November 13, 2022Rheumatology and Therapy98 citationsOpen Access

Evaluation of VTE, MACE, and Serious Infections Among Patients with RA Treated with Baricitinib Compared to TNFi: A Multi-Database Study of Patients in Routine Care Using Disease Registries and Claims Databases

CSClaudia A. Salinas ALAnthony Louder JPJennifer M. Polinski

Structured PICO

Does baricitinib increase the risk of VTE, MACE, and serious infections compared to TNFi in patients with rheumatoid arthritis?

Population

15,212 propensity score-matched patients with rheumatoid arthritis (7,606 treated with baricitinib and 7,606 treated with TNFi) from 14 real-world data sources (3 disease registries, 8 commercial, and 3 government health insurance claims databases) across the United States, Europe, and Japan.

Intervention

Baricitinib (new user)

Comparator

Tumor necrosis factor inhibitors (TNFi) (new user)

Outcome

Venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and serious infectionsafety

In a real-world cohort of patients with rheumatoid arthritis, baricitinib was associated with a 1.5-fold increased risk of venous thromboembolism compared to TNFi, highlighting the need to consider cardiovascular risks when prescribing JAK inhibitors.

Abstract

INTRODUCTION: The aim of this work is to evaluate baricitinib safety with respect to venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and serious infection relative to tumor necrosis factor inhibitors (TNFi) in patients with rheumatoid arthritis (RA). METHODS: Patients with RA from 14 real-world data sources (three disease registries, eight commercial and three government health insurance claims databases) in the United States (n = 9), Europe (n = 3), and Japan (n = 2) were analyzed using a new user active comparator design. Propensity score matching (1:1) controlled for potential confounding. Meta-analysis of incidence rate ratios (IRR) and incidence rate differences (IRD) for each outcome, from each data source was executed using modified Poisson regression and Cochran-Mantel-Haenszel analysis. RESULTS: Of 9013 eligible baricitinib-treated patients, 7606 were propensity score-matched with TNFi-treated patients, contributing 5879 and 6512 person-years of baricitinib and TNFi exposure, respectively. Across data sources, 97 patients (56 baricitinib) experienced VTE during follow-up, 93 experienced MACE (54 baricitinib), and 321 experienced serious infection (176 baricitinib). Overall IRRs comparing baricitinib with TNFi treatment were 1.51 (95% CI 1.10, 2.08) for VTE, 1.54 (95% CI 0.93, 2.54) for MACE, and 1.36 (95% CI 0.86, 2.13) for serious infection. IRDs for VTE, MACE, and serious infection, respectively, were 0.26 (95% CI -0.04, 0.57), 0.22 (95% CI -0.07, 0.52), and 0.57 (95% CI -0.07, 1.21) per 100 person-years greater for baricitinib than TNFi. CONCLUSIONS: Overall results suggest increased risk of VTE with baricitinib versus TNFi, with consistent point estimates from the two largest data sources. A numerically greater risk was observed for MACE and serious infection when comparing baricitinib versus TNFi, with different point estimates from the two largest data sources. Findings from this study and their impact on clinical practice should be considered in context of limitations and other evidence regarding the safety and efficacy of baricitinib and other Janus kinase inhibitors. TRIAL REGISTRATION: EU PAS Register ( http://encepp.eu ), identifier #32271.

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