Safety of Bimekizumab for Plaque Psoriasis: An Expert Consensus Panel

August 2024 | Volume 23 | Issue 8 | 8246 | Copyright © August 2024


Published online July 26, 2024

Joshua Burshtein MDa,b, Milaan Shah MDa,b, Danny Zakria MD MBAa,b, April W. Armstrong MD MPHc, Alexandra K. Golant MDa, Alice B. Gottlieb MD PhDa, Jeffrey M. Weinberg MDa, Leon Kircik MDa, George Han MD PhDd, Richard G. Langley MD FRCPCe, Andrea L. Neimann MDf, Mark Lebwohl MDa

aDepartment of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY
bRonald O. Perelman Department of Dermatology, NYU Langone Health, NY
cDivision of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA
dDepartment of Dermatology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY
eDivision of Dermatology, Dalhousie University, Halifax, NS, Canada
fDivision of Rheumatology, Department of Medicine, NYU Langone Health, NY

Abstract
Background: Plaque psoriasis is a chronic, relapsing systemic illness that has a significant effect on quality of life. Bimekizumab is the first monoclonal antibody to target both interleukin (IL)-17A and IL-17F, and recently received Food and Drug Administration (FDA) approval for moderate to severe plaque psoriasis. Guidance is necessary regarding the safety of bimekizumab.
Methods: A comprehensive literature search of PubMed, Scopus, and Google Scholar was completed for English-language original research articles on the safety of bimekizumab for moderate to severe psoriasis. A panel of 9 dermatologists and 1 rheumatologist with significant expertise in the treatment of psoriasis gathered to review the articles and create consensus statements on this new medication. A modified Delphi process was used to approve each statement, and strength of recommendation was assigned using the Strength of Recommendation Taxonomy criteria.
Results: The literature search produced 110 articles that met the criteria. A thorough screening of the studies for relevance to the research question resulted in 15 articles. These were distributed to all panelists for review prior to a roundtable discussion. The panel unanimously voted to adopt 5 consensus statements and recommendations, all of which were given a strength of "A".
Conclusion: Bimekizumab has a safety profile consistent with other biologics, except for a higher risk of oral candidiasis. Its hepatic safety profile is comparable with other currently FDA-approved biologics for plaque psoriasis. In addition, the data do not support an association of bimekizumab with suicide, and the incidence of inflammatory bowel disease is not greater than the incidence of other IL-17 blockers.

J Drugs Dermatol. 2024;23(8): doi:10.36849/JDD.8246

INTRODUCTION

Plaque psoriasis is a chronic, relapsing systemic illness that has a significant effect on quality of life.1-3 New biologic therapies targeting tumor necrosis factor (TNF), interleukin (IL)-12/23, IL-17, and IL-23 have demonstrated efficacy and safety for the treatment of plaque psoriasis.4 The IL-17 class of biologic therapies includes secukinumab and ixekizumab, which target IL-17A,5,6 and brodalumab, which targets IL-17RA.7 Bimekizumab, the first monoclonal IgG antibody to target both IL-17A and IL-17F, was recently approved by the Food and Drug Administration (FDA) for the treatment of plaque psoriasis.8 Clinical trial data as well as real-world studies have revealed bimekizumab’s rapid and long-lasting clinical efficacy for moderate to severe plaque psoriasis.9-15

The safety profile of bimekizumab has been extensively studied, demonstrating consistent adverse events to other biologics, apart from an increased incidence of oral candidiasis.16 Several important safety considerations for bimekizumab include its effects on the liver, rates of oral candidiasis, relationship with suicidal ideation and behavior (SIB), and rates of inflammatory bowel disease (IBD) (specifically Crohn's disease). As bimekizumab has been recently approved in the United States for plaque psoriasis and clinicians will begin prescribing it, a thorough evaluation of these safety considerations is vital. The purpose of this study was for a panel of experts in psoriasis to evaluate the current literature and provide consensus statements on the safety of bimekizumab.