Document resource
Objectives To evaluate the effectiveness and safety of anifrolumab in a cohort of patients with systemic lupus erythematosus (SLE) treated at a tertiary hospital.Methods A retrospective observational study including patients aged > 18 years with systemic lupus erythematosus (SLE) who initiated anifrolumab between October 2023 and October 2025 in a tertiary hospital. All patients fulfilled the 2019 EULAR/ACR classification criteria. Demographic data, Lupus Impact Tracker (LIT) scores, disease activity (SLEDAI, SLEDAS), corticosteroid use, laboratory parameters (CRP, anti-dsDNA, blood count, C3, C4…) and safety outcomes were collected at baseline and at 3, 6, 9, 12 and 18 months.Results 15 patients were included ( table 1), with a mean age of 40 years at anifrolumab initiation. Ten patients completed 12 months of treatment, and six reached 18 months. 5 patients had previously received biologic therapy (belimumab, rituximab or abatacept). The most frequent baseline manifestations were musculoskeletal (80%) and cutaneous (60%). Moderate-to high disease activity was defined as SLEDAI > 6; at baseline, 8 of 15 patients (53.33%) had a SLEDAI score >6. After 12 months, only 1 of 10 patients (10%) maintained an elevated SLEDAI, while 4 of 10 (40%) achieved complete remission. Laboratory parameters, including anti-dsDNA titers and CRP levels, showed progressive improvement over follow up.No severe adverse events were reported. There were no cases of herpes zoster infection, infusion reactions or hypersensitivit. The most common adverse events were mild infections, primarily of the upper respiratory and urinary tracts; none required hospitalization. Three patients discontinued treatment: two due to secondary loss of efficacy and one due to primary non-response.Abstract PO:11:276 Table 1–2Conclusions In this real-world cohort of patients with active SLE, anifrolumab treatment was associated with a significant reduction in disease activity and corticosteroid requirements, with an acceptable safety profile. These real-world findings are consistent with results from pivotal trials (TULIP-1 and TULIP-2), supporting anifrolumab as an effective therapeutic option for patients with SLE, although vigilance for infections is warranted.