Re-evaluation of the risk for major adverse cardiovascular events in patients
treated with anti-IL-12/23 biological agents for chronic plaque psoriasis: a
meta-analysis of randomized controlled trials.
Author(s): Tzellos T(1), Kyrgidis A, Zouboulis CC.
Affiliation(s): Author information:
(1)Department of Dermatology, Dessau Medical Center, Dessau, Germany.
Publication date & source: 2013, J Eur Acad Dermatol Venereol. , 27(5):622-7
OBJECTIVE: To detect a detrimental or beneficial effect of anti-IL-12/23
biological agents (ustekinumab and briakinumab) for the treatment of chronic
plaque psoriasis on major adverse cardiovascular events (MACEs).
DESIGN: Systematic review and meta-analysis MEDLINE, EMBASE, the Cochrane Skin
Group Specialised Register, Cochrane Central Register of Controlled Trials
(CENTRAL) in The Cochrane Library, SciVerse Scopus and ongoing trial registries
were searched from inception until December 2011. Search strategy, eligibility
criteria, data and statistical analysis methods were defined prior to the
literature search. Randomized, placebo-controlled, double-blind, monotherapy
studies with safety data for MACEs of IL-12/23 antibodies in adults were eligible
for inclusion. Studies of psoriatic arthritis were excluded. Information from
each study was extracted independently by two reviewers, using a standardized
data extraction form. The primary outcome measure was the number of MACEs during
the placebo-controlled phase of treatment.
RESULTS: MACEs include myocardial infarction, cerebrovascular accident or
cardiovascular death. No statistical heterogeneity across the studies using the
I(2) statistic (I(2) = 0) was found. We employed Peto one-step method to
determine odds ratios and quantify a possible detrimental or beneficial
association of IL-12/23 antibodies treatment with MACEs. We found a possible
higher risk of MACEs in those patients treated with IL-12/23 antibodies compared
with those at placebo (OR = 4.23, 95% CI: 1.07-16.75, P = 0.04). This study is
unaffected by non-reporting of outcomes with no events.
CONCLUSION: Compared with placebo, there was a significant difference in the rate
of MACEs observed in patients receiving anti-IL-12/23 biological agents.
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