Targeted biologic therapies have significantly expanded the therapeutic landscape for systemic lupus erythematosus (SLE). Although the precise etiology of SLE remains incompletely understood, activation of the type I interferon (IFN) pathway is recognized as a central driver of its immunopathogenesis. Many patients with SLE demonstrate overexpression of type I IFN–inducible genes, often referred to as the “interferon signature,” which contributes to persistent immune activation and tissue damage. In this context, therapies targeting the interferon pathway have emerged as promising disease-modifying strategies. A recent study published in Clinical and Experimental Rheumatology reported that anifrolumab, a human monoclonal antibody targeting the type I interferon receptor subunit 1, produced rapid and sustained reductions in disease activity among patients with SLE in a real-world clinical setting.
Anifrolumab is a fully human monoclonal antibody that binds to the type I interferon receptor subunit 1, thereby blocking signalling from all type I interferons. Since type I IFNs play a critical role in amplifying immune dysregulation and inflammation in SLE, inhibition of this pathway can help suppress disease activity and reduce immune-mediated tissue injury. The therapeutic potential of anifrolumab was first demonstrated in randomized clinical trials, including the phase 2b MUSE trial and the phase 3 TULIP-1 trial and TULIP-2 trial, which showed significant improvements in disease activity when the drug was added to standard therapy. Based on these results, anifrolumab received regulatory approval from the U.S. Food and Drug Administration for adults with moderate-to-severe SLE receiving standard treatment. Subsequent approvals were granted in Canada and Australia, by the Pharmaceuticals and Medical Devices Agency in Japan for patients with inadequate response to existing therapies, and by the European Medicines Agency for adults with moderate-to-severe active autoantibody-positive SLE despite standard therapy.
To evaluate its effectiveness in routine clinical practice, investigators conducted a prospective, single-centre observational cohort study at a German academic tertiary care centre. The study enrolled 26 patients with SLE who initiated anifrolumab therapy according to the recommendations of the EULAR 2024 guidelines. Disease activity was systematically assessed at baseline and during follow-up visits at 3, 6, 9, 12, 18, and 24 months using validated clinical indices.
The study demonstrated clinically meaningful reductions in disease activity as early as three months after treatment initiation. The SLEDAI-2K score decreased significantly from 6.0 ± 3.9 at baseline to 2.8 ± 2.6 (p ≤ 0.001), while the ECLAM index declined from 1.92 ± 1.16 to 0.94 ± 0.99 (p = 0.001). Sustained improvements were observed during continued follow-up. By 12 months, 53% of patients achieved remission according to the DORIS remission criteria, and 89% met the criteria for the Lupus Low Disease Activity State (LLDAS), highlighting the therapy’s ability to achieve stable disease control in a large proportion of patients.
Certain disease manifestations appeared to respond particularly rapidly to treatment. Mucocutaneous involvement improved early during therapy, and significant benefits were also observed in fatigue and musculoskeletal symptoms such as arthritis and arthralgia. Importantly, the treatment demonstrated a notable glucocorticoid-sparing effect across the cohort, allowing many patients to reduce corticosteroid exposure during follow-up. Favorable responses were observed regardless of prior treatment history or disease duration, suggesting that the therapy may be effective across a broad spectrum of patients.
Anifrolumab was generally safe and well tolerated throughout the observation period, with no unexpected safety concerns identified during the 12–24 months of follow-up. The favorable safety profile, combined with sustained reductions in disease activity, supports its long-term use in appropriately selected patients.
These real-world findings reinforce the evidence generated from earlier randomized clinical trials by demonstrating that anifrolumab’s clinical benefits extend beyond controlled study settings. The broad efficacy across diverse patient subgroups, together with its glucocorticoid-sparing potential and sustained disease control, supports the growing integration of anifrolumab into routine clinical practice for the management of systemic lupus erythematosus.
References
- Classen P, Boedecker-Lips S, Tomalla V, Kraus D, Kommer A, Stortz M, Weinmann A, Meineck M, Saurin S, Plath M, Riepl J, Weinmann-Menke J. Anifrolumab in systemic lupus erythematosus: real-world experience from a single academic tertiary care centre. Clin Exp Rheumatol. 2026 Jan;44(1):93-99.
- Tanaka Y. Viewpoint on anifrolumab in patients with systemic lupus erythematosus and a high unmet need in clinical practice. RMD Open. 2023 Aug;9(3):e003270. doi: 10.1136/rmdopen-2023-003270. Erratum in: RMD Open. 2024 Apr 4;10(2):e003270corr1.