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Clinical Trial
. 2025 Jul;26(4):611-622.
doi: 10.1007/s40257-025-00932-0. Epub 2025 Apr 11.

Safety of Baricitinib in Adults with Severe Alopecia Areata from Two Phase III Trials Over a Median of 2.3 Years and Up to 4 Years of Treatment

Brett King  1   2 , Arash Mostaghimi  3 , Yutaka Shimomura  4 , Bianca Maria Piraccini  5 , Ulrike Blume-Peytavi  6 , Angelina Sontag  7 , Yves Dutronc  7 , Karen Denning  7 , Jill Kolodsick  7 , Xiaoyu Lu  8 , Ayush Srivastava  7 , Rodney Sinclair  9
Affiliations
Clinical Trial

Safety of Baricitinib in Adults with Severe Alopecia Areata from Two Phase III Trials Over a Median of 2.3 Years and Up to 4 Years of Treatment

Brett King et al. Am J Clin Dermatol. 2025 Jul.

Abstract

Background: We report pooled safety data for baricitinib treatment of severe alopecia areata in patients in BRAVE-AA1 (phase II/III) and BRAVE-AA2 (phase III), including data from the long-term extension and bridging extension periods.

Methods: Data are reported from the extended dataset (patients receiving continuous baricitinib 2 mg or 4 mg) and the all-baricitinib dataset (all patients receiving any dose of baricitinib at any time during the trials). Safety outcomes include treatment-emergent adverse events, adverse events of special interest, and abnormal changes in laboratory test results. Incidence rates (IRs) per 100 patient-years were calculated based on time at risk. Data cutoff dates were 22 May, 2023, for BRAVE-AA1 and 8 May, 2023, for BRAVE-AA2 and included follow-up through at least 152 weeks.

Results: Data were collected for 1303 patients treated with baricitinib, reflecting 2789.7 patient-years of exposure (median, 825 days; maximum, 1460 days). Most treatment-emergent adverse events were mild to moderate in severity. Incidence rates of serious adverse events (IR = 2.6) and treatment discontinuations because of adverse events (IR = 1.7) were generally low and remained similar to data presented through at least 104 weeks of follow-up. In an additional 1 year of follow-up, no new cases of serious infections, opportunistic infections, major adverse cardiovascular events, deep vein thromboses, or pulmonary embolisms were observed. The IRs for non-melanoma skin cancer (IR = 0.1) and other malignancies (IR = 0.2) remained stable over time. The IR of herpes zoster was comparable to previously reported IRs (IR = 1.9). Laboratory changes were generally consistent over time. No deaths were reported in either study.

Conclusions: Long-term safety data from BRAVE-AA1 and BRAVE-AA2 are consistent with previously reported data from the baricitinib alopecia areata clinical trial program and demonstrate no new safety concerns or signals for baricitinib through a maximum exposure of 4 years.

Clinical trial registration: BRAVE-AA1 (NCT03570749) and BRAVE-AA2 (NCT03899259) were registered on 18 June, 2018, and 1 April, 2019, respectively.

Plain language summary

Baricitinib is a Janus kinase inhibitor approved in several countries to treat severe alopecia areata, an autoimmune disease that causes patchy or complete hair loss on the scalp, face, and body. Given the chronic nature of alopecia areata, it is important to understand the safety of longer term treatment with baricitinib. In this study, we examined the safety profile of baricitinib through at least 152 weeks and up to 4 years of exposure. Our analysis included two datasets from two ongoing alopecia areata clinical trials of baricitinib in adults with at least 50% scalp hair loss. The first dataset included patients treated continuously with baricitinib 2 mg or 4 mg, and the second dataset included patients treated with baricitinib 1 mg, 2 mg, or 4 mg at any time up to the data cutoff. The incidence rates of serious adverse events were low and similar across datasets and dose groups. There have been no new cases of serious infections, opportunistic infections, major adverse cardiovascular events, deep vein thromboses, or pulmonary embolisms since the previous safety analysis conducted through week 104. The incidence rates of non-melanoma skin cancer and other malignancies have remained low and stable. Overall, the incidence rates of adverse events of special interest were within or below those observed in the general alopecia areata population. The results of longer term treatment with baricitinib in adults with severe alopecia areata were consistent with prior reports and revealed no new safety concerns.

