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司库奇尤单抗通过 2ml 自动注射器给药在斑块状银屑病成年患者中显示出疗效、安全性和耐受性:一项随机、安慰剂对照试验的 52 周结果。

Secukinumab demonstrates efficacy, safety, and tolerability upon administration by 2 ml autoinjector in adult patients with plaque psoriasis: 52-week results from MATURE, a randomized, placebo-controlled trial.

机构信息

Faculty of Medicine, Department of Dermatology, University of Iceland, Reykjavík, Iceland.

Department of Dermatology, University of Texas Health Science Center San Antonio, Texas, USA.

出版信息

Dermatol Ther. 2022 Mar;35(3):e15285. doi: 10.1111/dth.15285. Epub 2022 Jan 8.

Abstract

Convenient administration is an important factor for treatment adherence in patients with psoriasis. MATURE study reports the efficacy, safety, tolerability, and pharmacokinetics (PKs) of secukinumab 300 mg 2 ml autoinjector (AI) from MATURE trial (NCT03589885). Eligible patients were randomized to secukinumab 300 mg 2 ml AI or 2× 1 ml prefilled syringe (PFS) or placebo. The co-primary endpoints were psoriasis area and severity index (PASI) 75 and investigator's global assessment (IGA) 0/1 response rates at Week 12 versus placebo. Other endpoints included PASI90/100 response, dermatology life quality index (DLQI) 0/1, PKs, 2 ml AI usability rated using self-injection assessment questionnaire (SIAQ), and safety. The study met both co-primary and secondary endpoints (p < 0.0001). Secukinumab 300 mg 2 ml AI and 2× 1 ml PFS treatments led to superior PASI75/90/100 (2 ml AI: 95.1%/75.6%/43.9%; 2× 1 mL PFS: 83.2%/62.6%/37.5% and placebo: 10%/5.0%/0.0%, respectively), IGA, and DLQI 0/1 responses compared with placebo, and efficacy was sustained through 52 weeks. SIAQ results showed high usability of self-injection with 2 mL AI device. No new safety signals were observed. Study design may bias the interpretation of safety profile after Week 12, due to different exposure of secukinumab versus placebo. Secukinumab 300 mg administered with the 2 mL AI demonstrated superior efficacy over placebo, good tolerability, and convenient administration.

摘要

方便的给药方式是提高银屑病患者治疗依从性的重要因素。MATURE 研究报告了 secukinumab 300mg 2ml 自动注射器(AI)在 MATURE 试验中的疗效、安全性、耐受性和药代动力学(PK)(NCT03589885)。符合条件的患者被随机分配至 secukinumab 300mg 2ml AI 或 2×1ml 预装注射器(PFS)或安慰剂组。主要共同终点为第 12 周与安慰剂相比,银屑病面积和严重程度指数(PASI)75 和研究者全球评估(IGA)0/1 应答率。其他终点包括 PASI90/100 应答、皮肤病生活质量指数(DLQI)0/1、PK、使用自我注射评估问卷(SIAQ)评估的 2ml AI 可用性以及安全性。该研究达到了主要和次要终点(p<0.0001)。Secukinumab 300mg 2ml AI 和 2×1ml PFS 治疗组在 PASI75/90/100(2ml AI:95.1%/75.6%/43.9%;2×1ml PFS:83.2%/62.6%/37.5%和安慰剂:10%/5.0%/0.0%)、IGA 和 DLQI0/1 应答方面均优于安慰剂,并且疗效在 52 周内得以维持。SIAQ 结果表明,2ml AI 装置的自我注射具有高度的可用性。未观察到新的安全性信号。由于 secukinumab 与安慰剂的暴露不同,第 12 周后安全性的解释可能存在偏倚。与安慰剂相比,secukinumab 300mg 联合 2ml AI 给药具有更好的疗效、良好的耐受性和方便的给药方式。

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