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Adalimumab for the treatment of fistulas in patients with Crohn’s disease

Gut, 2009-07, Vol.58 (7), p.940-948 [Peer Reviewed Journal]

Colombel et al 2009 ;2009 INIST-CNRS ;Copyright: 2009 (c) Colombel et al 2009 ;Colombel et al 2009 2009 ;ISSN: 0017-5749 ;EISSN: 1468-3288 ;DOI: 10.1136/gut.2008.159251 ;PMID: 19201775 ;CODEN: GUTTAK

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Title:
Adalimumab for the treatment of fistulas in patients with Crohn’s disease
Author: Colombel, J-F ; Schwartz, D A ; Sandborn, W J ; Kamm, M A ; D’Haens, G ; Rutgeerts, P ; Enns, R ; Panaccione, R ; Schreiber, S ; Li, J ; Kent, J D ; Lomax, K G ; Pollack, P F
Subjects: Adalimumab ; Adult ; Anti-Inflammatory Agents - therapeutic use ; Antibodies, Monoclonal - therapeutic use ; Antibodies, Monoclonal, Humanized ; Biological and medical sciences ; Bones, joints and connective tissue. Antiinflammatory agents ; Clinical trials ; Crohn Disease - complications ; Crohns disease ; Double-Blind Method ; Drainage ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Immunomodulators ; Inflammatory Bowel Disease ; Intestinal Fistula - drug therapy ; Intestinal Fistula - etiology ; Male ; Medical sciences ; Middle Aged ; Other diseases. Semiology ; Pharmacology. Drug treatments ; Prescription drugs ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Studies ; Treatment Outcome ; Tumor necrosis factor-TNF ; Wound Healing
Is Part Of: Gut, 2009-07, Vol.58 (7), p.940-948
Description: Objective:To evaluate the efficacy of adalimumab in the healing of draining fistulas in patients with active Crohn’s disease (CD).Design:A phase III, multicentre, randomised, double-blind, placebo controlled study with an open-label extension was conducted in 92 sites.Patients:A subgroup of adults with moderate to severely active CD (CD activity index 220–450) for ⩾4 months who had draining fistulas at baseline.Interventions:All patients received initial open-label adalimumab induction therapy (80 mg/40 mg at weeks 0/2). At week 4, all patients were randomly assigned to receive double-blind placebo or adalimumab 40 mg every other week or weekly to week 56 (irrespective of fistula status). Patients completing week 56 of therapy were then eligible to enroll in an open-label extension.Main Outcome Measures:Complete fistula healing/closure (assessed at every visit) was defined as no drainage, either spontaneous or with gentle compression.Results:Of 854 patients enrolled, 117 had draining fistulas at both screening and baseline (70 randomly assigned to adalimumab and 47 to placebo). The mean number of draining fistulas per day was significantly decreased in adalimumab-treated patients compared with placebo-treated patients during the double-blind treatment period. Of all patients with healed fistulas at week 56 (both adalimumab and placebo groups), 90% (28/31) maintained healing following 1 year of open-label adalimumab therapy (observed analysis).Conclusions:In patients with active CD, adalimumab therapy was more effective than placebo for inducing fistula healing. Complete fistula healing was sustained for up to 2 years by most patients in an open-label extension trial.ClinicalTrials.gov Identifier: NCT00077779 and NCT00195715.
Publisher: London: BMJ Publishing Group Ltd and British Society of Gastroenterology
Language: English
Identifier: ISSN: 0017-5749
EISSN: 1468-3288
DOI: 10.1136/gut.2008.159251
PMID: 19201775
CODEN: GUTTAK
Source: BMJ Journals
AUTh Library subscriptions: ProQuest Central
MEDLINE
Alma/SFX Local Collection

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Adalimumab for the treatment of fistulas in patients with Crohn’s disease

Colombel et al 2009 ;2009 INIST-CNRS ;Copyright: 2009 (c) Colombel et al 2009 ;Colombel et al 2009 2009 ;ISSN: 0017-5749 ;EISSN: 1468-3288 ;DOI: 10.1136/gut.2008.159251 ;PMID: 19201775 ;CODEN: GUTTAK

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