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| |  Long-Term Maintenance Infliximab Safe, Effective in Paediatric Crohn’s Disease: Presented at CDDW By Cameron Johnston TORONTO -- March 2, 2010 -- Maintenance therapy with infliximab appears useful and safe for children with moderate to severe Crohn’s disease, according to a study presented here on February 28 at the Canadian Digestive Diseases Week 2010 (CDDW). The study, led by Anne Griffiths, MD, University of Toronto, Toronto, Ontario, involved 112 paediatric patients. Patients underwent an induction phase consisting of 3 injections of infliximab 5 mg/kg at weeks 0, 2, and 4, and then no further therapy out to week 12. At week 12, the patients were randomised to receive infliximab 5 mg/kg at 8- or 12-week intervals; if they did not show a response within the first 8 weeks, the dose could be increased to 10 mg/kg every 8 weeks. The maintenance phase of the study lasted 46 weeks, at which point the patients were offered open-label infliximab, to be followed for a further 3 years. Outcomes for the study were based on the physician’s global assessment of the child’s health, the patient’s own observations when possible, and assessments from the child’s parent or caregivers. At the end of the second year of the extension study (104 weeks from baseline), physicians reported seeing no evidence of disease activity among 74% of the 35 children who completed this phase of the investigation. Two-thirds of the patients and 70% of their parents or caregivers reported that they or the kids “had felt in very good health over the past 2 weeks.” Approximately one-third of the patients or the patients’ caregivers said the patients’ health had been “fair” within the past 2 weeks. As for the safety aspects of the drug, while 30% of patients (n = 18) discontinued the study, only 3 did so because of lack of therapeutic effect and 1 discontinued due to an adverse effect. The rest were either lost to follow-up or quit for other reasons. The most common adverse events seen were upper respiratory tract infections (41.7%). One-third of the patients experienced at least 1 serious adverse event, the most common of which were gastrointestinal disorders. There was no difference in the number or nature of adverse events according to which dose of the treatment drug the patients received. As expected, the children involved in the study did experience significantly lower Z scores, which indicate their growth was somewhat stunted compared with other children of the same age and gender. Overall, the investigators concluded that on the basis of these data, infliximab demonstrates continued clinical efficacy in the long-term treatment of paediatric Crohn’s disease. Adverse events, including delayed growth, were, for the most part, manageable, and no unexpected safety issues were seen in this population. Funding for this study was provided by Centocor Ortho Biotech Inc. CDDW is the annual scientific conference of the Canadian Association of Gastroenterology (CAG) and the Canadian Association for the Study of the Liver (CASL). [Presentation title: Long-Term Efficacy and Safety of Maintenance Infliximab Therapy for the Treatment of Moderate to Severe Pediatric Crohn’s Disease. Abstract A113]
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