title: Infliximab in severe steroid-refractory ulcerative colitis: a pilot study.
abstract: Tumor necrosis factor-alpha (TNF alpha)-neutralization by infliximab has previously proven efficacious in chronic active Crohn's disease (CD). We performed an open-label pilot study of a single infusion of 5 mg/kg infliximab in six patients with severe active, steroid-refractory ulcerative colitis (UC). Clinical activity was evaluated according to Lichtiger on days -1, day 7, and day 28. Colonoscopy with biopsy was performed on day -1 and day 7. All patients showed marked clinical improvement by day 7 (Lichtiger score 16.3 +/- 0.4 [day -1] vs 4.8 +/- 0.7 [day 7], p < 0.0001). Four of six patients had long-term remission (Lichtiger score 7.7 +/- 2.2 [day 28], P < 0.01 compared to day -1), with a median follow-up of 5.5 months. Colonoscopy confirmed significant healing of endoscopic lesions. The inflammatory infiltrate disappeared on H&E stains, with a marked reduction in infiltrating neutrophils. Semiquantitative evaluation of T and B lymphocytes and macrophages by immunohistochemistry did not reveal major differences compared to pre-treatment. Apoptotic cells in the mucosa were reduced on day 7. Our data point toward a novel efficacious treatment option in severe steroid-refractory UC and raise the need for controlled trials.
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, University Hospital Innsbruck, Austria.
authors.forename: A
authors.initials: A
authors.lastname: Kaser
authors.forename: T
authors.initials: T
authors.lastname: Mairinger
authors.forename: W
authors.initials: W
authors.lastname: Vogel
authors.forename: H
authors.initials: H
authors.lastname: Tilg
mesh_terms: D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D003113:Colonoscopy; D005260:Female; D006801:Humans; D000069285:Infliximab; D007262:Infusions, Intravenous; D007413:Intestinal Mucosa / Q000187:drug effects / Q000276:immunology / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors
chemical_list: D000911:Antibodies, Monoclonal; D014409:Tumor Necrosis Factor-alpha; D011239:Prednisolone; D000069285:Infliximab