Background/Purpose: To provide initial characterization of the patients prescribed tofacitinib during the early period after United States (US) Food and Drug Administration (FDA) approval (11/6/2012).

Methods:   Rheumatoid Arthritis (RA) patients in the Corrona registry initiating tofacitinib through 3/1/2014 were identified. As a comparator, RA patients with no history of tofacitinib use initiating any biologic agent between 11/6/2012-3/1/2014 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 299 RA patients newly prescribed tofacitinib and 2418 newly prescribed biologic disease modifying antirheumatic drugs (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 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 (13.9 yrs) versus bDMARDs (9.9 years, p<0.001). Tofacitinib initiators also had a higher median (IQR) number of prior biologic drugs [tofacitinib 3 (2-4) 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 (43%) versus bDMARD (27%) users. 

Conclusion: Analysis of this US-based cohort reflects prescriber patient selection decisions.  The RA patients with long-standing severe disease and multiple prior biologics have tended to be the patients 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 may impact assessment of the comparative effectiveness and safety of tofacitinib versus other RA therapies during longitudinal followup.