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.
- 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.
- 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.