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Final Results from the Betaseron (Interferon Beta-1b) Pregnancy Registry: A Prospective Observational Study of Birth Defects and Pregnancy-Related Adverse Events

Citation

Coyle, Patricia K.; Sinclair, Susan M.; Scheuerle, Angela E.; Thorp, John M., Jr.; Albano, Jessica D.; & Rametta, Mark J. (2014). Final Results from the Betaseron (Interferon Beta-1b) Pregnancy Registry: A Prospective Observational Study of Birth Defects and Pregnancy-Related Adverse Events. BMJ Open, 4(5), e004536. PMCID: PMC4025462

Abstract

OBJECTIVE: Women with multiple sclerosis are often diagnosed and treated during their reproductive years. Limited data are available on the safety of treatment during pregnancy. The Betaseron Pregnancy Registry prospectively monitored women exposed to interferon beta-1b (IFNbeta-1b) during pregnancy to estimate the rates of birth defects, spontaneous abortions (SABs) and other negative outcomes in this population.
DESIGN: From 2006 to 2011, this observational registry enrolled women exposed prior to conception or during pregnancy (but prior to or without abnormalities on prenatal screening). Follow-up continued from enrolment through the 4-month paediatric visit.
SETTING: Patients in the USA who met these criteria were enrolled in the registry.
RESULTS: The registry enrolled 99 pregnant women; 3 were lost to follow-up. The earliest exposure to IFNbeta-1b occurred during the first trimester for 95 pregnancies and in the third trimester for 1 pregnancy. There were 99 birth outcomes (3 twins), including 86 (86.9%) live births, 11 (11.1%) SABs and 2 (2%) stillbirths. Birth defects were reported in five (5.1%) cases. Rates of birth defects and SAB were not significantly different from population comparators. No developmental concerns were identified at the 4-month paediatric visit.
CONCLUSIONS: The small sample size limits the ability to draw definitive conclusions; however, there was no pattern to suggest increased negative outcomes with IFNbeta-1b.

URL

http://dx.doi.org/10.1136/bmjopen-2013-004536

Reference Type

Journal Article

Year Published

2014

Journal Title

BMJ Open

Author(s)

Coyle, Patricia K.
Sinclair, Susan M.
Scheuerle, Angela E.
Thorp, John M., Jr.
Albano, Jessica D.
Rametta, Mark J.

PMCID

PMC4025462