Clinical–alimentary tractInfliximab Plus Azathioprine for Steroid-Dependent Crohn’s Disease Patients: A Randomized Placebo-Controlled Trial
Section snippets
Patients
Eligible patients were at least 18 years old and had luminal steroid-dependent CD. The diagnosis of CD was based on established clinical, endoscopic, radiologic, and histologic criteria. Steroid dependency was defined as follows: (1) prednisone had to be given for at least 6 months at a dosage 10 mg/day or more, with no interruption for more than 2 months within the past 6 months; (2) at least 2 clinical luminal relapses when tapering of steroids had been attempted, leading to an increase in
Baseline Characteristics of Patients
The trial profile is shown in Figure 1. A total of 115 patients were randomized (56 in the failure stratum/59 in the naive stratum); 57 patients (26 in the failure stratum) were assigned randomly to receive infliximab and 58 patients (30 in the failure stratum) to receive placebo. Two patients allocated to placebo treatment (1 in each stratum) were not enrolled and did not receive the first infusion, 1 patient because his CDAI was less than 150 at inclusion and the other patient because he
Discussion
Our study was designed to show the superiority of treatment with a combination of AZA/6-MP with infliximab (3 infusions at 0, 2, and 6 weeks), compared with AZA/6-MP alone, in patients with steroid-dependent CD. With the addition of infliximab to AZA/6-MP we showed the following: (1) the rate of success was nearly doubled, defined as complete clinical remission (CDAI, <150) without steroids from 38% to 75% at week 12, from 29% to 57% at week 24, and from 22% to 40% at 52 weeks; the
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Supported by Groupe d’Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID), and by grants from Schering Plough, France, with the specific help of Gérard Trape and Yves-Dominique Henry. Drugs were provided by Schering Plough, France. All data analysis and manuscript writing were performed independently by the GETAID, without the involvement of representatives of Schering Plough.