If necessary, women with relapsing multiple sclerosis can continue treatments based on interferon beta while pregnant and breastfeeding, according to an updated recommendation by an office of the European Medicines Agency (EMA).
Interferon beta-based treatments are a mainstay of approved MS therapies.
Three specific treatments were mentioned in press releases regarding this decision: Biogen‘s Plegridy (peginterferon beta-1a) and Avonex (interferon beta-1a), and Rebif (interferon beta-1a) by Merck KGaA (known as EMD Serono in North America).
The opinion by the Committee for Medicinal Products for Human Use (CHMP) was based on data from the European Interferon Beta Pregnancy Registry, and from the national health registers of Finland and Sweden. These contain information on pregnancy outcomes recorded in registries and experiences collected during clinical use.
These data suggest that exposure to interferon beta before conception or during the first trimester of pregnancy is not associated with an increased risk of fetal health problems.
It is worth noting that these data are by nature somewhat limited, because when the data were collected, it was recommended that interferon beta treatment be discontinued during pregnancy. As such, there is almost no reliable information available on the duration of interferon exposure during the first trimester or later in the pregnancy.
Because of this limitation, it is not possible at this point to draw reliable conclusions on the risk of spontaneous abortions in women exposed to interferon beta. But data available suggest no increased risk.
Similarly, preliminary data suggest that using interferon beta during breastfeeding poses no health risk to the baby.
The updated label for these treatments, recommended by CHMP, notes “levels of interferon beta-1a excreted in human milk are negligible,” Biogen and Merck announced in their respective releases.
Further studies and accumulating information in databases may help to clarify these potential risks, so that expecting parents and their healthcare providers can make more informed decisions.
“Women are diagnosed with MS at least two to three 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,” Alfred Sandrock, Jr., MD, PhD, executive vice president and chief medical officer at Biogen, said in the company’s press release.
“This CHMP opinion gives physicians and their patients added confidence when considering treatment with Plegridy or Avonex, two important therapies for relapsing MS that have been prescribed to more than half a million people living with the disease,” Sandrock added.
The EMA typically follows recommendations given by CHMP.
“The interferon beta label update is critically important because now physicians have options for treating women with relapsing MS into the beginning of pregnancy and if clinically needed during pregnancy and breastfeeding,” Kerstin Hellwig, MD, a neurologist at St. Josef Hospital in Bochum, Germany, said in the release by Merck.
“Interferon beta therapy has been approved for more than 20 years and, in that time, vital data have been collected that provide patients and physicians the confidence to consider treatment with interferon beta in this setting,” Hellwig added.