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Osteoarthritis Cartilage. 2008 Nov;16(11):1289-93. doi: 10.1016/j.joca.2008.04.009. Epub 2008 Jun 2.

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

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1
Division of Rheumatology, Johns Hopkins University, Baltimore, MD 21224, USA. Clifton.bingham@jhmi.edu

Abstract

OBJECTIVES:

To determine the proportion of responders in two identical osteoarthritis (OA) trials using Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) criteria and to assess the comparability and correlation of individual component measurements.

METHODS:

Data were pooled from two identical 26-week, double-blind, randomized, parallel, multicenter trials comparing once daily etoricoxib 30 mg (N=475), celecoxib 200 mg (N=488), and placebo (N=244) in patients with OA of the knee or hip. OMERACT-OARSI criteria were (1) improvement in pain or physical function > or =50% and an absolute change > or =20 mm on a 100-mm visual analog scale (VAS); or (2) improvement of > or =20% and with an absolute change > or =10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment. Correlations were assessed between endpoints measured as time-weighted average change from baseline over 12 weeks using Pearson's correlation coefficient (r).

RESULTS:

There were significantly greater proportions of responders in the etoricoxib (66.2%) and celecoxib (63.5%) groups compared with the placebo group (43.0%; P<0.001). There was no difference between the two active treatment groups. There was high correlation between pain and physical function (r=0.903), pain and global assessment (r=0.778), and physical function and global assessment (r=0.820). There was high sensitivity (75-87%) and specificity (80-96%) for changes in individual component measurements to predict OMERACT-OARSI responders.

CONCLUSIONS:

Significantly more patients receiving etoricoxib or celecoxib than placebo were OMERACT-OARSI responders. The high correlation between individual scales composing this composite response measurement suggests some redundancies between individual components, particularly between pain and physical function.

PMID:
18514551
DOI:
10.1016/j.joca.2008.04.009
[Indexed for MEDLINE]
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