Background A prospective observational study embedded within the United States (US) Consortium of Rheumatology Researchers of North America Registry was initiated to evaluate the safety and effectiveness of tofacitinib following US Food and Drug Administration (FDA) approval (6Nov2012).
Objectives To provide an updated characterisation of the patients prescribed tofacitinib during the early period after US FDA approval.
Methods Rheumatoid Arthritis (RA) patients in the Corrona registry initiating tofacitinib through 30Nov2014 were identified. As a comparator, RA patients with no history of tofacitinib use initiating any biologic disease modifying antirheumatic drugs (bDMARD) between 6Nov2012-30Nov2014 were also identified. Patient characteristics at the time of initiation are summarized and compared between groups. Continuous covariates are compared using a rank-sum test; categorical covariates are compared using a chi-square test.
Results Over the study period, there were 560 RA patients newly prescribed tofacitinib and 3458 newly prescribed bDMARD in the registry. Clinical characteristics are summarized in the Table 1. Tender and swollen joint counts and clinical disease activity index (CDAI) scores were generally similar for tofacitinib and bDMARD initiators, as were the distribution of CDAI scores (i.e. high/moderate/low disease activity and remission). However, tofacitinib initiators had significantly higher health assessment questionnaire (HAQ) scores. In addition, the mean disease duration was significantly longer for initiators of tofacitinib (13.4 yrs) versus bDMARDs (10.2 years, p<0.001). Tofacitinib initiators also had a higher median (IQR) number of prior biologic drugs [tofacitinib 3 (1-4) versus bDMARDs 1 (0-2)]. Use of monotherapy and combination DMARD therapies differed among tofacitinib versus bDMARD users (p<0.001), with monotherapy more commonly used for tofacitinib (46%) versus bDMARD (27%) users.
Conclusions Analysis of this US-based cohort reflects prescriber patient selection decisions. Overall, tofacitinib and bDMARD initiators were similar with respect to baseline demographics and disease severity. As expected for newer therapies, patients with longerstanding disease and prior bDMARD use were more common among those for whom tofacitinib has been initiated to date compared with those starting a bDMARD during the same time period, although prescribing is not limited to patients with moderate/high disease activity. Monotherapy and combination treatment strategies differed between tofacitinib versus bDMARD treated patients. These factors need to be considered in assessment an assessment of the comparative effectiveness and safety of tofacitinib versus other RA therapies during longitudinal followup
Acknowledgements This study is sponsored by Corrona, LLC. The Corrona RA registry has been supported through contracted subscriptions in the last two years by AbbVie, Amgen, Astra Zeneca, BMS, Genentech, Horizon Pharma USA, Janssen, Eli Lilly, Novartis, Pfizer, and UCB.
Disclosure of Interest A. Kavanaugh Grant/research support from: AbbVie, Amgen, Janssen, L.P., UCB, G. Reed Employee of: Corrona, LLC., K. Saunders Employee of: Corrona, LLC., A. Koenig Shareholder of: Pfizer, Inc., Employee of: Pfizer, Inc., J. Geier Shareholder of: Pfizer, Inc., Employee of: Pfizer, Inc., J. Kremer Shareholder of: Corrona, LLC., Consultant for: AbbVie, Amgen, BMS, Genentech, Lilly, Pfizer, Employee of: Corrona, LLC., J. Greenberg Shareholder of: Corrona, LLC., Consultant for: Astra Zeneca, Celgene, Novartis, Pfizer, Employee of: Corrona, LLC., C. Bingham III Grant/research support from: BMS, Janssen, Mesoblast, Pfizer, UCB, Consultant for: AbbVie, Amgen, BMS, Celgene, EMD/Serrono, Genentech/Roche, Janssen, Lilly, Novartis, NovoNordisk, Pfizer, UCB