Bochum, Germany—Women are affected by MS two to three times more often than men and usually are diagnosed during their childbearing years. DMTs are critical because they slow down accumulation of permanent damage to the CNS by lowering the frequency of episodes and lengthening the periods of stability between them.
That leads to a dilemma for breast-feeding mothers with MS, especially since safety data on DMTs for relapsing multiple sclerosis (RMS) during breast-feeding are limited.
An international study team led by researchers from Ruhr University in Germany sought to assess safety outcomes for offspring breast-fed by mothers undergoing treatment with glatiramer acetate (GA), marketed as Copaxone.
"In this study, we compared the development of 120 children in total, whose mothers suffer from MS; 50 percent of the mothers in this cohort had been treated with glatiramer acetate during lactation," explained Andrea Ciplea, PhD, who is part of the research group lead by investigator Kerstin Hellwig, PhD.
The study, named COBRA, aimed to assess offspring outcomes up to 18 months of development who were breast-fed by mothers (58 with 60 offspring) with RMS—the most common type in this group—undergoing GA treatment versus offspring of 60 mothers with RMS and 60 offspring. Results were published in the Multiple Sclerosis Journal.
"As up to 30% of mothers with MS may relapse within the first 3 months postpartum, DMT safety during breastfeeding is important," the authors wrote. "Safety data on DMTs in breastfeeding mothers and their offspring are lacking. Thus, many mothers with MS have to opt between breastfeeding or re/starting DMTs postpartum. Most DMTs for RMS are not advised during breastfeeding."
The study team monitored infant body measurements, developmental delays, as well as antibiotic treatments and inpatient hospital stays during the first 18 months of life.
"We didn't observe negative effects attributable to the administration of the MS drug," Dr. Ciplea reported.
She noted that Copaxone's label has been updated by the European Union to indicate that treatment with GA during breast-feeding period appears safe. The manufacturer, Teva Pharmaceuticals, also received a supplement approval letter from the FDA earlier this year.
The study found that annualized number of hospitalizations was similar for breast-fed offspring: 0.20 (95% CI: 0.09-0.31; GA) and 0.25 (0.12-0.38, controls) and that the proportion of offspring requiring hospitalization was comparable between cohorts (18.33% vs. 20.00%).
In addition, annualized number of antibiotic uses was similar in both cohorts (0.22, 0.10-0.33 [GA] vs. 0.17, 0.06-0.27 [controls]), and more developmental delays were identified in controls versus the GA cohort (3 [5.36%] vs. 0).
"Maternal intake of GA during breastfeeding did not adversely affect offspring safety outcomes assessed during the first 18 months of life," the researchers concluded.
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