Please use this identifier to cite or link to this item: http://hdl.handle.net/11054/283
Title: Certolizumab pegol for the treatment of Crohn's disease.
Authors: Sandborn, William J.
Feagan, Brian G.
Stoinov, Simeon
Honiball, Pieter J.
Rutgeerts, Paul
Mason, David
Bloomfield, Ralph
Schreiber, Stefan
Institutional Author: PRECISE 1 Study
Issue Date: 2007
Publisher: Massachusetts Medical Association
Place of publication: Boston, MA.
Journal title: New England Journal of Medicine
Volume: 357
Issue: 3
Start Page: 228
End Page: 238
Abstract: Background Certolizumab pegol is a pegylated humanized Fab′ fragment that binds tumor necrosis factor α. Methods In a randomized, double-blind, placebo-controlled trial, we evaluated the efficacy of certolizumab pegol in 662 adults with moderate-to-severe Crohn's disease. Patients were stratified according to baseline levels of C-reactive protein (CRP) and were randomly assigned to receive either 400 mg of certolizumab pegol or placebo subcutaneously at weeks 0, 2, and 4 and then every 4 weeks. Primary end points were the induction of a response at week 6 and a response at both weeks 6 and 26. Results Among patients with a baseline CRP level of at least 10 mg per liter, 37% of patients in the certolizumab group had a response at week 6, as compared with 26% in the placebo group (P=0.04). At both weeks 6 and 26, the corresponding values were 22% and 12%, respectively (P=0.05). In the overall population, response rates at week 6 were 35% in the certolizumab group and 27% in the placebo group (P=0.02); at both weeks 6 and 26, the response rates were 23% and 16%, respectively (P=0.02). At weeks 6 and 26, the rates of remission in the two groups did not differ significantly (P=0.17). Serious adverse events were reported in 10% of patients in the certolizumab group and 7% of those in the placebo group; serious infections were reported in 2% and less than 1%, respectively. In the certolizumab group, antibodies to the drug developed in 8% of patients, and antinuclear antibodies developed in 2%. This study was undertaken with data obtained from Ballarat Health Services - G. Phelps.
URI: http://hdl.handle.net/11054/283
metadata.dc.relation.uri: http://www.nejm.org/doi/full/10.1056/NEJMoa067594
ISSN: 0028-4793
Internal ID Number: 00273
Health Subject: CROHNS DISEASE
CERTOLIZUMAB PEGOL
GASTROINTESTINAL
MEDICATION
TREATMENT
RANDOMIZED CONTROL TRIAL
Type: Journal Article
Article
Appears in Collections:Research Output

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