Objective: This multi-centre study explored the effects of licofelone as a disease modifying drug (DMOAD) vis-à-vis naproxen in knee osteoarthritis (OA) patients, using magnetic resonance imaging (MRI) and X-rays.
Methods: Knee OA patients (n=355) were randomised to receive either licofelone (200 mg bid) or naproxen (500 mg bid). MRI and X-rays were performed at baseline, 6 (MRI only), 12, and 24 months. MRI was used to quantitatively assess changes in cartilage volume, and X-rays (Lyon-Schuss) to measure changes in the mean and minimum joint space width (JSW) in the medial compartment. Questionnaires probing symptoms were completed. Data were presented as intent-to-treat (ITT) and according-to-protocol (ATP).
Results: Cartilage volume loss in the global joint and medial and lateral compartments was significantly less in the licofelone compared to the naproxen group for ITT at 12 and 24 months, and for ATP at all times except in the medial compartment. Patients with medial meniscal extrusion had a greater loss of cartilage volume. In these patients, licofelone markedly reduced the cartilage loss for both ITT and ATP at 12 and 24 months. Although licofelone showed less reduction in the JSW than naproxen, this, however, did not reach significance. All clinical variables were improved at 24 months (P<0.0001) for both groups with a good safety profile.
Conclusion: Both drugs, licofelone and naproxen, were equally effective in reducing OA symptoms; however, licofelone significantly reduced cartilage volume loss over time, thus having a protective effect in knee OA patients. This study is the first to validate and to prove the superiority of qMRI over X-rays in a multi-centre clinical trial.