title: Adalimumab sustains steroid-free remission after 3 years of therapy for Crohn's disease.
abstract: BACKGROUND
  Treatments that achieve sustainable steroid-free clinical remission in Crohn's disease are needed; however, long-term steroid-sparing efficacy data are limited.
  
  
  OBJECTIVE
  To evaluate steroid-sparing efficacy and the impact of steroid discontinuation on adverse events during treatment of Crohn's disease with adalimumab in the phase III randomised, double-blind 1-year CHARM trial and for an additional 2 years in its open-label extension ADHERE.
  
  
  METHODS
  Steroid-free remission and response and steroid-sparing (≥50% steroid dose reduction) remission rates were evaluated over 3 years in patients who were taking corticosteroids at CHARM baseline.
  
  
  RESULTS
  Of 778 patients randomised in CHARM (including those who did not achieve clinical response to open-label induction therapy), 313 patients (40%) were on corticosteroids at baseline. In the 206 patients randomised to adalimumab, rates of steroid-free remission at 1 year and 3 years were 26% and 23% respectively; corresponding rates were 29% and 25% for steroid-sparing remission and 32% and 28% for steroid-free response. Although the incidence of serious infections with adalimumab treatment during CHARM was higher in patients taking steroids at baseline than those who were not, the rates of overall adverse events, serious infections and opportunistic infections were lower in patients who were able to discontinue corticosteroids than those who remained on steroids.
  
  
  CONCLUSIONS
  Adalimumab therapy resulted in modest but clinically meaningful rates of steroid-free remission, sustained over 3 years of treatment, in a heavily pretreated population of patients with Crohn's disease receiving steroids at the start of therapy (http://www.clinicaltrials.gov number: NCT00077779).
authors.affiliation: Department of Medicine, St Vincent's Hospital and the University of Melbourne, Melbourne, Victoria, Australia. mkamm@unimelb.edu.au
authors.forename: M A
authors.initials: MA
authors.lastname: Kamm
authors.forename: S B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: R
authors.initials: R
authors.lastname: Panaccione
authors.forename: J-F
authors.initials: JF
authors.lastname: Colombel
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: P F
authors.initials: PF
authors.lastname: Pollack
authors.forename: Q
authors.initials: Q
authors.lastname: Zhou
authors.forename: A M
authors.initials: AM
authors.lastname: Robinson
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D005938:Glucocorticoids; D000068879:Adalimumab