title: Treatment effect of natalizumab on relapse outcomes in multiple sclerosis patients despite ongoing MRI activity.
abstract: Natalizumab treatment significantly reduced the annualised relapse rate and MRI activity over 2 years compared with placebo in phase III trials when administered as monotherapy in AFFIRM or in combination with interferon β-1a (IFNβ) in SENTINEL. The post hoc analyses reported here sought to determine the effect of natalizumab treatment on relapse activity in the minority of patients who continued to show MRI activity (ie, ≥ 1 gadolinium enhancing (Gd+) lesions or new or enlarging T2 hyperintense lesions) over 2 years in these trials. These analyses demonstrated that natalizumab treatment, both alone (AFFIRM) and in combination with IFNβ (SENTINEL), resulted in a reduced annualised relapse rate despite the presence of Gd+ lesions (p=0.004 and p=0.008, respectively) or new or enlarging T2 hyperintense lesions (each p<0.0001). Thus patients treated with natalizumab show clinical benefit even in the presence of continued MRI activity. Long term clinical outcome of these patients has not been studied.
authors.affiliation: Department of Neurology, Royal Victoria Infirmary, Newcastle University, Newcastle on Tyne NE1 4LP, UK. david.bates@newcastle.ac.uk
authors.forename: David
authors.initials: D
authors.lastname: Bates
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Bartholomé
mesh_terms: D000293:Adolescent; D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D001921:Brain / Q000473:pathology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage / Q000627:therapeutic use; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000473:pathology; D000069442:Natalizumab; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D007155:Immunologic Factors; D000069442:Natalizumab; D016899:Interferon-beta; D000068556:Interferon beta-1a