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Effects and safety of rituximab in systemic sclerosis : An analysis from the European Scleroderma Trial and Research (EUSTAR) group

Authors :
Veronica Codullo
Thierry Zenone
Ulrich A. Walker
Dominique Farge-Bancel
Jacob M van Laar
Matija Tomšič
Simona Rednic
Francesco Paolo Cantatore
Sule Yavuz
Tore K Kvien
Sergiu Popa
Lidia Ananjeva
Suzana Jordan
Marco Matucci-Cerinic
Gabriela Szucs
Paolo Airò
Paola Caramaschi
Armando Gabrielli
Emmanuel Chatelus
Codrina Michaela Ancuta
Agneta Scheja
Francesca Ingegnoli
Gabriela Riemekasten
Gabriele Valentini
Vanessa Smith
Edoardo Rosato
Esthela Loyo
Martin Aringer
Alexandra Balbir-Gurman
Ulf Müller-Ladner
I. Herrgott
Britta Maurer
Yannick Allanore
Juan José Alegre Sancho
Dörte Huscher
Rosario Foti
Rene Westhovens
Øyvind Palm
Jörg H W Distler
Oliver Distler
M. Saracco
Carina Mihai
Jörg Henes
Florenzo Iannone
Walid Ahmed Abdel Atty Mohamed
Jordan, Suzana
Distler, Jörg H. W.
Maurer, Britta
Huscher, Dörte
Van Laar, Jacob M.
Allanore, Yannick
Distler, Oliver
Kvien, Tore K.
Airo, Paolo
Sancho, Juan José Alegre
Ananjeva, Lidia
Ancuta, Codrina Michaela
Aringer, Martin
Balbir Gurman, Alexandra
Cantatore, Francesco Paolo
Caramaschi, Paola
Chatelus, Emmanuel
Codullo, Veronica
Farge Bancel, Dominique
Foti, Rosario
Gabrielli, Armando
Henes, Jörg
Herrgott, Ilka
Iannone, Florenzo
Ingegnoli, Francesca
Loyo, Esthela
Matucci Cerinić, Marco
Mohamed, Walid Ahmed Abdel Atty
Müller Ladner, Ulf
Palm, Øyvind
Popa, Sergiu
Riemekasten, Gabriela
Rednic, Simona
Rosato, Edoardo
Saracco, Marta
Scheja, Agneta
Smith, Vanessa
Mihai, Carina
Szucs, Gabriela
Tomšić, Matija
Valentini, Gabriele
Walker, Ulrich A.
Westhovens, Rene
Yavuz, Sule Kurhan
Zenone, Thierry
Source :
Annals of the Rheumatic Diseases, 74(6), 1188. BMJ Publishing Group
Publication Year :
2015

Abstract

ObjectivesTo 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.MethodsInclusion 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.Results63 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.ConclusionsThe 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.

Details

Language :
English
ISSN :
00034967
Volume :
74
Issue :
6
Database :
OpenAIRE
Journal :
Annals of the Rheumatic Diseases
Accession number :
edsair.doi.dedup.....a34e02c4663860f549359d213dd4a1eb