Patient-Reported Outcomes by Baseline Body Surface Area Involvement Among Individuals Initiating Biologic Therapy: Results from the CorEvitas Psoriasis Registry.

IF 4.2 3区 医学 Q1 DERMATOLOGY
Dermatology and Therapy Pub Date : 2025-08-01 Epub Date: 2025-06-11 DOI:10.1007/s13555-025-01456-5
April W Armstrong, Steven R Feldman, Timothy Fitzgerald, Theodore Alkousakis, Adam Sima, Alvin Li, Hyung-Joo Kang, Sandra I Main, Saakshi Khattri, Linda Stein Gold
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引用次数: 0

Abstract

Introduction: Psoriasis body surface area (BSA) of 10% or more has been a major criterion for determining systemic therapy eligibility. However, patients with BSA < 10% and even ≤ 3% may have high disease burden and difficulties accessing biologics. To assess psoriasis burden among patients with BSA ≤ 10%, this study characterized patient-reported outcomes (PROs) across BSA categories among systemic treatment-naïve patients initiating biologic therapy.

Methods: Patients from the CorEvitas Psoriasis Registry initiating biologics between April 2015 and September 2023 were categorized according to low (< 3%), medium (3-10%), or high (> 10%) BSA involvement. Measures assessed at initiation of biologic therapy included health-related quality of life, itch, pain, fatigue, psoriatic arthritis, psoriasis disease characteristics, and medical history. Overlap between BSA groups for each outcome was calculated via non-parametric Mann-Whitney statistic transformation (range 0.0-1.0; 0.5 indicates complete similarity [i.e., for a comparison between low and high BSA groups, overlap of 0.5 means there is 50% probability that a randomly selected patient with low BSA would have the same or greater PRO burden as one with high BSA]; 0 or 1 indicates complete dissimilarity) to determine whether each measure differed in randomly selected patients with low or medium versus high BSA.

Results: Of 1640 patients who initiated biologics, 7.0% had low BSA, 46.9% had medium BSA, and 46.2% had high BSA involvement. PRO overlap statistics ranged from 0.52 to 0.59 and from 0.60 to 0.70 for randomly selected patients with high versus medium and low BSA, respectively, indicating patients with high and medium BSA are likely to have similar levels of disease burden, and patients with high BSA are slightly more likely to have higher disease burden than those with low BSA. Near complete overlap (range 0.44-0.58) was observed for psoriasis disease characteristics and medical history in the low versus high and medium BSA groups.

Conclusion: Observed overlap in PROs across BSA categories shows that patients with low BSA can experience similarly poor quality of life and high symptom burden to those with higher BSA. These findings support the appropriateness of considering biologic therapies for patients with low BSA and indicators of high disease burden.

Trial registration: ClinicalTrials.gov: NCT02707341.

在开始生物治疗的个体中,患者报告的基线体表面积累及的结果:来自CorEvitas牛皮癣登记处的结果。
牛皮癣体表面积(BSA)≥10%已成为确定全身治疗资格的主要标准。方法:2015年4月至2023年9月期间,CorEvitas银屑病登记处(CorEvitas Psoriasis Registry)启动生物制剂的患者根据低(10%)BSA受病灶进行分类。生物治疗开始时评估的措施包括与健康相关的生活质量、瘙痒、疼痛、疲劳、银屑病关节炎、银屑病疾病特征和病史。通过非参数Mann-Whitney统计转换计算每个结果的BSA组之间的重叠(范围为0.0-1.0;0.5表示完全相似[即,对于低BSA组和高BSA组的比较,0.5的重叠表示随机选择的低BSA患者与高BSA患者具有相同或更高PRO负担的概率为50%];0或1表示完全不相似),以确定随机选择的低、中、高BSA患者的每项测量是否不同。结果:在1640例开始使用生物制剂的患者中,7.0%为低BSA, 46.9%为中等BSA, 46.2%为高BSA累及。随机选择高、中、低BSA患者的PRO重叠统计值分别为0.52 ~ 0.59和0.60 ~ 0.70,表明高、中BSA患者可能具有相似的疾病负担水平,高BSA患者比低BSA患者具有更高疾病负担的可能性略高。在低BSA组与高BSA组和中等BSA组中,牛皮癣疾病特征和病史几乎完全重叠(范围0.44-0.58)。结论:观察到不同BSA类别的PROs重叠,表明低BSA患者与高BSA患者同样会经历生活质量差和高症状负担。这些发现支持对低BSA和高疾病负担指标患者考虑生物治疗的适宜性。试验注册:ClinicalTrials.gov: NCT02707341。
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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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