Long-term cardiovascular safety of ustekinumab in psoriasis and psoriatic arthritis: Results from an observational postauthorization safety study based on Swedish national registers.

Abstract

Evidence on the comparative cardiovascular (CV) safety of ustekinumab in psoriasis (PsO) and psoriatic arthritis (PsA) remains limited. To assess the risk of major adverse cardiovascular events (MACE) among PsO and PsA patients treated with ustekinumab compared to those treated with adalimumab, etanercept, or secukinumab in routine clinical practice. This new-user, active-comparator, observational cohort study used patient-level data from Swedish national registers, including adult PsO/PsA patients initiating treatment with ustekinumab or a comparator between 2009 and 2021, with patients assigned to mutually exclusive cohorts. The primary outcome was incident MACE, defined as myocardial infarction, ischemic stroke, or CV-related death. Adjusted hazard ratios were estimated using cause-specific Cox regression with stabilized inverse probability of treatment weighting by propensity scores. A total of 15,502 patients were included (852 ustekinumab-treated), with 147 MACE observed during follow-up. Adjusted hazard ratios (95% CI) comparing ustekinumab to adalimumab, etanercept, and secukinumab were 1.07 (0.49-2.33), 1.08 (0.48-2.42), and 1.19 (0.46-3.10), respectively. Observational study, drug allocation not randomized, and lack of disease severity data. This nationwide study of Swedish PsO/PsA patients spanning >10 years found no evidence of different CV safety profiles of ustekinumab versus adalimumab, etanercept, or secukinumab in real-world clinical practice.