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.
U2 - 10.1136/annrheumdis-2018-214816
DO - 10.1136/annrheumdis-2018-214816
M3 - Journal article
C2 - 30967395
SN - 0003-4967
VL - 78
SP - 979
EP - 987
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
IS - 7
ER -