The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL.
Calabresi, Peter A
Galetta, Steven L
Lublin, Fred D
Miller, David H
O'Connor, Paul W
Phillips, J Theodore
Polman, Chris H
Rudick, Richard A
Stuart, William H
Wynn, Daniel R
Panzara, Michael A
AffiliationDept. of Neurology, St. Vincent's University Hospital, Dublin, Ireland., email@example.com
Antibodies, Monoclonal/*therapeutic use
Antibodies, Monoclonal, Humanized
Immunologic Factors/*therapeutic use
Multiple Sclerosis, Relapsing-Remitting/*drug therapy/pathology/physiopathology
Proportional Hazards Models
Severity of Illness Index
MetadataShow full item record
CitationJ Neurol. 2009 Mar;256(3):405-15. Epub 2009 Mar 18.
JournalJournal of neurology
AbstractThe AFFIRM and SENTINEL studies showed that natalizumab was effective both as monotherapy and in combination with interferon beta (IFNbeta)-1a in patients with relapsing multiple sclerosis (MS). Further analyses of AFFIRM and SENTINEL data were conducted to determine the efficacy of natalizumab in prespecified patient subgroups according to baseline characteristics: relapse history 1 year before randomization (1, 2, > or = 3), Expanded Disability Status Scale score (< or = 3.5, > 3.5), number of T2 lesions (< 9, > or = 9), presence of gadolinium-enhancing (Gd+) lesions (0, > or = 1), age (< 40, > or = 40) and gender (male, female). A post hoc analysis was conducted to determine the efficacy of natalizumab in patients with highly active disease (i. e., > or = 2 relapses in the year before study entry and > or = 1 Gd+ lesion at study entry). In both AFFIRM and SENTINEL studies natalizumab reduced the annualized relapse rates across all subgroups (except the small subgroups with < 9 baseline T2 lesions) over 2 years. In AFFIRM, natalizumab significantly reduced the risk of sustained disability progression in most subgroups. In SENTINEL, natalizumab significantly reduced the risk of sustained disability progression in the following subgroups: > or = 9 T2 lesions at baseline, > or = 1 Gd+ lesions at baseline, female patients and patients < 40 years of age. Natalizumab reduced the risk of disability progression by 64 % and relapse rate by 81 % in treatment- naive patients with highly active disease and by 58 % and 76 %, respectively, in patients with highly active disease despite IFNbeta-1a treatment. These results indicate that natalizumab is effective in reducing disability progression and relapses in patients with relapsing MS, particularly in patients with highly active disease.
- Additional efficacy endpoints from pivotal natalizumab trials in relapsing-remitting MS.
- Authors: Weinstock-Guttman B, Galetta SL, Giovannoni G, Havrdova E, Hutchinson M, Kappos L, O'Connor PW, Phillips JT, Polman C, Stuart WH, Lynn F, Hotermans C
- Issue date: 2012 May
- Efficacy of natalizumab in second line therapy of relapsing-remitting multiple sclerosis: results from a multi-center study in German speaking countries.
- Authors: Putzki N, Yaldizli O, Mäurer M, Cursiefen S, Kuckert S, Klawe C, Maschke M, Tettenborn B, Limmroth V
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- Natalizumab plus interferon beta-1a for relapsing multiple sclerosis.
- Authors: Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW, SENTINEL Investigators.
- Issue date: 2006 Mar 2
- Natalizumab plus interferon beta-1a reduces lesion formation in relapsing multiple sclerosis.
- Authors: Radue EW, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Rudick RA, Lublin FD, Weinstock-Guttman B, Wynn DR, Fisher E, Papadopoulou A, Lynn F, Panzara MA, Sandrock AW, SENTINEL Investigators.
- Issue date: 2010 May 15
- Treatment effectiveness of alemtuzumab compared with natalizumab, fingolimod, and interferon beta in relapsing-remitting multiple sclerosis: a cohort study.
- Authors: Kalincik T, Brown JWL, Robertson N, Willis M, Scolding N, Rice CM, Wilkins A, Pearson O, Ziemssen T, Hutchinson M, McGuigan C, Jokubaitis V, Spelman T, Horakova D, Havrdova E, Trojano M, Izquierdo G, Lugaresi A, Prat A, Girard M, Duquette P, Grammond P, Alroughani R, Pucci E, Sola P, Hupperts R, Lechner-Scott J, Terzi M, Van Pesch V, Rozsa C, Grand'Maison F, Boz C, Granella F, Slee M, Spitaleri D, Olascoaga J, Bergamaschi R, Verheul F, Vucic S, McCombe P, Hodgkinson S, Sanchez-Menoyo JL, Ampapa R, Simo M, Csepany T, Ramo C, Cristiano E, Barnett M, Butzkueven H, Coles A, MSBase Study Group.
- Issue date: 2017 Apr