Bruce Strober, Wolf-Henning Boehncke, James G Krueger, Nina Magnolo, Ronald Vender, Richard B Warren, José Manuel López Pinto, Sarah Kavanagh, Bengt Hoepken, Paolo Gisondi
{"title":"比美珠单抗治疗银屑病的亚组疗效:3/3b期临床试验的事后分析","authors":"Bruce Strober, Wolf-Henning Boehncke, James G Krueger, Nina Magnolo, Ronald Vender, Richard B Warren, José Manuel López Pinto, Sarah Kavanagh, Bengt Hoepken, Paolo Gisondi","doi":"10.1007/s13555-025-01557-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Patient demographics, disease characteristics, and treatment history can impact the efficacy of biologic treatments in patients with psoriasis. Understanding the efficacy of biologics, such as bimekizumab, across diverse patient subgroups is important for optimising treatment outcomes. Here, we assess whether high overall clinical responses observed in bimekizumab-treated patients with moderate to severe plaque psoriasis are consistent across subgroups, both versus comparators and with long-term treatment.</p><p><strong>Methods: </strong>Data were analysed post hoc from the BE SURE, BE VIVID, and BE READY phase 3 trials, their open-label extension (OLE) BE BRIGHT, and the BE RADIANT phase 3b trial. Patients received either bimekizumab or adalimumab to week 24 (BE SURE), bimekizumab or ustekinumab to week 52 (BE VIVID), and bimekizumab or secukinumab to week 48 (BE RADIANT). In the 3-year pooled analysis (all trials), included patients received bimekizumab continuously from baseline into the OLE. Subgroups of patients with moderate to severe plaque psoriasis were defined by age, sex, weight, disease duration, disease severity, nail involvement (modified Nail Psoriasis Severity Index > 0), and prior biologic exposure, at baseline. The proportions of patients achieving complete skin clearance (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) in each subgroup are reported alongside 95% confidence intervals (CI). Modified non-responder imputation (mNRI) was used for missing data.</p><p><strong>Results: </strong>Following comparator-controlled periods, the proportion of bimekizumab-treated patients who achieved PASI 100 was consistent across subgroups and numerically greater versus patients who received adalimumab (to week 24), ustekinumab (to week 52), and secukinumab (to week 48) in all subgroups. Among patients who received bimekizumab continuously for 3 years (N = 1107), PASI 100 response rates remained consistent across age (68.6% [40 to < 65 years]-73.7% [≥ 65 years]), sex (69.6% [male]-71.4% [female]), weight (63.4% [≥ 103.9 kg]-75.5% [< 74.3 kg]), disease duration (65.5% [≤ 5 years]-71.1% [> 20 years]), disease severity (67.7% [PASI 12 to < 15]-71.1% [PASI ≥ 20]), nail involvement (69.1% [yes]/71.3% [no]), and prior biologic exposure (71.7% [yes]/69.1% [no]; prior anti-TNF exposure 67.6% [yes]/70.6% [no]) subgroups; 95% CIs overlapped in all instances, indicating no meaningful differences between subgroups.</p><p><strong>Conclusion: </strong>Bimekizumab demonstrated consistently high long-term efficacy in patients with psoriasis across diverse subgroups. Higher rates of PASI 100 were achieved with bimekizumab versus adalimumab, ustekinumab, and secukinumab, across all subgroups. These results highlight bimekizumab as an effective treatment for a broad range of people living with psoriasis.</p><p><strong>Trial registration: </strong>NCT03412747, NCT03370133, NCT03410992, NCT03598790, NCT03536884.</p>","PeriodicalId":11186,"journal":{"name":"Dermatology and Therapy","volume":" ","pages":""},"PeriodicalIF":4.2000,"publicationDate":"2025-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials.\",\"authors\":\"Bruce Strober, Wolf-Henning Boehncke, James G Krueger, Nina Magnolo, Ronald Vender, Richard B Warren, José Manuel López Pinto, Sarah Kavanagh, Bengt Hoepken, Paolo Gisondi\",\"doi\":\"10.1007/s13555-025-01557-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Patient demographics, disease characteristics, and treatment history can impact the efficacy of biologic treatments in patients with psoriasis. Understanding the efficacy of biologics, such as bimekizumab, across diverse patient subgroups is important for optimising treatment outcomes. Here, we assess whether high overall clinical responses observed in bimekizumab-treated patients with moderate to severe plaque psoriasis are consistent across subgroups, both versus comparators and with long-term treatment.</p><p><strong>Methods: </strong>Data were analysed post hoc from the BE SURE, BE VIVID, and BE READY phase 3 trials, their open-label extension (OLE) BE BRIGHT, and the BE RADIANT phase 3b trial. Patients received either bimekizumab or adalimumab to week 24 (BE SURE), bimekizumab or ustekinumab to week 52 (BE VIVID), and bimekizumab or secukinumab to week 48 (BE RADIANT). In the 3-year pooled analysis (all trials), included patients received bimekizumab continuously from baseline into the OLE. Subgroups of patients with moderate to severe plaque psoriasis were defined by age, sex, weight, disease duration, disease severity, nail involvement (modified Nail Psoriasis Severity Index > 0), and prior biologic exposure, at baseline. The proportions of patients achieving complete skin clearance (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) in each subgroup are reported alongside 95% confidence intervals (CI). Modified non-responder imputation (mNRI) was used for missing data.