TY - JOUR
T1 - Effects and safety of rituximab in systemic sclerosis: An analysis from the European Scleroderma Trial and Research (EUSTAR) group
AU - Jordan, Suzana
AU - Distler, Jörg H.W.
AU - Maurer, Britta
AU - Huscher, Dörte
AU - Van Laar, Jacob M.
AU - Allanore, Yannick
AU - Distler, Oliver
AU - Kvien, Tore K.
AU - Airo, Paolo
AU - Sancho, Juan José Alegre
AU - Ananjeva, Lidia
AU - Ancuta, Codrina Michaela
AU - Aringer, Martin
AU - Balbir-Gurman, Alexandra
AU - Cantatore, Francesco Paolo
AU - Caramaschi, Paola
AU - Chatelus, Emmanuel
AU - Codullo, Veronica
AU - Farge-Bancel, Dominique
AU - Foti, Rosario
AU - Gabrielli, Armando
AU - Henes, Jörg
AU - Herrgott, Ilka
AU - Iannone, Florenzo
AU - Ingegnoli, Francesca
AU - Loyo, Esthela
AU - Matucci-Cerinić, Marco
AU - Mohamed, Walid Ahmed Abdel Atty
AU - Müller-Ladner, Ulf
AU - Palm, Øyvind
AU - Popa, Sergiu
AU - Riemekasten, Gabriela
AU - Rednic, Simona
AU - Rosato, Edoardo
AU - Saracco, Marta
AU - Scheja, Agneta
AU - Smith, Vanessa
AU - Mihai, Carina
AU - Szucs, Gabriela
AU - Tomšić, Matija
AU - Valentini, Gabriele
AU - Walker, Ulrich A.
AU - Westhovens, Rene
AU - Yavuz, Sule Kurhan
AU - Zenone, Thierry
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2015/6/1
Y1 - 2015/6/1
N2 - Objectives: To assess the effects of Rituximab (RTX) on skin and lung fibrosis in patients with systemic sclerosis (SSc) belonging to the European Scleroderma Trial and Research (EUSTAR) cohort and using a nested case-control design. Methods: Inclusion criteria were fulfilment of American College of Rheumatology classification criteria for SSc, treatment with RTX and availability of follow-up data. RTX-treated patients were matched with control patients from the EUSTAR database not treated with RTX. Matching parameters for skin/lung fibrosis were the modified Rodnan Skin Score (mRSS), forced vital capacity (FVC), follow-up duration, scleroderma subtype, disease duration and immunosuppressive co-treatment. The primary analysis was mRSS change from baseline to follow-up in the RTX group compared with the control group. Secondary analyses included change of FVC and safety measures. Results: 63 patients treated with RTX were included in the analysis. The case-control analysis in patients with severe diffuse SSc showed that mRSS changes were larger in the RTX group versus matched controls (N=25; -24.0±5.2% vs-7.7±4.3%; p=0.03). Moreover, in RTX-treated patients, the mean mRSS was significantly reduced at follow-up compared with baseline (26.6±1.4 vs 20.3±1.8; p=0.0001). In addition, in patients with interstitial lung disease, RTX prevented significantly the further decline of FVC compared with matched controls (N=9; 0.4±4.4% vs-7.7±3.6%; p=0.02). Safety measures showed a good profile consistent with previous studies in autoimmune rheumatic diseases. Conclusions: The comparison of RTX treated versus untreated matched-control SSc patients from the EUSTAR cohort demonstrated improvement of skin fibrosis and prevention of worsening lung fibrosis, supporting the therapeutic concept of B cell inhibition in SSc.
AB - Objectives: To assess the effects of Rituximab (RTX) on skin and lung fibrosis in patients with systemic sclerosis (SSc) belonging to the European Scleroderma Trial and Research (EUSTAR) cohort and using a nested case-control design. Methods: Inclusion criteria were fulfilment of American College of Rheumatology classification criteria for SSc, treatment with RTX and availability of follow-up data. RTX-treated patients were matched with control patients from the EUSTAR database not treated with RTX. Matching parameters for skin/lung fibrosis were the modified Rodnan Skin Score (mRSS), forced vital capacity (FVC), follow-up duration, scleroderma subtype, disease duration and immunosuppressive co-treatment. The primary analysis was mRSS change from baseline to follow-up in the RTX group compared with the control group. Secondary analyses included change of FVC and safety measures. Results: 63 patients treated with RTX were included in the analysis. The case-control analysis in patients with severe diffuse SSc showed that mRSS changes were larger in the RTX group versus matched controls (N=25; -24.0±5.2% vs-7.7±4.3%; p=0.03). Moreover, in RTX-treated patients, the mean mRSS was significantly reduced at follow-up compared with baseline (26.6±1.4 vs 20.3±1.8; p=0.0001). In addition, in patients with interstitial lung disease, RTX prevented significantly the further decline of FVC compared with matched controls (N=9; 0.4±4.4% vs-7.7±3.6%; p=0.02). Safety measures showed a good profile consistent with previous studies in autoimmune rheumatic diseases. Conclusions: The comparison of RTX treated versus untreated matched-control SSc patients from the EUSTAR cohort demonstrated improvement of skin fibrosis and prevention of worsening lung fibrosis, supporting the therapeutic concept of B cell inhibition in SSc.
UR - http://www.scopus.com/inward/record.url?scp=84934991714&partnerID=8YFLogxK
U2 - 10.1136/annrheumdis-2013-204522
DO - 10.1136/annrheumdis-2013-204522
M3 - Journal articles
C2 - 24442885
AN - SCOPUS:84934991714
VL - 74
SP - 1188
EP - 1194
JO - Annals of the Rheumatic Diseases
JF - Annals of the Rheumatic Diseases
SN - 0003-4967
IS - 6
ER -