TY - JOUR
PY - 2018//
TI - Psychiatric adverse events during treatment with brodalumab: Analysis of psoriasis clinical trials
JO - Journal of the American Academy of Dermatology
A1 - Lebwohl, Mark G.
A1 - Papp, Kim A.
A1 - Marangell, Lauren B.
A1 - Koo, John
A1 - Blauvelt, Andrew
A1 - Gooderham, Melinda
A1 - Wu, Jashin J.
A1 - Rastogi, Shipra
A1 - Harris, Susan
A1 - Pillai, Radhakrishnan
A1 - Israel, Robert J.
SP - 81
EP - 89.e5
VL - 78
IS - 1
N2 - BACKGROUND: Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). OBJECTIVE: To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. METHODS: Data were evaluated 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 of patients with moderate-to-severe psoriasis. RESULTS: The analysis included 4464 patients with 9161.8 patient-years of brodalumab exposure. The follow-up time-adjusted incidence rates of SIB events were comparable between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years). In the brodalumab group, 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate; all patients had underlying psychiatric disorders or stressors. LIMITATIONS: There was no comparator arm past week 52. Controlled study periods were not powered to detect differences in rare events such as suicide. CONCLUSIONS: Comparison with controls and the timing of events do not indicate a causal relationship between SIB and brodalumab treatment. Language: en
LA - en
SN - 0190-9622
UR - http://dx.doi.org/10.1016/j.jaad.2017.08.024
ID - ref1
ER -