</p><p><strong>Results: </strong>Following comparator-controlled periods, the proportion of bimekizumab-treated patients who achieved PASI 100 was consistent across subgroups and numerically greater versus patients who received adalimumab (to week 24), ustekinumab (to week 52), and secukinumab (to week 48) in all subgroups. Among patients who received bimekizumab continuously for 3 years (N = 1107), PASI 100 response rates remained consistent across age (68.6% [40 to < 65 years]-73.7% [≥ 65 years]), sex (69.6% [male]-71.4% [female]), weight (63.4% [≥ 103.9 kg]-75.5% [< 74.3 kg]), disease duration (65.5% [≤ 5 years]-71.1% [> 20 years]), disease severity (67.7% [PASI 12 to < 15]-71.1% [PASI ≥ 20]), nail involvement (69.1% [yes]/71.3% [no]), and prior biologic exposure (71.7% [yes]/69.1% [no]; prior anti-TNF exposure 67.6% [yes]/70.6% [no]) subgroups; 95% CIs overlapped in all instances, indicating no meaningful differences between subgroups.</p><p><strong>Conclusion: </strong>Bimekizumab demonstrated consistently high long-term efficacy in patients with psoriasis across diverse subgroups. Higher rates of PASI 100 were achieved with bimekizumab versus adalimumab, ustekinumab, and secukinumab, across all subgroups. These results highlight bimekizumab as an effective treatment for a broad range of people living with psoriasis.</p><p><strong>Trial registration: </strong>NCT03412747, NCT03370133, NCT03410992, NCT03598790, NCT03536884.</p>\",\"PeriodicalId\":11186,\"journal\":{\"name\":\"Dermatology and Therapy\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.2000,\"publicationDate\":\"2025-10-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Dermatology and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s13555-025-01557-1\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"DERMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Dermatology and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s13555-025-01557-1","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"DERMATOLOGY","Score":null,"Total":0}
Bimekizumab Efficacy in Psoriasis by Subgroups: Post Hoc Analysis of Phase 3/3b Clinical Trials.
Introduction: Patient demographics, disease characteristics, and treatment history can impact the efficacy of biologic treatments in patients with psoriasis. Understanding the efficacy of biologics, such as bimekizumab, across diverse patient subgroups is important for optimising treatment outcomes. Here, we assess whether high overall clinical responses observed in bimekizumab-treated patients with moderate to severe plaque psoriasis are consistent across subgroups, both versus comparators and with long-term treatment.
Methods: Data were analysed post hoc from the BE SURE, BE VIVID, and BE READY phase 3 trials, their open-label extension (OLE) BE BRIGHT, and the BE RADIANT phase 3b trial. Patients received either bimekizumab or adalimumab to week 24 (BE SURE), bimekizumab or ustekinumab to week 52 (BE VIVID), and bimekizumab or secukinumab to week 48 (BE RADIANT). In the 3-year pooled analysis (all trials), included patients received bimekizumab continuously from baseline into the OLE. Subgroups of patients with moderate to severe plaque psoriasis were defined by age, sex, weight, disease duration, disease severity, nail involvement (modified Nail Psoriasis Severity Index > 0), and prior biologic exposure, at baseline. The proportions of patients achieving complete skin clearance (PASI 100; 100% improvement from baseline in Psoriasis Area and Severity Index) in each subgroup are reported alongside 95% confidence intervals (CI). Modified non-responder imputation (mNRI) was used for missing data.
Results: Following comparator-controlled periods, the proportion of bimekizumab-treated patients who achieved PASI 100 was consistent across subgroups and numerically greater versus patients who received adalimumab (to week 24), ustekinumab (to week 52), and secukinumab (to week 48) in all subgroups. Among patients who received bimekizumab continuously for 3 years (N = 1107), PASI 100 response rates remained consistent across age (68.6% [40 to < 65 years]-73.7% [≥ 65 years]), sex (69.6% [male]-71.4% [female]), weight (63.4% [≥ 103.9 kg]-75.5% [< 74.3 kg]), disease duration (65.5% [≤ 5 years]-71.1% [> 20 years]), disease severity (67.7% [PASI 12 to < 15]-71.1% [PASI ≥ 20]), nail involvement (69.1% [yes]/71.3% [no]), and prior biologic exposure (71.7% [yes]/69.1% [no]; prior anti-TNF exposure 67.6% [yes]/70.6% [no]) subgroups; 95% CIs overlapped in all instances, indicating no meaningful differences between subgroups.
Conclusion: Bimekizumab demonstrated consistently high long-term efficacy in patients with psoriasis across diverse subgroups. Higher rates of PASI 100 were achieved with bimekizumab versus adalimumab, ustekinumab, and secukinumab, across all subgroups. These results highlight bimekizumab as an effective treatment for a broad range of people living with psoriasis.
期刊介绍:
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.