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

Journal of autoimmunity
ISSN: 1095-9157
Titre abrégé: J Autoimmun
Pays: England
ID NLM: 8812164

Informations de publication

Date de publication:
11 2021
Historique:
received: 28 07 2021
revised: 22 09 2021
accepted: 24 09 2021
pubmed: 3 10 2021
medline: 11 3 2022
entrez: 2 10 2021
Statut: ppublish

Résumé

Belimumab was recently approved for treatment of lupus glomerulonephritis (LN). To evaluate renal response and its predictors in LN patients receiving belimumab in real-life. We considered all patients fulfilling the SLEDAI-2K renal items and/or having estimated glomerular filtration rate (eGFR)≤60 ml/min/1.73 m 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). Add-on therapy with belimumab led to durable renal response in patients with LN in a real-life setting.

Sections du résumé

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 m
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.

Identifiants

pubmed: 34600347
pii: S0896-8411(21)00137-2
doi: 10.1016/j.jaut.2021.102729
pii:
doi:

Substances chimiques

Antibodies, Monoclonal, Humanized 0
B-Cell Activating Factor 0
Immunosuppressive Agents 0
belimumab 73B0K5S26A

Types de publication

Journal Article Multicenter Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

102729

Informations de copyright

Copyright © 2021 Elsevier Ltd. All rights reserved.

Auteurs

Mariele Gatto (M)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy. Electronic address: mariele.gatto@gmail.com.

Francesca Saccon (F)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.

Laura Andreoli (L)

Rheumatology and Clinical Immunology, ASST Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Elena Bartoloni (E)

Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.

Francesco Benvenuti (F)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.

Alessandra Bortoluzzi (A)

Rheumatology Unit, Azienda Ospedaliero-Universitaria S. Anna - Ferrara, Department of Medical Sciences, University of Ferrara, Italy.

Enrica Bozzolo (E)

Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Milan, Italy.

Enrico Brunetta (E)

Humanitas Clinical and Research Center - IRCCS, 20089, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, 20090, Pieve Emanuele, Milan, Italy.

Valentina Canti (V)

Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Milan, Italy.

Paolo Cardinaletti (P)

Università Politecnica Delle Marche, Dipartimento di Scienze Cliniche e Molecolari, Ancona, Italy.

Fulvia Ceccarelli (F)

Dipartimento di Scienze Cliniche, Internistiche, Anestesiologiche e Cardiovascolari (SCIAC), Sezione di Reumatologia, 'Sapienza' University, Rome, Italy.

Francesco Ciccia (F)

Università Degli Studi Della Campania Luigi Vanvitelli, Department of Precision Medicine, Napoli, Italy.

Fabrizio Conti (F)

Dipartimento di Scienze Cliniche, Internistiche, Anestesiologiche e Cardiovascolari (SCIAC), Sezione di Reumatologia, 'Sapienza' University, Rome, Italy.

Ginevra De Marchi (G)

University of Udine, DAME, Rheumatology Clinic, Udine, Italy.

Amato de Paulis (A)

Dipartimento di Scienze Mediche Traslazionali e Centro di Ricerca Immunologia Base e Clinica (CISI), University of Napoli Federico II, Napoli, Italy.

Salvatore De Vita (S)

University of Udine, DAME, Rheumatology Clinic, Udine, Italy.

Giacomo Emmi (G)

Department of Experimental and Clinical Medicine, Lupus Clinic, University of Florence, Firenze, Toscana, IT, Italy.

Paola Faggioli (P)

ASST OVEST Milanese - Legnano, Internal Medicine, Rheumatology, Italy.

Serena Fasano (S)

Università Degli Studi Della Campania Luigi Vanvitelli, Department of Precision Medicine, Napoli, Italy.

Micaela Fredi (M)

Rheumatology and Clinical Immunology, ASST Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Armando Gabrielli (A)

Università Politecnica Delle Marche, Dipartimento di Scienze Cliniche e Molecolari, Ancona, Italy.

Michela Gasparotto (M)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.

Roberto Gerli (R)

Rheumatology Unit, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.

Maria Gerosa (M)

ASST Gaetano Pini, Department of Clinical Sciences and Community Health, Clinical Rheumatology Unit Milano, Lombardia, IT, Italy.

Marcello Govoni (M)

Rheumatology Unit, Azienda Ospedaliero-Universitaria S. Anna - Ferrara, Department of Medical Sciences, University of Ferrara, Italy.

Elisa Gremese (E)

Università Cattolica Del Sacro Cuore Sede di Roma, Rome, Italy; Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.

Antonella Laria (A)

ASST OVEST Milanese Presidio di Magenta, Unit of Rheumatology, Italy.

Maddalena Larosa (M)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.

Marta Mosca (M)

Rheumatology, University of Pisa, Pisa, Italy.

Giovanni Orsolini (G)

University of di Verona, Unit of Rheumatology, Verona, Italy.

Giulia Pazzola (G)

Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.

Luca Petricca (L)

Fondazione Policlinico Universitario A. Gemelli-IRCCS, Rome, Italy.

Giuseppe A Ramirez (GA)

Unit of Immunology, Rheumatology, Allergy and Rare Diseases, IRCCS Ospedale San Raffaele, Milan, Italy.

Francesca Regola (F)

Rheumatology and Clinical Immunology, ASST Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Francesca W Rossi (FW)

Dipartimento di Scienze Mediche Traslazionali e Centro di Ricerca Immunologia Base e Clinica (CISI), University of Napoli Federico II, Napoli, Italy.

Maurizio Rossini (M)

University of di Verona, Unit of Rheumatology, Verona, Italy.

Carlo Salvarani (C)

Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy; Università Degli Studi di Modena e Reggio Emilia, Reggio Emilia, Italy.

Salvatore Scarpato (S)

Rheumatology, Ospedale M. Scarlato, Scafati, Salerno, Italy.

Chiara Tani (C)

Rheumatology, University of Pisa, Pisa, Italy.

Angela Tincani (A)

Rheumatology and Clinical Immunology, ASST Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.

Tania Ubiali (T)

ASST Gaetano Pini, Department of Clinical Sciences and Community Health, Clinical Rheumatology Unit Milano, Lombardia, IT, Italy.

Maria Letizia Urban (ML)

Department of Experimental and Clinical Medicine, Lupus Clinic, University of Florence, Firenze, Toscana, IT, Italy.

Margherita Zen (M)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.

Andrea Doria (A)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy. Electronic address: adoria@unipd.it.

Luca Iaccarino (L)

Rheumatology Unit, Department of Medicine, University of Padova, Padova, Italy.

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