Relapsing-Remitting Multiple Sclerosis: Maintaining No Evidence of Disease Activity With Natalizumab

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At year 2, 76 of 171 patients had achieved no evidence of disease activity.
At year 2, 76 of 171 patients had achieved no evidence of disease activity.
The following article is part of live conference coverage from the 2018 ACTRIMS Forum in San Diego, California. Neurology Advisor's staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from ACTRIMS 2018.

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.

For more coverage of ACTRIMS Forum 2018, click here

Reference

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

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