PO:18:264 | Anifrolumab in Systemic Lupus Erythematosus: Bridging Clinical Trial Data with Real-World Evidence

Giulia Cassone², Filippo Santoro¹, Caterina Vacchi², Dilia Giuggioli², Chiara Cabassi¹ | ¹UOC Reumatologia, AOU Policlinico di Modena, Università degli studi di Modena e Reggio Emilia Modena e Reggio Emilia, Italy; ²UOC Reumatologia, AOU Policlinico di Modena Modena, Italy

Aim of the Study. Real-world data on anifrolumab (ANI) in Systemic Lupus Erythematosus (SLE) remain limited, primarily focusing on cutaneous manifestations. This study evaluates the efficacy and safety of ANI in a monocentric cohort of patients with active SLE.

Materials and Methods. We included all patients undergoing ANI therapy for SLE. At baseline (T0), 3 months (T3), and 6 months (T6), overall and organ-specific disease activity, flares, daily glucocorticoid dose, and adverse events were recorded. Clinical manifestations, laboratory parameters, disease activity index, and therapeutic management were documented for each patient.

Results. Six patients undergoing ANI therapy for active SLE were enrolled, with a median age of 51 years and a median disease duration of 8 years. All patients had a history of mucocutaneous involvement; 83% had articular manifestations, 33% hematological involvement, 17% serositis, and one patient exhibited suspected neuropsychiatric manifestations. No cases of lupus nephritis were reported. All patients had previously received immunosuppressive therapy, with a median of 2.5 prior treatments. Specifically, treatment failure rates were as follows: methotrexate (66%), belimumab (50%), mycophenolate mofetil (50%), rituximab (33%), cyclosporine (33%), and cyclophosphamide (17%). At enrollment, the most frequent active disease manifestations were articular (4/6 patients), mucocutaneous (4/6), and hematological (2/6). Two patients exhibited active serology (anti-dsDNA positivity and/or hypocomplementemia). Regarding concomitant therapy, two patients were receiving methotrexate (MTX), antimalarial agents, and low-dose oral corticosteroids (OCS); two patients were on MTX plus OCS, one on antimalarial plus OCS, one on OCS monotherapy. The median daily OCS dose at baseline was 7 mg/day. Following ANI initiation, a significant reduction in disease activity was observed. At three months, mean SLEDAI-2K decreased from 6.25 at baseline to 1.25, with disease activity remaining stable at six months. All four patients with articular involvement achieved complete arthritis remission within four months. Dermatologic manifestations improved markedly after one month, with sustained resolution throughout follow-up. In one patient with hematological involvement, lymphopenia normalized completely. OCS tapering was successful in all patients: two discontinued corticosteroids entirely within two months, while the remaining four significantly reduced their doses. No patients experienced disease relapse or discontinued ANI therapy, and no severe adverse events were recorded.

Conclusions. ANI demonstrated rapid and effective control of cutaneous, articular, and hematological SLE manifestations. It also enabled corticosteroid sparing without significant adverse events, reinforcing its favorable safety profile. Our real-world data align with findings from clinical trials, confirming ANI’s efficacy and safety in routine clinical practice.