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. Macrae; M. 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

doi:10.1056/NEJMoa067594

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

Research output: Contribution to journal › Article › peer-review

1038 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 language	English
Pages (from-to)	228-238
Number of pages	11
Journal	New England Journal of Medicine
Volume	357
Issue number	3
DOIs	https://doi.org/10.1056/NEJMoa067594
Publication status	Published - 19 Jul 2007
Externally published	Yes

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10.1056/NEJMoa067594

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Sandborn, W. J., Feagan, B. G., Stoinov, S., Honiball, P. J., Rutgeerts, P., Mason, D., Bloomfield, R., Schreiber, S., Fabian, H., Gangl, A., Haas, T., Petritsch, W., Wewalka, F., Connell, W., Crotty, B., Duggan, A., Florin, T., Gibson, P., Leong, R., ... PRECISE 1 Study Investigators (2007). Certolizumab pegol for the treatment of Crohn's disease. New England Journal of Medicine, 357(3), 228-238. https://doi.org/10.1056/NEJMoa067594

@article{9c893d2286cf47ae802e2b5ced5caded,

title = "Certolizumab pegol for the treatment of Crohn's disease",

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 = "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 R. Salupere and B. Bokemeyer and A. Dignass and J. Emmrich and R. Heimann and S. Hollerbach and H. Kramm and K. Kruis and H. Lochs and P. Malfertheiner and T. Ochsenk{\"u}hn and H. Porst and S. Schreiber and S. Seidler and H. Stahl and J. Stein and W. Leung and I. Altorjay and L. Bene and J. Lonovics and L. Simon and B. Hunyady and G. Bianchi-Porro and M. Campieri and M. Cottone and C. Petruzziello and C. Prantera and I. Tolmanis and A. Danilans and R. Torp and J. Bogdal and J. Chojnacki and E. Czajkowska-Kaczmarek and Z. Hebzda and D. Henzler and M. Klopocka and I. Krasnodebski and J. Leszczyszyn and K. Marlicz and L. Paradowski and R. Petryka and G. Rydzewska and J. Sasiewicz and M. S{\l}omka and G. Wallner and G. Mukhashavria and O. Alekseeva and A. Baranovsky and O. Dolgikh and V. Grinevich and I. Khalif and A. Lakhin and T. Mikhailova and V. Simanenkov and O. Solovyev and E. Tkachenko and M. Yurkov and B. Birsa and I. Ferkolj and B. Gorjup and H. Bloch and P. Honiball and A. Jacovides and A. Pappas and H. Schneider and {Van Eeden}, P. and J. Wright and R. Befrits and A. Daniellson and R. L{\"o}fberg and O. Babak and R. Dutka and N. Gubergrits and E. Levchenko and C. Barish and I. Bassan and S. Behar and D. Binion and E. Bonapace and R. Chasen and R. Cohen and K. Das and {De Villiers}, W. and M. Frankel and L. Gelrud and L. Goldberg and N. Grandhi and M. Griffin and R. Hardi and D. Helper and R. Ingle and M. Johnson and P. Kiyasu and R. McCabe and P. Moses and M. Murphy and J. Novick and F. Opper and D. Present and R. Pruitt and C. Randall and G. Rosman and M. Safdi and W. Sandborn and C. Schmitt and J. Schneider and R. Schuman and H. Schwartz and D. Silvers and C. Sninsky and J. Terdiman and R. Tobias and E. Valle and J. Willis and F. Wilson and J. Wo and L. Wruble and Z. Younes and {PRECISE 1 Study Investigators}",

year = "2007",

month = jul,

day = "19",

doi = "10.1056/NEJMoa067594",

language = "English",

volume = "357",

pages = "228--238",

journal = "New England Journal of Medicine",

issn = "0028-4793",

publisher = "Massachussetts Medical Society",

number = "3",

}

Sandborn, WJ, Feagan, BG, Stoinov, S, Honiball, PJ, Rutgeerts, P, Mason, D, Bloomfield, R, Schreiber, S, Fabian, H, Gangl, A, Haas, T, Petritsch, W, Wewalka, F, Connell, W, Crotty, B, Duggan, A, Florin, T, Gibson, P, Leong, R, Macrae, F, Merrett, M, Mitchell, B, Phelps, G, Radford-Smith, G, Marakhouski, Y, Pimanau, S, Varabei, A, De Vos, M, Louis, E, Van Gossum, A, Vermeire, S, Krastev, Z, Stoinov, S, Plourde, V, Rostom, A, Dostalik, Z, Drastich, P, Gregar, I, Hajek, J, Hep, A, Hradecka, Z, Konecny, M, Lukas, M, Shonova, O, Volfová, M, Zadorova, Z, Zdenek, P, Margus, B, Salupere, R, Bokemeyer, B, Dignass, A, Emmrich, J, Heimann, R, Hollerbach, S, Kramm, H, Kruis, K, Lochs, H, Malfertheiner, P, Ochsenkühn, T, Porst, H, Schreiber, S, Seidler, S, Stahl, H, Stein, J, Leung, W, Altorjay, I, Bene, L, Lonovics, J, Simon, L, Hunyady, B, Bianchi-Porro, G, Campieri, M, Cottone, M, Petruzziello, C, Prantera, C, Tolmanis, I, Danilans, A, Torp, R, Bogdal, J, Chojnacki, J, Czajkowska-Kaczmarek, E, Hebzda, Z, Henzler, D, Klopocka, M, Krasnodebski, I, Leszczyszyn, J, Marlicz, K, Paradowski, L, Petryka, R, Rydzewska, G, Sasiewicz, J, Słomka, M, Wallner, G, Mukhashavria, G, Alekseeva, O, Baranovsky, A, Dolgikh, O, Grinevich, V, Khalif, I, Lakhin, A, Mikhailova, T, Simanenkov, V, Solovyev, O, Tkachenko, E, Yurkov, M, Birsa, B, Ferkolj, I, Gorjup, B, Bloch, H, Honiball, P, Jacovides, A, Pappas, A, Schneider, H, Van Eeden, P, Wright, J, Befrits, R, Daniellson, A, Löfberg, R, Babak, O, Dutka, R, Gubergrits, N, Levchenko, E, Barish, C, Bassan, I, Behar, S, Binion, D, Bonapace, E, Chasen, R, Cohen, R, Das, K, De Villiers, W, Frankel, M, Gelrud, L, Goldberg, L, Grandhi, N, Griffin, M, Hardi, R, Helper, D, Ingle, R, Johnson, M, Kiyasu, P, McCabe, R, Moses, P, Murphy, M, Novick, J, Opper, F, Present, D, Pruitt, R, Randall, C, Rosman, G, Safdi, M, Sandborn, W, Schmitt, C, Schneider, J, Schuman, R, Schwartz, H, Silvers, D, Sninsky, C, Terdiman, J, Tobias, R, Valle, E, Willis, J, Wilson, F, Wo, J, Wruble, L, Younes, Z & PRECISE 1 Study Investigators 2007, 'Certolizumab pegol for the treatment of Crohn's disease', New England Journal of Medicine, vol. 357, no. 3, pp. 228-238. https://doi.org/10.1056/NEJMoa067594

