Matthias Augustin, Alice B. Gottlieb, Mark Lebwohl, Andreas Pinter, Richard B. Warren, Luis Puig, Rhys Warham, Jérémy Lambert, Susanne Wiegratz, Balint Szilagyi, Andrew Blauvelt
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Estimated proportions of patients achieving P-SIM = 0 were also higher for PASI 100 (itching: 61.7%; scaling: 82.2%; skin pain: 96.9%) than for PASI = 95% (50.8%; 72.3%; 95.7%) and PASI = 90% (39.8%; 59.5%; 94.0%). 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引用次数: 0
摘要
导言随着生物制剂的更新换代，实现皮肤完全清除已成为斑块状银屑病患者可以达到的治疗目标。我们评估了银屑病面积和严重程度指数（PASI）反应的改善，尤其是在接近皮肤完全清除（PASI 100）时的递增改善，如何转化为健康相关生活质量（HRQoL）和患者感知症状的改善。方法 使用混合效应逻辑回归模型分析了 BE RADIANT 3b 期试验（NCT03536884）及其开放标签扩展试验（OLE）的数据，这些数据汇集了 16 周（随机患者）和 2 年（进入 OLE 的患者）的所有研究访问和治疗。估算了在特定 PASI 改善水平下，皮肤科生活质量指数 (DLQI) 达到 0/1、DLQI 项目得分达到 0，以及瘙痒、脱屑和皮肤疼痛方面的银屑病症状和影响测量 (P-SIM) 项目得分达到 0 的患者比例。使用 16 周的汇总数据，与 PASI 改善程度达到 95% (PASI = 95%) 和 90% (PASI = 90%) 的患者相比，我们的模型估计 PASI 100 达到 DLQI 0/1 的患者比例有所提高（分别为 93.0%、89.3% 和 83.8% 达到 DLQI 0/1）。达到 DLQI 项目 0 分的估计比例在项目 1（皮肤瘙痒、疼痛或刺痛）、项目 2（尴尬）和项目 4（衣服的选择）的 PASI 改善水平较高时增幅最大。PASI = 100（瘙痒：61.7%；脱屑：82.2%；皮肤疼痛：96.9%）患者达到 P-SIM = 0 的估计比例也高于 PASI = 95% （50.8%；72.3%；95.7%）和 PASI = 90% （39.8%；59.5%；94.0%）。结论皮肤完全清除可为患者的 HRQoL 和患者感知的症状带来最大益处，超过 90% 至 100% 之间的皮肤清除率，突出了将 PASI 100 作为银屑病患者治疗结果目标的重要性。
Complete Skin Clearance is Associated with the Greatest Benefits to Health-Related Quality of Life and Perceived Symptoms for Patients with Psoriasis
Introduction
With newer biologics, the achievement of complete skin clearance has become an attainable treatment goal for patients with plaque psoriasis. We evaluate how improvements in Psoriasis Area and Severity Index (PASI) responses, particularly at incremental improvements approaching complete skin clearance (PASI 100), translate into improvements in health-related quality of life (HRQoL) and patient-perceived symptoms.
Methods
Data from the BE RADIANT phase 3b trial (NCT03536884) and its open-label extension (OLE), pooled across all study visits and treatments over 16 weeks (randomised patients) and 2 years (patients entering the OLE), were analysed using mixed-effects logistic regression models. Proportions of patients achieving a Dermatology Life Quality Index (DLQI) of 0/1, DLQI item scores of 0, and Psoriasis Symptoms and Impacts Measure (P-SIM) item scores of 0 for itching, scaling, and skin pain at specific PASI improvement levels were estimated.
Results
Seven hundred and forty-three patients were randomised to treatment; 654 entered the OLE. Using 16-week pooled data, there were incremental improvements in the proportions of patients estimated by our model to achieve DLQI 0/1 with PASI 100 compared with 95% (PASI = 95%) and 90% (PASI = 90%) improvements in PASI (93.0%, 89.3%, and 83.8% achieving DLQI 0/1, respectively). Estimated proportions achieving DLQI item scores of 0 had the greatest increases at higher PASI improvement levels for Items 1 (itchy, sore, painful, or stinging skin), 2 (embarrassment), and 4 (choice of clothing). Estimated proportions of patients achieving P-SIM = 0 were also higher for PASI 100 (itching: 61.7%; scaling: 82.2%; skin pain: 96.9%) than for PASI = 95% (50.8%; 72.3%; 95.7%) and PASI = 90% (39.8%; 59.5%; 94.0%). Similar benefits of incremental PASI improvements were estimated using 2-year data.
Conclusions
Complete skin clearance translated into the greatest benefits to HRQoL and patient-perceived symptoms, over and above skin clearance between 90% and 100%, highlighting the importance of targeting PASI 100 as a treatment outcome for patients 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.
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