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![]() , , DISTLER, Jorg H.W.. Effects and safety of rituximab in systemic sclerosis: An analysis from the European Scleroderma Trial and Research (EUSTAR) group. In: Annals of the Rheumatic Diseases, 2015, vol. 74, pp. 1188-1194. ISSN -. DOI: https://doi.org/10.1136/annrheumdis-2013-204522 |
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Annals of the Rheumatic Diseases | ||||||
Volumul 74 / 2015 / ISSN - /ISSNe 0003-4967 | ||||||
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DOI:https://doi.org/10.1136/annrheumdis-2013-204522 | ||||||
Pag. 1188-1194 | ||||||
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Rezumat | ||||||
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. |
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Cuvinte-cheie antibodies, Monoclonal, Murine-Derived, Antirheumatic Agents, Case-Control Studies, Cohort Studies, databases, Factual, female, fibrosis, Humans, Immunosuppressive Agents, Lung, lung diseases, Interstitial, Male, middle aged, Scleroderma, systemic, Severity of Illness Index |
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