The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL
| Autor: | A Wajgt, Peter A. Calabresi, Richard A. Rudick, Gavin Giovannoni, Michael Hutchinson, Eva Havrdova, DH Miller, Chris H. Polman, Bianca Weinstock-Guttman, F Lynn, SL Galetta, WH Stuart, Daniel Wynn, Christian Confavreux, Ernst Wilhelm Radue, Michael Panzara, JT Phillips, Paul O'Connor, Ludwig Kappos, Fred D. Lublin |
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| Přispěvatelé: | Neurology, NCA - Multiple Sclerosis and Other Neuroinflammatory Diseases |
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Neurology Adolescent Gadolinium Subgroup analysis Kaplan-Meier Estimate Antibodies Monoclonal Humanized Severity of Illness Index law.invention Young Adult Multiple Sclerosis Relapsing-Remitting Natalizumab Randomized controlled trial Recurrence law Internal medicine Severity of illness Post-hoc analysis medicine Humans Immunologic Factors In patient Proportional Hazards Models Expanded Disability Status Scale business.industry Multiple sclerosis Interferon beta-1a Antibodies Monoclonal Interferon-beta Middle Aged medicine.disease Surgery Treatment Outcome Disease Progression Physical therapy Female Neurology (clinical) business medicine.drug |
| Zdroj: | Journal of Neurology, 256(3), 405-415. D. Steinkopff-Verlag Hutchinson, M, Kappos, L, Calabresi, P A, Confavreux, C, Giovannoni, G, Galetta, S L, Havrdova, E, Lublin, F D, Miller, D, O'Connor, P W, Phillips, J T, Polman, C H, Radue, E W, Rudick, R A, Stuart, W H, Wajgt, A, Weinstock-Guttman, B, Wynn, D R, Lynn, F & Panzara, M A 2009, ' The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL ', Journal of Neurology, vol. 256, no. 3, pp. 405-415 . https://doi.org/10.1007/s00415-009-0093-1 |
| ISSN: | 0340-5354 |
| DOI: | 10.1007/s00415-009-0093-1 |
| Popis: | The 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 andor = 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 with9 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 patients40 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. |
| Databáze: | OpenAIRE |
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