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一项关于替度鲁单抗治疗中重度银屑病患者的 4 期真实世界研究的生活质量和患者报告症状:第 28 周中期分析。

Quality of life and patient-reported symptoms in a Phase 4, real-world study of tildrakizumab in patients with moderate-to-severe psoriasis: Week 28 interim analysis.

机构信息

Therapeutics Clinical Research, San Diego, CA, USA.

West Michigan Dermatology, Grandville, MI, USA.

出版信息

J Dermatolog Treat. 2023 Dec;34(1):2200872. doi: 10.1080/09546634.2023.2200872.

Abstract

BACKGROUND

Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis. Little real-world evidence is available regarding the effects of tildrakizumab on patients' health-related quality of life (HRQoL) and patient-reported symptoms.

OBJECTIVE

This real-world study of tildrakizumab evaluated changes in HRQoL and clinical symptoms in patients with psoriasis.

MATERIALS AND METHODS

In this Week (W)28 interim analysis of a 64-week Phase 4 study (NCT03718299), patients received tildrakizumab 100 mg at W0, W4, and every 12 weeks thereafter. Endpoints were improvement from baseline in Psychological General Well-Being Index (PGWBI), Dermatology Life Quality Index (DLQI), and Itch-, Pain-, and Scaling-Numerical Rating Scale scores through W28.

RESULTS

Of 55 patients enrolled, 53 were assessed at W28. Mean (standard deviation [SD]) total PGWBI score improved from baseline to W28 (change, 3.7 [12.4]; = .033), as did the positive well-being (1.0 [2.9]; = .018) and general health (1.5 [2.2]; < .001) domain scores. Mean (SD) DLQI score improved by -3.9 (4.3) at W4 and by -7.6 (5.1) at W28 ( < .001). Patient-reported symptoms improved starting at W4 ( < .001).

CONCLUSION

Tildrakizumab treatment improved HRQoL and patient-reported symptoms in patients with psoriasis in a real-world setting. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT03718299.

摘要

背景

替西单抗是一种抗白细胞介素-23 p19 单克隆抗体,已被批准用于治疗中重度斑块型银屑病成人患者。目前关于替西单抗对患者健康相关生活质量(HRQoL)和患者报告症状的影响,实际证据有限。

目的

本项针对替西单抗的真实世界研究评估了银屑病患者 HRQoL 和临床症状的变化。

材料和方法

在这项为期 64 周的 4 期研究(NCT03718299)的第 28 周中期分析中,患者在第 0 周、第 4 周和此后每 12 周接受替西单抗 100mg 治疗。终点是通过第 28 周评估患者的心理一般健康指数(PGWBI)、皮肤病生活质量指数(DLQI)和瘙痒、疼痛和评分数字评定量表评分的改善情况。

结果

55 例入组患者中,53 例在第 28 周时进行了评估。PGWBI 总分从基线到第 28 周的平均(标准差)改善了 3.7(12.4)分( =.033),积极幸福感(1.0 [2.9]; =.018)和一般健康(1.5 [2.2]; <.001)领域的评分也有所改善。第 4 周和第 28 周时,DLQI 评分分别改善了-3.9(4.3)分和-7.6(5.1)分( <.001)。患者报告的症状自第 4 周开始改善( <.001)。

结论

在真实环境中,替西单抗治疗可改善银屑病患者的 HRQoL 和患者报告的症状。临床试验注册:https://clinicaltrials.gov/ct2/show/NCT03718299。

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