Infliximab Not Helpful in Steroid-Refractory Ulcerative Colitis
Laurie Barclay, MD
July 3, 2003 — Infliximab is not helpful for treating patients with steroid-refractory ulcerative colitis, according to the results of a randomized controlled trial published in the July issue of Gut.
"[Tumor] necrosis factor (TNF) production is increased in the mucosa of patients with active ulcerative colitis," write C. S. J. Probert, from Bristol Royal Infirmary in the U.K., and colleagues. "Infliximab, a chimeric anti-TNF monoclonal antibody, is a potent anti-inflammatory agent that effectively blocks the action of TNF."
In this study, 43 patients with glucocorticoid-resistant ulcerative colitis received infusions of infliximab, 5 mg/kg, or placebo at weeks 0 and 2, and they were followed for eight weeks. Patients not in remission, defined as an ulcerative colitis symptom score (UCSS) of not greater than 2 and/or Baron score of 0 at week 6 were offered open-label infliximab 10 mg/kg and re-evaluated two weeks later.
There were no statistically significant differences between the infliximab and placebo groups in the proportion of patients with a Baron score of 0 after two weeks (3 [13%] of 23 patients vs. 1 [5%] of 19 patients; 95% confidence interval [CI], -9% to 24%; P = .74); remission (UCSS P = .76); median improvement in UCSS (3 vs. 2.5; P = .82), or improvement in the quality-of-life index for inflammatory bowel disease (P = .22) and EuroQol (P = 0.3).
Of 20 eligible patients given open-label infusions, 3 (27%) of 11 patients initially treated with infliximab and 1 (11%) of 9 patients treated with placebo achieved remission.
"Our data do not support the widespread use of infliximab in the management of glucocorticoid-resistant ulcerative colitis," the authors write. "The small advantage of infliximab in glucocorticoid sparing deserves further exploration in controlled trials. It is possible that, with refinement of laboratory techniques, a subgroup of responders may be found, but clinical observation alone has not shown any role for this drug in unselected glucocorticoid resistant patients with ulcerative colitis."
Schering-Plough supported this study through an institutional grant and along with Essex Pharma provided the drugs used.
Gut. 2003;52:998-1002
Reviewed by Gary D. Vogin, MD
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