TY - JOUR
T1 - 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
AU - Gatto, Mariele
AU - Saccon, Francesca
AU - Andreoli, Laura
AU - Bartoloni, Elena
AU - Benvenuti, Francesco
AU - Bortoluzzi, Alessandra
AU - Bozzolo, Enrica
AU - Brunetta, Enrico
AU - Canti, Valentina
AU - Cardinaletti, Paolo
AU - Ceccarelli, Fulvia
AU - Ciccia, Francesco
AU - Conti, Fabrizio
AU - De Marchi, Ginevra
AU - de Paulis, Amato
AU - De Vita, Salvatore
AU - Emmi, Giacomo
AU - Faggioli, Paola
AU - Fasano, Serena
AU - Fredi, Micaela
AU - Gabrielli, Armando
AU - Gasparotto, Michela
AU - Gerli, Roberto
AU - Gerosa, Maria
AU - Govoni, Marcello
AU - Gremese, Elisa
AU - Laria, Antonella
AU - Larosa, Maddalena
AU - Mosca, Marta
AU - Orsolini, Giovanni
AU - Pazzola, Giulia
AU - Petricca, Luca
AU - Ramirez, Giuseppe A.
AU - Regola, Francesca
AU - Rossi, Francesca W.
AU - Rossini, Maurizio
AU - Salvarani, Carlo
AU - Scarpato, Salvatore
AU - Tani, Chiara
AU - Tincani, Angela
AU - Ubiali, Tania
AU - Urban, Maria Letizia
AU - Zen, Margherita
AU - Doria, Andrea
AU - Iaccarino, Luca
N1 - Publisher Copyright:
© 2021
PY - 2021/11
Y1 - 2021/11
N2 - 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.
AB - 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.
KW - Belimumab
KW - Lupus nephritis
KW - Renal response
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U2 - 10.1016/j.jaut.2021.102729
DO - 10.1016/j.jaut.2021.102729
M3 - Article
AN - SCOPUS:85116189035
SN - 0896-8411
VL - 124
JO - Journal of Autoimmunity
JF - Journal of Autoimmunity
M1 - 102729
ER -