Citation

van Pesch V, Bartholomé E, Bissay V, Bouquiaux O, Bureau M, Caekebeke J, Debruyne J, Declercq I, Decoo D, Denayer P, De Smet E, D'Hooghe M, Dubois B, Dupuis M, Sankari SE, Geens K, Guillaume D, van Landegem W, Lysandropoulos A, de Noordhout AM, Medaer R, Melin A, Peeters K, Ba RP, Retif C, Seeldrayers P, Symons A, Urbain E, Vanderdonckt P, Van Ingelghem E, Vanopdenbosch L, Vanroose E, Van Wijmeersch B, Willekens B, Willems C, Sindic C. Acta Neurol. Belg. 2014; 114(3): 167-178.

Copyright

(Copyright © 2014, Acta Medica Belgica)

DOI

10.1007/s13760-014-0308-9

PMID

unavailable

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.

Language: en

Keywords

adolescent; Safety; adult; disability; human; suicide; female; male; aged; incidence; polymerase chain reaction; Multiple sclerosis; randomized controlled trial; scoring system; treatment outcome; migraine; article; major clinical study; controlled study; virus infection; glioblastoma; phase 3 clinical trial; vertigo; disease course; middle aged; bleeding; anxiety disorder; panic; urine retention; nuclear magnetic resonance imaging; influenza; lung embolism; tonic clonic seizure; drug safety; seizure; drug efficacy; drug withdrawal; acute heart infarction; Observational study; hepatitis; anemia; postoperative infection; Natalizumab; azathioprine; multiple sclerosis; nephrolithiasis; pneumonia; cystitis; drug hypersensitivity; trigeminus neuralgia; hip fracture; cytomegalovirus infection; spontaneous abortion; ovary polycystic disease; toxic hepatitis; deep vein thrombosis; observational study; disease activity; methotrexate; bacterial infection; uterine cervix cancer; beta1a interferon; glatiramer; incontinence; cerebrospinal fluid; colitis; cyclophosphamide; uterus myoma; interferon beta serine; endometriosis; anaphylactic shock; mitoxantrone; natalizumab; progressive multifocal leukoencephalopathy; rib fracture; fingolimod; intervertebral disk hernia; meningioma; Therapeutic efficacy; liquorrhea; non ST segment elevation myocardial infarction; medical device complication; avascular necrosis; bladder disease; allergic urticaria; bladder stone; diskitis; evaluation and follow up; group B streptococcal meningitis; hip osteoarthritis; hyperventilation syndrome; ischemic cardiomyopathy; primary sclerosing cholangitis