在真实世界环境中对中重度斑块状银屑病患者进行的替雷珠单抗 4 期研究的长期生活质量结果。

Neal Bhatia, Jayme Heim, J Gabriel Vasquez, Tina Bhutani, Brad Schenkel, Ranga Gogineni, John Koo
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引用次数: 0

摘要

背景介绍替雷珠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状银屑病。本报告介绍了一项为期64周的真实世界研究的最终主要结果,该研究探讨了替雷珠单抗对患者健康相关生活质量(HRQoL)的影响:在这项开放标签 4 期研究(NCT03718299)中,中重度斑块状银屑病患者在第 0 周、第 4 周接受了 100 毫克替雷珠单抗治疗,此后每 12 周接受一次治疗,直至第 52 周。主要终点是在第28周和第52周时通过心理综合幸福指数(PGWBI)总分衡量的HRQoL较基线的改善情况。次要HRQoL终点包括第64周皮肤科生活质量指数(DLQI)得分与基线相比的变化。缺失数据不予归类:结果:在 55 名入选患者中,有 45 人在第 64 周接受了评估。PGWBI总分的平均值±标准差(SD)从基线时的(78.1±14.1)分提高到第52周时的(85.2±12.0)分(p p 结论:Tildrakizumab改善了患者的生活质量:在真实世界中,替雷珠单抗改善了银屑病患者的长期 HRQoL。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Long-term quality of life outcomes from a phase 4 study of tildrakizumab in patients with moderate-to-severe plaque psoriasis in a real-world setting.

Background: Tildrakizumab is an anti-interleukin-23 p19 monoclonal antibody approved for the treatment of moderate-to-severe plaque psoriasis. This report describes final primary results of a 64-week real-world study of the effect of tildrakizumab on patients' health-related quality of life (HRQoL).

Materials and methods: In this open-label phase 4 study (NCT03718299), patients with moderate-to-severe plaque psoriasis received tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter through week 52. The primary endpoint was improvement from baseline in HRQoL measured by Psychological General Well-Being Index (PGWBI) total score at weeks 28 and 52. Secondary HRQoL endpoints included change from baseline in Dermatology Life Quality Index (DLQI) score through week 64. Missing data were not imputed.

Results: Of 55 patients enrolled, 45 were assessed at week 64. Mean ± standard deviation (SD) total PGWBI score improved from 78.1 ± 14.1 at baseline to 85.2 ± 12.0 at week 52 (p < .001). Mean ± SD DLQI score improved from 9.4 ± 5.2 at baseline to 2.0 ± 2.6 (p < .001) at week 64 with 62.2% of patients having a DLQI score of 0 or 1 at week 64.

Conclusions: Tildrakizumab improved long-term HRQoL in patients with psoriasis in a real-world setting.

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