Mrowietz Ulrich, Sommer Rachel, Gerdes Sascha, Reguiai Ziad, Weger Wolfgang, Daudén Esteban, Maul Julia-Tatjana, Ghislain Pierre-Dominique, Laws Philip M, Naldi Luigi, De Jong Elke, Mburu Sicily, Koscielny Volker, Massana Eric, Domenech Arnau, Gaarn du Jardin Kristian, Kasujee Ismail, Augustin Matthias
Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.
Psoriasis (Auckl). 2025 Jun 28;15:243-259. doi: 10.2147/PTT.S526748. eCollection 2025.
Psoriasis profoundly impairs patients' social, emotional, and physical condition, impacting on their overall well-being. Tildrakizumab is an interleukin-23p19 inhibitor labelled for the treatment of moderate-to-severe plaque psoriasis. The main objective of this study was to assess the effect of tildrakizumab on the overall well-being of people with psoriasis. Effectiveness, quality of life (QoL), symptomatology, treatment satisfaction, and the impact of psoriasis on the patients' partners were also evaluated.
POSITIVE is a 24-month observational study in adults with moderate-to-severe psoriasis treated with tildrakizumab in a real-world setting (ClinicalTrials.gov ID: NCT04823247). Outcome measurements included the 5-item WHO Well-being Index (WHO-5), Psoriasis Area and Severity Index (PASI), Dermatology Life Quality Index-Relevant (DLQI-R), Treatment Satisfaction Questionnaire for Medication (TSQM-9), and FamilyPso. We report 52-week (W52) interim data (N = 400; observed cases).
Mean ± 95% CI WHO-5 score increased from 53.8 ± 2.2 at baseline to 66.0 ± 2.3/65.7 ± 2.7 at W28/W52 (p < 0.0001, both). Mean ± 95% CI PASI decreased from 13.1 ± 0.8 at baseline to 1.7 ± 0.3/1.5 ± 0.3 at W28/W52 (p < 0.0001, both). At W28 and W52, 85.8%/54.8% and 88.4%/56.8% of patients achieved PASI ≤ 3/≤ 1. Mean ± 95% CI DLQI-R score decreased from 12.6 ± 0.8 at baseline to 3.3 ± 0.6/3.1 ± 0.6 at W28/W52 (p < 0.0001, both). At W52, mean ± 95% CI TSQM-9 domain scores were 77.4 ± 3.2 for effectiveness, 81.5 ± 2.6 convenience, and 81.1 ± 2.6 global satisfaction. Mean ± 95% CI total FamilyPso decreased from 1.3 ± 0.1 at baseline to 0.7 ± 0.2 at W52 (p < 0.0001). At the point of this analysis, 24.0% of patients had ≥1 adverse event (AE). Only one patient discontinued due to a treatment-related AE.
Tildrakizumab successfully contributes to value-based long-term health care for moderate-to-severe psoriasis by increasing patient wellbeing, QoL and clinical outcomes while showing very good safety and tolerability.
银屑病严重损害患者的社会、情感和身体状况，影响其整体幸福感。替拉珠单抗是一种白细胞介素-23p19抑制剂，获批用于治疗中度至重度斑块状银屑病。本研究的主要目的是评估替拉珠单抗对银屑病患者整体幸福感的影响。还评估了有效性、生活质量（QoL）、症状、治疗满意度以及银屑病对患者伴侣的影响。
POSITIVE是一项针对在现实环境中接受替拉珠单抗治疗的中度至重度银屑病成人患者的为期24个月的观察性研究（ClinicalTrials.gov标识符：NCT04823247）。结局测量包括5项世界卫生组织幸福感指数（WHO-5）、银屑病面积和严重程度指数（PASI）、皮肤病生活质量指数相关指标（DLQI-R）、药物治疗满意度问卷（TSQM-9）和家庭银屑病影响量表（FamilyPso）。我们报告了52周（W52）的中期数据（N = 400；观察病例）。
WHO-5评分的均值±95%置信区间从基线时的53.8±2.2增加到W28/W52时的66.0±2.3/65.7±2.7（两者p < 0.0001）。PASI的均值±95%置信区间从基线时的13.1±0.8下降到W28/W52时的1.7±0.3/1.5±0.3（两者p < 0.0001）。在W28和W52时，分别有85.8%/54.8%和88.4%/56.8%的患者达到PASI≤3/≤1。DLQI-R评分的均值±95%置信区间从基线时的12.6±0.8下降到W28/W52时的3.3±0.6/3.1±0.6（两者p < 0.0001）。在W52时，TSQM-9各领域评分的均值±95%置信区间为有效性77.4±3.2、便利性81.5±2.6、总体满意度81.1±2.6。家庭银屑病影响量表总分的均值±95%置信区间从基线时的1.3±0.1下降到W52时的0.7±0.2（p < 0.0001）。在本次分析时，24.0%的患者发生≥1次不良事件（AE）。仅1例患者因与治疗相关的AE停药。
替拉珠单抗通过提高患者幸福感、生活质量和临床结局，同时显示出非常好的安全性和耐受性，成功地为中度至重度银屑病患者提供了基于价值的长期医疗保健。
