No Negative Effects on Infants Whose Moms Take Copaxone While Breastfeeding

Treatment with Copaxone (glatiramer acetate), an approved therapy for relapsing forms of multiple sclerosis (MS), while breastfeeding does not appear to be harmful to infants in their first years, a study has found.

Investigators observed no differences between infants whose mothers were taking Copaxone and those whose mothers weren’t receiving any treatment, in terms of developmental delay, growth within the first 18 months of life, hospitalizations, and antibiotic treatment.

The findings were presented by Kerstin Hellwig, MD, PhD, an MS specialist at the Ruhr University, in Germany, during the 7th European Academy of Neurology Conference, held virtually earlier this month. Her talk was titled  “Safety analysis of offspring breastfed by mothers on glatiramer acetate therapy for relapsing multiple sclerosis,” (abstract OPR-189).

Copaxone, developed by Teva, is a disease-modifying therapy (DMT) that reduces MS relapses by mimicking a fragment of myelin, the biological compound that insulates neurons and is lost over the course of MS.

While early and continued treatment is important to prevent relapsed and disability accumulation in MS patients, most experts advise against DMT use during breastfeeding, recommending that patients postpone breastfeeding to at least three months after their last DMT dose. However, little safety data supports this concern.

In fact, “according to data available, every third woman with MS may experience disease reactivation after childbirth,” Danilo Lembo, MD, a vice president at Teva Pharmaceuticals, Copaxone’s developer, said in a press release. “Slowing disease progression, control of relapses and breastfeeding are priorities for many patients, especially in this particularly fragile period.”

To shed light on this subject, Hellwig and her colleagues conducted a retrospective study — dubbed the Real-world safety of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis pAtients (COBRA) study — using data from the national German MS and Pregnancy Registry from 2011 to 2020.

They identified 120 women who were diagnosed with relapsing MS and who were prescribed either Copaxone (60 women) or no DMT (60 women) while breastfeeding.

Results showed that infants had a similar number of hospital admissions — 0.20 per year for those whose mothers were on Copaxone vs. 0.25 for those whose mothers were not on DMT — and had a similar use of antibiotics.

These infants also were no different in terms of body weight, length, and head circumference (all growth parameters) at birth and at other time points during their first 18 months. Only three infants had developmental delays at one year — and these were all from the control group.

“We found no evidence of developmental delay, body growth issues, or increased hospitalization and antibiotic use in infants from the [Copaxone] cohort in comparison with controls,” Hellwig said.

Of note, most (86.7%) infants in the Copaxone group also had been exposed to the treatment during pregnancy, compared with 25% of those whose mothers were not on DMT while breastfeeding. Again, this suggests that Copaxone was safe for fetuses and infants during breastfeeding ages.

“The benefits of breastfeeding for both mothers and their offspring are clinically meaningful and well-documented, so it is imperative to provide clinical evidence on safety of disease modifying therapies (DMTs), so mothers with MS will no longer need to give up breastfeeding while on treatment ” Hellwig said.