{
  "abstract": "Objectives Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease. Anifrolumab, a monoclonal antibody targeting the type I interferon receptor, was approved in Italy in March 2023 for refractory or moderately active SLE. Real-world data are limited. This study evaluated the real-life effectiveness and safety of anifrolumab.Methods Patients initiating anifrolumab by 30-Jun-2025 were included. Demographics, clinical features, disease activity (SLEDAI-2K, SLE-DAS), treatment, and adverse events were collected. Laboratory markers, corticosteroid dose, and disease scores were obtained at T–3 (screening), T0 (baseline), T1 (1 month), T2 (3 months), T3 (6 months), T4 (9 months) and T5 (12 months). Paired t-test and GLM repeated measures analyzed changes over time.Results Twenty-nine patients (F:M 6,25:1; 75.9% Caucasian) started anifrolumab at mean age of 41.72±13.9 years and disease duration 15.9± 12.7 years. Cumulative organ involvement included mucocutaneous (93.1%), articular (79.3%), haematological (62.1%) and renal (20.7%) manifestations. Therapy was mainly initiated for mucocutaneous (86.2%) and joint (55.2%) activity.Six patients (20.8%) were biologic-naïve; mean prior DMARDs was 2.62±1.68. Baseline corticosteroid dose averaged 7.9±6.8 mg/dayThirteen patients (54.2%) developed infections (n=18), mostly respiratory (6 pneumonias); two progressed to sepsis. Six patients (20.7%) required hospitalization. Among pneumonia cases, three (50%) received additional immunosuppressive therapy.No Herpes Zoster occurred; four had herpes simplex infections. Temporary and permanent discontinuations affected 11 and 3 patients (12.5%), mainly due to infections or logistical issues.Longitudinal disease activity and serology were assessed in 22/29 patients. Disease activity at T0 was higher than at T-3 (p<0.001), with progressive improvement and stabilization after T2.CLASI-A scores improved (p=0.023). Complement, haemoglobin and leukocyte remained stable. Platelet counts increased significantly up to T2 (p=0.008), with a non-significant drop at T3. Anti-dsDNA positivity was less frequent at T3 vs T0, suggesting a trend toward seroreversion, though not statistically significant (p=0.063). CS use declined significantly over time (p=0.009).Abstract PO:11:302 Figure 1Conclusions In this real-world cohort, anifrolumab was mainly used for mucocutaneous and articular SLE, resulting in rapid reduction of disease activity followed by sustained stabilization. Corticosteroid use decreased, supporting a steroid-sparing effect. Laboratory parameters were mostly stable. Infections were common but mostly mild. The small sample size limits statistical power and generalizability.",
  "authors": [
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Paola Bizioli"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Chiara Orlandi"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Claudia Barison"
    },
    {
      "affiliations": [
        "Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy"
      ],
      "name": "Cesare Tomasi"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Alessia Caproli"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Silvia Piantoni"
    },
    {
      "affiliations": [
        "Laboratory of Clinical Chemistry, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy"
      ],
      "name": "Simona Signorini"
    },
    {
      "affiliations": [
        "Laboratory of Clinical Chemistry, Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy"
      ],
      "name": "Emirena Garrafa"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Cecilia Nalli"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Micol Frassi"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Ilaria Cavazzana"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Micaela Fredi"
    },
    {
      "affiliations": [
        "Rheumatology and Clinical Immunology Unit – ERN ReCONNET, ASST Spedali Civili of Brescia, Brescia, Italy"
      ],
      "name": "Franco Franceschini"
    }
  ],
  "title": "PO:11:302 Anifrolumab for systemic lupus erythematosus: preliminary safety and efficacy findings from the Italian experience",
  "uid": "4e91962e-7d9f-545d-8201-6280f425ec18"
}