0723: Risk of Major Adverse Cardiovascular and Venous Thromboembolism Events in Patients with Rheumatoid Arthritis Exposed to JAK Inhibitors versus Adalimumab: A Nationwide Cohort Study

Lea Hoisnard¹, Laura Pina Vegas², Rosemary Dray-Spira³, Alain Weill³, Mahmoud Zureik³ and Emilie sbidian⁴, ¹Fédération Hospitalo-Universitaire TRUE InnovaTive theRapy for immUne disordErs, Assistance Publique-Hôpitaux de Paris (AP-HP), Henri Mondor Hospital, Créteil, France, ²Service de Rhumatologie, AP-HP, Hôpital Henri Mondor, Créteil, France, ³EPI-PHARE Scientific Interest Group in Epidemiology of Health Products, French National Agency for Medicines and Health Products Safety, French National Health Insurance, Saint-Denis, France, ⁴Service de Dermatologie, AP-HP, Hôpital Henri Mondor, Créteil, France

Background/Purpose: 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 July 1, 2017 and May 31, 2021, and had rheumatoid arthritis with no history of cardiovascular diseases. 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.

Results: The cohort included 14,632 patients: 7,972 and 6,660 in the exposed (mean age 58.5 years, female 80.1%) and non-exposed (mean age 54.6 years female 72.2%) groups. During follow-up, 40 and 28 MACEs and 62 and 24 VTEs occurred in the exposed and non-exposed groups, respectively. Risk of MACEs for the exposed versus non-exposed group was not significant: HRw 1.1 [95% CI 0.6-1.7] (p=0.84), nor was risk of VTEs significant: HRw 1.3 [0.8-2.1] (p=0.23). Despite a lack of power, results were consistent among patients aged 65 years or older with at least one cardiovascular risk factor.

Conclusion: 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.

Disclosures: L. Hoisnard, None; L. Pina Vegas, None; R. Dray-Spira, None; A. Weill, None; M. Zureik, None; E. sbidian, None.