Premium
CDP571, a humanized monoclonal antibody to tumour necrosis factor‐α, for steroid‐dependent Crohn's disease: a randomized, double‐blind, placebo‐controlled trial
Author(s) -
FEAGAN B. G.,
SANDBORN W. J.,
LICHTENSTEIN G.,
RADFORDSMITH G.,
PATEL J.,
INNES A.
Publication year - 2006
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2006.02791.x
Subject(s) - medicine , placebo , prednisone , crohn's disease , prednisolone , azathioprine , gastroenterology , discontinuation , clinical endpoint , adverse effect , randomized controlled trial , budesonide , surgery , corticosteroid , disease , pathology , alternative medicine
Summary 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.