@article{ref1,
title="Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: Subgroup analysis of the natalizumab observational program",
journal="Acta neurologica Belgica",
year="2014",
author="van Pesch, V. and Bartholomé, E. and Bissay, V. and Bouquiaux, O. and Bureau, M. and Caekebeke, J. and Debruyne, J. and Declercq, I. and Decoo, D. and Denayer, P. and De Smet, E. and D'Hooghe, M. and Dubois, B. and Dupuis, M. and Sankari, S.E. and Geens, K. and Guillaume, D. and van Landegem, W. and Lysandropoulos, A. and de Noordhout, A.M. and Medaer, R. and Melin, A. and Peeters, K. and Ba, R.P. and Retif, C. and Seeldrayers, P. and Symons, A. and Urbain, E. and Vanderdonckt, P. and Van Ingelghem, E. and Vanopdenbosch, L. and Vanroose, E. and Van Wijmeersch, B. and Willekens, B. and Willems, C. and Sindic, C.",
volume="114",
number="3",
pages="167-178",
abstract="Natalizumab (Tysabri®) is highly efficacious in controlling disease activity in relapsing multiple sclerosis (MS) patients. As it is one of the more recent therapies for MS, there remains a need for long-term safety and efficacy data of natalizumab in a clinical practice setting. The Tysabri observational program (TOP) is an open-label, multicenter, multinational, prospective observational study, aiming to recruit up to 6,000 patients with relapsing-remitting MS from Europe, Canada and Australia. The objectives of this study are to collect long-term safety and efficacy data on disease activity and disability progression. We report here the interim results of the 563 patients included in TOP between December 2007 and 2012 from Belgium. This patient cohort was older at baseline, had longer disease duration, higher neurological impairment, and a higher baseline annualized relapse rate, when compared to patients included in the pivotal phase III AFFIRM trial. Nevertheless, the efficacy of natalizumab was comparable. The annualized relapse rate on treatment was reduced by 90.70 % (p < 0.0001) with a cumulative probability of relapse of 26.87 % at 24 months. The cumulative probabilities of sustained disability improvement and progression at 24 months were 25.68 and 9.01 %, respectively. There were no new safety concerns over the follow-up period. Two cases of progressive multifocal leukoencephalopathy were diagnosed. Our results are consistent with other observational studies in the post-marketing setting. © 2014 Belgian Neurological Society.<p /><p>Language: en</p>",
language="en",
issn="0300-9009",
doi="10.1007/s13760-014-0308-9",
url="http://dx.doi.org/10.1007/s13760-014-0308-9"
}