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

Authors

  • Kristian Reich Institute for Health Services Research in Dermatology and Nursing, University Medical Cen-ter Hamburg-Eppendorf, Martinistrasse 52, DE-20246 Hamburg, Germany
  • Diamant Thaçi
  • Georg Stingl
  • Jens Strodl Andersen
  • Line Conradsen Hiort
  • Michala Oron Lexner
  • David Winkler
  • Carle Paul

DOI:

https://doi.org/10.2340/actadv.v102.1993

Keywords:

brodalumab, interleukin-17, psoriasis, safety

Abstract

Brodalumab is approved for treatment of moderate-to-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.

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References

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Published

2022-03-28

How to Cite

Reich, K., Thaçi, D., Stingl, G., Andersen, J. S., Hiort, L. C., Lexner, M. O., Winkler, D., & Paul, C. (2022). Safety of Brodalumab in Plaque Psoriasis: Integrated Pooled Data from Five Clinical Trials. Acta Dermato-Venereologica, 102, adv00683. https://doi.org/10.2340/actadv.v102.1993

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