Long-Term Effectiveness and Safety of Natalizumab in African American and Hispanic/Latino Patients with Early Relapsing–Remitting Multiple Sclerosis: STRIVE Data Analysis

Jai Perumal*, Roumen Balabanov, Laura Balcer, Steven Galetta, Zhaonan Sun, Hanyue Li, Danette Rutledge, Robin L. Avila, Robert J. Fox

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

Abstract

Introduction: In STRIVE, natalizumab treatment demonstrated effectiveness in clinical, magnetic resonance imaging (MRI), and patient-reported outcomes (PROs) in patients with early relapsing–remitting multiple sclerosis (RRMS). This post hoc analysis examined the effectiveness and safety of natalizumab in patients who self-identified as either Black/African American (AA) or Hispanic/Latino. Methods: Clinical, MRI, and PROs were assessed for the Black/AA subgroup (n = 40) and compared with the non-Hispanic White subgroup (n = 158). As a result of the very small sample size, outcomes for the Hispanic/Latino subgroup (n = 18) were assessed separately, including a sensitivity analysis with Hispanic/Latino patients who completed the 4-year study on natalizumab. Results: Clinical, MRI, and PROs were comparable between the Black/AA and non-Hispanic White subgroups except for MRI outcomes at year 1. A higher proportion of non-Hispanic White than Black/AA patients achieved MRI no evidence of disease activity (NEDA; 75.4% vs. 50.0%, p = 0.0121) and no new or newly enlarging T2 lesions (77.6% vs. 50.0%, p = 0.0031) at year 1; these differences were not observed in years 2–4 of the study. For the Hispanic/Latino subgroup in the intent-to-treat population, 46.2% and 55.6% achieved NEDA at years 1 and 2; 66.7% and 90.0% achieved clinical NEDA at years 3 and 4. Annualized relapse rate was reduced by 93.0% at year 1 versus the year before natalizumab initiation; this reduction was maintained throughout the study. Over 4 years, 37.5–50.0% of patients had a clinically meaningful improvement in their Symbol Digit Modalities Test score, and 81.8–100.0% and 90.9–100.0% had stable/improved Multiple Sclerosis Impact Scale-29 physical and psychological scores, respectively. Similar results were observed in the sensitivity analysis with Hispanic/Latino subgroup of the 4-year natalizumab completers. Conclusion: These results highlight the effectiveness and safety of natalizumab in patients with early RRMS who self-identified as Black/AA or Hispanic/Latino. ClinicalTrials.gov: NCT01485003.

Original languageEnglish (US)
Pages (from-to)833-848
Number of pages16
JournalNeurology and Therapy
Volume12
Issue number3
DOIs
StatePublished - Jun 2023

Keywords

  • African American
  • Cognitive processing speed
  • Hispanic
  • Natalizumab
  • No evidence of disease activity
  • Patient-reported outcome
  • Relapsing–remitting multiple sclerosis

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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