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Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis.
- Source :
-
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association [Clin Gastroenterol Hepatol] 2012 Apr; Vol. 10 (4), pp. 391-9.e1. Date of Electronic Publication: 2011 Dec 08. - Publication Year :
- 2012
-
Abstract
- Background & Aims: We evaluated the efficacy and safety of infliximab for inducing and maintaining benefit in children with moderately to severely active ulcerative colitis (UC).<br />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.<br />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.<br />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.<br /> (Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adolescent
Antibodies, Monoclonal adverse effects
Child
Colitis, Ulcerative pathology
Female
Humans
Induction Chemotherapy methods
Infliximab
Maintenance Chemotherapy methods
Male
Severity of Illness Index
Treatment Outcome
Anti-Inflammatory Agents administration & dosage
Antibodies, Monoclonal administration & dosage
Colitis, Ulcerative drug therapy
Gastrointestinal Agents administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1542-7714
- Volume :
- 10
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
- Publication Type :
- Academic Journal
- Accession number :
- 22155755
- Full Text :
- https://doi.org/10.1016/j.cgh.2011.11.026