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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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

期刊介绍： Lippincott Williams & Wilkins is a leading international publisher of professional health information for physicians, nurses, specialized clinicians and students. For a complete listing of titles currently published by Lippincott Williams & Wilkins and detailed information about print, online, and other offerings, please visit the LWW Online Store. Recognized internationally as the leading journal in its field, Spine is an international, peer-reviewed, bi-weekly periodical that considers for publication original articles in the field of Spine. It is the leading subspecialty journal for the treatment of spinal disorders. Only original papers are considered for publication with the understanding that they are contributed solely to Spine. The Journal does not publish articles reporting material that has been reported at length elsewhere.