Responder analysis and correlation of outcome measures: pooled results from two identical studies comparing etoricoxib, celecoxib, and placebo in osteoarthritis

Osteoarthritis and Cartilage

Volumn 16, Issue 11, 2008, Pages 1289-1293

  Bingham III, C O ^a   Bird, S R ^b   Smugar, S S ^b   Xu, X ^b   Tershakovec, A M ^b  

^a JOHNS HOPKINS UNIVERSITY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Celecoxib; Etoricoxib; NSAID; OMERACT OARSI; Osteoarthritis; Responder criteria; Response

Indexed keywords

ACETYLSALICYLIC ACID; CELECOXIB; CYCLOOXYGENASE 2 INHIBITOR; ETORICOXIB; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PLACEBO;

ADULT; ARTHRALGIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORRELATION ANALYSIS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; HIP OSTEOARTHRITIS; HUMAN; KNEE OSTEOARTHRITIS; KNEE PAIN; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PARALLEL DESIGN; PREDICTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; SENSITIVITY AND SPECIFICITY; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; VISUAL ANALOG SCALE;

AGED; ANALYSIS OF VARIANCE; CYCLOOXYGENASE INHIBITORS; FEMALE; HEALTH STATUS INDICATORS; HUMANS; MALE; MIDDLE AGED; OSTEOARTHRITIS, HIP; OSTEOARTHRITIS, KNEE; PAIN MEASUREMENT; PYRAZOLES; PYRIDINES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SULFONAMIDES; SULFONES; TREATMENT OUTCOME;

EID: 53849096995     PISSN: 10634584     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.joca.2008.04.009     Document Type: Article

References (34)

