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BETASERON® (interferon beta-1b) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Have you explored the pregnancy data from 2 observational studies in patients treated with BETASERON®?
Women of childbearing age make up a considerable percentage of all MS patients, with approximately 10% experiencing disease onset during pregnancy.1
The effects of exposure to disease-modifying treatments can be a major concern during pregnancy. Data are limited.2
Over several years, the US BETASERON Pregnancy Registry and the European IFN-beta Pregnancy Registry have collected information on the rates of pregnancy and infant outcomes in women receiving BETASERON.
Risk Summary
Although there have been no well-controlled studies in pregnant women, available data—which include prospective observational studies—have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b use during pregnancy. Administration of BETASERON to monkeys during gestation resulted in increased embryo-fetal death at or above exposures greater than 3 times the human therapeutic dose.3
In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.3
Human Data
The majority of observational studies reporting on pregnancies exposed to interferon beta-1b did not identify an association between the use of interferon beta-1b during pregnancy and an increased risk of major birth defects.3
Risk Summary
There are no data on the presence of BETASERON in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.3
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BETASERON and any potential adverse effects on the breastfed child from BETASERON or from the underlying maternal condition.3
*Excludes spontaneous and elective abortions <20 weeks gestation with reported birth defects per MACDP convention. The denominator is restricted to live births.2
†Relative risk compared with 2.78% reported by MACDP.2
‡Relative risk compared with 16% rate of spontaneous abortion reported by National Survey of Family Growth.2
§Spontaneous abortion was defined as the pregnancy spontaneously ending before 22 completed weeks of gestation (<24 weeks from last menstrual period) and comprising spontaneous abortion, miscarriage, missed abortion, incomplete abortion, and early fetal death.5
CI, confidence interval; IFN-beta, interferon-beta; MACDP, Metropolitan Atlanta Congenital Defects Program; MS, multiple sclerosis; N/A, not available.
References:1. Bennett KA. Pregnancy and multiple sclerosis. Clin Obstet Gynecol. 2005;48(1):38-47. doi:10.1097/01.grf.0000153881.20014.86 2.Coyle PK, Sinclair SM, Scheuerle AE, Thorp Jr JM, Albano JD, Rametta MJ. Final results from the Betaseron (Interferon β-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events. BMJ Open. 2014;4(5):e004536. doi:10.1136/bmjopen-2013-004536 3.BETASERON. Prescribing Information. Bayer HealthCare Pharmaceuticals Inc.; 2023. 4. Reeves BC, Deeks JJ, Higgins JPT, Shea B, Tugwell P, Wells GA. Chapter 24: Including non-randomized studies on intervention effects. In: Higgins, J, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, Welch VA, eds. Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Cochrane; 2023. 5. Hellwig K, Geissbuehler Y, Sabidó M, et al; European Interferon-beta Pregnancy Study Group. Pregnancy outcomes in interferon-beta-exposed patients with multiple sclerosis: results from the European Interferon-beta Pregnancy Registry. J Neurol. 2020;267(6):1715-1723. doi:10.1007/s00415-020-09762-y