An Open-Label Pilot Study Evaluating by Magnetic Resonance Imaging the Potential for a Disease-Modifying Effect of Celecoxib Compared to a Modelized Historical Control Cohort in the Treatment of Knee Osteoarthritis
The aim of the study was to evaluate by quantitative magnetic resonance imaging the effect of celecoxib 200 mg daily on cartilage volume loss over 12 months in knee osteoarthritis. The primary outcome of this study was to evaluate cartilage volume loss in the medial compartment of the knee (femoral...
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| Published in | Seminars in arthritis and rheumatism Vol. 40; no. 3; pp. 185 - 192 |
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| Main Authors | , , , , , , , , |
| Format | Journal Article |
| Language | English |
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New York, NY
Elsevier Inc
01.12.2010
Elsevier |
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| Online Access | Get full text |
| ISSN | 0049-0172 1532-866X 1532-866X |
| DOI | 10.1016/j.semarthrit.2009.10.003 |
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| Abstract | The aim of the study was to evaluate by quantitative magnetic resonance imaging the effect of celecoxib 200 mg daily on cartilage volume loss over 12 months in knee osteoarthritis.
The primary outcome of this study was to evaluate cartilage volume loss in the medial compartment of the knee (femoral condyle and tibial plateau) assessed by quantitative magnetic resonance imaging on subjects receiving continuous treatment with celecoxib 200 mg daily for 12 months compared with a modelized historical control cohort, as expressed by the percentage loss from baseline. Safety of the medication was also assessed. Comparison of the observed volume loss to the expected loss was evaluated by a multivariate linear regression model based on a historical cohort.
For the primary outcome, the 95% confidence intervals for the mean observed celecoxib cohort joint medial compartment cartilage volume loss (6.81% [6.01; 7.60]) and mean predicted loss (modelized historical cohort) (5.65% [5.10; 6.19]) overlap, indicating no significant difference and hence no effect of celecoxib on the medial compartment cartilage volume loss. Similar findings were demonstrated for the lateral compartment cartilage loss. The safety data reported several minor adverse events similar to those typically seen in a 1-year clinical trial.
Although celecoxib was demonstrated to be safe for knee osteoarthritis at a 200 mg daily dose, it did not provide a protective effect on knee cartilage loss. Cohort modelization is an efficient and unbiased way to provide a comparator group for the assessment of novel treatments when classic head-to-head randomized controlled trials are not feasible. |
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| AbstractList | The aim of the study was to evaluate by quantitative magnetic resonance imaging the effect of celecoxib 200 mg daily on cartilage volume loss over 12 months in knee osteoarthritis.
The primary outcome of this study was to evaluate cartilage volume loss in the medial compartment of the knee (femoral condyle and tibial plateau) assessed by quantitative magnetic resonance imaging on subjects receiving continuous treatment with celecoxib 200 mg daily for 12 months compared with a modelized historical control cohort, as expressed by the percentage loss from baseline. Safety of the medication was also assessed. Comparison of the observed volume loss to the expected loss was evaluated by a multivariate linear regression model based on a historical cohort.
For the primary outcome, the 95% confidence intervals for the mean observed celecoxib cohort joint medial compartment cartilage volume loss (6.81% [6.01; 7.60]) and mean predicted loss (modelized historical cohort) (5.65% [5.10; 6.19]) overlap, indicating no significant difference and hence no effect of celecoxib on the medial compartment cartilage volume loss. Similar findings were demonstrated for the lateral compartment cartilage loss. The safety data reported several minor adverse events similar to those typically seen in a 1-year clinical trial.
