Rapid and Sustained Effect of Ixekizumab on Patient Global, Spinal Pain, Stiffness, and Fatigue in Chinese Patients with Radiographic Axial Spondyloarthritis.
IF 2.9
3区 医学
Q2 RHEUMATOLOGY
引用次数: 0
Abstract
Introduction: Ixekizumab, an interleukin 17A (IL-17A) inhibitor, has demonstrated rapid and sustained improvement in the signs and symptoms in patients with active radiographic axial spondyloarthritis (r-axSpA) in global and Chinese populations. We studied the effect of ixekizumab on patient-reported outcomes (PROs) (including patient global, spinal pain, stiffness, and fatigue) and overall health-related quality of life (HRQoL) of ixekizumab in the phase 3 study in China.
Methods: In this Chinese phase 3, randomized, double-blind, placebo-controlled study, patients with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W; starting dose 160 mg) or placebo for 16 weeks. At week 16, patients receiving placebo were switched to IXEQ4W, and those receiving IXEQ4W continued, until week 52. Data for patient global, spinal pain, spinal pain at night, stiffness, and fatigue were collected through week 52. Minimally clinical important differences (MCIDs) were determined for spinal pain and spinal pain at night. The subgroup analyses by baseline disease duration since diagnosis and baseline C-reactive protein (CRP) level were conducted post hoc.
Results: Compared with placebo, patients treated with IXEQ4W reported significantly greater improvement with a rapid onset in changes from baseline of PROs (patient global, spinal pain, spinal pain at night, stiffness, and fatigue) through week 16. Improvements were maintained through week 52. A similar trend of improvement was also observed in MCID response in spinal pain and spinal pain at night. The improvement in overall HRQoL was supported by EQ-5D-5L assessment. Subgroup analyses demonstrated that IXEQ4W provided significantly greater efficacy at week 16 compared with placebo, irrespective of baseline disease duration or baseline CRP level.
Conclusion: IXEQ4W provided rapid and sustained improvement in clinically relevant PROs and overall HRQoL through 1-year treatment in Chinese patients with r-axSpA. Regardless of the baseline disease duration or baseline CRP level, consistent efficacy was observed.
Trial registration: ClinicalTrials.gov identifier NCT04285229.
伊克珠单抗对中国轴性脊柱关节炎放射学检查患者的整体、脊柱疼痛、僵硬和疲劳的快速和持续影响
简介伊克珠单抗是一种白细胞介素17A（IL-17A）抑制剂，在全球和中国人群中已证明可快速、持续地改善活动性放射性轴性脊柱关节炎（r-axSpA）患者的体征和症状。我们研究了ixekizumab在中国3期研究中对患者报告结果（PROs）（包括患者总体、脊柱疼痛、僵硬和疲劳）和ixekizumab总体健康相关生活质量（HRQoL）的影响：在这项中国3期随机、双盲、安慰剂对照研究中，r-axSpA患者被随机（1:1）分配接受ixekizumab 80毫克，每4周一次（IXEQ4W；起始剂量160毫克）或安慰剂治疗16周。第16周时，接受安慰剂治疗的患者转为接受IXEQ4W治疗，接受IXEQ4W治疗的患者则继续接受IXEQ4W治疗，直至第52周。在第 52 周收集了患者的总体、脊柱疼痛、夜间脊柱疼痛、僵硬和疲劳数据。确定了脊柱疼痛和夜间脊柱疼痛的最小临床重要差异（MCID）。根据诊断后的基线病程和基线C反应蛋白（CRP）水平进行了亚组分析：结果：与安慰剂相比，接受IXEQ4W治疗的患者在第16周时的PROs（患者总体情况、脊柱疼痛、夜间脊柱疼痛、僵硬和疲劳）与基线相比有明显改善，且起效迅速。这种改善一直持续到第 52 周。脊柱疼痛和夜间脊柱疼痛的 MCID 反应也出现了类似的改善趋势。总体 HRQoL 的改善得到了 EQ-5D-5L 评估的支持。亚组分析表明，与安慰剂相比，无论基线病程或基线CRP水平如何，IXEQ4W在第16周的疗效显著提高：结论：IXEQ4W可快速、持续地改善r-axSpA中国患者的临床相关PROs和整体HRQoL，疗程为1年。无论基线病程长短或基线CRP水平如何，都能观察到一致的疗效：试验注册：ClinicalTrials.gov标识符NCT04285229。
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来源期刊
Rheumatology and Therapy
RHEUMATOLOGY-
CiteScore
6.00
自引率
5.30%
发文量
91
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.
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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). For more information on our publishing ethics policies, please see here: https://www.springer.com/gp/editorial-policies
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