title: Adalimumab for maintenance treatment of Crohn's disease: results of the CLASSIC II trial.
abstract: BACKGROUND
  Adalimumab induced clinical remission after four weeks in patients with active Crohn's disease in the CLASSIC I trial.
  
  
  OBJECTIVE
  To evaluate long term efficacy and safety of adalimumab maintenance therapy in Crohn's disease in a follow-on randomised controlled trial (CLASSIC II).
  
  
  METHODS
  In the preceding CLASSIC I trial, 299 patients with moderate to severe Crohn's disease naive to tumour necrosis factor antagonists received induction therapy with adalimumab 40 mg/20 mg, 80 mg/40 mg, or 160 mg/80 mg, or placebo, at weeks 0 and 2. In all, 276 patients from CLASSIC I enrolled in CLASSIC II and received open-label adalimumab 40 mg at weeks 0 (week 4 of CLASSIC I) and 2; 55 patients in remission at both weeks 0 and 4 were re-randomised to adalimumab 40 mg every other week, 40 mg weekly, or placebo for 56 weeks. Patients not in remission at both weeks 0 and 4 were enrolled in an open-label arm and received adalimumab 40 mg every other week. With non-response or flare, these patients could have their dosages increased to 40 mg weekly. Patients in the randomised arm with continued non-response or disease flare could switch to open-label adalimumab 40 mg every other week and again to 40 mg weekly. The primary end point was maintenance of remission (CDAI <150) in randomised patients through week 56.
  
  
  RESULTS
  Of 55 patients randomised at week 4, 79% who received adalimumab 40 mg every other week and 83% who received 40 mg weekly were in remission at week 56, v 44% for placebo (p<0.05). In all, 204 patients entered the open-label arm. Of these, 93 (46%) were in clinical remission at week 56. Adalimumab was generally well-tolerated in all patients.
  
  
  CONCLUSIONS
  Adalimumab induced and maintained clinical remission for up to 56 weeks in patients with moderate to severe Crohn's disease naive to anti-TNF treatment.
authors.affiliation: Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. sandborn.william@mayo.edu
authors.forename: W J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: S B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: P
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: R N
authors.initials: RN
authors.lastname: Fedorak
authors.forename: M
authors.initials: M
authors.lastname: Lukas
authors.forename: D G
authors.initials: DG
authors.lastname: MacIntosh
authors.forename: R
authors.initials: R
authors.lastname: Panaccione
authors.forename: D
authors.initials: D
authors.lastname: Wolf
authors.forename: J D
authors.initials: JD
authors.lastname: Kent
authors.forename: B
authors.initials: B
authors.lastname: Bittle
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.forename: P F
authors.initials: PF
authors.lastname: Pollack
mesh_terms: D000068879:Adalimumab; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D000906:Antibodies / Q000097:blood; D000974:Antibodies, Antinuclear / Q000097:blood; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D061067:Antibodies, Monoclonal, Humanized; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D007279:Injections, Subcutaneous; D008134:Long-Term Care / Q000379:methods; D008297:Male; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000906:Antibodies; D000974:Antibodies, Antinuclear; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D007166:Immunosuppressive Agents; D000068879:Adalimumab