Although celecoxib was demonstrated to be safe for knee osteoarthritis at a 200 mg daily dose, it did not provide a protective effect on knee cartilage loss. Cohort modelization is an efficient and unbiased way to provide a comparator group for the assessment of novel treatments when classic head-to-head randomized controlled trials are not feasible. The aim of the study was to evaluate by quantitative magnetic resonance imaging the effect of celecoxib 200 mg daily on cartilage volume loss over 12 months in knee osteoarthritis.OBJECTIVESThe aim of the study was to evaluate by quantitative magnetic resonance imaging the effect of celecoxib 200 mg daily on cartilage volume loss over 12 months in knee osteoarthritis.The primary outcome of this study was to evaluate cartilage volume loss in the medial compartment of the knee (femoral condyle and tibial plateau) assessed by quantitative magnetic resonance imaging on subjects receiving continuous treatment with celecoxib 200 mg daily for 12 months compared with a modelized historical control cohort, as expressed by the percentage loss from baseline. Safety of the medication was also assessed. Comparison of the observed volume loss to the expected loss was evaluated by a multivariate linear regression model based on a historical cohort.METHODSThe primary outcome of this study was to evaluate cartilage volume loss in the medial compartment of the knee (femoral condyle and tibial plateau) assessed by quantitative magnetic resonance imaging on subjects receiving continuous treatment with celecoxib 200 mg daily for 12 months compared with a modelized historical control cohort, as expressed by the percentage loss from baseline. Safety of the medication was also assessed. Comparison of the observed volume loss to the expected loss was evaluated by a multivariate linear regression model based on a historical cohort.For the primary outcome, the 95% confidence intervals for the mean observed celecoxib cohort joint medial compartment cartilage volume loss (6.81% [6.01; 7.60]) and mean predicted loss (modelized historical cohort) (5.65% [5.10; 6.19]) overlap, indicating no significant difference and hence no effect of celecoxib on the medial compartment cartilage volume loss. Similar findings were demonstrated for the lateral compartment cartilage loss. The safety data reported several minor adverse events similar to those typically seen in a 1-year clinical trial.RESULTSFor the primary outcome, the 95% confidence intervals for the mean observed celecoxib cohort joint medial compartment cartilage volume loss (6.81% [6.01; 7.60]) and mean predicted loss (modelized historical cohort) (5.65% [5.10; 6.19]) overlap, indicating no significant difference and hence no effect of celecoxib on the medial compartment cartilage volume loss. Similar findings were demonstrated for the lateral compartment cartilage loss. The safety data reported several minor adverse events similar to those typically seen in a 1-year clinical trial.Although celecoxib was demonstrated to be safe for knee osteoarthritis at a 200 mg daily dose, it did not provide a protective effect on knee cartilage loss. Cohort modelization is an efficient and unbiased way to provide a comparator group for the assessment of novel treatments when classic head-to-head randomized controlled trials are not feasible.CONCLUSIONSAlthough celecoxib was demonstrated to be safe for knee osteoarthritis at a 200 mg daily dose, it did not provide a protective effect on knee cartilage loss. Cohort modelization is an efficient and unbiased way to provide a comparator group for the assessment of novel treatments when classic head-to-head randomized controlled trials are not feasible. Objectives The aim of the study was to evaluate by quantitative magnetic resonance imaging the effect of celecoxib 200 mg daily on cartilage volume loss over 12 months in knee osteoarthritis. Methods The primary outcome of this study was to evaluate cartilage volume loss in the medial compartment of the knee (femoral condyle and tibial plateau) assessed by quantitative magnetic resonance imaging on subjects receiving continuous treatment with celecoxib 200 mg daily for 12 months compared with a modelized historical control cohort, as expressed by the percentage loss from baseline. Safety of the medication was also assessed. Comparison of the observed volume loss to the expected loss was evaluated by a multivariate linear regression model based on a historical cohort. Results For the primary outcome, the 95% confidence intervals for the mean observed celecoxib cohort joint medial compartment cartilage volume