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Article History

Accepted: 10 February 2025

First Online: 11 April 2025

Declarations

:

: This study was funded by Eli Lilly and Company under license from Incyte Corporation.

: 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.

: 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.

: All participants provided written informed consent for inclusion in the study.

: All participants provided written informed consent for the use of their de-identified anonymized aggregated data and their case details for publication.

: 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 .

: Not applicable.

: 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.