Gender Influence on Bimekizumab Response in Patients with Psoriasis: Results of a Real-World Multicenter Retrospective Study-IL PSO (Italian Landscape PSOriasis).

IF 3.5 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-13 DOI:10.1007/s13555-025-01435-w
Helena Gioacchini, Agnese Rossi, Maria Esposito, Emanuele Vagnozzi, Maria Concetta Fargnoli, Paolo Gisondi, Francesco Bellinato, Chiara Assorgi, Pina Brianti, Santo Raffaele Mercuri, Martina Burlando, Emanuele Cozzani, Giovanna Brunasso, Stefano Caccavale, Anna Balato, Giacomo Caldarola, Clara De Simone, Elena Campione, Alessandro Giunta, Francesco Tonon, Marina Venturini, Carlo Giovanni Carrera, Angelo Valerio Marzano, Andrea Carugno, Paolo Sena, Antonio Costanzo, Alessandra Narcisi, Francesco Cusano, Paolo Dapavo, Pietro Quaglino, Annunziata Dattola, Antonio Giovanni Richetta, Francesca Gaiani, Piergiorgio Malagoli, Matteo Megna, Luca Potestio, Edoardo Mortato, Francesco Loconsole, Francesca Romano, Andrea Faragalli, Rosaria Gesuita, Tommaso Bianchelli, Federico Diotallevi, Diego Orsini, Anna Campanati
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引用次数: 0

Abstract

Introduction: Several studies have demonstrated that psoriasis severity is generally greater in male patients, but it is unclear whether this gender difference may affect short-term therapeutic response. Notably, no studies have specifically investigated bimekizumab, a humanized, full-length IgG1 monoclonal antibody that acts as a dual inhibitor of interleukin (IL)-17A and IL-17F.

Methods: This was a cross-sectional, observational, retrospective, multicenter analysis. A cohort of 318 patients with moderate to severe psoriasis, 229 male patients (median [IQR] age 35 [23-67] years) and 89 female patients (median [IQR] age 33 [20-68] years), were retrospectively evaluated for short-term response (16 weeks) to bimekizumab according to standard dosage (320 mg at weeks 0, 4, 8, 12, and 16, and every 8 weeks thereafter). Patients were assessed to evaluate whether gender differences in demographic and clinical characteristics can affect treatment response to standard dose of bimekizumab, during the first 16 weeks of treatment. Therapeutic outcomes were evaluated by analyzing Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores recorded in each patient at three consecutive time points: baseline (T0), after 4 weeks (T4), and after 16 weeks of treatment (T16).

Results: Male patients showed more severe disease at baseline, compared to female patients (p = 0.01). A significant reduction in disease severity was observed in both male and female patients after 16 weeks of treatment, but male patients showed a faster decrease in PASI score between baseline and week 4 of treatment compared to female patients (p < 0.001). Nevertheless, by week 16, difference in PASI response and DLQI reduction between genders became less pronounced.

Conclusion: Although male patients exhibit greater disease severity at baseline compared to female patients, this does not result in a differential response to bimekizumab over the short term. Both male and female patients had equal probability of achieving complete or near-complete disease remission within the first 4 weeks of treatment, and both maintain this response status through week 16. The therapeutic benefit of bimekizumab may be due to the rapid dual inhibition of IL-17A and IL-17F, which may lead to consistent and robust clinical response across genders, regardless of baseline disease severity. Our results suggest a "gender severity-invariant effect" of bimekizumab, highlighting the treatment as rapidly effective in both genders, despite initial differences in disease severity.

性别对银屑病患者比美珠单抗反应的影响:一项真实世界多中心回顾性研究- il PSO(意大利景观银屑病)的结果。
几项研究表明,男性患者的银屑病严重程度通常更大,但尚不清楚这种性别差异是否会影响短期治疗反应。值得注意的是,没有研究专门研究bimekizumab,这是一种人源化的全长IgG1单克隆抗体,可作为白细胞介素(IL)-17A和IL- 17f的双重抑制剂。方法:采用横断面、观察性、回顾性、多中心分析。318例中重度银屑病患者,229例男性患者(中位[IQR]年龄35[23-67]岁)和89例女性患者(中位[IQR]年龄33[20-68]岁),根据标准剂量(在第0、4、8、12和16周320 mg,此后每8周)回顾性评估比美珠单抗的短期反应(16周)。对患者进行评估,以评估人口统计学和临床特征的性别差异是否会影响治疗前16周对标准剂量比美珠单抗的治疗反应。通过分析每位患者在基线(T0)、治疗后4周(T4)和治疗后16周(T16)三个连续时间点记录的银屑病面积和严重程度指数(PASI)和皮肤病生活质量指数(DLQI)评分来评估治疗结果。结果:与女性患者相比,男性患者在基线时病情更严重(p = 0.01)。治疗16周后,男性和女性患者均观察到疾病严重程度的显著降低,但与女性患者相比,男性患者在基线和治疗第4周之间的PASI评分下降速度更快(p结论:尽管男性患者在基线时比女性患者表现出更大的疾病严重程度,但这不会导致短期内对比美珠单抗的差异反应。男性和女性患者在治疗的前4周内达到完全或接近完全疾病缓解的概率相同,并且在第16周都保持这种缓解状态。比美珠单抗的治疗益处可能是由于IL-17A和IL-17F的快速双重抑制,这可能导致不分性别的一致和强大的临床反应,无论基线疾病严重程度如何。我们的研究结果表明,比美珠单抗具有“性别严重不变性效应”,尽管疾病严重程度最初存在差异,但该治疗在两性中均能迅速有效。
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来源期刊
Dermatology and Therapy
Dermatology and Therapy Medicine-Dermatology
CiteScore
6.00
自引率
8.80%
发文量
187
审稿时长
6 weeks
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.
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