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Title: Safety and tolerability of antagonist anti-human CD40 Mab ch5D12 in patients with moderate to severe Crohn's disease
Authors: Kasran, Ahmad ×
Boon, Louis
Wortel, C H
Hogezand, R A
Schreiber, S
Goldin, E
Boer, M
Geboes, Karel
Rutgeerts, Paul
Ceuppens, Jan #
Issue Date: Jul-2005
Series Title: Alimentary Pharmacology & Therapeutics vol:22 issue:2 pages:111-22
Abstract: BACKGROUND: The ligation of CD40 by CD154 is a critical step in the interaction between APC and T cells. In animals, antagonizing CD40L-CD40 has been shown to reduce the severity of several autoimmune and inflammatory disorders, including experimental colitis. AIM: To investigate tolerability and safety of an antagonist chimeric monoclonal anti-human CD40 antibody (ch5D12) for treatment of Crohn's disease. METHOD: ch5D12 was administrated to 18 patients with moderate to severe Crohn's disease in a single dose, open-label dose-escalation phase I/IIa study. RESULTS: ch5D12 plasma concentrations increased dose-dependently after infusion. Two patients developed an anti-ch5D12 antibody response. Overall response and remission rates were 72 and 22%, respectively with no evidence for a dose-response effect. Treatment with ch5D12 reduced microscopic disease activity and intensity of the lamina propria cell infiltrate, but did not alter percentages of circulating T and B cells. ch5D12 was well tolerated, although some patients experienced headache, muscle aches, or joint pains, which may have been related to the study drug. CONCLUSIONS: Antagonizing CD154-CD40 interactions with ch5D12 is a promising therapeutic approach for remission induction in Crohn's disease.
ISSN: 0269-2813
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Clinical Immunology
Translational Cell & Tissue Research
Translational Research in GastroIntestinal Disorders
× corresponding author
# (joint) last author

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