Comparative Risk of Venous Thromboembolism with Tofacitinib versus Tumour Necrosis Factor Inhibitor: A Cohort study of Rheumatoid Arthritis Patients
Occurrences of venous thromboembolism (VTE) in 50, 865 RA patients initiating Tofacitinib (TOF) or a TNF inhibitor (TNFi) was infrequent. No significant risk of VTE for TOF versus TNFi was observed.
Safety concerns of JAK inhibitor BARI include potentially increased risk of VTE at the higher 4 mg dose. It’s unclear if this is attributable to JAK-inhibition and extends to TOF. This study compared the risk of VTE with TOF, versus TNFi in real-world settings with RA patients.
RA patients initiating TOF or a TNFi without prior use of any biologic or tofacitinib were identified from Truven MarketScan (2012-2016) or Medicare (parts A, B, and D, 2012-2015). They were followed until treatment discontinuation, treatment switch, insurance disenrollment, or administrative censoring. VTE was identified using inpatient claims for pulmonary embolism or deep vein thrombosis.
Cox proportional hazards model provided hazard ratio (HR) and 95% CI after accounting for confounding through propensity score (PS) fine-stratification weighing. HRs were pooled across databases with inverse variance meta-analytic methods.
PS-adjusted HRs showed no significant difference in the risk of VTE between TOF and TNFi with a pooled HR of 1.33 (0.78–2.24). No significant difference was identified in the risk of VTE over the follow-up time between the two groups. Occurrences of VTE in RA patients initiating TOF or a TNFi was infrequent (<1 per 100). Statistically non-significant, but numerically higher, risk of VTE for TOF versus TNFis in RA patients was observed.
IRs of VTE in RA patients, regardless of the treatment are reported to be nearly 2.4 times higher than age and gender matched non-RA patients. Thus, physicians caring for RA patients should remain vigilant for the possibility of VTE development.