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Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data

Annals of Rheumatic Diseases Aug 11, 2020

Mease P, Charles-Schoeman C, Cohen S, et al. - Researchers sought to report on the incidence of deep vein thrombosis (DVT), PE, venous thromboembolism (VTE; DVT or PE) and arterial thromboembolism (ATE) from the tofacitinib rheumatoid arthritis (RA) (excluding Study A3921133), psoriatic arthritis (PsA) and psoriasis (PsO) development programs and observational studies. Further, they reported data from an ad hoc safety analysis of Study A3921133 separately. They assessed data of 12,410 tofacitinib-treated patients from the development programs (RA: n = 7,964; PsO: n = 3,663; PsA: n = 783). Incidence rates (IRs; patients with events per 100 patient-years’ exposure) of thromboembolic events were similar across tofacitinib doses (5 mg and 10 mg twice daily). Among the all tofacitinib cohorts’ average tofacitinib 5 mg and 10 mg twice daily treated patients for RA, respectively, IRs of thromboembolic events were: DVT (0.17 and 0.15); PE (0.12 and 0.13); ATE (0.32 and 0.38). For PsO patients, IRs were: DVT (0.06 and 0.06); PE (0.13 and 0.09); ATE (0.52 and 0.22). For PsA patients, IRs were: DVT (0.00 and 0.13); PE (0.08 and 0.00); ATE (0.31 and 0.38). In line with expectations, IRs of thromboembolic events were generally higher in cases with baseline cardiovascular or VTE risk factors and were broadly consistent with those noted in the Study A3921133 ad hoc safety analysis data, although the IR for PE was higher in patients managed with tofacitinib 10 mg twice daily in Study A3921133, vs patients with baseline cardiovascular risk factors managed with tofacitinib 10 mg twice daily in the RA program.

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