Real-world disability improvement in patients with relapsing-remitting multiple sclerosis treated with natalizumab in the Tysabri Observational Program

Mult Scler. 2021 Apr;27(5):719-728. doi: 10.1177/1352458520926869. Epub 2020 Jun 24.

Abstract

Background: Natalizumab has been associated with disability improvement as indicated by a confirmed Expanded Disability Status Scale (EDSS) score decrease.

Objective: The aim of this study was to characterize disability improvement in patients in the Tysabri Observational Program (TOP), an ongoing observational study of relapsing-remitting multiple sclerosis patients initiating natalizumab in clinical practice.

Methods: TOP data as of November 2018 were included. Confirmed disability improvement (CDI) was defined as a decrease ⩾1.0 confirmed 24 weeks later from a baseline EDSS score ⩾2.0. Confirmed functional system (FS) improvement was defined as a decrease ⩾1.0 confirmed 24 weeks later from a baseline score ⩾1.0 in that FS.

Results: Of 5384 patients, 1287 (23.9%) had CDI; 51.8% experienced CDI in the first treatment year. Among patients with CDI, 56.6% had CDI ⩾1.5 points; 34.4% had CDI ⩾2.0 points. The cumulative probability of maintaining improvement 8 years after the CDI event was 52.6%. At treatment initiation, 5363 patients (85.2%) had impairment in ⩾1 FS. At 8 years, the cumulative probability of confirmed improvement in any FS was 88.8% and ranged from 38.3% to 58.6% in individual FS.

Conclusion: These results highlight disability improvement as a potential benefit of natalizumab treatment. Improvements across all FS demonstrate the range of functional improvement.

Keywords: Disability; Expanded Disability Status Scale; disease-modifying therapy; functional systems; multiple sclerosis; natalizumab.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Disability Evaluation
  • Humans
  • Immunologic Factors
  • Multiple Sclerosis*
  • Multiple Sclerosis, Relapsing-Remitting* / drug therapy
  • Natalizumab / therapeutic use

Substances

  • Immunologic Factors
  • Natalizumab