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Abstract Details

Humoral Vaccine Responses and One-year Follow-up of Infants Potentially Exposed to Ocrelizumab During Pregnancy and Breastfeeding: Final Analyses of the Prospective, Multicenter, Open-label, Phase IV Studies MINORE and SOPRANINO
Multiple Sclerosis
S40 - Multiple Sclerosis: Clinical Trials/Science and Real-world Evidence (1:12 PM-1:24 PM)
002

To evaluate 1-year health, growth, development, B-cell kinetics and humoral vaccine responses in infants potentially exposed to ocrelizumab during pregnancy (MINORE [NCT04998812]) or breastfeeding (SOPRANINO [NCT04998851]).
Primary analyses of MINORE and SOPRANINO showed minimal placental and breastmilk transfer of ocrelizumab in women with MS (WwMS), with infants demonstrating normal B-cell levels at Week 6 of life or Day 30 post maternal ocrelizumab infusion, respectively.
MINORE enrolled 35 pregnant WwMS who received their last ocrelizumab infusion up to 6 months before their last menstrual period or during first trimester. SOPRANINO enrolled 13 breastfeeding WwMS who received ocrelizumab 2-24 weeks postpartum and their infants. Infant B-cell levels and humoral responses were measured at approximately 13 months of age. Growth (World Health Organization standards) and development (Ages and Stages Questionnaire, 3rd edition) were assessed. Infant and maternal safety were monitored.

Thirty-three infants (94.3%) and 32 mothers completed MINORE. Eleven mother-infant pairs (84.6%) completed SOPRANINO. At Month 13, B-cell levels were in normal ranges in 92.8% of infants (26/28) in MINORE (initial low B-cell levels in two infants normalized on retesting) and 100% (11/11) in SOPRANINO. Infants showed positive humoral responses to vaccines, in line with reported rates, in MINORE and SOPRANINO: measles, 96% and 100%; mumps, 85% and 78%; rubella, 96% and 100%; diphtheria, 100% and 100%; tetanus, 100% and 100%; H influenzae, 83% and 80%; hepatitis B, 95% and 100%; and pneumococcal (≥7 of 13 strains), 85% and 100%, respectively. Most infants had normal growth and development during the first year of life. No new safety signals were observed in infants, and infections were as expected during infancy.

