Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study

for EUSTAR network

doi:10.1136/annrheumdis-2018-214816

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice

Standard

Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice : a prospective cohort study. / for EUSTAR network.

In: ANN RHEUM DIS, Vol. 78, No. 7, 07.2019, p. 979-987.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

for EUSTAR network 2019, 'Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study', ANN RHEUM DIS, vol. 78, no. 7, pp. 979-987. https://doi.org/10.1136/annrheumdis-2018-214816

APA

for EUSTAR network (2019). Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study. ANN RHEUM DIS, 78(7), 979-987. https://doi.org/10.1136/annrheumdis-2018-214816

Vancouver

for EUSTAR network. Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study. ANN RHEUM DIS. 2019 Jul;78(7):979-987. https://doi.org/10.1136/annrheumdis-2018-214816

Bibtex

@article{4f39072b8293414f889537e1d53b0cc8,

title = "Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice: a prospective cohort study",

abstract = "OBJECTIVE: To assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice.METHODS: We performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab.RESULTS: 254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47-5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55-1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56-3.53], p<0.0001). Patients treated concomitantly with mycophenolate mofetil had a trend for better outcomes as compared with patients receiving rituximab alone (delta FVC: 5.22 [0.83-9.62]; p=0.019 as compared with controls vs 3 [0.66-5.35]; p=0.012).CONCLUSION: Rituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.",

keywords = "Adult, Aged, Antirheumatic Agents/therapeutic use, Female, Fibrosis, Humans, Lung/pathology, Male, Middle Aged, Propensity Score, Prospective Studies, Pulmonary Fibrosis/drug therapy, Registries, Respiratory Function Tests, Rituximab/therapeutic use, Scleroderma, Systemic/complications, Skin/pathology, Treatment Outcome, Vital Capacity",

author = "Muriel Elhai and Marouane Boubaya and Oliver Distler and Vanessa Smith and Marco Matucci-Cerinic and {Alegre Sancho}, {Juan Jos{\'e}} and Marie-Elise Truchetet and Yolanda Braun-Moscovici and Florenzo Iannone and Novikov, {Pavel I} and Alain Lescoat and Elise Siegert and Ivan Castellv{\'i} and Paolo Air{\'o} and Serena Vettori and {De Langhe}, Ellen and Eric Hachulla and Anne Erler and Lidia Ananieva and Martin Krusche and L{\'o}pez-Longo, {F J} and Distler, {J{\"o}rg H W} and Nicolas Hunzelmann and Anna-Maria Hoffmann-Vold and Valeria Riccieri and Hsu, {Vivien M} and Pozzi, {Maria R} and Codrina Ancuta and Edoardo Rosato and Carina Mihai and Masataka Kuwana and Saketkoo, {Lesley Ann} and Carlo Chizzolini and Roger Hesselstrand and Susanne Ullman and Sule Yavuz and Simona Rednic and Cristian Caimmi and Coralie Bloch-Queyrat and Yannick Allanore and {for EUSTAR network}",

note = "{\textcopyright} Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2019",

