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Article History

Accepted: 20 February 2023

First Online: 1 March 2023

Declarations

:

: This study was sponsored by Eli Lilly and Company (Lilly), under license from Incyte Corporation.

: Ohsang Kwon reports grants from Lilly during the conduct of the study and grants from Pfizer, Amorepacific Corporation and Juvic Co., and personal fees from Yuhan Pharmaceuticals outside the submitted work. Maryanne M. Senna has served on scientific advisory boards for Lilly, Pfizer, Concert, Arena, Follica, Deciphera, Cassiopea; as a speaker for Lilly & Pfizer; and as principal investigator (PI) for Lilly and Concert. Rodney Sinclair is a member of the Lilly advisory board and was PI in the Lilly-sponsored BRAVE clinical trials. Taisuke Ito has served on advisory boards and/or is a consultant and/or clinical trial investigator for Bristol-Myers Squibb, Lilly, Pfizer, Regeneron, and Maruho Co Ltd. Brett King has served on advisory boards and/or is a consultant and/or clinical trial investigator for AbbVie, AltruBio Inc., Almirall, AnaptysBio, Arena, Bioniz Therapeutics, Bristol-Myers Squibb, Concert, Horizon Therapeutics, Lilly, Incyte, LEO Pharma, Otsuka/Visterra Inc., Pfizer, Regeneron, Sanofi Genzyme, TWi Biotechnology Inc., and Viela Bio. He is on speaker bureaus for AbbVie, Incyte, Lilly, Pfizer, Regeneron, and Sanofi Genzyme. Yves Dutronc, Guanglei Yu, Chiara Chiasserini, Jill McCollam, and Wen-Shuo Wu are employees and shareholders of Lilly. Chen-Yen Lin was an employee of Lilly during the period the studies were conducted.

: Each author has met the authorship criteria established by the International Committee of Medical Journal Editors. All authors contributed to study design and data interpretation. Statistical analysis was performed by GY and CL. All authors contributed to writing and reviewing the manuscript, and all authors read and approved the final manuscript.

: Lilly 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 US and EU 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 .

: The trials were performed in accordance with ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The research protocols were approved by each center’s IRB or Ethics Committee; BRAVE-AA1 was first approved by Advarra IRB on 13 August 2018, and BRAVE-AA2 was first approved by Quorum Review IRB on 19 February 2019

: Written informed consent was obtained from all individual participants included in the study.

: Patients signed informed consent regarding publishing their data and photographs.

: Not applicable.