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|Title:||Certolizumab pegol for the treatment of Crohn's disease.|
|Authors:||Sandborn, William J.|
Feagan, Brian G.
Honiball, Pieter J.
|Institutional Author:||PRECISE 1 Study|
|Publisher:||Massachusetts Medical Association|
|Place of publication:||Boston, MA.|
|Publication Title:||New England Journal of Medicine|
|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.|
|Internal ID Number:||00273|
|Health Subject:||CROHNS DISEASE|
RANDOMIZED CONTROL TRIAL
|Appears in Collections:||Research Output|
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|NEJMoa067594.pdf||NEJM Sandborn et al||223.96 kB||Adobe PDF|
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