title: Six year adalimumab efficacy in steroid-dependent Crohn's disease patients: A prospective single-center real life study.
abstract: BACKGROUND
  Adalimumab is effective in the treatment of Crohn's disease. We have already reported data on the efficacy of adalimumab in 110 steroid-dependent patients. At the end of the study 90 patients (64.5%) maintained clinical remission.
  
  
  OBJECTIVE
  To assess efficacy and safety of adalimumab after 6 years in patients of the original cohort who responded to treatment.
  
  
  METHODS
  The present study is an extension of the published paper on 90/110 patients. We report results on clinical remission and safety of 6 year maintenance therapy with adalimumab.
  
  
  RESULTS
  Of the original cohort 90 patients completed the study, 17 were lost to follow-up and 3 died. At the end of follow-up (74.16±10.3 months) 37/90 patients (41%) maintained clinical remission. Of these, 32 (86%) continued adalimumab and 5 (13%) discontinued treatment due to clinical remission and mucosal healing. Of the remaining 53/90 patients, 47 (52%) discontinued adalimumab due to clinical failure and 6 (7%) to adverse events. We obtained endoscopy data in 31/32 patients in clinical remission continuing adalimumab: 11 (36%) did not improve, 6 (19%) worsened, 14 (45%) improved. At univariable analysis no variables were related to treatment outcome.
  
  
  CONCLUSIONS
  This "real life" prospective study shows that adalimumab is a long-term effective and safe maintenance treatment in steroid-dependent Crohn's disease patients.
authors: DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy. Electronic address: ambrogiorlando@gmail.com.
authors: Ambrogio
authors: A
authors: Orlando
authors: DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy.
authors: Sara
authors: S
authors: Renna
authors: Gastroenterology and Endoscopy Unit, ARNAS Civico-Di Cristina-Benfratelli Hospital, Palermo, Italy.
authors: Filippo
authors: F
authors: Mocciaro
authors: DiBiMis, Department of Gastroenterology and Hepatology, Palermo University, Palermo, Italy.
authors: Maria
authors: M
authors: Cappello
authors: Gastroenterology and Endoscopy Unit, "Villa Sofia-Cervello" Hospital, Palermo, Italy.
authors: Marco
authors: M
authors: Giunta
authors: DiBiMis, Department of Gastroenterology and Hepatology, Palermo University, Palermo, Italy.
authors: Marco
authors: M
authors: Mendolaro
authors: DiBiMis, Department of Gastroenterology and Hepatology, Palermo University, Palermo, Italy.
authors: Marta
authors: M
authors: Mazza
authors: DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy.
authors: Giulia
authors: G
authors: Rizzuto
authors: DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy.
authors: Emanuele
authors: E
authors: Orlando
authors: DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy.
authors: Marco
authors: M
authors: Affronti
authors: DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy.
authors: Mariangela
authors: M
authors: Dimarco
authors: Gastroenterology and Endoscopy Unit, ARNAS Civico-Di Cristina-Benfratelli Hospital, Palermo, Italy.
authors: Roberto
authors: R
authors: Di Mitri
authors: DiBiMis, Department of Gastroenterology and Hepatology, Palermo University, Palermo, Italy.
authors: Antonio
authors: A
authors: Craxì
authors: DiBiMis, Division of Internal Medicine, "Villa Sofia-Cervello" Hospital, Palermo University, Palermo, Italy.
authors: Mario
authors: M
authors: Cottone
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011446:Prospective Studies; D012074:Remission Induction; D013256:Steroids / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D013256:Steroids; D000068879:Adalimumab
keywords: Adalimumab; Crohn's disease; Inflammatory bowel disease; Long term therapy; Steroid dependency