Abstract
BackgroundThe cardiovascular safety profile of biologic therapies used for psoriasis is unclear.ObjectivesTo compare the risk of major cardiovascular events (CVEs; 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.MethodsProspective cohort study examining the comparative risk of major CVEs 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‐α inhibitors (TNFi: etanercept and adalimumab), whilst the secondary analyses compared ustekinumab, etanercept or methotrexate against adalimumab. Hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated using overlap weights by propensity score to balance baseline covariates among comparison groups.ResultsWe 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, TNFi, 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, TNFi, adalimumab, etanercept and methotrexate groups had 7, 29, 23, 6 and 9 patients experiencing major CVEs, respectively. No differences in the risk of major CVEs were observed between biologic therapies [adjusted HR for ustekinumab vs. TNFi: 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)].ConclusionsIn this large prospective cohort study, we found no significant differences in the risk of major CVEs 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 CVEs.
Highlights
IntroductionChronic inflammatory skin disease affecting over 125 million people worldwide.[1]
Psoriasis is a common, chronic inflammatory skin disease affecting over 125 million people worldwide.[1]
Concerns have been raised regarding an increased CV risk due to the use of anti-interleukin (IL)-12/23 agents after a number of major adverse CV events (CVEs) s [MACEs; myocardial infarction (MI), cerebrovascular accident or CV death] occurred in patients receiving briakinumab [anti-IL-12/ 23 agent; Five patients experiencing major adverse CVEs during the induction phase and two patients experiencing the events on day 131 and 225 during the maintenance phase] which in part resulted in the discontinuation of the development of this treatment.[6,7,8]
Summary
Chronic inflammatory skin disease affecting over 125 million people worldwide.[1]. Biologic therapies are increasingly used for the treatment of moderate–severe psoriasis, but their CV safety profile is still unclear. To assess the association between CVEs and treatments, participants in treatment and reference groups should have a similar severity of psoriasis since this may influence the development of CVEs.[16] Ideally, biologic therapies should be directly compared. The cardiovascular safety profile of biologic therapies used for psoriasis is unclear
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