Safety and tolerability of interferon beta-1b in pediatric multiple sclerosis.
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.
Banwell
B
B
The Hospital for Sick Children, University of Toronto, Ontario, Canada. Brenda.banwell@sickkids.ca
Reder
A T
AT
Krupp
L
L
Tenembaum
S
S
Eraksoy
M
M
Alexey
B
B
Pohl
D
D
Freedman
M
M
Schelensky
L
L
Antonijevic
I
I
D000276:Adjuvants, Immunologic / Q000627:therapeutic use*; D000293:Adolescent; D002648:Child; D006801:Humans; D000068576:Interferon beta-1b; D016899:Interferon-beta / Q000009:adverse effects / Q000627:therapeutic use*; D008111:Liver Function Tests; D008991:Monitoring, Physiologic; D009103:Multiple Sclerosis / Q000188:drug therapy*; D012189:Retrospective Studies; D012449:Safety
D000276:Adjuvants, Immunologic; D000068576:Interferon beta-1b; D016899:Interferon-beta