{
  "abstract": "MINORE ( NCT04998812) is a prospective Phase IV, open-label study measuring ocrelizumab placental transfer, infant B-cell levels and detailed maternal and infant clinical outcomes, humoral immunity and safety.Thirty-five women were enrolled, 32 of whom received ocrelizumab within 6 months before last menstrual period (LMP) (3–6 months before LMP, n=18; and 0–3 months before LMP, n=14), and three women received ocrelizumab in the first trimester.The primary endpoint was the proportion of infants with B-cell levels below the lower limit of normal (LLN), measured at week 6 (W6) of life.All 35 pregnancies resulted in full-term live births. Ocrelizumab was undetectable in most infants, both in the umbilical cord blood at birth (94.3%, 33/35) and serum at W6 of life (97.0%, 32/33). All infant B-cell levels were above the age-specific LLN at W6 (100%, 34/34). Rates and types of adverse events (AEs) in mothers were in line with expected AEs during pregnancy, delivery, postpartum and infancy.Results of this study indicate that pregnancy planning is compatible with ocrelizumab treatment and support treatment decisions by clinicians and women with MS.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": [
        "Department of Neurology, UCSF Weill Institute for Neurosciences, UCSF"
      ],
      "name": "Bove Riley"
    },
    {
      "affiliations": [
        "Neurology, Hospital Clínico San Carlos, IdISSC, Madrid"
      ],
      "name": "Oreja-Guevara Celia"
    },
    {
      "affiliations": [
        "Neurology Department, Hôpital de la Pitié Salpêtrière, Assistance Publique des Hôpitaux de Paris"
      ],
      "name": "Maillart Elizabeth"
    },
    {
      "affiliations": [
        "Department of Neurology, Perelman School of Medicine, University of Pennsylvania"
      ],
      "name": "Jacobs Dina"
    },
    {
      "affiliations": [
        "Division of Maternal-Fetal Medicine, Brigham and Women’s Hospital, Boston"
      ],
      "name": "McElrath Thomas"
    },
    {
      "affiliations": [
        "University Hospital Basel, University of Basel"
      ],
      "name": "Derfuss Tobias"
    },
    {
      "affiliations": [
        "Hoffmann-La Roche Ltd, Basel"
      ],
      "name": "Pasquarelli Noemi"
    },
    {
      "affiliations": [
        "Service de Neurologie et Sclérose en Plaques, Hôpital Neurologique Pierre Wertheimer, Lyon"
      ],
      "name": "Vukusic Sandra"
    }
  ],
  "title": "193 Ocrelizumab placental transfer during pregnancy: primary analysis of the prospective open-label phase IV minore study",
  "uid": "84c36ecc-b5f1-54f5-b9e5-04d811c36868"
}