Premium
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
Author(s) -
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.
Publication year - 2005
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.1365-2036.2005.02336.x
Subject(s) - medicine , corticosteroid , placebo , gastroenterology , prednisolone , crohn's disease , clinical endpoint , randomized controlled trial , adverse effect , surgery , disease , pathology , alternative medicine
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.