Efficacy and safety of off-label use of rituximab in refractory lupus

Data from the Italian Multicentre Registry

Luca Iaccarino, Elena Bartoloni, Linda Carli, Fulvia Ceccarelli, Fabrizio Conti, Salvatore De Vita, Gianfranco Ferraccioli, Mauro Galeazzi, Mariele Gatto, Roberto Gerli, Marcello Govoni, Elisa Gremese, Annamaria Iuliano, Elena Mansutti, Gabriella Moroni, Marta Mosca, Cecilia Nalli, Carla Naretto, Melissa Padovan, Lavinia Palma & 6 others Francesca Raffiotta, Dario Roccatello, Angela Tincani, Guido Valesini, Margherita Zen, Andrea Doria

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting. Methods: 145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1<ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis. Results Data from 134 (92.4%) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8% and CR in 45.5% of cases; RCR or RPR in 94.1% and RCR in 30.9% of patients after 12-month follow-up. Disease flares occurred in 35.1% and renal flares in 31.2% of patients during observational period. Among patients retreated, CR or PR were observed in 84.4% and CR in 57.8% of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively. No severe infusion reactions or deaths occurred. Conclusion Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.

Original languageEnglish
Pages (from-to)449-456
Number of pages8
JournalClinical and Experimental Rheumatology
Volume33
Issue number4
Publication statusPublished - 2015

Fingerprint

Off-Label Use
Registries
Safety
Kidney
Systemic Lupus Erythematosus
Lupus Nephritis
Retreatment
Rituximab

Keywords

  • Complete response
  • Italian registry
  • Lupus activity
  • Lupus nephritis
  • Rituximab
  • Systemic lupus erythematosus

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Immunology and Allergy
  • Medicine(all)

Cite this

Iaccarino, L., Bartoloni, E., Carli, L., Ceccarelli, F., Conti, F., De Vita, S., ... Doria, A. (2015). Efficacy and safety of off-label use of rituximab in refractory lupus: Data from the Italian Multicentre Registry. Clinical and Experimental Rheumatology, 33(4), 449-456.

Efficacy and safety of off-label use of rituximab in refractory lupus : Data from the Italian Multicentre Registry. / Iaccarino, Luca; Bartoloni, Elena; Carli, Linda; Ceccarelli, Fulvia; Conti, Fabrizio; De Vita, Salvatore; Ferraccioli, Gianfranco; Galeazzi, Mauro; Gatto, Mariele; Gerli, Roberto; Govoni, Marcello; Gremese, Elisa; Iuliano, Annamaria; Mansutti, Elena; Moroni, Gabriella; Mosca, Marta; Nalli, Cecilia; Naretto, Carla; Padovan, Melissa; Palma, Lavinia; Raffiotta, Francesca; Roccatello, Dario; Tincani, Angela; Valesini, Guido; Zen, Margherita; Doria, Andrea.

In: Clinical and Experimental Rheumatology, Vol. 33, No. 4, 2015, p. 449-456.

Research output: Contribution to journalArticle

Iaccarino, L, Bartoloni, E, Carli, L, Ceccarelli, F, Conti, F, De Vita, S, Ferraccioli, G, Galeazzi, M, Gatto, M, Gerli, R, Govoni, M, Gremese, E, Iuliano, A, Mansutti, E, Moroni, G, Mosca, M, Nalli, C, Naretto, C, Padovan, M, Palma, L, Raffiotta, F, Roccatello, D, Tincani, A, Valesini, G, Zen, M & Doria, A 2015, 'Efficacy and safety of off-label use of rituximab in refractory lupus: Data from the Italian Multicentre Registry', Clinical and Experimental Rheumatology, vol. 33, no. 4, pp. 449-456.
Iaccarino, Luca ; Bartoloni, Elena ; Carli, Linda ; Ceccarelli, Fulvia ; Conti, Fabrizio ; De Vita, Salvatore ; Ferraccioli, Gianfranco ; Galeazzi, Mauro ; Gatto, Mariele ; Gerli, Roberto ; Govoni, Marcello ; Gremese, Elisa ; Iuliano, Annamaria ; Mansutti, Elena ; Moroni, Gabriella ; Mosca, Marta ; Nalli, Cecilia ; Naretto, Carla ; Padovan, Melissa ; Palma, Lavinia ; Raffiotta, Francesca ; Roccatello, Dario ; Tincani, Angela ; Valesini, Guido ; Zen, Margherita ; Doria, Andrea. / Efficacy and safety of off-label use of rituximab in refractory lupus : Data from the Italian Multicentre Registry. In: Clinical and Experimental Rheumatology. 2015 ; Vol. 33, No. 4. pp. 449-456.
@article{3640a101ef4040dd924b246e6e9b5128,
title = "Efficacy and safety of off-label use of rituximab in refractory lupus: Data from the Italian Multicentre Registry",
abstract = "Objective: To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting. Methods: 145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1<ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis. Results Data from 134 (92.4{\%}) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8{\%} and CR in 45.5{\%} of cases; RCR or RPR in 94.1{\%} and RCR in 30.9{\%} of patients after 12-month follow-up. Disease flares occurred in 35.1{\%} and renal flares in 31.2{\%} of patients during observational period. Among patients retreated, CR or PR were observed in 84.4{\%} and CR in 57.8{\%} of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8{\%}, 16.4{\%}, and 3.8{\%} of patients and after retreatment in 33.3{\%}, 22.2{\%} and 11.1{\%}, respectively. No severe infusion reactions or deaths occurred. Conclusion Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.",
keywords = "Complete response, Italian registry, Lupus activity, Lupus nephritis, Rituximab, Systemic lupus erythematosus",
author = "Luca Iaccarino and Elena Bartoloni and Linda Carli and Fulvia Ceccarelli and Fabrizio Conti and {De Vita}, Salvatore and Gianfranco Ferraccioli and Mauro Galeazzi and Mariele Gatto and Roberto Gerli and Marcello Govoni and Elisa Gremese and Annamaria Iuliano and Elena Mansutti and Gabriella Moroni and Marta Mosca and Cecilia Nalli and Carla Naretto and Melissa Padovan and Lavinia Palma and Francesca Raffiotta and Dario Roccatello and Angela Tincani and Guido Valesini and Margherita Zen and Andrea Doria",
year = "2015",
language = "English",
volume = "33",
pages = "449--456",
journal = "Clinical and Experimental Rheumatology",
issn = "0392-856X",
publisher = "Clinical and Experimental Rheumatology S.A.S.",
number = "4",

