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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Certolizumab pegol for the treatment of Crohn's disease
New England Journal of Medicine, Volume 357, No. 3, Year 2007
Notification
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Description
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. Copyright © 2007 Massachusetts Medical Society.
Authors & Co-Authors
Sandborn, William J.
United States, Rochester
Mayo Clinic
Feagan, Brian Gordon
Canada, London
Western University
Stoǐnov, Simeon G.
Bulgaria, Sofia
Multiprofile Hospitals for Active Treatment Queen Ioanna
Honiball, Pieter J.
South Africa, Pretoria
Arcadia
Rutgeerts, Paul J.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Mason, David
Belgium, Braine-l'alleud
Ucb S.a.
Bloomfield, Ralph
Belgium, Braine-l'alleud
Ucb S.a.
Schreiber, Stefan W.
Germany, Kiel
Universitätsklinikum Schleswig-holstein Campus Kiel
Fabian, H.
Austria, Aflenz-kurort
Rehazentrum Aflenz
Gangl, Alfred
Austria, Vienna
Medizinische Universität Wien
Haas, Thomas
Austria, Salzburg
St. Johanns-spital
Petritsch, Wolfgang
Austria, Graz
Lkh-universitätsklinikum Graz
Wewalka, Friedrich W.
Austria, Vienna
Krankenhaus Der Barmherzigen Bruder
Connell, William R.
Australia, Fitzroy
St. Vincent's Hospital Melbourne
Crotty, Brendan J.
Australia, Melbourne
Austin Health
Duggan, Annette E.
Australia, Newcastle
John Hunter Hospital
Florin, Timothy Hj J.
Australia, Brisbane
Mater Hospital Brisbane
Gibson, Peter
Australia, Box Hill
Hill Hospital
Leong, Rupert W.
Australia, Bankstown
Bankstown-lidcombe Hospital
MacRae, Finlay Alistair
Australia, Melbourne
Royal Melbourne Hospital
Merrett, Michael N.
Australia, Frankston
Frankston Hospital
Mitchell, Brent L.
Australia, Launceston
Launceston General Hospital
Phelps, G. J.
Australia, Ballarat
Ballarat Health Services
Radford –Smith, Graham L.
Australia, Brisbane
Royal Brisbane and Women's Hospital
Marakhouski, Y. Kh
Belarus, Minsk
Minsk Regional Clinical Hospital
Pimanov, Sergey I.
Belarus, Vitebsk
Vitebsk State Medical University
Varabei, Aliaksander Vladimir
Belarus, Minsk Region
Minsk Regional Pediatric Clinical Hospital
de Vos, Martine M.P.
Belgium, Ghent
Universitair Ziekenhuis Gent
Louis, Édouard J.
Belgium, Liege
Centre Hospitalier Universitaire de Liege
van Gossum, André M.
Belgium, Brussels
Hôpital Erasme
Vermeire, Sèverine A.R.A.
Belgium, Leuven
Ku Leuven– University Hospital Leuven
Krastev, Zachariy A.
Bulgaria, Sofia
Clinic of Gastroenterology
Plourde, Victor
Canada, Montreal
Centre Hospitalier de L'universite de Montreal
Rostom, Alaa
Canada, Ottawa
L'hôpital D'ottawa
Dostalík, Z.
Czech Republic, Ostrava
Municipal Hospital Ostrava
Drastich, Pavel
Czech Republic, Prague
Institutu Klinické a Experimentální Medicíny
Gregar, I.
Czech Republic, Olomouc
Private Internal Clinic
Hajek, J.
Czech Republic, Pardubice
Pardubice Hospital
Hep, Aleš
Czech Republic, Brno
Fakultni Nemocnice Brno
Hradecka, Z.
Czech Republic, Melnik
Hospital with Out-patient Clinic
Lukáš, Milan
Czech Republic, Prague
Iv Internal Clinic of Gastroenterology
Shonová, Olga
Czech Republic, Ceske Budejovice
Hospital Ceske Budejovice
Volfová, Miroslava
Czech Republic, Hradec Kralove
Hepato-gastroenterologie hk
Zádorová, Zdena
Czech Republic, Prague
Fakultní Nemocnice Královské Vinohrady
Zdeněk, Petr
Czech Republic, Pilsen
Fakultní Nemocnice Plzeň
Margus, Benno
Estonia, Tallinn
East-tallin Central Hospital
Salupere, Riina
Estonia, Tartu
Tartu University Clinics
Bokemeyer, Bernd
Unknown Affiliation
Dignass, Axel U.
Germany, Berlin
Charité – Universitätsmedizin Berlin
Emmrich, Jörg
Germany, Rostock
Universität Rostock
Heimann, Ruth
Unknown Affiliation
Hollerbach, Stephan H.
Germany, Celle
Hospital of Celle
Kramm, Heinzjochen J.
Unknown Affiliation
Kruis, K.
Germany, Koln
Evangelic Hospital Kalk
Lochs, Heribert L.
Germany, Berlin
Charité – Universitätsmedizin Berlin
Malfertheiner, P.
