Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group. Issue 6 (17th January 2014)

• Record Type: Journal Article
• Authors: Jordan, Suzana; Distler, Jörg H W; Maurer, Britta; Huscher, Dörte; van Laar, Jacob M; Allanore, Yannick; Distler, Oliver
• Other Names: Airo Paolo author non-byline.; Sancho Juan José Alegre author non-byline.; Ananjeva Lidia author non-byline.; Ancuta Codrina Michaela author non-byline.; Aringer Martin author non-byline.; Balbir-Gurman Alexandra author non-byline.; Cantatore Francesco Paolo author non-byline.; Caramaschi Paola author non-byline.; Chatelus Emmanuel author non-byline.; Codullo Veronica author non-byline.; Farge-Bancel Dominique author non-byline.; Foti Rosario author non-byline.; Gabrielli Armando author non-byline.; Henes Jörg author non-byline.; Herrgott Ilka author non-byline.; Iannone Florenzo author non-byline.; Ingegnoli Francesca author non-byline.; Loyo Esthela author non-byline.; Matucci-Cerinić Marco author non-byline.; Abdel Atty Mohamed Walid Ahmed author non-byline.; Müller-Ladner Ulf author non-byline.; Palm Øyvind author non-byline.; Popa Sergiu author non-byline.; Riemekasten Gabriela author non-byline.; Rednic Simona author non-byline.; Rosato Edoardo author non-byline.; Saracco Marta author non-byline.; Scheja Agneta author non-byline.; Smith Vanessa author non-byline.; Mihai Carina author non-byline.; Szucs Gabriela author non-byline.; Tomšič Matija author non-byline.; Valentini Gabriele author non-byline.; Walker Ulrich A author non-byline.; Westhovens Rene author non-byline.; Yavuz Sule Kurhan author non-byline.; Zenone Thierry author non-byline.;
• Is Part Of: Annals of the rheumatic diseases. Volume 74:Issue 6(2015)
• Page Start: 1188
• Page End: 1194
• Publication Date: 2014-01-17
• Subjects: Systemic Sclerosis -- B cells -- Treatment; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2013-204522
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : 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.