title: Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial.
abstract: OBJECTIVE
  This study evaluated the efficacy and safety of adalimumab, a fully human, anti-tumor necrosis factor monoclonal antibody administered subcutaneously, in the maintenance of response and remission in patients with moderate to severe Crohn's disease (CD).
  
  
  METHODS
  Patients received open-label induction therapy with adalimumab 80 mg (week 0) followed by 40 mg (week 2). At week 4, patients were stratified by response (decrease in Crohn's Disease Activity Index > or =70 points from baseline) and randomized to double-blind treatment with placebo, adalimumab 40 mg every other week (eow), or adalimumab 40 mg weekly through week 56. Co-primary end points were the percentages of randomized responders who achieved clinical remission (Crohn's Disease Activity Index score <150) at weeks 26 and 56.
  
  
  RESULTS
  The percentage of randomized responders in remission was significantly greater in the adalimumab 40-mg eow and 40-mg weekly groups versus placebo at week 26 (40%, 47%, and 17%, respectively; P < .001) and week 56 (36%, 41%, and 12%, respectively; P < .001). No significant differences in efficacy between adalimumab eow and weekly were observed. More patients receiving placebo discontinued treatment because of an adverse event (13.4%) than those receiving adalimumab (6.9% and 4.7% in the 40-mg eow and 40-mg weekly groups, respectively).
  
  
  CONCLUSIONS
  Among patients who responded to adalimumab, both adalimumab eow and weekly were significantly more effective than placebo in maintaining remission in moderate to severe CD through 56 weeks. Adalimumab was well-tolerated, with a safety profile consistent with previous experience with the drug.
authors.affiliation: Department of Hepatogastroenterology, Hôpital Claude Huriez, Centre Hospitalier Universitaire de Lille, Rue Michel Polonovski, 59037 Lille, France. jfcolombel@chru-lille.fr
authors.forename: Jean-Frédéric
authors.initials: JF
authors.lastname: Colombel
authors.forename: William J
authors.initials: WJ
authors.lastname: Sandborn
authors.forename: Paul
authors.initials: P
authors.lastname: Rutgeerts
authors.forename: Robert
authors.initials: R
authors.lastname: Enns
authors.forename: Stephen B
authors.initials: SB
authors.lastname: Hanauer
authors.forename: Remo
authors.initials: R
authors.lastname: Panaccione
authors.forename: Stefan
authors.initials: S
authors.lastname: Schreiber
authors.forename: Dan
authors.initials: D
authors.lastname: Byczkowski
authors.forename: Ju
authors.initials: J
authors.lastname: Li
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Kent
authors.forename: Paul F
authors.initials: PF
authors.lastname: Pollack
mesh_terms: D000068879:Adalimumab; D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003424:Crohn Disease / Q000150:complications / Q000188:drug therapy* / Q000276:immunology*; D016154:Digestive System Fistula / Q000188:drug therapy / Q000209:etiology / Q000276:immunology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D012074:Remission Induction; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D010919:Placebos; D000068879:Adalimumab