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Journal of Neurology

, Volume 257, Issue 2, pp 207–211 | Cite as

Demographic and clinic characteristics of French patients treated with natalizumab in clinical practice

  • Olivier OutteryckEmail author
  • J.-C. Ongagna
  • H. Zéphir
  • M.-C. Fleury
  • A. Lacour
  • F. Blanc
  • P. Vermersch
  • J. de Sèze
Original Communication

Abstract

Natalizumab is the first selective adhesion molecule inhibitor indicated for treatment of active relapsing-remitting multiple sclerosis (RRMS). Natalizumab has been available in France since April 2007. The aims of this study are to analyze demographic, clinical, and tolerance data from French patients with RRMS treated with natalizumab in actual clinical practice and to draw comparisons with patients in the pivotal AFFIRM study. All patients with RRMS in the Nord-Pas de Calais and Alsace regions of France treated with natalizumab at any time since April 2007 were included. Variables analyzed included previous treatments; disability status [Expanded Disability Status Scale (EDSS) score]; annualized relapse rate (ARR) at baseline and after 12 months of treatment; and adverse events. Data from 384 patients (72% female) were evaluated. Mean baseline EDSS score was 3.53 and mean baseline ARR was 2.19, both significantly greater than in AFFIRM. One hundred twenty-seven patients completed 12 months of treatment; mean EDSS score in this group was 3.02 (14% reduction) and mean ARR was 0.59 (73% reduction). Although these patients had significantly different baseline characteristics and greater disability compared with patients receiving natalizumab in AFFIRM, average disability remained stable and ARR declined by 73%. Tolerability was similar to that observed in AFFIRM.

Keywords

Multiple sclerosis Natalizumab Treatment efficacy Safety Cohort analysis France 

Notes

Acknowledgments

The authors thank the neurologists who participated in the ALSACEP and GSEP networks and who contributed to the follow-up of this cohort of patients: A. Bahn, S. Dufour-Delalande, D. Ferriby (CH. Tourcoing); G. Calais, C. Crinquette, P. Hautecoeur, A. Manceaux (CH. Saint Philibert); S. Courtois, F. Derouiche, E. Muller (CH. Mulhouse); P. Devos (CH. Boulogne sur Mer); AC. Lepoutre, M. Marcel (CH. Lens); A. Monjour, C. Renglewicz-Destuynde, F. Sellal (CH. Colmar); and A. Verier (CH Valenciennes). Michael Theisen, Ann Marie Galioto, and Matthew Hasson, Scientific Connexions, Newtown, PA, USA provided technical and editorial support during the preparation of this manuscript for submission; funding for these activities was provided by Biogen Idec, Inc. and Elan Pharmaceuticals, Inc.

References

  1. 1.
    Agence Française de Sécurité Sanitaire des Produits de Santé. Bon usage; Mise au point: Utilisation de la spécialité TYSABRI® 300 mg (natalizumab) dans le traitement de la sclérose en plaques [PDF in French]. http://www.afssaps.fr/content/download/6205/60160/version/4/file/mise_au_tysabri.pdf. Accessed 22 Mar 2009
  2. 2.
    Biogen Idec, Inc. TYSABRI update. http://www.biogenidec.com/site/tysabri-information-center.html. Accessed 26 Mar 2009
  3. 3.
    Calabresi PA, Giovannoni G, Confavreux C, Galetta SL, Havrdova E, Hutchinson M, Kappos L, Miller DH, O’Connor PW, Phillips JT, Polman CH, Radue EW, Rudick RA, Stuart WH, Lublin FD, Wajgt A, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA (2007) The incidence and significance of anti-natalizumab antibodies: results from AFFIRM and SENTINEL. Neurology 69:1391–1403CrossRefPubMedGoogle Scholar
  4. 4.
    Confavreux C, Vukusic S (2006) Natural history of multiple sclerosis: a unifying concept. Brain 129:606–616CrossRefPubMedGoogle Scholar
  5. 5.
    European Medicines Agency. TYSABRI European public assessment report: scientific discussion. http://www.emea.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-en6.pdf. Accessed 31 Mar 2009
  6. 6.
    Hartung HP (2009) New cases of progressive multifocal leukoencephalopathy after treatment with natalizumab. Lancet Neurol 8:28–30CrossRefPubMedGoogle Scholar
  7. 7.
    Lublin FD, Reingold SC (1996) Defining the clinical course of multiple sclerosis: results of an international survey. Neurology 46:907–911PubMedGoogle Scholar
  8. 8.
    Mancardi GL, Amato MP, D’Alessandro R, Drago F, Milanese C, Popoli P, Provinciali L, Rossi P, Savettieri G, Tedeschi G, Rosaria Tola M, Vanacore N, Covezzoli A, De Rosa M, Piccinni C, Montarano N, Periotto L, Addis A, Martini N (2008) Natalizumab: a country-based surveillance program. Neurol Sci 29(Suppl 2):S235–S237CrossRefPubMedGoogle Scholar
  9. 9.
    Munschauer F, Giovannoni G, Lublin F, O’Connor PW, Phillips JT, Polman CH, Pace A, Kim R, Panzara MA (2008) Natalizumab significantly increases the cumulative probability of sustained improvement in physical disability. Poster 474 ACTRIMS/ECTRIMS 2008Google Scholar
  10. 10.
    Oturai AB, Koch-Henriksen N, Petersen T, Jensen PEH, Sellebjerg F, Sorensen PS (2009) Efficacy of natalizumab in multiple sclerosis patients with high disease activity: a Danish nationwide study. Eur J Neurol 16:420–423CrossRefPubMedGoogle Scholar
  11. 11.
    Polman CH, O’Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips T, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW (2006) A randomized, placebo-controlled trial of natalizumab for relapsing multiple sclerosis. N Engl J Med 354:899–910CrossRefPubMedGoogle Scholar
  12. 12.
    Polman CH, Reingold SC, Edan G, Filippi M, Hartung HP, Kappos L, Lublin FD, Metz LM, McFarland HF, O’Connor PW, Sandberg-Wollheim M, Thompson AJ, Weinshenker BG, Wolinsky JS (2005) Diagnostic criteria for multiple sclerosis: 2005 revisions to the “McDonald criteria”. Ann Neurol 58:840–846CrossRefPubMedGoogle Scholar
  13. 13.
    Putzki N, Kollila K, Woods S, Igwe E, Diener HC, Limmroth V (2009) Natalizumab is effective as second line therapy in the treatment of relapsing remitting multiple sclerosis. Eur J Neurol 16:424–426CrossRefPubMedGoogle Scholar
  14. 14.
    Schumacher GA, Beebe G, Kibler RF, Kurland LT, Kurtzke JF, McDowell F (1965) Problems of experimental trials of therapy in multiple sclerosis: report by the panel on the evaluation of experimental trials of therapy in multiple sclerosis. Ann NY Acad Sci 122:552–568CrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2009

Authors and Affiliations

  • Olivier Outteryck
    • 1
    Email author
  • J.-C. Ongagna
    • 2
  • H. Zéphir
    • 1
  • M.-C. Fleury
    • 2
  • A. Lacour
    • 1
  • F. Blanc
    • 2
  • P. Vermersch
    • 1
  • J. de Sèze
    • 2
  1. 1.Service de Neurologie DUniversité Lille Nord de France (EA2686), Pôle Neurologique, Hôpital Roger Salengro, CHRU LILLELille CedexFrance
  2. 2.Service de NeurologieHôpitaux UniversitairesStrasbourgFrance

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