{
  "abstract": "Objectives Belimumab (BEL), a B-cell modulator mAb that selectively inhibits soluble B-lymphocyte stimulator and reduces autoreactive B cells driving lupus disease activity, is approved for adult and paediatric SLE and LN. 1 Prolonged oral glucocorticoids (OGC) can lead to organ damage, and real-world data demonstrate reduced OGC use with BEL. Here, we identified characteristics predicting early responses to BEL by OGC reduction or discontinuation among US patients with SLE.Methods This retrospective, longitudinal cohort study (GSK Study 222157) of health record data (Specialty Networks) included adults with SLE initiating subcutaneous (SC)/intravenous (IV) BEL (9/1/2011–4/25/2024; ‘index’) with clinical activity >=12 months pre-index (‘baseline period’) and >=10 months post-index and >=1 OGC prescription with dose information (prednisone-equivalent) and no baseline discontinuation. Exposure required >=1 SC/IV (SC BEL) or >=1 SC or >=2 IV (IV BEL) BEL records <=3 months of index. A least absolute shrinkage and selection operator (LASSO) regression model identified predictors of early OGC dose reduction by >=50% or discontinuation (>=120 consecutive days without supply) <=6 months of initiating BEL. ‘Early’ was occurrence within the first quartile of time from index to either event across patients. Candidate predictors included age, sex, race, index year, SLE disease severity, organ damage, Quan-Charlson Comorbidity Index, and comorbidities.Results Of 541 patients, >=50% OGC dose reduction or discontinuation was achieved by 50.8% (n=275) in <=6 months and 25% (n=136) in <2 months (57 days) of BEL initiation, with a median time of 177 days. Patients with versus without early (i.e. <=57 days) OGC reduction or discontinuation were slightly older (50.3 vs 48.3 years) with a greater proportion of moderate (74.3% vs 66.9%) or severe (3.7% vs 2.2%) SLE, but similar baseline organ damage ( table 1). Baseline moderate/severe (vs mild) SLE (odds ratio [95% confidence interval]: 1.64 [1.04, 2.65]) was a predictor of early OGC dose reduction or discontinuation (table 2).Abstract PT3:03 Table 1Patient baseline demographics and clinical characteristics by early OGC dose reduction by ≥50% or discontinuation*Abstract PT3:03 Table 2LASSO-selected predictors of early OGC dose reduction or discontinuation*Conclusions Of patients initiating BEL, half achieved OGC discontinuation or dose reduction by >=50% in <=6 months and 25% in <2 months of BEL initiation. Earlier benefit was more likely in patients with moderate/severe SLE.Funding GSK Reference GSK. Benlysta US prescribing information. 2024.Original presentation ACR 2025",
  "authors": [
    {
      "affiliations": [
        "Analysis Group, Los Angeles, USA"
      ],
      "name": "Yan Chen"
    },
    {
      "affiliations": [
        "Analysis Group, Los Angeles, USA"
      ],
      "name": "Maral Dersarkissian"
    },
    {
      "affiliations": [
        "Analysis Group, Los Angeles, USA"
      ],
      "name": "Shumin Rui"
    },
    {
      "affiliations": [
        "Analysis Group, Los Angeles, USA"
      ],
      "name": "Justin Clark"
    },
    {
      "affiliations": [
        "GSK, Global Real-World Evidence and Health Outcomes Research, Toronto, Canada"
      ],
      "name": "Daniel Moldaver"
    },
    {
      "affiliations": [
        "GSK, Global Real-World Evidence and Health Outcomes Research, Collegeville, USA"
      ],
      "name": "Jeffrey J Ellis"
    },
    {
      "affiliations": [
        "GSK, Global Real-World Evidence and Health Outcomes Research, Collegeville, USA"
      ],
      "name": "Karen Worley"
    },
    {
      "affiliations": [
        "GSK, Medical Department, Spain"
      ],
      "name": "Beatriz Velasco"
    },
    {
      "affiliations": [
        "GSK, US Medical Affairs, Durham, USA",
        "Department of Pediatrics, University of Virginia, Charlottesville, USA"
      ],
      "name": "Aarat M Patel"
    }
  ],
  "title": "PT3:03 Rapid Oral glucocorticoid discontinuation or dose reduction among US patients with SLE receiving belimumab in a real-world setting",
  "uid": "e51e89e4-62ec-596e-9bf2-31aaa1fc338a"
}