Anti-tumour necrosis factor alpha (infliximab) in the treatment of severe ulcerative colitis: result of an open study on 13 patients

Dig Liver Dis. 2002 Sep;34(9):626-30. doi: 10.1016/s1590-8658(02)80204-3.


Background: Conventional treatment options for patients with severe steroid-refractory ulcerative colitis include intravenous cyclosporine, which is frequently burdened by toxicity, or colectomy. Preliminary data suggest a benefit from anti-tumour necrosis factor alpha (Infliximab) therapy in patients with steroid refractory ulcerative colitis.

Aim: To evaluate the efficacy of Infliximab in the treatment of severe ulcerative colitis refractory to conventional therapy

Patients and methods: A series of 13 patients with severe ulcerative colitis, refractory to therapy with methyl-prednisolone, 60 mg daily for seven or more days, were treated with a single intravenous infusion of Infliximab 5 mg/kg.

Results and conclusions: Of these 13 patients, 10 (77%) had a clinical response to therapy defined by a clinical activity index 10 on two consecutive days. In 2 patients (15%) total colectomy was necessary on account of clinical worsening whilst one patient refused surgery and was lost to follow-up. All patients who responded showed very rapid clinical improvement, within 2 to 3 days of infusion. Infusion with Infliximab produced no significant adverse events. The mean time of follow-up was 10.1 months (range 5-12; during this time, 9 out of 10 patients (90%) maintained clinical remission and were able to discontinue corticosteroid therapy. Infliximab appears to be an effective agent for inducing long-standing remission in refractory patients with severe ulcerative colitis.

Publication types

  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Antineutrophil Cytoplasmic / blood
  • Antibodies, Monoclonal / therapeutic use*
  • C-Reactive Protein / analysis
  • Child
  • Colitis, Ulcerative / blood
  • Colitis, Ulcerative / classification
  • Colitis, Ulcerative / drug therapy*
  • Female
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Infliximab
  • Male
  • Methylprednisolone / therapeutic use
  • Middle Aged
  • Severity of Illness Index
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha / antagonists & inhibitors*


  • Antibodies, Antineutrophil Cytoplasmic
  • Antibodies, Monoclonal
  • Gastrointestinal Agents
  • Tumor Necrosis Factor-alpha
  • C-Reactive Protein
  • Infliximab
  • Methylprednisolone