Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study. Academic Article uri icon

Overview

abstract

  • INTRODUCTION: STRIVE was a 4-year, multicenter, observational, open-label, single-arm study of natalizumab treatment in anti-JC virus antibody-negative (JCV-negative) relapsing-remitting multiple sclerosis (RRMS) patients with disease duration ≤ 3 years. The objective of STRIVE was to examine no evidence of disease activity (NEDA) status and predictors of NEDA in natalizumab-treated patients with early RRMS. METHODS: Proportions of patients with NEDA were evaluated along with baseline predictors of NEDA, annualized relapse rate, 24-week confirmed disability worsening (CDW), magnetic resonance imaging assessments (T2 and gadolinium-enhancing lesions), and serious adverse events. RESULTS: In years 1 and 2, 56.1% (95% confidence interval [CI] 48.7-63.4%) and 73.6% (95% CI 66.2-80.2%) of patients (intent-to-treat population [N = 222]), respectively, achieved NEDA. In years 3 and 4, 84.6% (95% CI 78.0-89.9%) and 91.9% (95% CI 86.4-95.8%) of patients, respectively, achieved Clinical NEDA (no relapses or 24-week CDW). Baseline predictors of NEDA in year 4 were Expanded Disability Status Scale score ≤ 2.0 (odds ratio [OR] = 3.85 [95% CI 1.54-9.63]; p = 0.004) and T2 lesion volume > 4 cc (OR = 0.39 [95% CI 0.15-0.98]; p = 0.046), with the latter also predicting Clinical NEDA in year 4 (OR = 0.21 [95% CI 0.05-0.92]; p = 0.038). The cumulative probability of CDW at year 4 was 19.3%. Serious adverse events were reported in 11.3% of patients. CONCLUSION: These results support the long-term safety and effectiveness of natalizumab. Baseline predictors of NEDA help to inform benefit-risk assessments of natalizumab treatment in JCV-negative patients with early RRMS. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01485003.

authors

  • Perumal, Jai S.
  • Balabanov, Roumen
  • Su, Ray
  • Chang, Roger
  • Balcer, Laura
  • Galetta, Steven
  • Campagnolo, Denise I
  • Avila, Robin
  • Lee, Lily
  • Rutledge, Danette
  • Fox, Robert J

publication date

  • May 20, 2021

Research

keywords

  • Multiple Sclerosis
  • Multiple Sclerosis, Relapsing-Remitting

Identity

PubMed Central ID

  • PMC8279996

Scopus Document Identifier

  • 85106212226

Digital Object Identifier (DOI)

  • 10.1016/j.msard.2020.102543

PubMed ID

  • 34014549

Additional Document Info

volume

  • 38

issue

  • 7