Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE)
Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomized controlled trial in psoriasis (FEATURE)
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DOI：
10.1111/bjd.13348
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发表时间：
2015-02-01
影响因子：
10.3
通讯作者：
Cooper, S.
中科院分区：
文献类型：
--
作者：
Blauvelt, A.;Prinz, J. C.;Cooper, S.
背景：苏金单抗是一种全人源抗白细胞介素17 A单克隆抗体，经皮下注射给药对中重度斑块状银屑病有效且安全。通过预充式注射器（PFS）自我给药可以为患者提供药物的临床益处，并且增加了便利性。第12周的结果见此处。每种治疗使用PFS每周一次递送至第4周，并在第8周再次递送。共同主要终点是在第12周PASI 75（银屑病面积和严重程度指数降低>= 75%）和伊加mod 2011（2011年修订的研究者总体评估）0/1应答率方面，阿基诺单抗优于安慰剂。次要终点包括PFS可用性，通过观察者对成功、无危险自我注射的评级和受试者对自我注射评估问卷（SIAQ）的可接受性评级确定。共主要终点得到满足，证明了在第12周时每种剂量的阿基诺单抗相对于安慰剂的优效性（PASI 75：阿基诺单抗300 mg、150 mg和安慰剂分别为75.9%、69.5%和0%;伊加mod 2011 0/1：分别为69.0%、52.5%和0%;所有与安慰剂相比的比较P < 0.0001）。PFS可用性高：100%的受试者在第1周成功进行自我给药治疗，并且受试者在整个试验期间报告了较高的SIAQ评估的PFS可接受性。没有观察到新的/意外的安全信号。结论通过PFS给予苏金单抗是有效的，具有可接受的安全性特征和高可用性。PFS为中重度斑块状银屑病受试者提供了一种可靠、方便的阿基诺单抗给药形式。
Background Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, demonstrated efficacy and safety in moderate-to-severe plaque psoriasis when administered via subcutaneous injection. Self-administration by pre-filled syringe (PFS) can offer patients clinical benefits of a drug, with increased convenience.Objectives To assess efficacy, safety and usability of secukinumab administration via PFS in subjects with moderate-to-severe plaque psoriasis.Materials and methods Subjects in this phase 3 trial were randomized 1 : 1 : 1 to secukinumab 300 or 150 mg or matching placebo.Results to week 12 are presented here. Each treatment was delivered using a PFS once weekly to week 4, and again at week 8. Co-primary endpoints were secukinumab superiority over placebo for week 12 PASI 75 (>= 75% reduction in Psoriasis Area and Severity Index) and IGA mod 2011 (2011 modified Investigator's Global Assessment) 0/1 response rates. Secondary endpoints included PFS usability, determined by observer rating of successful, hazard-free self-injection and subject rating of acceptability by the Self-Injection Assessment Questionnaire (SIAQ). Results Co-primary endpoints were met, with demonstration of superiority for each secukinumab dose vs. placebo at week 12 (PASI 75: 75.9%, 69.5% and 0% for secukinumab 300 mg, 150 mg and placebo; IGA mod 2011 0/1:69.0%, 52.5% and 0%, respectively; P < 0.0001 for all comparisons vs. placebo). PFS usability was high: 100% of subjects successfully self-administered treatment at week 1, and subjects reported high SIAQ-assessed acceptability of the PFS throughout the trial. No new/unexpected safety signals were observed.Conclusions Secukinumab administration by PFS was effective, with an acceptable safety profile and high usability. The PFS provides a reliable, convenient form of secukinumab administration in subjects with moderate-to-severe plaque psoriasis.