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)

Bracalenti M.;Zen M.;Bianchi B.;Bortoluzzi A.;Brussino L.;Castrignano P.;Cauli A.

Member of the Collaboration Group

;Cavagna L.;Chessa E.

Member of the Collaboration Group

;Chiara E.;De Angelis R.;De Marchi G.;Di Carlo M.;Emmi G.;Galvagni I.;Gasparotto M.;Gatto M.;Gerli R.;Govoni M.;Lo Gullo A.;Nano A.;Negrini S.;Noviello S.;Orsolini G.;Pazzola G.;Piga M.

Data Curation

;Quartuccio L.;Rossini M.;Salvarani C.;Silvagni E.;Silvestri E.;Tamussin M.;Tizian M.;Tomietto P.;Urban M. L.;Vacca A.;Doria A.;Iaccarino L.

2025-01-01

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Abstract

Objective: To evaluate the effectiveness of belimumab in different joint and skin phenotypes of systemic lupus erythematosus (SLE). 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.