Vedolizumab as induction and maintenance therapy for Crohn's disease
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F13%3A10193647" target="_blank" >RIV/00216208:11110/13:10193647 - isvavai.cz</a>
Výsledek na webu
<a href="http://dx.doi.org/10.1056/NEJMoa1215739" target="_blank" >http://dx.doi.org/10.1056/NEJMoa1215739</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1056/NEJMoa1215739" target="_blank" >10.1056/NEJMoa1215739</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Vedolizumab as induction and maintenance therapy for Crohn's disease
Popis výsledku v původním jazyce
BACKGROUND The efficacy of vedolizumab, an ?4?7 integrin antibody, in Crohn's disease is unknown. METHODS In an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6.In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52. RESULTS At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of LESS-THAN OR EQUAL TO150, with scores ranging from 0 to approximately 600 and higher scores indicating greater
Název v anglickém jazyce
Vedolizumab as induction and maintenance therapy for Crohn's disease
Popis výsledku anglicky
BACKGROUND The efficacy of vedolizumab, an ?4?7 integrin antibody, in Crohn's disease is unknown. METHODS In an integrated study with separate induction and maintenance trials, we assessed intravenous vedolizumab therapy (300 mg) in adults with active Crohn's disease. In the induction trial, 368 patients were randomly assigned to receive vedolizumab or placebo at weeks 0 and 2 (cohort 1), and 747 patients received open-label vedolizumab at weeks 0 and 2 (cohort 2); disease status was assessed at week 6.In the maintenance trial, 461 patients who had had a response to vedolizumab were randomly assigned to receive placebo or vedolizumab every 8 or 4 weeks until week 52. RESULTS At week 6, a total of 14.5% of the patients in cohort 1 who received vedolizumab and 6.8% who received placebo were in clinical remission (i.e., had a score on the Crohn's Disease Activity Index [CDAI] of LESS-THAN OR EQUAL TO150, with scores ranging from 0 to approximately 600 and higher scores indicating greater
Klasifikace
Druh
J<sub>x</sub> - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)
CEP obor
FE - Ostatní obory vnitřního lékařství
OECD FORD obor
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Návaznosti výsledku
Projekt
—
Návaznosti
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Ostatní
Rok uplatnění
2013
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
New England Journal of Medicine
ISSN
0028-4793
e-ISSN
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Svazek periodika
369
Číslo periodika v rámci svazku
8
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
11
Strana od-do
711-721
Kód UT WoS článku
000323349300008
EID výsledku v databázi Scopus
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