Clinical-alimentary tractInfliximab as Rescue Therapy in Severe to Moderately Severe Ulcerative Colitis: A Randomized, Placebo-Controlled Study
Section snippets
Study Design
This study engaged patients with an acute severe or moderately severe attack of UC that did not respond quickly to IIVT. The study had a parallel design so that half of the patients were randomized to additional treatment with infliximab to the ongoing corticosteroid therapy, and the other half were randomized to additional placebo.
Clinical Indices
The Seo index 17 for the preceding day was calculated from the following formula
Patient Population
Forty-five patients were randomized: 24 to infliximab and 21 to placebo. The first patient was included in July 2001 and the last in January 2004. Because of the slow enrollment, it was decided to perform the interim analysis earlier than specified in the protocol.
Population demographics and disease characteristics are summarized in Table 2. The patients were well distributed between groups regarding age, extent of UC, Seo index on day 0, randomization according to the fulminant colitis index
Discussion
Infliximab has become an established treatment of CD. In UC, however, the results have been conflicting. Only 2 placebo-controlled studies have been performed. One included 43 patients with moderately severe steroid-resistant UC. No significant effect in favor of infliximab was noted. However, that study excluded patients who were at risk for an emergency colectomy. 21 All patients in this study who did not respond quickly to IIVT faced this possibility. The other placebo-controlled study
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Supported by the Swedish Federation of County Councils, Örebro County Research Foundation, Schering-Plough AB, Sweden, Clinical Research Centre, Örebro University Hospital, the Medical Research Council of Southeast Sweden, Foundation of Medical Science Region 3, Denmark (Grant 2-47-19-02), and participating hospitals (infliximab/placebo).