Germany, Magdeburg
Otto-von-guericke-universität Magdeburg
Ochsenkuḧn, Thomas
Germany, Munich
Ludwig-maximilians-universität München
Porst, Heiner
Germany, Dresden
Krankenhaus Dresden-friedrichstadt
Seidler, S.
Germany, Hannover
Hannover Medical School
Stahl, Hans Detlev
Germany, Leipzig
Clinpharm International
Stein, Jürgen Michael
Germany, Frankfurt am Main
Universitätsklinikum Frankfurt
Leung, Wai Keung
Hong Kong
Prince of Wales Hospital Hong Kong
Altorjay, István
Hungary, Debrecen
Debreceni Egyetem
Bene, László
Hungary, Budapest
Peterfy Teaching Hospital
Lonovics, János
Hungary, Szeged
Szegedi Tudományegyetem Általános Orvostudományi Kar
Simon, László
Hungary, Szekszard
Szekszard County Hospital
Hunyady, Béla
Hungary, Pecs
Pécsi Tudományegyetem
Bianchi-Porro, G.
Italy, Milan
Ospedale Luigi Sacco - Polo Universitario
Campieri, Massimo
Italy, Bologna
Irccs Azienda Ospedaliero-universitaria Di Bologna
Cottone, Mario
Italy, Palermo
Istituto Di Medicina Generale e Pneumologia
Petruzziello, Carmelina
Italy, Rome
Cattedra Di Gastroenterologia
Prantera, Cosimo
Italy, Rome
Azienda Ospedaliera San Camillo Forlanini
Tolmanis, Ivars
Latvia, Riga
Digestive Diseases Centre Gastro
Danilans, Antons
Latvia, Riga
Paula Stradina Clinical University Hospital
Torp, Roald A.
Norway, Hamar
Sentralsjukehuset I Hedmark
Bogdal, J.
Poland, Krakow
Kliniczny Oddział Otolaryngologiczny
Chojnacki, Jan
Poland, Lodz
Medical University of Lodz
Czajkowska-Kaczmarek, Eugenia
Poland, Lodz
Niepubliczny Zaklud Opieki Zdrowotnej Nzoz Polimedica
Hebzda, Zbigniew
Poland, Krakow
Wojskowy Szpital Kliniczny z Poliklinika w Krakowie
Henzler, D.
Poland, Opole
Szpital Wojewódzki
Kłopocka, Maria
Poland, Bydgoszcz
Samodzielny Publiczny Zaklud Opieki Zdrowotnej Wojewodzki Szpital Im Bydgoszcz
Krasnodebski, I.
Poland, Warsaw
Klinika Chirurgii Ogólnej
Leszczyszyn, Jaroslaw Jerzy
Poland, Wroclaw
Euromedicare Specialist Hospital
Marlicz, Krzysztof
Poland, Szczecin
Pomeranian Medical University in Szczecin
Paradowski, Leszek
Poland, Wroclaw
Wroclaw Medical University
Petryka, Robert
Poland, Warsaw
Nzoz Medicenter
Rydzewska, Graźyna M.
Poland, Warsaw
Central Clinical Hospital of Ministry of Home Affairs
Sasiewicz, J.
Poland, Bialystok
Regional Polyclinical Hospital Wojewódzki Szpital Zespolony
Słomka, Maria
Poland, Lublin
Medical University of Lublin
Wallner, G.
Poland, Lublin
Ii Katedra I Klinika Chirurgii Ogólnej
Mukhashavria, G.
Georgia, Tbilisi
Center of Coloproctology
Alekseeva, O.
Russian Federation, Nizhny Novgorod
Mlpu City Hospital 33
Baranovsky, A. Yu
Russian Federation, Saint Petersburg
Maps
Dolgikh, Oleg Y.
Russian Federation, Samara
Zheleznodorozhnaya Bolnitsa
Grinevich, Vladimir B.
Russian Federation, Saint Petersburg
Saint Petersburg City Hospital of Saint Elizabeth
Khalif, Igor Lvovich
Russian Federation, Moscow
State Scientific Centre of Coloproctology
Lakhin, Aleksandr V.
Russian Federation, Lipetsk
Lipetsk Regional Clinical Hospital
Mikhaǐlova, Tatyana L.
Russian Federation, Moscow
State Scientific Centre of Coloproctology
Simanenkov, Vladimir I.
Unknown Affiliation
Jacovides, Andrew
Unknown Affiliation
Schneider, H.
South Africa, Johannesburg
Milpark Hospital
Wright, John P.
South Africa, Cape Town
Kingsbury Hospital
Gubergrits, Natalya B.
Unknown Affiliation
Cohen, Russell D.
United States, Chicago
The University of Chicago
de Villiers, Willem Johan Simon
United States, Lexington
Uk Albert B. Chandler Hospital
Frankel, Michael R.
Unknown Affiliation
Johnson, Matthew Warren
Unknown Affiliation
Statistics
Citations: 994
Authors: 107
Affiliations: 110
Identifiers
Doi:
10.1056/NEJMoa067594
ISSN:
00284793
Research Areas
Cancer
Disability
Study Design
Cross Sectional Study