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Introduction <p>We report an exploratory subgroup analysis of a Chinese phase 3 study to investigate the effect of baseline inflammation measured by magnetic resonance imaging (MRI) on ixekizumab efficacy in radiographic axial spondyloarthritis (r-axSpA).</p> Methods <p>Adults with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo for 16 weeks. Endpoints analyzed by baseline Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine or sacroiliac joint (SIJ) inflammation score (&lt; 2 or ≥ 2; elevated inflammation defined as score ≥ 2) were: Assessment of SpondyloArthritis International Society 40 (ASAS40); Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) &lt; 2.1; ASDAS clinically important improvement (CII; change from baseline ≥ 1.1); Patient Global Assessment of Disease Activity (PtGA); spinal pain; nocturnal spinal pain; stiffness/inflammation; function; fatigue; Short Form-36 Physical Component Score (SF-36 PCS); European Quality of Life 5 Dimensions 5 Levels visual analog scale (EQ-5D-5L VAS).</p> Results <p>Overall, 145 patients were included. At Week 16, ASAS40 response rates were numerically improved with IXEQ4W versus placebo in the SPARCC MRI spine score &lt; 2 subgroup (40.9% vs. 14.3%; <i>p</i> = 0.088) and significantly improved in the ≥ 2 subgroup (37.3% vs. 5.9%; <i>p</i> &lt; 0.001). ASAS40 response rates were significantly improved in the SPARCC MRI SIJ score &lt; 2 (34.4% vs. 8.6%; <i>p</i> &lt; 0.05) and ≥ 2 (41.5% vs. 8.1%; <i>p</i> &lt; 0.001) subgroups. Similar results were obtained on BASDAI50, ASDAS &lt; 2.1, and ASDAS CII. IXEQ4W significantly improved PtGA, inflammation, and fatigue across all subgroups. Spinal and nocturnal spinal pain were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup and both SPARCC MRI SIJ score subgroups. Function and SF-36 PCS were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup. There were no significant differences in EQ-5D-5L VAS.</p> Conclusion <p>These findings support IXEQ4W as an effective treatment for Chinese patients with r-axSpA, irrespective of baseline MRI inflammation.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT04285229.</p>

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Efficacy of Ixekizumab in Chinese Patients with Radiographic-Axial Spondyloarthritis by Baseline Inflammation Status on Magnetic Resonance Imaging

  • 期刊论文

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  • 发表日期：

    2026年1月6日

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  • Xiaoxia Zhu,
  • Jiankang Hu,
  • Dongzhou Liu,
  • Jingyang Li,
  • Huaxiang Wu,
  • Lingyun Sun,
  • Lie Dai,
  • Chunyu Tan,
  • Zhijun Li,
  • Zhengyu Xiao,
  • Yongfu Wang,
  • Lingli Dong,
  • Yan Yan,
  • Hongying Li,
  • Hejian Zou

摘要

Introduction

We report an exploratory subgroup analysis of a Chinese phase 3 study to investigate the effect of baseline inflammation measured by magnetic resonance imaging (MRI) on ixekizumab efficacy in radiographic axial spondyloarthritis (r-axSpA).

Methods

Adults with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo for 16 weeks. Endpoints analyzed by baseline Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine or sacroiliac joint (SIJ) inflammation score (< 2 or ≥ 2; elevated inflammation defined as score ≥ 2) were: Assessment of SpondyloArthritis International Society 40 (ASAS40); Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1; ASDAS clinically important improvement (CII; change from baseline ≥ 1.1); Patient Global Assessment of Disease Activity (PtGA); spinal pain; nocturnal spinal pain; stiffness/inflammation; function; fatigue; Short Form-36 Physical Component Score (SF-36 PCS); European Quality of Life 5 Dimensions 5 Levels visual analog scale (EQ-5D-5L VAS).

Results

Overall, 145 patients were included. At Week 16, ASAS40 response rates were numerically improved with IXEQ4W versus placebo in the SPARCC MRI spine score < 2 subgroup (40.9% vs. 14.3%; p = 0.088) and significantly improved in the ≥ 2 subgroup (37.3% vs. 5.9%; p < 0.001). ASAS40 response rates were significantly improved in the SPARCC MRI SIJ score < 2 (34.4% vs. 8.6%; p < 0.05) and ≥ 2 (41.5% vs. 8.1%; p < 0.001) subgroups. Similar results were obtained on BASDAI50, ASDAS < 2.1, and ASDAS CII. IXEQ4W significantly improved PtGA, inflammation, and fatigue across all subgroups. Spinal and nocturnal spinal pain were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup and both SPARCC MRI SIJ score subgroups. Function and SF-36 PCS were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup. There were no significant differences in EQ-5D-5L VAS.

Conclusion

These findings support IXEQ4W as an effective treatment for Chinese patients with r-axSpA, irrespective of baseline MRI inflammation.

Trial Registration

ClinicalTrials.gov identifier, NCT04285229.