背景:Ixekizumab,白细胞介素17A(IL-17A)抑制剂,在全球和中国人群中,活动性放射学轴性脊柱关节炎(r-axSpA)患者的体征和症状得到了快速和持续的改善。我们研究了ixekizumab对患者报告结果(PRO)的影响(包括患者全球,脊椎疼痛,刚度,和疲劳)和ixekizumab在中国的3期研究中的整体健康相关生活质量(HRQoL)。
方法:在中国第三阶段,随机,双盲,安慰剂对照研究,r-axSpA患者被随机分组(1∶1),每4周接受ixekizumab80mg(IXEQ4W;起始剂量160mg)或安慰剂,共16周.在第16周,接受安慰剂的患者切换到IXEQ4W,那些接受IXEQ4W的人继续说,直到第52周。全球患者数据,脊椎疼痛,夜间脊髓疼痛,刚度,和疲劳收集到第52周。确定了脊柱疼痛和夜间脊柱疼痛的最小临床重要差异(MCID)。根据自诊断以来的基线疾病持续时间和基线C反应蛋白(CRP)水平进行亚组分析。
结果:与安慰剂相比,接受IXEQ4W治疗的患者报告显着改善,与PRO基线相比变化迅速开始(患者全局,脊椎疼痛,夜间脊髓疼痛,刚度,和疲劳)直到第16周。改善持续到第52周。在脊柱疼痛和夜间脊柱疼痛的MCID反应中也观察到类似的改善趋势。EQ-5D-5L评估支持整体HRQoL的改善。亚组分析表明,与安慰剂相比,IXEQ4W在第16周提供了显著更大的疗效。无论基线疾病持续时间或基线CRP水平。
结论:IXEQ4W在中国r-axSpA患者中通过1年的治疗,在临床相关的PRO和整体HRQoL方面提供了快速和持续的改善。无论基线疾病持续时间或基线CRP水平如何,观察到一致的疗效。
背景:ClinicalTrials.gov标识符NCT04285229。
BACKGROUND: 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.
CONCLUSIONS: 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.
BACKGROUND: ClinicalTrials.gov identifier NCT04285229.