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Abstract Details

Interim analysis of peginterferon beta-1a in the breast milk of lactating patients with multiple sclerosis
Multiple Sclerosis
P6 - Poster Session 6 (12:00 PM-1:00 PM)
9-013
Data on the transfer of MS disease-modifying therapies into breast milk are limited. In a previous study of intramuscular interferon beta-1a (IM IFN), the highest observed breast milk concentration was 179 pg/mL, with an estimated relative infant dose of 0.006%. However, the extent to which peginterferon beta-1a, a larger pegylated molecule, is excreted into human breastmilk is not known.
Evaluate the concentration of peginterferon beta-1a in the breast milk of lactating multiple sclerosis (MS) patients receiving subcutaneous peginterferon beta-1a treatment.
This interim analysis includes data from 6 women with MS who initiated peginterferon beta-1a treatment during lactation. Patients collected a baseline breast milk sample prior to treatment initiation. Following a single injection of peginterferon beta-1a 125 mcg, daily breast milk samples ≥10 mL were collected on days 1-14. Patients did not up-titrate peginterferon beta-1a. Mean breast milk concentrations, geometric mean maximum concentration (Cmax), median time to Cmax (Tmax), and median time to last measurable concentration (Tlast) were assessed. Samples below the detection threshold (15.0 pg/mL) were treated as missing values.
The peginterferon beta-1a concentration in breast milk at baseline was below detectable levels. After peginterferon beta-1a dosing, the maximum breast milk concentration recorded was 126.2 pg/mL. The geometric mean Cmax was 48.9 pg/mL; median Tmax and Tlast were 4 and 7 days, respectively. Mean breast milk concentrations were 56.0, 56.9, 42.8, and 27.4 pg/mL on days 1, 5, 10 and 14.
In this analysis, the maximum peginterferon beta-1a concentration in breast milk was 126.2 pg/mL. These findings may be useful for clinicians considering postpartum treatment options for patients with MS.
Authors/Disclosures
Maria K. Houtchens, MD
PRESENTER
Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche . Dr. Houtchens has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Serono. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Cravath. Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Beasley . Dr. Houtchens has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Biogen. The institution of Dr. Houtchens has received research support from Genzyme. The institution of Dr. Houtchens has received research support from Biogen. The institution of Dr. Houtchens has received research support from Genentech.
Maria Claudia Manieri No disclosure on file
No disclosure on file
Andrea I. Ciplea (St. Josef Hospital Bochum) An immediate family member of Ms. Ciplea has received personal compensation for serving as an employee of Astra Zeneca. Ms. Ciplea has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Bayer Healthcare. Ms. Ciplea has received personal compensation in the range of $0-$499 for serving as a payment of travel-related expenses with Novartis. Ms. Ciplea has received personal compensation in the range of $0-$499 for serving as a payment of congress fees with Teva.
No disclosure on file
No disclosure on file
Sarah England, PhD (Biogen) Dr. England has received personal compensation for serving as an employee of Biogen. Dr. England has stock in Biogen.
Robin L. Avila, PhD (Biogen) Mrs. Avila has received personal compensation for serving as an employee of Biogen. Mrs. Avila has stock in Biogen.
Kerstin Hellwig (St. Josef Hospital Bochum) 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.