title: Effect of natalizumab on clinical and radiological disease activity in a French cohort of patients with relapsing-remitting multiple sclerosis.
abstract: "Disease activity free" in relapsing-remitting multiple sclerosis (RRMS) is a new concept introduced by the results of the AFFIRM study. Our objective was to analyze the clinical and radiological efficacy of natalizumab treatment in actual clinical practice and compare it with the post hoc analysis of the AFFIRM study. All patients with RRMS who began treatment with natalizumab at our two French MS centres between April 2007 and May 2008 were included and followed-up for at least 2 years. No measurable disease activity ("disease activity free") was defined as no activity on clinical measures (no relapses and no sustained disability progression) and radiological measures (no gadolinium-enhancing lesions and no new T2-hyperintense lesions on cerebral MRI). A total of 193 patients were included. Natalizumab was discontinued in 25.9% of cases before the completion of 2 years of treatment. In our cohort, we observed patients with more severe disease than in the AFFIRM study. The proportion of patients remaining free of clinical activity during 2 years of treatment was lower than in the AFFIRM study (37.8% vs. 64.3%). The proportion of patients remaining free of radiological activity during 2 years of treatment was higher than in the AFFIRM study (68.9% vs. 57.7%), while the proportion of patients remaining free of disease activity during 2 years of treatment was comparable to the AFFIRM study (33.3% vs. 36.7%). Natalizumab seems to be as effective in a real-life setting as in pivotal and post hoc studies. The confirmation of such benefits is important because of the progressive multifocal leukoencephalopathy risk.
authors.affiliation: Department of Neurology, Université Lille Nord de France, Roger Salengro Hospital, 1 Rue Emile Laine, 59037 Lille Cedex, France.
authors.forename: A
authors.initials: A
authors.lastname: Melin
authors.forename: O
authors.initials: O
authors.lastname: Outteryck
authors.forename: N
authors.initials: N
authors.lastname: Collongues
authors.forename: H
authors.initials: H
authors.lastname: Zéphir
authors.forename: M C
authors.initials: MC
authors.lastname: Fleury
authors.forename: F
authors.initials: F
authors.lastname: Blanc
authors.forename: A
authors.initials: A
authors.lastname: Lacour
authors.forename: J C
authors.initials: JC
authors.lastname: Ongagna
authors.forename: A S
authors.initials: AS
authors.lastname: Berteloot
authors.forename: P
authors.initials: P
authors.lastname: Vermersch
authors.forename: J
authors.initials: J
authors.lastname: de Sèze
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D020529:Multiple Sclerosis, Relapsing-Remitting / Q000000981:diagnostic imaging* / Q000188:drug therapy* / Q000453:epidemiology; D000069442:Natalizumab; D011446:Prospective Studies; D011859:Radiography; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069442:Natalizumab