Certolizumab pegol for the treatment of Crohn's disease

William J. Sandborn*, Brian G. Feagan, Simeon Stoinov, Pieter J. Honiball, Paul Rutgeerts, David Mason, Ralph Bloomfield, Stefan Schreiber, H. Fabian, A. Gangl, T. Haas, W. Petritsch, F. Wewalka, W. Connell, B. Crotty, A. Duggan, T. Florin, P. Gibson, R. Leong, F. MacraeM. Merrett, B. Mitchell, G. Phelps, G. Radford-Smith, Y. Marakhouski, S. Pimanau, A. Varabei, M. De Vos, E. Louis, A. Van Gossum, S. Vermeire, Z. Krastev, S. Stoinov, V. Plourde, A. Rostom, Z. Dostalik, P. Drastich, I. Gregar, J. Hajek, A. Hep, Z. Hradecka, M. Konecny, M. Lukas, O. Shonova, M. Volfová, Z. Zadorova, P. Zdenek, B. Margus, R. Salupere, B. Bokemeyer, A. Dignass, J. Emmrich, R. Heimann, S. Hollerbach, H. Kramm, K. Kruis, H. Lochs, P. Malfertheiner, T. Ochsenkühn, H. Porst, S. Schreiber, S. Seidler, H. Stahl, J. Stein, W. Leung, I. Altorjay, L. Bene, J. Lonovics, L. Simon, B. Hunyady, G. Bianchi-Porro, M. Campieri, M. Cottone, C. Petruzziello, C. Prantera, I. Tolmanis, A. Danilans, R. Torp, J. Bogdal, J. Chojnacki, E. Czajkowska-Kaczmarek, Z. Hebzda, D. Henzler, M. Klopocka, I. Krasnodebski, J. Leszczyszyn, K. Marlicz, L. Paradowski, R. Petryka, G. Rydzewska, J. Sasiewicz, M. Słomka, G. Wallner, G. Mukhashavria, O. Alekseeva, A. Baranovsky, O. Dolgikh, V. Grinevich, I. Khalif, A. Lakhin, T. Mikhailova, V. Simanenkov, O. Solovyev, E. Tkachenko, M. Yurkov, B. Birsa, I. Ferkolj, B. Gorjup, H. Bloch, P. Honiball, A. Jacovides, A. Pappas, H. Schneider, P. Van Eeden, J. Wright, R. Befrits, A. Daniellson, R. Löfberg, O. Babak, R. Dutka, N. Gubergrits, E. Levchenko, C. Barish, I. Bassan, S. Behar, D. Binion, E. Bonapace, R. Chasen, R. Cohen, K. Das, W. De Villiers, M. Frankel, L. Gelrud, L. Goldberg, N. Grandhi, M. Griffin, R. Hardi, D. Helper, R. Ingle, M. Johnson, P. Kiyasu, R. McCabe, P. Moses, M. Murphy, J. Novick, F. Opper, D. Present, R. Pruitt, C. Randall, G. Rosman, M. Safdi, W. Sandborn, C. Schmitt, J. Schneider, R. Schuman, H. Schwartz, D. Silvers, C. Sninsky, J. Terdiman, R. Tobias, E. Valle, J. Willis, F. Wilson, J. Wo, L. Wruble, Z. Younes, PRECISE 1 Study Investigators

*Corresponding author for this work

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902 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
Pages (from-to)228-238
Number of pages11
JournalNew England Journal of Medicine
Volume357
Issue number3
DOIs
Publication statusPublished - 19 Jul 2007
Externally publishedYes

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