Abstract | OBJECTIVES: METHODS: Fifteen consecutive children (mean age 12.8 +/- 3.2 yr) with medically refractory Crohn's disease were enrolled in a prospective, open-label trial of a single, 5-mg/kg infliximab intravenous infusion. Medically refractory disease was defined as an inability to taper steroids, lack of response to immunomodulator therapy over 4 months, and active disease as measured by the Pediatric Crohn's Disease Activity Index (PCDAI). Primary endpoints included measurements of disease activity (PCDAI), steroid use, and duration of clinical response. RESULTS: In all, 14/15 children (94%) improved after infliximab infusion, with a significant decrease of both PCDAI and daily steroid use by 4 wk. Ten patients (67%) achieved complete remission by 10 wk. Among the 14 patients who responded, three of six children (50%) with early disease maintained clinical response through the 12-month trial period, compared to none of eight children with late disease. There were no serious complications associated with the use of infliximab in any of the patients. CONCLUSIONS:
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Authors | S Kugathasan, S L Werlin, A Martinez, M T Rivera, J B Heikenen, D G Binion |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 95
Issue 11
Pg. 3189-94
(Nov 2000)
ISSN: 0002-9270 [Print] United States |
PMID | 11095340
(Publication Type: Clinical Trial, Comparative Study, Journal Article)
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Chemical References |
- Antibodies, Monoclonal
- Gastrointestinal Agents
- Tumor Necrosis Factor-alpha
- Infliximab
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Topics |
- Antibodies, Monoclonal
(administration & dosage, therapeutic use)
- Child
- Crohn Disease
(drug therapy)
- Female
- Gastrointestinal Agents
(administration & dosage, therapeutic use)
- Humans
- Infliximab
- Infusions, Intravenous
- Male
- Prospective Studies
- Time Factors
- Treatment Outcome
- Tumor Necrosis Factor-alpha
(immunology, physiology)
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