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The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL

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An Erratum to this article was published on 29 May 2009

Abstract

The AFFIRM and SENTINEL studies showed that natalizumab was effective both as monotherapy and in combination with interferon beta (IFNβ)-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, ≥ 3), Expanded Disability Status Scale score (≤ 3.5, > 3.5), number of T2 lesions (< 9, ≥ 9), presence of gadolinium-enhancing (Gd+) lesions (0, ≥ 1), age (< 40, ≥ 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., ≥ 2 relapses in the year before study entry and ≥ 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: ≥ 9 T2 lesions at baseline, ≥ 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 IFNβ-1a treatment. These results indicate that natalizumab is effective in reducing disability progres- sion and relapses in patients with relapsing MS, particularly in patients with highly active disease.

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Authors and Affiliations

  1. Dept. of Neurology, St. Vincent’s University Hospital, Dublin, Ireland

    M. Hutchinson MD

  2. Dept. of Neurology, University Hospital Basel, Basel, Switzerland

    L. Kappos & E.-W. Radue

  3. Dept. of Neurology, The Johns Hopkins University School of Medicine, Baltimore, MD, USA

    P. A. Calabresi

  4. Hôpital Neurologique, Lyon, France

    C. Confavreux

  5. Institute of Neurology, London, United Kingdom

    G. Giovannoni & D. H. Miller

  6. Dept. of Neurology, University of Pennsylvania, School of Medicine, Philadelphia, PA, USA

    S. L. Galetta

  7. General Teaching Hospital, Prague, Czech Republic

    E. Havrdova

  8. Mt. Sinai School of Medicine, New York, NY, USA

    F. D. Lublin

  9. St. Michael’s Hospital, Toronto, Ontario, CA, USA

    P. W. O’Connor

  10. Multiple Sclerosis Center at Texas Neurology, Dallas, TX, USA

    J. T. Phillips

  11. Vrije Universiteit Medical Center, Amsterdam, The Netherlands

    C. H. Polman

  12. Mellen Center for Multiple Sclerosis Research, Cleveland Clinic Foundation, Cleveland, OH, USA

    R. A. Rudick

  13. MS Center of Atlanta, Atlanta, GA, USA

    W. H. Stuart

  14. Silesian Medical University, Katowice, Poland

    A. Wajgt

  15. Baird Multiple Sclerosis Center, State University of New York at Buffalo, Buffalo, NY, USA

    B. Weinstock-Guttman

  16. Consultants in Neurology, Multiple Sclerosis Center, Northbrook, IL, USA

    D. R. Wynn

  17. Biogen Idec, Cambridge, MA, USA

    F. Lynn & M. A. Panzara

Authors
  1. M. Hutchinson MD
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  2. L. Kappos
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  3. P. A. Calabresi
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  4. C. Confavreux
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  5. G. Giovannoni
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  6. S. L. Galetta
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  7. E. Havrdova
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  8. F. D. Lublin
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  9. D. H. Miller
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  10. P. W. O’Connor
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  15. W. H. Stuart
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  18. D. R. Wynn
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  19. F. Lynn
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  20. M. A. Panzara
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for the AFFIRM and SENTINEL Investigators

Corresponding author

Correspondence to M. Hutchinson MD.

Additional information

An erratum to this article is available at http://dx.doi.org/10.1007/s00415-009-5183-6.

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Hutchinson, M., Kappos, L., Calabresi, P.A. et al. The efficacy of natalizumab in patients with relapsing multiple sclerosis: subgroup analyses of AFFIRM and SENTINEL. J Neurol 256, 405–415 (2009). https://doi.org/10.1007/s00415-009-0093-1

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  • DOI: https://doi.org/10.1007/s00415-009-0093-1

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