Introduction: Concerns have been raised about an increased risk of major adverse cardiovascular events (MACEs) - stroke, myocardial infarction and sudden cardiac death - in patients with plaque psoriasis receiving biologic therapies.
Aim: This review and meta-analysis of randomized controlled trials (RCTs) was to evaluate the risk difference of MACEs between experimental and comparator interventions.
Material and methods: We searched MEDLINE database for suitable trials. Prior to that we identified the search strategy and eligibility criteria. Each RCT was double-blind, placebo controlled and scored five points in Jadad scale. We calculated risk difference (RD) with use of the Mantel-Haenszel fixed-effect method with 95% confidence intervals (CIs) and calculated i2 statistic to assess heterogeneity. A total of 43 RCTs were included, involving 19,161 patients. Overall, the risk of MACEs in the included studies was 0.1% (n = 21).
Results: There were no statistically significant risk differences in patients treated with biologic therapy vs. placebo (RD = 0.0; Z = 1.09; 95% CI: 0.0-0.0; p = 0.28); tumour necrosis inhibitors vs. placebo (RD = 0.0; Z = 0.47; 95% CI: -0.0-0.0; p = 0.64); anti-IL-17A agents vs. placebo (RD = 0.0; Z = 1.25; 95% CI: -0.0-0.01; p = 0.21); anti-IL-23 agents vs. placebo (RD = 0; Z = 0.36; 95% CI: -0.0-0.01; p = 0.72); anti-IL-12/23 agents vs. placebo (RD = 0.0; Z = 0.73; 95% CI: -0.0-0.0; p = 0.46).
Conclusions: Further trials are needed, including longer follow-up and patients with an increased cardiovascular risk, to assess the risk of MACEs.
Keywords: biologic therapies; major adverse cardiac events; psoriasis.
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