Association of ustekinumab and briakinumab with major adverse cardiovascular events
نویسندگان
چکیده
Safety concerns have been raised regarding possible association of major adverse cardiovascular events (MACEs) with use of anti-IL-12/23 biologic agents for the treatment of chronic plaque psoriasis (CPP). Ten MACEs have been recorded in actively-treated patients during the placebo-controlled phase of phase II and III studies compared with zero events in placebo-treated patients, along with a total of 53 MACEs (26 ustekinumab, 27 briakinumab) and five cardiovascular deaths (1 ustekinumab, 4 briakinumab) across all phases of these studies. Two industry-independent meta-analyses of randomized, double-blind, placebo-controlled, monotherapy trials calculated risk for MACEs. One detected statistically significant increase in cardiovascular risk using Peto method (p = 0.04), while the other utilized Mantel-Haenszel fixed-effects model with absolute risk differences as effect measure, but did not achieve significance (p = 0.11). Statistical theory reports that Peto method is more suitable for meta-analyses of studies with baseline event rates of 1% or less and randomization ratios ranging from 1:5 to 1:1 as is the case in these meta-analyses. Potential of anti-IL-12/23 biologic agents to further increase cardiovascular morbidity cannot be excluded and a class effect cannot be denied. Clinicians should screen CPP patients for manageable cardiovascular risk factors before initiating anti-IL-12/23 agents along with intensive monitoring of these patients.
منابع مشابه
Cardiovascular risk and psoriasis: the role of biologic therapy.
One of the most clinically important aspects of recent advances in our understanding of psoriasis has been the detection of an association between this disease and an increased prevalence of cardiovascular risk factors. This increase in prevalence is, in turn, linked to a greater risk of morbidity and mortality related to acute myocardial infarction, cerebrovascular accident, and peripheral art...
متن کاملAmerican academy of dermatology, summer academy meeting.
inhibit progression of joint destruction. He said that TNF inhibitors are unique in their ability to do that but added that uste kinumab is unproven in PsA. Although one pilot study indicated a degree of response,1 “the jury is still out,” he claimed. In his own experience, he said that ustekinumab did not perform as well as the TNF blockers—or methotrexate— against PsA. Regarding cardiovascula...
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BACKGROUND Many studies have identified cardiovascular risk factors in patients with psoriasis. Some psoriasis therapies may increase cardiovascular disease (CVD) and others may decrease CVD. OBJECTIVE We reviewed the literature to define the impact of common psoriasis therapies on cardiovascular measures and outcomes. RESULTS Phototherapy has no major cardiovascular impact and may reduce l...
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