Lacour Jean-Philippe, Bewley Anthony, Hammond Edward, Hansen Jes B, Horne Laura, Paul Carle, Reich Kristian, Seneschal Julien, De Simone Clara, Sohrt Anne, Augustin Matthias, Pellacani Giovanni
Department of Dermatology, Archet 2 Hospital, University Hospital of Nice, Nice, France.
Department of Dermatology, Barts Health NHS Trust, London, UK.
Dermatol Ther (Heidelb). 2020 Oct;10(5):1099-1109. doi: 10.1007/s13555-020-00428-1. Epub 2020 Aug 6.
Clinical trials have shown that psoriasis patients who achieve complete skin clearance are more likely to report no impairment in health-related quality of life (HRQoL) and no psoriasis symptoms versus patients who achieve almost complete skin clearance. However, real-world data are lacking. The objective of this study was to estimate the real-world proportion of moderate-to-severe psoriasis patients on biologic treatment who achieved a Psoriasis Symptom Inventory (PSI) total score of 0 (PSI 0; no symptoms) and a Dermatology Life Quality Index (DLQI) score of 0/1 (DLQI 0/1; no impact on HRQoL), and to study the relationship between patient-reported symptoms and HRQoL versus physician-reported psoriasis severity (Psoriasis Area and Severity Index [PASI]).
The PSO-BIO-REAL study was a multinational, prospective, real-world, non-interventional study that included patients aged ≥ 18 years with moderate-to-severe plaque psoriasis who had initiated biologic therapy (either biologic-naïve or had switched biologics [biologic-experienced]). Psoriasis symptoms were evaluated using the PSI, and HRQoL was assessed using the DLQI. Assessments were conducted at baseline and at 6 and 12 months after initiating biologic treatment. Associations between PSI and DLQI with PASI were evaluated using Spearman correlation coefficients. Post-hoc analyses evaluated individual PSI items and the association to PASI response, DLQI and PSI by index biologic.
At 12 months, 25.5% of patients achieved PSI 0, and 51.2% achieved DLQI 0/1, with greater proportions achieving these scores among biologic-naïve than among biologic-experienced patients. There was a moderate-to-strong correlation between PSI and DLQI scores and PASI scores, with 64.8% of patients with absolute PASI 0 and 19.4% with absolute PASI > 0 ≤ 2 achieving PSI 0 (6 and 12 months pooled). Achievement of response varied by index biologic.
This study demonstrates that in a real-world setting patients' QoL improves with skin clearance. The results also demonstrate that the correlation between skin clearance and improvements in HRQoL (DLQI) and psoriasis symptoms (PSI) is not complete, which highlights the importance of considering both patient- and physician-reported outcomes in the assessment of psoriasis treatment outcomes.
临床试验表明，与几乎实现皮肤完全清除的银屑病患者相比，实现皮肤完全清除的银屑病患者更有可能报告其健康相关生活质量（HRQoL）未受损害且无银屑病症状。然而，缺乏真实世界的数据。本研究的目的是估计接受生物治疗的中度至重度银屑病患者在现实世界中达到银屑病症状量表（PSI）总分0（PSI 0；无症状）和皮肤病生活质量指数（DLQI）评分0/1（DLQI 0/1；对HRQoL无影响）的比例，并研究患者报告的症状与HRQoL之间以及与医生报告的银屑病严重程度（银屑病面积和严重程度指数[PASI]）之间的关系。
PSO-BIO-REAL研究是一项多国、前瞻性、现实世界、非干预性研究，纳入了年龄≥18岁、患有中度至重度斑块状银屑病且已开始生物治疗（初治生物制剂或已转换生物制剂[有生物制剂治疗经验]）的患者。使用PSI评估银屑病症状，使用DLQI评估HRQoL。在基线以及开始生物治疗后的6个月和12个月进行评估。使用Spearman相关系数评估PSI和DLQI与PASI之间的关联。事后分析评估了各个PSI项目以及按索引生物制剂划分的与PASI反应、DLQI和PSI的关联。
在12个月时，25.5%的患者达到PSI 0，51.2%的患者达到DLQI 0/1，初治生物制剂的患者中达到这些分数的比例高于有生物制剂治疗经验的患者。PSI和DLQI评分与PASI评分之间存在中度至强相关性，在绝对PASI为0的患者中，64.8%在6个月和12个月合并时达到PSI 0，在绝对PASI>0≤2的患者中，19.4%达到PSI 0。达到反应的情况因索引生物制剂而异。
本研究表明，在现实世界中，患者的生活质量随着皮肤清除而改善。结果还表明，皮肤清除与HRQoL（DLQI）改善和银屑病症状（PSI）改善之间的相关性并不完全，这突出了在评估银屑病治疗结果时同时考虑患者报告和医生报告结果的重要性。
