Natalizumab in Early Relapsing-Remitting Multiple Sclerosis: A 4-Year, Open-Label Study

Area of Science:

• Neurology
• Immunology
• Pharmacology

Background:

• Relapsing-remitting multiple sclerosis (RRMS) is a chronic autoimmune disease affecting the central nervous system.
• Early intervention in RRMS is crucial for long-term outcomes.
• Natalizumab is an established treatment for MS, but its use in specific patient populations requires ongoing evaluation.

Purpose of the Study:

• To evaluate the achievement of no evidence of disease activity (NEDA) in patients with early RRMS treated with natalizumab.
• To identify baseline predictors of NEDA in this patient cohort.
• To assess the long-term safety and efficacy of natalizumab in anti-JC virus antibody-negative (JCV-negative) RRMS patients.

Main Methods:

• The STRIVE study was a 4-year, multicenter, observational, open-label, single-arm trial.
• Participants included JCV-negative RRMS patients with disease duration ≤ 3 years.
• NEDA status, relapse rates, disability worsening, MRI lesions, and adverse events were assessed.

Main Results:

• NEDA rates increased over time, reaching 91.9% in year 4 for Clinical NEDA (no relapses or 24-week confirmed disability worsening).
• Predictors of NEDA in year 4 included lower Expanded Disability Status Scale scores and T2 lesion volume.
• The cumulative probability of confirmed disability worsening at year 4 was 19.3%, with 11.3% of patients reporting serious adverse events.

Conclusions:

• Natalizumab demonstrates long-term safety and effectiveness in JCV-negative early RRMS patients.
• Identifying baseline predictors of NEDA can aid in optimizing natalizumab treatment strategies.
• These findings support the use of natalizumab for managing early-stage RRMS in selected patients.