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替拉珠单抗对中度至重度银屑病患者生活质量的影响:一项为期36周的前瞻性单中心真实世界观察性研究。

Impact of tildrakizumab on the quality of life of patients with moderate-to-severe psoriasis: a 36-week prospective monocentric real-life observational study.

作者信息

Cacciapuoti Sara, Battista Teresa, Potestio Luca, Scalvenzi Massimiliano, Megna Matteo, Ruggiero Angelo

机构信息

Section of Dermatology - Department of Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy.

出版信息

Clin Exp Dermatol. 2025 Feb 24;50(3):544-550. doi: 10.1093/ced/llae433.

DOI:10.1093/ced/llae433
PMID:39400048
Abstract

BACKGROUND

Psoriasis may significantly affect the health-related quality of life (HRQoL) of patients. Clinical assessment has been combined with HRQoL scores to evaluate the ways in which cutaneous disease affects patients. Tildrakizumab is a humanized IgG1 monoclonal antibody that targets the p19 subunit of interleukin-23 and is approved for the management of moderate-to-severe plaque psoriasis.

OBJECTIVES

To evaluate the impact of tildrakizumab treatment on the psychological symptoms experienced by patients with moderate-to-severe plaque psoriasis.

METHODS

A 36-week observational study that enrolled patients with psoriasis who initiated treatment with tildrakizumab 100 mg was carried out. The Dermatology Life Quality Index (DLQI) and Skindex-16 questionnaires were administered at baseline and at weeks 12, 24 and 36. Psoriasis Area Severity Index (PASI), body surface area (BSA) involvement (%) and a visual analogue scale for pruritus (p-VAS) were also assessed at baseline and at each follow-up visit.

RESULTS

Thirty-four patients were enrolled. Baseline mean (SD) PASI score and BSA involvement were 28.4 (5.6) and 38.8 (21.4), respectively. The mean (SD) DLQI, Skindex-16 and p-VAS scores at baseline were 26.4 (3.2), 68 (5.8) and 8.2 (SD not available for p-VAS). Clinical improvement was assessed at weeks 12 [PASI: 12.4 (4.2); BSA involvement: 16.5 (7.3)], 24 [PASI: 4.2 (2.8); BSA involvement: 6.1 (3.1)] and 36 [PASI: 3.6 (3.2); BSA involvement: 4.2 (1.37)]. Clinical improvement was accompanied by an improvement in quality of life at weeks 16 [DLQI: 15.5 (2.9); Skindex-16: 28.2 (4.2); p-VAS: 3.8], 24 [DLQI: 8.2 (1.4); Skindex-16: 16.2 (3.6); p-VAS: 2.6] and 36 [DLQI: 3.1 (2.4); Skindex-16: 9.3 (2.8); p-VAS: 2.8]. Our study also confirmed the safety of tildrakizumab in real-life settings, with no treatment discontinuation due to inefficacy or adverse events.

CONCLUSIONS

Our results confirm tildrakizumab as an effective treatment option for improving the HRQoL of patients with psoriasis.

摘要

背景

银屑病可能会显著影响患者的健康相关生活质量(HRQoL)。临床评估已与HRQoL评分相结合,以评估皮肤疾病影响患者的方式。替拉珠单抗是一种靶向白细胞介素-23 p19亚基的人源化IgG1单克隆抗体,已被批准用于治疗中度至重度斑块状银屑病。

目的

评估替拉珠单抗治疗对中度至重度斑块状银屑病患者心理症状的影响。

方法

开展了一项为期36周的观察性研究,纳入开始使用100mg替拉珠单抗治疗的银屑病患者。在基线以及第12、24和36周时进行皮肤病生活质量指数(DLQI)和Skindex-16问卷调查。在基线和每次随访时还评估银屑病面积和严重程度指数(PASI)、体表面积(BSA)受累百分比以及瘙痒视觉模拟量表(p-VAS)。

结果

共纳入34例患者。基线时PASI评分和BSA受累的平均值(标准差)分别为28.4(5.6)和38.8(21.4)。基线时DLQI、Skindex-16和p-VAS评分的平均值(标准差)分别为26.4(3.2)、68(5.8)和8.2(p-VAS未提供标准差)。在第12周[PASI:12.4(4.2);BSA受累:16.5(7.3)]、第24周[PASI:4.2(2.8);BSA受累:6.1(3.1)]和第36周[PASI:3.6(3.2);BSA受累:4.2(1.37)]评估了临床改善情况。临床改善伴随着生活质量在第16周[DLQI:15.5(2.9);Skindex-16:28.2(4.2);p-VAS:3.8]、第24周[DLQI:8.2(1.4);Skindex-16:16.2(3.6);p-VAS:2.6]和第36周[DLQI:3.1(2.4);Skindex-16:9.3(2.8);p-VAS:2.8]的改善。我们的研究还证实了替拉珠单抗在实际临床环境中的安全性,没有因疗效不佳或不良事件而停药的情况。

结论

我们的结果证实替拉珠单抗是改善银屑病患者HRQoL的有效治疗选择。

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