Abstract Details

Title Child Development After Exposure to Monoclonal Antibodies During Breastfeeding

Topic Multiple Sclerosis

Presentation(s) S7 - Multiple Sclerosis: Special Populations and Non-MS CNS Neuroinflammatory Disease (3:54 PM-4:06 PM)

Poster/Presentation
Number 003

Background

Most mAbs used to treat multiple sclerosis (MS) are not approved for use during lactation. Studies on excretion of other mAbs used in MS therapy show low transfer into breast milk and no adverse effects on exposed infants, but clinical data are limited.

Objective

To analyze how infants breastfed under monoclonal antibodies (mAb) develop during the first 36 months of life.

Design/Methods

Live births with (≥1 day) or without mAb exposure during breastfeeding and ≥6 months follow-up were identified in the German MS and Pregnancy Registry. Primary outcomes (hospitalizations, systemic antibiotic use, developmental delay, weight at follow-up visits) were compared between breastfed mAb-exposed (exposed group) and unexposed (control group) infants. We matched groups for disease modifying therapy exposure during pregnancy and performed adjusted linear, logistic and poisson regression analyses.

Results

We identified 183 mAb breastfed exposed cases (median follow-up 1 year, range 0.5-3) with a diagnosis of MS (n=180) or neuromyelitis optica spectrum disease (n=3), with no significant differences in demographic characteristics compared to the control group (n=183).

MAb exposure during breastfeeding started on median day 19 (range 0-293) postpartum (median duration 172 days, range 2-1104). Natalizumab (n=125/68.31%) was most commonly used, followed by ocrelizumab (n=34/18.58%), rituximab (n=11/6.01%), and ofatumumab (n=10/5.46%); therapy was switched from natalizumab to ocrelizumab in 2 cases (1.09%), from rituximab to ocrelizumab in 1 case (0.55%) while breastfeeding. Three children had been previously breastfed on glatiramer acetate and two on interferons.

Adjusted regression analyses showed no association of annual hospitalization (rate ratio 1.23; 95% confidence interval [CI] 0.70,2.16; p 0.473), annual systemic antibiotic use (rate ratio 1.55; 95%CI 0.93,2.57; p 0.093), developmental delay (odds ratio [OR] 1.16; 95%CI 0.52,2.60; p 0.716), or weight at follow-up visits with mAb-exposed breastfeeding.

Conclusions

Our data show that mAb exposure during breastfeeding had no negative effect on the development or health of breastfed infants.

Authors/Disclosures
Kerstin Hellwig (St. Josef Hospital Bochum) PRESENTER	Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Teva . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for INC research . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Merck . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer . The institution of Kerstin Hellwig has received research support from Roche . The institution of Kerstin Hellwig has received research support from Merck . The institution of Kerstin Hellwig has received research support from Biogen. The institution of Kerstin Hellwig has received research support from Genzyme . The institution of Kerstin Hellwig has received research support from Novartis . The institution of Kerstin Hellwig has received research support from TEVA.
Laura Witt (St. Josef Hospital, Ruhr University Bochum)	No disclosure on file
Sandra Thiel (Department of Neurology, St. Josef Hospital, Ruhr University, Bochum, Germany)	Ms. Thiel has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer Healthcare .
Ralf Gold, MD (Neurologische Universitaetsklinik)	Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Gold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer Vital. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharamaceuticals. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Publishers. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Biogen. The institution of Dr. Gold has received research support from Novartis. The institution of Dr. Gold has received research support from Biogen.