopecia areata may necessitate more extended observation periods

“In order to further evaluate the long-term effectiveness and safety profile of baricitinib in adults with severe [alopecia areata], we conducted a multicenter retrospective study following patients for at least 52 weeks of continuous treatment with baricitinib 4 mg,” Vignoli and colleagues wrote.1

Trial Design Details

The research team evaluated a set of patients who underwent baricitinib treatment for severe alopecia areata, using a retrospective observational study design. Patients were included in the study population who met the criteria for systemic therapy based on clinical guidelines, with recruitment taking place at 11 dermatology units across Italy.

These individuals would be selected by the team if they had shown inadequate responses or intolerance to prior treatments, or if alternative treatments were found not to be suitable for these individuals. They would have to report a Severity of Alopecia Tool (SALT) score of 50 or more and be 18 years or older as well.

Given baricitinib’s product characteristics, the investigators screened each of the participants for latent tuberculosis and viral hepatitis prior to the drug’s initiation. The researchers performed blood tests at baseline and then repeated the processes at the 4 and 16-week marks, in addition to tests deemed necessary based on the patients’ individual needs.

The study ran from October 2022 - July 2024. The investigative team carried out dermatological assessments at the 0, 8, 16, 24, 32, 36, 44, and 52-week marks. Only trial participants who finished out the 52-week follow-up were involved in the team’s final analysis.

The team also collected participant information such as clinical and treatment history from their electronic medical records. Over the course of the study, baricitinib was administered to patients as monotherapy at a dosage of 4 mg orally on a once-per-day.

The researchers’ main endpoint was determined to be the proportion of subjects with a SALT score of 20 or less by the 52-week study’s treatment period. In terms of secondary endpoints, examples included the percentage of participants reporting a Clinician-Reported Outcome (ClinRO) Measure for Eyebrow Hair Loss (ClinRO EB) and Eyelash Hair Loss (ClinRO EL) with scores of 0 or 1, as well as an improvement of ≥ 2 points from baseline among those who started showing scores of either 2 or 3.

The investigators also carried out safety assessments throughout the course of their research by tracking adverse events (AEs) as well as serious AEs. They implemented descriptive statistics to summarize any safety and efficacy outcomes.

Conclusions

The investigators reported that at the conclusion of the 52-week treatment period, 61.5% of the subjects successfully achieved a SALT score ≤ 20. This suggested that participants had achieved significant regrowth of scalp hair.

Additionally, the research team noted that 67.6% and 69.7% of study subjects demonstrated marked improvements in their loss of hair on the eyebrows and eyelashes, respectively. Specifically, they highlighted ClinRO EB and ClinRO EL scores of 0 or 1 with a ≥ 2-point improvement from the point of baseline.

There were not any examples of significant AEs reported among the participants. This lack of serious AEs suggests that the medication was well-tolerated throughout the analysis’s treatment period.

“In conclusion, our study supports the long-term effectiveness of baricitinib in patients with severe [alopecia areata],” they wrote. “Our study associated a very severe clinical picture at baseline with slower clinical responses.”1

References

1. Amram, T., Duek, O.A., Golan-Tripto, I., Goldbart, A., Greenberg, D. and Hazan, G. (2025), The Interplay Between Respiratory Syncytial Virus and Asthma Inception: Insights Gained From the COVID-19 Pandemic. Pediatric Pulmonology e27474. https://doi.org/10.1002/ppul.27474.
2. Gargiulo L, Ibba L, Vignoli CA, et al. Effectiveness and safety of baricitinib in patients with severe alopecia areata: a 36-week multicenter real-world experience. J Dermatolog Treat. 2023;34(1):2268764. doi: 10.1080/09546634.2023.2268764.