Real-world outcomes after anifrolumab initiation in systemic lupus erythematosus: a pragmatic treat-to-target analysis

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Abstract
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. Key Points • The proportion of evaluable patients meeting a pragmatic low disease activity composite increased during the 12 months after anifrolumab initiation. • Disease activity criteria were met earlier than glucocorticoid dose thresholds, while later composite attainment coincided with progressive glucocorticoid tapering. • These exploratory findings suggest a potential role for anifrolumab within T2T strategies in SLE and require confirmation in larger controlled studies.

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