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Natalizumab and drug holiday in clinical practice: an observational study in very active relapsing remitting multiple sclerosis patients

Abstract : BACKGROUND: In order to reduce the risk of progressive multifocal leucoencephalopathy when using natalizumab for more than 12 months, a 6-month drug holiday has been discussed. However, the consequences on short term disease activity have been poorly assessed. OBJECTIVE: The aim of this study was to assess clinical and radiological disease activity within 6 months after stopping natalizumab in very active relapsing remitting Multiple Sclerosis (RRMS) patients. METHODS: In 8 hospitals from Western France, we retrospectively collected clinical and MRI data from consecutive RRMS patients treated with natalizumab for at least 6 months, and who stopped the drug for various reasons except therapeutic failure. Patients didn't receive any other disease modifying treatment after discontinuing natalizumab. RESULTS: A total of 27 patients with very active RRMS before natalizumab start (mean annualized relapse rate of 2.3, MRI activity in 21 of 27 patients) were studied. Within 6 months after discontinuing natalizumab, 18 patients (67%) experienced clinical relapse and 3 additional patients had radiological activity, without clinical relapse. Four patients (15%) experienced a rebound activity, with severe relapse and 20 or more gadolinium enhancing lesions on MRI. CONCLUSION: Such observational data didn't support the concept of drug holiday when using natalizumab in very active RRMS.
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https://hal-univ-rennes1.archives-ouvertes.fr/hal-01147033
Contributor : Laurent Jonchère <>
Submitted on : Wednesday, April 29, 2015 - 3:01:44 PM
Last modification on : Wednesday, August 19, 2020 - 12:08:19 PM

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Anne Kerbrat, E. Le Page, Emmanuelle Leray, T. Anani, M. Coustans, et al.. Natalizumab and drug holiday in clinical practice: an observational study in very active relapsing remitting multiple sclerosis patients. Journal of the Neurological Sciences, Elsevier, 2011, 308 (1-2), pp.98--102. ⟨10.1016/j.jns.2011.05.043⟩. ⟨hal-01147033⟩

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