title: Induction and maintenance infliximab therapy for the treatment of moderate-to-severe Crohn's disease in children.
abstract: OBJECTIVE
  The REACH study evaluated the safety and efficacy of infliximab in children with moderately to severely active Crohn's disease.
  
  
  METHODS
  Patients (n = 112) with a Pediatric Crohn's Disease Activity Index (PCDAI) score >30 received infliximab 5 mg/kg at weeks 0, 2, and 6. Patients responding to treatment at week 10 were randomized to infliximab 5 mg/kg every 8 or 12 weeks through week 46. A concurrent immunomodulator was required. Clinical response (decrease from baseline in the PCDAI score > or =15 points; total score < or =30) and clinical remission (PCDAI score < or =10 points) were evaluated at weeks 10, 30, and 54.
  
  
  RESULTS
  At week 10, 99 of 112 (88.4%) patients responded to infliximab (95% confidence interval: [82.5%, 94.3%]) and 66 of 112 (58.9%) patients achieved clinical remission (95% confidence interval: [49.8%, 68.0%]). At week 54, 33 of 52 (63.5%) and 29 of 52 (55.8%) patients receiving infliximab every 8 weeks did not require dose adjustment and were in clinical response and clinical remission, respectively, compared with 17 of 51 (33.3%) and 12 of 51 (23.5%) patients receiving treatment every 12 weeks (P = .002 and P < .001, respectively).
  
  
  CONCLUSIONS
  Pediatric patients responding to an induction regimen of infliximab were more likely to be in clinical response and remission at week 54 without dose adjustment when their maintenance therapy was given every 8 weeks rather than every 12 weeks. Allowing for dose intensification in the case of relapse, remission rates, but not response rates, at week 54 were superior with every 8-week dosing compared with every 12-week dosing.
authors.affiliation: Connecticut Children's Medical Center, Hartford, Conneticut 06106, USA. jhyams@ccmckids.org
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hyams
authors.forename: Wallace
authors.initials: W
authors.lastname: Crandall
authors.forename: Subra
authors.initials: S
authors.lastname: Kugathasan
authors.forename: Anne
authors.initials: A
authors.lastname: Griffiths
authors.forename: Allan
authors.initials: A
authors.lastname: Olson
authors.forename: Jewel
authors.initials: J
authors.lastname: Johanns
authors.forename: Grace
authors.initials: G
authors.lastname: Liu
authors.forename: Suzanne
authors.initials: S
authors.lastname: Travers
authors.forename: Robert
authors.initials: R
authors.lastname: Heuschkel
authors.forename: James
authors.initials: J
authors.lastname: Markowitz
authors.forename: Stanley
authors.initials: S
authors.lastname: Cohen
authors.forename: Harland
authors.initials: H
authors.lastname: Winter
authors.forename: Gigi
authors.initials: G
authors.lastname: Veereman-Wauters
authors.forename: George
authors.initials: G
authors.lastname: Ferry
authors.forename: Robert
authors.initials: R
authors.lastname: Baldassano
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000627:therapeutic use; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D000906:Antibodies / Q000097:blood; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D001827:Body Height / Q000187:drug effects; D002648:Child; D003424:Crohn Disease / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005060:Europe; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D000069285:Infliximab; D008297:Male; D009656:North America; D011788:Quality of Life; D012074:Remission Induction; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000305:Adrenal Cortex Hormones; D000893:Anti-Inflammatory Agents; D000906:Antibodies; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D007155:Immunologic Factors; D000069285:Infliximab