作者
Jeffrey Hyams, Wallace Crandall, Subra Kugathasan, Anne Griffiths, Allan Olson, Jewel Johanns, Grace Liu, Suzanne Travers, Robert Heuschkel, James Markowitz, Stanley Cohen, Harland Winter, Gigi Veereman–Wauters, George Ferry, Robert Baldassano, REACH Study Group
发表日期
2007/3/1
期刊
Gastroenterology
卷号
132
期号
3
页码范围
863-873
出版商
WB Saunders
简介
Background & Aims
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 ≥15 points; total score ≤30) and clinical remission (PCDAI score ≤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 …
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