Progression of Quality of Life in Patients with Plaque Psoriasis Who Achieved Three or More Years of Complete Skin Clearance with Guselkumab Treatment: a Post hoc Analysis of the VOYAGE 1 Clinical Trial.

IF 3.5 3区 医学 Q1 DERMATOLOGY Dermatology and Therapy Pub Date : 2024-09-01 Epub Date: 2024-08-17 DOI:10.1007/s13555-024-01245-6
Luis Puig, Antonio Costanzo, Elke M G J de Jong, Tiago Torres, Richard B Warren, Robert Wapenaar, Sven Wegner, Patricia Gorecki, Talia Gramiccia, Maria Jazra, Jozefien Buyze, Curdin Conrad
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Abstract

Introduction: The interleukin-23p19 subunit inhibitor, guselkumab, has demonstrated improvements in clinical and patient-reported outcome (PRO) measures in patients with moderate-to-severe psoriasis. Understanding the relationship among clinical response, PRO measures and baseline characteristics could help clinicians individualize treatment plans. The objective of this analysis was to examine changes in signs, symptoms and quality-of-life (QoL) PRO measures in patients who maintained complete skin clearance through ≥ 3 years in the phase 3 VOYAGE 1 trial.

Methods: A descriptive post hoc analysis of data from VOYAGE 1 was conducted to compare baseline characteristics of patients who maintained complete skin clearance (Psoriasis Area and Severity Index [PASI] = 0 for ≥ 156 consecutive weeks) versus patients who did not. Mean scores for individual domains of the Dermatology Life Quality Index (DLQI) and Psoriasis Symptom and Sign Diary (PSSD) were evaluated in patients who maintained complete skin clearance, and baseline characteristics of patients who achieved PRO scores of DLQI = 0/1 and PSSD = 0 were compared with those who did not.

Results: Of the 329 patients included in this post hoc analysis, 73 (22.2%) maintained PASI = 0 for ≥ 156 weeks. This group had a numerically lower proportion of patients at baseline with obesity, depression or previous biologic treatment and a higher proportion who had never smoked. Patients who maintained PASI = 0 generally achieved positive DLQI and PSSD outcomes, though some impact of residual disease was observed, largely related to the DLQI "Symptoms and feelings" sub-scale and PSSD components "Dryness," "Redness" and "Itch." Patients reporting continued disease impact (despite sustaining PASI = 0) had greater disease severity at baseline versus those achieving DLQI = 0/1 and PSSD = 0.

Conclusion: Clinical measures alone do not capture the full patient experience. While both QoL and clinical symptoms are responsive to highly effective treatment, a subset of patients with complete clinical response is still impacted by their psoriasis. Further investigation into this population is warranted.

Trial registration: ClinicalTrials.gov, NCT02207231.

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斑块状银屑病患者接受古谢库单抗治疗三年或三年以上皮肤完全清除后生活质量的改善:VOYAGE 1 临床试验的事后分析。
简介:白细胞介素-23p19亚基抑制剂古舍库单抗(guselkumab)已证明可改善中重度银屑病患者的临床和患者报告结果(PRO)。了解临床反应、PRO指标和基线特征之间的关系有助于临床医生制定个体化治疗方案。本分析的目的是研究在VOYAGE 1三期试验中皮肤完全清除≥3年的患者的体征、症状和生活质量(QoL)PRO指标的变化:对 VOYAGE 1 的数据进行了描述性事后分析,比较了保持皮肤完全清除(银屑病面积和严重程度指数 [PASI] = 0,连续≥ 156 周)与未保持皮肤完全清除的患者的基线特征。对保持皮肤完全清除的患者的皮肤科生活质量指数(DLQI)和银屑病症状与体征日记(PSSD)各领域的平均得分进行评估,并对达到DLQI = 0/1和PSSD = 0的患者与未达到DLQI = 0/1和PSSD = 0的患者的基线特征进行比较:结果:在纳入本次事后分析的 329 名患者中,有 73 人(22.2%)的 PASI = 0 维持了 ≥ 156 周。这组患者基线时患有肥胖症、抑郁症或曾接受生物治疗的比例较低,从未吸烟的比例较高。维持 PASI = 0 的患者一般都能获得积极的 DLQI 和 PSSD 结果,但也观察到一些残余疾病的影响,主要与 DLQI 的 "症状和感觉 "子量表以及 PSSD 的 "干燥"、"发红 "和 "瘙痒 "组成部分有关。与达到 DLQI = 0/1 和 PSSD = 0 的患者相比,报告疾病持续影响(尽管 PASI = 0)的患者在基线时的疾病严重程度更高:结论:仅靠临床指标并不能反映患者的全部经历。虽然 QoL 和临床症状对高效治疗都有反应,但临床反应完全正常的部分患者仍受到银屑病的影响。有必要对这部分人群进行进一步调查:试验注册:ClinicalTrials.gov,NCT02207231。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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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