{
  "abstract": "Introduction Nipocalimab, as an add-on to standard-of-care (SOC), demonstrated significant improvements in MG-ADL scores compared to placebo+SOC in a 24-week double-blind phase 3 study of generalized myasthenia gravis. Post-hoc analyses evaluated improvements across specific muscle function groups using MG-ADL items and domains.Methods The distribution of baseline floor effects (score=0) was assessed using median and mean scores. Mean change from baseline (CFB) for four domains (bulbar, respiratory, limb, and ocular) was analyzed at 24 weeks with analysis of variance to identify treatment differences between nipocalimab and placebo. Responders were defined by a threshold of 1-point for items and 2-points for domains, except for the respiratory domain, which used a 1-point threshold.Results In 153 patients, median baseline MG-ADL item scores ranged from 1.0-2.0. Mean domain scores were: bulbar [2.7 for both], limb [2.4/nipocalimab; 2.5/placebo], ocular [3.5/nipocalimab; 2.8/placebo], and respiratory [1.1/nipocalimab; 1.0/placebo]. Mean CFB favored nipocalimab (p<0.05), with response rates from 42.7% (swallowing) to 97.6% (respiratory).Conclusions Improvements in MG-ADL total scores were driven by enhancements in symptom levels across all muscle function groups favoring nipocalimab.GReynol1@ITS.JNJ.com",
  "authors": [
    {
      "affiliations": [
        "University of Kansas Medical Center, Kansas City, KS, USA"
      ],
      "name": "Farmakidis Constantine"
    },
    {
      "affiliations": [
        "Janssen-Cilag Limited a Johnson and Johnson company, High Wycombe, UK"
      ],
      "name": "Reynolds Diogo Gil"
    },
    {
      "affiliations": [
        "Janssen Global Services, LLC, Raritan, NJ, USA"
      ],
      "name": "Gandhi Kavita"
    },
    {
      "affiliations": [
        "Janssen Global Medical Affairs, Titusville, NJ"
      ],
      "name": "Ait-Tihyaty Maria"
    },
    {
      "affiliations": [
        "Janssen Research and Development, LLC, Titusville, NJ"
      ],
      "name": "Turkoz Ibrahim"
    },
    {
      "affiliations": [
        "Janssen Global Services, LLC, Raritan, NJ, USA"
      ],
      "name": "Pease Sheryl"
    },
    {
      "affiliations": [
        "Janssen Scientific Affairs, LLC, Titusville, NJ, USA"
      ],
      "name": "Choudhry Zia"
    },
    {
      "affiliations": [
        "Janssen-Cilag, Issy-les-Moulineaux, France"
      ],
      "name": "Gary Charlotte"
    },
    {
      "affiliations": [
        "Janssen Global Services, LLC, Raritan, NJ, USA"
      ],
      "name": "El Khoury Antoine C"
    }
  ],
  "title": "25 Assessment of MG-ADL items during a 24-week, phase-3 study (VIVACITY) of nipocalimab in myasthenia gravis",
  "uid": "e5eb7680-13ea-5156-9c6f-21b45e8ffca2"
}