司库奇尤单抗治疗活动性强直性脊柱炎3年以上达到缓解终点：两项3期研究的汇总分析
Achievement of Remission Endpoints with Secukinumab Over 3 Years in Active Ankylosing Spondylitis: Pooled Analysis of Two Phase 3 Studies.
作者信息
Baraliakos Xenofon, Van den Bosch Filip, Machado Pedro M, Gensler Lianne S, Marzo-Ortega Helena, Sherif Bintu, Quebe-Fehling Erhard, Porter Brian, Gaillez Corine, Deodhar Atul
机构信息
Rheumazentrum Ruhrgebiet Herne, Ruhr-University Bochum, Bochum, Germany.
Department of Internal Medicine and Pediatrics, Ghent University, Ghent, Belgium.
出版信息
Rheumatol Ther. 2021 Mar;8(1):273-288. doi: 10.1007/s40744-020-00269-6. Epub 2020 Dec 22.
INTRODUCTION
Clinical remission in patients with ankylosing spondylitis (AS) has been determined using composite indices such as the AS Disease Activity Score inactive disease (ASDAS-ID), Assessment of SpondyloArthritis international Society criteria partial remission (ASAS-PR), and low Bath AS Disease Activity Index (BASDAI) scores. The objective of this exploratory analysis was to evaluate the proportion of secukinumab-treated patients with AS achieving remission defined based on the ASDAS-ID (score < 1.3), ASAS-PR or BASDAI score ≤ 2.
METHODS
The analysis pooled data from the MEASURE 1 and 2 studies over 3 years. The proportion of patients who achieved ASDAS-ID, ASAS-PR, or BASDAI ≤ 2 with secukinumab was compared with placebo at week 16; results for secukinumab-treated patients were summarized through week 156. Sustainability of each criterion was assessed from week 16 to 156 using shift analysis. The association between each of these criteria and specific patient-reported outcomes (PROs), such as health-related quality of life, function, fatigue, and work impairment, was also explored.
RESULTS
At week 16, a higher proportion of secukinumab-treated patients versus placebo achieved ASDAS-ID (17.6 vs. 3.5%), ASAS-PR (15.4 vs. 4.1%), or BASDAI ≤ 2 (22.3 vs. 6.4%) criteria (all P < 0.0001), which were sustained through 156 weeks. Shift analysis showed that the majority of secukinumab-treated patients achieving remission at week 16 maintained their status at week 156 (ASDAS-ID, 57.1%; ASAS-PR, 68.0% and BASDAI ≤ 2, 74.3%). Remission was also associated with improved PROs over 156 weeks.
CONCLUSIONS
Secukinumab-treated patients maintained ASDAS-ID, ASAS-PR, or BASDAI ≤ 2 from week 16 up to 3 years. Patients who achieved at least one of the three responses/states, reported improvement in PROs, which suggests an association of clinical remission/ID with PROs in patients with active AS.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT01358175, NCT01863732, and NCT01649375.
引言
强直性脊柱炎（AS）患者的临床缓解情况已通过综合指标来判定，如AS疾病活动评分不活动疾病（ASDAS-ID）、国际脊柱关节炎评估协会标准部分缓解（ASAS-PR）以及低巴斯强直性脊柱炎疾病活动指数（BASDAI）评分。这项探索性分析的目的是评估接受司库奇尤单抗治疗的AS患者达到基于ASDAS-ID（评分<1.3）、ASAS-PR或BASDAI评分≤2所定义缓解的比例。
方法
该分析汇总了MEASURE 1和2研究3年期间的数据。在第16周，将接受司库奇尤单抗治疗达到ASDAS-ID、ASAS-PR或BASDAI≤2的患者比例与安慰剂组进行比较；对接受司库奇尤单抗治疗患者至第156周的结果进行了总结。使用转移分析评估从第16周至156周各标准的持续性。还探索了这些标准中的每一项与特定患者报告结局（PROs）之间的关联，如健康相关生活质量、功能、疲劳和工作障碍。
结果
在第16周，接受司库奇尤单抗治疗的患者达到ASDAS-ID（17.6%对3.5%）、ASAS-PR（15.4%对4.1%）或BASDAI≤2（22.3%对6.4%）标准的比例高于安慰剂组（所有P<0.0001），这些标准在156周内持续存在。转移分析显示，在第16周达到缓解的大多数接受司库奇尤单抗治疗的患者在第156周维持了其状态（ASDAS-ID为57.1%；ASAS-PR为68.0%，BASDAI≤2为74.3%）。在156周内，缓解也与PROs改善相关。
结论
接受司库奇尤单抗治疗的患者从第16周直至3年维持了ASDAS-ID、ASAS-PR或BASDAI≤2。达到这三种反应/状态中至少一种的患者报告PROs有所改善，这表明活动性AS患者的临床缓解/ID与PROs之间存在关联。
试验注册
ClinicalTrials.gov：NCT01358175、NCT01863732和NCT01649375。
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