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Valdecoxib Effective With or Without Concomitant Medications, Including DMARDs: Presented at ACR

By Bruce Sylvester

NEW ORLEANS, LA -- October 29, 2002 -- A retrospective analysis of data from two clinical trials indicates that valdecoxib is effective for treating rheumatoid arthritis (RA) when administered with or without other common medications for RA.

The findings were presented here October 28 at the annual meeting of the American College of Rheumatology (ACR).

"Our analysis of the data from these two pivotal clinical trials suggested that patients experienced additional relief from the pain and inflammation of rheumatoid arthritis when they were given BEXTRA (valdecoxib) in addition to other types of medications such as disease-modifying anti-rheumatic drugs (DMARDs) or low-dose corticosteroids," said lead author Arthur Weaver, M.D., director of clinical research at the Arthritis Center of Nebraska in Lincoln, Nebraska, United States.

The studies also included subjects receiving no concomitant therapy, methotrexate or other DMARDs, or prednisone 10 mg/daily (or equivalent). A total of 95 subjects ( approximately 4.5 percent of the total) received etanercept.

Investigators analyzed pooled data from the two independent, 12 week, randomised, double blind, placebo controlled studies, originally designed to determine the efficacy and tolerability for RA subjects of valdecoxib 10 mg once daily or 20 mg daily compared with naproxen 500 mg bid, or placebo.

All subjects discontinued non-steroidal anti-inflammatory therapy and had RA flare prior to entry.

The investigators measured efficacy using the ACR-20 Responders Index, duration of morning stiffness, and Patient's Assessment of Arthritis Pain-visual analog scale (VAS).

The investigators evaluated data specifically for the incremental effect of valdecoxib in relieving pain and inflammation among RA subjects receiving ongoing treatment with DMARDs or low-dose oral corticosteroids, or those who were not taking a concomitant RA treatment.

Data on subjects receiving methotrexate were evaluated separately.

The pooled analysis indicated that valdecoxib subjects achieved improvement in the ACR-20 Responders Index compared to placebo when valdecoxib was given with or without a DMARD, methotrexate or the low-dose oral corticosteroid prednisone.

The investigators gauged whether concurrent treatment with valdecoxib 10 and 20 mg plus a DMARD, methotrexate or prednisone would affect treatment outcome by determining the odds ratio of improvement versus placebo when compared with naproxen versus placebo.

They found that for subjects treated with a DMARD other than methotrexate, valdecoxib 10 mg and 20 mg showed, respectively, a 1.7 and 1.3 odds ratio of improvement versus placebo. Naproxen showed an odds ratio of improvement versus placebo of 2.2.

This means that subjects receiving valdecoxib 10 mg were 1.7 times as likely as those treated with placebo to experience relief of signs and symptoms of RA, and those treated with valdecoxib 20 mg were 1.3 times as likely to experience the same. Subjects receiving naproxen were 2.2 times as likely to experience such relief.

Subjects not using a DMARD (other than methotrexate), who received valdecoxib 10 mg were 2.0 times as likely as those given placebo to experience relief. Those subjects receiving valdecoxib 20 mg were 2.3 times as likely to experience relief, and those using naproxen were 1.9 times as likely to experience relief.

The investigators found similar outcomes for subjects taking or not taking methotrexate. The odds ratio of improvement versus placebo for patients taking valdecoxib with methotrexate was 1.9 for valdecoxib 10 mg, 2.0 with valdecoxib 20 mg and 1.9 with naproxen.

For subjects not using methotrexate, the researchers found that it was 2.0 times more likely that a subject who received valdecoxib 10 mg would experience relief compared to one who received placebo. Subjects treated with valdecoxib 20 mg were 1.9 times as likely to experience relief compared to subjects treated with naproxen, who were 2.2 times as likely to experience relief.

The use of prednisone with either valdecoxib or naproxen did not significantly affect the results of the ACR-20 Responder Index.

The investigators concluded that valdecoxib showed similar efficacy to naproxen in all subject groups, whether or not they were taking prednisone or any comparator DMARD.

They observed improvements in the relief of the signs and symptoms of RA when valdecoxib was given to subjects along with prednisone and comparator DMARDs, suggesting that there may be a benefit to using both treatments together.

"Valdecoxib 10 and 20 mg once daily provides improvement over placebo when administered to RA patients already taking DMARDs or corticosteroids. This improvement in efficacy was observed even when valdecoxib was administered with highly effective and common DMARDs such as etanercept and methotrexate. Valdecoxib offers an incremental benefit over methotrexate alone, DMARDs or low-dose corticosteroids in the population studied," the authors concluded.

The study was supported by Pfizer Inc. and the Pharmacia Corporation.

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