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Two-year results from research presented at ACTRIMS Forum 2018 in San Diego, California, show that natalizumab was effective in maintaining no evidence of disease activity in patients with relapsing-remitting multiple sclerosis (RRMS).
To determine the proportion of early patients with RRMS treated with natalizumab who achieve no evidence of disease activity at year 2, researchers conducted STRIVE, a multicenter, observational, open-label, single-arm study.
“No evidence of disease activity” was defined as no Expanded Disability Status Scale (EDSS) progression (24-week confirmed), no relapses, no gadolinium-enhancing (Gd+) lesions, and no new or enlarging T2-hyperintense lesions. Clinical “no evidence of disease activity” was defined as no EDSS progression and no relapses.
“The intent-to-treat population (N=222) had early MS with mean (standard deviation [SD]) time since MS diagnosis of 1.6 (0.8) years and a mean (SD) EDSS score of 2.0 (1.1),” the researchers wrote. Of the 222 patients, 50% had not received prior disease-modifying therapies.
Statistical analyses included the following: summary statistics to analyze continuous variables, frequency distributions to analyze categorical variables, and a Kaplan-Meier analysis to evaluate time to disability worsening and time to disability improvement. P values and odds ratios (ORs) were calculated with logistic regression models adjusted for baseline EDSS score (≤2 vs >2), age group (<40 vs ≥40 years), number of relapses 1 year before natalizumab infusion, baseline T2 lesion volume, baseline Gd+ lesions, and MS disease duration, as applicable.
At year 2, the researchers found that 76 (44.4%) of 171 patients had achieved no evidence of disease activity (95% CI, 37.0%-51.9%), and 131 (72.4%) of 181 patients had achieved no clinical evidence of disease activity (95% CI, 65.9%-78.9%). A higher proportion of patients without baseline Gd+ lesions (54.7%) achieved no evidence of disease activity at year 2 than patients with baseline Gd+ lesions (31.9%; odds ratio, 2.89; 95% CI, 1.35-6.18; P =.006).
Patients with baseline EDSS score ≤2 had a significantly higher chance of achieving no evidence of disease activity than those with baseline EDSS score >2 (odds ratio, 2.33; 95% CI, 1.08-5.04; P =.032). At year 2, researchers also found that a higher percentage of patients experienced improvement in 24-week confirmed EDSS score (28.4%) than worsening in 24-week-confirmed EDSS score (14.1%). “The serious adverse event profile up to year 2 was consistent with natalizumab’s well-established safety profile,” the researchers wrote.
“These 2-year results support the effectiveness of natalizumab in maintaining [no evidence of disease activity] in early RRMS patients,” they concluded.
Study supported by Biogen. Disclosure: Several study authors are employed at Biogen.
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Perumal JS, Fox RJ, Balabanov R, et al. No evidence of disease activity in natalizumab-treated patients with early relapsing-remitting multiple sclerosis: a 2-year analysis of STRIVE. Presented at: ACTRIMS Forum 2018. February 1-3, 2018; San Diego, California. Abstract P037