Certolizumab pegol for the treatment of Crohn's disease

PRECISE 1 Study Investigators

Research output: Contribution to journalArticle

854 Citations (Scopus)

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%. 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.

Original languageEnglish (US)
Pages (from-to)228-238
Number of pages11
JournalNew England Journal of Medicine
Volume357
Issue number3
DOIs
StatePublished - Jul 19 2007

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Crohn Disease
Placebos
C-Reactive Protein
Therapeutics
Immunoglobulin Fab Fragments
Antinuclear Antibodies
Certolizumab Pegol
Tumor Necrosis Factor-alpha
Antibodies
Infection
Pharmaceutical Preparations
Population

ASJC Scopus subject areas

  • Medicine(all)

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Certolizumab pegol for the treatment of Crohn's disease. / PRECISE 1 Study Investigators.

In: New England Journal of Medicine, Vol. 357, No. 3, 19.07.2007, p. 228-238.

Research output: Contribution to journalArticle

PRECISE 1 Study Investigators. / Certolizumab pegol for the treatment of Crohn's disease. In: New England Journal of Medicine. 2007 ; Vol. 357, No. 3. pp. 228-238.
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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{\%}. 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.",
author = "{PRECISE 1 Study Investigators} and Sandborn, {William J.} and Feagan, {Brian G.} and Simeon Stoinov and Honiball, {Pieter J.} and Paul Rutgeerts and David Mason and Ralph Bloomfield and Stefan Schreiber and H. Fabian and A. Gangl and T. Haas and W. Petritsch and F. Wewalka and W. Connell and B. Crotty and A. Duggan and T. Florin and P. Gibson and R. Leong and F. Macrae and M. Merrett and B. Mitchell and G. Phelps and G. Radford-Smith and Y. Marakhouski and S. Pimanau and A. Varabei and {De Vos}, M. and E. Louis and {Van Gossum}, A. and S. Vermeire and Z. Krastev and S. Stoinov and V. Plourde and A. Rostom and Z. Dostalik and P. Drastich and I. Gregar and J. Hajek and A. Hep and Z. Hradecka and M. Konecny and M. Lukas and O. Shonova and M. Volfov{\'a} and Z. Zadorova and P. Zdenek and B. Margus and Debra Helper and John Wo",
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AU - PRECISE 1 Study Investigators

AU - Sandborn, William J.

AU - Feagan, Brian G.

AU - Stoinov, Simeon

AU - Honiball, Pieter J.

AU - Rutgeerts, Paul

AU - Mason, David

AU - Bloomfield, Ralph

AU - Schreiber, Stefan

AU - Fabian, H.

AU - Gangl, A.

AU - Haas, T.

AU - Petritsch, W.

AU - Wewalka, F.

AU - Connell, W.

AU - Crotty, B.

AU - Duggan, A.

AU - Florin, T.

AU - Gibson, P.

AU - Leong, R.

AU - Macrae, F.

AU - Merrett, M.

AU - Mitchell, B.

AU - Phelps, G.

AU - Radford-Smith, G.

AU - Marakhouski, Y.

AU - Pimanau, S.

AU - Varabei, A.

AU - De Vos, M.

AU - Louis, E.

AU - Van Gossum, A.

AU - Vermeire, S.

AU - Krastev, Z.

AU - Stoinov, S.

AU - Plourde, V.

AU - Rostom, A.

AU - Dostalik, Z.

AU - Drastich, P.

AU - Gregar, I.

AU - Hajek, J.

AU - Hep, A.

AU - Hradecka, Z.

AU - Konecny, M.

AU - Lukas, M.

AU - Shonova, O.

AU - Volfová, M.

AU - Zadorova, Z.

AU - Zdenek, P.

AU - Margus, B.

AU - Helper, Debra

AU - Wo, John

PY - 2007/7/19

Y1 - 2007/7/19

N2 - 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%. 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.

AB - 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%. 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.

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