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The effectiveness of natalizumab vs fingolimod-A comparison of international registry studies
JB. Andersen, S. Sharmin, M. Lefort, N. Koch-Henriksen, F. Sellebjerg, PS. Sørensen, CC. Hilt Christensen, PV. Rasmussen, MB. Jensen, JL. Frederiksen, S. Bramow, HK. Mathiesen, KI. Schreiber, D. Horakova, EK. Havrdova, R. Alroughani, G....
Language English Country Netherlands
Document type Journal Article
- MeSH
- Fingolimod Hydrochloride * therapeutic use MeSH
- Immunosuppressive Agents therapeutic use MeSH
- Humans MeSH
- Natalizumab therapeutic use MeSH
- Registries MeSH
- Multiple Sclerosis, Relapsing-Remitting * drug therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
BACKGROUND: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening. METHODS: By re-analyzing original published results from MSBase, France, and Denmark using uniform methodologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/exclusion criteria and statistical methods with Inverse Probability Treatment Weighting. RESULTS: The pooled analyses comprised 968 natalizumab- and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod. CONCLUSION: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed.
Aarhus University Hospital Neurology PPJ Boulevard DK 8200 Aarhus N
Assistance publique des hôpitaux de Paris Hôpital Saint Antoine Service de neurologie Paris France
Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino Avellino Italy
Central Clinical School Monash University Melbourne Australia
Centre hospitalier de Pontoise Service de neurologie Pontoise France
Centre hospitalier de Saint Denis Hôpital Casanova Service de neurologie Saint Denis France
Centre hospitalier de Versailles Hôpital André Mignot Service de neurologie Le Chesnay France
Centre hospitalier intercommunal de Poissy Saint Germain en Laye Service de neurologie Poissy France
Centre hospitalier sud francilien Service de neurologie Corbeil Essonnes France
Centre hospitalier universitaire d'Amiens Picardie Site sud Service de neurologie Amiens France
Centre hospitalier universitaire de Bordeaux Hôpital Pellegrin Service de neurologie Bordeaux France
Centre hospitalier universitaire de Lille Hôpital Salengro Service de neurologie D Lille France
Centre hospitalier universitaire de Nîmes Hôpital Carémeau Service de neurologie Nîmes France
Centre hospitalier universitaire de Rennes Hôpital Pontchaillou Service de neurologie Rennes France
Centre hospitalier universitaire Limoges Hôpital Dupuytren Service de neurologie Limoges France
CHU de Nantes Service de Neurologie and CIC015 INSERM F 44093 Nantes France
CISSS Chaudiere Appalache Levis Canada
CORe Department of Medicine University of Melbourne Melbourne Australia
CSSS Saint Jerome Saint Jerome Canada
Department of Basic Medical Sciences Neuroscience and Sense Organs University of Bari Bari Italy
Department of Clinical Epidemiology Aarhus University Hospital Aarhus Denmark
Department of Emergency and General Medicine Parma University Hospital Parma Italy
Department of Medicine and Surgery University of Parma Parma Italy
Department of Neurology Aalborg University Hospital Multiple Sclerosis Unit
Department of Neurology ASL3 Genovese Genova Italy
Department of Neurology Box Hill Hospital Monash University Melbourne Australia
Department of Neurology Faculty of Medicine University of Debrecen Debrecen Hungary
Department of Neurology John Hunter Hospital Hunter New England Health Newcastle Australia
Department of Neurology Royal Melbourne Hospital Melbourne Australia
Department of Neurology The Alfred Hospital Melbourne Australia
Department of Neurology University Hospital of Northern Sealand
Department of Neuroscience Azienda Ospedaliera Universitaria Modena Italy
Department of Neuroscience Imaging and Clinical Sciences University G d'Annunzio Chieti Italy
Department of Rehabilitaiton ML Novarese Hospital Moncrivello
Division of Neurology Department of Medicine Amiri Hospital Sharq Kuwait
Dokuz Eylul University Konak Izmir Turkey
Flinders University Adelaide Australia
Fondation Adolphe de Rothschild de l'œil et du cerveau Service de neurologie Paris France
