title: Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis.
abstract: OBJECTIVE
  We evaluated the efficacy and safety of infliximab for inducing and maintaining benefit in children with moderately to severely active ulcerative colitis (UC).
  
  
  METHODS
  Patients (6-17 years old) who had active UC (Mayo scores of 6-12; endoscopic subscores ≥ 2) and had not responded to or tolerated conventional treatment were given 5 mg/kg infliximab at weeks 0, 2, and 6. The primary end point was response at week 8 (decreases in Mayo scores ≥ 30% and ≥ 3 points and decreases in rectal bleeding subscores of ≥ 1 or an absolute subscore of ≤ 1). At week 8, only responders were randomly assigned to groups given infliximab every 8 or 12 weeks (q8w or q12w) and followed through week 54. Maintenance end points included pediatric UC activity index scores <10 points, defined as remission.
  
  
  RESULTS
  At week 8, infliximab induced a response in 73.3% of patients (44 of 60) (95% confidence interval, 62.1%-84.5%; a positive result was defined by 95% confidence interval lower limit >40%). Among responders, twice as many were in remission at week 54 after q8w (8 of 21, 38.1%) than q12w (4 of 22, 18.2%; P = .146) therapy. Assuming the q8w remission rate for responders, the overall remission rate at week 54 would be 28.6%. Serious adverse events and infusion reactions occurred in similar proportions in the q8w and q12w groups. No deaths, malignancies, opportunistic infections, tuberculosis, or delayed hypersensitivity reactions were reported.
  
  
  CONCLUSIONS
  Infliximab was safe and effective, inducing a response at week 8 in 73.3% of pediatric patients with moderate to severely active UC who did not respond to conventional therapy. The overall remission rate at week 54 for all enrolled patients was 28.6%, assuming the more effective q8w remission rate.
authors.affiliation: Division of Digestive Diseases and Nutrition, Connecticut Children’s Medical Center, 282 Washington Street, Hartford, Connecticut 06106, USA. jhyams@ccmckids.org
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Hyams
authors.forename: Lakshmi
authors.initials: L
authors.lastname: Damaraju
authors.forename: Marion
authors.initials: M
authors.lastname: Blank
authors.forename: Jewel
authors.initials: J
authors.lastname: Johanns
authors.forename: Cynthia
authors.initials: C
authors.lastname: Guzzo
authors.forename: Harland S
authors.initials: HS
authors.lastname: Winter
authors.forename: Subra
authors.initials: S
authors.lastname: Kugathasan
authors.forename: Stanley
authors.initials: S
authors.lastname: Cohen
authors.forename: James
authors.initials: J
authors.lastname: Markowitz
authors.forename: Johanna C
authors.initials: JC
authors.lastname: Escher
authors.forename: Gigi
authors.initials: G
authors.lastname: Veereman-Wauters
authors.forename: Wallace
authors.initials: W
authors.lastname: Crandall
authors.forename: Robert
authors.initials: R
authors.lastname: Baldassano
authors.forename: Anne
authors.initials: A
authors.lastname: Griffiths
mesh_terms: D000293:Adolescent; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage*; D006801:Humans; D060828:Induction Chemotherapy / Q000379:methods; D000069285:Infliximab; D060046:Maintenance Chemotherapy / Q000379:methods; D008297:Male; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D005765:Gastrointestinal Agents; D000069285:Infliximab