Do biological psoriasis therapies increase cardiovascular risk?

January 01, 0001

Do biological psoriasis therapies increase cardiovascular risk?

Concerns have been raised about major adverse cardiovascular events (MACEs) in some biological therapies for chronic plaque psoriasis. These US researchers looked at whether there was a link between such therapies therapies and MACEs via meta-analysis. The Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and Ovid MEDLINE were searched for randomized placebo-controlled, double-blind, monotherapy trials of anti-IL- 12/23 agents (ustekinumab and briakinumab) and anti-tumor necrosis factor á (TNF-á) agents (adalimumab, etanercept, and infliximab) used in treating chronic plaque psoriasis, along with abstracts or poster presentations of unpublished data. Twenty two trials met inclusion criteria (10 183 patients). The primary outcome measure was a composite end point of heart attack, stroke, or cardiovascular death (MACE).

The researchers found: "There was no evidence of statistical heterogeneity across the studies using the I2 statistic, allowing for combination of trial results using the Mantel-Haenszel fixed-effects method. During the placebo-controlled phases of the anti-IL-12/23 studies, 10 of 3179 patients receiving anti-IL-12/23 therapies experienced MACEs compared with zero events in 1474 patients receiving placebo (Mantel-Haenszel risk difference, 0.012 events/person-year). In the anti-TNF-á trials, only 1 of 3858 patients receiving anti-TNF-á agents experienced a MACE compared with 1 of 1812 patients receiving placebo (Mantel-Haenszel risk difference, -0.0005 events/person-year)."

The researchers concluded: "Compared with placebo, there was no significant difference in the rate of MACEs observed in patients receiving anti-IL-12/IL-23 antibodies or anti-TNF-á treatments. This study may have been underpowered to identify a significant difference."

While anti-IL-12/IL-23 agents appeared to have a higher associated rate of cardiovascular events, it was not statistically significant.

For the full abstract, click here.

JAMA 306(8):864-871, 24 August 2011 © 2011 American Medical Association
Association Between Biologic Therapies for Chronic Plaque Psoriasis and Cardiovascular Events. Caitriona Ryan, Craig L. Leonardi, James G. Krueger, et al.

Category: K. Circulatory, S. Skin. Keywords: Psoriasis, cardiovascular risk, interleukin-12, interleuikin-23, tumor necrosis factor alpha, systematic review with meta-analysis, journal watch.
Synopsis edited by Dr Paul Schaefer, Toledo, Ohio. Posted on Global Family Doctor 16 September 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.