Risk of venous thromboembolism associated with tofacitinib in patients with rheumatoid arthritis: a population-based cohort study.

Abstract

OBJECTIVE\nTo evaluate the risk of venous thromboembolism (VTE) with tofacitinib compared to tumor necrosis factor inhibitors (TNFIs) in patients with rheumatoid arthritis (RA).\n\n\nMETHODS\nRA patients initiating tofacitinib or a TNFI without use of any biologic or tofacitinib any time prior were identified from IBM MarketScan (2012-2018), Medicare (parts A, B, and D, 2012-2017), or Optum Clinformatics (2012-2019) and followed until treatment discontinuation, treatment switch, insurance disenrollment, or administrative censoring. The primary outcome, VTE, was identified using inpatient claims for pulmonary embolism or deep vein thrombosis. A Cox proportional hazards model provided hazard ratio (HR) and 95% confidence intervals (CI) after accounting for confounding through propensity score (PS) fine-stratification weighting. HRs were pooled across databases with inverse variance meta-analytic method.\n\n\nRESULTS\nA total of 42,201, 25,078, and 20,374 RA patients were identified from MarketScan, Medicare, and Optum, respectively; of whom 7.1%, 7.1%, and 9.7% were tofacitinib initiators. The crude incidence rates (IRs)/100 person-years (95% CI) were 0.42 (0.20-0.77) and 0.35 (0.29-0.42) in MarketScan, 1.18 (0.68-1.92) and 0.83 (0.71-0.97) in Medicare, and 0.19 (0.04-0.57) and 0.34 (0.26-0.44) in Optum for tofacitinib and TNFIs, respectively. PS-weighted HRs showed no significant differences in the risk of VTE between tofacitinib and TNFIs in any database with a pooled HR (95% CI) of 1.13 (0.77-1.65).\n\n\nCONCLUSION\nOverall, VTE occurred infrequently (<1 per 100) in a total of 87,653 RA patients initiating tofacitinib or a TNFI. We observed no evidence for an increased risk of VTE for tofacitinib versus TNFIs in RA patients.