根据炎症的客观指标探讨伊昔单抗对强直性脊柱炎患者疼痛的影响：大型随机临床试验的事后分析

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2024-04-18 DOI:10.1007/s40744-024-00660-7

Kurt de Vlam, Walter P. Maksymowych, Gaia Gallo, Proton Rahman, Philip Mease, Venkatesh Krishnan, Conor J. McVeigh, Jeffrey Lisse, Danting Zhu, Rebecca J. Bolce, Philip G. Conaghan

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引用次数: 0

摘要

方法COAST-V 52 周双盲、安慰剂对照随机 III 期试验考察了ixekizumab 对活动性强直性脊柱炎患者的疗效；阿达木单抗被用作活性参照组。通过对控制性和持续性炎症（由磁共振成像[MRI]、C反应蛋白[CRP]或磁共振成像+CRP状态定义）的客观测量来评估治疗对减轻疼痛的效果。结果在强直性脊柱炎患者中，当通过MRI评估炎症得到控制时，与安慰剂（平均值=-1.6）相比，接受ixekizumab治疗的患者在第16周时夜间脊柱疼痛有所减轻（SP-N，数字评分量表，ixekizumab平均值=-3.9，p <0.001，阿达木单抗平均值=-2.6，p <0.05）。当通过核磁共振成像+CRP评估炎症得到控制时，与安慰剂相比，ixekizumab和阿达木单抗在第16周时的SP-N下降幅度更大。在第52周时，所有ixekizumab组都有进一步改善。根据核磁共振成像+CRP的评估，当炎症持续存在时，ixekizumab治疗组患者的SP-N（平均值=-3.7，p< 0.001）与安慰剂（平均值=-1.7）相比有显著下降，而阿达木单抗的改善没有达到显著性（平均值=-2.6，p=0.06）。在第16周的路径分析中，与阿达木单抗相比，ixekizumab对疼痛结果的影响更大。结论这项事后分析支持ixekizumab通过可测量炎症减轻以外的其他机制减轻强直性脊柱炎患者疼痛的假设。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

Exploring the Effects of Ixekizumab on Pain in Patients with Ankylosing Spondylitis Based on Objective Measures of Inflammation: Post Hoc Analysis from a Large Randomized Clinical Trial

查看原文本刊更多论文

Exploring the Effects of Ixekizumab on Pain in Patients with Ankylosing Spondylitis Based on Objective Measures of Inflammation: Post Hoc Analysis from a Large Randomized Clinical Trial

Introduction

The objective of this analysis is to evaluate the improvement in spinal pain with ixekizumab, placebo, and adalimumab based on objective measures of inflammation response in patients with ankylosing spondylitis (AS).

Methods

The COAST-V 52-week, double-blind, placebo-controlled, randomized phase III trial examined the efficacy of ixekizumab in patients with active AS; adalimumab was used as an active reference arm. Treatment effects on reduction in pain were assessed by objective measures of controlled and persisting inflammation (defined by magnetic resonance imaging [MRI], C-reactive protein [CRP], or MRI + CRP status). Pathway analysis was used to analyze treatment effect that was not attributable to reduction in inflammation biomarkers.

Results

In patients with AS, when inflammation was controlled as assessed by MRI, patients treated with ixekizumab experienced a reduction in spinal pain at night (SP-N, numeric rating scale, ixekizumab mean = − 3.9, p < 0.001, adalimumab mean = − 2.6, p < 0.05) compared to placebo (mean = − 1.6) at week 16. When inflammation was controlled as assessed by MRI + CRP, ixekizumab and adalimumab had numerically greater reductions at week 16 in SP-N versus placebo. All ixekizumab groups had further improvements at week 52. When inflammation was persisting as assessed by MRI + CRP, ixekizumab-treated patients had significant reduction in SP-N (mean = − 3.7, p < 0.001) versus placebo (mean = − 1.7), improvement with adalimumab did not reach significance (mean = − 2.6, p = 0.06). In the pathway analysis at week 16, ixekizumab had a greater effect on pain outcomes compared to adalimumab.

Conclusion

This post hoc analysis is supportive of the hypothesis that ixekizumab reduces pain in AS by additional mechanisms other than the reduction of measurable inflammation.

Trial Registration Number

NCT02696785.

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来源期刊

Rheumatology and Therapy RHEUMATOLOGY-

CiteScore

6.00

自引率

5.30%

发文量

审稿时长

6 weeks

期刊介绍： Aims and Scope Rheumatology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of rheumatologic therapies. Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed. Areas of focus include, but are not limited to, rheumatoid arthritis, gout, gouty arthritis, psoriatic arthritis, osteoarthritis, juvenile idiopathic/rheumatoid arthritis, systemic lupus erythematosus, axial spondyloarthritis, Pompe’s disease, inflammatory joint conditions, musculoskeletal conditions, systemic sclerosis, and fibromyalgia. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial protocols, communications and letters. 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