PO:09:247 Anifrolumab in systemic lupus erythematosus with renal involvement: national multicenter registry in clinical practice

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Objectives To evaluate the effectiveness, safety and glucocorticoids sparing potential of ANI in a multicenter, real-world cohort of Spanish patients with SLE and renal involvement.Methods Observational multicenter study of patients diagnosed with SLE (EULAR/ACR 2019 criteria), treated with ANI who presented renal involvement (renal insufficiency and/or hematuria and/or proteinuria). Data were collected from medical records up to January 31 2025. Demographic, clinical, laboratory, and pathologic variables were evaluated, along with previous and concomitant therapies, disease activity indices (SLE-DAS, SLEDAI-2K, PGA), organ damage index (SLICC SDI) and safety.Results We studied 18 patients (16 women/2 men), mean age 38.16±10.35 years (range 20-63). Baseline characteristics, prior starting ANI and LN subtypes are summarized in table 1. The most common renal manifestations at ANI initiation were proteinuria (50%), hematuria (27.8%), and renal insufficiency (11.1%).The mean number of immunosuppressive treatments (synthetic/biologic) received prior to ANI was 4.3±2.4 (range 1-12). All of them had received belimumab, and 15 mycophenolate mofetil. The standard ANI regimen was 300 milligrams every 4 weeks, except in two patients who received loading doses (900 milligrams every 4 weeks for 3 months, then 300 milligrams every 4 weeks).In addition to corticosteroids, ANI was administered concomitantly with antimalarials (n=16), mycophenolate mofetil (n=11), tacrolimus (n=4), azathioprine (n=2), methotrexate (n=1), and voclosporin (n=1). A rapid (from the first month) and maintained significant improvement was observed in: a) disease activity (SLE-DAS, SLEDAI-2K, PGA) (figure 1) b) immunologic markers c) renal parameters (figure 2) and d) patients achieving LLDAS and DORIS remission (figure 3).After a mean follow-up of 8.8±5.5 months, a reduction in the number of relapses was observed, from a median [IQR] of 2 [0-3] to 0 [0-0]. The organ damage index remained stable. All 18 patients remained on ANI, and the most relevant adverse events were herpes zoster (n=1) and hidradenitis suppurativa (n=1). The prednisone dose was decreased from 9.2±7.9 mg/day to 3.3±2 mg/day (p= 0.1).Abstract PO:09:247 Figures and TableConclusions To our knowledge, this is the first real-life study of ANI in LN. In refractory patients to multiple immunosuppressive therapies, we observed a rapid and maintained effectiveness in SLE activity and renal manifestations, with a good safety profile.

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