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Mental health outcomes in patients with moderate to severe psoriasis treated with bimekizumab: Analysis of phase 2/3 randomized trials
被引:0
|作者:
Blauvelt, Andrew
[11
]
Armstrong, April
[1
]
Merola, Joseph F.
[2
]
Strober, Bruce
[3
,4
,5
]
de Cuyper, Dirk
[6
]
Peterson, Luke
[7
]
Davies, Owen
[8
]
Stark, Jeffrey L.
[9
]
Lebwohl, Mark
[10
]
机构:
[1] Oregon Med Res Ctr, Portland, OR USA
[2] Univ Calif Los Angeles UCLA, Los Angeles, CA USA
[3] UT Southwestern Med Ctr, Div Rheumatol, Dept Dermatol, Dallas, TX USA
[4] UT Southwestern Med Ctr, Dept Med, Div Rheumatol, Dallas, TX USA
[5] Yale Univ, Dept Dermatol, New Haven, CT USA
[6] Cent Connecticut Dermatol Res, Cromwell, CT USA
[7] UCB Pharm, Brussels, Belgium
[8] UCB Pharm, Morrisville, NC USA
[9] UCB Pharm, Slough, England
[10] UCB Pharm, Smyrna, GA USA
[11] Icahn Sch Med Mt Sinai, Dept Dermatol, New York, NY USA
关键词:
bimekizumab;
clinical trial;
depression;
eC-SSRS;
long-term;
mental health;
PHQ-9;
plaque;
SEVERE PLAQUE PSORIASIS;
DOUBLE-BLIND;
MULTICENTER;
BRODALUMAB;
DEPRESSION;
USTEKINUMAB;
SUICIDALITY;
EFFICACY;
VALIDITY;
ANXIETY;
D O I:
10.1016/j.jaad.2024.02.039
中图分类号:
R75 [皮肤病学与性病学];
学科分类号:
100206 ;
摘要:
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
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页码:72 / 81
页数:10
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