Efficacy of Belimumab on Different Joint and Skin Manifestations of Systemic Lupus Erythematosus: Real-Life Data from a New Multicentric, Nationwide Italian Cohort (BeRLiSS-JS 2.0).
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Bracalenti Marisol, Zen Margherita, Bianchi Benedetta, Bortoluzzi Alessandra, Brussino Luisa, Castrignanò Paola, Cauli Alberto, Cavagna Lorenzo, Chessa Elisabetta, Chiara Emanuele, De Angelis Rossella, De Marchi Ginevra, Di Carlo Marco, Emmi Giacomo, Galvagni Isotta, Gasparotto Michela, Gatto Mariele, Gerli Roberto, Govoni Marcello, Lo Gullo Alberto, Nano Alessia, Negrini Simone, Noviello Silvia, Orsolini Giovanni, Pazzola Giulia, Piga Matteo, Quartuccio Luca, Rossini Maurizio, Salvarani Carlo, Silvagni Ettore, Silvestri Elena, Tamussin Marianna, Tizian Martina, Tomietto Paola, Urban Maria Letizia, Vacca Angelo, Doria Andrea, Iaccarino Luca
Аннотация
METHODS: The BeRLiSS-JS 2.0 is a decade-long observational study including adult SLE patients from 14 Italian Centers treated with belimumab (intravenous/subcutaneous) stratified by articular (nondeforming nonerosive arthritis -NDNE-, Jaccoud's arthropathy, Rhupus) and cutaneous phenotypes (acute -ACLE-, subacute -SCLE-, and chronic cutaneous lupus erythematosus -CCLE-, and nonspecific manifestations). Outcome variables measured every 6 months up to 36 months included Disease Activity Score-28 joints (DAS28) and Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) scores, remission rates (DAS28<2.6; CLASI-A=0), and prednisone intake (mg/day).
RESULTS: Of 443 patients, 221 (49.9%) had NDNE, 30 (6.8%) Jaccoud's arthropathy, 21 (4.7%) rhupus, 112 (25.3%) had ACLE, 54 (12.2%) SCLE, and 18 (4.1%) CCLE. At 6 months a significant decrease of DAS28 was observed in NDNE (p<0.001) and by CLASI-A in ACLE and SCLE (both p<0.001). Non-specific cutaneous manifestations did not improve significantly. CLASI-D scores remained stable over 36 months. Remission rates were higher in NDNE and ACLE patients (at 6 months: NDNE 59.6%, Jaccoud's 18.8%, rhupus 30.3% - p=0.002; at 18 months: ACLE 75.9%, SCLE 56.4%, CCLE 33.3% - p=0.018). Daily prednisone dosage decreased in all organ-specific phenotypes, but more pronouncedly in patients with NDNE, ACLE, and SCLE. Higher baseline CLASI-A and DAS28 and CLASI-D were associated with lower remission rates.
CONCLUSION: Treatment with belimumab was associated with reduced disease activity and increased remission especially in NDNE and ACLE patients. Glucocorticoid-sparing effect was also found.