{
  "abstract": "Objective To assess the effectiveness of belimumab (BEL) in improving anaemia, thrombocytopenia, lymphopenia and leucopenia in patients with SLE.Methods The BeRLiSS (Belimumab in Real Life Setting Study) 2.0 cohort included patients with SLE from 14 Italian referral centres treated with BEL for active joint or skin involvement, based on physician judgement, between June 2013 and May 2024. Clinical and laboratory parameters were recorded at baseline and every 6 months. Patients were eligible if they had baseline haematological abnormalities defined according to British Isles Lupus Assessment Group (BILAG) (grade C or higher): haemoglobin (Hb) ≤10.9 g/dL, platelets (Plts) ≤149×10 9/L, lymphocytes (Lym) ≤1.0×109/L or leucocytes (Leuc) ≤3.0×109/L. Follow-up data up to month 48 were available for 33 patients with anaemia, 20 with thrombocytopenia, 44 with lymphopenia and 18 with leucopenia.Results At baseline, 76 patients had anaemia, 44 thrombocytopenia, 107 lymphopenia and 53 leucopenia. Hb levels increased significantly from 9.9±0.6 g/dL to 11.7±1.4 g/dL at month 48 (p<0.001). Platelet counts rose from 110.2±38.1×10 9/L to 176.6±88.7×109/L (p=0.004), Lym counts from 0.72±0.21×109/L to 1.14±0.45×109/L (p<0.001) and leucocyte counts from 2.437±0.533×109/L to 4.732±1.897×109/L at 48 months (p<0.001). Improvement in Hb (p=0.97), Plts (p=0.12), Lym (p=0.86) and Leuc (p=0.73) was similar regardless of the use of concomitant immunosuppressants. Glucocorticoid (GC) doses decreased significantly across all manifestations, except for leucopenia: anaemia (12.9±12.1 to 3.6±4.9 mg/day, p=0.003), thrombocytopenia (10.8±9.6 to 4.4±5.5 mg/day, p=0.004), lymphopenia (10.6±8.6 to 3.1±3.2 mg/day, p<0.001). Proportion of GC users declined over 48 months: anaemia 96.1–60.7%, thrombocytopenia 93.1–80%, lymphopenia 96.3–70.3% and leucopenia 95.3–80%.Conclusion In this real-world cohort, BEL treatment was associated with improvement in anaemia, thrombocytopenia, lymphopenia and leucopenia with over half of patients achieving normalisation of blood counts. Haematological responses were similar regardless of concomitant immunosuppressive therapy, supporting the role of BEL as a therapeutic option for haematological abnormalities in SLE.",
  "authors": [
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Greta Hulej"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy",
        "Department of Medicine, San Francesco Hospital, Nuoro, Sardinia, Italy"
      ],
      "name": "Federico Arru"
    },
    {
      "affiliations": [
        "Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Marche, Italy"
      ],
      "name": "Benedetta Bianchi"
    },
    {
      "affiliations": [
        "Department of Medical Sciences, University of Ferrara, Ferrara, Emilia-Romagna, Italy"
      ],
      "name": "Alessandra Bortoluzzi"
    },
    {
      "affiliations": [
        "Department of Medical Sciences, University of Turin, Turin, Piedmont, Italy"
      ],
      "name": "Luisa Brussino"
    },
    {
      "affiliations": [
        "Department of Transplantology, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Emilia-Romagna, Italy"
      ],
      "name": "Paola Castrignanò"
    },
    {
      "affiliations": [
        "Department of Medical Science and Public Health, University of Cagliari, Cagliari, Sardinia, Italy"
      ],
      "name": "Alberto Cauli"
    },
    {
      "affiliations": [
        "Department of Internal Medicine, University of Pavia, Pavia, Lombardia, Italy"
      ],
      "name": "Lorenzo Cavagna"
    },
    {
      "affiliations": [
        "Department of Medical Science and Public Health, University of Cagliari, Cagliari, Sardinia, Italy"
      ],
      "name": "Elisabetta Chessa"
    },
    {
      "affiliations": [
        "Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Friuli-Venezia Giulia, Italy",
        "Department of Experimental and Clinical Medicine, University of Florence, Florence, Tuscany, Italy"
      ],
      "name": "Emanuele Chiara"
    },
    {
      "affiliations": [
        "Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Marche, Italy"
      ],
      "name": "Rossella De Angelis"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Udine, Udine, Friuli-Venezia Giulia, Italy"
      ],
      "name": "Ginevra De Marchi"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Roberto Depascale"
    },
    {
      "affiliations": [
        "Department of Clinical and Molecular Sciences, Polytechnic University of Marche, Ancona, Marche, Italy"
      ],
      "name": "Marco Di Carlo"
    },
    {
      "affiliations": [
        "Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Friuli-Venezia Giulia, Italy",
