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; Dario Mattia 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; Francesco Conti; Ginevra De Marchi; Amato De Paulis; Salvatore De Vita; Giacomo Emmi; Paola Faggioli; Serena Fasano; Micaela Fredi; Armando Gabrielli; Francesca Augusta Gabrielli; Michela Gasparotto; Roberto Gerli; Maria Gerosa; Marcello Govoni; Elisa Gremese; Antonella Laria; Maddalena Larosa; Marta Mosca; Miranda Mosca; Giovanni Orsolini; Giulia Pazzola; Luca Petricca; Giuseppe A. Ramirez; Francesca Regola; Francesca W. Rossi; Maurizio Rossini; Paolo Maria Rossini; Carlo Salvarani; Salvatore Scarpato; Chiara Tani; Angela Tincani; Tania Ubiali; Maria Letizia Urban; Margherita Zen; Maria Pia Zen; Andrea Doria; Luca Iaccarino; Ludovica Iaccarino

doi:10.1016/j.jaut.2021.102729

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, Dario Mattia 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, Francesco Conti, Ginevra De Marchi, Amato De Paulis, Salvatore De Vita, Giacomo Emmi, Paola FaggioliSerena Fasano, Micaela Fredi, Armando Gabrielli, Francesca Augusta Gabrielli, Michela Gasparotto, Roberto Gerli, Maria Gerosa, Marcello Govoni, Elisa Gremese, Antonella Laria, Maddalena Larosa, Marta Mosca, Miranda Mosca, Giovanni Orsolini, Giulia Pazzola, Luca Petricca, Giuseppe A. Ramirez, Francesca Regola, Francesca W. Rossi, Maurizio Rossini, Paolo Maria Rossini, Carlo Salvarani, Salvatore Scarpato, Chiara Tani, Angela Tincani, Tania Ubiali, Maria Letizia Urban, Margherita Zen, Maria Pia Zen, Andrea Doria, Luca Iaccarino, Ludovica Iaccarino

Risultato della ricerca: Contributo in rivista › Articolo in rivista

Abstract

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.

Lingua originale	English
pagine (da-a)	102729-N/A
Rivista	Journal of Autoimmunity
Volume	124
DOI	https://doi.org/10.1016/j.jaut.2021.102729
Stato di pubblicazione	Pubblicato - 2021

Keywords

Adult
Antibodies, Monoclonal, Humanized
B-Cell Activating Factor
Belimumab
Cohort Studies
Female
Follow-Up Studies
Glomerular Filtration Rate
Humans
Immunosuppressive Agents
Italy
Kidney
Lupus Erythematosus, Systemic
Lupus Nephritis
Lupus nephritis
Male
Middle Aged
Proteinuria
Renal response
Treatment Outcome

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10.1016/j.jaut.2021.102729

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Gatto, M., Gatto, D. M., Saccon, F., Andreoli, L., Bartoloni, E., Benvenuti, F., Bortoluzzi, A., Bozzolo, E., Brunetta, E., Canti, V., Cardinaletti, P., Ceccarelli, F., Ciccia, F., Conti, F., Conti, F., De Marchi, G., De Paulis, A., De Vita, S., Emmi, G., ... Iaccarino, L. (2021). 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. Journal of Autoimmunity, 124, 102729-N/A. https://doi.org/10.1016/j.jaut.2021.102729

@article{77d8594fa4024cdab59d5d217cf15844,

title = "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",

abstract = "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.",

keywords = "Adult, Antibodies, Monoclonal, Humanized, B-Cell Activating Factor, Belimumab, Cohort Studies, Female, Follow-Up Studies, Glomerular Filtration Rate, Humans, Immunosuppressive Agents, Italy, Kidney, Lupus Erythematosus, Systemic, Lupus Nephritis, Lupus nephritis, Male, Middle Aged, Proteinuria, Renal response, Treatment Outcome, Adult, Antibodies, Monoclonal, Humanized, B-Cell Activating Factor, Belimumab, Cohort Studies, Female, Follow-Up Studies, Glomerular Filtration Rate, Humans, Immunosuppressive Agents, Italy, Kidney, Lupus Erythematosus, Systemic, Lupus Nephritis, Lupus nephritis, Male, Middle Aged, Proteinuria, Renal response, Treatment Outcome",

