Safety of celecoxib in patients with ulcerative colitis in remission: A randomized, placebo-controlled, pilot study

William J. Sandborn, William F. Stenson, Jørn Brynskov, Robin G. Lorenz, Gina M. Steidle, Jeffery L. Robbins, Jeffery D. Kent, Bradley J. Bloom

Research output: Contribution to journalArticlepeer-review

161 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)203-211
Number of pages9
JournalClinical Gastroenterology and Hepatology
Volume4
Issue number2
DOIs
StatePublished - Feb 1 2006

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