{
  "abstract": "Objective To evaluate the feasibility and safety of belimumab dose spacing and withdrawal in patients with SLE in long-standing remission on belimumab.Methods Patients with SLE fulfilling the 2019 European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) criteria who underwent belimumab spacing and/or discontinuation were identified across four tertiary rheumatology centres. The shared belimumab step-down strategy consisted of spacing to subcutaneous (SC) 200 mg/10 days (or intravenous (IV) 10 mg/kg/6 weeks). In the absence of flares, belimumab could be progressively tapered every 6–12 months to SC 200 mg/14 days (or IV 10 mg/kg/8 weeks), SC 200 mg/21 days (or IV 10 mg/kg/12 weeks), SC 200 mg/28 days (or IV 10 mg/kg/16 weeks) and eventually discontinued. Primary endpoint: SLE flares occurrence.Results Among 152 patients with SLE treated with belimumab, 22 (14.5%) underwent spacing for sustained remission (21 females (95.5%), mean±SD age 47±11 years). Spacing patients had longer mean remission duration compared with standard-dose belimumab (67±30 vs 33±32 months, p<0.001), less serological activity (low complement and/or positive anti-double stranded DNA 31.8% vs 54.6%, p=0.048), lower SLE Disease Activity Index 2000 (0.77±1.23 vs 1.98±2.01, p<0.001) and were less often on glucocorticoids (22.7% vs 47.7%, p=0.029) or additional immunosuppressants (0.0% vs 50.8%, p<0.001). During the 21±5.4 months of follow-up, no SLE flares occurred. None of the patients required glucocorticoid dose escalation or reduced the dose interval. Seven patients discontinued belimumab.Conclusion Progressive belimumab dose spacing and withdrawal, coupled with clinical monitoring, could be a practicable approach in selected patients with SLE with long-standing disease remission on minimal glucocorticoid doses, no additional immunosuppressants and low serological activity.",
  "authors": [
    {
      "affiliations": [
        "Clinical Rheumatology, ASST Gaetano Pini, Milan, Italy"
      ],
      "name": "Alice Bartoletti"
    },
    {
      "affiliations": [
        "Clinical Rheumatology, ASST Gaetano Pini, Milan, Italy",
        "Physical Medicine and Rehabilitation, ASST Gaetano Pini, Milan, Italy"
      ],
      "name": "Lorenza Maria Argolini"
    },
    {
      "affiliations": [
        "Unit of Immunology, Rheumatology, Allergology and Rare diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy"
      ],
      "name": "Giuseppe Alvise Ramirez"
    },
    {
      "affiliations": [
        "Unit of Immunology, Rheumatology, Allergology and Rare diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy"
      ],
      "name": "Luca Moroni"
    },
    {
      "affiliations": [
        "Internal Medicine II, San Paolo Hospital, ASST Santi Paolo e Carlo, Milan, Italy"
      ],
      "name": "Tommaso Schioppo"
    },
    {
      "affiliations": [
        "Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy",
        "Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy"
      ],
      "name": "Chiara Bellocchi"
    },
    {
      "affiliations": [
        "Clinical Rheumatology, ASST Gaetano Pini, Milan, Italy",
        "Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy"
      ],
      "name": "Sofia Aliprandi"
    },
    {
      "affiliations": [
        "Unit of Immunology, Rheumatology, Allergology and Rare diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy"
      ],
      "name": "Biancamaria Venerandi"
    },
    {
      "affiliations": [
        "Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy",
        "Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy"
      ],
      "name": "Annalaura Fasiello"
    },
    {
      "affiliations": [
        "Unit of Immunology, Rheumatology, Allergology and Rare diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy"
      ],
      "name": "Gabriele Domenico Gallina"
    },
    {
      "affiliations": [
        "Referral Center for Systemic Autoimmune Diseases, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy"
      ],
      "name": "Lorenzo Beretta"
    },
    {
      "affiliations": [
        "Unit of Immunology, Rheumatology, Allergology and Rare diseases (UnIRAR), IRCCS Ospedale San Raffaele, Milan, Italy"
      ],
      "name": "Lorenzo Dagna"
    },
    {
      "affiliations": [
        "Clinical Rheumatology, ASST Gaetano Pini, Milan, Italy",
        "Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy"
      ],
      "name": "Roberto Caporali"
    },
    {
      "affiliations": [
        "Clinical Rheumatology, ASST Gaetano Pini, Milan, Italy",
        "Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy"
      ],
      "name": "Maria Gerosa"
    },
    {
      "affiliations": [],
      "name": "on behalf of SMILE, Milan Lupus Consortium"
    }
  ],
  "title": "Real-world experience with personalised belimumab spacing in sustained SLE remission: a multicentre study",
  "uid": "52d1e8b6-30a3-5aba-934c-56f116550e4e"
}