GF Ingrassia Department University of Catania Catania Policlinico G Rodolico Italy
Hacettepe University Ankara Turkey
Haydarpasa Numune Training and Research Hospital Istanbul Turkey
Hôpital Henri Mondor Department of Neurology F 94000 Créteil France
Hopital Notre Dame Montreal Canada CHUM and Universite de Montreal Montreal Canada
Hospital Universitario Virgen Macarena Sevilla Spain
INSERM CR1064 F 44000 Nantes France
Isfahan University of Medical Sciences Isfahan Iran
KTU Medical Faculty Farabi Hospital Trabzon Turkey
Medical Faculty 19 Mayis University Samsun Turkey
Melbourne MS Centre Department of Neurology Royal Melbourne Hospital Melbourne Australia
Monash University Melbourne Australia
Rehabilitation and MS Centre Overpelt and Hasselt University Hasselt Belgium
Rennes University EHESP REPERES EA 7449 F 35000 Rennes France
School of Medicine and Public Health University Newcastle Newcastle Australia
Univ Rennes CHU Rennes Inserm CIC 1414 F 35000 Rennes France
University of Queensland Brisbane Australia Royal Brisbane and Women's Hospital
References provided by Crossref.org
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- $a Andersen, Johanna B $u The Danish Multiple Sclerosis Registry, Department of Neurology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. Electronic address: johanna.balslev.andersen@regionh.dk
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- $a The effectiveness of natalizumab vs fingolimod-A comparison of international registry studies / $c JB. Andersen, S. Sharmin, M. Lefort, N. Koch-Henriksen, F. Sellebjerg, PS. Sørensen, CC. Hilt Christensen, PV. Rasmussen, MB. Jensen, JL. Frederiksen, S. Bramow, HK. Mathiesen, KI. Schreiber, D. Horakova, EK. Havrdova, R. Alroughani, G. Izquierdo, S. Eichau, S. Ozakbas, F. Patti, M. Onofrj, A. Lugaresi, M. Terzi, P. Grammond, F. Grand Maison, B. Yamout, A. Prat, M. Girard, P. Duquette, C. Boz, M. Trojano, P. McCombe, M. Slee, J. Lechner-Scott, R. Turkoglu, P. Sola, D. Ferraro, F. Granella, V. Shaygannejad, J. Prevost, O. Skibina, C. Solaro, R. Karabudak, BV. Wijmeersch, T. Csepany, D. Spitaleri, S. Vucic, R. Casey, M. Debouverie, G. Edan, J. Ciron, A. Ruet, JD. Sèze, E. Maillart, H. Zephir, P. Labauge, G. Defer, C. Lebrun, T. Moreau, E. Berger, P. Clavelou, J. Pelletier, B. Stankoff, O. Gout, E. Thouvenot, O. Heinzlef, A. Al-Khedr, B. Bourre, O. Casez, P. Cabre, A. Montcuquet, A. Wahab, JP. Camdessanché, A. Marousset, I. Patry, K. Hankiewicz, C. Pottier, N. Maubeuge, C. Labeyrie, C. Nifle, E. Leray, DA. Laplaud, H. Butzkueven, T. Kalincik, S. Vukusic, M. Magyari
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- $a BACKGROUND: Natalizumab and fingolimod were the first preparations recommended for disease breakthrough in priorly treated relapsing-remitting multiple sclerosis. Of three published head-to-head studies two showed that natalizumab is the more effective to prevent relapses and EDSS worsening. METHODS: By re-analyzing original published results from MSBase, France, and Denmark using uniform methodologies, we aimed at identifying the effects of differences in methodology, in the MS-populations, and at re-evaluating the differences in effectiveness between the two drugs. We gained access to copies of the individual amended databases and pooled all data. We used uniform inclusion/exclusion criteria and statistical methods with Inverse Probability Treatment Weighting. RESULTS: The pooled analyses comprised 968 natalizumab- and 1479 fingolimod treated patients. The on-treatment natalizumab/fingolimod relapse rate ratio was 0.77 (p=0.004). The hazard ratio (HR) for a first relapse was 0.82 (p=0.030), and the HR for sustained EDSS improvement was 1.4 (p=0.009). There were modest differences between each of the original published studies and the replication study, but the conclusions of the three original studies remained unchanged: in two of them natalizumab was more effective, but in the third there was no difference between natalizumab and fingolimod. CONCLUSION: The results were largely invariant to the epidemiological and statistical methods but differed between the MS populations. Generally, the advantage of natalizumab was confirmed.
