Safety of Brodalumab in Plaque Psoriasis: Integrated Pooled Data from Five Clinical Trials

Kristian Reich*, Diamant Thaçi, Georg Stingl, Jens Strodl Andersen, Line Conradsen Hiort, Michala Oron Lexner, David Winkler, Carle Paul

*Corresponding author for this work
5 Citations (Scopus)

Abstract

Brodalumab is approved for treatment of moderateto-severe plaque psoriasis. Here, we assess the safety profile of brodalumab using pooled safety data from 5 phase II/III trials of brodalumab 140 mg or 210 mg. In total, 4,464 patients received brodalumab, representing 8,891.6 patient-years of exposure. During the placebo-controlled 12-week induction period, rates of serious adverse events per 100 patient-years were 10.8 and 9.6 (brodalumab 140 mg and 210 mg, respectively) vs 4.3 and 6.5 (ustekinumab and placebo, respectively); infections were the most frequent serious adverse event. Rates of serious adverse events during the comparator-controlled 52-week period were 14.4, 10.2 and 8.3 per 100 patient-years for brodalumab 210 mg, brodalumab 140 mg, and ustekinumab, respectively. Brodalumab was not associated with increased risks of malignancy, major adverse cardiac events, suicidal ideation and behaviour, or fatal events. Overall, brodalumab demonstrated an acceptable safety profile in short-and long-term treatment.

Original languageEnglish
Article numberadv00683
JournalActa Dermato-Venereologica
Volume102
ISSN0001-5555
DOIs
Publication statusPublished - 2022

Research Areas and Centers

  • Academic Focus: Center for Infection and Inflammation Research (ZIEL)
  • Centers: Center for Research on Inflammation of the Skin (CRIS)

DFG Research Classification Scheme

  • 205-19 Dermatology

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