Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials.
J Am Acad Dermatol
; 91(1): 72-81, 2024 Jul.
Article
en En
| MEDLINE
| ID: mdl-38447700
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.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Psoriasis
/
Índice de Severidad de la Enfermedad
/
Depresión
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Ideación Suicida
/
Anticuerpos Monoclonales Humanizados
Límite:
Adult
/
Female
/
Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2024
Tipo del documento:
Article