        "Monash University, Melbourne, Victoria, Australia"
      ],
      "name": "Giacomo Emmi"
    },
    {
      "affiliations": [
        "Rheumatology Unit, Department of Medicine, University of Verona, Verona, Veneto, Italy"
      ],
      "name": "Isotta Galvagni"
    },
    {
      "affiliations": [
        "Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Friuli-Venezia Giulia, Italy"
      ],
      "name": "Michela Gasparotto"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy",
        "Department of Clinical and Biological Sciences, University of Turin, Turin, Piedmont, Italy"
      ],
      "name": "Mariele Gatto"
    },
    {
      "affiliations": [
        "Rheumatology Unit, Department of Medicine & Surgery, University of Perugia, Perugia, Umbria, Italy"
      ],
      "name": "Roberto Gerli"
    },
    {
      "affiliations": [
        "Department of Medical Sciences, University of Ferrara, Ferrara, Emilia-Romagna, Italy"
      ],
      "name": "Marcello Govoni"
    },
    {
      "affiliations": [
        "UOSD Papardo, Hospital of Messina, Messina, Sicily, Italy"
      ],
      "name": "Alberto Lo Gullo"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Udine, Udine, Friuli-Venezia Giulia, Italy"
      ],
      "name": "Alessia Nano"
    },
    {
      "affiliations": [
        "Department of Medical Sciences, University of Turin, Turin, Piedmont, Italy"
      ],
      "name": "Simone Negrini"
    },
    {
      "affiliations": [
        "Internal Medicine ‘Guido Baccelli’, Department of Precision and Rigenerative Medicine and Ionian Area, Università degli Studi di Bari Aldo Moro, Bari, Puglia, Italy"
      ],
      "name": "Silvia Noviello"
    },
    {
      "affiliations": [
        "Rheumatology Unit, Department of Medicine, University of Verona, Verona, Veneto, Italy"
      ],
      "name": "Giovanni Orsolini"
    },
    {
      "affiliations": [
        "Department of Transplantology, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Emilia-Romagna, Italy"
      ],
      "name": "Giulia Pazzola"
    },
    {
      "affiliations": [
        "Department of Medical Science and Public Health, University of Cagliari, Cagliari, Sardinia, Italy"
      ],
      "name": "Matteo Piga"
    },
    {
      "affiliations": [
        "Department of Medicine, University of Udine, Udine, Friuli-Venezia Giulia, Italy"
      ],
      "name": "Luca Quartuccio"
    },
    {
      "affiliations": [
        "Rheumatology Unit, Department of Medicine, University of Verona, Verona, Veneto, Italy"
      ],
      "name": "Maurizio Rossini"
    },
    {
      "affiliations": [
        "Department of Transplantology, Oncology and Regenerative Medicine, University of Modena and Reggio Emilia, Modena, Emilia-Romagna, Italy"
      ],
      "name": "Carlo Salvarani"
    },
    {
      "affiliations": [
        "Department of Medical Sciences, University of Ferrara, Ferrara, Emilia-Romagna, Italy"
      ],
      "name": "Ettore Silvagni"
    },
    {
      "affiliations": [
        "Department of Experimental and Clinical Medicine, University of Florence, Florence, Tuscany, Italy"
      ],
      "name": "Elena Silvestri"
    },
    {
      "affiliations": [
        "Department of Medical Sciences, University of Ferrara, Ferrara, Emilia-Romagna, Italy"
      ],
      "name": "Marianna Tamussin"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Martina Tizian"
    },
    {
      "affiliations": [
        "Department of Medical, Surgery and Health Sciences, University of Trieste, Trieste, Friuli-Venezia Giulia, Italy"
      ],
      "name": "Paola Tomietto"
    },
    {
      "affiliations": [
        "Department of Experimental and Clinical Medicine, University of Florence, Florence, Tuscany, Italy"
      ],
      "name": "Maria Letizia Urban"
    },
    {
      "affiliations": [
        "Internal Medicine ‘Guido Baccelli’, Department of Precision and Rigenerative Medicine and Ionian Area, Università degli Studi di Bari Aldo Moro, Bari, Puglia, Italy"
      ],
      "name": "Angelo Vacca"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Filippo Vesentini"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Marisol Bracalenti"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Roberta Ramonda"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Andrea Doria"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Luca Iaccarino"
    },
    {
      "affiliations": [
        "Department of Medicine, Rheumatology Unit, University of Padua, Padua, Veneto, Italy"
      ],
      "name": "Margherita Zen"
    }
  ],
  "title": "Efficacy of belimumab in patients with SLE and haematological manifestations: retrospective analysis from the BeRLiSS 2.0 cohort",
  "uid": "71d09ff0-a22e-53b5-8c1d-fad1ec84fb06"
}