OBJECTIVE: To assess the incidence of major adverse cardiovascular events (MACE) in RA patients treated with JAKi, TNF-inhibitors (TNFi) or biologic Disease-Modifying Anti-Rheumatic Drugs with other modes of action (bDMARD-OMA) in a multi-country, real-world population. METHODS: RA patients from 15 registries in the JAK-pot collaboration were included. MACE incidence was analysed using two approaches: a within-registry analysis aggregating country-specific estimates from registers with >25 incident MACE events through meta-analysis, and an individual-level data combined analysis. We used adjusted linear mixed Poisson regression to obtain incidence rate ratios (IRR) of MACE between treatment groups, accounting for multiple treatment courses. RESULTS: The study included 73'008 treatment courses (16'417 JAKi, 35'373 TNFi and 21'218 bDMARD-OMA) and 828 incident MACE among 51'233 patients. Median follow-up time was 1.3 years, with most of the follow-up concentrated in the first two years of treatment. Incidence rates were 7.0, 7.6 and 11.8 per 1'000 person-years for JAKi, TNFi and bDMARD-OMA, respectively. Compared to TNFi, JAKi (within-registry adjusted IRR: 0.89, 95%CI 0.63 to 1.25)) had similar incidence rates of MACE and bDMARD-OMA had higher rates (within-registry adjusted IRR: 1.35, 95%CI 1.10 to 1.66). Combined analysis showed similar results. CONCLUSION: Observational data from the JAK-pot collaboration show no evidence of an increase in cardiovascular events during the first 2 years of use with JAKi compared to TNFi in the general RA population.

BioReg Vienna Austria

Centre for Epidemiology Versus Arthritis Division of Musculoskeletal and Dermatological Sciences School of Biological Sciences Faculty of Biology Medicine and Health The University of Manchester Manchester Academic Health Science Centre Manchester United Kingdom

Charité Universitätsmedizin Berlin Germany

CHUM Institut de Recherche en Rhumatologie Montréal Canada

Clinical Epidemiology Division Department of Medicine Solna Karolinska Institutet Stockholm Sweden

Department of Rheumatology University Medical Centre Ljubljana and Faculty of Medicine University of Ljubljana Ljubljana Slovenia

Departments of Medicine and Rheumatology Helsinki University Hospital ROB FIN Helsinki Finland

Diakonhjemmet Hospital Center for Treatment of Rheumatic and Musculoskeletal Diseases Oslo Norway

DiMePRe J Rheumatology Unit University of Bari Italy

DRFZ Programme Area Epidemiology Berlin Germany

Geneva Center for Inflammation Research University of Geneva

Geneva University Hospital Rheumatology Geneva Switzerland

Hospital Clinico Universitario Rheumatology Santiago de Compostela Spain

Institute of Rheumatology Rheumatology Prague Czech Republic

NIHR Manchester Biomedical Research Centre Manchester University NHS Trust Manchester United Kingdom

Physiology and Experimental Medicine of the Heart and Muscles Montpellier France

Research Unit Spanish Society of Rheumatology Madrid Spain

Reuma pt Sociedade Portuguesa de Reumatologia Lisbon Portugal

Rheumatology and Clinical Immunology University Hospital of Heraklion Crete Greece

Universidade Nova de Lisaboa NOVA Medical School Lisbon Portugal

University of Medicine Center of Rheumatic Diseases Bucharest Romania

University of Montpellier Montpellier France

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