Endoscopic and histological healing with infliximab anti-tumor necrosis factor antibodies in Crohn's disease: A European multicenter trial

Background & Aims: Tumor necrosis factor (TNF) is a pivotal cytokine in int estinal inflammation. Controlled trials using a chimeric anti-TNF antibody (infliximab) have shown its efficacy in refractory Crohn's disease. Methods : Endoscopic and histological response to infliximab was investigated in a multicenter, randomized, double-blind, and placebo-controlled trial includi ng 30 patients with active Crohn's disease undergoing ileocolonoscopy befor e and 4 weeks after intravenous administration of 5, 10, or 20 mg/kg of inf liximab or placebo as a single infusion. Lesions were scored by means of th e validated Crohn's Disease Endoscopic Index of Severity (CDEIS), Endoscopi c biopsy specimens were taken during both procedures from 9 of 30 patients and scored by a single gastrointestinal pathologist. Results: CDEIS scores decreased significantly in most infliximab-treated patients without an appa rent dose response. No endoscopic improvement was observed in the placebo g roup. The changes in CDEIS correlated highly with those of the Crohn's Dise ase Activity Index. At a histological level, disappearance of the inflammat ory infiltrate was observed in infliximab-treated patients but not in place bo-treated ones; however, architectural changes persisted in most patients. Strictures developed in several patients. Conclusions: Clinical improvemen t after infliximab therapy in active Crohn's disease is accompanied by sign ificant healing of endoscopic lesions and disappearance of the mucosal infl ammatory infiltrate.