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Psychiatric adverse events during treatment with brodalumab: Analysis of psoriasis clinical trials

Lebwohl MG, et al. – The intent here was to differentiate between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis treated with brodalumab, which was a fully human anti–interleukin 17 receptor A monoclonal antibody. The data unveiled that contrasting with the controls and the timing of events did not reflect a causal tie-up between suicidal ideation and behavior (SIB) and brodalumab therapy.

Methods

  • Data analysis was done from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions.
  • It comprised of patients with moderate-to-severe psoriasis.

Results

  • 4464 patients with 9161.8 patient-years of brodalumab exposure were enrolled for this study.
  • Comparable follow-up time-adjusted incidence rates of SIB events were found between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years).
  • 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate, in the brodalumab group.
  • All the enrollees presented with underlying psychiatric disorders or stressors.
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About Dr. J. Kim

Dr Kim developed (and is continuing to develop) dermatology research news as we way from dermatologists to stay on top of the latest advances in the field of dermatology.

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