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

Elhai, Muriel; Boubaya, Marouane; Distler, Oliver; Smith, Vanessa; Matucci-Cerinic, Marco; Alegre Sancho, Juan José; Truchetet, Marie Elise; Braun-Moscovici, Yolanda; Iannone, Florenzo and Novikov, Pavel I., et al. (2019) In Annals of the Rheumatic Diseases 78(7). p.979-987
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... (More)

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.

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publication status
published
subject
keywords
lung fibrosis, rituximab, skin fibrosis, systemic sclerosis
in
Annals of the Rheumatic Diseases
volume
78
issue
7
pages
979 - 987
publisher
British Medical Association
external identifiers
  • scopus:85064192589
ISSN
0003-4967
DOI
10.1136/annrheumdis-2018-214816
language
English
LU publication?
yes
id
62df79a8-ffb3-4fc5-8c2e-ef4cf0b28694
date added to LUP
2019-05-09 14:29:22
date last changed
2019-08-14 04:36:20
@article{62df79a8-ffb3-4fc5-8c2e-ef4cf0b28694,
  abstract     = {<p>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)&gt;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&lt;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.</p>},
  author       = {Elhai, Muriel and Boubaya, Marouane and Distler, Oliver and Smith, Vanessa and Matucci-Cerinic, Marco and Alegre Sancho, Juan José and Truchetet, Marie Elise and Braun-Moscovici, Yolanda and Iannone, Florenzo and Novikov, Pavel I. and Lescoat, Alain and Siegert, Elise and Castellví, Ivan and Airó, Paolo and Vettori, Serena and De Langhe, Ellen and Hachulla, Eric and Erler, Anne and Ananieva, Lidia and Krusche, Martin and López-Longo, F. J. and Distler, Jörg H.W. and Hunzelmann, Nicolas and Hoffmann-Vold, Anna Maria and Riccieri, Valeria and Hsu, Vivien M. and Pozzi, Maria R. and Ancuta, Codrina and Rosato, Edoardo and Mihai, Carina and Kuwana, Masataka and Saketkoo, Lesley Ann and Chizzolini, Carlo and Hesselstrand, Roger and Ullman, Susanne and Yavuz, Sule and Rednic, Simona and Caimmi, Cristian and Bloch-Queyrat, Coralie and Allanore, Yannick},
  issn         = {0003-4967},
  keyword      = {lung fibrosis,rituximab,skin fibrosis,systemic sclerosis},
  language     = {eng},
  number       = {7},
  pages        = {979--987},
  publisher    = {British Medical Association},
  series       = {Annals of the Rheumatic Diseases},
  title        = {Outcomes of patients with systemic sclerosis treated with rituximab in contemporary practice : A prospective cohort study},
  url          = {http://dx.doi.org/10.1136/annrheumdis-2018-214816},
  volume       = {78},
  year         = {2019},
}