Acta Neurologica Belgica

, Volume 114, Issue 3, pp 167–178 | Cite as

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

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 sclerosis Natalizumab Observational study Therapeutic efficacy Safety 

Notes

Conflict of interest

The natalizumab Observational Program is funded by Biogen Idec. Although the authors had full editorial control, Biogen Idec reviewed the manuscript prior to submission and provided feedback to the authors.

V. van Pesch: has received travel grants, honoraria for consultancy and lectures from Bayer-Schering, Biogen Idec, Merck Serono, Novartis, Sanofi-Aventis-Genzyme and Teva.

E. Bartholomé: EB is Chief Medical Officer of Medical Device Works. EB has received scientific and travel grants from Abbvie, Bayer Schering, Biogen Idec, Novartis, Sanofi-Aventis-Genzyme, Merck Serono and TEVA. EB has had consultancy contracts with Biogen Idec, Novartis, Sanofi-Aventis-Genzyme, and Merck Serono. EB is or has been member of Advisory Boards for Biogen Idec, Novartis, Sanofi-Aventis-Genzyme, and Serono.

V. Bissay: has been a member of an Advisory Board for Biogen Idec and has received travel grants from Bayer Schering, Biogen Idec, Novartis, Merck Serono and TEVA.

O. Bouquiaux: has received scientific grants from Biogen Idec and Novartis.

M. Bureau: has no disclosures to report.

Jo Caekebeke: scientific and/or travel grants from Abboth, GSK, Bayer Schering, Biogen Idec, Novartis, Merck Serono and TEVA.

J. Debruyne: has received grants from Novartis, Biogen Idec, Bayer Schering, Merck Serono and Teva.

I. Declercq: no disclosures reported.

D. Decoo: has received scientific and travel grants from Abbvie, Bayer Schering, Biogen Idec,

Novartis, Sanofi-Aventis/Genzyme, Merck Serono and Teva. DD has consultancy contracts with Biogen Idec, Novartis, Sanofi-Aventis/Genzyme and GLG. DD is or has been member of Advisory Boards for Biogen Idec, Novartis, Sanofi-Aventis-Genzyme.

P. Denayer: no disclosures to report.

E. Desmet: has received grants from Biogen Idec and Teva.

B. D’Hooghe: has been a consultant for Biogen Idec, Bayer Schering, Merck Serono, Allergan, Novartis and Genzyme Sanofi.

B. Dubois: is a Clinical Investigator of the Fund for Scientific Research (FWO-Vlaanderen), and is supported by the Merck Chair Multiple Sclerosis. She also received an educational grant from Novartis.

M. Dupuis: no disclosures reported.

S. El Sankari: has received travel grants from Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Sanofi Genzyme. SE is a member of an advisory board for Biogen Idec.

K. Geens: has received scientific and/or travel grants from Abboth, Glaxo-Smith-Kline, Bayer Schering, Biogen Idec, Novartis, Sanofi-Aventis-Genzyme, Merck Serono and TEVA.

D. Guillaume: DG has received scientific and travel grants from Bayer Schering, Biogen Idec, Novartis, Sanofi-Aventis and Sanofi-Genzyme, Merck Serono and TEVA. DG has been member of Advisory Boards for Biogen Idec, Novartis, Sanofi-Genzyme.

W. van Landeghem: has received scientific and/or travel grants from Abboth, Allergan, Bayer, Biogen Idec, Boehringer, Cyberonics, Glaxo-Smith-Kline, Ipsen, Medelec, Merck Serono, Novartis, Sanofi-Aventis-Genzyme, UCB and TEVA.

A. Lyssandropoulos: has received scientific and travel grants from Bayer, Biogen Idec,

Sanofi-Aventis-Genzyme, Serono and TEVA. AL has had consultancy contracts with Bayer and Novartis. AL is or has been the member of Advisory Boards for Biogen Idec and Sanofi-Aventis-Genzyme.

A. Maertens: has received travel grants from Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Sanofi Genzyme.

R. Medaer: no disclosures reported.

A. Melin: no disclosures reported.

K. Peeters: no disclosures reported.

R. Phan–Ba: has served at Scientific Advisory Boards for Genzyme Sanofi Aventis and has received funding for travel from Genyzme–Sanofi Aventis, Bayer Schering Pharma and Biogen Idec.

C. Retif: no disclosures reported.

P. Seeldrayers: is a member of Advisory Boards for Biogen Idec, Novartis, Merck Serono, Bayer Schering, Teva and Sanofi Genzyme. PS has received travel grant and research support from Biogen Idec.

A. Symons: has been a member of advisory boards of Biogen Idec, Genzyme and Merck Serono. AS is currently an employee of Biogen Idec.

E. Urbain: has received scientific and travel grants from Biogen Idec, Bayer Schering, Sanofi-Aventis, Novartis and Merck Serono.

P. Vanderdonckt: has received scientific and/or travel grants from Abboth, GSK, Bayer Schering, Biogen Idec, Novartis, Merck Serono, TEVA and Cyberonics.

E. Van Ingelghem: no disclosures reported.

L Vanopdenbosch: has received honoraria for consultancy and lectures, educational and occasional institutional grants by Novartis, Merck Serono, Teva, Biogen Idec, Bayer Schering and UCB. LV serves on the editorial board of Tijdschrift van Neurologie en Neurochirurgie.

E. Vanroose: has received travel grants from Biogen Idec, Bayer Schering, Merck Serono, Teva, Novartis and Sanofi Genzyme.

B. Van Wijmersch: has received scientific and travel grants from Biogen Idec, Novartis, Sanofi-Aventis-Genzyme, TEVA, Merck Serono and Bayer Schering.

B. Willekens: has served as a member of advisory boards for Biogen Idec, Genzyme, Bayer Schering, Merck Serono, Novartis; has received honoraria for lectures from Biogen Idec, Novartis and Bayer Schering; has received travel grants from Biogen Idec, Merck Serono, Bayer schering, Novartis and TEVA.

C. Willems: has no disclosures to report.

C. Sindic: has received honoraria for consultancy and lectures, educational and research grants from Bayer-Schering, Biogen Idec, GSK Biological Vaccines, Merck Serono, Novartis, Sanofi-Aventis and Teva.

Supplementary material

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Supplementary material 1 (DOCX 99 kb)
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Supplementary material 3 (DOCX 73 kb)
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Supplementary material 5 (DOCX 58 kb)

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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

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