Hetland, Merete Lund
Strangfeld, Anja
Bonfanti, Gianluca
Soudis, Dimitrios
Deuring, J. Jasper
Edwards, Roger A.
Funding for this research was provided by:
Pfizer
Article History
Received: 18 December 2023
Accepted: 10 July 2024
First Online: 27 August 2024
Declaration
:
: This study was a post hoc analysis of existing data from the tofacitinib rheumatoid arthritis clinical development program. All included studies were approved by an Institutional Review Board or Independent Ethics Committee at each study site. Patients provided written informed consent.
: Not applicable.
: MLH has received grants from AbbVie, Biogen, Bristol Myers Squibb, Celltrion, Eli Lilly, Janssen Biologics B.V., Lundbeck Foundation, MSD, Pfizer Inc, Roche, Samsung Bioepis, Sandoz, and Novartis; honoraria from Medac, Pfizer Inc, and Sandoz; is a member of the advisory board for AbbVie; is a co-chair of EuroSpA; and has chaired for DANBIO DRQ. AS is a principal investigator of RABBIT, which is jointly sponsored by a consortium of pharmaceutical manufacturers as follows: AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Eli Lilly, Fresenius-Kabi, Galapagos, Hexal, MSD, Pfizer Inc, Samsung Bioepis, Sanofi-Aventis, UCB, and Viatris; and has received lecture fees from AbbVie, Bristol Myers Squibb, Celltrion, Eli Lilly, MSD, Pfizer Inc, Roche, Sanofi-Aventis, and UCB. GB is a stockholder of Engineering Ingegneria Informatica, which acquired and merged with Fair Dynamics Consulting; and a paid consultant contracted by Health Services Consulting Corporation in connection with this study. Health Services Consulting Corporation was a paid contractor to Pfizer Inc in connection with the formal data analysis. DS and JJD are employees and stockholders of Pfizer Inc. RAE is the owner of Health Services Consulting Corporation and was a paid consultant to Pfizer Inc in connection with data generation.
: List of baseline variables included in analysis (Table ); Percentage of available data across all baseline variables extracted from studies in the tofacitinib RA program (Fig. ); Feature importance of the Extreme Gradient Boosted prediction model for all studies (group 1) (Fig. S2). Feature importance of the Extreme Gradient Boosted prediction model for phase 3 and 3b/4 studies (group 2) (Fig. S3); Feature importance of the Extreme Gradient Boosted prediction model for ORAL Surveillance (NCT02092467; group 3) (Fig. S4).