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Background Certolizumab pegol is a pegylated humanized Fab' fragment that binds tumor necrosis factor
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%.
Conclusions In patients with moderate-to-severe Crohn's disease, induction and maintenance therapy with certolizumab pegol was associated with a modest improvement in response rates, as compared with placebo, but with no significant improvement in remission rates. (ClinicalTrials.gov number, NCT00152490
[ClinicalTrials.gov]
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Source Information
From the Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN (W.J.S.); the University of Western Ontario, London, ON, Canada (B.G.F.); Clinic of Gastroenterology, Multiprofile Hospitals for Active Treatment Queen Ioanna, Sofia, Bulgaria (S. Stoinov); Arcadia, Pretoria, South Africa (P.J.H.); Division of Gastroenterology, University Hospital, Leuven, Belgium (P.R.); UCB Pharma, Slough, Berkshire, United Kingdom (D.M., R.B.); and the Department of General Internal Medicine, Christian-Albrechts University, Kiel, Germany (S. Schreiber).
Address reprint requests to Dr. Sandborn at the Mayo Clinic, 200 First St. SW, Rochester, MN 55905, or at sandborn.william{at}mayo.edu.
Related Letters:
Anti-TNF Antibodies for Crohn's Disease
Camilleri M., Lewis J. D.
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N Engl J Med 2007;
357:1662, Oct 18, 2007.
Correspondence
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