{
  "abstract": "SOPRANINO ( NCT04998851) is the first prospective study measuring both pharmacodynamic and pharmacokinetic breastmilk parameters alongside infant humoral response to vaccines, safety, growth and development.13 women with multiple sclerosis (WwMS) who gave birth to one healthy-term infant and decided to start/resume ocrelizumab at 2–24 weeks postpartum while partially or exclusively breastfeeding were enrolled. Co-primary outcomes were proportion of infants with B-cell levels below the lower limit of normal at 30 days post-infusion and ocrelizumab average daily infant dose (ADID) over 60 days post-infusion.Ocrelizumab levels in breast milk were negligible (median ADID: 45.09 μg; median relative infant dose: 0.27%) and were undetectable in infant serum. All infant B-cell levels were within age-specific normal ranges. Eleven infants (84.6%) had ≥1 adverse event (AE), of which 10experienced ≥1 infancy infection. Most infant AEs were mild to moderate with one severe bronchiolitis reported that resolved. No serious AEs or relapses were observed during pregnancy, or the postpartum period. Infant follow-up showed consistent growth and development.Results show negligible transfer of ocrelizumab into breastmilk, undetectable ocrelizumab levels in infant serum, normal infant B-cell levels and expected infant health outcomes, indicating that breastfeeding is compatible with ocrelizumab.ruth.dobson@qmul.ac.uk",
  "authors": [
    {
      "affiliations": [
        "Centre for Preventive Neurology, Wolfson Institute of Population Health, QMUL"
      ],
      "name": "Dobson Ruth"
    },
    {
      "affiliations": [
        "Katholisches Klinikum Bochum, St. Josef Hospital, Universitätsklinikum der Ruhr-Universität, Bochum"
      ],
      "name": "Hellwig Kerstin"
    },
    {
      "affiliations": [
        "Neurology, Hospital Clínico San Carlos, Idissc, Madrid"
      ],
      "name": "Oreja-Guevara Celia"
    },
    {
      "affiliations": [
        "Service de Neurologie et Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Lyon"
      ],
      "name": "Vukusic Sandra"
    },
    {
      "affiliations": [
        "Rocky Mountain MS Center, Department of Neurology, University of Colorado School of Medicine"
      ],
      "name": "Shah Anna"
    },
    {
      "affiliations": [
        "Multiple Sclerosis and Neuroimmunology, Northwestern University, Chicago"
      ],
      "name": "Graham Edie"
    },
    {
      "affiliations": [
        "Division of Maternal-Fetal Medicine, Brigham and Women’s Hospital, Boston"
      ],
      "name": "McElrath Thomas"
    },
    {
      "affiliations": [
        "Department of Clinical Sciences and Community Health, University of Milan"
      ],
      "name": "Pietrasanta Carlo"
    },
    {
      "affiliations": [
        "F. Hoffmann-La Roche Ltd, Basel"
      ],
      "name": "Pasquarelli Noemi"
    },
    {
      "affiliations": [
        "Department of Neurology, UCSF Weill Institute for Neurosciences, UCSF"
      ],
      "name": "Bove Riley"
    }
  ],
  "title": "199 B-cell levels in infants of lactating women with multiple sclerosis receiving ocrelizumab: SOPRANINO primary results",
  "uid": "45dd972b-a50e-565b-97e1-a8a5b7945b46"
}