Eighteen-month safety analysis of offspring breastfed by mothers receiving glatiramer acetate therapy for relapsing multiple sclerosis - COBRA study.

ABSTRACT

BACKGROUND: Safety data on disease-modifying therapies (DMTs) for relapsing multiple sclerosis (RMS) during breastfeeding are limited. OBJECTIVE: Assess safety outcomes for offspring breastfed by mothers undergoing glatiramer acetate (GA; Copaxone®) treatment. METHODS: This non-interventional, retrospective study used German Multiple Sclerosis and Pregnancy Registry data. Participants had RMS, a live birth, and received GA or no DMT during breastfeeding. RESULTS: GA cohort 58 mothers/60 offspring; matched controls 60 mothers/60 offspring; 86.7% (GA) and 25% (control) of offspring were born to mothers who had GA at some point during pregnancy. Maternal demographics and disease activity were comparable. Annualized number of hospitalizations was similar for breastfed offspring 0.20 (95% confidence interval 0.09-0.31; GA) and 0.25 (0.12-0.38, controls). Proportion of offspring requiring hospitalization was comparable between cohorts (18.33% vs. 20.00%). 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)) The proportion of offspring requiring antibiotics was 15.00% (both cohorts). More developmental delays were identified in controls versus the GA cohort (3 (5.36%) vs. 0). Growth parameters were comparable between cohorts. CONCLUSION: Maternal intake of GA during breastfeeding did not adversely affect offspring safety outcomes assessed during the first 18 months of life.