Acta Neurologica Belgica

, Volume 114, Issue 3, pp 167–178

Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program

  • Vincent van Pesch
  • Emmanuel Bartholomé
  • Véronique Bissay
  • Olivier Bouquiaux
  • Michel Bureau
  • Jo Caekebeke
  • Jan Debruyne
  • Inge Declercq
  • Dany Decoo
  • Pierre Denayer
  • Eric De Smet
  • Marie D’hooghe
  • Bénédicte Dubois
  • Michel Dupuis
  • Souraya El Sankari
  • Karine Geens
  • Daniel Guillaume
  • William van Landegem
  • Andreas Lysandropoulos
  • Alain Maertens de Noordhout
  • Robert Medaer
  • Annick Melin
  • Katelijne Peeters
  • Rémy Phan Ba
  • Cécile Retif
  • Pierrette Seeldrayers
  • Anoek Symons
  • Etienne Urbain
  • Patrick Vanderdonckt
  • Erwin Van Ingelghem
  • Ludo Vanopdenbosch
  • Erwin Vanroose
  • Bart Van Wijmeersch
  • Barbara Willekens
  • Christiana Willems
  • Christian Sindic
Original Article

DOI: 10.1007/s13760-014-0308-9

Cite this article as:
van Pesch, V., Bartholomé, E., Bissay, V. et al. Acta Neurol Belg (2014) 114: 167. doi:10.1007/s13760-014-0308-9

Abstract

Natalizumab (Tysabri®) is highly efficacious in controlling disease activity in relapsing multiple sclerosis (MS) patients. As it is one of the more recent therapies for MS, there remains a need for long-term safety and efficacy data of natalizumab in a clinical practice setting. The Tysabri observational program (TOP) is an open-label, multicenter, multinational, prospective observational study, aiming to recruit up to 6,000 patients with relapsing-remitting MS from Europe, Canada and Australia. The objectives of this study are to collect long-term safety and efficacy data on disease activity and disability progression. We report here the interim results of the 563 patients included in TOP between December 2007 and 2012 from Belgium. This patient cohort was older at baseline, had longer disease duration, higher neurological impairment, and a higher baseline annualized relapse rate, when compared to patients included in the pivotal phase III AFFIRM trial. Nevertheless, the efficacy of natalizumab was comparable. The annualized relapse rate on treatment was reduced by 90.70 % (p < 0.0001) with a cumulative probability of relapse of 26.87 % at 24 months. The cumulative probabilities of sustained disability improvement and progression at 24 months were 25.68 and 9.01 %, respectively. There were no new safety concerns over the follow-up period. Two cases of progressive multifocal leukoencephalopathy were diagnosed. Our results are consistent with other observational studies in the post-marketing setting.

Keywords

Multiple sclerosisNatalizumabObservational studyTherapeutic efficacySafety

Supplementary material

13760_2014_308_MOESM1_ESM.docx (99 kb)
Supplementary material 1 (DOCX 99 kb)
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Supplementary material 2 (DOCX 97 kb)
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Supplementary material 3 (DOCX 73 kb)
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Supplementary material 4 (DOCX 58 kb)
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Supplementary material 5 (DOCX 58 kb)

Copyright information

© Belgian Neurological Society 2014

Authors and Affiliations

  • Vincent van Pesch
    • 1
  • Emmanuel Bartholomé
    • 2
  • Véronique Bissay
    • 3
  • Olivier Bouquiaux
    • 4
  • Michel Bureau
    • 5
  • Jo Caekebeke
    • 6
  • Jan Debruyne
    • 7
  • Inge Declercq
    • 8
  • Dany Decoo
    • 9
  • Pierre Denayer
    • 10
  • Eric De Smet
    • 11
  • Marie D’hooghe
    • 12
  • Bénédicte Dubois
    • 13
  • Michel Dupuis
    • 14
  • Souraya El Sankari
    • 1
  • Karine Geens
    • 15
  • Daniel Guillaume
    • 16
  • William van Landegem
    • 17
  • Andreas Lysandropoulos
    • 18
  • Alain Maertens de Noordhout
    • 19
  • Robert Medaer
    • 20
  • Annick Melin
    • 21
  • Katelijne Peeters
    • 22
  • Rémy Phan Ba
    • 23
  • Cécile Retif
    • 24
  • Pierrette Seeldrayers
    • 25
  • Anoek Symons
    • 26
  • Etienne Urbain
    • 27
  • Patrick Vanderdonckt
    • 28
  • Erwin Van Ingelghem
    • 29
  • Ludo Vanopdenbosch
    • 30
  • Erwin Vanroose
    • 31
  • Bart Van Wijmeersch
    • 11
  • Barbara Willekens
    • 32
  • Christiana Willems
    • 22
  • Christian Sindic
    • 1
  1. 1.Neurology DepartmentCliniques Universitaires St-LucWoluwe-Saint-LambertBelgium
  2. 2.CHU TivoliLa LouviereBelgium
  3. 3.UZ BrusselBrusselBelgium
  4. 4.CHA LibramontLibramontBelgium
  5. 5.Clinique Reine AstridMalmédyBelgium
  6. 6.OLVZ AalstAalstBelgium
  7. 7.UZ GentGhentBelgium
  8. 8.Europaziekenhuizen, Site Sainte-ElisabethBrusselsBelgium
  9. 9.AZ AlmaSijseleBelgium
  10. 10.A.I.T. TournaiTournaiBelgium
  11. 11.Revalidatie and MS-CentrumOverpeltBelgium
  12. 12.MS CenterMelsbroekBelgium
  13. 13.UZ LeuvenLouvainBelgium
  14. 14.Clinique St. PierreOttigniesBelgium
  15. 15.AZ KlinaBrasschaatBelgium
  16. 16.Centre NeurologiqueFraitureBelgium
  17. 17.GZA St. AugustinusWilijkBelgium
  18. 18.Hopital ErasmeBrussels, AnderlechtBelgium
  19. 19.C.H.R. CitadelleLiègeBelgium
  20. 20.C.N.L. N.VBochholtBelgium
  21. 21.Cliniques Saint JosephLiègeBelgium
  22. 22.Jessaziekenhuis campus SalvatorHasseltBelgium
  23. 23.Hopital Universitaire du Sart-TilmanLiègeBelgium
  24. 24.CHU St. PierreBrusselsBelgium
  25. 25.CHU de Charleroi, Hopital CivilCharleroiBelgium
  26. 26.ZNA MiddelheimAntwerpBelgium
  27. 27.Grand Hôpital de Charleroi, Site Notre DameCharleroiBelgium
  28. 28.AZ GroeningeKortrijkBelgium
  29. 29.AZ DamiaanOstendBelgium
  30. 30.AZ Sint Jan BruggeBruggeBelgium
  31. 31.Ziekenhuis Oost-LimburgGenkBelgium
  32. 32.UZ AntwerpenEdegemBelgium