KiOmedine® CM-Chitosan is Effective for Treating Advanced Symptomatic Knee Osteoarthritis up to Six Months Following a Single Intra-Articular Injection: A Post Hoc Analysis of Aproove Clinical Study

Abstract

Background: Symptomatic knee osteoarthritis (OA) is typically treated with hyaluronan-based intra-articular injections. Advanced knee OA patients are often unresponsive to hyaluronan. KiOmedine ® Carboxymethyl-Chitosan (CM-Chitosan), a novel fluid implant, was safe and effective for treating symptomatic knee OA. Objective: The objective of this study is to describe the efficacy of a single injection of KiOmedine ® CM-Chitosan in advanced knee OA. Methods: Patients with advanced knee OA enrolled in the APROOVE trial and treated with KiOmedine ® CM-Chitosan were identified: subgroup-1, BMI >30 kg/m 2 and/or Kellgren Lawrence (KL) grade III (n=39), and subgroup-2, BMI >30 kg/m 2 and KL-grade III (n=8). Within-group analyses were performed using the WOMAC scores and OMERACT-OARSI responder criteria at 3 and 6 months. Results: In both subgroups, significant improvements in all WOMAC scores were observed at 3 and 6 months (p<0.001 for all comparisons). A high responder rate was observed at 3 and 6 months in subgroup-1 (63.2% and 65.8%) and in subgroup-2 (57.1% and 62.5%). Conclusion: This post hoc analysis of the APROOVE trial showed that a single intra-articular injection with KiOmedine ® CM-Chitosan could be an effective therapeutic option for patients with advanced knee OA. Clinical trial registration number: Clinicaltrial.gov identifier: Net30679208.