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依奇珠单抗临床试验中按自我认定种族分组的银屑病结局:汇总分析。

Outcomes for Psoriasis by Self-Identified Racial Groups in Ixekizumab Clinical Trials: A Pooled Analysis.

出版信息

J Drugs Dermatol. 2024 Feb 1;23(2):17-22. doi: 10.36849/JDD.7672.

DOI:10.36849/JDD.7672
PMID:38306141
Abstract

BACKGROUND

Biologics have shown promising outcomes in psoriasis clinical trials. However, there is a paucity of data exploring the potential differences in outcomes between self-identified racial groups.

OBJECTIVE

To evaluate treatment response to ixekizumab in patients with psoriasis across different self-identified racial subgroups.

METHODS

This study analyzed pooled data from 5 clinical studies (UNCOVER-1, UNCOVER-2, UNCOVER-3, IXORA-R, and IXORA-S) with patients of different self-identified racial subgroups, who were treated with an on-label dose of ixekizumab for psoriasis through 12 weeks. Treatment response to ixekizumab was assessed using the Psoriasis Area and Severity Index (PASI) and static Physician’s Global Assessment response rates. Patient Global Assessment of Disease Severity, Itch Numeric Rating Scale, Skin Pain Visual Analog Scale, and Dermatology Life Quality Index were used to evaluate the patient-reported outcomes (PROs) and impact on quality of life (QoL).

RESULTS

A total of 1825 ixekizumab-treated patients from 5 pooled studies were included. Consistent with the clinical outcomes from the overall population, all self-identified racial groups showed rapid improvement in PASI through Week 12, although the response was somewhat slower in American Indian/Alaska Native patients. Differences in PROs and QoL assessments were observed among racial groups, especially in patients who identified as Black/African American and American Indian/Alaska Native.

CONCLUSION

Ixekizumab is effective through 12 weeks of treatment for psoriasis across different self-identified racial groups. Sample sizes for some racial groups were small (N≤12), therefore, further research is required to understand potential differences in psoriasis treatment with ixekizumab between various racial groups.J Drugs Dermatol. 2024;23(2):17-22.  doi:10.36849/JDD.7672.

摘要

背景

生物制剂在银屑病临床试验中显示出了良好的疗效。然而,关于不同自我认定的种族群体之间结局潜在差异的数据却很少。

目的

评估依奇珠单抗治疗银屑病患者在不同自我认定的种族亚组中的疗效。

方法

本研究分析了来自 5 项临床试验(UNCOVER-1、UNCOVER-2、UNCOVER-3、IXORA-R 和 IXORA-S)的汇总数据,这些研究纳入了接受依奇珠单抗治疗的不同自我认定的种族亚组患者,治疗方案为依奇珠单抗标签剂量,疗程为 12 周。采用银屑病面积和严重程度指数(PASI)和静态医师总体评估应答率评估依奇珠单抗的疗效。患者总体疾病严重程度评估、瘙痒数字评分量表、皮肤疼痛视觉模拟量表和皮肤病生活质量指数用于评估患者报告结局(PRO)和对生活质量(QoL)的影响。

结果

共有 5 项汇总研究的 1825 例依奇珠单抗治疗患者纳入分析。与总体人群的临床结局一致,所有自我认定的种族群体在第 12 周时 PASI 均迅速改善,尽管美国印第安人/阿拉斯加原住民患者的应答速度稍慢。在种族群体之间观察到 PROs 和 QoL 评估的差异,尤其是在自我认定为黑人/非裔美国人和美国印第安人/阿拉斯加原住民的患者中。

结论

依奇珠单抗治疗银屑病在不同自我认定的种族群体中治疗 12 周均有效。一些种族群体的样本量较小(N≤12),因此,需要进一步研究以了解不同种族群体之间依奇珠单抗治疗银屑病的潜在差异。

皮肤病药物杂志。2024;23(2):17-22.doi:10.36849/JDD.7672.

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