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)
Year: 2025
Type: article
Study design: Observational Study
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. Plain Language Summary: Belimumab is known to be an effective treatment for systemic lupus erythematosus (SLE), achieving the highest level of recommendation for non-responders to hydroxychloroquine/immunosuppressive agents (1a/A), while reaching a level B for active cutaneous involvement (1a/B) in the latest EULAR recommendations. On the other hand, belimumab effectiveness across different joint and skin phenotypes of SLE had not been thoroughly evaluated. This study was necessary to understand how belimumab performs in specific SLE phenotypes, such as nondeforming nonerosive arthritis (NDNE), Jaccoud’s arthropathy, rhupus, and various cutaneous manifestations (acute, subacute, chronic, and nonspecific) by using disease specific and validated clinimetric measures, such as DAS28 and CLASI. Belimumab significantly decreased disease activity and improved remission rates especially in NDNE and acute cutaneous lupus erythematosus (ACLE) patients while also highlighting a glucocorticoid-sparing effect particularly in NDNE, ACLE, and subacute cutaneous lupus erythematosus (SCLE) patients. Therefore, these findings suggest that belimumab could be more beneficial for patients with NDNE and ACLE than other phenotypes, potentially guiding more personalized treatment approaches in clinical practice. Keywords: systemic lupus erythematosus, skin manifestations, joint manifestations, belimumab, remission
Source: Biologics
DOI: 10.2147/btt.s536660
Authors: Marisol Bracalenti, Margherita Zen, Benedetta Bianchi, Alessandra Bortoluzzi, Luisa Brussino, Paola Castrignanò, Alberto Cauli, Lorenzo Cavagna, Elisabetta Chessa, Emanuele Chiara, Rossella De Angelis, Ginevra De Marchi, Marco Di Carlo, Giacomo Emmi, Isotta Galvagni, Michela Gasparotto, Mariele Gatto, Roberto Gerli, Marcello Govoni, Alberto Lo Gullo, Alessia Nano, Simone Negrini, Silvia Noviello, Giovanni Orsolini, Giulia Pazzola, Matteo Piga, Luca Quartuccio, Maurizio Rossini, Carlo Salvarani, Ettore Silvagni, Elena Silvestri, Marianna Tamussin, Martina Tizian, Paola Tomietto, Maria Urban, Angelo Vacca, Andrea Doria, Luca Iaccarino
Institutions: University of Padua, Marche Polytechnic University, University of Ferrara, University of Turin, University of Modena and Reggio Emilia, University of Cagliari, University of Pavia, University of Trieste, University of Florence, University of Udine, Monash University, University of Verona, University of Perugia, University of Bari Aldo Moro, Azienda Sanitaria Unità Locale di Reggio Emilia
Language: English
Subfield: Rheumatology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,320
Funder: GlaxoSmithKline
OpenAlex ID: W4415958725