Level 2: Mid-level evidence
An open-label randomized trial compared combination therapy for Crohn’s disease with conventional therapy in 133 newly diagnosed patients (mean duration of diagnosis two weeks) (Lancet. 2008;371:660-667). Participants ranged in age from 16 to 75 years (mean 30 years). Combination therapy consisted of infliximab 5 mg/kg infusions at weeks zero, two, and six plus azathioprine 2-2.5 mg/kg/day (or methotrexate in azathioprine-intolerant patients); additional infliximab or corticosteroids were given if symptoms worsened after six weeks. Conventional therapy consisted of initial treatment with one of two corticosteroids: methylprednisone 32 mg daily for three weeks, then tapered weekly by 4 mg/day, or budesonide 9 mg daily for eight weeks, then tapered weekly by 3 mg/day. During conventional therapy, the corticosteroid dose was increased if symptoms worsened during corticosteroid tapering; azathioprine 2-2.5 mg/kg/day was added if symptoms worsened after increased corticosteroid dose. If patients were symptomatic after 16 weeks, infliximab 5 mg/kg was added at weeks zero, two, and six.
Comparing combination therapy vs. conventional therapy, 80% vs. 74% of patients were followed for two years. Combination therapy was associated with increased remission rate without corticosteroids at 26 weeks (60% vs. 36%, P=.0062, NNT 5) and 52 weeks (61.5% vs. 42.2%, P=.0278, NNT 6). At 104 weeks, more combination-therapy patients were ulcer-free on endoscopy (73.1% vs. 30.4%, P=.0028, NNT 3). There were no significant differences in bowel resections or adverse events between groups.