Durable renal response and safety with add-on belimumab in patients with lupus nephritis in real-life setting (BeRLiSS-LN). Results from a large, nationwide, multicentric cohort

Mariele Gatto, Francesca Saccon, Laura Andreoli, Elena Bartoloni, Francesco Benvenuti, Alessandra Bortoluzzi, Enrica Bozzolo, Enrico Brunetta, Valentina Canti, Paolo Cardinaletti, Fulvia Ceccarelli, Francesco Ciccia, Fabrizio Conti, Ginevra De Marchi, Amato de Paulis, Salvatore De Vita, Giacomo Emmi, Paola Faggioli, Serena Fasano, Micaela FrediArmando Gabrielli, Michela Gasparotto, Roberto Gerli, Maria Gerosa, Marcello Govoni, Elisa Gremese, Antonella Laria, Maddalena Larosa, Marta Mosca, Giovanni Orsolini, Giulia Pazzola, Luca Petricca, Giuseppe A. Ramirez, Francesca Regola, Francesca W. Rossi, Maurizio Rossini, Carlo Salvarani, Salvatore Scarpato, Chiara Tani, Angela Tincani, Tania Ubiali, Maria Letizia Urban, Margherita Zen, Andrea Doria, Luca Iaccarino

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Background: Belimumab was recently approved for treatment of lupus glomerulonephritis (LN). Aim: To evaluate renal response and its predictors in LN patients receiving belimumab in real-life. Patients and methods: We considered all patients fulfilling the SLEDAI-2K renal items and/or having estimated glomerular filtration rate (eGFR)≤60 ml/min/1.73 m2, with positive anti-dsDNA and/or low C3/C4 enrolled in the multicentre Italian lupus cohort BeRLiSS (BElimumab in Real LIfe Setting Study), treated with monthly IV Belimumab 10 mg/kg over standard treatment. Primary efficacy renal response (PERR), defined as proteinuria ≤0.7 g/24 h, eGFR≥60 ml/min/1.73 m2 without rescue therapy, was considered as primary outcome. Complete renal response (CRR; proteinuria <0.5 g/24 h, eGFR≥90 ml/min/1.73 m2) was considered as secondary outcome. Prevalence and predictors of PERR were evaluated at 6, 12, 24 months by multivariate logistic regression. Results: Among the 466 SLE patients of BeRLiSS, 91 fulfilled the inclusion criteria, 79 females, median age 41.0 (33.0–47.0) years, median follow-up 22.0 (12.0–36.0) months. Sixty-four (70.3%) achieved PERR, of whom 38.4% reached CRR. Among patients achieving PERR at 6 months, 86.7% maintained response throughout the follow-up. At multivariable analysis, hypertension (OR [95%CI]: 0.28 [0.09–0.89], p = 0.032), high baseline serum creatinine (0.97 [0.95–0.99], p = 0.01) and high baseline proteinuria (0.37, [0.19–0.74], p = 0.005) negatively predicted PERR. Positive predictors of PERR at 12 and 24 months were baseline anti-Sm positivity (OR [95%CI]: 6.2 [1.21–31.7], p = 0.029; 19.8 [2.01–186.7], p = 0.009, respectively) and having achieved PERR at 6 months (14.4 [3.28–63.6]; 11.7 [2.7–48.7], p = 0.001 for both). Conclusions: Add-on therapy with belimumab led to durable renal response in patients with LN in a real-life setting.

Original languageEnglish
Article number102729
JournalJournal of Autoimmunity
Publication statusPublished - Nov 2021


  • Belimumab
  • Lupus nephritis
  • Renal response

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology


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