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Protective effects of licofelone, a 5-lipoxygenase and cyclo-oxygenase inhibitor, versus naproxen on cartilage loss in knee osteoarthritis: a first multicentre clinical trial using quantitative MRI
  1. J-P Raynauld1,
  2. J Martel-Pelletier1,
  3. P Bias2,
  4. S Laufer3,
  5. B Haraoui1,
  6. D Choquette1,
  7. A D Beaulieu4,
  8. F Abram5,
  9. M Dorais6,
  10. É Vignon7,
  11. J-P Pelletier1,
  12. and the Canadian Licofelone Study Group
  1. 1
    Osteoarthritis Research Unit, University of Montreal Hospital Centre (CHUM), Notre-Dame Hospital, Montreal, Quebec, Canada
  2. 2
    Clinical Research, Merckle GmbH, Ulm, Germany
  3. 3
    Pharmaceutical Chemistry/Medicinal Chemistry, Eberhard-Karls-University Tübingen, Tübingen, Germany
  4. 4
    Faculty of Medicine, Laval University, Quebec, Canada
  5. 5
    ArthroVision Inc, Montreal, Quebec, Canada
  6. 6
    Research Group in Pharmacoepidemiology and Pharmacoeconomics, Research Centre, University of Montreal Hospital Centre (CHUM), Hôtel-Dieu, Montreal, Quebec, Canada
  7. 7
    Rheumatology, Centre hospitalier Lyon-Sud, Pierre-Bénite, Rhône, France
  1. Dr J-P Pelletier, Osteoarthritis Research Unit, University of Montreal Hospital Centre, Notre-Dame Hospital, 1560 Sherbrooke Street East, Montreal, Quebec, Canada H2L 4M1; dr{at}jppelletier.ca

Abstract

Objective: In a multicentre study to explore the effects of licofelone as a disease-modifying osteoarthritis drug in comparison with naproxen in patients with knee osteoarthritis (OA), using MRI and x-ray examination.

Methods: Patients with knee OA (n = 355) were randomised to receive either licofelone (200 mg twice a day) or naproxen (500 mg twice a day). MRI and x-ray examinations were performed at baseline, 6 months (MRI only), 12 and 24 months. MRI was used to assess quantitatively changes in cartilage volume, and x-ray examinations (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 intention 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 than in 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 did not reach significance. All clinical variables were improved at 24 months (p<0.001) for both groups, with a good safety profile.

Conclusion: 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 patients with knee OA. This study proves the superiority of quantitative MRI over x-ray examinations in a multicentre clinical trial.

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Footnotes

  • Competing interests: JPR is a consultant for ArthroVision Inc, MD is a consultant for ArthroLab Inc, JMP and JPP are consultants for, and shareholders in, ArthroLab Inc and ArthroVision Inc. PB is an employee and SL a scientific advisor of Merckle GmbH. BH, DC and EV received honoraria from ArthroLab Inc. FA is an employee of ArthroVision Inc.

  • Funding: This study was supported in part by grants from Merckle GmbH (Ulm, Germany) and ArthroLab Inc (Montreal, Quebec, Canada).

  • Contributors: We have read and approved the manuscript and contributed to the study design, data analysis, interpretation of data and drafting and revision of the manuscript. A data review committee (JPP, JMP, SL and PB) analysed the data and MD and JPR were responsible for the accuracy of the data.

  • Ethics approval: Approved by the local ethics committees.

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