CDP571, a humanized monoclonal antibody to tumour necrosis factor-α, for steroid-dependent Crohn's disease: a randomized, double-blind, placebo-controlled trial
Article first published online: 14 FEB 2006
Alimentary Pharmacology & Therapeutics
Volume 23, Issue 5, pages 617–628, March 2006
How to Cite
FEAGAN, B. G., SANDBORN, W. J., LICHTENSTEIN, G., RADFORD-SMITH, G., PATEL, J. and INNES, A. (2006), CDP571, a humanized monoclonal antibody to tumour necrosis factor-α, for steroid-dependent Crohn's disease: a randomized, double-blind, placebo-controlled trial. Alimentary Pharmacology & Therapeutics, 23: 617–628. doi: 10.1111/j.1365-2036.2006.02791.x
- Issue published online: 14 FEB 2006
- Article first published online: 14 FEB 2006
- Publication data Submitted 26 July 2005 First decision 29 July 2005 Resubmitted 8 December 2005 Accepted 8 December 2005
Background More than 50% of patients with Crohn's disease become either steroid resistant or dependent. Accordingly, development of new treatments for steroid-dependent Crohn's disease is a research priority.
Aim To evaluate CDP571, a humanized antibody to tumour necrosis factor-α, for the treatment of steroid-dependent Crohn's disease.
Methods Patients with steroid-dependent Crohn's disease (n = 271) were enrolled in a 36-week, double-blind, placebo-controlled trial. Steroid dependence was defined as use of prednisolone or prednisone (15–40 mg/day) or budesonide (9 mg/day) for ≥8 weeks, a previous failed attempt to decrease or discontinue steroids within 8 weeks of screening, and a Crohn's Disease Activity Index score of ≤150 points. Patients were randomized to receive intravenous CDP571 10 mg/kg or placebo 8-weekly through to week 32. Steroids were then tapered using a defined schedule. The primary efficacy endpoint was the percentage of patients with steroid sparing, defined as discontinuation of steroid therapy without a disease flare (Crohn's Disease Activity Index score ≥220 points) at week 36.
Results Steroid sparing occurred in 53 of 181 (29.3%) CDP571 patients and 33 of 90 (36.7%) placebo patients (P = 0.24). Adverse events occurred at similar frequencies in both treatment groups.
Conclusions CDP571 was ineffective for sparing steroids in patients with steroid-dependent Crohn's disease. CDP571 was well tolerated.