1. Effects and safety of rituximab in systemic sclerosis : An analysis from the European Scleroderma Trial and Research (EUSTAR) group
- Author
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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, and Zenone, Thierry
- Subjects
Male ,Vital capacity ,Databases, Factual ,Fibrosi ,Vital Capacity ,Gastroenterology ,Severity of Illness Index ,Biochemistry ,Scleroderma ,Cohort Studies ,Antibodies, Monoclonal, Murine-Derived ,Immunosuppressive Agent ,Immunology and Allergy ,Lung ,Skin ,Medicine(all) ,B cell ,integumentary system ,Medicine (all) ,Interstitial lung disease ,Antirheumatic Agent ,Orvostudományok ,Middle Aged ,Connective tissue disease ,Rheumatoid arthritis ,Antirheumatic Agents ,Rituximab ,Female ,Case-Control Studie ,Immunosuppressive Agents ,medicine.drug ,Human ,medicine.medical_specialty ,Immunology ,Observational Study ,Klinikai orvostudományok ,General Biochemistry, Genetics and Molecular Biology ,FEV1/FVC ratio ,Rheumatology ,Internal medicine ,medicine ,Journal Article ,Humans ,Systemic Sclerosi ,Scleroderma, Systemic ,Biochemistry, Genetics and Molecular Biology (all) ,business.industry ,Biochemistry, Genetics and Molecular Biology(all) ,medicine.disease ,Fibrosis ,Treatment ,Case-Control Studies ,Cohort Studie ,business ,Lung Diseases, Interstitial ,Genetics and Molecular Biology(all) - 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.
- Published
- 2015