Author/Authors :
Nartowicz, Sonia Department of Dermatology - Poznan University of Medical Sciences, Poland , Jakielska, Ewelina Department of Dermatology - Poznan University of Medical Sciences, Poland , Priadka, Monika Department of Dermatology - Poznan University of Medical Sciences, Poland , Adamski, Zygmunt Department of Dermatology - Poznan University of Medical Sciences, Poland , Ratajczak, Piotr Department of Pharmacoeconomics and Social Pharmacy - Poznan University of Medical Sciences, Poland , Kus, Krzysztof Department of Pharmacoeconomics and Social Pharmacy - Poznan University of Medical Sciences, Poland
Abstract :
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.