{
  "abstract": "Background Patients with generalised myasthenia gravis (gMG) may experience disabling ocular symptoms including diplopia/double vision and ptosis/eyelid drooping. In the Phase 3 MycarinG study ( NCT03971422), rozanolixizumab demonstrated clinically meaningful improvements across myasthenia gravis (MG)-specific outcomes and was generally well tolerated. Post hoc analyses investigated the effect of rozanolixizumab on ocular symptoms.Methods Adults with MGFA Disease Class II-IVa, acetylcholine receptor/muscle-specific tyrosine kinase autoantibody-positive gMG received once-weekly subcutaneous rozanolixizumab 7mg/kg, 10mg/kg or placebo for 6 weeks (to Day 43). Mean change from baseline (CFB) in ocular item scores across MG-Activities of Daily Living (MG-ADL), Quantitative MG (QMG) and MG Symptoms Patient-Reported Outcome (MG Symptoms PRO) Ocular Muscle Weakness scales for patients with baseline score ≥1 were assessed.Results 200 patients received rozanolixizumab 7mg/kg (n=66), 10mg/kg (n=67) or placebo (n=67). Mean baseline scores for ocular items were 1.6–1.9 for MG-ADL, 1.8–2.1 for QMG and 1.5–1.8 for MG Symptoms PRO. For rozanolixizumab 7mg/kg, 10mg/kg and placebo, mean CFB at Day 43 in MG-ADL ocular item scores was −0.6, −0.6 and −0.2, respectively, for diplopia, and −0.5, −0.7 and 0.0, respectively, for ptosis. Mean CFB in QMG scores was −0.6, −0.8 and 0.1, respectively, for diplopia, and −0.5, −1.0 and −0.5, respectively, for ptosis. Mean CFB in MG Symptoms PRO scores was −0.5, −0.6 and −0.2, respectively, for diplopia, and −0.5, −0.7 and −0.1, respectively, for ptosis. Most treatment-emergent adverse events were mild/moderate.Conclusions Rozanolixizumab demonstrated greater improvements in ocular item scores across MG-specific outcomes compared with placebo. Funding: UCB.",
  "authors": [
    {
      "affiliations": [
        "UCB, Melbourne, VIC, Australia"
      ],
      "name": "Besma Nash"
    },
    {
      "affiliations": [
        "Department of Neuromuscular Medicine and Clinical Neurophysiology, University of Kentucky, Lexington, KY, USA"
      ],
      "name": "Zabeen K Mahuwala"
    },
    {
      "affiliations": [
        "MDA ALS and Neuromuscular Center, University of California, Irvine, Irvine, CA, USA"
      ],
      "name": "Ali A Habib"
    },
    {
      "affiliations": [
        "Neurology Department, Indiana University School of Medicine, Indiana University Health, Indianapolis, IN, USA"
      ],
      "name": "Robert M Pascuzzi"
    },
    {
      "affiliations": [
        "Department of Neurology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark"
      ],
      "name": "John Vissing"
    },
    {
      "affiliations": [
        "Department of Neurology, University of South Florida Morsani College of Medicine, Tampa, FL, USA"
      ],
      "name": "Tuan Vu"
    },
    {
      "affiliations": [
        "UCB, Brussels, Belgium"
      ],
      "name": "Jos Bloemers"
    },
    {
      "affiliations": [
        "UCB, Slough, UK"
      ],
      "name": "Fiona Grimson"
    },
    {
      "affiliations": [
        "UCB, Madrid, Spain"
      ],
      "name": "Thais Tarancón"
    },
    {
      "affiliations": [
        "University Health Network, Toronto, ON, Canada"
      ],
      "name": "Vera Bril"
    }
  ],
  "title": "3595 Effect of rozanolixizumab on ocular symptoms in generalised myasthenia gravis: post hoc item-level analysis of myasthenia gravis-specific outcomes in MycarinG",
  "uid": "59fd86c6-da07-50ce-ba58-a9ecfb983788"
}