Infants with potential ocrelizumab exposure during pregnancy or breastfeeding maintained normal B-cell levels and humoral responses to vaccines. These data expand the knowledge on ocrelizumab in the context of family planning.
Authors/Disclosures
Ruth Dobson (Queen Mary University London)
PRESENTER 		The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis . The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sandoz. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. The institution of Ruth Dobson has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis . Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sandoz. Ruth Dobson has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Epionex. The institution of Ruth Dobson has received research support from NMSS. The institution of Ruth Dobson has received research support from MS Society UK . The institution of Ruth Dobson has received research support from BMA Foundation . The institution of Ruth Dobson has received research support from Biogen . The institution of Ruth Dobson has received research support from Merck . The institution of Ruth Dobson has received research support from Horne Family Charitable Trust . The institution of Ruth Dobson has received research support from MRC. The institution of Ruth Dobson has received research support from NIHR. Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Medscape . Ruth Dobson has received personal compensation in the range of $0-$499 for serving as a Speaker with Limbus. Ruth Dobson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Neurology Academy .
Riley Bove, MD, FAAN (University of California, San Francisco) Dr. Bove has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Bove has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Bove has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme-Sanofi. Dr. Bove has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Bove has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD-Serono. Dr. Bove has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cadenza. The institution of Dr. Bove has received research support from Biogen. The institution of Dr. Bove has received research support from Eli Lilly. The institution of Dr. Bove has received research support from Novartis. The institution of Dr. Bove has received research support from Roche Genentech.
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 BMS. Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 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 Sanofi Genzyme . Kerstin Hellwig has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mylan . 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 $5,000-$9,999 for serving on a Speakers Bureau for Novartis . Kerstin Hellwig has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche . 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 BMS .
Celia Oreja Guevara Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for novartis. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for viatris. Celia Oreja Guevara has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for biogen. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for bms. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for jannsen.
Tobias Derfuss An immediate family member of Tobias Derfuss has received personal compensation for serving as an employee of Roche. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. The institution of Tobias Derfuss has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. The institution of Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Celgene. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for GeNeuro. The institution of Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. The institution of Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neuraxpharm. The institution of Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. The institution of Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Johnson&Johnson. The institution of Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck Sharp Dome. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for MedDay. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Actelion. The institution of Tobias Derfuss has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Merck. Tobias Derfuss has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Roche. An immediate family member of Tobias Derfuss has stock in Novartis. An immediate family member of Tobias Derfuss has stock in Roche. The institution of Tobias Derfuss has received research support from Roche. The institution of Tobias Derfuss has received research support from Biogen. The institution of Tobias Derfuss has received research support from Alexion.
Anna Shah, MD (University of Colorado, Neurology Dept) The institution of Dr. Shah has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb. The institution of Dr. Shah has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. The institution of Dr. Shah has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. The institution of Dr. Shah has received research support from Rocky Mountain MS Center. The institution of Dr. Shah has received research support from Genentech/Roche. Dr. Shah has received personal compensation in the range of $500-$4,999 for serving as a 好色先生al Speaker with Rocky Mountain MS Center.
Edith Graham, MD (Northwestern University) Dr. Graham has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Graham has received personal compensation in the range of $500-$4,999 for serving as a Consultant for TG Therapeutics. The institution of Dr. Graham has received research support from F. Hoffman-La Roche Ltd. The institution of Dr. Graham has received research support from Novartis.
Thomas McElrath, MD, PhD (Brigham and Women's Hospital) Thomas McElrath, MD, PhD has received personal compensation for serving as an employee of Mirvie Inc, San Francisco, Ca. Service on scientific advisory board, equity. Thomas McElrath, MD, PhD has received personal compensation for serving as an employee of Hoffman – LaRoache, Basel SW. Service on scientific advisory board. Cash payment.
Carlo Pietrasanta No disclosure on file
Elisabeth Maillart, MD Dr. Maillart has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Maillart has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Maillart has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Maillart has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Maillart has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Maillart has received personal compensation in the range of $0-$499 for serving as a Consultant for Sanofi. Dr. Maillart has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. The institution of Dr. Maillart has received research support from Biogen.
Dina Jacobs, MD (Hosp of Univ of PA/Dept of Neruo) Dr. Jacobs has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Jacobs has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck/EMD Serono. Dr. Jacobs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cycle Pharmaceuticals. Dr. Jacobs has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Jacobs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi . Dr. Jacobs has received personal compensation in the range of $500-$4,999 for serving as a Consultant for William Blair &Company . Dr. Jacobs has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Jacobs has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Jacobs has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Jacobs has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi . The institution of Dr. Jacobs has received research support from Roche/Genentech .
Agne Kazlauskaite, PhD Dr. Kazlauskaite has received personal compensation for serving as an employee of Roche. Dr. Kazlauskaite has stock in Roche.
Daniela Alves (Hoffmann La Roche) No disclosure on file
Catarina Raposo, PhD (F. Hoffmann-La Roche) Dr. Raposo has received personal compensation for serving as an employee of F. Hoffman-La Roche. Dr. Raposo has received stock or an ownership interest from F.Hoffman-La Roche.
Licinio M. Craveiro, MD, PhD (Roche) Dr. Craveiro has received personal compensation for serving as an employee of Hoffmann La-Roche. Dr. Craveiro has received stock or an ownership interest from Hoffmann La-Roche.
Chien-Ju Lin Chien-Ju Lin has nothing to disclose.
Noemi Pasquarelli Noemi Pasquarelli has nothing to disclose.
Sandra Vukusic, MD (Hopital Neurologique Pierre Wertheimer) The institution of Dr. Vukusic has received research support from Biogen. The institution of Dr. Vukusic has received research support from Janssen. The institution of Dr. Vukusic has received research support from Merck. The institution of Dr. Vukusic has received research support from Novartis. The institution of Dr. Vukusic has received research support from Roche.