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布那西单抗治疗后实现完全与接近完全皮肤清除的患者的患者报告结局比较:一项III期试验的事后分析

Comparison of patient-reported outcomes in patients achieving complete versus near-complete skin clearance following Vunakizumab treatment: a post-hoc analysis of a phase III trial.

作者信息

Wang Shuang, Li Fuqiu

机构信息

Department of Dermatology, The Second Hospital of Jilin University, No. 218 Ziqiang Street, Nanguan District, Changchun, 130041, Jilin, China.

出版信息

Naunyn Schmiedebergs Arch Pharmacol. 2025 Aug 25. doi: 10.1007/s00210-025-04490-4.

Abstract

OBJECTIVE

This post-hoc analysis used the data from a previous randomized controlled trial (NCT04839016) and aimed to compare patient-reported outcomes (PROs) between patients who achieved complete (PASI 100; N = 178) and near-complete (PASI 90-99; N = 181) skin clearance during 12 weeks of Vunakizumab treatment.

METHODS

PROs included the Dermatology Life Quality Index (DLQI) score, DLQI 0/1 response rate, Itch Numerical Rating Scale (NRS) score, and Short Form-36 (SF-36) Mental Component Score (MCS) and Physical Component Score (PCS).

RESULTS

The proportion of patients who achieved a DLQI of 0/1 at week (W)8 (P < 0.010), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.050), W36 (P < 0.010), and W52 (P < 0.050) was higher in the PASI 100 group compared to the PASI 90-99 group. The mean DLQI score at W4 (P < 0.010), W8 (P < 0.010), W12 (P < 0.001), W20 (P < 0.001), W28 (P < 0.001), W36 (P < 0.001), W44 (P < 0.001), and W52 (P < 0.001), as well as itch NRS score at W8 (P < 0.001), W12 (P < 0.010), W20 (P < 0.001), W28 (P < 0.010), W36 (P < 0.001), W44 (P < 0.010), and W52 (P < 0.010) were lower in the PASI 100 group than in the PASI 90-99 group. The mean SF-36 MCS at W4 (P < 0.050), W12 (P < 0.001), W20 (P < 0.010), W28 (P < 0.001), W36 (P < 0.050), W44 (P < 0.010), and W52 (P < 0.050), as well as SF-36 PCS at W8 (P < 0.050) and W36 (P < 0.050) were higher in the PASI 100 group than in the PASI 90-99 group.

CONCLUSION

Patients with complete skin clearance following Vunakizumab treatment showed improved quality of life, reduced pruritus, and enhanced mental health compared to those with near-complete skin clearance.

摘要

目的

这项事后分析使用了之前一项随机对照试验(NCT04839016)的数据,旨在比较在接受12周的武纳奇单抗治疗后实现完全(PASI 100;N = 178)和接近完全(PASI 90 - 99;N = 181)皮肤清除的患者之间的患者报告结局(PROs)。

方法

PROs包括皮肤病生活质量指数(DLQI)评分、DLQI 0/1缓解率、瘙痒数字评定量表(NRS)评分以及简明健康状况调查量表(SF - 36)的心理成分评分(MCS)和身体成分评分(PCS)。

结果

与PASI 90 - 99组相比,PASI 100组在第8周(W8)(P < 0.010)、第12周(W12)(P < 0.010)、第20周(W20)(P < 0.001)、第28周(W28)(P < 0.050)、第36周(W36)(P < 0.010)和第52周(W52)(P < 0.050)达到DLQI 0/1的患者比例更高。PASI 100组在第4周(W4)(P < 0.010)、第8周(W8)(P < 0.010)、第12周(W12)(P < 0.001)、第20周(W20)(P < 0.001)、第28周(W28)(P < 0.001)、第36周(W36)(P < 0.001)、第44周(W44)(P < 0.001)和第52周(W52)(P < 0.001)的平均DLQI评分,以及在第8周(W8)(P < 0.001)、第12周(W12)(P < 0.010)、第20周(W20)(P < 0.001)、第28周(W28)(P < 0.010)、第36周(W36)(P < 0.001)、第44周(W44)(P < 0.010)和第52周(W52)(P < 0.010)的瘙痒NRS评分均低于PASI 90 - 99组。PASI 100组在第4周(W4)(P < 0.050)、第12周(W12)(P < 0.001)、第20周(W20)(P < 0.010)、第28周(W28)(P < 0.001)、第36周(W36)(P < 0.050)、第44周(W44)(P < 0.010)和第52周(W52)(P < 0.050)的平均SF - 36 MCS,以及在第8周(W8)(P < 0.050)和第36周(W36)(P < 0.050)的SF - 36 PCS均高于PASI 90 - 99组。

结论

与接近完全皮肤清除的患者相比,接受武纳奇单抗治疗后实现完全皮肤清除的患者生活质量得到改善,瘙痒减轻,心理健康增强。

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