Objectives To assess the risk of major adverse cardiovascular events (MACEs) and venous thromboembolism events (VTEs) among patients initiating a Janus kinase inhibitor (JAKi) (tofacitinib and baricitinib) versus adalimumab in a large real-world population of patients with rheumatoid arthritis.

Methods We conducted a nationwide population-based cohort study of the French national health data system, the exposed group initiating a JAKi and non-exposed group initiating adalimumab. We included all individuals who had their first dispensation of a JAKi or adalimumab between 1 July 2017 and 31 May 2021 and had rheumatoid arthritis. The primary endpoints were the occurrence of a MACE or VTE. Weighted hazard ratio (HRw) values were estimated with the inverse probability of treatment weighting method to account for confounding factors with concomitant administration of methotrexate as a time-varying variable.

Results The cohort included 15 835 patients: 8481 and 7354 in the exposed and non-exposed groups (mean age 59.3 and 55.3 years, female 78.3% and 71.2%, respectively). During follow-up, 54 and 35 MACEs and 75 and 32 VTEs occurred in the exposed and non-exposed groups, respectively. Risk of MACEs for the exposed versus non-exposed group was not significant: HRw 1.0 (95% CI 0.7 to 1.5) (p=0.99), nor was risk of VTEs significant: HRw 1.1 (0.7 to 1.6) (p=0.63). Despite a lack of power, results were consistent among patients aged 65 years or older with at least one cardiovascular risk factor.

Conclusions This study provides reassuring data regarding the risks of MACEs and VTEs in patients initiating a JAKi versus adalimumab, including patients at high risk of cardiovascular diseases.

No data are available. Data sharing is not applicable. According to data protection and the French regulation, the authors cannot publicly release the data from the French national health data system (SNDS). However, any person or structure, public or private, for-profit or nonprofit, is able to access SNDS data upon authorization from the French Data Protection Office (CNIL Commission Nationale de l’Informatique et des Libertés) to carry out a study, research, or an evaluation of public interest (https://www.snds.gouv.fr/SNDS/Processus-d-acces-aux-donnees and https://www.indsante.fr/).