Risk of serious infections, myocardial infarction or stroke, venous thromboembolic events, and malignancy in patients with psoriatic arthritis treated with tofacitinib compared with biologic treatments in the United States

This United States (US)-based claims analysis evaluated the real-world safety of tofacitinib versus biologic treatments in patients with psoriatic arthritis (PsA). Risk of serious infections, myocardial infarction (MI) or stroke, venous thromboembolism (VTE), and malignancy (excluding non-melanoma skin cancer) were assessed using data from a US real-world database of administrative data and claims from medical/pharmacy insurances (Komodo Health). Patients with PsA aged ≥ 18 years who initiated tofacitinib or a biologic treatment (tumor necrosis factor inhibitors [TNFi], interleukin-17 A inhibitors [IL-17Ai], risankizumab or ustekinumab) between December 2017–February 2023, with ≥ 12 months of prior continuous enrollment, were included. Crude incidence rates (IRs)/100 patient-years (PY) and stabilized inverse probability treatment weighting (sIPTW) were calculated. Cox proportional hazards models with sIPTW were used to calculate adjusted hazard ratios with bootstrapping for 95% confidence intervals. In total, 48,167 patients were included (tofacitinib, N = 3,166; TNFi, N = 26,760; IL-17Ai, N = 20,252; risankizumab, N = 4,381; ustekinumab, N = 4,499). Mean age at index ranged from 48.2 to 50.3 years; mean follow-up was 288.5–347.0 days. Crude IRs/100 PY ranged from 1.78 to 2.53 for serious infections, 0.27–0.61 for MI/stroke, 0.17–0.42 for VTE, and 0.74–1.06 for malignancy. In the main analysis, there were no statistically significant differences in the risk of developing serious infections, MI or stroke, or malignancy between treatments. Patients initiating tofacitinib versus TNFi (but not other biologics) had significantly higher VTE risk. A higher proportion of tofacitinib initiators had surgery (potential VTE risk factor) during the baseline period (45.9–46.7%) and 6 months post-index (28.1–28.9%), versus biologic initiators (40.2–44.3% and 22.2–27.4%, respectively). In patients with PsA who were not enriched for cardiovascular/VTE risk factors, no significant differences in the risk of serious infections, MI or stroke, or malignancy were reported in patients initiating tofacitinib versus biologic treatments. Tofacitinib was associated with a higher risk of VTE compared with TNFi, aligning with previous clinical data. Limitations included the low number of safety events, residual confounding, and factors associated with claims data. EUPAS103443.