Observational studyRMD open2026
Real-world longitudinal assessment of anifrolumab in patients with systemic lupus erythematosus: clinical outcomes, safety and modulation of cytokines and neutrophil activity.
Observational study in RMD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
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Corrections and comments
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Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess clinical effectiveness, safety and in vivo effects on cytokines, chemokines and low-density neutrophils (LDNs) in patients with active systemic lupus erythematosus (SLE) treated with anifrolumab over a 12-month real-world follow-up.
methodsWe established a longitudinal, multicentre, observational cohort of adult patients with active SLE receiving anifrolumab 300 mg intravenously every 4 weeks. Patients with active lupus nephritis or central nervous system involvement were excluded. Clinical and laboratory measures were recorded at baseline and at months 3, 6, 9 and 12. Chemokines, cytokines, LDNs and neutrophil extracellular trap degradation products were assessed at the respective time points. Longitudinal changes were analysed using generalised additive models with patient-level random intercepts.
resultsTwenty patients were recruited. Baseline mean Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) was 10.9±5.0, with frequent musculoskeletal, immunological and cutaneous involvement. Over 12 months, mean SLEDAI-2K declined to 3.1 (95% CI 1.1 to 5.1; p<0.001). SLE Responder Index-4 response rates were 64.7% at month 12 in intention-to-treat analyses with non-responder imputation. By month 12, 86% of patients reached Lupus Low Disease Activity State and 50% achieved Definition of Remission in SLE remission. Physician Global Assessment improved from 1.6 to 0.2 (95% CI 0.0 to 0.5; p<0.001). Daily prednisolone equivalents were significantly reduced (p=0.036); a dose ≤5 mg/day was achieved in 11/13 patients receiving glucocorticoids at baseline, including three who discontinued glucocorticoids. Drug persistence at 12 months was 65%. Fifty-five adverse events were recorded, of which four were serious. Anifrolumab significantly reduced circulating LDNs (p=0.032), interferon-driven chemokines and inflammatory cytokines.
conclusionThis real-world cohort provides clinical and mechanistic evidence that anifrolumab improves clinical outcomes, enables glucocorticoid tapering and reduces LDNs as well as interferon-driven chemokines in patients with active SLE. Safety and drug persistence were consistent with clinical trial data. TRIAL REGISTRATION NUMBER: DRKS00024360.
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