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Conflict of interest statement

Declarations. Funding: This study was funded by Eli Lilly and Company under license from Incyte Corporation. Conflict of interest: Brett King has served on advisory boards and/or is a consultant and/or a clinical trial investigator and/or is on a data monitoring committee for AbbVie, Almirall, AltruBio, AnaptysBio, Arena Pharmaceuticals, ASLAN Pharmaceuticals, Bioniz Therapeutics, Bristol Myers Squibb, Concert Pharmaceuticals, Eli Lilly and Company, Equillium, Horizon Therapeutics, Incyte Corporation, Janssen, LEO Pharma, Merck, Otsuka/Visterra, Pfizer, Q32 Bio, Regeneron, Sanofi Genzyme, Sun Pharma, Twi Biotechnology, Ventyx Biosciences, and Viela Bio; has served on speaker’s bureaus for AbbVie, Eli Lilly and Company, Incyte Corporation, Pfizer, Regeneron, and Sanofi Genzyme; and is a scientific advisor for BiologicsMD. Arash Mostaghimi has been a consultant for AbbVie, Concert Pharmaceuticals, Digital Diagnostics, Eli Lilly and Company, and Pfizer. Yutaka Shimomura has been an investigator for Eli Lilly and Company. Bianca Maria Piraccini has received honoraria from or been a consultant for Almirall, Eli Lilly and Company, ISDIN, Pfizer, and Vichy Laboratoires. Ulrike Blume-Peytavi has served as a consultant for and/or received grants and/or honoraria from AbbVie, Boots Healthcare, Concert Pharmaceuticals, Eli Lilly and Company, NeuroDerm, Novartis, Pfizer, Sanofi Regeneron, and Vichy Laboratoires. Angelina Sontag, Yves Dutronc, Karen Denning, Jill Kolodsick, and Ayush Srivastava are employees and stockholders of Eli Lilly and Company. Xiaoyu Lu is an employee of TechData Service Company. Rodney Sinclair has been an investigator for and/or provided professional services to AbbVie, Aerotek Scientific, Akeso Biopharma, Amgen, Arcutis, Arena Pharmaceuticals, Ascend Laboratories, AstraZeneca, Bayer Pharmaceuticals, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Coherus BioSciences, Connect Biopharma, Cutanea, Dermira, Eli Lilly and Company, Galderma, GlaxoSmithKline, Janssen, LEO Pharma, MedImmune/AstraZeneca, Merck Sharp & Dohme, Novartis, Oncobiologics, Pfizer, Regeneron, Reistone Biopharma, Roche, Samson Medical Technologies, Sanofi, Sun Pharma, and UCB Pharma. Ethics approval: The BRAVE-AA1 and BRAVE-AA2 studies were conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines, and the research protocols were approved by each center’s institutional review board or ethics committee. Consent to participate: All participants provided written informed consent for inclusion in the study. Consent for publication: All participants provided written informed consent for the use of their de-identified anonymized aggregated data and their case details for publication. Availability of data and material: Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the USA and the European Union and after primary publication acceptance, whichever is later. No expiration date of data requests is currently set once data are made available. Access is provided after a proposal has been approved by an independent review committee identified for this purpose and after receipt of a signed data-sharing agreement. Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank or annotated case report forms, will be provided in a secure data-sharing environment. For details on submitting a request, see the instructions provided at http://www.vivli.org . Code availability: Not applicable. Author contributions: All named authors meet the International Committee of Medical Journal Editors authorship criteria and have read and approved the final version. AS, YD, KD, JK, XL, and AS contributed to the study conception and design, data analysis and interpretation, and manuscript drafting and revision. BK, AM, YS, BMP, UB-P, and RS contributed to the data interpretation and critical revision of the manuscript for important intellectual content. All authors read and approved the final manuscript.

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