Safety of celecoxib in patients with ulcerative colitis in remission: a randomized, placebo-controlled, pilot study.
OBJECTIVE
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.
Sandborn
William J
WJ
Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. sandborn.william@mayo.edu
Stenson
William F
WF
Brynskov
Jørn
J
Lorenz
Robin G
RG
Steidle
Gina M
GM
Robbins
Jeffery L
JL
Kent
Jeffery D
JD
Bloom
Bradley J
BJ
D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001168:Arthritis / Q000188:drug therapy; D000068579:Celecoxib; D003093:Colitis, Ulcerative / Q000503:physiopathology*; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011720:Pyrazoles / Q000627:therapeutic use*; D012008:Recurrence; D013449:Sulfonamides / Q000627:therapeutic use*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib