Efficacy of Adalimumab for the Treatment of TNF-Antagonist-Naïve Patients with Crohnʼs Disease

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Purpose: Adalimumab (ADA) is approved in the U.S. for use in the treatment of moderate to severe Crohn's disease (CD) in adults. The CHARM trial was a 56-week, Phase III, randomized controlled trial that assessed ADA in maintaining clinical remission in patients (pts) with moderate to severe CD. Methods: We sought to evaluate the impact of ADA maintenance therapy on clinical efficacy for TNF-antagonist-naïve pts in the CHARM trial. Pts received open-label induction therapy of 80 mg ADA at baseline (Week 0) and 40 mg at Week 2. At Week 4, pts were stratified by responder status and randomized to 40 mg ADA every other week (eow), 40 mg ADA weekly, or placebo. All TNF-antagonist-naïve pts were included in the analysis regardless of Week 4 response status. Efficacy outcomes included remission (CDAI < 150), CR-70 (a decrease of 70 points in CDAI from the baseline), and CR-100 (a decrease of 100 points in CDAI from the baseline), which were compared by chi-square analysis. ANCOVA was used to control for baseline score and Week-4 responder status, and was used to compare the differences in change of IBDQ score from baseline at Week 26 and Week 56 between the ADA and placebo groups. Nonresponder imputation was used when CDAI scores were missing or pts moved out of the double-blind treatment arm. Results: The percentage of pts in remission was significantly greater for the ADA 40-mg eow and 40-mg weekly groups vs. placebo at Weeks 26 and 56. At these same time points, clinical response rates were also significantly greater for the ADA groups vs. placebo (Table). ADA maintenance therapy also demonstrated a significant benefit in IBDQ total score compared with placebo at all points after the induction period (P < 0.05).Table: Clinical Remission and Response in TNF-Antagonist-Naïve Patients Receiving Adalimumab