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


Andersen J. B. , Sharmin S., Lefort M., Koch-Henriksen N., Sellebjerg F., Sorensen P. S. , ...More

MULTIPLE SCLEROSIS AND RELATED DISORDERS, vol.53, 2021 (Journal Indexed in SCI) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 53
  • Publication Date: 2021
  • Doi Number: 10.1016/j.msard.2021.103012
  • Title of Journal : MULTIPLE SCLEROSIS AND RELATED DISORDERS
  • Keywords: Multiple sclerosis, Natalizumab, Fingolimod, Treatment effectiveness, Head-to-head comparison, MULTIPLE-SCLEROSIS

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 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.