TY - JOUR T1 - Impact of cardiovascular risk enrichment on incidence of major adverse cardiovascular events in the tofacitinib rheumatoid arthritis clinical programme JF - Annals of the Rheumatic Diseases JO - Ann Rheum Dis SP - 575 LP - 577 DO - 10.1136/ard-2022-223406 VL - 82 IS - 4 AU - Maxime Dougados AU - Christina Charles-Schoeman AU - Zoltán Szekanecz AU - Jon T Giles AU - Steven R Ytterberg AU - Deepak L Bhatt AU - Gary G Koch AU - Ivana Vranic AU - Joseph Wu AU - Cunshan Wang AU - Kenneth Kwok AU - Sujatha Menon AU - Carol A Connell AU - Arne Yndestad AU - Jose L Rivas AU - Maya H Buch Y1 - 2023/04/01 UR - http://ard.bmj.com/content/82/4/575.abstract N2 - The ORAL Surveillance trial found that patients with rheumatoid arthritis (RA) aged ≥50 years with ≥1 additional cardiovascular (CV) risk factor had an increased risk of major adverse cardiovascular events (MACE) with tofacitinib versus tumour necrosis factor inhibitors (TNFi).1 A post hoc analysis indicated that the increased risk of MACE with tofacitinib versus TNFi was apparent primarily in patients with a history of atherosclerotic CV disease (ASCVD), that is, pre-existing coronary artery, cerebrovascular or peripheral artery disease.2 Excess risk of MACE was not identified in the wider tofacitinib RA clinical trial programme (consisting of 21 phase 1–3b/4 and 2 long-term extension studies, hereafter collectively referred to as P123LTE).3 To better understand the results from ORAL Surveillance vs P123LTE, we: (1) applied the ORAL Surveillance CV risk-enrichment criteria to P123LTE (patients who received ≥1 tofacitinib dose) to create a CV risk-enriched P123LTE cohort (P123LTE-CV+; patients aged ≥50 years who had ≥1 additional CV risk factor (current smoker, hypertension, high-density lipoprotein cholesterol <40 mg/dL, diabetes mellitus, history of coronary artery disease)) and (2) assessed MACE incidence rates (IRs) in all patients, and separately in patients with and without history of ASCVD, in P123LTE and P123LTE-CV+.P123LTE included 7964 patients; of these, 3125 (39.2%) were included in P123LTE-CV+. MACE data were summarised by tofacitinib dose (average 5 or 10 mg two times per day, based on an average total daily dose of <15 or ≥15 mg, respectively). IRs (patients with unique events/100 patient-years) with 95% CI were evaluated for adjudicated MACE and compared with previously published data from ORAL Surveillance.1 2 Adjudication of MACE was performed concurrently in phase 3 studies and retrospectively in phases 1 and 2 studies. Baseline CV risk profiles of P123LTE and P123LTE-CV+were determined as previously described.2 Briefly, patients were grouped according to history of ASCVD, and patients with … ER -