SAT0199 An estimate of the proportion of patients with sle receiving off-label treatment with rituximab in european countries
| Autor: | S Jacobsen, R. van Vollenhoven, Frédéric Houssiau, Alexandre E. Voskuyl, Anca D. Askanase, Sasha Bernatsky, Thomas Dörner, Danilo Squatrito, G. F. Ferraccioli, K. Lászlό, Twj Huizinga, Maria Seddighzadeh, David A. Isenberg, Guillermo Ruiz-Irastorza |
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| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Off-Label Treatment business.industry Immunology Rheumatology specialty General Biochemistry Genetics and Molecular Biology Rheumatology Patient population immune system diseases Internal medicine Clinical information Physical therapy Immunology and Allergy Medicine media_common.cataloged_instance Rituximab European union skin and connective tissue diseases business medicine.drug media_common |
| Zdroj: | Annals of the Rheumatic Diseases. 71:539.1-539 |
| ISSN: | 1468-2060 0003-4967 |
| DOI: | 10.1136/annrheumdis-2012-eular.3146 |
| Popis: | Background Rituximab (MabThera; RTX) has not been approved for use in SLE, but uncontrolled observations have suggested efficacy in some patients. There clearly is off-label use of this medication in practice in Europe, but the extent of it has not previously been analyzed. The International Registry for Biologics in SLE (IRBIS), initiated by the SLICC group provided the data for this study. Objectives To estimate the proportion of SLE patients treated with RTX in Europe. Methods Data previously submitted to the IRBIS registry by 28 centers in 11 European countries were complemented with additional clinical information from the participating sites and SLE prevalence estimates based on previously published data and data provided by direct contact with participating physicians. For the remaining countries in the European Union (EU) and European Economic Area-European Free Trade Association (EEA-EFTA), estimates were extrapolated on the assumption of regional similarities between countries. Results Most of the SLE-dedicated rheumatology specialty centers represented in this study had 200 to 300 SLE patients of whom generally Conclusions In Europe, RTX is estimated to be used off-label in 0.5-1.3% of SLE patients. This modest number suggests that it is chosen only for those patients in whom established therapeutic options have been exhausted. Limitations of the study include the use of extrapolations, and the fact that RTX use by non-rheumatologists was not ascertained. Although controlled evidence for the efficacy of RTX in SLE is lacking, the current usage of RTX in SLE may be considered conservative, given the high medical need in the larger SLE patient population. Supported by a research grant from Roche Disclosure of Interest None Declared |
| Databáze: | OpenAIRE |
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