Patient Disease Trajectories in Rheumatoid Arthritis Patients Treated with Baricitinib 4-mg in Four Phase 3 Clinical Studies

Funding

This work, including open-access fees, was supported by Eli Lilly and Company.

Author Contributions

All authors participated in the interpretation of the study results and in the drafting, critical revision, and approval of the final version of the manuscript. PCT, JP, and MW were involved in the study design. EM, ARR, and TH were involved in data collection. TH was involved in medical study monitoring. YC, BJ, LS, and YL were involved in data analyses and plotting. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Medical Writing, Editorial, and Other Assistance

This study was sponsored by Eli Lilly and Company. Medical writing support, under the guidance of the authors, was provided by Elizabeth Flate, PhD, and Thomas Melby, MS, and editorial assistance was provided by Dana Schamberger, MA, all of Syneos Health (Morrisville, NC, USA) and funded by Eli Lilly and Company (Indianapolis, IN, USA) in accordance with Good Publication Practice guidelines. PCT would like to acknowledge support from the National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC).

Disclosures

Peter Taylor reports research grants from Celgene and Galapagos; and consultation fees from AbbVie, Biogen, Galapagos, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Bristol Meyers Squibb, Pfizer, Roche, Sanofi, Nordic Pharma, Fresenius, and UCB. Janet Pope reports consultation and speaking fees from Eli Lilly, as well as being an advisory board member for Eli Lilly. Michael Weinblatt reports research grants from Amgen, Bristol Meyers Squibb, Eli Lilly, and Sanofi; and consultation fees from AbbVie, Amgen, Bristol Meyers Squibb, Corrona, Crescendo Bioscience, GlaxoSmithKline, Horizon, Eli Lilly, Pfizer, Roche (which owns Genentech), Scipher, and SetPoint; as well as owning stock in Can-Fite, Inmedix, Scipher, and Vorso. Eduardo Mysler has received honorarium as speaker or participation in advisory boards from AbbVie, Eli Lilly, Janssen, Sanofi, Pfizer, GlaxoSmithKline, AstraZeneca, Bristol Myers Squibb, Roche, Sandoz, and Gemmene. Andrea Rubbert-Roth reports honoraria for lectures and consultation fees from Eli Lilly. Yun-Fei Chen, Bochao Jia, Luna Sun, Yushi Liu, and Thorsten Holzkämper are full-time employees of and own stock in Eli Lilly. Yoshiya Tanaka has received speaking fees and/or honoraria from Daiichi Sankyo, Eli Lilly, Novartis, YL Biologics, Bristol Myers Squibb, Eisai, Chugai, AbbVie, Astellas, Pfizer, Sanofi, Asahi Kasei, Glaxo Smith Kline, Mitsubishi Tanabe, Gilead, Janssen, and has received research grants from AbbVie, Mitsubishi Tanabe, Chugai, Asahi Kasei, Eisai, Takeda, and Daiichi Sankyo.

Compliance with Ethics Guidelines

All studies were conducted in accordance with ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines and approved by the institutional review board or ethics committee for each center. All patients provided written informed consent before the first study procedure. The master IRB that approved the protocol for each of the studies was Quorum Review. Ethics approvals were also obtained for all 281 sites for RA-BEAM, all 182 sites for RA-BUILD, all 178 sites for RA-BEACON, and all 198 sites for RA-BEGIN.

Data Availability

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, 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.

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