Guselkumab在银屑病中的保留、有效性和安全性:一项为期260周的真实世界多中心回顾性研究,探索伴有PsA-IL PSO(意大利景观银屑病)的作用。

IF 4.2 3区 医学 Q1 DERMATOLOGY
Mario Valenti, Luciano Ibba, Sara Di Giulio, Paolo Dapavo, Piergiorgio Malagoli, Angelo V Marzano, Francesco Loconsole, Martina Burlando, Anna Balato, Valentina Dini, Matteo Megna, Giampiero Girolomoni, Emanuele Trovato, Claudia Lasagni, Massimo Travaglini, Claudio Guarneri, Nicola Zerbinati, Simone Ribero, Francesca M Gaiani, Carlo G Carrera, Emanuele C Cozzani, Eugenia V Di Brizzi, Alessandra Michelucci, Luca Potestio, Martina Maurelli, Martina Dragotto, Luca Mastorino, Eleonora Bongiovanni, Francesco Messina, Andrea Sechi, Rossana Moroni, Antonio Costanzo, Alessandra Narcisi
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引用次数: 0

摘要

Guselkumab是一种靶向白介素(IL)-23的p19亚基的单克隆抗体,已被批准用于治疗中重度斑块性银屑病和银屑病关节炎(PsA)。虽然银屑病患者通常获得较高的临床缓解率(银屑病面积和严重程度指数[PASI] 90和PASI 100),但PsA的存在可能会影响长期预后。我们进行了一项为期260周的多中心回顾性研究,比较了guselkumab在伴有和不伴有PsA的患者中的有效性、安全性和药物生存期。方法:共纳入1765例患者,其中352例合并PsA诊断,1413例孤立性皮肤受累。所有患者均按照批准的治疗中度至重度斑块性银屑病的给药方案接受guselkumab治疗至少1年。在第16、28、52、104、156、204和260周时,根据PASI 90、PASI 100和绝对PASI≤2来评估治疗效果。使用Kaplan-Meier法在同一时间点评估Guselkumab药物生存期。通过分析每次随访时病历中记录的不良事件来评估安全性。结果:在整个研究期间,两组患者的缓解率保持可比性,在2年的随访中,PASI 90有显著差异(80.51%对74.02%)。总体而言,药物生存期保持稳定和相似,无PsA患者的79.5%(95%置信区间(CI) 76.9-81.9)和PsA患者的78.5% (95% CI 72.9-83.1)在5年后仍接受guselkumab治疗。结论:我们的研究结果证实了guselkumab在中重度牛皮癣患者中的长期有效性、持久性和良好的安全性,无论是否伴有PsA。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Guselkumab Retention, Effectiveness, and Safety in Psoriasis: A 260-Week Real-World Multicenter Retrospective Study Exploring the Role of Concomitant PsA-IL PSO (Italian Landscape Psoriasis).

Introduction: Guselkumab is a monoclonal antibody targeting the p19 subunit of interleukin (IL)-23, approved for the treatment of moderate-to-severe plaque psoriasis and psoriatic arthritis (PsA). While patients with psoriasis often achieve high clinical response rates (Psoriasis Area and Severity Index [PASI] 90 and PASI 100), the presence of PsA may influence long-term outcomes. We conducted a 260-week, multicenter, retrospective study to compare the effectiveness, safety, and drug survival of guselkumab in patients with and without concomitant PsA.

Methods: A total of 1765 patients were enrolled, including 352 with a concomitant diagnosis of PsA and 1413 with isolated skin involvement. All patients were treated with guselkumab following the approved dosing schedule for moderate-to-severe plaque psoriasis for at least 1 year. Treatment effectiveness was evaluated in terms of PASI 90, PASI 100, and absolute PASI ≤ 2 at weeks 16, 28, 52, 104, 156, 204, and 260. Guselkumab drug survival was assessed using the Kaplan-Meier method at the same time points. The safety profile was evaluated by analyzing adverse events recorded in medical charts at each follow-up visit.

Results: Throughout the study period, response rates remained comparable between the two cohorts of patients, with a significant difference at 2 years of follow-up in terms of PASI 90 (80.51% versus 74.02%). Drug survival overall remained stable and similar, with 79.5% (95% confidence interval (CI) 76.9-81.9) of patients without PsA and 78.5% (95% CI 72.9-83.1) of patients with PsA still receiving guselkumab treatment after 5 years.

Conclusions: Our results confirm the long-term effectiveness, persistence, and favorable safety profile of guselkumab in patients with moderate-to-severe psoriasis, regardless of the presence of concomitant PsA.

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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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