loss (6.81% [6.01; 7.60]) and mean predicted loss (modelized historical cohort) (5.65% [5.10; 6.19]) overlap, indicating no significant difference and hence no effect of celecoxib on the medial compartment cartilage volume loss. Similar findings were demonstrated for the lateral compartment cartilage loss. The safety data reported several minor adverse events similar to those typically seen in a 1-year clinical trial. Conclusions Although celecoxib was demonstrated to be safe for knee osteoarthritis at a 200 mg daily dose, it did not provide a protective effect on knee cartilage loss. Cohort modelization is an efficient and unbiased way to provide a comparator group for the assessment of novel treatments when classic head-to-head randomized controlled trials are not feasible. |
| Author | Bessette, Louis Choquette, Denis Pelletier, Jean-Pierre Martel-Pelletier, Johanne Beaulieu, André Haraoui, Boulos Abram, François Morin, Frédéric Raynauld, Jean-Pierre |
| Author_xml | – sequence: 1 givenname: Jean-Pierre surname: Raynauld fullname: Raynauld, Jean-Pierre organization: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, Quebec, Canada – sequence: 2 givenname: Johanne surname: Martel-Pelletier fullname: Martel-Pelletier, Johanne organization: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, Quebec, Canada – sequence: 3 givenname: André surname: Beaulieu fullname: Beaulieu, André organization: Faculty of Medicine, Laval University, Quebec, Quebec, Canada – sequence: 4 givenname: Louis surname: Bessette fullname: Bessette, Louis organization: Groupe de Recherche en Rhumatologie et Maladies Osseuses, Sainte-Foy, Quebec, Canada – sequence: 5 givenname: Frédéric surname: Morin fullname: Morin, Frédéric organization: Centre de Recherche Musculo-squelettique, Trois-Rivières, Quebec, Canada – sequence: 6 givenname: Denis surname: Choquette fullname: Choquette, Denis organization: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, Quebec, Canada – sequence: 7 givenname: Boulos surname: Haraoui fullname: Haraoui, Boulos organization: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, Quebec, Canada – sequence: 8 givenname: François surname: Abram fullname: Abram, François organization: ArthroVision Inc., Montreal, Quebec, Canada – sequence: 9 givenname: Jean-Pierre surname: Pelletier fullname: Pelletier, Jean-Pierre email: dr@jppelletier.ca organization: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre (CRCHUM), Notre-Dame Hospital, Montreal, Quebec, Canada |
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| Keywords | BML RCT cohort study CBC MRI NSAID qMRI quantitative MRI COX cartilage loss OA MCO WOMAC HC modelization BMI magnetic resonance imaging osteoarthritis Western Ontario and McMaster Universities Osteoarthritis Index quantitative magnetic resonance imaging modelized historical cohort celecoxib cohort body mass index cyclooxygenase randomized controlled trial bone marrow lesion historical cohort nonsteroidal anti-inflammatory drug Knee Knee osteoarthritis Diseases of the osteoarticular system Rheumatology Celecoxib Nuclear magnetic resonance imaging Non steroidal antiinflammatory agent Cartilage Treatment Cohort study Arthropathy Medical imagery Degenerative disease Osteoarthritis Quantitative analysis |
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| SubjectTerms | Aged Anti-Inflammatory Agents, Non-Steroidal - therapeutic use Biological and medical sciences Bones, joints and connective tissue. Antiinflammatory agents cartilage loss Cartilage, Articular - pathology Celecoxib Cohort Studies cohort study Cyclooxygenase 2 Inhibitors - adverse effects Cyclooxygenase 2 Inhibitors - therapeutic use Disease Progression Diseases of the osteoarticular system Dose-Response Relationship, Drug Dyspepsia - chemically induced Female Heart Failure - chemically induced Humans Hypertension - chemically induced Linear Models Longitudinal Studies Magnetic Resonance Imaging Male Medical sciences Middle Aged Miscellaneous. Osteoarticular involvement in other diseases modelization Osteoarthritis Osteoarthritis, Knee - drug therapy Osteoarthritis, Knee - pathology Pharmacology. Drug treatments Pilot Projects Pyrazoles - adverse effects Pyrazoles - therapeutic use quantitative MRI Rheumatology Sulfonamides - adverse effects Sulfonamides - therapeutic use Treatment Outcome |
| Title | An Open-Label Pilot Study Evaluating by Magnetic Resonance Imaging the Potential for a Disease-Modifying Effect of Celecoxib Compared to a Modelized Historical Control Cohort in the Treatment of Knee Osteoarthritis |
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