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- 700 1_
- $a Alroughani, Raed $u Division of Neurology, Department of Medicine, Amiri Hospital, Sharq, Kuwait
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- $a Izquierdo, Guillermo $u Hospital Universitario Virgen Macarena, Sevilla, Spain
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- $a Eichau, Sara $u Hospital Universitario Virgen Macarena, Sevilla, Spain
- 700 1_
- $a Ozakbas, Serkan $u Dokuz Eylul University, Konak/Izmir, Turkey
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- $a Patti, Francesco $u GF Ingrassia Department, University of Catania, Catania, Policlinico G Rodolico, Italy
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- $a Onofrj, Marco $u Department of Neuroscience, Imaging, and Clinical Sciences, University G. d'Annunzio, Chieti, Italy
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- 700 1_
- $a Terzi, Murat $u Medical Faculty, 19 Mayis University, Samsun, Turkey
- 700 1_
- $a Grammond, Pierre $u CISSS Chaudiere-Appalache, Levis, Canada
- 700 1_
- $a Grand Maison, Francois $u Neuro Rive-Sud, Quebec, Canada
- 700 1_
- $a Yamout, Bassem $u Nehme and Therese Tohme Multiple Sclerosis Center, American University of Beirut Medical Center, Beirut, Lebanon
- 700 1_
- $a Prat, Alexandre $u Hopital Notre Dame, Montreal, Canada, CHUM and Universite de Montreal, Montreal, Canada
- 700 1_
- $a Girard, Marc $u Hopital Notre Dame, Montreal, Canada, CHUM and Universite de Montreal, Montreal, Canada
- 700 1_
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- 700 1_
- $a Boz, Cavit $u KTU Medical Faculty Farabi Hospital, Trabzon, Turkey
- 700 1_
- $a Trojano, Maria $u Department of Basic Medical Sciences, Neuroscience and Sense Organs, University of Bari, Bari, Italy
- 700 1_
- $a McCombe, Pamela $u University of Queensland, Brisbane, Australia, Royal Brisbane and Women's Hospital
- 700 1_
- $a Slee, Mark $u Flinders University, Adelaide, Australia
- 700 1_
- $a Lechner-Scott, Jeannette $u School of Medicine and Public Health, University Newcastle, Newcastle, Australia; Department of Neurology, John Hunter Hospital, Hunter New England Health, Newcastle, Australia
- 700 1_
- $a Turkoglu, Recai $u Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey
- 700 1_
- $a Sola, Patrizia $u Department of Neuroscience, Azienda Ospedaliera Universitaria, Modena, Italy
- 700 1_
- $a Ferraro, Diana $u Department of Neuroscience, Azienda Ospedaliera Universitaria, Modena, Italy
- 700 1_
- $a Granella, Franco $u Department of Medicine and Surgery, University of Parma, Parma, Italy; Department of Emergency and General Medicine, Parma University Hospital, Parma, Italy
- 700 1_
- $a Shaygannejad, Vahid $u Isfahan University of Medical Sciences, Isfahan, Iran
- 700 1_
- $a Prevost, Julie $u CSSS Saint-Jerome, Saint-Jerome, Canada
- 700 1_
- $a Skibina, Olga $u Monash University, Melbourne, Australia
- 700 1_
- $a Solaro, Claudio $u Department of Neurology, ASL3 Genovese, Genova, Italy; Department of Rehabilitaiton, ML Novarese Hospital Moncrivello
- 700 1_
- $a Karabudak, Rana $u Hacettepe University, Ankara, Turkey
- 700 1_
- $a Wijmeersch, Bart V $u Rehabilitation and MS-Centre Overpelt and Hasselt University, Hasselt, Belgium
- 700 1_
- $a Csepany, Tunde $u Department of Neurology, Faculty of Medicine, University of Debrecen, Debrecen, Hungary
- 700 1_
- $a Spitaleri, Daniele $u Azienda Ospedaliera di Rilievo Nazionale San Giuseppe Moscati Avellino, Avellino, Italy
- 700 1_
- $a Vucic, Steve $u Westmead Hospital, Sydney, Australia
- 700 1_
