The Strive Study of Natalizumab in Patients with Early MS: Baseline Characteristics

Background: Initiating natalizumab treatment early in the course of disease may improve long-term outcomes for relapsing-remitting MS (RRMS) patients. However, the effects of natalizumab on patients with early-stage RRMS have not been systematically studied.

Objectives: To report baseline patient characteristics in the ongoing STRIVE study.

Methods: STRIVE is a prospective, multicenter, single-arm study of outcomes and predictors of treatment response in patients initiating natalizumab early in RRMS. Target enrollment is approximately 300 patients, 18–50 years of age, with Expanded Disability Status Scale (EDSS) score ≤4.0, who initiated natalizumab treatment ≤3 years after MS diagnosis. Patients must test negative for anti-JCV antibodies ≤6 months before initiation. Prior treatment with disease-modifying therapy for a total of ≤36 months is permitted. Primary endpoints are the proportion of patients free of measured disease activity (no 24-week confirmed EDSS progression, no relapses, no gadolinium-enhancing lesions, and no new or enlarging T2-hyperintense lesions) at years 1 and 2 and the proportion of patients free of measured clinical disease activity at years 3 and 4. Additional endpoints include 24-week confirmed EDSS progression, relapse rate, magnetic resonance imaging (MRI) measures, cognitive function using the Symbol Digit Modality Test (SDMT), and quality-of-life assessments. In approximately 100 patients, the visual system will be assessed with optical coherence tomography (OCT) and low-contrast visual acuity testing. Baseline characteristics of enrolled patients were assessed using descriptive statistics.

Results: As of August 23, 2013, 120 patients were enrolled. At baseline, mean age was 32.6 years, 78% were female, mean EDSS score was 2.0, mean time since RRMS diagnosis was 0.6 years, mean number of relapses within the past year was 1.5, and mean SDMT score was 53.0. Of enrolled patients, 51% were treatment naive; 28% had received prior interferon treatment, 23% had received glatiramer acetate, and 2% had received teriflunomide. Baseline OCT was performed in 40 patients (33%); macular measurements will be presented.

Conclusions: Enrollment is ongoing. STRIVE will provide long-term data on the effectiveness of natalizumab as measured by MRI and clinical parameters in patients initiating treatment in the early stages of RRMS.