}

TY - JOUR

T1 - Efficacy and safety of off-label use of rituximab in refractory lupus

T2 - Data from the Italian Multicentre Registry

AU - Iaccarino, Luca

AU - Bartoloni, Elena

AU - Carli, Linda

AU - Ceccarelli, Fulvia

AU - Conti, Fabrizio

AU - De Vita, Salvatore

AU - Ferraccioli, Gianfranco

AU - Galeazzi, Mauro

AU - Gatto, Mariele

AU - Gerli, Roberto

AU - Govoni, Marcello

AU - Gremese, Elisa

AU - Iuliano, Annamaria

AU - Mansutti, Elena

AU - Moroni, Gabriella

AU - Mosca, Marta

AU - Nalli, Cecilia

AU - Naretto, Carla

AU - Padovan, Melissa

AU - Palma, Lavinia

AU - Raffiotta, Francesca

AU - Roccatello, Dario

AU - Tincani, Angela

AU - Valesini, Guido

AU - Zen, Margherita

AU - Doria, Andrea

PY - 2015

Y1 - 2015

N2 - Objective: To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting. Methods: 145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1<ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis. Results Data from 134 (92.4%) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8% and CR in 45.5% of cases; RCR or RPR in 94.1% and RCR in 30.9% of patients after 12-month follow-up. Disease flares occurred in 35.1% and renal flares in 31.2% of patients during observational period. Among patients retreated, CR or PR were observed in 84.4% and CR in 57.8% of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively. No severe infusion reactions or deaths occurred. Conclusion Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.

AB - Objective: To evaluate the efficacy and safety of rituximab (RTX) in patients with systemic lupus erythematosus (SLE) refractory to standard therapy in the clinical practice setting. Methods: 145 SLE patients (ACR criteria) were treated with RTX in 11 Italian Centres: 118 with two infusions (1 g), two weeks apart; 27 with 4 infusions (375 mg/m2), one week apart, followed in 10 cases by two further doses, after 1 and 2 months. Systemic complete response (CR) was defined as European Consensus Lupus Activity Measurement (ECLAM) score ≤1 and partial response (PR) as 1<ECLAM ≤3. Renal CR (RCR) and renal PR (RPR) were defined according to EULAR recommendations for management of lupus nephritis. Results Data from 134 (92.4%) patients were available. The mean±SD follow-up was 27.3±18.5 months. After the first course of RTX, CR or PR were observed in 85.8% and CR in 45.5% of cases; RCR or RPR in 94.1% and RCR in 30.9% of patients after 12-month follow-up. Disease flares occurred in 35.1% and renal flares in 31.2% of patients during observational period. Among patients retreated, CR or PR were observed in 84.4% and CR in 57.8% of cases. Adverse events, infections, and infusion reactions occurred after first RTX course in 23.8%, 16.4%, and 3.8% of patients and after retreatment in 33.3%, 22.2% and 11.1%, respectively. No severe infusion reactions or deaths occurred. Conclusion Data from Italian multicentre RTX Registry confirmed the efficacy and safety of RTX in SLE patients refractory to standard treatment in clinical practice setting.

KW - Complete response

KW - Italian registry

KW - Lupus activity

KW - Lupus nephritis

KW - Rituximab

KW - Systemic lupus erythematosus

UR - http://www.scopus.com/inward/record.url?scp=84939521363&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84939521363&partnerID=8YFLogxK

M3 - Article

VL - 33

SP - 449

EP - 456

JO - Clinical and Experimental Rheumatology

JF - Clinical and Experimental Rheumatology

SN - 0392-856X

IS - 4

ER -