title: Adalimumab in steroid-dependent Crohn's disease patients: prognostic factors for clinical benefit.
abstract: BACKGROUND
  Corticosteroids are effective in the treatment of Crohn's disease but some patients relapse during tapering or after discontinuation. We report data on efficacy and prognostic factors of response of adalimumab in steroid-dependent patients.
  
  
  METHODS
  In all, 110 steroid-dependent patients were treated with adalimumab (80/40 or 160/80 mg every other week followed by 40 mg every other week). Clinical remission was defined as steroid discontinuation without symptomatic recurrence and clinical response as the reduction or maintenance of the initial Crohn's Disease Activity Index (CDAI) value reducing steroid dosage but without its discontinuation at week 6 and at the end of follow-up.
  
  
  RESULTS
  At week 6, 91% of patients had a clinical benefit (remission: 45.5%, response: 45.5%). At the end of the follow-up (mean 14.6 months), 80.9% of responders maintained the clinical benefit (remission: 64.5%, response: 16.4%). At univariate analysis four variables were associated with remission at week 6: age of patients <40 years at baseline, no previous history of surgery, inflammatory pattern, and higher induction regimen. At multivariate analysis only higher induction regimen was related to remission at week 6. At the end of the follow-up, none of the variables were associated with remission. None of the variables were related to response at 6 weeks and at the end of follow-up. Adalimumab was well tolerated.
  
  
  CONCLUSIONS
  This study shows that adalimumab is a powerful and safe weapon for steroid discontinuation in patients with steroid-dependent Crohn's disease. Higher induction regimen dosage is the better therapeutic choice for achieving clinical remission with low risk of clinical relapse.
authors.affiliation: DI.BI.MIS., Division of Internal Medicine Villa Sofia-V. Cervello Hospital, University of Palermo, Palermo, Italy. ambrogiorlando@gmail.com
authors.forename: Ambrogio
authors.initials: A
authors.lastname: Orlando
authors.forename: Sara
authors.initials: S
authors.lastname: Renna
authors.forename: Filippo
authors.initials: F
authors.lastname: Mocciaro
authors.forename: Maria
authors.initials: M
authors.lastname: Cappello
authors.forename: Roberto
authors.initials: R
authors.lastname: Di Mitri
authors.forename: Claudia
authors.initials: C
authors.lastname: Randazzo
authors.forename: Mario
authors.initials: M
authors.lastname: Cottone
mesh_terms: D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D012074:Remission Induction; D055502:Secondary Prevention; D055815:Young Adult
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D000068879:Adalimumab