- $a Casey, Romain $u Service de neurologie, sclérose en plaques, pathologies de la myéline et neuro-inflammation, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, 69677 Lyon/Bron, France; Centre des Neurosciences de Lyon, Observatoire Français de la Sclérose en Plaques, INSERM 1028 et CNRS UMR5292, 69003 Lyon, France ; Université Claude Bernard Lyon 1, Faculté de médecine Lyon Est, F-69000 Lyon, France, Eugene Devic EDMUS Foundation, 69677 Lyon/Bron, France
- 700 1_
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- 700 1_
- $a Edan, Gilles $u Centre hospitalier universitaire de Rennes, Hôpital Pontchaillou, Service de neurologie, Rennes, France
- 700 1_
- $a Ciron, Jonathan $u Centre hospitalier universitaire de Toulouse, Hôpital Purpan, Service de neurologie inflammatoire et neuro-oncologie, Toulouse, France
- 700 1_
- $a Ruet, Aurélie $u Centre hospitalier universitaire de Bordeaux, Hôpital Pellegrin, Service de neurologie, Bordeaux, France
- 700 1_
- $a Sèze, Jérôme D $u Hôpitaux universitaire de Strasbourg, Hôpital de Hautepierre, Service des maladies inflammatoires du système nerveux - neurologie, Strasbourg, France
- 700 1_
- $a Maillart, Elisabeth $u Assistance publique des hôpitaux de Paris, Hôpital de la Pitié-Salpêtrière, Service de neurologie, Paris, France
- 700 1_
- $a Zephir, Hélène $u Centre hospitalier universitaire de Lille, Hôpital Salengro, Service de neurologie D, Lille, France
- 700 1_
- $a Labauge, Pierre $u Centre hospitalier universitaire de Montpellier, Hôpital Gui de Chauliac, Service de neurologie, Montpellier, France
- 700 1_
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- 700 1_
- $a Lebrun, Christine $u Centre hospitalier universitaire de Nice, Université Nice Côte d'Azur, Hôpital Pasteur, Service de neurologie, Nice, France
- 700 1_
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- 700 1_
- $a Berger, Eric $u Centre hospitalier régional universitaire de Besançon, Hôpital Jean Minjoz, Service de neurologie, Besançon, France
- 700 1_
- $a Clavelou, Pierre $u Centre hospitalier universitaire de Clermont-Ferrand, Hôpital Gabriel-Montpied, Service de neurologie, Clermont-Ferrand, France
- 700 1_
- $a Pelletier, Jean $u Assistance publique des hôpitaux de Marseille, Centre hospitalier de la Timone, Service de neurologie et unité neuro-vasculaire, Marseille, France
- 700 1_
- $a Stankoff, Bruno $u Assistance publique des hôpitaux de Paris, Hôpital Saint-Antoine, Service de neurologie, Paris, France
- 700 1_
- $a Gout, Olivier $u Fondation Adolphe de Rothschild de l'œil et du cerveau, Service de neurologie, Paris, France
- 700 1_
- $a Thouvenot, Eric $u Centre hospitalier universitaire de Nîmes, Hôpital Carémeau, Service de neurologie, Nîmes, France
- 700 1_
- $a Heinzlef, Olivier $u Centre hospitalier intercommunal de Poissy Saint-Germain-en-Laye, Service de neurologie, Poissy, France
- 700 1_
- $a Al-Khedr, Abdullatif $u Centre hospitalier universitaire d'Amiens Picardie, Site sud, Service de neurologie, Amiens, France
- 700 1_
- $a Bourre, Bertrand $u Centre hospitalier universitaire Rouen Normandie, Hôpital Charles-Nicolle, Service de neurologie, Rouen, France
- 700 1_
- $a Casez, Olivier $u Centre hospitalier universitaire Grenoble-Alpes, Site nord, Service de neurologie, Grenoble/La Tronche, France
- 700 1_
- $a Cabre, Philippe $u Centre hospitalier universitaire de Martinique, Hôpital Pierre Zobda-Quitman, Service de Neurologie, Fort-de-France, France
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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- 700 1_
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