Safety and tolerability of interferon beta-1b in pediatric multiple sclerosis

Neurology. 2006 Feb 28;66(4):472-6. doi: 10.1212/01.wnl.0000198257.52512.1a.


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 (IFNbeta-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 IFNbeta-1b treatment was 13 years. Eight children were < or =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 (IFNbeta-1b) in children with multiple sclerosis and related diseases. All patients treated with IFNbeta-1b should undergo regular monitoring of liver function.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / therapeutic use*
  • Adolescent
  • Child
  • Humans
  • Interferon beta-1b
  • Interferon-beta / adverse effects
  • Interferon-beta / therapeutic use*
  • Liver Function Tests
  • Monitoring, Physiologic
  • Multiple Sclerosis / drug therapy*
  • Retrospective Studies
  • Safety


  • Adjuvants, Immunologic
  • Interferon beta-1b
  • Interferon-beta