Use of MS drug Glatiramer acetate by breastfeeding mothers safe for offsprings

Delhi: Glatiramer acetate use by mothers during nursing had no negative effects on child safety outcomes examined throughout the first 18 months of life, says an article published in SAGE Journals.

There is a scarcity of evidence on the safety of disease-modifying treatments (DMTs) for relapsing multiple sclerosis (RMS) while breastfeeding. Andrea Ines Ciplea and colleagues conducted this study to evaluate the safety effects for kids nursed by moms receiving glatiramer acetate medication.

Data from the German Multiple Sclerosis and Pregnancy Registry were utilized in this non-interventional, retrospective analysis. Participants experienced RMS, had a live delivery, and either got GA or no DMT while nursing.

The key findings of this study were as follows:

1. Glatiramer acetate cohort: 58 mothers/60 offspring; matched control cohort: 60 mothers/60 offspring; 86.7% (GA) and 25% (control) of offspring were born to moms who had GA at some stage during pregnancy.

2. The demographics of mothers and the prevalence of sickness were comparable.

3. The annualized number of hospitalizations was 0.20 (95% confidence interval: 0.09–0.31; GA) and 0.25 (0.12–0.38, controls).

4. The proportion of kids who required hospitalization was consistent across cohorts (18.33% vs. 20.00% ).

5. The annualized number of antibiotic uses in both cohorts was comparable (0.22, 0.10–0.33 (GA) vs. 0.17, 0.06–0.27 (controls)).

6. Antibiotics were required by 15.00 percent of the kids (both cohorts).

7. Controls had more developmental delays than the GA cohort (3 (5.36%) vs. 0). Growth rates were comparable across groups.

In conclusion, these data imply that the advantage of maternal RMS therapy with GA during breastfeeding may exceed the potentially minimal risk of adverse effects in breastfed infants. COBRA results, together with another registry discovery with GA, as well as the unlikely transfer of GA into breast milk and low GA absorption by the gastrointestinal system owing to GA breakdown in the offspring gut, may help support clinical decision-making.

To corroborate the results of COBRA, larger and longer confirmatory investigations are necessary. Kids nursed during maternal GA treatment, like other breastfed offspring whose mothers are undergoing medication, should be monitored for potential harmful effects.

Reference:

Ines Ciplea, A., Kurzeja, A., Thiel, S., Haben, S., Alexander, J., Adamus, E., & Hellwig, K. (2022). Eighteen-month safety analysis of offspring breastfed by mothers receiving glatiramer acetate therapy for relapsing multiple sclerosis – COBRA study. In Multiple Sclerosis Journal (p. 135245852210839). SAGE Publications. https://doi.org/10.1177/13524585221083982