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

被引:3
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
引用
收藏
页码:72 / 81
页数:10
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