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Safety and efficacy of maintenance infliximab therapy for moderate-to-severe Crohn's disease in children: REACH open-label extension.

Author(s): Hyams J, Walters TD, Crandall W, Kugathasan S, Griffiths A, Blank M, Johanns J, Lang Y, Markowitz J, Cohen S, Winter HS, Veereman-Wauters G, Ferry G, Baldassano R

Affiliation(s): Division of Digestive Diseases and Nutrition, Connecticut Children's Medical Center, Hartford, CT 06106, USA. jhyams@ccmckids.org

Publication date & source: 2011-03, Curr Med Res Opin., 27(3):651-62. Epub 2011 Jan 18.

Publication type: Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: Assess long-term effects of maintenance infliximab therapy in children with moderately-to-severely active Crohn's disease. RESEARCH DESIGN AND METHODS: One hundred twelve patients with a Pediatric Crohn's Disease Activity Index (PCDAI) score >30 received infliximab 5 mg/kg at weeks 0, 2, and 6 in the REACH study. Patients considered responders at week 10 were randomized to infliximab 5 mg/kg every 8 (q8w) or 12 (q12w) weeks. Patients who completed treatment through week 46, and who the investigator believed would benefit from continued treatment, could enter the open-label extension (OLE) and receive up to three additional years of infliximab. No hypothesis testing was performed. CLINICAL TRIAL REGISTRATION: www.clinicaltrials.gov, identifier: NCT0020767. RESULTS: Sixty children entered the OLE: 33, 12, and 15 patients were receiving infliximab 5 mg/kg q8w, 5 mg/kg q12w, and 10 mg/kg q8w, respectively, at extension entry. Patients receiving infliximab for up to 3 years during the OLE maintained clinical benefit, with approximately 80% of patients consistently having no to mild disease activity per the physician's global assessment and very good to fair health in the past 2 weeks per the patient and parent/guardian global assessments. Patients with >/=1-year delay in bone age at baseline trended toward improvement in height during the OLE. Respiratory system disorders, most commonly upper respiratory infections, were the most prevalent adverse events reported; six (10%) patients had serious infections. CONCLUSIONS: Among children with moderately-to-severely active Crohn's disease who received infliximab for 46 weeks in REACH and then for up to 3 additional years in the REACH OLE, infliximab was effective in maintaining clinical benefit and was generally well-tolerated.

Page last updated: 2011-12-09

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