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
来源：
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY | 2024年 / 91卷 / 01期
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
相关论文
共 50 条
  • [31] Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis Reply
    Gordon, Kenneth B.
    Colombel, Jean-Frederic
    Hardin, Dana S.
    NEW ENGLAND JOURNAL OF MEDICINE, 2016, 375 (21): : 2102 - 2102
  • [32] BIMEKIZUMAB EFFICACY IN HIGH-IMPACT AREAS FOR PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS: POOLED RESULTS THROUGH TWO YEARS FROM THE BE SURE AND BE RADIANT PHASE 3 TRIALS
    Merola, J. F.
    Gottlieb, A. B.
    Morita, A.
    Carrascosa, J. M.
    Elewski, B.
    Tilt, N.
    Wiegratz, S.
    Wixted, K.
    Mrowietz, U.
    ANNALS OF THE RHEUMATIC DISEASES, 2023, 82 : 1766 - 1767
  • [33] Bimekizumab short-term and longer-term anxiety, depression, and suicidal ideation/behavior in patients with moderate to severe plaque psoriasis: Analysis of pooled data from eight phase 2/3 clinical trials
    Strober, Bruce
    Papp, Kim A.
    Blauvelt, Andrew
    Lebwohl, Mark
    Wu, Jashin J.
    Deherder, Delphine
    Madden, Cynthia
    Wixted, Krista
    Wang, Maggie
    Augustin, Matthias
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2021, 85 (03) : AB149 - AB149
  • [34] Impact of Adalimumab on Symptoms of Psoriatic Arthritis in Patients with Moderate to Severe Psoriasis: A Pooled Analysis of Randomized Clinical Trials
    Mease, Philip J.
    Signorovitch, James
    Yu, Andrew P.
    Wu, Eric Q.
    Gupta, Shiraz R.
    Bao, Yanjun
    Mulani, Parvez M.
    DERMATOLOGY, 2010, 220 (01) : 1 - 7
  • [35] Secukinumab is Efficacious and Safe in Hispanic Patients with Moderate-to-Severe Plaque Psoriasis: Pooled Analysis of Four Phase 3 Trials
    Sandra Adsit
    Enrique Rivas Zaldivar
    Howard Sofen
    Ignacio Dei-Cas
    César Maldonado-García
    Elkin O. Peñaranda
    Luís Puig
    Xiangyi Meng
    Todd Fox
    Adriana Guana
    Advances in Therapy, 2017, 34 : 1327 - 1339
  • [36] Secukinumab is Efficacious and Safe in Hispanic Patients with Moderate-to-Severe Plaque Psoriasis: Pooled Analysis of Four Phase 3 Trials
    Adsit, Sandra
    Rivas Zaldivar, Enrique
    Sofen, Howard
    Dei-Cas, Ignacio
    Maldonado-Garcia, Cesar
    Penaranda, Elkin O.
    Puig, Luis
    Meng, Xiangyi
    Fox, Todd
    Guana, Adriana
    ADVANCES IN THERAPY, 2017, 34 (06) : 1327 - 1339
  • [37] Correction to: Deucravacitinib Improves Patient-Reported Outcomes in Patients with Moderate to Severe Psoriasis: Results from the Phase 3 Randomized POETYK PSO-1 and PSO-2 Trials
    April W. Armstrong
    Matthias Augustin
    Jennifer L. Beaumont
    Tan P. Pham
    Stacie Hudgens
    Kenneth B. Gordon
    Joe Zhuo
    Brandon Becker
    Yichen Zhong
    Renata M. Kisa
    Subhashis Banerjee
    Kim A. Papp
    Dermatology and Therapy, 2025, 15 (4) : 1037 - 1044
  • [38] Impact of efalizumab on patient-reported outcomes in patients with moderate to severe plaque psoriasis: Pooled results from three randomized phase III trials
    Menter, A
    Hamilton, T
    Caro, I
    Chen-Rundle, A
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2004, 50 (03) : P156 - P156
  • [39] Effect of adalimumab treatment on metabolic parameters over 3 years: Integrated analysis from phase 2/3 clinical trials in patients with moderate to severe psoriasis
    Prussick, Ronald
    Maa, Jen-Fue
    Servin, Ofelia Reyes
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2017, 76 (06) : AB108 - AB108
  • [40] Psoriasis Symptoms and Impacts Measure (P-SIM) responses from the BE SURE bimekizumab in moderate to severe plaque psoriasis phase 3 trial
    Warren, Richard B.
    Augustin, Matthias
    Gottlieb, Alice B.
    Duffin, Kristina Callis
    Ciaravino, Valerie
    Cioffi, Christopher
    Peterson, Luke
    Blauvelt, Andrew
    JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY, 2021, 85 (03) : AB138 - AB138
12345