A randomized, double‐blind, placebo‐controlled trial of CDP571, a humanized monoclonal antibody to tumour necrosis factor‐α, in patients with corticosteroid‐dependent Crohn's disease

• Published in: Alimentary pharmacology & therapeutics 2005-02, Vol.21 (4), p.373-384
• Main Authors: Feagan, B. G., Sandborn, W. J., Baker, J. P., Cominelli, F., Sutherland, L. R., Elson, C. O., Salzberg, B. A., Archambault, A., Bernstein, C. N., Lichtenstein, G. R., Heath, P. K., Cameron, S., Hanauer, S. B.
• Format: Article
• Language: English
• Subjects: Adult; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anti-Inflammatory Agents, Non-Steroidal - therapeutic use; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - therapeutic use; Biological and medical sciences; Budesonide - administration & dosage; Crohn Disease - drug therapy; Crohn Disease - pathology; Digestive system; Double-Blind Method; Drug Administration Schedule; Female; Gastroenterology. Liver. Pancreas. Abdomen; Gastrointestinal Agents - therapeutic use; Humans; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Prednisolone - administration & dosage; Quality of Life; Severity of Illness Index; Treatment Outcome; Tumor Necrosis Factor-alpha - antagonists & inhibitors
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2005.02336.x

Summary Aim : To evaluate CDP571, a humanized monoclonal antibody to tumour necrosis factor‐α, for the treatment of corticosteroid‐dependent Crohn's disease. Methods : Patients with corticosteroid‐dependent Crohn's disease (use of prednisolone 15–40 mg/day or budesonide 9 mg/day for at least 8 weeks, a previous failed attempt to discontinue corticosteroids within 8 weeks, and Crohn's Disease Activity Index score 150 points or less) were enrolled in a 16‐week, randomized, double‐blind, placebo‐controlled trial. The patients received intravenous CDP571 (20 mg/kg at week 0 and 10 mg/kg at week 8) or placebo. Corticosteroid therapy was decreased following a predefined schedule. The primary efficacy end‐point was the percentage of patients with corticosteroid‐sparing [i.e. no disease flare (Crohn's Disease Activity Index score ≥220 points) and no longer requiring corticosteroid therapy] at week 10. The major secondary efficacy end‐point was corticosteroid‐sparing at week 16. Results : Seventy‐one patients received treatment. Corticosteroid‐sparing was achieved by 19 of 39 (48.7%) CDP571 patients and 13 of 42 (40.6%) placebo patients (P = 0.452) at week 10, and by 18 of 39 (46.2%) CDP571 patients and seven of 32 (21.9%) placebo patients (P = 0.032) at week 16. CDP571 therapy was well‐tolerated and the incidence of serious adverse events was similar to placebo. Conclusions : The CDP571 was effective for corticosteroid‐sparing at week 16 but not week 10, and was well‐tolerated in patients with corticosteroid‐dependent Crohn's disease.