The authors thank the patients in DISCOVER-2 for their participation in the study.

Funding

Sponsorship for this study and Rapid Service Fee were funded by Janssen Research & Development, LLC.

Medical Writing and Editorial Assistance

The authors thank Michelle L. Perate, M.S. of Janssen Scientific Affairs, LLC, and Diane Harrison, M.D. (consultant funded by Janssen Research & Development, LLC) for substantive review. Medical writing support was provided by Amy C. Porter, PhD of Certara Synchrogenix, under the direction of the authors in accordance with Good Publication Practice guidelines (Ann Intern Med 2015;163:461-4) and was funded by Janssen Scientific Affairs, LLC.

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

Georg Schett, Matthew J. Loza, Arumugam Palanichamy, Oliver FitzGerald, Christopher Ritchlin, Elizabeth C. Hsia, Alexa P. Kollmeier, Xie L. Xu, Frédéric Baribaud, and Kristen Sweet were responsible for the study design. Matthew J. Loza, Anne-Christine Bay-Jensen, Signe Holm Nielsen, Sheng Gao and Kristen Sweet were responsible for data collection and analysis. Georg Schett, Matthew J. Loza, Arumugam Palanichamy, Oliver FitzGerald, Christopher Ritchlin, Anne-Christine Bay-Jensen, Signe Holm Nielsen, Sheng Gao Elizabeth C. Hsia, Alexa P. Kollmeier, Xie L. Xu, Frédéric Baribaud and Kristen Sweet were responsible for interpreting the data. Drafting and critical revisions were carried out by Georg Schett, Matthew J. Loza, Arumugam Palanichamy, Oliver FitzGerald, Christopher Ritchlin, Anne-Chrisitne Bay-Jensen, Signe Holm Nielsen, Sheng Gao, Elizabeth C. Hsia, Alexa P. Kollmeier, Xie L. Xu, Frédéric Baribaud and Kristen Sweet.

Prior Presentation

These data have been presented, in part, at the American College of Rheumatology 2020 Annual Meeting.

Disclosures

Georg Schett has received speaker's honoraria from AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Gilead, Janssen, Novartis, and UCB. Christopher Ritchlin has received grant/research support from AbbVie, Amgen, and UCB Pharma and consulting fees from AbbVie, Amgen, AbbVie, Eli Lilly, Gilead, Janssen, Novartis, Pfizer, and UCB Pharma. Anne-Christine Bay-Jensen and Signe Holm Nielsen are employees of and own stock in Nordic Bioscience. Matthew J. Loza, Arumugam Palanichamy, Sheng Gao, Elizabeth C Hsia, Alexa P Kollmeier, Kristen Sweet, Xie L. Xu, and Frédéric Baribaud are or were employees of Janssen Research & Development, LLC, when this work was performed and own stock in Johnson & Johnson, of which Janssen Research & Development, LLC is a wholly-owned subsidiary. Arumugam Palanichamy is currently an employee of Cerecor, Inc. Frédéric Baribaud is currently an employee of Bristol Myers Squibb.

Compliance with Ethics Guidelines

This study (ClinicalTrials.gov identifier: NCT03158285) was conducted according to the Declaration of Helsinki of 1964 and its later amendments and the International Committee on Harmonisation good clinical practices. Protocols were approved by ethics committees at each site (Sterling IRB approval number for US sites: 5910C), and all patients provided written informed consent.

Data Availability

The data sharing policy of Janssen Pharmaceutical Companies of Johnson & Johnson is available at https://www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at http://yoda.yale.edu.