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The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies
- Source :
- Andersen , J B , Sharmin , S , Lefort , M , Koch-Henriksen , N , Sellebjerg , F , Sørensen , P S , Hilt Christensen , C C , Rasmussen , P V , Jensen , M B , Frederiksen , J L , Bramow , S , Mathiesen , H K , Schreiber , K I , Horakova , D , Havrdova , E K , Alroughani , R , Izquierdo , G , Eichau , S , Ozakbas , S , Patti , F , Onofrj , M , Lugaresi , A , Terzi , M , Grammond , P , Grand Maison , F , Yamout , B , Prat , A , Girard , M , Duquette , P , Boz , C , Trojano , M , McCombe , P , Slee , M , Lechner-Scott , J , Turkoglu , R , Sola , P , Ferraro , D , Granella , F , Shaygannejad , V , Prevost , J , Skibina , O , Solaro , C , Karabudak , R , Wijmeersch , B V , Csepany , T , Spitaleri , D , Vucic , S , Casey , R , Debouverie , M , Edan , G , Ciron , J , Ruet , A , Sèze , J D , Maillart , E , Zephir , H , Labauge , P , Defer , G , Lebrun , C , Moreau , T , Berger , E , Clavelou , P , Pelletier , J , Stankoff , B , Gout , O , Thouvenot , E , Heinzlef , O , Al-Khedr , A , Bourre , B , Casez , O , Cabre , P , Montcuquet , A , Wahab , A , Camdessanché , J P , Marousset , A , Patry , I , Hankiewicz , K , Pottier , C , Maubeuge , N , Labeyrie , C , Nifle , C , Leray , E , Laplaud , D A , Butzkueven , H , Kalincik , T , Vukusic , S & Magyari , M 2021 , ' The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies ' , Multiple Sclerosis and Related Disorders , vol. 53 , 103012 .
- Publication Year :
- 2021
-
Abstract
- 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.
Details
- Database :
- OAIster
- Journal :
- Andersen , J B , Sharmin , S , Lefort , M , Koch-Henriksen , N , Sellebjerg , F , Sørensen , P S , Hilt Christensen , C C , Rasmussen , P V , Jensen , M B , Frederiksen , J L , Bramow , S , Mathiesen , H K , Schreiber , K I , Horakova , D , Havrdova , E K , Alroughani , R , Izquierdo , G , Eichau , S , Ozakbas , S , Patti , F , Onofrj , M , Lugaresi , A , Terzi , M , Grammond , P , Grand Maison , F , Yamout , B , Prat , A , Girard , M , Duquette , P , Boz , C , Trojano , M , McCombe , P , Slee , M , Lechner-Scott , J , Turkoglu , R , Sola , P , Ferraro , D , Granella , F , Shaygannejad , V , Prevost , J , Skibina , O , Solaro , C , Karabudak , R , Wijmeersch , B V , Csepany , T , Spitaleri , D , Vucic , S , Casey , R , Debouverie , M , Edan , G , Ciron , J , Ruet , A , Sèze , J D , Maillart , E , Zephir , H , Labauge , P , Defer , G , Lebrun , C , Moreau , T , Berger , E , Clavelou , P , Pelletier , J , Stankoff , B , Gout , O , Thouvenot , E , Heinzlef , O , Al-Khedr , A , Bourre , B , Casez , O , Cabre , P , Montcuquet , A , Wahab , A , Camdessanché , J P , Marousset , A , Patry , I , Hankiewicz , K , Pottier , C , Maubeuge , N , Labeyrie , C , Nifle , C , Leray , E , Laplaud , D A , Butzkueven , H , Kalincik , T , Vukusic , S & Magyari , M 2021 , ' The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies ' , Multiple Sclerosis and Related Disorders , vol. 53 , 103012 .
- Notes :
- application/pdf, English
- Publication Type :
- Electronic Resource
- Accession number :
- edsoai.on1340141303
- Document Type :
- Electronic Resource