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Methods: In CHARM, a Phase III study of 854 patients with moderately to severely active CD, open-label adalimumab was administered at Weeks 0 and 2 (80 mg and 40 mg, respectively). Patients were then randomized to receive blinded therapy of adalimumab 40 mg every other week (eow), adalimumab 40 mg weekly, or placebo for up to 56 weeks. Patients receiving steroids were included in the study if they had been on a stable dosage of 30 mg/day prednisone (or equivalent) for 2 weeks prior to screening. The current post-hoc subanalysis evaluated data from the intention-to-treat population of patients receiving steroids at baseline who were randomized to adalimumab and assessed for steroid-free remission at 3 years from CHARM baseline. Remission rates were calculated using nonresponder imputation (NRI) analysis. Results: In CHARM, 206 patients receiving steroids at baseline were randomized to adalimumab treatment. At 2 and 3 years after CHARM baseline, respectively, 27% and 28% of these patients were in steroid-free remission (table).

P084 - Fistula healing with adalimumab treatment in bioloigic-naive and anti-TNF-experienced patients with Crohn's disease: results of the CARE trial