Analysis of Disease Activity Metrics in a Methotrexate Withdrawal Study among Patients with Rheumatoid Arthritis Treated with Tofacitinib plus Methotrexate

The authors would like to thank the patients and study investigators for their contributions.

Funding

This study was sponsored by Pfizer Inc, New York, NY, USA. Pfizer Inc funded the journal’s Rapid Service Fee.

Medical Writing Assistance

Medical writing support, under the direction of the authors, was provided by Kimberley Haines, MSc, CMC Connect, a division of IPG Health Medical Communications, funded by Pfizer Inc, New York, NY, USA in accordance with Good Publication Practice (GPP 2022) guidelines (Ann Intern Med 2022; 175(9):1298–1304).

Authorship

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.

Author Contributions

All authors contributed to the data interpretation, critically reviewed the manuscript and approved the final version for submission. Boulos Haraoui, David Gold, Gosford Sawyerr, Harry Shi, Annette Diehl and Kristen Lee also contributed to the study conception and design. Roy Fleischmann, Gosford Sawyerr, Harry Shi, Annette Diehl and Kristen Lee also contributed to the data acquisition. Roy Fleischmann, David Gold, Gosford Sawyerr, Harry Shi, Annette Diehl and Kristen Lee also contributed to the data analysis.

Prior Presentation

This work was previously presented at EULAR European Congress of Rheumatology, 2021 [20].

Disclosures

Roy Fleischmann has received grants and/or research support from AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Galvani, Genentech, Gilead, GlaxoSmithKline, Horizon, Janssen, Novartis, Pfizer Inc, Samumed, Sanofi-Aventis, TEVA, UCB, Viela and VORSO; has acted as a consultant for AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Galvani, Gilead, GlaxoSmithKline, Janssen, Novartis, Pfizer Inc, Sanofi-Aventis and UCB; and has participated in a speakers’ bureau for AbbVie and Pfizer Inc. Boulos Haraoui has received grants and/or research support from AbbVie; has acted as a consultant for AbbVie, Amgen, Eli Lilly, Merck, Pfizer Inc and UCB; and has participated in speakers’ bureaus for Amgen, Pfizer Inc and UCB. Maya H. Buch has received grants and/or research support from Gilead, Pfizer Inc and UCB; has acted as a consultant for AbbVie, Eli Lilly, Gilead, MSD and Pfizer Inc; has participated in a speakers’ bureau for AbbVie (paid to host institution); and is in receipt of a National Institute of Health and Care Research (NIHR) Senior Investigator Award (Disclaimer: The views expressed are those of the author and not necessarily those of the NIHR or the Department of Health and Social Care). David Gold, Harry Shi, Annette Diehl and Kristen Lee are employees and shareholders of Pfizer Inc. Gosford Sawyerr is an employee of Syneos Health Inc, which was a paid contractor to Pfizer Inc in the development of this manuscript.

Compliance with Ethics Guidelines

The study was conducted in accordance with the Guidelines for Good Clinical Practice (International Conference on Harmonisation), the Declaration of Helsinki and local regulatory requirements and laws. The study protocol, any amendments and informed consent documents were reviewed and approved by the institutional review boards and the independent ethics committees of each study centre. Further ethical approval was not required for this post hoc analysis. All patients provided written informed consent to participate in the study.

Data Availability

Upon request, and subject to review, Pfizer will provide the data that support the findings of this study. Subject to certain criteria, conditions and exceptions, Pfizer may also provide access to the related individual de-identified participant data. See https://www.pfizer.com/science/clinical-trials/trial-data-and-results for more information.

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