Original article
Safety of Celecoxib in Patients With Ulcerative Colitis in Remission: A Randomized, Placebo-Controlled, Pilot Study

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Background & Aims: The safety of selective cyclooxygenase-2 inhibitors in patients with ulcerative colitis in remission is unknown. Methods: We performed a placebo-controlled pilot trial to evaluate the safety of celecoxib in patients with ulcerative colitis in remission who had a present or past history of nonspecific arthritis, arthralgia, or other condition amenable to nonsteroidal anti-inflammatory drug therapy. A total of 222 patients with ulcerative colitis in remission were randomized to receive oral celecoxib 200 mg or placebo twice daily for 14 days. Remission was defined as a total Mayo Clinic score of 2 points or less and an endoscopic score of 1 point or less. Disease exacerbation was defined as a total Mayo Clinic score of 5 points or more and an increase in the endoscopic score of 1 point or more. The primary analysis was disease exacerbation through day 14 among patients who underwent randomization, had at least 1 dose of study drug, and had both endoscopy and Mayo Clinic disease activity index scores at the baseline and final assessments. Results: Three percent of patients in the celecoxib group experienced disease exacerbation through day 14, as compared with 4% in the placebo group (P = .719). Eleven percent of patients in each group experienced a bowel-related adverse event (P > .20). Conclusions: Therapy with celecoxib for up to 14 days did not have a greater relapse rate than placebo in patients with ulcerative colitis in remission who had a present or past history of nonspecific arthritis, arthralgia, or other condition amenable to nonsteroidal anti-inflammatory drug therapy.

Section snippets

Patients

This multicenter, randomized, double-blind, placebo-controlled, pilot trial was conducted at 34 centers in Argentina, Canada, Croatia, Denmark, Russia, Sweden, Turkey, and the United States between August 13, 2001, and March 10, 2004. The protocol was approved by the institutional review board at each center. All patients gave written informed consent.

The criteria for eligibility for the trial included men and women (18–75 years of age) with a history of ulcerative colitis, previously

Characteristics of the Patients

Figure 1 shows the enrollment and treatment of patients in the trial. The baseline characteristics of the patients who were randomized to celecoxib were similar to those of patients randomized to placebo (Table 2).

Ulcerative Colitis Disease Exacerbation

The rates of ulcerative colitis disease exacerbation were similar in the 2 groups (Table 3). Among randomized patients who had at least 1 dose of study drug and both an endoscopy assessment and a Mayo Clinic score at the baseline and final assessments (the prespecified primary

Discussion

Safe analgesic therapy for selected extraintestinal manifestations of ulcerative colitis including colitis-associated arthritis, sacroileitis, and ankylosing spondylitis, and for the treatment of acute pain in patients with ulcerative colitis, constitute important unmet medical needs. The results of our pilot safety trial indicate that short-term treatment with the selective cyclooxygenase-2 inhibitor celecoxib for up to 14 days did not have a greater clinical and endoscopic relapse rate than

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    Supported by a research grant from Pfizer Inc, Ann Arbor, MI. William Sandborn and William Stenson have served as consultants for Pfizer Inc. William Sandborn, William Stenson, and Jørn Brynskov have received research support from Pfizer Inc. Gina Steidle, Jeffery Robbins, and Bradley Bloom are employees of Pfizer Inc. Jeffery Kent is a former employee of Pfizer Inc. Robin G. Lorenz received partial compensation from Pfizer for the pathology services reported in the manuscript.

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