Real-world longitudinal assessment of anifrolumab in patients with systemic lupus erythematosus: clinical outcomes, safety and modulation of cytokines and neutrophil activity

Temiz A, Noversa de Sousa R, Schoen J, Reichardt C, Standfest K, Wirsching A, Hagen M, Corte G, Munoz Becerra M, Tascilar K, Hueber AJ, Schett G, Munoz Becerra L, Fagni F (2026)

Publication Type: Journal article

Publication year: 2026

Journal

Book Volume: 12

Article Number: e006806

Journal Issue: 2

DOI: 10.1136/rmdopen-2026-006806

Abstract

Objectives: To 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. Methods: We 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. Results: Twenty 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. Conclusion: This 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.

Authors with CRIS profile

Involved external institutions

Klinikum Nürnberg Germany (DE)

How to cite

APA:

Temiz, A., Noversa de Sousa, R., Schoen, J., Reichardt, C., Standfest, K., Wirsching, A.,... Fagni, F. (2026). Real-world longitudinal assessment of anifrolumab in patients with systemic lupus erythematosus: clinical outcomes, safety and modulation of cytokines and neutrophil activity. RMD Open, 12(2). https://doi.org/10.1136/rmdopen-2026-006806

MLA:

Temiz, Alp, et al. "Real-world longitudinal assessment of anifrolumab in patients with systemic lupus erythematosus: clinical outcomes, safety and modulation of cytokines and neutrophil activity." RMD Open 12.2 (2026).

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