Impacto de las Terapias Biológicas en el Riesgo de Eventos Cardiovasculares Adversos Mayores en Pacientes con Psoriasis: Revisión Sistemática y Meta-análisis de Ensayos Controlados Aleatorios.

BACKGROUND:

Concerns have been raised regarding an increased risk of major adverse cardiovascular events (MACEs) (myocardial infarction, cerebrovascular accident, or cardiovascular death) in patients treated with anti-interleukin (IL)-12/23 agents for moderate-to-severe psoriasis.

OBJECTIVE:

To examine the risk of MACEs in adult patients with plaque psoriasis that are exposed to biologic therapies via a meta-analysis of randomised controlled trials (RCTs).

METHODS:

(i) Data sources: Systematic searches were performed in the Cochrane Library, MEDLINE and EMBASE, US Food and Drug Administration, European Medicines Agency, individual pharmaceutical companies online search platforms and 5 trials registers (until 31 March 2016). (ii) Study selection: RCTs reporting adverse events in adults with plaque psoriasis receiving at least one licensed dose of biologic therapy, conventional systematic therapy or placebo (iii) Data synthesis: Peto odds ratios (OR) with 95% confidence intervals (CI) were calculated and I(2) statistics were used to assess heterogeneity using RevMan5.3.

RESULTS:

Overall, 38 RCTs involving 18,024 patients were included. No MACEs were observed in 29 studies, while 9 RCTs reported 10 patients experiencing MACEs. There was no statistically significant difference in risk of MACEs associated with the use of biologic therapies overall (OR 1.45, 95%CI 0.34-6.24); tumour necrosis factor α inhibitors (adalimumab, etanercept and infliximab) (OR 0.67, 95%CI0.10-4.63); anti-IL-17A agents (secukinumab and ixekizumab) (OR1.00, 95CI% 0.09-11.09) or ustekinumab (OR4.48, 95%CI0.24-84.77). No heterogeneity was observed in these comparisons.

CONCLUSIONS:

The limited existing evidence suggests that licensed biologic therapies are not associated with MACEs during the short randomised controlled periods in clinical trials. This article is protected by copyright. All rights reserved.