Efficacy of Ixekizumab in Chinese Patients with Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level.

IF 2.9 3区医学 Q2 RHEUMATOLOGY

Rheumatology and Therapy Pub Date : 2025-08-01 Epub Date: 2025-05-09 DOI:10.1007/s40744-025-00765-7

Ning Kong, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Lingyun Sun, Dai Lie, Chunyu Tan, Zhijun Li, Zhengyu Xiao, Cibo Huang, Jian Xu, Yan Yan, Hongying Li, Hejian Zou

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引用次数: 0

Abstract

Introduction: Ixekizumab, an interleukin 17A inhibitor, improved the Assessment of SpondyloArthritis international Society 40 (ASAS40) response rates irrespective of baseline inflammation in international populations with radiographic axial spondyloarthritis (r-axSpA). We investigated the association of baseline inflammation (measured by serum C-reactive protein [CRP] levels) with ixekizumab efficacy in Chinese patients with r-axSpA.

Methods: This was a subgroup analysis of a Chinese phase 3 study. Adults with r-axSpA who were biologic-naïve, or tumor necrosis factor inhibitor-experienced with baseline CRP > 5 mg/l, were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo, for 16 weeks. The following endpoints were analyzed by normal (≤ 5 mg/l) or elevated (> 5 mg/l) baseline CRP levels: 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); ASDAS major improvement (MI; change from baseline ≥ 2.0 or achievement of lowest possible score); Bath Ankylosing Spondylitis Metrology Index (BASMI) linear score; Bath Ankylosing Spondylitis Functional Index (BASFI); Short Form-36 Physical Component Score (SF-36 PCS).

Results: A total of 147 patients were randomized. At week 16, the ASAS40 response rate was greater with IXEQ4W versus placebo in the normal (50.0% vs. 15.0%; p < 0.05) and elevated (29.5% vs. 5.7%; p < 0.01) CRP subgroups. Significant improvements in BASDAI50 response rate, ASDAS < 2.1, and ASDAS CII with IXEQ4W versus placebo were observed in both subgroups (normal CRP: p < 0.05, p < 0.01, and p < 0.05, respectively; elevated CRP: p < 0.01, p < 0.001, and p < 0.001, respectively); IXEQ4W significantly improved ASDAS MI in the elevated CRP subgroup (p < 0.001). IXEQ4W significantly improved linear BASMI and BASFI scores in the normal CRP subgroup (p < 0.001 and p < 0.01, respectively), while SF-36 PCS improved in both subgroups (both p < 0.05).

Conclusions: Ixekizumab showed efficacy in Chinese patients with r-axSpA, irrespective of baseline CRP levels, consistent with results in international populations with r-axSpA.

Trial registration: ClinicalTrials.gov identifier, NCT04285229.

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Ixekizumab基线c反应蛋白水平对中国中轴性脊柱炎患者的疗效。

简介：Ixekizumab，一种白细胞介素17A抑制剂，提高了国际社会评估脊椎关节炎40 （ASAS40）的应答率，无论放射轴型脊椎关节炎（r-axSpA）的国际人群的基线炎症。我们研究了基线炎症（通过血清c反应蛋白[CRP]水平测量）与中国r-axSpA患者ixekizumab疗效的关系。方法：这是一项中国三期研究的亚组分析。患有r-axSpA的成人，如果基线CRP水平为biologic-naïve或肿瘤坏死因子抑制剂水平为5 mg/l，则随机（1:1）接受每4周80 mg的ixekizumab （IXEQ4W）或安慰剂治疗，为期16周。通过正常（≤5mg /l）或升高（> 5mg /l）基线CRP水平分析以下终点：ASAS40；浴缸强直性脊柱炎疾病活动指数50 (BASDAI50)；强直性脊柱炎疾病活动评分（ASDAS）结果：共147例患者被随机分组。在第16周，IXEQ4W治疗组的ASAS40反应率高于安慰剂组(50.0% vs 15.0%；结论：Ixekizumab在中国r-axSpA患者中显示出疗效，无论基线CRP水平如何，与国际r-axSpA人群的结果一致。试验注册：ClinicalTrials.gov识别码，NCT04285229。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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. The journal is read by a global audience and receives submissions from all over the world. Rheumatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Ethics and Disclosures The journal is a member of the Committee on Publication Ethics (COPE) and subscribes to its principles on how to deal with acts of misconduct thereby committing to investigate allegations of misconduct in order to ensure the integrity of research. Content in this journal is peer-reviewed (Single-blind). 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