Adalimumab Sustains Deep Remission for 3 Years: Data From CHARM and ADHERE

Abstract

BACKGROUND: Deep remission (DR), defined as clinical remission and mucosal healing (MH), has been associated with improved patient outcomes.1Evidence of DR beyond 1 year has not been characterized. We aimed to evaluate the impact of adalimumab (ADA) on DR over a 3-year period. METHODS: We analyzed the intention-to-treat (ITT) population from CHARM (56 weeks, randomized at Week 4 to placebo [PBO], ADA 40 mg every other week [eow], and ADA 40 mg weekly) and its 2-year open label extension ADHERE (all patients given open-label ADA 40 mg eow or weekly). Due to the absence of endoscopic measurements in CHARM and ADHERE, a practical index obtained from a Least Absolute Shrinkage and Selection Operator (LASSO) procedure was used to predict MH (defined as a CD Endoscopic Index of Severity [CDEIS] score <4.24). DR was defined as a Crohn's Disease Activity Index (CDAI) score <150 plus predicted MH. Patients who discontinued, had missing data, or switched to open-label therapy during CHARM were classified as DR nonresponders at subsequent time points. Rates of DR (assessed at Weeks 26 and 56) were compared between the ADA and PBO arms using chi-square tests. The rates of DR are also assessed in the open-label extension ADHERE (up to Week 164). RESULTS: Of 517 patients randomized to ADA in CHARM, 318 (62%) entered ADHERE. DR rates at Weeks 26 and 56 were significantly higher for the ADA eow and ADA weekly arms compared with PBO. Rates of DR on open-label ADA were maintained up to Week 164 during ADHERE (figure). CONCLUSION(S): DR was achieved by a substantial proportion of patients in CHARM. Rates of DR achievement were sustained over 3 years (Figure Presented).