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

研究概要

Three hundred forty-one randomized patients with Lumbar Disk Herniation (LDH) -associated unilateral radicular leg pain were analyzed (modified ITT): condoliase (n=169) vs sham (n=172). The primary outcomes for this exploratory report were HRQoL changes (EQ-5D-5L domains and EQ-VAS) at weeks 13 and 52. Secondary outcomes included SF-36 PCS/MCS, PGIC and CGIC responder proportions, and WPAI domains; assessments continued through 52 weeks. Overall, the results of the study revealed greater improvements with condoliase in EQ-5D-5L self-care and pain/discomfort, EQ-VAS at week 52, SF-36 PCS, higher PGIC/CGIC responder rates from week 6 onward, and modest advantages across WPAI domains. In short, a single condoliase injection produced clinically meaningful, durable gains in physical HRQoL and perceived overall improvement versus sham over one year.