Treatment of severe Crohn's disease with anti-CD4 monoclonal antibody.
BACKGROUND
Monoclonal CD4 antibodies have been proposed as a new immunosuppressant drug in the treatment of inflammatory bowel disease. We report our experience of treatment with a monoclonal anti-CD4 (B-F5) antibody in severe refractory Crohn's disease.


METHODS
Twelve patients with severe refractory Crohn's disease were treated in an open clinical 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 at 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 patient had dyspnoea and tachycardia requiring cessation of the treatment. 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 one patient. No sustained depletion of CD4+ cells could be observed.


CONCLUSIONS
In this uncontrolled open trial, monoclonal anti-CD4 B-F5 antibody was not successful in severe Crohn's disease.
Service d'Hépato-Gastroentérologie, Hôpital Huriez, CH et U Lille, France.
V
V
Canva-Delcambre
S
S
Jacquot
E
E
Robinet
M
M
Lémann
C
C
Drouet
M
M
Labalette
J P
JP
Dessaint
D
D
Bengoufa
C
C
Rabian
R
R
Modigliani
J
J
Wijdenes
J P
JP
Revillard
J F
JF
Colombel
D000293:Adolescent; D000328:Adult; D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D000918:Antibody Specificity; D015704:CD4 Antigens / Q000276:immunology*; D003424:Crohn Disease / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004361:Drug Tolerance; D004724:Endoscopy; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male
D000911:Antibodies, Monoclonal; D015704:CD4 Antigens