Conaghan, Philip G. http://orcid.org/0000-0002-3478-5665
Mysler, Eduardo
Tanaka, Yoshiya http://orcid.org/0000-0002-0807-7139
Da Silva-Tillmann, Barbara
Shaw, Tim
Liu, John
Ferguson, Ryan
Enejosa, Jeffrey V.
Cohen, Stanley http://orcid.org/0000-0002-9226-979X
Nash, Peter
Rigby, William http://orcid.org/0000-0002-1382-7299
Burmester, Gerd http://orcid.org/0000-0001-7518-1131
Funding for this research was provided by:
AbbVie
Article History
Accepted: 16 December 2020
First Online: 2 February 2021
Declarations
:
: AbbVie Inc. funded this study and participated in the study design, research, analysis, data collection, interpretation of data, review, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.
: Philip G. Conaghan has received consultancy or speakers’ bureau fees from AbbVie, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Flexion Therapeutics, Galapagos, Gilead, Janssen, Novartis, and Pfizer. Eduardo Mysler has received research grants and/or consulting fees from AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Pfizer, Roche, and Sandoz. Yoshiya Tanaka has received speaking fees and/or honoraria from AbbVie GK, Astellas Pharma Inc., Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Eli Lilly Japan KK, Janssen Pharmaceutical KK, Mitsubishi-Tanabe Pharma, Novartis, Pfizer Japan Inc., Takeda, Teijin, and YL Biologics and research grants from Asahi-Kasei Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi Sankyo, Eisai, Mitsubishi-Tanabe Pharma, Ono Pharmaceutical, Sanofi KK, Takeda, and UCB Japan. Barbara Da Silva-Tillmann, Tim Shaw, John Liu, Ryan Ferguson, and Jeffrey V. Enejosa are employees of AbbVie and may own AbbVie stock or options. Stanley Cohen has received grant money/research support from, and has acted as consultant to, Amgen, AbbVie, Boehringer Ingelheim, Pfizer, and Sandoz. Peter Nash has received funding for clinical trials, research grants, and honoraria for lectures and advice from AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, Roche, Sandoz, Sanofi-Aventis, and UCB. William Rigby has received grant/research support from, and has acted as a consultant for, AbbVie, Bristol-Myers Squibb, Eli Lilly, Pfizer, Roche, and Sun Pharma. Gerd Burmester has acted as consultant and participated in speakers’ bureaus for AbbVie, Eli Lilly, Gilead, and Pfizer.
: Studies were conducted in compliance with the Declaration of Helsinki, International Conference on Harmonisation of Technical Regulations for Pharmaceuticals for Human Use guidelines, and applicable local country regulations. All study-related documents were approved by independent ethics committees and institutional review boards.
: All patients provided written informed consent to participate in the trials.
: Not applicable.
: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), provided the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. Data requests can be submitted at any time, and the data will be accessible for 12 months, with possible extensions considered. For more information on the process, or to submit a request, visitExternalRef removed.
: Not applicable.
: All authors contributed to the study concept/design, data acquisition, analysis, and interpretation, as well as writing and critical review of the manuscript. All authors provided final approval of the submitted version.