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Article History

Received: 23 November 2020

Revised: 7 June 2021

Accepted: 24 June 2021

First Online: 15 July 2021

Competing interests

: All authors have completed the ICMJE uniform disclosure form at and declare: Mr. Sena reports personal fees from Janssen Research & Development, outside the submitted work; Dr. DuVall reports grants from Anolinx, LLC, grants from Astellas Pharma, Inc, grants from AstraZeneca Pharmaceuticals LP, grants from Boehringer Ingelheim International GmbH, grants from Celgene Corporation, grants from Eli Lilly and Company, grants from Genentech Inc., grants from Genomic Health, Inc., grants from Gilead Sciences Inc., grants from GlaxoSmithKline PLC, grants from Innocrin Pharmaceuticals Inc., grants from Janssen Pharmaceuticals, Inc., grants from Kantar Health, grants from Myriad Genetic Laboratories, Inc., grants from Novartis International AG, grants from Parexel International Corporation through the University of Utah or Western Institute for Biomedical Research, outside the submitted work; Mr Ahmed reports funding from the NIHR Oxford Biomedical Research Center (BRC), Aziz Foundation, Wolfson Foundation, and the Royal College Surgeons of England; Dr. Golozar reports personal fees from Regeneron Pharmaceuticals, outside the submitted work. She is a full-time employee at Regeneron Pharmaceuticals. This work was not conducted at Regeneron Pharmaceuticals. Miss Lane is supported by a Medical Research Council Doctoral Research Fellowship (MR/K501256/1) and a Versus Arthritis Clinical Research Fellowship (21605). Dr. Morales is supported by a Wellcome Trust Clinical Research Development Fellowship (Grant 214588/Z/18/Z) and reports grants from Chief Scientist Office (CSO), grants from Health Data Research UK (HDR-UK), grants from National Institute of Health Research (NIHR), outside the submitted work; Dr. Nyberg reports other from AstraZeneca, outside the submitted work; Dr. Subbian reports grants from National Science Foundation, grants from State of Arizona; Arizona Board of Regents, grants from Agency for Healthcare Research and Quality, outside the submitted work; Dr Prieto-Alhambra reports grants and other from AMGEN; grants, non-financial support and other from UCB Biopharma; grants from Les Laboratoires Servier, outside the submitted work; and Janssen, on behalf of IMI-funded EHDEN and EMIF consortiums, and Synapse Management Partners have supported training programs organized by DPA’s department and open for external participants. Ms. Kostka and Dr. Reich report being employees of IQVIA Inc at the time the analysis was conducted. Dr. Rijnbeek reports grants from Innovative Medicines Initiative, grants from Janssen Research and Development, during the conduct of the study. Dr. Ryan is an employee of Janssen Research and Development and shareholder of Johnson & Johnson. The views expressed are those of the authors and do not necessarily represent the views or policy of the Department of Veterans Affairs or the United States Government. No other relationships or activities that could appear to have influenced the submitted work.

: All the data partners received Institutional Review Board (IRB) approval or exemption. STARR-OMOP had approval from IRB Panel #8 (RB-53248) registered to Leland Stanford Junior University under the Stanford Human Research Protection Program (HRPP). The use of VA data was reviewed by the Department of Veterans Affairs Central IRB, was determined to meet the criteria for exemption under Exemption Category 4 (3), and approved for Waiver of HIPAA Authorization. The research was approved by the Columbia University Institutional Review Board as an OHDSI network study. The use of SIDIAP was approved by the Clinical Research Ethics Committee of the IDIAPJGol (project code: 20/070-PCV). The use of CPRD was approved by the Independent Scientific Advisory Committee (ISAC) (protocol number 20_059RA2). The use of IQVIA-OpenClaims was exempted from IRB approval.

: Lead authors affirm that the paper is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned have been explained.

: Analyses were performed locally in compliance with all applicable data privacy laws. Although the underlying data is not readily available to be shared, authors contributing to this paper have direct access to the data sources used in this study. All results (e.g., aggregate statistics, not presented at a patient-level with redactions for minimum cell count) are available for public inquiry. These results are inclusive of site-identifiers by contributing data sources to enable interrogation of each contributing site. All analytic code and result sets are made available at: .