RT Journal Article
SR Electronic
T1 Anifrolumab in Refractory Systemic Lupus Erythematosus: A Real-World, Multicenter Study
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 1096
OP 1101
DO 10.3899/jrheum.2024-0053
VO 51
IS 11
A1 Tani, Chiara
A1 Cardelli, Chiara
A1 Zen, Margherita
A1 Moroni, Luca
A1 Piga, Matteo
A1 Ceccarelli, Fulvia
A1 Fasano, Serena
A1 De Marchi, Ginevra
A1 Coladonato, Laura
A1 Emmi, Giacomo
A1 Gatto, Mariele
A1 Trentin, Francesca
A1 Ramirez, Giuseppe A.
A1 Chessa, Elisabetta
A1 Gallina, Gabriele
A1 Picciariello, Licia
A1 Patrone, Martina
A1 Urban, Maria L.
A1 Biancalana, Edoardo
A1 Quartuccio, Luca
A1 Ciccia, Francesco
A1 Conti, Fabrizio
A1 Cauli, Alberto
A1 Dagna, Lorenzo
A1 Doria, Andrea
A1 Mosca, Marta
YR 2024
UL http://www.jrheum.org/content/51/11/1096.abstract
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.