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

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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.

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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.

Author information

Authors and Affiliations

  1. Neurology Department, Cliniques Universitaires St-Luc, Avenue Hippocrate 10, 1200, Woluwe-Saint-Lambert, Belgium

    Vincent van Pesch, Souraya El Sankari & Christian Sindic

  2. CHU Tivoli, Avenue Max Buset 34, 7100, La Louviere, Belgium

    Emmanuel Bartholomé

  3. UZ Brussel, Laarbeeklaan 101, 1090, Brussel, Belgium

    Véronique Bissay

  4. CHA Libramont, Avenue de Houffalize 35, 6800, Libramont, Belgium

    Olivier Bouquiaux

  5. Clinique Reine Astrid, Rue devant les Religieuses 2, 4960, Malmédy, Belgium

    Michel Bureau

  6. OLVZ Aalst, Moorselbaan 164, 9300, Aalst, Belgium

    Jo Caekebeke

  7. UZ Gent, De Pintelaan 185, 9000, Ghent, Belgium

    Jan Debruyne

  8. Europaziekenhuizen, Site Sainte-Elisabeth, Avenue De Fré 206, 1180, Brussels, Belgium

    Inge Declercq

  9. AZ Alma, Gentse Steenweg 132, 8340, Sijsele, Belgium

    Dany Decoo

  10. A.I.T. Tournai, Boulevard Lalaing 39, 7500, Tournai, Belgium

    Pierre Denayer

  11. Revalidatie and MS-Centrum, Boemerangstraat 2, 3900, Overpelt, Belgium

    Eric De Smet & Bart Van Wijmeersch

  12. MS Center, Vanheylenstraat 16, 1820, Melsbroek, Belgium

    Marie D’hooghe

  13. UZ Leuven, Herestraat 49, 3000, Louvain, Belgium

    Bénédicte Dubois

  14. Clinique St. Pierre, Avenue Reine Fabiola 9, 1340, Ottignies, Belgium

    Michel Dupuis

  15. AZ Klina, Augustijnslei 100, 2930, Brasschaat, Belgium

    Karine Geens

  16. Centre Neurologique, Champ des Alouettes 30, 4557, Fraiture, Belgium

    Daniel Guillaume

  17. GZA St. Augustinus, Oosterveldlaan 24, 2610, Wilijk, Belgium

    William van Landegem

  18. Hopital Erasme, Route de Lennik 808, 1070, Brussels, Anderlecht, Belgium

    Andreas Lysandropoulos

  19. C.H.R. Citadelle, Boulevard du 12ème de Ligne 1, 4000, Liège, Belgium

    Alain Maertens de Noordhout

  20. C.N.L. N.V, Kaulillerdorp 24, 3950, Bochholt, Belgium

    Robert Medaer

  21. Cliniques Saint Joseph, Rue de Hesbaye 75, 4000, Liège, Belgium

    Annick Melin

  22. Jessaziekenhuis campus Salvator, Salvatorstraat 20, 3500, Hasselt, Belgium

    Katelijne Peeters & Christiana Willems

  23. Hopital Universitaire du Sart-Tilman, Batiment B35, 4000, Liège, Belgium

    Rémy Phan Ba

  24. CHU St. Pierre, Rue Haute 322, 1000, Brussels, Belgium

    Cécile Retif

  25. CHU de Charleroi, Hopital Civil, Boulevard Paul Janson 92, 6000, Charleroi, Belgium

    Pierrette Seeldrayers

  26. ZNA Middelheim, Lindendreef 1, 2020, Antwerp, Belgium

    Anoek Symons

  27. Grand Hôpital de Charleroi, Site Notre Dame, Grand Rue 3, 6000, Charleroi, Belgium

    Etienne Urbain

  28. AZ Groeninge, President Kennedylaan 4, 8500, Kortrijk, Belgium

    Patrick Vanderdonckt

  29. AZ Damiaan, Gouwelozestraat 100, 8400, Ostend, Belgium

    Erwin Van Ingelghem

  30. AZ Sint Jan Brugge, Ruddershove 10, 8000, Brugge, Belgium

    Ludo Vanopdenbosch

  31. Ziekenhuis Oost-Limburg, Campus St.-Jan, Schiepse bos 6, 3600, Genk, Belgium

    Erwin Vanroose

  32. UZ Antwerpen, Wilrijkstraat 10, 2650, Edegem, Belgium

    Barbara Willekens

Authors
  1. Vincent van Pesch
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  2. Emmanuel Bartholomé
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  3. Véronique Bissay
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  4. Olivier Bouquiaux
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  5. Michel Bureau
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  6. Jo Caekebeke
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  7. Jan Debruyne
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  8. Inge Declercq
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  9. Dany Decoo
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  10. Pierre Denayer
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  11. Eric De Smet
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  12. Marie D’hooghe
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  13. Bénédicte Dubois
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  14. Michel Dupuis
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  15. Souraya El Sankari
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  16. Karine Geens
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  17. Daniel Guillaume
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  18. William van Landegem
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  19. Andreas Lysandropoulos
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  20. Alain Maertens de Noordhout
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  21. Robert Medaer
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  22. Annick Melin
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  23. Katelijne Peeters
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  24. Rémy Phan Ba
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  25. Cécile Retif
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  26. Pierrette Seeldrayers
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  27. Anoek Symons
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  28. Etienne Urbain
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  29. Patrick Vanderdonckt
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  30. Erwin Van Ingelghem
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  31. Ludo Vanopdenbosch
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  32. Erwin Vanroose
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  33. Bart Van Wijmeersch
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  34. Barbara Willekens
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  35. Christiana Willems
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  36. Christian Sindic
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Corresponding author

Correspondence to Vincent van Pesch.

Additional information

On behalf of the Belgian Study Group for Multiple Sclerosis.

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van Pesch, V., Bartholomé, E., Bissay, V. et al. Safety and efficacy of natalizumab in Belgian multiple sclerosis patients: subgroup analysis of the natalizumab observational program. Acta Neurol Belg 114, 167–178 (2014). https://doi.org/10.1007/s13760-014-0308-9

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  • DOI: https://doi.org/10.1007/s13760-014-0308-9

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