Based on datasets from 2 national registries and the European Interferon Beta Pregnancy Registry, the EMA’s Committee for Medicinal Products for Human Use has given a positive opinion to remove the contraindications, which would allow the Biogen agents to be used by pregnant and breastfeeding women with multiple sclerosis.
Alfred Sandrock, Jr., MD, PhD
Pregnancy contraindications for 2 multiple sclerosis (MS) treatments, interferon-beta treatments, peginterferon beta-1a (Plegridy) and interferon beta-1a (Avonex), were recommended to be removed by the EMA’s Committee for Medicinal Products for Human Use (CHMP). This label update would allow for the Biogen agents to be used by pregnant and breastfeeding women with MS.1
This opinion was built based on data from the largest cohort studies of safety data of interferon-beta exposure in this cohort, using datasets from the European Interferon Beta Pregnancy Registry, and Finland and Sweden’s national health registers.
“Women are diagnosed with MS at least 2 to 3 times more frequently than men, and the disease may strike during their child-bearing years. Choosing a treatment plan that allows women to continue or start their MS therapy while pregnant or breastfeeding is a step forward for those living with this chronic, debilitating disease and their partners,” Alfred Sandrock, Jr., MD, PhD, executive vice president and chief medical officer, Biogen, said in a statement.
The data included outcomes from more than 1000 pregnancies from the registries and post-marketing reports, which indicate that no increased risk of major congenital anomalies existed after exposure to interferon beta, either before conception or during the first trimester of pregnancy.
Although, due to data collection being conducted during a period when the agents were contraindicated, the duration of exposure was uncertain. In many cases, treatment was likely interrupted upon the detection or confirmation of pregnancy. In turn, data from the second and third trimesters is still limited.
“This CHMP opinion gives physicians and their patients added confidence when considering treatment with Plegridy or Avonex, 2 important therapies for relapsing MS that have been prescribed to more than half a million people living with the disease,” Sandrock Jr, said.
Biogen noted that while the risk of spontaneous abortions in pregnant women treated with interferon beta has not been adequately assessed with the currently available data, though current data thus far do not suggest an increased risk. As for breastfeeding, what data is available, though also limited, suggest the levels of the treatment excreted in human milk are negligible and result in no adverse effects on the breastfed newborns or infants.
This news comes just months after results of a population-based study led by Annette Langer-Gould, MD, PhD, of Kaiser Permanente Southern California, presented at the 2019 American Academy of Neurology Annual Meeting
, sought to refresh current literature on pregnancy in MS. She and colleagues did so with a contemporary cohort of patients by prospectively collecting complete EHR data for 375 women with MS with 466 documented pregnancies from 2008 through 2016, finding the postpartum relapse is no longer a top concern.2
“Having MS should not factor into family planning decisions for most women diagnosed with MS today,” Langer-Gould told NeurologyLive
in May. “They have a lower risk of relapse during pregnancy and their risk of relapse in the postpartum year is the same as if they had not gotten pregnant regardless of whether they are on MS DMTs or not. Breastfeeding exclusively appears to be the best way to minimize their risk of postpartum relapse in addition to providing many additional health benefits for the child and mother.”
1. Interferon beta treatments, including Plefridy® (peginterferon beta-1a) and Avonex® (interferon beta-1a), receive positive chmp opinon for use during pregnancy and breastfeeding [press release]. Cambridge, MA: Biogen; Published September 23, 2019. media.biogen.com/news-releases/news-r.elease-details/interferon-beta-treatments-including-plegridyr-peginterferon. Accessed September 20, 2019.
2. Langer-Gould A, Smith J, Albers K, et al. Pregnancy-related relapses in a large, contemporary multiple sclerosis cohort: no increased risk in the postpartum period. Presented at: 2019 American Academy of Neurology Annual Meeting. May 4-10, 2019; Philadelphia, PA. Abstract S6.007