Article (Scientific journals)
Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program.
van Pesch, Vincent; Bartholome, Emmanuel; Bissay, Veronique et al.
2014In Acta Neurologica Belgica, 114 (3), p. 167-78
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Abstract :
[en] Natalizumab (Tysabri((R))) 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.
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Author, co-author :
van Pesch, Vincent
Bartholome, Emmanuel
Bissay, Veronique
Bouquiaux, Olivier
Bureau, Michel
Caekebeke, Jo
Debruyne, Jan
Declercq, Inge
Decoo, Dany
Denayer, Pierre
De Smet, Eric
D'hooghe, Marie
Dubois, Benedicte
Dupuis, Michel
Sankari, Souraya El
Geens, Karine
Guillaume, Daniel ;  Université de Liège - ULiège > Département des sciences cliniques > Médecine générale
van Landegem, William
Lysandropoulos, Andreas
de Noordhout, Alain Maertens
Medaer, Robert
Melin, Annick
Peeters, Katelijne
Phan Ba, Rémy ;  Université de Liège - ULiège > Doct. sc. médicales (Bologne)
Retif, Cecile
Seeldrayers, Pierrette
Symons, Anoek
Urbain, Etienne
Vanderdonckt, Patrick
Van Ingelghem, Erwin
Vanopdenbosch, Ludo
Vanroose, Erwin
Van Wijmeersch, Bart
Willekens, Barbara
Willems, Christiana
Sindic, Christian
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Title :
Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program.
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Journal title :
Acta Neurologica Belgica
Publisher :
Acta Medica Belgica, Bruxelles, Belgium
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