Ethics approval and consent to participate
All procedures were in accordance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice Guidelines, and were approved by the Institutional Review Board/Ethics Committee at each study center. All patients provided written informed consent.
Consent for publication
Availability of data and materials
Upon request, and subject to certain criteria, conditions, and exceptions (see https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information), Pfizer will provide access to individual de-identified participant data from Pfizer-sponsored global interventional clinical studies conducted for medicines, vaccines, and medical devices (1) for indications that have been approved in the US and/or EU, or (2) in programs that have been terminated (i.e., development for all indications has been discontinued). Pfizer will also consider requests for the protocol, data dictionary, and statistical analysis plan. Data may be requested from Pfizer trials 24 months after study completion. The de-identified participant data will be made available to researchers whose proposals meet the research criteria and other conditions, and for which an exception does not apply, via a secure portal. To gain access, data requestors must enter into a data access agreement with Pfizer.
TT has received research grants from AbbVie, Asahi Kasei, Astellas, AYUMI, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Nippon Kayaku, Novartis, Pfizer Japan Inc, and Takeda; has received consulting fees or other remuneration from AbbVie, Astellas, AstraZeneca, Chugai, Eli Lilly Japan, GSK, Janssen, Mitsubishi-Tanabe, Nippon Kayaku, Novartis, Taiho, Taisho Toyama, and UCB Japan; and has participated in speakers bureaus for AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Daiichi-Sankyo, Eisai, Mitsubishi-Tanabe, Novartis, Pfizer Japan Inc, Sanofi, Takeda, and Teijin. RF has received grants/research support from, and is a consultant for, AbbVie, Amgen, AstraZeneca, Bristol-Myers Squibb, Celltrion, Eli Lilly, EMD Serono, Genentech, Gilead, GlaxoSmithKline, Janssen, Merck, Novartis, Pfizer Inc, Regeneron, Roche, Sanofi-Aventis, Taiho, and UCB. NI, HS, KS, and TH are employees and shareholders of Pfizer Inc. JP is an employee of Syneos Health, who were paid contractors to Pfizer Inc in the development of this manuscript and in providing statistical support. JSS has received research grants from AbbVie, AstraZeneca, Eli Lilly, Janssen, MSD, Pfizer Inc, and Roche; and has received consulting fees or other remuneration from AbbVie, Amgen, AstraZeneca, Astro, Bristol‑Myers Squibb, Celgene, Celltrion, Chugai, Eli Lilly, Gilead, GSK, ILTOO, Janssen, MedImmune, MSD, Novartis, Pfizer Inc, Roche, Samsung, Sanofi, and UCB.
This study was funded by Pfizer Inc.
All authors were involved in the conception and design of the study. RF, KS, and TH acquired the data. All authors contributed to the analysis and interpretation of data. All authors revised and approved the final manuscript.
The authors thank Ermeg Akylbekova for her contributions to supporting the data analyses. This study was sponsored by Pfizer Inc. Medical writing support, under the guidance of the authors, was provided by Sarah Piggott, MChem, CMC Connect, McCann Health Medical Communications and was funded by Pfizer Inc, New York, NY, USA, in accordance with Good Publication Practice (GPP3) guidelines (Ann Intern Med 2015;163:461-4).
Some data reported in this manuscript have been previously presented at the Annual EULAR European Congress of Rheumatology, Amsterdam, The Netherlands, June 13–16, 2018, Takeuchi T, Smolen JS, Fleischmann R, et al. Clinical and functional response to tofacitinib and adalimumab in patients with rheumatoid arthritis: probability plot analysis of results from the ORAL Strategy trial. Ann Rheum Dis 2018;77(Suppl 2):987–8. Some data were also previously presented at the ACR Annual Scientific Meeting, Chicago, IL, USA, October 19–24, 2018, Takeuchi T, Smolen JS, Fleischmann R, et al. Clinical and functional response to tofacitinib and adalimumab in patients with rheumatoid arthritis: probability plot analysis of results from the ORAL Strategy trial. Arthritis Rheum 2018;70(Suppl 9):653–4.