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

Rheumatology (Oxford). 2021 Mar 22:keab294. Epub ahead of print. DOI: 10.1093/rheumatology/keab294

A population-based cohort study of 87,653 RA patients has found no evidence for an increased risk of venous thromboembolism (VTE) for tofacitinib, versus TNFis, in patients with RA.The introduction of JAKinibs, almost a decade ago, has provided an important oral option for the treatment of RA. However, in recent years, a safety concern, relating to incidence of VTE after treatment, has emerged. Consequently, both the US and European regulatory authorities now recommend caution for use of tofacitinib in relation to VTE.While trials remain ongoing regarding the risk of VTE and tofacitinib, Desai and colleagues took the opportunity to evaluate the data of over 87,000 patients with RA from three US insurance programmes. Hazard ratios showed no significant differences in the risk of VTE between tofacitinib and TNFis in any of the databases, with a pooled HR (95% CI) of 1.13 (0.77–1.65). Such findings provide reassurance regarding the risk of VTE after tofacitinib treatment.