دورية أكاديمية
220 Safety of multiple sclerosis patients treated by natalizumab (Network EDMUS)
| العنوان: | 220 Safety of multiple sclerosis patients treated by natalizumab (Network EDMUS) |
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| المؤلفون: | Vukusic, S, Passante, N, Ritleng, C, Laforest, L, Van Ganse, E, Rocher, F, Clanet, M, Castot, A, Confavreux, C |
| بيانات النشر: | BMJ Publishing Group Ltd |
| سنة النشر: | 2010 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | IV-Preliminary Results |
| الوصف: | Background Natalizumab, a monoclonal antibody, has shown efficacy in reducing the relapse rate and delaying disability accumulation in relapsing remitting (RR) multiple sclerosis (MS) patients. However, severe opportunistic infections and infusion reactions have been observed in clinical trials. Therefore, a national risk management plan (RMP) has been launched in France by AFSSAPS with the participation of FFN. Evaluation of the benefit/risk ratio (BRR) of natalizumab in real life settings will give a measurement of the RMP impact. Objectives The main objective of the TYSEDMUS study is to establish the safety profile of natalizumab in real life settings. Secondary objectives are to describe the conditions for use of the treatment, the clinical evolution of the patients in terms of relapses and disability, and to compare the occurrence of malignancies and serious infections in this natalizumab-exposed population vs a non-exposed one. Methods TYSEDMUS is a multicentre observational cohort study promoted by AFSSAPS (Agence Française de Sécurité Sanitaire des Produits de Santé) involving French neurologists prescribing natalizumab. It aims at including all the patients exposed at least once to natalizumab. Patients' characteristics under natalizumab (including clinical evolution), utilisation patterns of natalizumab and occurrence of adverse events are described and included in EDMUS databases. A group of non-exposed patients, never treated with natalizumab, either receiving or not other immuno-active therapies, will be later extracted from the EDMUS databases for comparison. Preliminary Results The study has been launched in November 2007. The follow-up duration is planned to be at least 5 years. By October 2009, a total of 1296 patients had been recruited. Study methods and descriptive results regarding the first 873 patients (76% female) are presented. The French neurologists mainly followed the requirements of the RMP recommendations. The overall tolerance of natalizumab was quite good. Less than 4% ... |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| العلاقة: | http://qualitysafety.bmj.com/cgi/content/short/19/1_MeetingAbstracts/A179Test; http://dx.doi.org/10.1136/qshc.2010.041632.33Test |
| DOI: | 10.1136/qshc.2010.041632.33 |
| الإتاحة: | https://doi.org/10.1136/qshc.2010.041632.33Test http://qualitysafety.bmj.com/cgi/content/short/19/1_MeetingAbstracts/A179Test |
| حقوق: | Copyright (C) 2010, BMJ Publishing Group Ltd |
| رقم الانضمام: | edsbas.E9AD4111 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/qshc.2010.041632.33 |
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