PT - JOURNAL ARTICLE AU - Tani, Chiara AU - Cardelli, Chiara AU - Zen, Margherita AU - Moroni, Luca AU - Piga, Matteo AU - Ceccarelli, Fulvia AU - Fasano, Serena AU - De Marchi, Ginevra AU - Coladonato, Laura AU - Emmi, Giacomo AU - Gatto, Mariele AU - Trentin, Francesca AU - Ramirez, Giuseppe A. AU - Chessa, Elisabetta AU - Gallina, Gabriele AU - Picciariello, Licia AU - Patrone, Martina AU - Urban, Maria L. AU - Biancalana, Edoardo AU - Quartuccio, Luca AU - Ciccia, Francesco AU - Conti, Fabrizio AU - Cauli, Alberto AU - Dagna, Lorenzo AU - Doria, Andrea AU - Mosca, Marta TI - Anifrolumab in Refractory Systemic Lupus Erythematosus: A Real-World, Multicenter Study AID - 10.3899/jrheum.2024-0053 DP - 2024 Nov 01 TA - The Journal of Rheumatology PG - 1096--1101 VI - 51 IP - 11 4099 - http://www.jrheum.org/content/51/11/1096.short 4100 - http://www.jrheum.org/content/51/11/1096.full SO - J Rheumatol2024 Nov 01; 51 AB - Objective To report real-world experience on the use of anifrolumab (ANI) in refractory systemic lupus erythematosus (SLE).Methods The present study is a multicenter, retrospective study involving 9 Italian SLE referral centers participating in a compassionate use program for the use of ANI in adult patients with active SLE in whom all the available treatment choices failed, were not tolerated, or were contraindicated. At baseline and 1, 3, 6, 9, and 12 months of treatment, overall and organ-specific disease activity, flares, daily glucocorticoid (GC) dose, and adverse events were recorded.Results A total of 26 patients were enrolled. At 4 weeks after starting ANI, a significant decrease in the Systemic Lupus Erythematosus Disease Activity Index 2000 (P = 0.01), Systemic Lupus Erythematosus–Disease Activity Score (P = 0.01), and physician global assessment (P = 0.001) was recorded, and the same trend was maintained over time. A significant reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index-activity (P < 0.001) and in tender (P = 0.03) and swollen (P = 0.02) joint counts was also recorded. At 3 months of follow-up, 33% of patients already achieved a remission state, whereas 46% were in Lupus Low Disease Activity State (LLDAS); at 6 months, 50% were in remission and 80% were in LLDAS. A significant reduction in the mean GC daily dose was observed, starting from week 4 (P = 0.04). A total of 4 disease flares according to the Safety of Estrogens in Lupus Erythematosus National Assessment–Systemic Lupus Erythematosus Disease Activity Index were recorded (3 mild-moderate and 1 severe). Overall, 4/20 patients with at least 24 weeks of follow-up (20%) were considered nonresponders.Conclusion This study provides real-world experience on the use of ANI in patients with refractory SLE, confirming its rapid effectiveness and an overall acceptable safety profile.