OP0268 COMPARISON OF MAJOR CARDIOVASCULAR AND THROMBOEMBOLIC EVENTS IN SAFETY REPORTS BETWEEN RHEUMATOID ARTHRITIS PATIENTS TREATED WITH JAK INHIBITORS VERSUS ANTI-TNF: RESULTS FROM VigiBase

Background Recently, awareness has raised regarding JAK inhibitor safety in rheumatoid arthritis (RA), particular with tofacitinib. Indeed, a trial involving more than 4,000 patients (ORAL Surveillance), numerically higher number of major cardiovascular events (MACEs) treated tofacitinib compared to anti-TNF (1), and risk venous thromboembolic (VTE) 10mg twice day 5mg or was observed. This increased MACEs also suspected another study performed on American Health databases (2). the FDA extended warnings use’s recommendations other JAK-inhibitor drugs (3). Objectives To corroborate these warnings, we reporting VTEs inhibitors versus alpha from World Organization (WHO) Global Individual Case Safety Report (ICSR) database (VigiBase). Methods We selected reports Vigibase aged between 18 75 years, 01/01/2011 12/31/2020, (tofacitinib, baricitinib, upadacitinib, filgotinib) (etanercept, adalimumab, infliximab, certolizumab pegol, golimumab) diagnosis RA. In including myocardial infarction, strokes deaths VTE deep thromboses (DVT) pulmonary embolisms (PE). Characteristics age patients, country declaration, drug involved, co-reported drugs, type event were described. The investigated using disproportionality analyses expressed as Reporting Odds Ratios (ROR) 95% Confidence Interval (95%CI). A sensibility analysis stratifying by category (≥ 65 ≥ 50 years), sex. Results Of 11,455,891 years period interest, 39,097 for RA (mean 60.6 SD:16.3) 231,860 an age: 57.2 SD: 13.0). Most came USA Canada (respectively 77.4% 12.5% 86.4% 2,6% anti-TNF). Among reports, 611 (1.6%) 3240 (1.4%) while 341 (0.9%) JAK-inhibitors 571 (0.2%) VTE. Disproportionality identified (DVT: ROR = 3.99 [95%CI: 3.15-5.04], PE: 3.47 [2.90-4.13], Figure 1). not modified after stratification No MACE found. 1. Conclusion Based real-world data, did identify increase declaration whereas could observe three times declarations anti-TNF. References [1]Ytterberg SR, Bhatt DL, Mikuls TR, Koch GG, Fleischmann R, Rivas JL, et al. Cardiovascular Cancer Risk Tofacitinib Rheumatoid Arthritis. N Engl J Med. 2022;386(4):316-26. [2]Khosrow-Khavar F, Kim SC, Lee H, SB, Desai RJ. outcomes: results TofAcitinib Routine care Arthritis (STAR-RA) study. Ann Rheum Dis. 2022. [3]FDA. requires about serious heart-related events, cancer, blood clots, death that treat certain chronic inflammatory conditions. https://wwwfdagov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death . 2021. Disclosure Interests None declared