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

Suzana Jordan, Jörg H.W. Distler, Britta Maurer, Dörte Huscher, Jacob M. Van Laar, Yannick Allanore, Oliver Distler*, Tore K. Kvien, Paolo Airo, Juan José Alegre Sancho, Lidia Ananjeva, Codrina Michaela Ancuta, Martin Aringer, Alexandra Balbir-Gurman, Francesco Paolo Cantatore, Paola Caramaschi, Emmanuel Chatelus, Veronica Codullo, Dominique Farge-Bancel, Rosario FotiArmando Gabrielli, Jörg Henes, Ilka Herrgott, Florenzo Iannone, Francesca Ingegnoli, Esthela Loyo, Marco Matucci-Cerinić, Walid Ahmed Abdel Atty Mohamed, Ulf Müller-Ladner, Øyvind Palm, Sergiu Popa, Gabriela Riemekasten, Simona Rednic, Edoardo Rosato, Marta Saracco, Agneta Scheja, Vanessa Smith, Carina Mihai, Gabriela Szucs, Matija Tomšić, Gabriele Valentini, Ulrich A. Walker, Rene Westhovens, Sule Kurhan Yavuz, Thierry Zenone

*Corresponding author for this work
241 Citations (Scopus)


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.

Original languageEnglish
JournalAnnals of the Rheumatic Diseases
Issue number6
Pages (from-to)1188-1194
Number of pages7
Publication statusPublished - 01.06.2015

Research Areas and Centers

  • Academic Focus: Center for Infection and Inflammation Research (ZIEL)


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