Infliximab for acute, not steroid-refractory ulcerative colitis: a randomized pilot study.
OBJECTIVE
Therapeutic alternatives for patients with acute ulcerative colitis in whom steroids would usually be contraindicated are rare. The antibody to tumor necrosis factor alpha, infliximab, has shown to be effective in the treatment of steroid-refractory ulcerative colitis in pilot studies. We therefore evaluated whether infliximab can achieve remission in patients with acute ulcerative pancolitis who were not steroid-refractory.


METHODS
Patients were eligible if they had acute disease with a modified Truelove and Witts activity score of more than 10 for at least 2 weeks and if they were currently not receiving immunomodulators or more than 10 mg/day prednisolone. Patients were randomly assigned to receive either three intravenous infusions of infliximab at 5 mg/kg (group A) or high-dose prednisolone (1.5 mg/kg body weight) daily for 2 weeks, followed by 1 mg/kg for 1 week, followed by a weekly reduction of 5 mg (group B). Therapy success was defined as clinical response in terms of a decrease of more than 5 points from the baseline score and to less than 10 points total after 3 weeks as well as after 13 weeks.


RESULTS
Thirteen patients (seven women, six men) were randomized (six for group A and seven for group B). The median baseline activity scores were 13.5 (12-18) in group A and 14.0 (11-18) in group B. Five of six patients in group A and six of seven patients in group B showed therapy success after 3 weeks as well as after 13 weeks.


CONCLUSIONS
Infliximab could be effective in the treatment of acute moderate or severe ulcerative colitis. The obtained data call for larger controlled trials.
Department of Medicine II, Klinikum Grosshadern, University of Munich, Germany.
Thomas
T
Ochsenkühn
Michael
M
Sackmann
Burkhard
B
Göke
D000208:Acute Disease; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011239:Prednisolone / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D011239:Prednisolone; D000069285:Infliximab