Secukinumab 在美国银屑病关节炎患者中的疗效和安全性：3 期 FUTURE 研究的分组分析
IF 2.9
3区 医学
Q2 RHEUMATOLOGY
引用次数: 0
摘要
导言：这项研究的目的是在银屑病关节炎（PsA）患者的国际FUTURE 2-5研究中，对具有治疗挑战性且较小的美国患者亚群进行secukinumab与安慰剂的对比评估。方法：汇总参加3期FUTURE 2-5研究（NCT01752634、NCT01989468、NCT02294227和NCT02404350）的美国患者的数据。患者接受secukinumab 300或150毫克皮下负荷剂量、secukinumab 150毫克（不含皮下负荷剂量）或安慰剂治疗。第16周时对分类疗效和健康相关生活质量（QoL）结果及安全性进行评估。根据肿瘤坏死因子抑制剂（TNFi）状态和体重指数（BMI）进行了分组分析。为了提出假设，使用逻辑回归估算了美国风湿病学会（ACR）20/50/70 和银屑病面积和严重程度指数（PASI）75/90/100 治疗反应的几率比（ORs），但未对多重比较进行调整。平均体重指数为30 kg/m2，55.2%的患者曾接受过TNFi治疗。与安慰剂相比，接受secukinumab 300毫克和150毫克（含负荷剂量）治疗的患者在ACR20/50/70方面的ORs明显增加（P< 0.05），但接受secukinumab 150毫克（不含负荷剂量）治疗的患者与安慰剂相比则没有增加。在PASI75方面，所有secukinumab组都优于安慰剂组（P< 0.05）；在PASI90和PASI100方面，只有secukinumab 300毫克组明显优于安慰剂组（P< 0.05）。PsA和活动性银屑病患者可能从300毫克的secukinumab中比150毫克的secukinumab中获益更多。本文章由计算机程序翻译，如有差异，请以英文原文为准。
Efficacy and Safety of Secukinumab in US Patients with Psoriatic Arthritis: A Subgroup Analysis of the Phase 3 FUTURE Studies
Introduction
The aim of this work is to evaluate secukinumab vs. placebo in a challenging-to-treat and smaller US patient subpopulation of the international FUTURE 2–5 studies in patients with psoriatic arthritis (PsA).
Methods
Data were pooled from US patients enrolled in the phase 3 FUTURE 2–5 studies (NCT01752634, NCT01989468, NCT02294227, and NCT02404350). Patients received secukinumab 300 or 150 mg with subcutaneous loading dose, secukinumab 150 mg without subcutaneous loading dose, or placebo. Categorical efficacy and health-related quality-of-life (QoL) outcomes and safety were evaluated at week 16. Subgroup analyses were performed based on tumor necrosis factor inhibitor (TNFi) status and body mass index (BMI). For hypothesis generation, odds ratios (ORs) for American College of Rheumatology (ACR) 20/50/70 and Psoriasis Area and Severity Index (PASI) 75/90/100 responses by treatment were estimated using logistic regression without adjustment for multiple comparisons.
Results
Of 2148 international patients originally randomized, 279 US patients were included in this pooled analysis. Mean BMI was > 30 kg/m2 and 55.2% had prior TNFi treatment. ORs for ACR20/50/70 significantly favored patients receiving secukinumab 300 mg and 150 mg with loading dose vs. placebo (P < 0.05), but not those receiving secukinumab 150 mg without loading dose vs. placebo. For PASI75, ORs favored all secukinumab groups over placebo (P < 0.05); for PASI90 and PASI100, only the secukinumab 300-mg group was significantly favored over placebo (P < 0.05).
Conclusions
In this challenging sub-population of US patients with PsA, secukinumab provided rapid improvements in disease activity and QoL. Patients with PsA and active psoriasis might benefit more from secukinumab 300 mg than 150 mg.
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来源期刊
Rheumatology and Therapy
RHEUMATOLOGY-
CiteScore
6.00
自引率
5.30%
发文量
91
审稿时长
6 weeks
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