{
  "abstract": "Introduction OCARINA I ( NCT03972306) and II (NCT05232825) show that subcutaneous (SC) ocrelizumab (OCR) 920 mg has a similar benefit-risk profile to intravenous (IV) OCR 600 mg in people with (Pw) relapsing and primary progressive multiple sclerosis (RMS/PPMS).Methods In OCARINA I, PwRMS/PPMS transitioned to SC OCR 920 mg after dose escalation to assess safety, tolerability, and serum neurofilament light chain (sNfL) level. In OCARINA II, OCR-naive PwRMS/PPMS patients were randomized to OCR IV or SC, and all later received SC OCR; endpoints included safety and efficacy.Results In OCARINA I (n=118), patients experienced adverse events (AEs; n=105, 89.0%), serious AEs (SAEs; n=11, 9.3%), and injection reactions (IRs; n=70, 59.3%). In OCARINA II (n=233), patients experienced AEs (n=175, 75.1%), SAEs (n=6, 2.6%), and IRs (n=120, 51.5%). SC OCR showed near-complete suppression of MRI and relapse activity up to week 48, with B-cell depletion maintained via IV/SC routes. sNfL levels were decreased via IV/SC routes.Conclusions SC OCR has shown similar clinical/MRI outcomes to IV OCR, with a sustained reduction of sNFL. It was well tolerated, with no new safety concerns.jay.azmi@roche.com",
  "authors": [
    {
      "affiliations": [
        "Johns Hopkins University School of Medicine, Baltimore, MD, USA"
      ],
      "name": "SD Newsome"
    },
    {
      "affiliations": [
        "Department of Neurology, Medical University of Silesia, Katowice, Poland"
      ],
      "name": "E Krzystanek"
    },
    {
      "affiliations": [
        "Department of Neurology, University of Warmia and Mazury, Olsztyn, Poland"
      ],
      "name": "K Selmaj"
    },
    {
      "affiliations": [
        "Department of Neurology and Rehabilitation, University of Cincinnati, OH, USA"
      ],
      "name": "L Goldstick"
    },
    {
      "affiliations": [
        "Mellen Center for MS, Department of Neurology, Cleveland Clinic, Cleveland, OH, USA"
      ],
      "name": "R Bermel"
    },
    {
      "affiliations": [
        "F. Hoffmann-La Roche Ltd, Basel, Switzerland"
      ],
      "name": "D Zecevic"
    },
    {
      "affiliations": [
        "Roche Products Ltd, Welwyn Garden City, UK"
      ],
      "name": "A Augustin"
    },
    {
      "affiliations": [
        "Roche Products Ltd, Welwyn Garden City, UK"
      ],
      "name": "J Azmi"
    },
    {
      "affiliations": [
        "Genentech, Inc., South San Francisco, CA, USA"
      ],
      "name": "Y-A Shen"
    },
    {
      "affiliations": [
        "Department of Systems Medicine, Tor Vergata University, Rome"
      ],
      "name": "D Centonze"
    }
  ],
  "title": "13 Subcutaneous ocrelizumab in multiple sclerosis: benefit-risk profile from the OCARINA clinical development program",
  "uid": "4551f49f-f1b2-5beb-82a2-1f45f6b046da"
}