Citation

Yeroushalmi S, Chung M, Bartholomew E, Hakimi M, Koo J. JAAD Int. 2022; 9: 119-121.

Copyright

(Copyright © 2022, Elsevier Publishing)

DOI

10.1016/j.jdin.2022.08.010

PMID

36248199

PMCID

PMC9563208

Abstract

To the Editor: Biologics are highly efficacious biologic for treating moderate-to-severe plaque psoriasis, particularly brodalumab. However, the use of brodalumab has been severely limited due to a black box warning and an associated Risk Evaluation and Mitigation Strategies program indicating a possible increased risk of suicidality. This warning was applied due to 4 possible suicides during phase III clinical trials, of which only 3 were verified. Closer examination of these cases shows that all 3 had significant life stressors and no chronological relationship between drug administration and suicide was present. Given that brodalumab has been approved for nearly half of a decade, we aimed to examine worldwide postmarketing data to evaluate the association between brodalumab use and risk of suicide compared to 10 other biologics approved for psoriasis.

The total number of completed suicides for each biologic was extracted from the Food and Drug Administration Adverse Events Reporting System (FAERS) for all indications included through December 31, 2021.

The FAERS is a publicly available international database for reporting postmarketing drug adverse events. The total number of patients prescribed each drug for all indications was determined by contacting pharmaceutical companies.

The number of total completed suicides for each biologic agent and the number of completed suicides per total patients prescribed are ...

Language: en