Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials

Mark Lebwohl; Joseph F Merola; Bruce Strober; April Armstrong; Ayumi Yoshizaki; Paolo Gisondi; Balint Szilagyi; Luke Peterson; Dirk de Cuyper; Nancy Cross; Owen Davies; Alice B Gottlieb

doi:10.1016/j.jaad.2024.03.041

Bimekizumab safety in moderate to severe plaque psoriasis: Rates of hepatic events and changes in liver parameters over 2 years in randomized phase 3/3b trials

J Am Acad Dermatol. 2024 Apr 6:S0190-9622(24)00568-1. doi: 10.1016/j.jaad.2024.03.041. Online ahead of print.

Authors

Affiliations

¹ Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: lebwohl@aol.com.
² Harvard Medical School, Brigham and Women's Hospital, Boston, Massachusetts.
³ Department of Dermatology, Yale University, New Haven, Connecticut; Central Connecticut Dermatology Research, Cromwell, Connecticut.
⁴ University of California Los Angeles (UCLA), Los Angeles, California.
⁵ Department of Dermatology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan; Department of Clinical Cannabinoid Research, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
⁶ Section of Dermatology and Venereology, Department of Medicine, University of Verona, Verona, Italy.
⁷ UCB Pharma, Monheim, Germany.
⁸ UCB Pharma, Morrisville, North Carolina.
⁹ UCB Pharma, Brussels, Belgium.
¹⁰ UCB Pharma, Slough, UK.
¹¹ Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.

PMID: 38588819
DOI: 10.1016/j.jaad.2024.03.041

Abstract

Background: Patients with psoriasis are at increased risk of liver function abnormalities.

Objective: Explore rates of hepatic treatment-emergent adverse events (TEAEs) and changes in liver parameters in bimekizumab-treated patients with psoriasis.

Methods: Data are reported from 5 phase 3/3b trials over 2 years. Hepatic TEAEs, laboratory elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST), and changes in clinical markers of liver fibrosis (Fibrosis-4 [FIB-4] Index and AST to Platelet Ratio Index [APRI]) are reported. TEAEs are presented using exposure-adjusted incidence rates (EAIRs) per 100 patient-years (PY).

Results: 2186 patients received ≥1 bimekizumab dose. Over 2 years, the EAIR of hepatic TEAEs was 3.5/100 PY and did not increase from first to second year. 2-year EAIRs of ALT/AST elevations >3x and >5x the upper limit of normal were 2.3 and 0.6/100 PY; rates were similar to placebo, adalimumab, secukinumab, and ustekinumab during controlled study periods. FIB-4 and APRI scores did not increase through 2 years, regardless of fibrosis risk at baseline.

Limitations: Obesity, diabetes, dyslipidemia, chronic alcohol consumption, and medication changes are confounding factors for hepatic dysfunction.

Conclusion: Rates of hepatic adverse events (AEs) with bimekizumab were consistent through 2 years; incidences of transaminase elevations were similar to comparators during phase 3/3b controlled study periods.

Keywords: alanine aminotransferase; aspartate aminotransferase; bimekizumab; enzyme; hepatic; liver; liver fibrosis; plaque psoriasis; psoriasis; safety; transaminase.