WEST PALM BEACH, FL More patients with early relapsing-remitting multiple sclerosis (RRMS) treated with natalizumab experienced confirmed disability improvement than confirmed disability worsening, with the majority of improvement occurring in the first year and most patients maintaining confirmed disability improvement through the end of a 4-year study, according to research presented at the 5th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020, held February 27-29 in West Palm Beach, Florida.

This 4-year, multicenter, observational, open-label, single-arm study of patients initiating natalizumab therapy <3 years postdiagnosis of RRMS (STRIVE), was designed to evaluate disability improvement over 4 years of treatment. Confirmed disability improvement was defined as a >1.0 decrease in Expanded Disability Status Scale (EDSS) score from a baseline score >2.0, confirmed after 24 weeks. Confirmed disability worsening was defined as a >0.5 increase in EDSS from a baseline score > 6.0, or a >1.0 increase from a baseline score of 1.0 to 5.5, or a >1.5 from a baseline score of 0.0, confirmed after 24 weeks.

Cumulative confirmed disability improvement or disability worsening probabilities were assessed with Kaplan-Meier methods. Confirmed disability improvement maintenance was defined by a continued EDSS reduction by >1 point. A multivariate spline-based accelerated failure time model was used to evaluate baseline characteristics (age, multiple sclerosis disease duration, EDSS score, T2 lesion volume, number of gadolinium-enhancing lesions, and relapses in the prior year) as confirmed disability improvement predictors.

A total of 222 participants were included in the intent-to-treat population, of whom 133 had a baseline EDSS score of >2.0. During the 4-year study, 32.3% of participants with such an EDSS score experienced confirmed disability improvement; 62.8% had an EDSS score reduction of >1.5, and 44.2% had a reduction of >2.0 points. The cumulative probability of confirmed disability improvement was 19.9% at 1 year, 28.4% at 2 years, 38.5% at 3 years, and 43.9% at 4 years.

Among those with confirmed disability improvement, 62.8% maintained improvement through all 4 years of the study. No baseline characteristics were found to be confirmed disability improvement predictors, and the cumulative confirmed disability worsening probability at 4 years was 19.3%.

The investigators concluded, In this analysis of patients treated with natalizumab in STRIVE, more patients experienced [confirmed disability improvement] than CDW. [Confirmed disability improvement] occurred during each year of the study with most improvement taking place in the first yearThese results are consistent with findings from other real-world studies and support the effectiveness of natalizumab in patients with early RRMS.

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Reference

Perumal J, Fox R, Balabanov R, et al. Disability improvement in early multiple sclerosis patients treated with natalizumab in STRIVE, a phase 4 multicenter observational study. Presented at: ACTRIMS Forum 2020; February 27-29, 2020; West Palm Beach, FL. Abstract P056.

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