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Clin Gastroenterol Hepatol. 2012 Apr;10(4):391-9.e1. doi: 10.1016/j.cgh.2011.11.026. Epub 2011 Dec 8.

Induction and maintenance therapy with infliximab for children with moderate to severe ulcerative colitis.

Author information

1
Division of Digestive Diseases and Nutrition, Connecticut Children’s Medical Center, 282 Washington Street, Hartford, Connecticut 06106, USA. jhyams@ccmckids.org

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).

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.

PMID:
22155755
DOI:
10.1016/j.cgh.2011.11.026
[Indexed for MEDLINE]

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