TY - JOUR

T1 - Certolizumab pegol for the treatment of Crohn's disease

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 - Salupere, R.

AU - Bokemeyer, B.

AU - Dignass, A.

AU - Emmrich, J.

AU - Heimann, R.

AU - Hollerbach, S.

AU - Kramm, H.

AU - Kruis, K.

AU - Lochs, H.

AU - Malfertheiner, P.

AU - Ochsenkühn, T.

AU - Porst, H.

AU - Schreiber, S.

AU - Seidler, S.

AU - Stahl, H.

AU - Stein, J.

AU - Leung, W.

AU - Altorjay, I.

AU - Bene, L.

AU - Lonovics, J.

AU - Simon, L.

AU - Hunyady, B.

AU - Bianchi-Porro, G.

AU - Campieri, M.

AU - Cottone, M.

AU - Petruzziello, C.

AU - Prantera, C.

AU - Tolmanis, I.

AU - Danilans, A.

AU - Torp, R.

AU - Bogdal, J.

AU - Chojnacki, J.

AU - Czajkowska-Kaczmarek, E.

AU - Hebzda, Z.

AU - Henzler, D.

AU - Klopocka, M.

AU - Krasnodebski, I.

AU - Leszczyszyn, J.

AU - Marlicz, K.

AU - Paradowski, L.

AU - Petryka, R.

AU - Rydzewska, G.

AU - Sasiewicz, J.

AU - Słomka, M.

AU - Wallner, G.

AU - Mukhashavria, G.

AU - Alekseeva, O.

AU - Baranovsky, A.

AU - Dolgikh, O.

AU - Grinevich, V.

AU - Khalif, I.

AU - Lakhin, A.

AU - Mikhailova, T.

AU - Simanenkov, V.

AU - Solovyev, O.

AU - Tkachenko, E.

AU - Yurkov, M.

AU - Birsa, B.

AU - Ferkolj, I.

AU - Gorjup, B.

AU - Bloch, H.

AU - Honiball, P.

AU - Jacovides, A.

AU - Pappas, A.

AU - Schneider, H.

AU - Van Eeden, P.

AU - Wright, J.

AU - Befrits, R.

AU - Daniellson, A.

AU - Löfberg, R.

AU - Babak, O.

AU - Dutka, R.

AU - Gubergrits, N.

AU - Levchenko, E.

AU - Barish, C.

AU - Bassan, I.

AU - Behar, S.

AU - Binion, D.

AU - Bonapace, E.

AU - Chasen, R.

AU - Cohen, R.

AU - Das, K.

AU - De Villiers, W.

AU - Frankel, M.

AU - Gelrud, L.

AU - Goldberg, L.

AU - Grandhi, N.

AU - Griffin, M.

AU - Hardi, R.

AU - Helper, D.

AU - Ingle, R.

AU - Johnson, M.

AU - Kiyasu, P.

AU - McCabe, R.

AU - Moses, P.

AU - Murphy, M.

AU - Novick, J.

AU - Opper, F.

AU - Present, D.

AU - Pruitt, R.

AU - Randall, C.

AU - Rosman, G.

AU - Safdi, M.

AU - Sandborn, W.

AU - Schmitt, C.

AU - Schneider, J.

AU - Schuman, R.

AU - Schwartz, H.

AU - Silvers, D.

AU - Sninsky, C.

AU - Terdiman, J.

AU - Tobias, R.

AU - Valle, E.

AU - Willis, J.

AU - Wilson, F.

AU - Wo, J.

AU - Wruble, L.

AU - Younes, Z.

AU - PRECISE 1 Study Investigators

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.

UR - http://www.scopus.com/inward/record.url?scp=34447523749&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa067594

DO - 10.1056/NEJMoa067594

M3 - Article

C2 - 17634458

SN - 0028-4793

VL - 357

SP - 228

EP - 238

JO - New England Journal of Medicine

JF - New England Journal of Medicine

IS - 3

ER -

Certolizumab pegol for the treatment of Crohn's disease

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