TREATMENT OF SEVERE CROHNS-DISEASE WITH ANTI-CD4 MONOCLONAL-ANTIBODY

Background: Monoclonal CD4 antibodies have been proposed as a new immu nosuppressant drug in the treatment of inflammatory bowel disease, We report our experience of treatment with a monoclonal anti-CD4 (B-F5) a ntibody in severe refractory Crohn's disease, Methods: Twelve patients with severe refractory Crohn's disease were treated in an open clinic al trial, B-F5 was given intravenously at a dose of 0.5 mg.day/kg for 7 consecutive days (patients 1-8). For patients 9-12, B-F5 was given a t a dose of 0.5 mg.day/kg on the first day (day 0) and of 1 mg.day/kg on days 1-6, Follow-up examinations were carried out at days 8, 15, 22 and 30, Endoscopic evaluation was performed on days 0 and 30 in eight of 12 patients, Results: Immediately after the first infusion, one pa tient had dyspnoea and tachycardia requiring cessation of the treatmen t, Among the 11 patients who received the complete course of treatment , two had prolonged clinical improvement and two had partial clinical improvement, Significant endoscopic improvement was observed in only o ne patient. No sustained depletion of CD4+ cells could be observed: Co nclusion: In this uncontrolled open trial, monoclonal anti-CD4 B-F5 an tibody was not successful in severe Crohn's disease.