Risk of major adverse cardiovascular events in patients initiating biologics/apremilast for psoriatic arthritis: a nationwide cohort study.

OBJECTIVE: Several biological disease-modifying anti-rheumatic drugs (bDMARDs) have demonstrated anti-inflammatory effects in psoriatic arthritis (PsA). However, their comparative cardiovascular safety profiles remain unknown. We evaluated the risk of major adverse cardiovascular events (MACEs) in PsA patients on therapy with different classes of bDMARDs and apremilast. METHODS: This nationwide cohort study involved the administrative healthcare database of the French health insurance scheme linked to the hospital discharge database. All adults with PsA who were new users of bDMARDs/apremilast (neither in the year before the index date) during 2015-2019 were included. Patients with previous cardiovascular diseases were excluded. End of follow-up was December 31, 2019. The primary end point was an occurrence of MACE in a time-to-event analysis with propensity score-weighted Cox and Fine-Gray models. RESULTS: Between 2015 and 2019, we included 9,510 bDMARD new users (mean age 48.5 ± 12.7 years; 42% men), including 7,289 starting a TNF inhibitor, 1,058 an IL12/23 inhibitor and 1,163 an IL17 inhibitor, with 1,885 apremilast new users (mean age 54.0 ± 12.5 years; 44% men). MACEs occurred in 51 (0.4%) patients. After propensity score weighting, the risk of MACEs was significantly greater with IL12/23 (HRw 2.0, 95%CI 1.3-3.0) and IL17 (HRw 1.9, 95%CI 1.2-3.0) inhibitors than TNF inhibitors, with no significant increased risk with apremilast (HRw 1.3, 95%CI 0.8-2.2). Similar results were observed with the Fine-Gray competing-risks survival model. CONCLUSION: Analysis of a large database revealed a small overall number of MACEs, and the risk of MACEs was greater for PsA new users of IL12/23 and IL17 vs TNF inhibitors.