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依奇珠单抗对中重度斑块状银屑病患者报告结局和生活质量的影响:UNCOVER-1 和 -2 研究的 5 年结果。

Effect of Ixekizumab on Patient Reported Outcomes and Quality of Life in Patients With Moderate-to-Severe Plaque Psoriasis: 5-Year Results from the UNCOVER-1 and -2 Studies.

出版信息

J Drugs Dermatol. 2021 Apr 1;20(4):394-401. doi: 10.36849/JDD.2021.5821.

DOI:10.36849/JDD.2021.5821
PMID:33852247
Abstract

OBJECTIVE

We describe patient-reported outcomes and quality of life through 5 years of treatment in patients with moderate-to-severe plaque psoriasis in the UNCOVER-1 and -2 studies.

METHODS

This analysis included patients who were randomized to ixekizumab every 2 weeks then received ixekizumab every 4 weeks during the maintenance period, and who achieved static physician global assessment (0,1) at week 12, completed week 60, and entered the long-term extension period (weeks 60–264). Outcomes measures included responses in itch numeric rating scale (NRS), skin pain visual analog scale (VAS), and dermatology life quality index (DLQI) (0,1), and mean change from baseline in short form health survey (SF-36) mental (MCS) and physical component summaries (PCS), psoriasis skin appearance bothersomeness (PSAB), and work productivity activity impairment (WPAI).

RESULTS

At week 264 in UNCOVER-1 and -2, the observed itch NRS ≥4 responses were 82.4% and 93.1%, respectively, the itch NRS=0 responses were 51.7% and 58.5%, respectively, the skin pain VAS=0 responses were 59.3% and 63.1%, respectively, and the DLQI (0,1) responses were 75.0% and 88.1%, respectively. The observed mean changes from baseline at week 264 in UNCOVER-1 and UNCOVER-2 were 3.4 and 6.5, respectively, for SF-36 MCS, 4.4 and 4.8, respectively, for SF-36 PCS, and -21.3 and -22.0, respectively, for PSAB. WPAI psoriasis item scores improved from baseline in both UNCOVER-1 and -2.

CONCLUSION

Ixekizumab provided clinically meaningful and sustained improvements in itch, skin pain, DLQI, PSAB, SF-36 PCS, SF-36 MCS, and WPAI through 5 years of treatment in patients with moderate-to-severe plaque psoriasis. J Drugs Dermatol. 20(4):394-401. doi:10.36849/JDD.5821Visit the JDD Psoriasis Resource Center for more.

摘要

目的

在 UNCOVER-1 和 -2 研究中,我们描述了中重度斑块型银屑病患者接受治疗 5 年的患者报告结局和生活质量。

方法

本分析纳入了随机接受依奇珠单抗每 2 周治疗,随后在维持期每 4 周治疗的患者,并且在第 12 周达到静态医师整体评估(0,1),完成第 60 周,进入长期扩展期(第 60-264 周)。结局测量包括瘙痒数字评分量表(NRS)、皮肤疼痛视觉模拟量表(VAS)和皮肤病生活质量指数(DLQI)(0,1)的应答,以及简短健康调查(SF-36)精神(MCS)和身体成分综合(PCS)、银屑病皮肤外观烦恼(PSAB)和工作生产力活动障碍(WPAI)从基线的平均变化。

结果

在 UNCOVER-1 和 -2 的第 264 周,观察到的瘙痒 NRS ≥4 应答率分别为 82.4%和 93.1%,瘙痒 NRS=0 应答率分别为 51.7%和 58.5%,皮肤疼痛 VAS=0 应答率分别为 59.3%和 63.1%,DLQI(0,1)应答率分别为 75.0%和 88.1%。在 UNCOVER-1 和 UNCOVER-2 中,从基线的观察到的平均变化分别为第 264 周的 SF-36 MCS 的 3.4 和 6.5,SF-36 PCS 的 4.4 和 4.8,PSAB 的-21.3 和-22.0。在 UNCOVER-1 和 -2 中,WPAI 银屑病项目评分均从基线改善。

结论

依奇珠单抗在中重度斑块型银屑病患者中提供了 5 年治疗中瘙痒、皮肤疼痛、DLQI、PSAB、SF-36 PCS、SF-36 MCS 和 WPAI 的具有临床意义的持续改善。《皮肤病药物杂志》。20(4):394-401。doi:10.36849/JDD.5821访问 JDD 银屑病资源中心获取更多信息。

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