Researchers performed a trial in order to evaluate CDP571, a humanized monoclonal antibody to tumor necrosis factor, for the treatment of corticosteroid-dependent Crohn's disease.
Patients with corticosteroid-dependent Crohn's disease were enrolled in a 16-week, randomized, double-blind, placebo-controlled trial.
The patients were using prednisolone 1540 mg/day or budesonide 9 mg/day for at least 8 weeks, had a previous failed attempt to discontinue corticosteroids within 8 weeks, and had a Crohn's Disease Activity Index score 150 points or less.
The patients received intravenous CDP571 (20 mg/kg at week 0 and 10 mg/kg at week 8) or placebo.
| Corticosteroid-sparing was achieved by 19 of 39 (48.7%) CDP571 patients|
|Alimentary Pharmacology and Therapeutics|
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.
71 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 7 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.
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.