{
  "abstract": "Objectives Belimumab (BEL) is a B-cell modulator targeting the central immunopathogenic pathway in SLE by selectively inhibiting B lymphocyte stimulator and reducing autoreactive B cells that drive disease activity. This abstract reports on the incidence of adverse events of special interest (AESI) in patients with SLE from the SABLE registry, treated with or without BEL.Methods The real-world, prospective, observational SABLE registry (GSK Study 116543; NCT01729455) enrolled patients with active SLE (2013–2020), treated with BEL (BEL group) or a conventional immunosuppressant (non-BEL group), plus standard therapy at baseline. Patients with prior BEL discontinuation, or antimalarial- or glucocorticoid-only therapy were excluded. Patients were followed-up for >=5 years, with AESI recorded every 6 months. AESI incidence per 100 patient-years was analysed in three unweighted exposure cohorts: initial exposure (intent-to-treat [ITT] population), and time-varying exposure accounting for treatment switching post-baseline (14-week [98 days] or 6-month [183 days] washout period after last BEL dose).Results Of 2967 patients, 2030 and 937 were in the BEL and non-BEL groups, respectively. Baseline characteristics were similar except for a numerically greater proportion of patients in the BEL vs non-BEL group with other autoimmune and psychiatric disorders ( table 1).For the initial exposure cohort, the 0–60+ month AESI incidence rates were numerically lower in the BEL vs non-BEL group for mortality and malignancy, higher for serious infections and serious psychiatric events, and similar (incidence rate difference between groups <=0.1) for opportunistic infections, other infections of special interest, and NMSC (table 2). For the time-varying exposure cohort (14-week), most AESI incidence rates were either numerically lower in the BEL vs non-BEL group or similar, including serious infections and serious psychiatric events (table 2). Incidence rates were similar for 14-week and 6-month time-varying exposure strategies.Abstract PO:11:294 Table 1–2Conclusions The large global SABLE registry of patients treated in routine clinical practice, with diverse racial backgrounds and a range of disease severity, provides data with tight confidence intervals around key safety parameters. Overall, the results demonstrate that the 5-year incidence of key AESI with BEL is low and similar to standard therapy, and reinforce the role of BEL in long-term SLE management.Funding GSK",
  "authors": [
    {
      "affiliations": [
        "Department of Rheumatology, Amsterdam Rheumatology and Immunology Center, Amsterdam University Medical Centers, Amsterdam, The Netherlands"
      ],
      "name": "Ronald Van Vollenhoven"
    },
    {
      "affiliations": [
        "Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK"
      ],
      "name": "Ian N Bruce"
    },
    {
      "affiliations": [
        "Department of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, USA"
      ],
      "name": "Joan T Merrill"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Toronto, Toronto, Canada"
      ],
      "name": "Murray B Urowitz"
    },
    {
      "affiliations": [
        "Clinic and Hiller Research Unit of Rheumatology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine Univ, Düsseldorf, Germany"
      ],
      "name": "Matthias Schneider"
    },
    {
      "affiliations": [
        "Medicines Research Centre, GSK, Stevenage, UK"
      ],
      "name": "Sofia Fernandes"
    },
    {
      "affiliations": [
        "Safety Evaluation and Risk Management, GSK, Wavre, Belgium"
      ],
      "name": "Poonam Dixit"
    },
    {
      "affiliations": [
        "Immunology and Hepatology Biostatistics, GSK, Bangalore, India"
      ],
      "name": "Abhishek Roy"
    },
    {
      "affiliations": [
        "Development RandD, GSK, Collegeville, USA"
      ],
      "name": "Ryan Tomlinson"
    },
    {
      "affiliations": [
        "Department of Medicine, Division of Rheumatology, Emory University School of Medicine, Atlanta, USA"
      ],
      "name": "S Sam Lim"
    }
  ],
  "title": "PO:11:294 Five-year safety of belimumab in SLE: insights from the global, prospective, observational SABLE registry",
  "uid": "cd12f191-9e20-549b-b955-c0e268028214"
}