1. Altman R., Brandt K., Hochberg M., Moskowitz R., Bellamy N., Bloch D.A., et al. Design and conduct of clinical trials in patients with osteoarthritis: recommendations from a task force of the Osteoarthritis Research Society. Results from a workshop. Osteoarthritis Cartilage 4 (1996) 217-243
2. Bellamy N., Kirwan J., Boers M., Brooks P., Strand V., Tugwell P., et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 24 (1997) 799-802
3. Bellamy N., Buchanan W.W., Goldsmith C.H., Campbell J., and Stitt L.W. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 15 (1988) 1833-1840
4. Meenan R.F., Mason J.H., Anderson J.J., Guccione A.A., and Kazis L.E. AIMS2. The content and properties of a revised and expanded Arthritis Impact Measurement Scales Health Status Questionnaire. Arthritis Rheum 35 (1992) 1-10
5. Lequesne M.G., Mery C., Samson M., and Gerard P. Indexes of severity for osteoarthritis of the hip and knee. Validation-value in comparison with other assessment tests. Scand J Rheumatol Suppl 65 (1987) 85-89
6. Dougados M., Leclaire P., van der Heijde D., Bloch D.A., Bellamy N., and Altman R.D. Response criteria for clinical trials on osteoarthritis of the knee and hip: a report of the Osteoarthritis Research Society International Standing Committee for Clinical Trials response criteria initiative. Osteoarthritis Cartilage 8 (2000) 395-403
7. Pham T., van der Heijde D., Altman R.D., Anderson J.J., Bellamy N., Hochberg M., et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthritis Cartilage 12 (2004) 389-399
8. Felson D.T., Anderson J.J., Boers M., Bombardier C., Furst D., Goldsmith C., et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 38 (1995) 727-735
9. Anderson J.J., Baron G., van der Heijde D., Felson D.T., and Dougados M. Ankylosing spondylitis assessment group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 44 (2001) 1876-1886
10. Bingham III C.O., Sebba A.I., Rubin B.R., Ruoff G.E., Kremer J., Bird S., et al. Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies. Rheumatology (Oxford) 46 (2007) 496-507
11. Sheldon E.A., Bird S., Smugar S.S., and Tershakovec A.M. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine 33 (2008) 533-538
12. Bayat N., Keen H.I., and Hill C.L. Randomized clinical trials of osteoarthritis: a review. APLAR J Rheumatol 4 (2005) 171-176
13. Fleischmann R., Sheldon E., Maldonado-Cocco J., Dutta D., Yu S., and Sloan V.S. Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a prospective randomized 13-week study versus placebo and celecoxib. Clin Rheumatol 25 (2006) 42-53
14. Lehmann R., Brzosko M., Kopsa P., Nischik R., Kreisse A., Thurston H., et al. Efficacy and tolerability of lumiracoxib 100 mg once daily in knee osteoarthritis: a 13-week, randomized, double-blind study vs. placebo and celecoxib. Curr Med Res Opin 21 (2005) 517-526
15. Sheldon E., Beaulieu A., Paster Z., Dutta D., Yu S., and Sloan V.S. Efficacy and tolerability of lumiracoxib in the treatment of osteoarthritis of the knee: a 13-week, randomized, double-blind comparison with celecoxib and placebo. Clin Ther 27 (2005) 64-77
16. Mazieres B., Hucher M., Zaim M., and Garnero P. Effect of chondroitin sulphate in symptomatic knee osteoarthritis: a multicentre, randomised, double-blind, placebo-controlled study. Ann Rheum Dis 66 (2007) 639-645
17. Thumboo J., Chew L.H., and Soh C.H. Validation of the Western Ontario and McMaster University osteoarthritis index in Asians with osteoarthritis in Singapore. Osteoarthritis Cartilage 9 (2001) 440-446
18. Creamer P., Lethbridge-Cejku M., and Hochberg M.C. Factors associated with functional impairment in symptomatic knee osteoarthritis. Rheumatology (Oxford) 39 (2000) 490-496
19. Faucher M., Poiraudeau S., Lefevre-Colau M.M., Rannou F., Fermanian J., and Revel M. Algo-functional assessment of knee osteoarthritis: comparison of the test-retest reliability and construct validity of the WOMAC and Lequesne indexes. Osteoarthritis Cartilage 10 (2002) 602-610
20. Bruce B., and Fries J. Longitudinal comparison of the Health Assessment Questionnaire (HAQ) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Arthritis Rheum 51 (2004) 730-737
21. Wolfe F. Determinants of WOMAC function, pain and stiffness scores: evidence for the role of low back pain, symptom counts, fatigue and depression in osteoarthritis, rheumatoid arthritis and fibromyalgia. Rheumatology (Oxford) 38 (1999) 355-361
22. Lingard E.A., Katz J.N., Wright R.J., Wright E.A., and Sledge C.B. Validity and responsiveness of the Knee Society Clinical Rating System in comparison with the SF-36 and WOMAC. J Bone Joint Surg Am 83-A (2001) 1856-1864
23. Ryser L., Wright B.D., Aeschlimann A., Mariacher-Gehler S., and Stucki G. A new look at the Western Ontario and McMaster Universities Osteoarthritis Index using Rasch analysis. Arthritis Care Res 12 (1999) 331-335
24. Stratford P.W., and Kennedy D.M. Does parallel item content on WOMAC's pain and function subscales limit its ability to detect change in functional status?. BMC Musculoskelet Disord 5 (2004) 17
25. Guccione A.A., Felson D.T., and Anderson J.J. Defining arthritis and measuring functional status in elders: methodological issues in the study of disease and physical disability. Am J Public Health 80 (1990) 945-949
26. Stratford P.W., and Kennedy D.M. Performance measures were necessary to obtain a complete picture of osteoarthritic patients. J Clin Epidemiol 59 (2006) 160-167
27. Witvrouw E., Victor J., Bellemans J., Rock B., Van Lummel R., Van Der Slikke R., et al. A correlation study of objective functionality and WOMAC in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 10 (2002) 347-351
28. Lamb S.E., Guralnik J.M., Buchner D.M., Ferrucci L.M., Hochberg M.C., Simonsick E.M., et al. Factors that modify the association between knee pain and mobility limitation in older women: the Women's Health and Aging Study. Ann Rheum Dis 59 (2000) 331-337
29. Bellamy N., Carr A., Dougados M., Shea B., and Wells G. Towards a definition of "difference" in osteoarthritis. J Rheumatol 28 (2001) 427-430
30. Ehrich E.W., Davies G.M., Watson D.J., Bolognese J.A., Seidenberg B.C., and Bellamy N. Minimal perceptible clinical improvement with the Western Ontario and McMaster Universities osteoarthritis index questionnaire and global assessments in patients with osteoarthritis. J Rheumatol 27 (2000) 2635-2641
31. Leung A.T., Malmstrom K., Gallcher A.E., Sarembock B., Poor G., Beaulieu A., et al. Efficacy and tolerability profile of etoricoxib in patients with osteoarthritis: a randomized, double-blind, placebo and active-comparator controlled 12-week efficacy trial. Curr Med Res Opin 18 (2002) 49-58
32. Gibofsky A., Williams G.W., McKena F., and Fort J.G. Comparing the efficacy of cyclooxygenase 2-specific inhibitors in treating osteoarthritis: appropriate trial design considerations and results of a randomized, placebo-controlled trial. Arthritis Rheum 48 (2003) 3102-3111
33. Reginster J.Y., Malmstrom K., Mehta A., Bergman G., Ko A.T., Curtis A.P., et al. Evaluation of the efficacy and safety of etoricoxib compared with naproxen in two, 138-week randomised studies of patients with osteoarthritis. Ann Rheum Dis 66 (2007) 945-951
34. Tubach F., Ravaud P., Baron G., Falissard B., Logeart I., Bellamy N., et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis 64 (2005) 29-33