Clinical rheumatology · 2026
Real-world outcomes after anifrolumab initiation in systemic lupus erythematosus: a pragmatic treat-to-target analysis.
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Núñez Dalifer Freites, Diaz Paloma Camarero, Montes Sara Rodríguez, Prada Cristina Martínez, Petisco Cristina Lajas, Abasolo Lydia, Gutierrez Benjamin Fernández
Аннотация
INTRODUCTION/OBJECTIVES: Treat-to-target (T2T) strategies in systemic lupus erythematosus (SLE) emphasise remission or low disease activity together with glucocorticoid minimisation. Real-world evidence evaluating anifrolumab using predefined target-oriented outcomes remains limited. We evaluated outcomes after anifrolumab initiation within a pragmatic T2T framework.
METHODS: This retrospective single-centre cohort included adults with SLE receiving anifrolumab. The study-defined pragmatic low disease activity composite required SLEDAI-2K ≤ 4, Physician Global Assessment ≤ 1, prednisone ≤ 7.5 mg/day, and absence of clinically significant renal activity. Prednisone ≤ 5 mg/day was explored in sensitivity analyses. Outcomes were assessed at baseline and 1, 3, 6, and 12 months. Longitudinal changes in SLEDAI-2K, PGA, and prednisone dose were analysed using linear mixed-effects models.
RESULTS: Nineteen patients were included (median baseline SLEDAI-2K 12.0 and median PGA 2.0). Composite attainment using prednisone ≤ 7.5 mg/day was 5.3% at 1 month, 47.4% at 3 months, 50.0% at 6 months, and 8/12 (66.7%) at 12 months. Using prednisone ≤ 5 mg/day, attainment was 36.8% at 3 months, 50.0% at 6 months, and 66.7% at 12 months. Disease activity components were met earlier than glucocorticoid thresholds. Mixed-effects models showed significant reductions in SLEDAI-2K, PGA, and prednisone dose during follow-up. One patient permanently discontinued anifrolumab due to influenza A, and one temporarily interrupted treatment because of pneumonia.
CONCLUSIONS: After anifrolumab initiation, the proportion of evaluable patients meeting the pragmatic composite increased alongside reductions in disease activity and glucocorticoid dose. These exploratory findings suggest a potential role for anifrolumab within T2T strategies and warrant confirmation in larger controlled studies using validated treatment targets.
METHODS: This retrospective single-centre cohort included adults with SLE receiving anifrolumab. The study-defined pragmatic low disease activity composite required SLEDAI-2K ≤ 4, Physician Global Assessment ≤ 1, prednisone ≤ 7.5 mg/day, and absence of clinically significant renal activity. Prednisone ≤ 5 mg/day was explored in sensitivity analyses. Outcomes were assessed at baseline and 1, 3, 6, and 12 months. Longitudinal changes in SLEDAI-2K, PGA, and prednisone dose were analysed using linear mixed-effects models.
RESULTS: Nineteen patients were included (median baseline SLEDAI-2K 12.0 and median PGA 2.0). Composite attainment using prednisone ≤ 7.5 mg/day was 5.3% at 1 month, 47.4% at 3 months, 50.0% at 6 months, and 8/12 (66.7%) at 12 months. Using prednisone ≤ 5 mg/day, attainment was 36.8% at 3 months, 50.0% at 6 months, and 66.7% at 12 months. Disease activity components were met earlier than glucocorticoid thresholds. Mixed-effects models showed significant reductions in SLEDAI-2K, PGA, and prednisone dose during follow-up. One patient permanently discontinued anifrolumab due to influenza A, and one temporarily interrupted treatment because of pneumonia.
CONCLUSIONS: After anifrolumab initiation, the proportion of evaluable patients meeting the pragmatic composite increased alongside reductions in disease activity and glucocorticoid dose. These exploratory findings suggest a potential role for anifrolumab within T2T strategies and warrant confirmation in larger controlled studies using validated treatment targets.