Alimentary TractA multicenter trial of 6-mercaptopurine and prednisone in children with newly diagnosed Crohn's disease☆,☆☆
Section snippets
Study design
This prospective, double-blind, placebo-controlled 18-month clinical trial involved 18 U.S. pediatric centers (Appendix 1). The protocol was approved by the institutional review board of each collaborating investigator. Written informed consent was obtained from parents. Children older than 12 years signed a statement of assent. All subjects were <18 years of age, had CD diagnosed within 8 weeks of randomization, and had disease activity scores in the moderate-to-severe range. Children with
Study population
Sixty-five children were randomized at 18 collaborating sites (range, 1–12 subjects per site), but 10 were excluded from analysis, including 7 whose parents changed their minds about participating in the study before initiating treatment and 2 (1 from each treatment group) whose poor compliance with follow-up appointments resulted in significantly incomplete and noninterpretable data records. One additional randomized subject took <85% of the prescribed dose of medication within the first 2
Discussion
This is the first prospective, placebo-controlled trial to evaluate the effects of 6-MP in a pediatric population with CD. It is also the first to assess the efficacy of 6-MP as part of an initial treatment regimen for patients of any age with newly diagnosed CD. The results clearly support the use of 6-MP in the initial treatment of children and adolescents with moderate-to-severe CD. Compared with subjects treated with prednisone alone, those receiving 6-MP in addition to prednisone
References (35)
- et al.
Controlled trial of azathioprine in Crohn's disease
Lancet
(1971) - et al.
Controlled trial of azathioprine in Crohn's disease
Lancet
(1971) - et al.
Treatment of Crohn's disease with azathioprine: a controlled evaluation
Gastroenterology
(1974) - et al.
Double-blind withdrawal trial of azathioprine as maintenance treatment for Crohn's disease
Lancet
(1978) - et al.
Azathioprine combined with prednisolone or monotherapy with prednisolone in active Crohn's disease
Gastroenterology
(1993) - et al.
Azathioprine in the treatment of children with inflammatory bowel disease
J Pediatr
(1990) - et al.
6-Mercaptopurine therapy in selected cases of corticosteroid-dependent Crohn's disease
Mayo Clin Proc
(1991) - et al.
A simple index of Crohn's disease activity
Lancet
(1980) - et al.
Inflammatory bowel disease in children and adolescents
Gastrointestinal Endoscopy Clin North Am
(1994) - et al.
National cooperative Crohn's disease study: results of drug treatment
Gastroenterology
(1979)
European cooperative Crohn's disease study (ECCDS): results of drug treatment
Gastroenterology
Medical management of Crohn's disease in adolescence
Gastroenterology
Relationship of type I procollagen to corticosteroid therapy in children with inflammatory bowel disease
J Pediatr
Growth failure in children with inflammatory bowel disease: a prospective study
Gastroenterology
Safety of azathioprine and 6-mercaptopurine in pediatric patients with inflammatory bowel disease
Gastroenterology
Incidence of cancer in rheumatoid arthritis and other disorders after immunosuppressive treatment
Am J Med
Long-term neoplasia risk after azathioprine treatment in inflammatory bowel disease
Lancet
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Supported by grants from the Crohn's and Colitis Foundation of America and from Reach Out for Youth with Ileitis and Colitis.
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Address requests for reprints to: James Markowitz, M.D., Division of Pediatric Gastroenterology and Nutrition, North Shore–Long Island Jewish Health System, 300 Community Drive, Manhasset, New York 11030. e-mail: [email protected]; fax: (516) 562-2527.