COPAXONE® for Use in Breastfeeding Mothers with Relapsing Multiple Sclerosis

COBRA, the largest standardized analysis of data from the National German Multiple Sclerosis and Pregnancy Registry, assessed safety outcomes in a total of 120 infants including 60 of them breastfed by mothers under GA. It concluded that no evidence was found to suggest that infants were adversely affected by maternal exposure to GA during breastfeeding. This was measured by number of hospitalisations, antibiotic treatments, developmental delays and growth parameters in the first 18 months of life.ⁱⁱⁱ The label update provides information for neurologists and other healthcare professionals treating MS patients of GA’s positive benefit/risk balance in breastfeeding.

Professor Kerstin Hellwig, Principal Investigator of COBRA RWE Study, Department of Neurology, Katholisches Klinikum Bochum, Germany says: “The benefits of breastfeeding for both mothers and their offspring are clinically meaningful and well-documented, but historically there has been limited clinical safety data for infants breastfed by mothers undergoing MS treatment. It is now believed breastfeeding could be protective for mothers with MS. The COBRA study results support mothers with MS in their choice to breastfeed without having to preclude MS treatment. This is an important contribution to current significant medical need.”

There are almost half a million women in Europe living with MS¹; it is most common during childbearing age and about half of mothers with MS start their families after diagnosis. The pregnancy rate in MS is constantly increasing^iv and recent research shows pregnancy does not worsen the disease progression (which traditionally has been a concern for patients).^v

However, studies have found an increase in relapse incidence after child birth, in the postpartum period^vi, so MS treatment may need to be resumed. The majority of MS therapies’ labels advise against breastfeeding, so mothers are often faced with a choice to breastfeed their babies or restart their treatment. Given that according to a U.S. study approximately half of women with MS want to breastfeed ^vii, the safety of medications used to treat MS while breastfeeding is of concern to mothers. A further treatment option that can be used during breastfeeding may help address a significant medical need for mothers with MS.