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Safety

Ryan C, Leonardi CL, Krueger JG et al. JAMA 2011;306:864–71.

Ustekinumab and briakinumab, monoclonal antibodies to the shared p40 subunit of interleukin-12 (IL-12) and IL-23, are effective for the treatment of chronic plaque psoriasis; however, preliminary reports suggest that major adverse cardiovascular events (MACEs) occur more frequently in psoriasis patients receiving these agents than in those who do not. In this meta-analysis of 22 randomized controlled trials, 10 of 3179 patients receiving anti-IL-12/-23 therapies experienced MACEs compared with none of 1474 patients receiving placebo. This excess risk was non-significant, but the power to detect a difference was limited.

 

Rofecoxib, a nonsteroidal anti-inflammatory drug, is a prime example of a drug that continued to be prescribed for a considerable length of time – in this case to >80 million patients – despite warnings from preliminary data showing increased cardiovascular (CV) risks associated with the drug. A randomized controlled trial of 2586 patients ultimately demonstrated an excess of thrombotic events with rofecoxib relative to placebo, and the drug was withdrawn.

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