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COX-2-specific Inhibition In Musculoskeletal Pain And Inflammation - Clinical Update: Presented at ACR

By Maria Bishop

PHILADELPHIA, PA -- December 7, 2000 -- The currently available cyclo-oxygenase-2 specific inhibitors, celecoxib and rofecoxib, are equal in efficacy to the conventional non-steroidal anti-inflammatory drugs (NSAIDs), stated Steven B. Abramson, MD, at a satellite symposium of the American College of Rheumatology 2000 National Scientific Meeting held on Oct. 29 to Nov. 2 in Philadelphia, Pennsylvania.

Dr. Abramson is a professor of medicine and pathology, and chief of the division of rheumatology for New York University School of Medicine, in New York City. He is also chairman of the department of rheumatology and medicine at the Hospital for Joint Diseases in New York City.

In his address, Dr. Abramson noted that many clinical trials of the cyclo-oxygenase-2 (COX-2) inhibitors support efficacy claims in the treatment of osteoarthritis (OA).

He cited several studies of celecoxib, most of them measuring efficacy by means of patient-reported improvements in OA symptoms using the Western Ontario and McMaster Universities (WOMAC) indices (for pain, stiffness and physical function) and patient- and physician-assessed visual analog scales (VAS) for pain. These studies included the following:

- celecoxib (100 mg twice daily and 200 mg twice daily) versus diclofenac (50 mg three times daily and 75 mg twice daily);

- celecoxib (100 mg twice daily and 200 mg twice daily) versus naproxen (500 mg twice daily); and

- celecoxib (200 mg once daily) versus celecoxib (100 mg twice daily).

In all of these studies, celecoxib was found to be comparable to non-steroidal anti-inflammatory drugs (NSAIDs) in terms of clinical efficacy, Dr. Abramson noted. (Bensen WG, et al. Mayo Clin Proc 1999; 74:1095-1105.) As well, once-daily doses of celecoxib were found to be clinically comparable to twice-daily doses for efficacy, leading researchers to decide that a once-daily 200-mg dose is sufficient for most OA patients, Dr. Abramson stated. (Williams GW, et al. Clin Rheumatol 2000; 6:65-74.)

He also presented findings from studies of rofecoxib in the treatment of OA, which measured patient-reported improvements using the WOMAC indices as well as other, official patient-assessment vehicles for determining pain and response to treatment. Studies examined included the following:

- Rofecoxib (12.5 mg daily and 25 mg daily) and ibuprofen (800 mg three times daily);

- Rofecoxib (12.5 mg daily and 25 mg daily) and diclofenac (50 mg three times daily).

Again, Dr. Abramson noted, the COX-2 inhibitor was found to be comparable to NSAIDs in terms of clinical efficacy. (Day R, et al. Arch Intern Med 2000; 160:1781-1787. Cannon GW, et al. Arthritis Rheum 2000; 43:978-987.)

A subsequent six-week trial compared the efficacy of once-daily doses of celecoxib (200 mg) to rofecoxib (25 mg) in OA of the knee. Using outcomes similar to those in the previously discussed trials, both agents proved equally efficacious. (Presented at 2000 Scientific Assembly, American Academy of Family Physicians; September 21, 2000.)

Celecoxib is also indicated for use in the treatment of rheumatoid arthritis (RA). While RA is not an indication for rofecoxib at press time, it is expected that this agent will shortly be approved in the United States for use in treating patients with RA.

Dr. Abramson also discussed results from clinical trials for efficacy in treating RA, including the following:

- Celecoxib (100 mg twice daily, 200 mg twice daily, 400 mg twice daily) versus naproxen (500 mg twice daily);

- Celecoxib (200 mg twice daily) versus diclofenac SR (75 mg twice daily).

Once again, the trials demonstrated that specific inhibition of COX-2 by celecoxib is equivalent to the anti-inflammatory effects of non-selective NSAIDs in treating RA. (Simon LS, et al. JAMA 1999; 282:1921-1928. Kosinski M, et al. Arthritis Rheum 2000; 43:1478-1487. Emery P, et al. Lancet 1999; 354:2106-2111.)

Dr. Abramson also mentioned an eight-week trial of rofecoxib (5 mg daily, 25 mg daily and 50 mg daily) in the treatment of RA. "In this trial," he noted, "significant improvements were shown for rofecoxib at both of the higher doses, as measured by the Health Assessment Questionnaire (HAQ) index. The 50-mg daily dose, however, is not recommended because of side effects." (Schnitzer TJ, et al. Clin Ther 1999; 21:1688-1702.)

Dr. Abramson concluded that the equal efficacy of the COX-2 agents compared to NSAIDs in these diseases is well-documented.

Steven B. Abramson is a consultant for Searle, and a member of the Speakers Bureau for Pfizer, Inc.

Supported by an unrestricted educational grant from Pharmacia.

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