{
  "abstract": "Objective To evaluate the long-term safety and efficacy of nipocalimab, an FcRn blocker, in patients with generalized myasthenia gravis (gMG) from the Vivacity-MG3 ( NCT04951622) open-label extension (OLE) phase.Background There is a significant need for effective and safe treatments for gMG. In autoantibody-positive patients, nipocalimab showed marked improvement over baseline in the MG-ADL score compared to placebo in the phase 3 Vivacity-MG3 study.Methods In a 24-week double-blind study, autoantibody-positive (n=153) and triple-autoantibody-negative patients (n=43) with inadequately controlled gMG were randomized 1:1 to receive either nipocalimab+standard of care (SOC) or placebo+SOC. Those who completed the double-blind phase could enter the ongoing OLE. Safety was assessed for patients receiving at least one dose of study drug.Results Of 137 autoantibody-positive patients from the double-blind phase, 81 and 37 patients were assessed at OLE weeks 24 and 48, respectively. The mean change in MG-ADL was –5.73 and –5.97, respectively. Nipocalimab was well-tolerated with no new safety findings reported.Conclusion Nipocalimab maintained sustained disease control over 72 weeks, as measured by the MG-ADL scale, in autoantibody-positive gMG patients.GReynol1@ITS.JNJ.com",
  "authors": [
    {
      "affiliations": [
        "Neurology IV – Neuroimmunology and Neuromuscular Diseases Unit, Fondazione I.R.C.C.S. Istituto",
        "Neur"
      ],
      "name": "Antozzi Carlo"
    },
    {
      "affiliations": [
        "Janssen-Cilag Limited a Johnson and Johnson company, High Wycombe, UK"
      ],
      "name": "Reynolds Diogo Gil"
    },
    {
      "affiliations": [
        "Neurology, University of South Florida, Tampa, FL, USA"
      ],
      "name": "Vu Tuan"
    },
    {
      "affiliations": [
        "Neuroscience, Janssen Research and Development, LLC, Titusville, NJ, USA"
      ],
      "name": "Ramchandren Sindhu"
    },
    {
      "affiliations": [
        "Department of Neurology, Yale University School of Medicine, New Haven, CT, USA"
      ],
      "name": "Nowak Richard J"
    },
    {
      "affiliations": [
        "Neurology, University of Kansas Medical Center, Kansas City, KS, USA"
      ],
      "name": "Farmakadis Constantine"
    },
    {
      "affiliations": [
        "Neurology, University of Toronto, University Health Network, Toronto, Canada"
      ],
      "name": "Bril Vera"
    },
    {
      "affiliations": [
        "Neurology, Ghent University Hospital, Ghent, Belgium"
      ],
      "name": "De Bleecker Jan"
    },
    {
      "affiliations": [
        "Neurology, Xiangya Hospital, Central South University, Changsha, China"
      ],
      "name": "Yang Huan"
    }
  ],
  "title": "21 Long-term safety and efficacy of nipocalimab in generalized myasthenia gravis: vivacity-MG3 open-label extension phase results",
  "uid": "1302f379-e2a0-57a5-8a39-c76dfa07844a"
}