Azathioprine dose reduction in inflammatory bowel disease patients on combination therapy: an open-label, prospective and randomised clinical trial - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Alimentary Pharmacology and Therapeutics Année : 2017

Azathioprine dose reduction in inflammatory bowel disease patients on combination therapy: an open-label, prospective and randomised clinical trial

S. Paul

Résumé

BACKGROUND: Infliximab (IFX) combined with azathioprine (AZA) is more effective than IFX monotherapy in inflammatory bowel disease (IBD). AIM: To identify the AZA optimal dose that is required for efficacy when receiving combination therapy. METHODS: Patients with IBD in durable remission on combination therapy were enrolled in a 1-year, open-label, prospective trial after randomisation into three groups: AZA steady (2-2.5~mg/kg/day, n=28) vs AZA down (dose was halved 1-1.25~mg/kg/day, n=27) vs AZA stopped (n=26). Primary endpoint was failure defined as occurrence of a clinical relapse and/or any change in IBD therapy. RESULTS: Eighty-one patients were included. Five (17.9%), 3 (11.1%), and 8 (30.8%) patients experienced failure at 1~year in groups AZA steady, AZA down and AZA stopped, respectively (P=.1 across the groups). The median trough levels of IFX at inclusion were close to those measured at the end of follow-up in group AZA steady (3.65 vs 3.45~μg/mL, P=.9) and in group AZA down (3.95 vs 3.60~μg/mL, P=.5), whereas these levels dropped from 4.25 to 2.15~μg/mL (P=.02) in group AZA stopped. Four (14.3%), four (14.8%) and 11 (42.3%) patients experienced an unfavourable evolution of IFX pharmacokinetics in groups AZA steady, AZA down and AZA stopped, respectively. A threshold of 6-TGN \textless105~pmoles/8.108 RBC was associated with an unfavourable evolution of IFX pharmacokinetics. CONCLUSIONS: Under combination therapy, AZA dose reduction, but not withdrawal, appears to be as effective as continuation of AZA at full dose.

Dates et versions

hal-01908994 , version 1 (30-10-2018)

Identifiants

Citer

X. Roblin, Gilles Boschetti, N. Williet, Stéphane Nancey, H. Marotte, et al.. Azathioprine dose reduction in inflammatory bowel disease patients on combination therapy: an open-label, prospective and randomised clinical trial. Alimentary Pharmacology and Therapeutics, 2017, 46 (2), pp.142-149. ⟨10.1111/apt.14106⟩. ⟨hal-01908994⟩
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