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Citation
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Lebwohl MG, Papp KA, Marangell LB, Koo J, Blauvelt A, Gooderham M, Wu JJ, Rastogi S, Harris S, Pillai R, Israel RJ. J. Am. Acad. Dermatol. 2018; 78(1): 81-89.e5. |
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Abstract
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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 |
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Keywords
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Humans; United States; Adult; Female; Male; Middle Aged; Incidence; mental health; Age Factors; Risk Assessment; Sex Factors; Randomized Controlled Trials as Topic; Double-Blind Method; psychiatry; depression; Psychometrics; Prognosis; psychiatric; Psoriasis; Depressive Disorder; psoriasis; Antibodies, Monoclonal; Antibodies, Monoclonal, Humanized; adverse events; Clinical Trials, Phase III as Topic; Clinical Trials, Phase II as Topic; suicidal ideation and behavior |