Funding for this research was provided by:
Janssen Scientific Affairs, LLC (None)
Text and Data Mining valid from 2019-05-02
Received: 20 January 2019
Revised: 26 March 2019
Accepted: 1 April 2019
First Online: 2 May 2019
Compliance with ethical standards
: All study participants provided written informed consent. Institutional Review Board (IRB) approvals for this study were obtained from a central IRB (New England IRB, Needham, Massachusetts, USA; IRB registration number 120160610) for private practice sites and local IRBs of participating academic sites.
: Dr. Cohen has served as an investigator and consultant for Amgen, AbbVie, Janssen, Genentech, Pfizer, Merck, Bristol-Myers Squibb, and Roche (less than $10,000 each). Dr. Kremer is employed by and has equity interest in Corrona, LLC, and has served as a consultant for AbbVie, Amgen, Bristol-Myers Squibb, Gilead, GSK, Eli Lilly and Company, Genentech, Medimmune, Sanofi, and Pfizer Inc. (less than $10,000 each) and an investigator for AbbVie, Genentech, Eli Lilly and Company, Novartis, and Pfizer Inc. (less than $10,000 each). Ms. Dandreo is employed by Corrona, LLC. Dr. Reed is employed by and has stock ownership in Corrona, LLC. Mr. Magner is employed by Corrona, LLC. Dr. Shan is employed by Corrona, LLC. Dr. Kafka is employed by and has stock ownership in Johnson and Johnson. Dr. DeHoratius was employed by (at the time the work was conducted) and has stock ownership in Johnson and Johnson. Dr. Ellis is employed by and has stock ownership in Johnson and Johnson. Dr. Parenti was employed by (at the time the work was conducted) and has stock ownership in Johnson and Johnson.The authors have full control of all primary data. Corrona dataset is based on a large US multicenter study adhering to a number of institutional review boards, with complex logistics. Patients did not provide consent to raw data sharing during the data collection for this purpose, and the Corrona data sharing policies do not permit raw data sharing for this purpose. An aggregated limited dataset from the current analyses is available to qualified investigators with an approved protocol. Data requests may be sent to Corrona, represented by Dr. Leslie Harrold, email firstname.lastname@example.org.