month = jul,

doi = "10.1136/annrheumdis-2018-214816",

language = "English",

volume = "78",

pages = "979--987",

journal = "ANN RHEUM DIS",

issn = "0003-4967",

publisher = "BMJ PUBLISHING GROUP",

number = "7",

}

RIS

TY - JOUR

T1 - Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice

T2 - a prospective cohort study

AU - Elhai, Muriel

AU - Boubaya, Marouane

AU - Distler, Oliver

AU - Smith, Vanessa

AU - Matucci-Cerinic, Marco

AU - Alegre Sancho, Juan José

AU - Truchetet, Marie-Elise

AU - Braun-Moscovici, Yolanda

AU - Iannone, Florenzo

AU - Novikov, Pavel I

AU - Lescoat, Alain

AU - Siegert, Elise

AU - Castellví, Ivan

AU - Airó, Paolo

AU - Vettori, Serena

AU - De Langhe, Ellen

AU - Hachulla, Eric

AU - Erler, Anne

AU - Ananieva, Lidia

AU - Krusche, Martin

AU - López-Longo, F J

AU - Distler, Jörg H W

AU - Hunzelmann, Nicolas

AU - Hoffmann-Vold, Anna-Maria

AU - Riccieri, Valeria

AU - Hsu, Vivien M

AU - Pozzi, Maria R

AU - Ancuta, Codrina

AU - Rosato, Edoardo

AU - Mihai, Carina

AU - Kuwana, Masataka

AU - Saketkoo, Lesley Ann

AU - Chizzolini, Carlo

AU - Hesselstrand, Roger

AU - Ullman, Susanne

AU - Yavuz, Sule

AU - Rednic, Simona

AU - Caimmi, Cristian

AU - Bloch-Queyrat, Coralie

AU - Allanore, Yannick

AU - for EUSTAR network

N1 - © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2019/7

Y1 - 2019/7

N2 - OBJECTIVE: To assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice.METHODS: We performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab.RESULTS: 254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47-5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55-1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56-3.53], p<0.0001). Patients treated concomitantly with mycophenolate mofetil had a trend for better outcomes as compared with patients receiving rituximab alone (delta FVC: 5.22 [0.83-9.62]; p=0.019 as compared with controls vs 3 [0.66-5.35]; p=0.012).CONCLUSION: Rituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.

AB - OBJECTIVE: To assess the safety and efficacy of rituximab in systemic sclerosis (SSc) in clinical practice.METHODS: We performed a prospective study including patients with SSc from the European Scleroderma Trials and Research (EUSTAR) network treated with rituximab and matched with untreated patients with SSc. The main outcomes measures were adverse events, skin fibrosis improvement, lung fibrosis worsening and steroids use among propensity score-matched patients treated or not with rituximab.RESULTS: 254 patients were treated with rituximab, in 58% for lung and in 32% for skin involvement. After a median follow-up of 2 years, about 70% of the patients had no side effect. Comparison of treated patients with 9575 propensity-score matched patients showed that patients treated with rituximab were more likely to have skin fibrosis improvement (22.7 vs 14.03 events per 100 person-years; OR: 2.79 [1.47-5.32]; p=0.002). Treated patients did not have significantly different rates of decrease in forced vital capacity (FVC)>10% (OR: 1.03 [0.55-1.94]; p=0.93) nor in carbon monoxide diffusing capacity (DLCO) decrease. Patients having received rituximab were more prone to stop or decrease steroids (OR: 2.34 [1.56-3.53], p<0.0001). Patients treated concomitantly with mycophenolate mofetil had a trend for better outcomes as compared with patients receiving rituximab alone (delta FVC: 5.22 [0.83-9.62]; p=0.019 as compared with controls vs 3 [0.66-5.35]; p=0.012).CONCLUSION: Rituximab use was associated with a good safety profile in this large SSc-cohort. Significant change was observed on skin fibrosis, but not on lung. However, the limitation is the observational design. The potential stabilisation of lung fibrosis by rituximab has to be addressed by a randomised trial.

KW - Adult

KW - Aged

KW - Antirheumatic Agents/therapeutic use

KW - Female

KW - Fibrosis

KW - Humans

KW - Lung/pathology

KW - Male

KW - Middle Aged

KW - Propensity Score

KW - Prospective Studies

KW - Pulmonary Fibrosis/drug therapy

KW - Registries

KW - Respiratory Function Tests

KW - Rituximab/therapeutic use

KW - Scleroderma, Systemic/complications

KW - Skin/pathology

KW - Treatment Outcome

KW - Vital Capacity

U2 - 10.1136/annrheumdis-2018-214816

DO - 10.1136/annrheumdis-2018-214816

M3 - SCORING: Journal article

C2 - 30967395

VL - 78

SP - 979

EP - 987

JO - ANN RHEUM DIS

JF - ANN RHEUM DIS

SN - 0003-4967

IS - 7

ER -