Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis

Tomas Kalincik, Dana Horakova, Tim Spelman, Vilija Jokubaitis, Maria Trojano, Alessandra Lugaresi, Guillermo Izquierdo, C. Rózsa, Pierre Grammond, Raed Alroughani, Pierre Duquette, Marc Girard, Eugenio Pucci, Jeannette Lechner-Scott, Mark Slee, Ricardo Fernandez-Bolanos, Francois Grand'Maison, Raymond Hupperts, Freek Verheul, Suzanne Hodgkinson & 13 others Celia Oreja-Guevara, Daniele Spitaleri, Michael Barnett, Murat Terzi, Roberto Bergamaschi, Pamela McCombe, Jose Sanchez-Menoyo, Magdolna Simo, Tunde Csepany, Gabor Rum, Cavit Boz, Eva Havrdova, Helmut Butzkueven

Research output: Contribution to journalArticle

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Abstract

Objective: In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents. Methods: Using MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses. Results: Of the 792 included patients, 578 patients were matched (natalizumab, n = 407; fingolimod, n = 171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50% relative postswitch difference in relapse hazard (p = 0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p

Original languageEnglish
Pages (from-to)425-435
Number of pages11
JournalAnnals of Neurology
Volume77
Issue number3
DOIs
Publication statusPublished - Mar 1 2015

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Relapsing-Remitting Multiple Sclerosis
Recurrence
Propensity Score
Random Allocation
Interferons
Multiple Sclerosis
Cohort Studies
Natalizumab
Fingolimod Hydrochloride
Therapeutics

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Medicine(all)

Cite this

Kalincik, T., Horakova, D., Spelman, T., Jokubaitis, V., Trojano, M., Lugaresi, A., ... Butzkueven, H. (2015). Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. Annals of Neurology, 77(3), 425-435. https://doi.org/10.1002/ana.24339

Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. / Kalincik, Tomas; Horakova, Dana; Spelman, Tim; Jokubaitis, Vilija; Trojano, Maria; Lugaresi, Alessandra; Izquierdo, Guillermo; Rózsa, C.; Grammond, Pierre; Alroughani, Raed; Duquette, Pierre; Girard, Marc; Pucci, Eugenio; Lechner-Scott, Jeannette; Slee, Mark; Fernandez-Bolanos, Ricardo; Grand'Maison, Francois; Hupperts, Raymond; Verheul, Freek; Hodgkinson, Suzanne; Oreja-Guevara, Celia; Spitaleri, Daniele; Barnett, Michael; Terzi, Murat; Bergamaschi, Roberto; McCombe, Pamela; Sanchez-Menoyo, Jose; Simo, Magdolna; Csepany, Tunde; Rum, Gabor; Boz, Cavit; Havrdova, Eva; Butzkueven, Helmut.

In: Annals of Neurology, Vol. 77, No. 3, 01.03.2015, p. 425-435.

Research output: Contribution to journalArticle

Kalincik, T, Horakova, D, Spelman, T, Jokubaitis, V, Trojano, M, Lugaresi, A, Izquierdo, G, Rózsa, C, Grammond, P, Alroughani, R, Duquette, P, Girard, M, Pucci, E, Lechner-Scott, J, Slee, M, Fernandez-Bolanos, R, Grand'Maison, F, Hupperts, R, Verheul, F, Hodgkinson, S, Oreja-Guevara, C, Spitaleri, D, Barnett, M, Terzi, M, Bergamaschi, R, McCombe, P, Sanchez-Menoyo, J, Simo, M, Csepany, T, Rum, G, Boz, C, Havrdova, E & Butzkueven, H 2015, 'Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis', Annals of Neurology, vol. 77, no. 3, pp. 425-435. https://doi.org/10.1002/ana.24339
Kalincik T, Horakova D, Spelman T, Jokubaitis V, Trojano M, Lugaresi A et al. Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. Annals of Neurology. 2015 Mar 1;77(3):425-435. https://doi.org/10.1002/ana.24339
Kalincik, Tomas ; Horakova, Dana ; Spelman, Tim ; Jokubaitis, Vilija ; Trojano, Maria ; Lugaresi, Alessandra ; Izquierdo, Guillermo ; Rózsa, C. ; Grammond, Pierre ; Alroughani, Raed ; Duquette, Pierre ; Girard, Marc ; Pucci, Eugenio ; Lechner-Scott, Jeannette ; Slee, Mark ; Fernandez-Bolanos, Ricardo ; Grand'Maison, Francois ; Hupperts, Raymond ; Verheul, Freek ; Hodgkinson, Suzanne ; Oreja-Guevara, Celia ; Spitaleri, Daniele ; Barnett, Michael ; Terzi, Murat ; Bergamaschi, Roberto ; McCombe, Pamela ; Sanchez-Menoyo, Jose ; Simo, Magdolna ; Csepany, Tunde ; Rum, Gabor ; Boz, Cavit ; Havrdova, Eva ; Butzkueven, Helmut. / Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis. In: Annals of Neurology. 2015 ; Vol. 77, No. 3. pp. 425-435.
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abstract = "Objective: In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents. Methods: Using MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses. Results: Of the 792 included patients, 578 patients were matched (natalizumab, n = 407; fingolimod, n = 171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50{\%} relative postswitch difference in relapse hazard (p = 0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p",
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T1 - Switch to natalizumab versus fingolimod in active relapsing-remitting multiple sclerosis

AU - Kalincik, Tomas

AU - Horakova, Dana

AU - Spelman, Tim

AU - Jokubaitis, Vilija

AU - Trojano, Maria

AU - Lugaresi, Alessandra

AU - Izquierdo, Guillermo

AU - Rózsa, C.

AU - Grammond, Pierre

AU - Alroughani, Raed

AU - Duquette, Pierre

AU - Girard, Marc

AU - Pucci, Eugenio

AU - Lechner-Scott, Jeannette

AU - Slee, Mark

AU - Fernandez-Bolanos, Ricardo

AU - Grand'Maison, Francois

AU - Hupperts, Raymond

AU - Verheul, Freek

AU - Hodgkinson, Suzanne

AU - Oreja-Guevara, Celia

AU - Spitaleri, Daniele

AU - Barnett, Michael

AU - Terzi, Murat

AU - Bergamaschi, Roberto

AU - McCombe, Pamela

AU - Sanchez-Menoyo, Jose

AU - Simo, Magdolna

AU - Csepany, Tunde

AU - Rum, Gabor

AU - Boz, Cavit

AU - Havrdova, Eva

AU - Butzkueven, Helmut

PY - 2015/3/1

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N2 - Objective: In patients suffering multiple sclerosis activity despite treatment with interferon β or glatiramer acetate, clinicians often switch therapy to either natalizumab or fingolimod. However, no studies have directly compared the outcomes of switching to either of these agents. Methods: Using MSBase, a large international, observational, prospectively acquired cohort study, we identified patients with relapsing-remitting multiple sclerosis experiencing relapses or disability progression within the 6 months immediately preceding switch to either natalizumab or fingolimod. Quasi-randomization with propensity score-based matching was used to select subpopulations with comparable baseline characteristics. Relapse and disability outcomes were compared in paired, pairwise-censored analyses. Results: Of the 792 included patients, 578 patients were matched (natalizumab, n = 407; fingolimod, n = 171). Mean on-study follow-up was 12 months. The annualized relapse rates decreased from 1.5 to 0.2 on natalizumab and from 1.3 to 0.4 on fingolimod, with 50% relative postswitch difference in relapse hazard (p = 0.002). A 2.8 times higher rate of sustained disability regression was observed after the switch to natalizumab in comparison to fingolimod (p

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