{
  "abstract": "Objectives To evaluate the safety and efficacy of BEL in patients with a retention rate exceeding 10 years.Methods Review of a monocentric case series of SLE patients treated with BEL for more than 10 years, analyzing safety and efficacy parameters.Results Among 277 SLE patients in follow-up, 7 were treated with BEL for more than 10 years. All were female, mean age at diagnosis 33.0 ± 8.6 years and a mean disease duration 12.3 ± 5.7 years. The disease course was relapsing-remitting in 43% and chronic-active in 57%. The most frequent organ involvements were articular (86%), mucocutaneous (86%), constitutional (86%), serositis (57%), hematologic (71%), and renal (29%). The mean number of pre-BEL cDMARDs per patient was 3.14 ± 1.21. BEL induced a progressive reduction in disease activity indices (SLEDAI-2K 10.4 ± 2.4 at baseline vs. 1.7 ± 1.0 at last follow-up) and allowed complete discontinuation of prednisone in all patients (10.4 ± 12.7 mg/day at baseline vs. 0 mg/day at last follow-up). After 6 months of BEL, there was an average reduction of SLEDAI-2K by 5.71 ± 2.56 points and of prednisone dose to 7.5 ± 12.01 mg/day; at 12 months, all patients had achieved a Low Lupus Disease Activity State (LLDAS) and/or remission. At the last follow-up (2025), only 2 patients remained on cDMARDs and 5 were receiving hydroxychloroquine. Two patients temporarily discontinued BEL, one for a severe neurological flare and one for pregnancy, both resuming BEL afterward. The mean annual flare rate per patient was 0.43 ± 0.31/year, mostly artrocutaneous or hematologic. Overall, 16 adverse events were reported, none severe (9/16 infectious, 6/16 non-infectious, and 1/16 mild hypersensitivity reaction), with a mean of 2.3 ± 1.7 events per patient.Conclusions These data confirm that the rapid and significant clinical response observed as early as 6–12 months after starting BEL is sustained over long-term follow-up, with a reduction in disease flares and sparing of both prednisone and cDMARDs. Moreover, this case series highlights that BEL maintains a satisfactory tolerability profile, with no new safety signals, even after more than 10 years of continuous therapy, currently the longest retention rate described in RWE.",
  "authors": [
    {
      "affiliations": [
        "Rheumatology Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy"
      ],
      "name": "Ginevra De Marchi"
    },
    {
      "affiliations": [
        "Rheumatology Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy"
      ],
      "name": "Alessia Nano"
    },
    {
      "affiliations": [
        "Rheumatology Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy"
      ],
      "name": "Luisa Occhipinti"
    },
    {
      "affiliations": [
        "Rheumatology Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy"
      ],
      "name": "Laura Di Centa"
    },
    {
      "affiliations": [
        "Rheumatology Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy"
      ],
      "name": "Benedetta Fazzi"
    },
    {
      "affiliations": [
        "Rheumatology Division, Department of Medicine, University of Udine and Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy"
      ],
      "name": "Luca Quartuccio"
    }
  ],
  "title": "PO:10:269 Analysis of a monocentric case series of patients with systemic lupus erythematosus treated with belimumab for more than 10 years",
  "uid": "7911a302-49a7-57df-b10e-be42e82dab3a"
}