Vedolizumab as induction and maintenance therapy for Crohn's disease.

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Auteurs
Date

2013

Type de document
Périmètre
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Source

Serveur académique Lausannois

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Ce document est lié à :
info:eu-repo/semantics/altIdentifier/doi/10.1056/NEJMoa1215739

Ce document est lié à :
info:eu-repo/semantics/altIdentifier/pmid/23964933

Ce document est lié à :
info:eu-repo/semantics/altIdentifier/eissn/1533-4406

Ce document est lié à :
info:eu-repo/semantics/altIdentifier/urn/urn:nbn:ch:serval-BIB_17E994FDC9870

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Serveur Académique Lausannois

Organisation

Université de Lausanne et CHUV

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info:eu-repo/semantics/openAccess , Copying allowed only for non-profit organizations , https://serval.unil.ch/disclaimer

Mots-clés 0

Adult; Antibodies/blood; Antibodies, Monoclonal, Humanized/adverse effects; Antibodies, Monoclonal, Humanized/immunology; Crohn Disease/drug therapy; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Glucocorticoids/therapeutic use; Humans; Immunosuppressive Agents/therapeutic use; Induction Chemotherapy; Infusions, Intravenous/adverse effects; Integrins/antagonists & inhibitors; Integrins/immunology; Maintenance Chemotherapy; Male; Middle Aged

Sujets proches En

Therapy Treatments for diseases Medical treatment Therapy Treatment of diseases Ileitis, Regional Colitis, Granulomatous Regional enteritis Crohn disease Regional ileitis Enteritis, Regional Ileocolitis Granulomatous colitis Terminal enteritis Granulomatous enteritis

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W.J. Sandborn et al., « Vedolizumab as induction and maintenance therapy for Crohn's disease. », Serveur académique Lausannois, ID : 10.1056/NEJMoa1215739

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BACKGROUND: The efficacy of vedolizumab, an α4β7 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 ≤150, with scores ranging from 0 to approximately 600 and higher scores indicating greater disease activity) (P=0.02); a total of 31.4% and 25.7% of the patients, respectively, had a CDAI-100 response (≥100-point decrease in the CDAI score) (P=0.23). Among patients in cohorts 1 and 2 who had a response to induction therapy, 39.0% and 36.4% of those assigned to vedolizumab every 8 weeks and every 4 weeks, respectively, were in clinical remission at week 52, as compared with 21.6% assigned to placebo (P

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