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From The Hospital for Sick Children (B.B.), University of Toronto, Ontario, Canada; Department of Neurology MC-2030 (A.T.R.), University of Chicago, IL; Pediatric Multiple Sclerosis Center (L.K.), Stony Brook, NY; Hospital de Pediatría Dr JP Garrahan (S.T.), Buenos Aires, Argentina; Faculty of Medicine (M.E.), University of Istanbul, Turkey; Russian State Medical University (B.A.), Moscow, Russia; Department of Pediatrics and Pediatric Neurology (D.P.), Georg August University Goettingen, Germany; The Ottawa Hospital (M.F.), Ottawa, Ontario, Canada; and Schering AG (L.S., I.A.), Medical Development CNS, Berlin, Germany.
Address correspondence and reprint requests to Dr. Brenda Banwell, Assistant Professor of Pediatrics (Neurology), Director, Pediatric Multiple Sclerosis Clinic, Associate Scientist, Research Institute, The Hospital for Sick Children, 555 University Ave., Toronto, Ontario, Canada M5G 1X8; e-mail: Brenda.banwell{at}sickkids.ca
Background: Immunomodulatory therapies are widely used in adults with multiple sclerosis (MS) and safety and tolerability is well-established. Although at least 5% of all patients with MS experience the clinical onset of their disease prior to age 18 years, the available literature on safety and tolerability of immunomodulatory therapies for pediatric-onset MS is limited.
Methods: The authors retrospectively reviewed safety and tolerability of interferon beta-1b (IFNß-1b) in a cohort of 43 children and adolescents treated for a mean of 29.2 months (SD 22.3 months).
Results: Mean age at start of IFNß-1b treatment was 13 years. Eight children were 
10 years. Most common adverse events included flu-like syndrome (35%), abnormal liver function test (26%), and injection site reaction (21%). No serious or unexpected adverse events were reported.
Conclusions: Although data on long-term effects on the maturing organ systems are lacking, the safety profile supports the safety and tolerability of interferon beta-1b (IFNß-1b) in children with multiple sclerosis and related diseases. All patients treated with IFNß-1b should undergo regular monitoring of liver function.
Sponsored by a grant from Schering AG, Germany, Berlin, and Berlex Laboratories Inc., Montville, NJ.
Disclosure: All authors, or their institutions, received nominal financial compensation for their contributions to this work. Drs. Banwell, Krupp, Reder, Tenembaum, Eraksoy, Boiko, and Freedman have received speaker’s honoraria from the sponsor of this study. None of the authors received honoraria in excess of $10,000. Dr. Antonijevic and L. Schelensky were employees of Schering at the time of the study.
Received May 4, 2005. Accepted in final form October 27, 2005.
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