CONTEXT: Presentation of a non-interventional study on breastfeeding mothers with Relapsing Multiple Sclerosis (MS) taking Copaxone at the 7th annual congress of the European Academy of Neurology (EAN). Around a third of women with MS see a re-activation of the disease following childbirth. Prior to this research physicians generally advise against the use of disease modifying therapies (DMTs) while breastfeeding or postponing breastfeeding for 3 months following the last dose of a DMT. Clearly not good news for new mothers. However this study showed no significant impact on the growth and development of infants from mothers taking Copaxone compared to no DMTs.
IMPACT: Medium
READ TIME: 2 mins
Quality Level Mean [1 – 10]: 7
1. ““Against the backdrop of the global COVID-19 pandemic, our analysis, which included 60 offsprings in the glatiramer acetate group and 60 in a control group (offspring of mothers with MS not treated with any disease-modifying treatment during breastfeeding), is an important contribution to this significant unmet medical need.”
2. “AMSTERDAM–(BUSINESS WIRE)–The COBRA study, a new real world evidence study undertaken by Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and St. Josef Hospital (Bochum, Germany), was presented today at EAN congress and provided new insight on the use of COPAXONE® (glatiramer acetate or GA) by mothers with multiple sclerosis (MS) who are breastfeeding.”
3. ““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 ” said Professor Kerstin Hellwig, Principal Study Investigator, Department of Neurology, St. Josef Hospital, Ruhr University Bochum, Germany .”
4. “There is historically limited clinical safety data for infants who are breastfed by mothers undergoing treatment for MS. We found no evidence of developmental delay, body growth issues or increased hospitalisation and antibiotic use in group of infants from the glatiramer acetate cohort in comparison with controls.”
5. ““Real-world safety of Copaxone in Offspring of Breastfeeding and Treated Relapsing Multiple Sclerosis (RMS) pAtients” (COBRA study) was retrospective data analysis using the national German Multiple Sclerosis and Pregnancy Registry.”