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

year = "2021",

doi = "10.1016/j.jaut.2021.102729",

language = "English",

volume = "124",

pages = "102729--N/A",

journal = "Journal of Autoimmunity",

issn = "0896-8411",

publisher = "Academic Press",

}

Gatto, M, Gatto, DM, Saccon, F, Andreoli, L, Bartoloni, E, Benvenuti, F, Bortoluzzi, A, Bozzolo, E, Brunetta, E, Canti, V, Cardinaletti, P, Ceccarelli, F, Ciccia, F, Conti, F, Conti, F, De Marchi, G, De Paulis, A, De Vita, S, Emmi, G, Faggioli, P, Fasano, S, Fredi, M, Gabrielli, A, Gabrielli, FA, Gasparotto, M, Gerli, R, Gerosa, M, Govoni, M, Gremese, E, Laria, A, Larosa, M, Mosca, M, Mosca, M, Orsolini, G, Pazzola, G, Petricca, L, Ramirez, GA, Regola, F, Rossi, FW, Rossini, M, Rossini, PM, Salvarani, C, Scarpato, S, Tani, C, Tincani, A, Ubiali, T, Urban, ML, Zen, M, Zen, MP, Doria, A, Iaccarino, L & Iaccarino, L 2021, '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', Journal of Autoimmunity, vol. 124, pagg. 102729-N/A. https://doi.org/10.1016/j.jaut.2021.102729

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. / Gatto, Mariele; Gatto, Dario Mattia; Saccon, Francesca et al.
In: Journal of Autoimmunity, Vol. 124, 2021, pag. 102729-N/A.

Risultato della ricerca: Contributo in rivista › Articolo in rivista

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 - Gatto, Dario Mattia

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 - Conti, Francesco

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 - Gabrielli, Francesca Augusta

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 - Mosca, Miranda

AU - Orsolini, Giovanni

AU - Pazzola, Giulia

AU - Petricca, Luca

AU - Ramirez, Giuseppe A.

AU - Regola, Francesca

AU - Rossi, Francesca W.

AU - Rossini, Maurizio

AU - Rossini, Paolo Maria

AU - Salvarani, Carlo

AU - Scarpato, Salvatore

AU - Tani, Chiara

AU - Tincani, Angela

AU - Ubiali, Tania

AU - Urban, Maria Letizia

AU - Zen, Margherita

AU - Zen, Maria Pia

AU - Doria, Andrea

AU - Iaccarino, Luca

AU - Iaccarino, Ludovica

PY - 2021

Y1 - 2021

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 - Adult

KW - Antibodies, Monoclonal, Humanized

KW - B-Cell Activating Factor

KW - Belimumab

KW - Cohort Studies

KW - Female

KW - Follow-Up Studies

KW - Glomerular Filtration Rate

KW - Humans

KW - Immunosuppressive Agents

KW - Italy

KW - Kidney

KW - Lupus Erythematosus, Systemic

KW - Lupus Nephritis

KW - Lupus nephritis

KW - Male

KW - Middle Aged

KW - Proteinuria

KW - Renal response

KW - Treatment Outcome

KW - Adult

KW - Antibodies, Monoclonal, Humanized

KW - B-Cell Activating Factor

KW - Belimumab

KW - Cohort Studies

KW - Female

KW - Follow-Up Studies

KW - Glomerular Filtration Rate

KW - Humans

KW - Immunosuppressive Agents

KW - Italy

KW - Kidney

KW - Lupus Erythematosus, Systemic

KW - Lupus Nephritis

KW - Lupus nephritis

KW - Male

KW - Middle Aged

KW - Proteinuria

KW - Renal response

KW - Treatment Outcome

UR - http://hdl.handle.net/10807/209067

U2 - 10.1016/j.jaut.2021.102729

DO - 10.1016/j.jaut.2021.102729

M3 - Article

SN - 0896-8411

VL - 124

SP - 102729-N/A

JO - Journal of Autoimmunity

JF - Journal of Autoimmunity

ER -

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

Abstract

Keywords

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