The effectiveness of natalizumab vs fingolimod-A comparison of international registry studies
Language English Country Netherlands Media print-electronic
Document type Journal Article
PubMed
34116480
DOI
10.1016/j.msard.2021.103012
PII: S2211-0348(21)00279-0
Knihovny.cz E-resources
- Keywords
- Fingolimod, Head-to-head comparison, Multiple sclerosis, Natalizumab, Treatment effectiveness,
- 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
- Names of Substances
- Fingolimod Hydrochloride * MeSH
- Immunosuppressive Agents MeSH
- Natalizumab 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
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
CISSS Chaudiere Appalache Levis Canada
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 Neurology Aalborg University Hospital Multiple Sclerosis Unit
Department of Neurology Faculty of Medicine University of Debrecen Debrecen Hungary
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
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
Isfahan University of Medical Sciences Isfahan Iran
KTU Medical Faculty Farabi Hospital Trabzon Turkey
Medical Faculty 19 Mayis University Samsun Turkey
Monash University Melbourne Australia
Rehabilitation and MS Centre Overpelt and Hasselt University Hasselt Belgium
University of Queensland Brisbane Australia Royal Brisbane and Women's Hospital
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