Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study
Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study
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DOI：
10.1136/rmdopen-2019-001005
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发表时间：
2019-06-01
期刊：
影响因子：
6.2
通讯作者：
Fierlinger, Anke
中科院分区：
文献类型：
--
作者：
Baraliakos, Xenofon;Braun, Juergen;Fierlinger, Anke
目的本研究旨在报告阿基诺单抗150 mg治疗强直性脊柱炎患者5年的疗效和安全性研究结束结果（AS; MEASURE 1扩展试验（NCT 01863732））。方法在2年核心试验后，274例患者接受皮下注射阿基诺单抗150或75 mg（在静脉内负荷或初始安慰剂治疗至16/24周之后）每4周被邀请进入3年扩展研究。根据主治医生的判断，允许在第156周或之后将剂量从75 mg递增至150 mg（批准剂量）。第260周（5年）的评估包括国际脊柱关节炎协会（ASAS）20/40和其他疗效结局评估。数据按观察结果显示。安全性评估包括所有接受≥ 1剂研究治疗的患者。结果在进入扩展研究的274例患者中，84%（230/274）完成了5年的治疗。苏金单抗150 mg治疗5年后，ASAS 20/40缓解率为78.6/65.2%，巴斯强直性脊柱炎疾病活动指数（BASDAI）50缓解率为63.4%，平均（+/- SD）BASDAI总分为2.6 +/- 1.76。疗效结局的改善持续5年。在第168周后，共有82例接受75 mg阿基诺单抗治疗的患者（56.2%）的剂量递增至150 mg;在剂量从75 mg阿基诺单抗递增至150 mg的患者中，ASAS 40、ASAS-PR、ASAS 5/6和BASDAI 50应答得到改善。Secukinumab耐受性良好，安全性在整个研究过程中保持一致。结论Secukinumab 150 mg在AS的多个领域提供了持续的疗效，通过5年的治疗，具有良好的和一致的安全性。超过50%的患者需要将剂量从75 mg递增至150 mg，这些患者的疗效得到改善。
Objective This study aimed to report end-of-study results on efficacy and safety of secukinumab 150 mg through 5 years in patients with ankylosing spondylitis (AS; MEASURE 1 extension trial (NCT01863732)).Methods After the 2-year core trial, 274 patients receiving subcutaneous secukinumab 150 or 75 mg (following intravenous loading or initial placebo treatment to 16/24 weeks) every 4 weeks were invited to enter the 3-year extension study. Dose escalation from 75 to 150 mg (approved dose) was allowed at or after week 156 based on the judgement of the treating physician. Assessments at week 260 (5 years) included Assessment of SpondyloArthritis international Society (ASAS) 20/40 and other efficacy outcomes. Data are presented as observed. Safety assessment included all patients who received >= 1 dose of study treatment.Results Of the 274 patients who entered the extension study, 84% (230/274) completed 5 years of treatment. ASAS20/40 responses were 78.6/65.2%, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 response was 63.4% and mean (+/- SD) BASDAI total score was 2.6 +/- 1.76 with secukinumab 150 mg at 5 years. Improvements in efficacy outcomes were sustained through 5 years. A total of 82 patients on secukinumab 75 mg (56.2%) had their dose escalated to 150 mg after week 168; ASAS40, ASAS-PR, ASAS 5/6 and BASDAI50 responses were improved in patients whose dose was escalated from secukinumab 75 to 150 mg. Secukinumab was well tolerated with a safety profile consistent over the course of the study.Conclusions Secukinumab 150 mg provided sustained efficacy across multiple domains of AS with a favourable and consistent safety profile through 5-year treatment. Over 50% of patients required dose escalation from 75 to 150 mg and efficacy improved in these patients.