{
  "abstract": "Background and Importance Multiple sclerosis (MS) is a chronic autoimmune disease that causes inflammation and neurodegeneration in the central nervous system, leading to physical and cognitive disability. Despite available treatments, there is a need for therapies that effectively slow disease progression with a good safety profile. Ocrelizumab, a monoclonal antibody targeting CD20-positive B cells, is used in MS, but real-world data on its efficacy and safety remain limited.Aim and Objectives To evaluate the real-world efficacy and safety of ocrelizumab in MS patients. The study aimed to assess treatment impact on disability progression, measured by confirmed disability progression (CDP), as well as on relapse rates and the incidence of adverse events during at least 12 months of therapy.Material and Methods A retrospective study was conducted on MS patients treated with ocrelizumab between January 2018 and March 2025, with ≥1 year of follow-up. Efficacy was evaluated through relapse rates and disability outcomes using EDSS and CDP, defined by EMA criteria as an increase of ≥1.0 point from baseline if ≤5.5, or ≥0.5 if >5.5. Safety assessments included laboratory parameters, infections, neoplasms, and severe lymphopenia (<200 cells/μL).Results Since 2018, 82 patients started ocrelizumab. Five who received one dose were excluded, leaving 77 for the final analysis, with a mean follow-up of 2.1 ± 1.6 years. Mean age at initiation was 43.8 ± 8.8 years, and 63.2% were women. CDP was observed in 29 of 77 patients (37.7%) during follow-up. Mean relapse rate was 0.14 ± 0.68. Infections occurred in 64 patients (83.1%). Among infected patients, respiratory infections were most frequent (71.9%), followed by urinary tract (48.4%) and herpetic (9.4%). As patients could present more than one type, percentages are not mutually exclusive. No elevated liver enzymes or severe lymphopenia (<200/µL) were observed. However, lymphocyte counts significantly decreased at 12 months (mean –284.1 ± 871.7/µL, p = 0.024). Neoplasms were reported in 5.2% (two breast, one lung, one testicular).Conclusion and Relevance Ocrelizumab demonstrated clinical stability with low relapse rates and moderate disability progression. Infections were frequent but manageable, and no severe hepatic or haematologic toxicity was observed. The incidence of neoplasms highlights the need for continued long-term safety monitoring in real-world practice.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Pharmacy Department, Valladolid, Spain"
      ],
      "name": "S Maganto Garrido"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Pharmacy Department, Valladolid, Spain"
      ],
      "name": "S Fernández Peña"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Pharmacy Department, Valladolid, Spain"
      ],
      "name": "M Montero Lázaro"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Neurology Department, Valladolid, Spain"
      ],
      "name": "E Varas Martín"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Pharmacy Department, Valladolid, Spain"
      ],
      "name": "E Abad Lecha"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Neurology Department, Valladolid, Spain"
      ],
      "name": "MN Téllez Lara"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Neurology Department, Valladolid, Spain"
      ],
      "name": "P Mulero Carrillo"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Neurology Department, Valladolid, Spain"
      ],
      "name": "A Chavarría Miranda"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Neurology Department, Valladolid, Spain"
      ],
      "name": "MJ Neri Crespo"
    },
    {
      "affiliations": [
        "Hospital Clínico Universitario De Valladolid, Pharmacy Department, Valladolid, Spain"
      ],
      "name": "MT Sánchez Sánchez"
    }
  ],
  "title": "5PSQ-074 Real-world evaluation of ocrelizumab: efficacy and safety in patients with multiple sclerosis",
  "uid": "ff1374d3-1d55-50e1-9799-51d1194162a2"
}