title: Adalimumab induces deep remission in patients with Crohn's disease.
abstract: OBJECTIVE
  Patients with moderate to severe ileocolonic Crohn's disease (CD) who received adalimumab induction and maintenance therapy had greater rates of mucosal healing than patients who received placebo after adalimumab induction therapy in a 52-week trial (EXTend the Safety and Efficacy of Adalimumab Through ENDoscopic Healing). We investigated whether this treatment also induced deep remission-a composite clinical and endoscopic end point.
  
  
  METHODS
  Rates of deep remission, defined as the absence of mucosal ulceration and CD Activity Index scores less than 150, were compared between patients given continuous adalimumab and those given only induction therapy followed by placebo. We assessed the relationships between deep remission and other outcomes among patients who received adalimumab. The outcomes of patients with deep remission were compared with those of patients with only the absence of mucosal ulceration or only clinical remission.
  
  
  RESULTS
  Rates of deep remission were 16% in patients given adalimumab vs 10% in those given placebo (P = .34) at week 12, and 19% vs 0% (P < .001) at week 52. Rates of deep remission were greatest among patients who received adalimumab and had CD for 2 years or less (33% at weeks 12 and 52). At week 52, patients who achieved deep remission at week 12 required significantly fewer adalimumab treatment adjustments, hospitalizations, and CD-related surgeries; had significantly less activity impairment; and had better quality of life and physical function compared with patients not achieving deep remission. Deep remission generally was associated with better outcomes than only an absence of mucosal ulceration; outcomes of patients with deep remission vs only clinical remission were similar. Deep remission was associated with estimated total cost savings of $10,360 (from weeks 12 through 52) compared with lack of deep remission.
  
  
  CONCLUSIONS
  In an exploratory study of patients with moderate to severe ileocolonic CD who received adalimumab induction and maintenance therapy, patients achieving deep remission appeared to have better 1-year outcomes than those not achieving deep remission. These findings should be validated in large, prospective trials. ClinicalTrials.gov number: NCT00348283.
authors.affiliation: Mount Sinai Hospital School of Medicine, New York, New York. Electronic address: jean-frederic.colombel@mssm.edu.
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.affiliation: University Hospital of Gasthuisberg, Leuven, Belgium.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Rutgeerts
authors.affiliation: University of California San Diego, La Jolla, California.
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Mei
authors.initials: M
authors.lastname: Yang
authors.affiliation: AbbVie Deutschland GmbH & Co KG, Ludwigshafen, Germany.
authors.forename: Anne
authors.initials: A
authors.lastname: Camez
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pollack
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Roopal B
authors.initials: RB
authors.lastname: Thakkar
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Anne M
authors.initials: AM
authors.lastname: Robinson
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Naijun
authors.initials: N
authors.lastname: Chen
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Parvez M
authors.initials: PM
authors.lastname: Mulani
authors.affiliation: AbbVie, Inc, North Chicago, Illinois.
authors.forename: Jingdong
authors.initials: J
authors.lastname: Chao
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* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D061067:Antibodies, Monoclonal, Humanized; D010919:Placebos; D000068879:Adalimumab
keywords: CDAI; Clinical Trial; IBD; Mucosal Healing