Journal
RHEUMATOLOGY
Volume 61, Issue 1, Pages 121-130Publisher
OXFORD UNIV PRESS
DOI: 10.1093/rheumatology/keab294
Keywords
Janus Kinase inhibitors; tofacitinib; safety; venous thromboembolism
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Funding
- Division of Pharmacoepidemiology & Pharmacoeconomics, Brigham & Women's Hospital, Harvard Medical School
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There was no significant difference in the risk of venous thromboembolism between patients with rheumatoid arthritis treated with tofacitinib and those treated with TNFα inhibitors.
Objective To evaluate the risk of venous thromboembolism (VTE) with tofacitinib compared with TNFis in patients with RA. Methods RA patients initiating tofacitinib or a TNFi without use of any biologic or tofacitinib any time prior were identified from IBM 'MarketScan' (2012-18), Medicare (parts A, B and D, 2012-17) or 'Optum' Clinformatics (2012-19) 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% CIs after accounting for confounding through propensity score fine-stratification weighting. HRs were pooled across databases with inverse variance meta-analytic method. Results A 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 per 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. Propensity score-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). Conclusion Overall, 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 vs TNFis in RA patients.
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