司库奇尤单抗治疗强直性脊柱炎附着点炎的疗效：四项关键 III 期研究的汇总分析。
Secukinumab Efficacy on Enthesitis in Patients With Ankylosing Spondylitis: Pooled Analysis of Four Pivotal Phase III Studies.
机构信息
G. Schett, MD, Department of Internal Medicine, Friedrich Alexander University Erlangen-Nuremberg, Erlangen, Germany;
X. Baraliakos, MD, Rheumazentrum Ruhrgebiet Herne, Ruhr University Bochum, Germany.
出版信息
J Rheumatol. 2021 Aug;48(8):1251-1258. doi: 10.3899/jrheum.201111. Epub 2021 Mar 15.
OBJECTIVE
To assess the efficacy of secukinumab on axial and peripheral enthesitis in patients with ankylosing spondylitis (AS) using pooled data from randomized controlled phase III studies.
METHODS
In this posthoc analysis, data were pooled from patients originally randomized to secukinumab 150 mg, 300 mg, or placebo (PBO) from phase III MEASURE 1-4 studies (ClinicalTrials.gov: NCT01358175, NCT01649375, NCT02008916, and NCT02159053). Maastricht AS Enthesitis Score (MASES) was used for assessments of enthesitis through Week 52. Efficacy outcomes were mean change in MASES score and complete resolution (MASES = 0) of enthesitis in patients with baseline MASES > 0.
RESULTS
A total of 693 (71.5%) patients had enthesitis at baseline in secukinumab 300 mg, 150 mg, and PBO groups (58 [76.3%], 355 [70.4%], and 280 [72%], respectively) out of 969 patients pooled in this analysis. At Week 16, mean changes from baseline for overall MASES and enthesitis at axial MASES sites, respectively, were as follows: -2.9 ( < 0.01) and -2.9 ( < 0.01) for secukinumab 300 mg; -2.4 ( < 0.015) and -2.3 ( < 0.05) for secukinumab 150 mg; and -1.9 and -1.8 for PBO, with improvements seen through Week 52. More than one-third of secukinumab-treated patients (300 mg: 36.2%; 150 mg: 40.8%) achieved complete resolution of enthesitis at Week 16.
CONCLUSION
Secukinumab improved enthesitis at overall MASES and axial sites in patients with AS.
目的
评估司库奇尤单抗治疗强直性脊柱炎（AS）患者轴性和外周附着点炎的疗效，数据来自于三项 III 期随机对照研究的汇总分析。
方法
这是一项事后分析，数据来自于 MEASURE 1-4 三项 III 期研究（ClinicalTrials.gov：NCT01358175、NCT01649375、NCT02008916 和 NCT02159053）中原本随机分配至司库奇尤单抗 150mg、300mg 或安慰剂（PBO）的患者。采用马斯特里赫特附着点炎评分（MASES）评估附着点炎，至第 52 周。疗效终点为 MASES 评分的平均变化和基线 MASES＞0 的患者附着点炎完全缓解（MASES=0）。
结果
在这项汇总分析的 969 例患者中，共有 693 例（71.5%）患者在司库奇尤单抗 300mg、150mg 和 PBO 组中基线时存在附着点炎（分别为 58[76.3%]、355[70.4%]和 280[72%]）。至第 16 周，整体 MASES 和轴向 MASES 部位附着点炎的平均变化分别为：司库奇尤单抗 300mg 组为-2.9（＜0.01）和-2.9（＜0.01）；司库奇尤单抗 150mg 组为-2.4（＜0.015）和-2.3（＜0.05）；PBO 组为-1.9 和-1.8，改善持续至第 52 周。超过三分之一的司库奇尤单抗治疗患者（300mg 组：36.2%；150mg 组：40.8%）在第 16 周时达到附着点炎完全缓解。
结论
司库奇尤单抗改善了 AS 患者整体 MASES 和轴向附着点炎。
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