2026 American Academy of Neurology Abstract Website

Ruth Dobson¹, Riley Bove², Kerstin Hellwig³, Celia Oreja-Guevara⁴, Tobias J. Derfuss⁵, Anna Shah⁶, Edith L. Graham⁷, Thomas F. McElrath⁸, Carlo Pietrasanta⁹, Elisabeth Maillart¹⁰, Dina Jacobs¹¹, Agne Kazlauskaite¹², Daniela Alves¹², Catarina Raposo¹², Licinio Craveiro¹², Chien-Ju Lin¹³, Noemi Pasquarelli¹², Sandra Vukusic¹⁴
¹Centre for Preventive Neurology, Wolfson Institute of Population Health, Queen Mary University of London, London, UK, ²Department of Neurology, UCSF Weill Institute for Neurosciences, University of California San Francisco, San Francisco, CA, USA, ³Katholisches Klinikum Bochum, St. Josef Hospital, Universitätsklinikum, Bochum, Germany, ⁴Neurology, Hospital Clínico San Carlos, IdISSC, Madrid, Spain, ⁵University Hospital Basel, University of Basel, Basel, Switzerland, ⁶Rocky Mountain MS Center, Department of Neurology, University of Colorado School of Medicine, Aurora, CO, USA, ⁷Multiple Sclerosis and Neuroimmunology, Northwestern University, Chicago, IL, USA, ⁸Division of Maternal-Fetal Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA, ⁹NICU, Department of Woman, Child and Newborn, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico and Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy, ¹⁰Neurology Department, Hôpital de la Pitié Salpêtrière, Assistance Publique des Hôpitaux de Paris, Paris, France, ¹¹Department of Neurology, Perelman School of Medicine at the Hospital of the University of Pennsylvania, Philadelphia, PA, USA, ¹²F. Hoffmann-La Roche Ltd, Basel, Switzerland, ¹³Roche Products Ltd, Welwyn Garden City, UK, ¹⁴Service de Neurologie et Sclérose en Plaques, Fondation Eugène Devic EDMUS contre la Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Lyon, France

Objective:

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]).

Background:

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.

Design/Methods:

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.

Results:

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.

Conclusions:

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.