Ulrich Mrowietz, Rachel Sommer, Sascha Gerdes, Ziad Reguiai, Wolfgang Weger, Esteban Daudén, Julia-Tatjana Maul, Pierre-Dominique Ghislain, Philip M Laws, Luigi Naldi, Elke De Jong, Sicily Mburu, Volker Koscielny, Eric Massana, Arnau Domenech, Kristian Gaarn du Jardin, Ismail Kasujee, Matthias Augustin
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Effectiveness, quality of life (QoL), symptomatology, treatment satisfaction, and the impact of psoriasis on the patients' partners were also evaluated.</p><p><strong>Patients and methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":74589,"journal":{"name":"Psoriasis (Auckland, N.Z.)","volume":"15 ","pages":"243-259"},"PeriodicalIF":5.2000,"publicationDate":"2025-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12219165/pdf/","citationCount":"0","resultStr":"{\"title\":\"Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study.\",\"authors\":\"Ulrich Mrowietz, Rachel Sommer, Sascha Gerdes, Ziad Reguiai, Wolfgang Weger, Esteban Daudén, Julia-Tatjana Maul, Pierre-Dominique Ghislain, Philip M Laws, Luigi Naldi, Elke De Jong, Sicily Mburu, Volker Koscielny, Eric Massana, Arnau Domenech, Kristian Gaarn du Jardin, Ismail Kasujee, Matthias Augustin\",\"doi\":\"10.2147/PTT.S526748\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Psoriasis profoundly impairs patients' social, emotional, and physical condition, impacting on their overall well-being. 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We report 52-week (W52) interim data (N = 400; observed cases).</p><p><strong>Results: </strong>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). 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引用次数: 0
摘要
目的：牛皮癣严重损害患者的社会，情感和身体状况，影响他们的整体健康。Tildrakizumab是一种白介素-23p19抑制剂，用于治疗中度至重度斑块性银屑病。本研究的主要目的是评估tildrakizumab对牛皮癣患者整体健康状况的影响。对疗效、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进行评估。患者和方法：POSITIVE是一项为期24个月的观察性研究，在现实环境中接受tildrakizumab治疗的中度至重度牛皮癣成人患者（ClinicalTrials.gov ID: NCT04823247）。结果测量包括5项WHO幸福指数（WHO-5）、牛皮癣面积和严重程度指数（PASI）、皮肤病生活质量指数相关（DLQI-R）、药物治疗满意度问卷（TSQM-9）和FamilyPso。我们报告了52周（W52）的中期数据(N = 400；观察到的情况下)。结果：平均±95% CI WHO-5评分从基线时的53.8±2.2增加到W28/W52时的66.0±2.3/65.7±2.7 （p均< 0.0001）。平均±95% CI PASI从基线时的13.1±0.8降至W28/W52时的1.7±0.3/1.5±0.3 （p均< 0.0001）。在W28和W52时，85.8%/54.8%和88.4%/56.8%的患者达到PASI≤3/≤1。平均±95% CI DLQI-R评分从基线时的12.6±0.8降至W28/W52时的3.3±0.6/3.1±0.6 （p均< 0.0001）。在W52时，TSQM-9域的有效性评分为77.4±3.2，便利性评分为81.5±2.6，整体满意度评分为81.1±2.6。总FamilyPso的平均±95% CI从基线时的1.3±0.1降至W52时的0.7±0.2 （p < 0.0001）。在本分析时，24.0%的患者有≥1个不良事件（AE）。仅有1例患者因治疗相关AE而停药。结论：Tildrakizumab通过提高患者的幸福感、生活质量和临床结果，成功地为中重度牛皮癣患者提供了基于价值的长期医疗保健，同时显示出非常好的安全性和耐受性。
Patient-Reported Well-Being in Value-Based Routine Care Using Tildrakizumab: 52-week Interim Data of the Phase IV Positive Study.
Purpose: 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.
Patients and methods: 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).
Results: 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.
Conclusion: 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.
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