Impact of Condoliase on Health-Related Quality of Life in Participants with Radicular Leg Pain Associated with Lumbar Disc Herniation: Results From a United States Phase 3 Clinical Trial.

IF 2.6 2区医学 Q2 CLINICAL NEUROLOGY

Spine Pub Date : 2025-03-11 DOI:10.1097/BRS.0000000000005327

Kevin E Macadaeg, Kee D Kim, Pragya B Gupta, Jose Rivera, Anand Patel, Kinsuk Chauhan, Jun Watanabe, Takayuki Seo, Evan Zucker, Kenneth Candido

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引用次数: 0

Abstract

Study design: An exploratory analysis of a randomized, double-blind, sham-controlled, phase 3 study.

Objective: To evaluate the impact of SI-6603 (condoliase) on health-related quality of life (HRQoL)-related outcomes in patients with lumbar disc herniation (LDH)-associated radicular leg pain from the Discovery 6603 study (NCT03607838).

Summary of background data: Condoliase is a novel chemonucleolytic agent that selectively degrades chondroitin sulfate in the nucleus pulposus. Condoliase is approved in Japan for the treatment of radicular leg pain associated with LDH. Recently, the Discovery 6603 study demonstrated the efficacy and tolerability of condoliase in the United States (US).

Methods: Adults with LDH and unilateral radicular leg pain were randomized to receive a single intradiscal injection of condoliase (1.25 units) or sham followed by 52 weeks of observation. Exploratory HRQoL-related outcomes included change from baseline (CFB) in EuroQol Group 5-Dimension Quality of Life instrument, 5-Level version (EQ-5D-5L) and visual analogue scale (EQ-VAS), CFB in the 36-item Short Form Health Survey (SF-36), Patient Global Impression of Change (PGIC), Clinical Global Impression of Change (CGIC), and CFB in Work Productivity and Activity Impairment (WPAI) scores. EQ-5D-5L and SF-36 measures were assessed using a longitudinal analysis model.

Results: Of 352 randomized participants, 341 constituted the modified intention-to-treat population (condoliase: 169; sham: 172). Condoliase showed numerically greater improvements in EQ-5D-5L self-care and pain/discomfort dimensions at Week 13 and Week 52 compared with sham (P<0.05). The SF-36 physical component and WPAI scores numerically favored condoliase compared with sham. Patients and clinicians more frequently reported "very much improved" in overall status following condoliase treatment vs sham.

Conclusion: Previous findings confirmed the efficacy and tolerability of condoliase for LDH management. Condoliase showed notable improvements in exploratory HRQoL-related outcomes, which were consistent across multiple patient-reported measures. Condoliase has the potential to enhance QoL and work productivity in individuals with LDH.

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吊唁对腰椎间盘突出相关神经根性腿痛患者健康相关生活质量的影响：来自美国一项3期临床试验的结果

研究设计：对一项随机、双盲、假对照的3期研究进行探索性分析。目的：从Discovery 6603研究（NCT03607838）中评估SI-6603（吊慰剂）对腰椎间盘突出症（LDH）相关神经根性腿痛患者健康相关生活质量（HRQoL）相关结局的影响。背景资料概述：慰问酶是一种新型化学溶核剂，可选择性降解髓核中的硫酸软骨素。在日本，康多莉安被批准用于治疗LDH相关的神经根性腿痛。最近，美国的发现6603研究证明了吊唁的有效性和耐受性。方法：将LDH合并单侧神经根性腿痛的成人患者随机分为单次椎间盘内注射（1.25单位）或假注射，观察52周。探索性hrqol相关结果包括EuroQol组5维生活质量量表的基线变化（CFB）、5级版本（EQ-5D-5L）和视觉模拟量表（EQ-VAS）、36项简短健康调查（SF-36）中的CFB、患者总体变化印象（PGIC）、临床总体变化印象（CGIC）和工作效率和活动障碍（WPAI）评分的CFB。EQ-5D-5L和SF-36测量采用纵向分析模型进行评估。结果：352名随机参与者中，341人构成了修改意向治疗人群(吊唁：169；骗局:172)。在第13周和第52周，与假组相比，吊唁剂在EQ-5D-5L自我护理和疼痛/不适维度上显示了更大的数字改善(p)结论：先前的研究结果证实了吊唁剂对LDH管理的有效性和耐受性。康多莉安在探索性hrqol相关结果中显示出显著的改善，这在多个患者报告的测量中是一致的。吊唁有可能提高LDH患者的生活质量和工作效率。

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

Spine 医学-临床神经学

CiteScore

5.90

自引率

6.70%

发文量

361

审稿时长

6.0 months

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