Hospitalization Rates in Patients with Crohnʼs Disease and Deep Remission: Data from the 56-week CHARM Trial

Abstract

Purpose: Deep remission (DR), an emerging treatment goal in Crohn's disease (CD), may be associated with improved patient outcomes. Methods: We assessed all-cause and CD-related hospitalization rates among patients (both ADA- and PBO- treated) in the 56-week CHARM trial (NCT00077779) who achieved predicted DR vs. those who did not. Predicted DR was defined as having both predicted mucosal healing (using an index comprised of non-invasive biomarkers and symptomatology1) and clinical remission (Crohn's Disease Activity Index [CDAI] total score <150) at week 12 in CHARM. Hospitalization rates were compared in predicted DR achievers vs. non-achievers from week 12 to week 56 using chi-square tests. Logistic regression was used to compare the odds of being hospitalized from week 12 to week 56, adjusting for adalimumab treatment and CD disease duration at week 12. Analyses were performed as observed and with non-responder imputation (NRI) for patients with missing predicted DR data. Results: At week 12 in CHARM, 193 of 686 patients achieved predicted DR at week 12 in CHARM. From week 12 to week 56, hospitalizations for any reason (11% vs. 18%; odds ratio [OR] 0.59; 95% confidence interval [CI] 0.36, 0.98; P=.04) as well as those specifically related to CD (6% vs. 13%; OR 0.43; 95% CI 0.23, 0.83; P=.01) were significantly less among predicted DR achievers vs. non-achievers (Table, as observed). In the NRI analysis, CD-related hospitalizations were significantly less in DR achievers vs. non-achievers (6% vs. 12%; OR 0.68; 95% CI 0.25, 0.93; P=.03).Table: Table. Hospitalization rates in predicted DR achievers vs. non-achieversConclusion: Hospitalizations for any reason or specifically related to CD were fewer in patients with CD who achieved predicted DR compared with those who did not.