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Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program

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Van Pesch, Vincent [UCL] Bartholomé, Emmanuel Bissay, Véronique Bouquiaux, Olivier Bureau, Michel El Sankari, Souraya [UCL] Sindic, Christian [UCL]

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.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2014
Language Anglais
Journal information "Acta Neurologica Belgica" - Vol. 114, no.3, p. 167-178 (2014)
Peer reviewed yes
Publisher Springer ((Italia) Milano)
issn 0300-9009
e-issn 2240-2993
Publication status Publié
Affiliations UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire
UCL - (SLuc) Service de neurologie
UCL - SSS/IONS/NEUR - Clinical Neuroscience
Links
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Bibliographic reference Van Pesch, Vincent ; Bartholomé, Emmanuel ; Bissay, Véronique ; Bouquiaux, Olivier ; Bureau, Michel ; et. al. Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program. In: Acta Neurologica Belgica, Vol. 114, no.3, p. 167-178 (2014)
Permanent URL http://hdl.handle.net/2078.1/153416