Copaxone Appears Safe for Infants Whose Mothers Breastfeed: Study
Taking Copaxone (glatiramer acetate), an approved therapy for relapsing forms of multiple sclerosis (MS), while breastfeeding does not appear to be harmful to infants during their first 18 months, according to a real-life study in Germany called COBRA.
“In this study, we compared the development of 120 children in total, whose mothers suffer from MS” and half “had been treated with [Copaxone] during lactation,” Andrea Ciplea, the study’s first author at the Ruhr-University Bochum (RUB) clinic, said in a press release.
“We didn’t observe negative effects attributable to the administration of the MS drug,” Ciplea added.
These findings, along with other clinical and non-clinical evidence submitted last year by Teva Pharmaceuticals, Copaxone’s developer, supported an update to the therapy’s label in Europe to no longer contain a warning against its use during breastfeeding.
Notably, the label also was updated in 2016 to remove a similar warning regarding its use during pregnancy. In the U.S., Copaxone’s label states that there are no available or sufficient data to draw conclusions on the safety and effects of the therapy during pregnancy and breastfeeding.
COBRA’s detailed results “Eighteen-month safety analysis of offspring breastfed by mothers receiving glatiramer acetate therapy for relapsing multiple sclerosis – COBRA study,” have now been published in the Multiple Sclerosis Journal.
MS affects two to three times more women than men, “with disease onset common during childbearing age,” the researchers wrote.
Therefore, pregnancy is a top consideration when choosing a treatment plan, particularly as “up to 30% of mothers with MS may relapse within the first 3 months [after pregnancy],” they added.
Labels on most disease-modifying therapies (DMTs), however, advise against use during breastfeeding, forcing mothers often to choose between breastfeeding their babies or swiftly restarting their treatment. Having DMTs that can be used during breastfeeding may help to address a significant medical need for women with MS.
Copaxone is an approved DMT for relapsing forms of MS that is given through an under-the-skin injection at a dose of 20 mg/mL once a day, or 40 mg/mL three times a week. It is a large molecule, making it “unlikely to diffuse into breast milk,” the researchers wrote.
While animal studies suggest that the therapy is safe to use during pregnancy and breastfeeding, there is limited evidence of Copaxone’s effects on children of women with MS.
To address this, Ciplea and colleagues led by Kerstin Hellwig, MD, PhD, an MS specialist at RUB, conducted a real-world safety study of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis pAtients (COBRA).
By retrospectively analyzing 2011–20 data from the national German MS and Pregnancy Registry, the team identified 120 infants whose mothers were receiving either Copaxone (58 women, 59 pregnancies) or no DMT (60 women, 60 pregnancies) while breastfeeding.
Infants’ safety outcomes during the first 18 months of life (1.5 years), including hospitalizations, antibiotic treatment, growth, and developmental delays, were compared between the two groups.
The mothers had a mean age of 33.1 years in the Copaxone group and of 32.9 years in the no-DMT group, used as a control. In each group, about 80% of infants were exclusively breastfed and three infants were born before 37 weeks of gestation. Copaxone was given for a median of seven months during breastfeeding.
Most (86.7%) infants in the Copaxone group also were exposed to the treatment during pregnancy, compared with 25% of those whose mothers were not on a DMT while breastfeeding.
Results showed that the proportion of infants in the Copaxone group who needed hospitalization was comparable to that of those in the control group (18.3% vs. 20%), and that the number of infant hospitalizations per year was similar between groups (0.2 vs. 0.25).
The number of antibiotic treatments was also comparable in both groups (0.22 vs. 0.17 per year), as well as the proportion of infants requiring antibiotics (15% in both groups).
Similar findings were obtained when looking at patients with at least 18 months of follow-up. Further, the proportion of infants hospitalized or receiving antibiotics was similar or lower than that reported for the general German population.
Infants in both groups showed no differences in terms of body weight, length, and head circumference (all growth parameters) at birth and at other time points during their first 18 months. Developmental delay was reported in three infants in the control group and none in the Copaxone group.
Copaxone treatment before and during pregnancy and breastfeeding also was not associated with negative infant outcomes relative to no treatment, except for the number of antibiotic treatments, which were higher in the Copaxone group.
This “was due to one offspring receiving four antibiotic treatments due to urinary tract infections as a result of kidney disease,” the researchers wrote.
COBRA findings support “the lack of any clinically relevant exposure of offspring to GA [glatiramer acetate; Copaxone] from breast milk as no adverse effects on outcomes in offspring from mothers treated with GA were seen,” the researchers wrote.
“The benefit of maternal [relapsing MS] treatment with GA during breastfeeding may outweigh the potential, apparently low risk of untoward events in breastfed offspring,” they added.
“COBRA data alongside that of another registry finding with GA together with the unlikelihood of GA transfer into breast milk and negligible GA absorption by the gastrointestinal tract due to GA breakdown in the offspring gut may help support clinical decision-making,” the team wrote.
Larger studies with longer follow-up periods are needed to confirm these findings.
“Offspring breastfed during maternal GA therapy should be monitored for possible adverse effects, as with all breastfed offspring whose mothers are receiving medication,” the researchers concluded.