Risk of major cardiovascular events in adult patients with psoriasis treated with biologic therapies or methotrexate: Cohort study in the British Association of Dermatologists Biologic Interventions Register (BADBIR)

Abstract

Background
The cardiovascular safety profile of biologic therapies used for psoriasis is unclear.

Objectives
To compare the risk of major cardiovascular events (CVE s; acute coronary syndrome, unstable angina, myocardial infarction and stroke) in patients with chronic plaque psoriasis treated with adalimumab, etanercept or ustekinumab in a large prospective cohort.

Methods
Prospective cohort study examining the comparative risk of major CVE s was conducted using the British Association of Dermatologists Biologics and Immunomodulators Register. The main analysis compared adults with chronic plaque psoriasis receiving ustekinumab with tumour necrosis-a inhibitors (TNF i: etanercept and adalimumab), whilst the secondary analyses compared ustekinumab, etanercept or methotrexate against adalimumab. Hazard ratios (HR s) with 95% confidence intervals (CI s) were calculated using overlap weights by propensity score to balance baseline covariates among comparison groups.

Results
We included 5468 biologic-naïve patients subsequently exposed (951 ustekinumab; 1313 etanercept; and 3204 adalimumab) in the main analysis. The secondary analyses also included 2189 patients receiving methotrexate. The median (p25–p75) follow-up times for patients using ustekinumab, TNF i, adalimumab, etanercept and methotrexate were as follows: 2.01 (1.16–3.21), 1.93 (1.05–3.34), 1.94 (1.09–3.32), 1.92 (0.93–3.45) and 1.43 (0.84–2.53) years, respectively. Ustekinumab, TNF i, adalimumab, etanercept and methotrexate groups had 7, 29, 23, 6 and 9 patients experiencing major CVE s, respectively. No differences in the risk of major CVE s were observed between biologic therapies [adjusted HR for ustekinumab vs. TNF i: 0.96 (95% CI 0.41–2.22); ustekinumab vs. adalimumab: 0.81 (0.30–2.17); etanercept vs. adalimumab: 0.81 (0.28–2.30)] and methotrexate against adalimumab [1.05 (0.34–3.28)].

Conclusions
In this large prospective cohort study, we found no significant differences in the risk of major CVE s between three different biologic therapies and methotrexate. Additional studies, with longer term follow-up, are needed to investigate the potential effects of biologic therapies on incidence of major CVE s.