Résumé
Situation
Les fistules entérocutanées sont des complications sévères de la maladie de Crohn et de traitement difficile. L’infliximab, anticorps monoclonal chimérique dirigé contre le tumor necrosis factor α, a récemment montré son efficacité dans le traitement de la maladie de Crohn. Nous avons élaboré un essai multicentrique randomisé en double insu comparant l’infliximab au placebo dans le traitement des fistules chez les patients atteints de maladie de Crohn.
Méthodes
Quatre-vingt-quartorze patients adultes atteints de maladie de Crohn, souffrant de fistules abdominales ou périnéales, évoluant depuis plus de trois mois ont été inclus. Les patients ont été randomisés en trois bras: placebo (n = 31), infliximab 5 mg/kg (n = 31) et infliximab 10 mg/kg (n = 32); tous trois administrés par voie intraveineuse aux semaines 0, 2 et 6. Le critère de jugement principal (réponse) était la réduction d’au moins 50 % du nombre de trajets fistuleux productifs observé au cours d’au moins deux visites consécutives. Le critère secondaire était la fermeture complète de tous les trajets.
Résultats
Chez 68 % des patients ayant reçu 5 mg/kg d’infliximab et chez 56 % des patients ayant reçu 5 mg/kg d’infliximab, une réponse était obtenue contre 26 % dans le groupe placebo (p = 0,002 et p = 0,02 respectivement). De plus, 55 % des patients traités par 5 mg/kg d’infliximab et 38 % des patients traités par 10 mg/kg avaient une fermeture complète des trajets fistuleux contre 13 % des patients du groupe placebo (p = 0,001 et p = 0,04). La durée médiane de fermeture des fistules était de trois mois. Plus de 60 % des patients dans chaque groupe avaient des effets indésirables. Sous infliximab, les plus fréquemment observés étaient: céphalées, abcès, infections respiratoires et asthénie.
Conclusion
L’infliximab est un traitement efficace des fistules chez les patients souffrant de maladie de Crohn.
Abstract
Background
Enterocutaneous fistulas are a serious complication of Crohn’s disease and are difficult to treat. Infliximab, a chimeric monoclonal antibody to tumor necrosis factor α, has recently been developed as a treatment for Crohn’s disease. We conducted a randomized, multicenter, double blind, placebo-controlled trial of infliximab for the treatment of fistulas in patients with Crohn’s disease.
Method
The study included 94 adult patients who had draining abdominal or perianal fistulas of at least three months’ duration as a complication of Crohn’s disease. Patients were randomly assigned to receive one of three treatments: placebo (31 patients), 5 mg of infliximab per kilogram of body weight (31 patients), or 10 mg of infliximab per kilogram (32 patients); all three were to be administered intravenously at weeks 0, 2, and 6. The primary end point was a reduction of 50 percent or more from base line in the number of draining fistulas observed at two or more consecutive study visits. A secondary end point was the closure of all fistulas.
Results
Sixty-eight percent of the patients who received 5 mg of infliximab per kilogram and 56 percent of those who received 10 mg per kilogram achieved the primary end point, as compared with 26 percent of the patients in the placebo group (p = 0.002 and p = 0.02, respectively). In addition, 55 percent of the patients assigned to receive 5 mg of infliximab per kilogram and 38 percent of those assigned to 10 mg per kilogram had closure of all fistulas, as compared with 13 percent of the patients assigned to placebo (p = 0.001 and p = 0.04, respectively). The median length of time during which the fistulas remained closed was three months. More than 60 percent of patients in all the groups had adverse events. For patients treated with infliximab, the most common were headache, abscess, upper respiratory tract infection and fatigue.
Conclusions
Infliximab is an effective treatment for fistulas in patients with Crohn’s disease.
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Tréton, X. Traitement des fistules de la maladie de Crohn par infliximab. Colon Rectum 2, 161–164 (2008). https://doi.org/10.1007/s11725-008-0095-7
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DOI: https://doi.org/10.1007/s11725-008-0095-7