The role of anifrolumab in reshaping the treatment landscape of extra-renal systemic lupus erythematosus.

Objective: Systemic lupus erythematosus (SLE) is a multifaceted autoimmune disorder that typically requires management with immunosuppressive and anti-inflammatory treatments. The 2023 guidelines of the European Alliance of Associations for Rheumatology now recommend lowering maintenance glucocorticoid doses to ≤5 mg/day to reduce long-term health risks, a decrease from the previous 7.5 mg/day threshold set in 2019. To help achieve these reduced doses, early initiation of biologic therapies is suggested, even before conventional immunosuppressants. Belimumab and anifrolumab, the biologics currently approved for SLE treatment, have shown greater efficacy than placebo in clinical trials and similar safety profiles, supporting their use in achieving remission and enabling glucocorticoid tapering or discontinuation. This review evaluates the role of biologics, especially anifrolumab, in treating extra-renal SLE in Italy, using clinical scenarios to illustrate situations where early anifrolumab therapy could be beneficial.

Methods: Hypothetical scenarios derived from clinical practice were examined to identify real-life contexts suitable for the early initiation of anifrolumab treatment.

Results: Anifrolumab represents an effective therapeutic option for various extra-renal SLE patients. These include those who have failed to achieve or maintain remission with standard care, have contraindications to conventional immunosuppressants, are glucocorticoid-dependent, or experience mucocutaneous and musculoskeletal manifestations. Anifrolumab also offers potential benefits for patients planning pregnancy by promoting remission or low disease activity.

Conclusions: Despite its recent approval and limited real-world evidence, anifrolumab has emerged as a promising therapeutic option for non-renal lupus. We hope this review will encourage further studies on the efficacy and safety of anifrolumab in real-life SLE patient cohorts.