Ziyadeh, Najat J. http://orcid.org/0000-0002-7191-9140
Geldhof, Anja
Noël, Wim
Otero-Lobato, Marijo
Esslinger, Suzan
Chakravarty, Soumya D.
Wang, Yiting
Seeger, John D.
Article History
First Online: 10 August 2020
Declarations
:
: The study was supported through a research contract between Optum Epidemiology and Janssen Biologics B.V., who is the Marketing Authorization Holder of golimumab.
: NJZ and JDS are employed by Optum and hold stock/stock options in the parent company of Optum (United HealthGroup, Inc.). AG, WN, MO-L, and SE are or were employees of Janssen Biologics B.V. at the time of this study while SDC and YW are employees of Janssen Scientific Affairs, LLC. AG, WN, MO-L, SE, SDC, and YW hold stock/stock options of Johnson & Johnson.
: Medical record abstraction and the NDI search were performed only after receiving approval from the New England Institutional Review Board and a waiver of authorization from the Privacy Board.
: Informed consent was not required as the HIPAA Privacy Rule (45 CFR 164.512(i)(2)) permits protected health information (PHI) to be used or disclosed for research, without patient authorization. This study was an observational study to provide surveillance of prespecified safety outcomes among patients with rheumatic disease and given the size of the insurance population from which study subjects were drawn (approximately 14 million health insurance participants), individual-level consent was deemed impractical.
: Not applicable.
: All co-authors have consented for publication of this study.
: Not applicable.
: Not applicable.