Real-world use of anifrolumab in systemic lupus erythematosus: A retrospective study from a Danish tertiary center (2022–2025)

Abstract

Objective

To evaluate the real-world safety, efficacy, and steroid-sparing effects of anifrolumab in patients with systemic lupus erythematosus (SLE) treated at a tertiary referral center in Denmark.

Methods

We conducted a retrospective observational study of all SLE/discoid lupus patients who received at least one infusion of anifrolumab between May 2022 and February 2025 at Aarhus University Hospital. Clinical and laboratory data were extracted from electronic medical records at baseline, 3 months, 6 months, and last follow-up. Disease activity was assessed using SLEDAI-2K, Physician’s Global Assessment (PGA), LLDAS, and DORIS criteria.

Results

Thirty-six patients (94% female, mean age 52 years) received anifrolumab for a mean of 462 days. Median SLEDAI-2K decreased from 8 at baseline to 2 at month 3, and to 0 at both month 6 and last follow-up. The proportion achieving SLEDAI-2K = 0 increased from 0% at baseline to 52% at both 6 months and last follow-up. At the last follow-up, 87% achieved both PGA ≤0.5 and LLDAS, while 70% achieved DORIS remission. Prednisolone doses declined by >50%. Skin and musculoskeletal involvement showed the greatest improvement. Herpesvirus-related infections were the most frequent adverse events; two severe cases occurred, though treatment was generally continued.

Conclusion

Anifrolumab was associated with rapid, sustained disease control and significant steroid-sparing effects. Herpesvirus infections were common, underscoring the importance of vaccination prior to treatment initiation. These findings support anifrolumab as an effective therapeutic option for SLE in routine clinical care.