Early Administration of Azathioprine vs Conventional Management of Crohn's Disease: a Randomized Controlled Trial. - Université Paris Cité Accéder directement au contenu
Article Dans Une Revue Gastroenterology Année : 2013

Early Administration of Azathioprine vs Conventional Management of Crohn's Disease: a Randomized Controlled Trial.

Résumé

BACKGROUND: & Aims: Immunomodulator therapy is effective for patients with Crohn's disease, but has not been shown to affect disease progression-presumably because it is given too late after diagnosis. We compared the efficacy of early treatment (within 6 mo after diagnosis) with azathioprine vs conventional management of patients at high risk for disabling disease. METHODS: We performed an open-label trial of adults with a diagnosis of Crohn's disease for less than 6 months who were at risk for disabling disease. From July 2005 through November 2010, patients at 24 French centers were randomly assigned to groups given azathioprine (2.5 mg/kg/day, n=65) or conventional management (placed on azathioprine only in cases of steroid-dependency, chronic active disease, with frequent flares, poor response to steroids, or development of severe perianal disease) (controls, n=67). The primary endpoint was the proportion of trimesters spent in steroid-free and anti-tumor necrosis factor (TNF)-free remission during the first 3 years after inclusion. RESULTS: During 3 y follow-up period, 16 patients in the azathioprine group were switched to mercaptopurine or methotrexate therapy, because of intolerance or poor efficacy. Forty-one controls required immunosuppressants (61%; median time to first prescription, 11 months). In the azathioprine group, a median 67% of trimesters were spent in remission (interquartile range, 11%-85%), compared with 56% in the control group (interquartile range, 29%-73%) (P=.69). Among secondary outcomes, a higher cumulative proportion of patients in the azathioprine group were free of perianal surgery than in the control group (96%±3% and 82%±6% at month 36, respectively; P=.036). The cumulative proportions of patients free of intestinal surgery and anti-TNF therapy did not differ between groups. CONCLUSION: Based on results from a clinical trial, administration of azathioprine within 6 months diagnosis of Crohn's disease was no more effective than conventional management in increasing time of clinical remission.

Domaines

Chimie organique
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Dates et versions

hal-00821802 , version 1 (13-05-2013)

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Jacques Cosnes, Anne Bourrier, David Laharie, Stéphane Nahon, Yoram Bouhnik, et al.. Early Administration of Azathioprine vs Conventional Management of Crohn's Disease: a Randomized Controlled Trial.. Gastroenterology, 2013, 145 (4), pp.758-765.e2. ⟨10.1053/j.gastro.2013.04.048⟩. ⟨hal-00821802⟩
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