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A Randomized Controlled Trial

Lee S. Simon, MD; Arthur L. Weaver, MD; David Y. Graham, MD; Alan J. Kivitz, MD; Peter E. Lipsky, MD; Richard C. Hubbard, MD; Peter C. Isakson, PhD; Kenneth M. Verburg, PhD; Shawn S. Yu, PhD; William W. Zhao, PhD; G. Steven Geis, PhD, MD

JAMA. 1999;282:1921-1928.

Context  In vitro studies have shown that celecoxib inhibits cyclooxygenase 2 (COX-2) but not COX-1, suggesting that this drug may have anti-inflammatory and analgesic activity without adverse upper gastrointestinal (GI) tract effects that result from COX-1 inhibition.

Objective  To test whether celecoxib has efficacy as an anti-inflammatory and analgesic with reduced GI tract mucosal damage compared with conventional nonsteroidal anti-inflammatory drugs in patients with rheumatoid arthritis.

Design  Randomized, multicenter, placebo-controlled, double-blind trial lasting 12 weeks, with follow-up at weeks 2, 6, and 12, from September 1996 thorugh February 1998.

Setting  Seventy-nine clinical sites in the United States and Canada.

Patients  A total of 1149 patients aged 18 years or older with symptomatic rheumatoid arthritis who met inclusion criteria were randomized; 688 (60%) of these completed the study.

Interventions  Patients were randomized to receive celecoxib, 100 mg, 200 mg, or 400 mg twice per day (n = 240, 235, and 218, respectively); naproxen, 500 mg twice per day (n = 225); or placebo (n = 231).

Main Outcome Measures  Improvement in signs and symptoms of rheumatoid arthritis as assessed using standard measures of efficacy and GI tract safety as assessed by upper GI tract endoscopy before and after treatment, compared among treatment groups.

Results  All dosages of celecoxib and naproxen significantly improved the signs and symptoms of arthritis compared with placebo. Maximal anti-inflammatory and analgesic activity was evident within 2 weeks of initiating treatment and was sustained throughout the 12 weeks. The incidence of endoscopically determined gastroduodenal ulcers in placebo-treated patients was 4 (4%) of 99, and the incidences across all dosages of celecoxib were not significantly different (P>.40): 9 (6%) of 148 with 100 mg twice per day, 6 (4%) of 145 with 200 mg twice per day, and 8 (6%) of 130 with 400 mg twice per day. In contrast, the incidence with naproxen was 36 (26%) of 137, significantly greater than either placebo or celecoxib (P<.001). The overall incidences of GI tract adverse effects were 19% for placebo; 28%, 25%, and 26% for celecoxib 100 mg, 200 mg, and 400 mg twice per day, respectively; and 31% for naproxen.

Conclusion  In this study, all dosages of celecoxib were efficacious in the treatment of rheumatoid arthritis and did not affect COX-1 activity in the GI tract mucosa as evidenced by less frequent incidence of endoscopic ulcers compared with naproxen.

Author Affiliations: Department of Medicine, Division of Rheumatology and Metabolic Bone Disease, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass (Dr Simon); the Arthritis Center of Nebraska, Lincoln (Dr Weaver); Department of Medicine, Veterans Affairs Medical Center/Baylor College of Medicine, Houston, Tex (Dr Graham); Altoona Center for Clinical Research, Altoona, Pa (Dr Kivitz); Rheumatic Diseases Division, University of Texas Southwestern Medical Center, Dallas (Dr Lipsky); and Departments of Clinical Research (Drs Hubbard, Verburg, Yu, Zhao, and Geis) and COX-2 Technology (Dr Isakson), Searle Research and Development, Skokie, Ill.

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