Background/Purpose

The Multicentre Osteoarthritis interVEntion trial with Sysadoa (MOVES) compared efficacy and safety of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) with that of Celecoxib (CE) in patients with knee osteoarthritis (OA) and severe knee pain.

Methods

606 patients with knee OA (Kellgren-Lawrence grade 2 or 3) and moderate to severe pain (WOMAC pain >300) were randomized to 400 mg CS + 500 mg GH tid or 200 mg CE qd for 6 months.

Methods 

Primary outcome was decrease in WOMAC pain (0–500 scale) from baseline to 6 months; non-inferiority margin was set at 40 (corresponding to 8 mm on a 0-100 mm scale). Secondary outcomes included WOMAC function/stiffness, VAS pain, joint swelling/effusion, use of rescue medication, OMERACT-OARSI Responder Index and EuroQoL-5D.

Patients were excluded if they had a history of known cardiovascular or gastrointestinal disease.

The main study analyses were performed using PP population. Primary efficacy analysis was also performed according to ITT to test the robustness of results.

Results

Mean age at baseline was 62.7 years, 83.9% were women, WOMAC pain was 371.3 (41.6) and 62.6% had KL grade 2. There were no differences between treatment groups.

Adjusted mean change (95% CI) from baseline to 6 months in WOMAC pain was –185.7 (–200.3; –171.1) (50.1% decrease) in CS+GH group and –186.8 (–201.7; –171.9) (50.2% decrease) in CE group (Figure 1). The mean difference at 6 months met non-inferiority margin: –1.11 (–22.0; 19.8). All sensitivity analyses confirmed the non-inferiority conclusion.

There were no differences at 6 months between treatment groups in the secondary outcomes, including WOMAC stiffness, with a decrease of 46.9% and 49.2% (P=0.434); WOMAC function, 45.5% and 46.0% (P=0.530); and VAS, 48.0% and 48.8% (P=0.924); in GH+CS and CE groups respectively. Similarly, there were no significant differences in patient and physician global assessments of disease activity or response to therapy. Over 70% of patients in both groups fulfilled OMERACT-OARSI responder criteria at 120 days with ~ 80% response rate at 6 months. Both groups had a reduction (>50%) in joint swelling from baseline, from 12.5% to 5.9% for CS+GH, and from 14.0% to 4.5% for CE. Use of rescue medication was low and similar between treatments. There was no difference in proportion of patients with treatment-emergent or SAEs between groups; no deaths occurred in this study.

Finally, there were no significant subgroup by treatment interactions for either efficacy or safety confirming consistence of non-inferiority of CS+GH across clinically relevant subgroups.

Conclusion

The MOVES trial confirms that CS+GH is comparable to CE in reducing pain in patients with knee OA and extends results from GAIT. This fixed-dose CS+GH combination should offer a safe and effective alternative for those patients with cardiovascular or gastrointestinal conditions who have contraindications to celecoxib.