Remitting-relapsing multiple sclerosis (RRMS) is the most common form of MS, affecting about 85% of people living with MS. The disease is characterized by episodes of worsening or new symptoms (relapse) followed by periods of recovery (remittance). The incidence of MS is higher in women than in men, and although MS symptoms may improve during pregnancy, there is an increased risk of relapse postpartum.
The World Health Organization recommends exclusive breastfeeding for the first six months of an infant’s life, and studies have found that exclusive breastfeeding may lower the risk of postpartum MS relapses. However, options for disease-modifying therapies (DMTs) for MS that are not contraindicated for use while breastfeeding are limited. One is Teva Pharmaceutical’s Copaxone (glatiramer acetate), indicated to treat relapsing forms of MS. The immunomodulator is also marketed under the generic names glatiramer acetate injection by Mylan Pharmaceuticals and Glatopa by Sandoz (a part of Novartis).
In a study published in July 2023 in Multiple Sclerosis and Related Disorders, researchers analyzed data from the real-world safety of Copaxone in Offsprings of Breastfeeding and treated RMS pAtients (COBRA) study to determine the safety of Copaxone treatment on infants of mothers using Copaxone while breastfeeding. Previously published results of the COBRA study, which was funded by Teva, suggested that the use of Copaxone while breastfeeding outweighed the potential risks.
The COBRA study and the recent July analysis were both led by Andrea Ines Ciplea from the Department of Neurology at St. Josef Hospital in Bochum, Germany. The COBRA study used data from the German MS and Pregnancy Registry from 2011 through 2020. It included 60 infants whose mothers were treated with Copaxone while breastfeeding and 60 infants whose mothers did not receive any DMT while breastfeeding. The children were followed for up to 18 months postpartum.
The median length of breastfeeding was approximately 8 months for both groups. Infants in the Copaxone group were exposed to the treatment for a median of 7 months while breastfeeding, and 87% were also exposed during pregnancy. In the control group, 25% of children were born to mothers who had stopped Copaxone treatment during the first trimester of pregnancy.
The new analysis found a similar total number of adverse events in both groups (82 in the Copaxone group versus 83 in the control group). Non-serious adverse events were also similar in both groups (59 versus 61), as were serious adverse events (23 versus 22). The rate of hospitalizations was also comparable between the two groups, with an 18% rate in the Copaxone group versus 20% in the control group. The most common cause of hospitalization was infection, which was consistent with the general infant population in the study area. The rate of antibiotic use was similar between the two groups.Ciplea and her colleagues conclude that Copaxone does not increase the risk of side effects, hospitalization, or antibiotic use in infants born of mothers with RRMS who breastfeed while using Copaxone compared with infants born of mothers who do not take any DMT while breastfeeding.
The most current Copaxone FDA label recommends weighing the benefits and risks of breastfeeding during Copaxone treatment before starting therapy. Based on results from this extended data analysis, the COBRA study, and other sources, the National Institutes of Health Drugs and Lactation Database lists glatiramer acetate as generally safe to use while breastfeeding and finds that it “does not appear to cause any adverse effects in breastfed infants”.