CDP571, a humanized anti‐tumor necrosis factor‐α monoclonal antibody in pediatric Crohn's disease

• Published in: Inflammatory bowel diseases Vol. 10; no. 6; pp. 723 - 730
• Main Authors: Mamula, Petar, Cohen, Stanley A., Ferry, George D., Kirschner, Barbara S., Winter, Harland S., Innes, Alison, Patel, Jatin, Baldassano, Robert N.
• Format: Journal Article
• Language: English
• Published: Philadelphia Lippincott Williams & Wilkins, Inc 01.11.2004
• Subjects: Adolescent; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - blood; Antibodies, Monoclonal - pharmacokinetics; Antibodies, Monoclonal - therapeutic use; anti‐TNF; CDP571; Child; Crohn Disease - drug therapy; Crohn Disease - pathology; Crohn's disease; Female; Gastrointestinal Agents - administration & dosage; Gastrointestinal Agents - adverse effects; Gastrointestinal Agents - blood; Gastrointestinal Agents - pharmacokinetics; Gastrointestinal Agents - therapeutic use; Humans; Male; monoclonal antibody; pediatric; Treatment Outcome; Tumor Necrosis Factor-alpha - antagonists & inhibitors; United States; United States
• ISSN: 1078-0998; 1536-4844
• DOI: 10.1097/00054725-200411000-00005

Objectives: The objectives of this study were to evaluate the safety, pharmacokinetics, and immunogenicity of CDP571 in pediatric patients with Crohn's disease. Methods: A single dose of CDP571, 10 mg/kg, was administered by infusion to pediatric patients (aged 6–17 years) with Crohn's disease in a 12‐week open‐label study. Adverse events were monitored during infusion and throughout the study. Plasma concentrations of CDP571 and standard clinical and laboratory values were assessed. Changes in disease activity were monitored using the Pediatric Crohn's Disease Activity Index (PCDAI). Results: Twenty patients were enrolled and stratified by age: 6 to 13 (n = 9) and 14 to 17 years (n = 11). Fourteen patients experienced adverse events, which were mainly mild or moderate in intensity. The plasma concentration profile was consistent with a half‐life of approximately 2 weeks. At Week 4, 4 patients in the 6‐ to 13‐year‐old group and 2 patients in the 14‐ to 17‐year‐old group had detectable anti‐CDP571 antibodies. By Week 2, 7 patients in the 6‐ to 13‐year‐old group and 6 patients in the 14‐ to 17‐year‐old group had responded to treatment (reduction in PCDAI score >10 points). Conclusion: In conclusion, CDP571 was well tolerated among pediatric patients with Crohn's disease.