{
    "abstract": "Nipocalimab is a neonatal fragment crystallizable (Fc) receptor (FcRn)-blocking monoclonal antibody that inhibits placental immunoglobulin G (IgG) transfer and lowers circulating maternal IgG levels. In an open-label, single-arm, phase 2 study, nipocalimab demonstrated evidence of safety and efficacy that support further investigation in a pivotal phase 3 trial of recurrent hemolytic disease of the fetus and newborn (HDFN). The phase 3 AZALEA study aims to evaluate the efficacy and safety of nipocalimab in a larger population at risk for severe HDFN, defined as HDFN associated with poor fetal outcomes or neonatal death.AZALEA is a multicenter, randomized, placebo-controlled, double-blind, phase 3 study enrolling alloimmunized pregnant individuals (",
    "authors": [
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Yosuke",
            "initials": "Y",
            "lastname": "Komatsu"
        },
        {
            "affiliation": "Division of Fetal Therapy, Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.",
            "firstname": "E J T Joanne",
            "initials": "EJTJ",
            "lastname": "Verweij"
        },
        {
            "affiliation": "Clinical Epidemiology Division, Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden.",
            "firstname": "Eleonor",
            "initials": "E",
            "lastname": "Tiblad"
        },
        {
            "affiliation": "Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, The Netherlands.",
            "firstname": "Enrico",
            "initials": "E",
            "lastname": "Lopriore"
        },
        {
            "affiliation": "Division of Fetal Therapy, Department of Obstetrics, Leiden University Medical Center, Leiden, The Netherlands.",
            "firstname": "Dick",
            "initials": "D",
            "lastname": "Oepkes"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Prasheen",
            "initials": "P",
            "lastname": "Agarwal"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Edwin",
            "initials": "E",
            "lastname": "Lam"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Jocelyn H",
            "initials": "JH",
            "lastname": "Leu"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Leona E",
            "initials": "LE",
            "lastname": "Ling"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Robert M",
            "initials": "RM",
            "lastname": "Nelson"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Victor",
            "initials": "V",
            "lastname": "Olusajo"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Shumyla",
            "initials": "S",
            "lastname": "Saeed-Khawaja"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "May Lee",
            "initials": "ML",
            "lastname": "Tjoa"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Jie",
            "initials": "J",
            "lastname": "Zhou"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Umair",
            "initials": "U",
            "lastname": "Amin"
        },
        {
            "affiliation": "Janssen Pharmaceutical Companies of Johnson and Johnson, Cambridge, Massachusetts.",
            "firstname": "Waheeda",
            "initials": "W",
            "lastname": "Sirah"
        },
        {
            "affiliation": "Dell Medical School, The University of Texas at Austin, Austin, Texas.\nComprehensive Fetal Care Center at Dell Children's Medical Center, Austin, Texas.",
            "firstname": "Kenneth J",
            "initials": "KJ",
            "lastname": "Moise"
        }
    ],
    "conclusions": null,
    "copyrights": "The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/).",
    "doi": "10.1055/a-2404-8089",
    "journal": "American journal of perinatology",
    "keywords": [],
    "methods": null,
    "publication_date": "2024-08-31",
    "pubmed_id": "39197469\n25899660\n25824811\n24366465\n37229151\n36275497\n35133072\n14641860\n22105262\n23551577\n20509139\n27706858\n28277805\n28503958\n37743689\n29902448\n22024691\n21304232\n30574060\n28648573\n29250791\n17306655\n33741541\n36100813\n30402880\n35229965\n22235228\n30849355\n39115062\n34215352\n34215351\n38165333\n23466397\n27275238\n11303214\n31850521\n30063902\n38362023\n36036539",
    "results": null,
    "title": "Design of a Phase 3, Global, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn.",
    "xml": "<Element 'PubmedArticle' at 0x7885028d8090>"
}