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Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study

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Abstract

Introduction

Ixekizumab, an interleukin-17A inhibitor, was efficacious and well tolerated for the treatment of active radiographic axial spondyloarthritis (r-axSpA) in international clinical studies. This phase III study aimed to determine the efficacy and safety of ixekizumab for treating Chinese patients with active r-axSpA.

Methods

Adults with active r-axSpA naïve to biologic disease-modifying antirheumatic drugs (bDMARDs), or with an inadequate response/intolerance to one tumor necrosis factor inhibitor, were randomized (1:1), double-blind, to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg), or placebo, for 16 weeks. Patients receiving placebo were then switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. The primary endpoint was the proportion of bDMARD-naïve patients achieving an Assessment of SpondyloArthritis International Society 40 (ASAS40) response at week 16.

Results

In total, 147 patients were randomized to receive placebo (n = 73) or IXEQ4W (n = 74). At week 16, more bDMARD-naive patients achieved ASAS40 in the IXEQ4W group (n = 66; 40.9%) than the placebo group (n = 64, 7.8%; p < 0.001). In the overall study population, ASAS40 was also achieved by more patients in the IXEQ4W group (37.8%) than the placebo group (8.2%; p < 0.001) at week 16, with a significant difference observed as early as week 1. There were significant improvements in all key secondary endpoints at week 16 with IXEQ4W versus placebo. Efficacy was sustained at week 52 in patients who continued IXEQ4W and there were also clinical improvements from weeks 16 to 52 in patients switched to IXEQ4W. The safety profile of ixekizumab was consistent with that described previously. Infections and injection-site reactions were the most frequently reported events of special interest.

Conclusions

IXEQ4W was associated with rapid and significant improvements in the signs and symptoms of active r-axSpA in Chinese patients at week 16 that were sustained at week 52, with no new safety signals.

Trial registration number

ClinicalTrials.gov identifier: NCT04285229.

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Acknowledgements

Editorial assistance in the preparation of this article was provided by Jake Burrell of Rude Health Consulting Ltd, and Huanjun Chen of Eli Lilly and Company. Support for this assistance was funded by Eli Lilly and Company. Hongying Li of Eli Lilly and Company provided statistical support for this article.

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Author notes

  1. Cibo Huang

    Present address: South China Hospital Affiliated to Shenzhen University, Shenzhen, China

Authors and Affiliations

  1. Huashan Hospital affiliated to Fudan University, 12 Wulumuqi Zhong Rd, Shanghai, 200040, China

    Yu Xue & Hejian Zou

  2. Pingxiang People’s Hospital, Pingxiang, Jiangxi Province, China

    Jiankang Hu

  3. Shenzhen People’s Hospital, The Second Clinical Medical College of Jinan University, Shenzhen, China

    Dongzhou Liu

  4. The Affiliated Zhuzhou Hospital Xiangya Medical College Central South University, Zhuzhou, Hunan Province, China

    Jingyang Li

  5. The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China

    Huaxiang Wu

  6. West China Hospital of Sichuan University, Chengdu, Sichuan Province, China

    Chunyu Tan

  7. Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong Province, China

    Lie Dai

  8. Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu Province, China

    Lingyun Sun

  9. The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui Province, China

    Zhijun Li

  10. The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong Province, China

    Zhengyu Xiao

  11. Beijing Hospital, Beijing, China

    Cibo Huang

  12. Eli Lilly and Company, Shanghai, China

    Yan Yan, Fei Ji & Rong Chen

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Funding

Sponsorship for this study was provided by Eli Lilly and Company.

Conflicts of interest

Dongzhou Liu and Cibo Huang received research grants from Eli Lilly and Company. Yan Yan and Rong Chen are employees and shareholders of Eli Lilly and Company. Fei Ji was an employee and shareholder of Eli Lilly and Company during the period of this work. Yu Xue, Jiankang Hu, Jingyang Li, Huaxiang Wu, Chunyu Tan, Lie Dai, Lingyun Sun, Zhijun Li, Zhengyu Xiao, and Hejian Zou have no conflicts of interest to declare in relation to this work.

Ethics approval

The study protocol was approved by local ethics committees and the study was conducted in accordance with the principles outlined in the Declaration of Helsinki and the Council of International Organizations of Medical Sciences International Ethical Guidelines.

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All patients gave written, informed consent before participating in the study.

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All named authors of this article meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship, take responsibility for the integrity of the work as a whole, and have provided approval for this version to be published. All authors contributed to the study conception and design. Hejian Zou, Yu Xue, Jiankang Hu, Dongzhou Liu, Jingyang Li, Huaxiang Wu, Chunyu Tan, Lie Dai, Lingyun Sun, Zhijun Li, Zhengyu Xiao and Cibo Huang contributed to the acquisition of data. Fei Ji contributed to data analysis. Substantial contributions to the interpretation of data were provided by all authors. The first draft of the manuscript was written by Jake Burrell, PhD, and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Prior presentation

Partial results presented in this manuscript were presented as posters at the American College of Rheumatology (ACR) Congress 2022 (10–14 November 2022) and the Asia-Pacific League of Associations for Rheumatology (APLAR) congress 2022 (6–9 December 2022).

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Xue, Y., Hu, J., Liu, D. et al. Ixekizumab for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 52-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study. BioDrugs 38, 145–156 (2024). https://doi.org/10.1007/s40259-023-00625-2

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