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PO:11:281 Spanish real-world ambispective multicenter registry of anifrolumab in systemic lupus erythematosus: efficacy and safety at 3- and 6-month follow-up (ANIFRO-reu study)

lupusscimed · 2026-03-01 · canonical JSON source

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Objectives Anifrolumab is a biologic recently approved for systemic lupus erythematosus (SLE), with efficacy shown in trials, but data from real-world practice remain limited. The aim of this registry is to evaluate the effectiveness and safety of anifrolumab in SLE patients under real-life routine care in Spanish rheumatology centers.Methods Multicenter, ambispective study including SLE patients (2019 EULAR/ACR criteria), treated with anifrolumab and followed up to 6m. Clinical, labs, and treatment data were collected. Disease activity (SLEDAI-2k, SLE-DAS, PGA), damage (SLICC/ACR/DI), remission (DORIS-21), low disease activity (LLDAS), Comparisons across visits were done using Friedman’s test (adjusted by Holm’s method) and Cochran’s Q with McNemar’s test (Bonferroni correction) for binary outcomes.Results Among 133 patients, 100 completed the 3-month visit and 82 the 6-month visit. Median age was 49 years (IQR ±17), 87.9% were female. Significant improvements at 3 and 6m compared with the baseline were observed in SLEDAI, SLEDAS, PGA, percentage of patients in remission DORIS-21 and in LLDAS, and the number of patients receiving glucocorticoids (GC) at 6m ( figures 1 and 2). Flares significantly dropped from 2 (±2) at baseline to 0 (±0 at 3m and ±1 at 6m). Response rates were: physician’s criteria 77.1% at 3m and 75.7% at 6m; 50% response in 63.5% and 65.1%; 20% response in 83.6% and 74.5%; serological response in 41.3% and 34.9% (all p = not significant) (figure 2). There were no differences in either SDI at baseline vs. 6m (0 ± 1 vs. 0 ± 1), or anti-dsDNA titers or GC dosages among any of the 3 visits. Number of csDMARDS was reduced substantially (figure 1).Discontinuation occurred in 5/95 patients (5%) before 3m and 10/72 (12.2%) between 3–6m. Five (3.8%) patients presented a COVID-19 and 4 (3%) a herpes zoster. None of the patients died. Two patients were hospitalized due to serious infections and 3 to both SLE activity and infection.Abstract PO:11:281 Figure 1–2Conclusions 1° In real-life clinical setting, anifrolumab improved multiple SLE activity measures at 3 and 6 months, with a substantial proportion of patients achieving early LLDAS or DORIS-Remission, along with reduced flare rates and glucocorticoids use; 2° No new security alarms have appeared.