Risk for venous thromboembolism in patients with RA considered when starting new therapy
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A 2019 European Medicines Agency warning that tofacitinib could increase risk for venous thromboembolism in patients with rheumatoid arthritis did not affect characteristics of patients starting the drug since then, according to a study.
“Yet, the results suggest that rheumatologists have taken into account the potential VTE risk,” Cecile Philippoteaux, MS, MSc, said in a poster presentation at ACR Convergence 2021.
Baricitinib (Olumiant, Eli Lilly) and tofacitinib (Xeljanz, Pfizer) were the first janus kinase (JAK) inhibitors to be recommended for moderate-to-severe RA after conventional synthetic disease-modifying anti-rheumatic drug (DMARD) failure, but subsequently, several alerts have arisen concerning an increased risk of venous thromboembolism (VTE) with these drugs, Philippoteaux said.
Philippoteaux and colleagues retrospectively studied a multicenter cohort of 232 JAK inhibitor-naive patients with RA in France who began taking baricitinib or tofacitinib between October 2017 and September 2020; 155 started baricitinib and 77 started tofacitinib. They compared characteristics of patients who started treatment before and after the May 2019 EMA announcement, as well as the persistence of tofacitinib and baricitinib in practice.
Before 2019, statistically significantly more patients taking one of the two JAK inhibitors were reported to have a history of deep vein thrombosis (10 of 161; 6.2%) compared with 1 of 71 (1.4%) after 2019 (P = .18), suggesting “a lower proportion of VTE history in patients starting a JAK inhibitor after May 2019,” Philippoteaux said.
Of 155 patients taking baricitinib, 14.8% were naive to biologic DMARDs, compared with 9.1% of 77 patients taking tofacitinib. Conventional synthetic DMARDs were used in 38.7% and 37.4% of patients taking baricitinib and tofacitinib, respectively.
Five VTE events occurred during the study period, four of which were in patients who started JAK inhibitors before the EMA warning.
Comparison of persistence assessed with propensity score methods showed persistent use of the drugs at 2 years was similar for baricitinib and tofacitinib at 39.3% and 42.8%, respectively.
“EMA’s warnings have not significantly changed RA patient characteristics initiating a JAK inhibitor,” Philippoteaux said. “[Baricitinib and tofacitinib] have a similar real-world persistence in our study. Whether the VTE risk is a class effect of JAK inhibitors remains to be determined.”
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Philippoteaux C, et al. Abstract 1245. Presented at: ACR Convergence 2021; November 3-10, 2021 (virtual meeting).
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