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The effectiveness of natalizumab vs fingolimod–A comparison of international registry studies

Tijdschriftbijdrage - Tijdschriftartikel

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 meth-odologies, 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.
Tijdschrift: Multiple Sclerosis and Related Disorders
ISSN: 2211-0348
Volume: 53
Jaar van publicatie:2021
Trefwoorden:Multiple sclerosis, Natalizumab, Fingolimod, Treatment effectiveness, Head-to-head comparison
BOF-keylabel:ja
IOF-keylabel:ja
BOF-publication weight:1
Auteurs:International
Authors from:Higher Education
Toegankelijkheid:Open