Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials

Andrew Blauvelt; April Armstrong; Joseph F Merola; Bruce Strober; Dirk de Cuyper; Luke Peterson; Owen Davies; Jeffrey L Stark; Mark Lebwohl

doi:10.1016/j.jaad.2024.02.039

Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials

J Am Acad Dermatol. 2024 Mar 4:S0190-9622(24)00438-9. doi: 10.1016/j.jaad.2024.02.039. Online ahead of print.

Authors

Andrew Blauvelt¹, April Armstrong², Joseph F Merola³, Bruce Strober⁴, Dirk de Cuyper⁵, Luke Peterson⁶, Owen Davies⁷, Jeffrey L Stark⁸, Mark Lebwohl⁹

Affiliations

¹ Oregon Medical Research Center, Portland, Oregon. Electronic address: blauveltconsults@gmail.com.
² University of California Los Angeles (UCLA), Los Angeles, California.
³ Division of Rheumatology, Departments of Dermatology and Medicine, Division of Rheumatology, Departments of Dermatology and Medicine, UT Southwestern Medical Center, Dallas, Texas.
⁴ Department of Dermatology, Yale University, New Haven, Connecticut; Central Connecticut Dermatology Research, Cromwell, Connecticut.
⁵ UCB Pharma, Brussels, Belgium.
⁶ UCB Pharma, Morrisville, North Carolina.
⁷ UCB Pharma, Slough, UK.
⁸ UCB Pharma, Smyrna, Georgia.
⁹ Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, New York.

PMID: 38447700
DOI: 10.1016/j.jaad.2024.02.039

Abstract

Background: Patients with psoriasis have increased risk of suicidal ideation and behavior (SIB) and depression. Bimekizumab, a biologic that inhibits interleukin (IL)-17A and IL-17F, received Food and Drug Administration approval in 2023 for moderate to severe plaque psoriasis, following 2021 European Medicines Agency approval.

Objective: To report SIB and depression in patients with moderate to severe psoriasis treated in bimekizumab clinical trials.

Methods: Mental health changes, including neuropsychiatric events, were actively monitored across 9 bimekizumab clinical trials in psoriasis phase 2/3 trials. The patient-reported electronic Columbia-Suicide Severity Rating Scale (measuring SIB) and Patient Health Questionnaire-9 (measuring depression) were administered, monitored by an independent Neuropsychiatric Adjudication Committee.

Results: Throughout 7166 patient-years (PY) of bimekizumab exposure, the adjudicated SIB rate was 0.13/100PY; SIB ranges for the general psoriasis population and patients receiving anti-IL-17A/anti-IL-23 therapies are 0.09 to 0.54/100PY and 0.09 to 0.19/100PY, respectively. At week 16, 92.9% vs 81.1% of bimekizumab- vs placebo-treated patients had no/minimal depression. Newonset positive electronic Columbia-Suicide Severity Rating Scale responses and mean Patient Health Questionnaire-9 scores were low for bimekizumab-treated patients.

Limitations: Patient exclusion for significant/severe prespecified SIB/depression history.

Conclusion: The long-term adjudicated SIB rate with bimekizumab was low and within ranges reported in the general psoriasis patient population and psoriasis patients treated with anti-IL-17A/anti-IL-23 biologics. Screening/monitoring questionnaires reported low SIB and depression levels.

Keywords: PHQ-9; bimekizumab; clinical trial; depression; eC-SSRS; long-term; mental health; plaque psoriasis; safety; suicidality; suicide.