{
  "abstract": "Introduction Nipocalimab is a fully human, effectorless IgG1 monoclonal antibody targeting the neonatal Fc receptor (FcRn). It aims to alleviate generalized myasthenia gravis (gMG) symptoms by reducing pathogenic autoantibodies through IgG recycling inhibition.Objective To assess the effectiveness and safety of intravenous nipocalimab added to standard-of-care therapy in adolescents with gMG.Methods Seropositive patients aged 12-<18 years with gMG (MGFA Class II-IV) inadequately controlled on stable therapy were enrolled in a 24-week open-label study. Participants received a 30 mg/kg IV loading dose of nipocalimab, followed by 15 mg/kg IV every two weeks. The primary endpoint was the change in total serum IgG, with secondary endpoints including changes in MG-ADL and QMG scores, alongside safety assessments.Results Seven adolescents were enrolled, with five completing 24 weeks. Mean age was 14.1 years; seven were anti-AChR positive. At week 24, nipocalimab significantly reduced total serum IgG (mean percent change: -68.98%). Improvements in MG-ADL (-2.40) and QMG (-3.80) scores were observed, with four of five patients achieving minimum symptom expression. Nipocalimab was well-tolerated, with no serious adverse events reported.Conclusion Nipocalimab demonstrated both efficacy and safety in a 6-month trial involving seropositive adolescents with gMG.GReynol1@ITS.JNJ.com",
  "authors": [
    {
      "affiliations": [
        "UCSF Benioff Children’s Hospital San Francisco, CA, USA"
      ],
      "name": "Strober Jonathan"
    },
    {
      "affiliations": [
        "Janssen-Cilag Limited a Johnson and Johnson company, High Wycombe, UK"
      ],
      "name": "Reynolds Diogo Gil"
    },
    {
      "affiliations": [
        "Janssen Research and Development, LLC, Spring House, PA, USA"
      ],
      "name": "Black Shawn"
    },
    {
      "affiliations": [
        "Janssen Research and Development, LLC, Titusville, NJ, USA"
      ],
      "name": "Ramchandren Sindhu"
    },
    {
      "affiliations": [
        "Phoenix Children’s Hospital, Phoenix, AZ, USA"
      ],
      "name": "Bernes Saunder"
    },
    {
      "affiliations": [
        "Chiba University Hospital, Chiba, Japan"
      ],
      "name": "Uzawa Akiyuki"
    },
    {
      "affiliations": [
        "University of Miyazaki Hospital, Miyazaki, Japan"
      ],
      "name": "Kimoto Yasuhiro"
    },
    {
      "affiliations": [
        "Women’s Medical University Hospital, Tokyo, Japan"
      ],
      "name": "Ishigaki Keiko"
    },
    {
      "affiliations": [
        "University of South Florida, Tampa, FL, USA"
      ],
      "name": "Vu Tuan"
    }
  ],
  "title": "23 Nipocalimab’s safety and effectiveness in adolescents in the open label phase 2–3 vibrance-Mg study",
  "uid": "10954c65-e4b7-52d1-8c52-6b3cee271581"
}