Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2.
Secukinumab provides sustained improvements in the signs and symptoms of active ankylosing spondylitis with high retention rate: 3-year results from the phase III trial, MEASURE 2.
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DOI：
10.1136/rmdopen-2017-000592
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发表时间：
2017
期刊：
影响因子：
6.2
通讯作者：
Richards H
中科院分区：
文献类型：
--
作者：
Marzo-Ortega H;Sieper J;Kivitz A;Blanco R;Cohen M;Delicha EM;Rohrer S;Richards H
此前已有研究表明，Secukinumab治疗可显著改善活动性强直性脊柱炎（AS）的体征和症状，反应持续2年。在这里，我们在MEASURE 2研究中报告了secukinumab的长期（3年）疗效和安全性。MEASURE 2 （NCT01649375）是一项为期5年的III期随机、双盲、双哑、平行组、安慰剂对照研究，旨在评估成人活动性AS患者皮下负荷和维持剂量的有效性、安全性和耐受性。受试者在基线、第1周、第2周和第3周以及从第4周开始每4周随机接受皮下皮下secukinumab 150mg、75mg或安慰剂。在第16周，安慰剂治疗的受试者被重新随机分配接受secukinumab 150/75 mg。在第16-156周，保留率很高，secukinumab 150和75 mg的保留率分别为86%和76%。与第52周（74.2%/57.0%）相比，Secukinumab 150 mg在第156周（70.1%/60.9%）评估脊椎关节炎国际协会ASAS 20/40缓解率方面提供了持续的改善；然而，secukinumab 75 mg组略有下降（分别为54.3%/37.0%和62.5%/43.2%）。所有其他终点均观察到持续改善，包括Bath强直性脊柱炎疾病活动指数、AS疾病活动评分（C反应蛋白失活）、ASAS 5/6、Short -36物理成分总结和ASAS部分缓解。无论先前是否暴露于抗肿瘤坏死因子药物，均观察到临床获益。安全概况仍然是有利的，与以前的报告一致。这项研究表明，经过3年的持续改善，体征，症状和身体功能的受试者。保留率高，secukinumab耐受性良好，具有良好的安全性。
Secukinumab treatment has previously been shown to significantly improve the signs and symptoms of active ankylosing spondylitis (AS), with responses sustained through 2 years. Here, we report the long-term (3 years) efficacy and safety of secukinumab in the MEASURE 2 study. MEASURE 2 (NCT01649375) is a 5-year phase III, randomised, double-blind, double-dummy, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of subcutaneous loading and maintenance dosing of secukinumab in adult subjects with active AS. Subjects were randomised to receive subcutaneous secukinumab 150 mg, 75 mg or placebo at baseline, weeks 1, 2 and 3 and every 4 weeks from week 4. At week 16, placebo-treated subjects were rerandomised to receive secukinumab 150/75 mg. Retention rates were high during weeks 16–156 and were 86% and 76% for secukinumab 150 and 75 mg, respectively. Secukinumab 150 mg provided sustained improvements in the Assessment of Spondyloarthritis International Society ASAS 20/40 response rates at week 156 (70.1%/60.9%) compared with week 52 (74.2%/57.0%); however, there was a slight decrease for secukinumab 75 mg (54.3%/37.0% vs 62.5%/43.2%, respectively). Sustained improvements were observed in all other end points, including Bath Ankylosing Spondylitis Disease Activity Index, AS Disease Activity Score with C reactive protein inactive disease, ASAS 5/6, Short Form-36 Physical Component Summary and ASAS partial remission. Clinical benefits were observed regardless of prior exposure to anti-tumour necrosis factor agents. The safety profile remained favourable and was consistent with previous reports. This study showed sustained improvement through 3 years in signs, symptoms and physical function in subjects with AS. Retention rates were high and secukinumab was well tolerated, with a favourable safety profile.