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古塞库单抗与司库奇尤单抗治疗中重度斑块型银屑病亚组患者的疗效:来自 ECLIPSE 研究的结果。

Efficacy of guselkumab versus secukinumab in subpopulations of patients with moderate-to-severe plaque psoriasis: results from the ECLIPSE study.

机构信息

Oregon Medical Research Center, Portland, OR, USA.

Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

出版信息

J Dermatolog Treat. 2022 Jun;33(4):2317-2324. doi: 10.1080/09546634.2021.1959504. Epub 2021 Aug 4.

Abstract

PURPOSE

Guselkumab, an interleukin (IL)-23 inhibitor, effectively treats moderate-to-severe plaque psoriasis.

MATERIALS AND METHODS

ECLIPSE, was a Phase 3, multicenter, 56-week, double-blinded, active-comparator study of guselkumab vs. secukinumab (IL-17A inhibitor) in patients with moderate-to-severe psoriasis. Patients were treated with guselkumab 100 mg ( = 534) or secukinumab 300 mg ( = 514) through week 44. Efficacy (at least a 90% and 100% improvement from baseline in Psoriasis Area and Severity Index [PASI 90 and PASI 100], Investigator's Global Assessment [IGA] 0/1, and IGA 0) was analyzed across subpopulations defined by baseline: age (<45, 45 to <65, and ≥65 years old), body weight, body mass index (BMI), psoriasis disease severity (body surface area, disease duration, PASI, and IGA), psoriasis by body regions (head, trunk, upper and lower extremities), and prior psoriasis medication history at week 48.

RESULTS

Overall, 1048 patients were randomized. At week 48, numerically greater proportions of patients achieved PASI 90, PASI 100, IGA 0/1, and IGA 0 with guselkumab vs. secukinumab regardless of baseline age, body weight, BMI, disease severity, body region, and prior medication. The largest differences were in patients ≥65 years old and patients weighing >100 kg.

CONCLUSIONS

Guselkumab treatment provided greater efficacy vs. secukinumab at week 48 in most subpopulations of patients with psoriasis.

摘要

目的

古塞库单抗是一种白细胞介素(IL)-23 抑制剂,能有效治疗中重度斑块状银屑病。

材料和方法

Eclipse 是一项为期 56 周的 3 期、多中心、双盲、活性对照研究,评估古塞库单抗对比司库奇尤单抗(IL-17A 抑制剂)治疗中重度银屑病患者的疗效。患者接受古塞库单抗 100mg( = 534 例)或司库奇尤单抗 300mg( = 514 例)治疗,治疗时间至第 44 周。根据基线情况(年龄(<45、45-<65、≥65 岁)、体重、体质量指数(BMI)、银屑病疾病严重程度(体表面积、疾病病程、PASI、IGA)、银屑病皮损分布(头部、躯干、上肢、下肢)和第 48 周时既往银屑病药物治疗史),评估患者的亚组人群中疗效(PASI90 和 PASI100 至少改善 90%和 100%、研究者全球评估 [IGA]0/1 和 IGA0)。

结果

共有 1048 例患者被随机分组。在第 48 周时,无论基线年龄、体重、BMI、疾病严重程度、皮损分布和既往药物治疗史如何,古塞库单抗组患者的 PASI90、PASI100、IGA0/1 和 IGA0 比例均大于司库奇尤单抗组。最大的差异出现在年龄≥65 岁和体重>100kg 的患者中。

结论

在大多数银屑病患者亚组中,古塞库单抗治疗在第 48 周时的疗效优于司库奇尤单抗。

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