1. Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program
- Author
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Marie-Claire D'Hooghe, Véronique Bissay, Eric De Smet, Erwin Van Ingelghem, Olivier Bouquiaux, Etienne Urbain, Katelijne Peeters, Daniel Guillaume, Andreas Lysandropoulos, Johan Caekebeke, Jana Debruyne, Pierrette Seeldrayers, Annick Melin, Pierre Denayer, Vincent Van Pesch, Ludo Vanopdenbosch, D Decoo, Inge Declercq, Patrick Vanderdonckt, Robert Medaer, Rémy Phan Ba, Bart Van Wijmeersch, Christian Sindic, Christiana Willems, Souraya El Sankari, Michel Dupuis, Anoek Symons, Barbara Willekens, Alain Maertens De Noordhout, Cécile Retif, Bénédicte Dubois, William van Landegem, Michel Bureau, Karine Geens, Emmanuel Bartholomé, Erwin Vanroose, Physics, Elementary Particle Physics, Clinical sciences, and Neuroprotection & Neuromodulation
- Subjects
Adult ,Male ,medicine.medical_specialty ,Multiple Sclerosis ,Time Factors ,Adolescent ,International Cooperation ,Subgroup analysis ,Antibodies, Monoclonal, Humanized ,Severity of Illness Index ,Cohort Studies ,Disability Evaluation ,Young Adult ,Age Distribution ,Natalizumab ,Belgium ,Internal medicine ,Severity of illness ,Product Surveillance, Postmarketing ,medicine ,Humans ,Immunologic Factors ,Aged ,business.industry ,Multiple sclerosis ,Progressive multifocal leukoencephalopathy ,General Medicine ,Middle Aged ,medicine.disease ,Magnetic Resonance Imaging ,Treatment Outcome ,Cohort ,Physical therapy ,Female ,Observational study ,Neurology (clinical) ,Human medicine ,business ,Cohort study ,medicine.drug - Abstract
Natalizumab (Tysabri(A (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.
- Published
- 2014