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一项关于司库奇尤单抗在不同种族和族裔中重度银屑病患者群体中的疗效和安全性的描述性事后分析。

A Descriptive, Post Hoc Analysis of Efficacy and Safety of Risankizumab in Diverse Racial and Ethnic Patient Populations With Moderate-to-Severe Psoriasis.

作者信息

Alexis Andrew F, Gooderham Melinda, Kwatra Shawn G, Amin Ahmad, Taylor Susan, Espaillat Ramon, Rettig Trisha, Wu Tianshuang, Shi Linyu, Kaldas Mark I, Dilley Deanne M, Sinvhal Ranjeeta, Nduaka Chudy, Lockshin Benjamin

机构信息

Weill Cornell Medicine, 211 East 80 St, New York, NY, 10075, USA.

Queen's University, Kingston, ON, Canada.

出版信息

Dermatol Ther (Heidelb). 2024 Oct;14(10):2877-2887. doi: 10.1007/s13555-024-01268-z. Epub 2024 Oct 2.

Abstract

INTRODUCTION

Historically, patients with skin of color are underdiagnosed with psoriasis and underrepresented in clinical trials. In this study, we assess the efficacy and safety of risankizumab in patients with moderate-to-severe plaque psoriasis by race and ethnicity in the open label extension LIMMitless (NCT03047395).

METHODS

Patients received continuous treatment with 150 mg risankizumab through their initial trial and the open label extension. Patients self-identified their race and ethnicity. Efficacy was assessed using Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI). Safety is reported by events/100 patient-years.

RESULTS

A total of 897 patients (race: 662 White, 196 Asian, 25 Black or African American, 14 Other; ethnicity: 98 Hispanic or Latino, 799 non-Hispanic or Latino) were included in this analysis. Compared to baseline, patients had a mean percent reduction in PASI between 94.6% (Asian) and 99.3% (Black or African American) and reported mean percent improvements in DLQI ranging from 87.1% (Asian and Black or African American) to 93.7% (Hispanic or Latino) at week 100.

CONCLUSION

While the data presented here comprise a small retrospective descriptive analysis and cannot detect statistical differences, efficacy of risankizumab for the treatment of moderate-to-severe plaque psoriasis appears similar across the racial and ethnic groups studied and no new safety signals were detected.

摘要

引言

从历史上看,有色人种患者的银屑病诊断不足,并且在临床试验中的代表性不足。在本研究中,我们在开放标签扩展LIMMitless(NCT03047395)中,按种族和民族评估了司库奇尤单抗治疗中度至重度斑块状银屑病患者的疗效和安全性。

方法

患者在初始试验和开放标签扩展阶段接受150mg司库奇尤单抗的持续治疗。患者自行确定其种族和民族。使用银屑病面积和严重程度指数(PASI)和皮肤病生活质量指数(DLQI)评估疗效。安全性按事件/100患者年报告。

结果

本分析共纳入897例患者(种族:662例白人、196例亚洲人、25例黑人或非裔美国人、14例其他;民族:98例西班牙裔或拉丁裔、799例非西班牙裔或拉丁裔)。与基线相比,患者在第100周时PASI平均降低百分比在94.6%(亚洲人)至99.3%(黑人或非裔美国人)之间,DLQI平均改善百分比在87.1%(亚洲人和黑人或非裔美国人)至93.7%(西班牙裔或拉丁裔)之间。

结论

虽然此处提供的数据包括一项小型回顾性描述性分析,无法检测到统计学差异,但在研究的种族和民族群体中,司库奇尤单抗治疗中度至重度斑块状银屑病的疗效似乎相似,并且未检测到新的安全信号。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/26a9/11480268/39a83d387eb9/13555_2024_1268_Fig1_HTML.jpg

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