Contributions
Abstract: EP1787
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Background: Treatment with natalizumab early in the relapsing-remitting multiple sclerosis (RRMS) disease course may improve clinical outcomes. STRIVE was designed to determine the proportion of anti-JC virus antibody-negative RRMS patients initiating natalizumab early in their disease course who demonstrated no evidence of disease activity (NEDA).
Objective: To determine the proportion of natalizumab-treated early RRMS patients who achieve NEDA at year 2.
Methods: STRIVE is a multicenter, observational, open-label, single-arm study in which NEDA 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 NEDA was defined as no EDSS progression and no relapses. Continuous variables were analyzed with summary statistics. Categorical variables were analyzed with frequency distributions. P values and odds ratios (ORs) were obtained from logistic regression models adjusted for baseline EDSS score (≤2 vs >2), age group (< 40 vs ≥40 years), number of relapses 1 year prior to natalizumab infusion, baseline T2 lesion volume, baseline Gd+ lesions, and multiple sclerosis (MS) disease duration, as applicable.
A Kaplan-Meier analysis was used to evaluate time to disability worsening and time to disability improvement.
Results: 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). Half (50%) of the patients had not received prior disease-modifying therapies. At year 2, 76 of 171 patients (44.4%) had achieved NEDA (95% confidence interval [CI]: 37.0%-51.9%), and 131 of 181 patients (72.4%) had achieved clinical NEDA (95% CI: 65.9%-78.9%). A higher proportion of patients without than with baseline Gd+ lesions (54.7% vs 31.9%) achieved NEDA at year 2 (OR: 2.89; 95% CI: 1.35-6.18; P=0.006). At year 2, patients with baseline EDSS score ≤2 had a significantly higher chance of achieving NEDA than those with baseline EDSS score >2 (OR: 2.33; 95% CI: 1.08-5.04; P=0.032). At year 2, a higher proportion of patients experienced 24-week-confirmed EDSS improvement than worsening
(28.4% vs 14.1%). The serious adverse event profile up to year 2 was consistent with natalizumab's well-established safety profile.
Conclusions: These 2-year results support the effectiveness of natalizumab in maintaining NEDA in early RRMS patients.
Disclosure: Supported by Biogen.
JP: fees from Acorda, Biogen, Genzyme, and Teva.
RJF: consulting fees from Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, Teva, and XenoPort; advisory board fees from Biogen and Novartis; grant/research support from Novartis.
RB: consulting fees from Biogen, Sanofi, and Teva; grant/research support from Biogen.
SM, QD, CH, JW, LL: employees of and hold stock and/or stock options in Biogen.
LB: consulting fees from Biogen and Genzyme.
SG: consulting fees from Biogen.
Abstract: EP1787
Type: ePoster
Abstract Category: Therapy - disease modifying - 32 Others
Background: Treatment with natalizumab early in the relapsing-remitting multiple sclerosis (RRMS) disease course may improve clinical outcomes. STRIVE was designed to determine the proportion of anti-JC virus antibody-negative RRMS patients initiating natalizumab early in their disease course who demonstrated no evidence of disease activity (NEDA).
Objective: To determine the proportion of natalizumab-treated early RRMS patients who achieve NEDA at year 2.
Methods: STRIVE is a multicenter, observational, open-label, single-arm study in which NEDA 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 NEDA was defined as no EDSS progression and no relapses. Continuous variables were analyzed with summary statistics. Categorical variables were analyzed with frequency distributions. P values and odds ratios (ORs) were obtained from logistic regression models adjusted for baseline EDSS score (≤2 vs >2), age group (< 40 vs ≥40 years), number of relapses 1 year prior to natalizumab infusion, baseline T2 lesion volume, baseline Gd+ lesions, and multiple sclerosis (MS) disease duration, as applicable.
A Kaplan-Meier analysis was used to evaluate time to disability worsening and time to disability improvement.
Results: 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). Half (50%) of the patients had not received prior disease-modifying therapies. At year 2, 76 of 171 patients (44.4%) had achieved NEDA (95% confidence interval [CI]: 37.0%-51.9%), and 131 of 181 patients (72.4%) had achieved clinical NEDA (95% CI: 65.9%-78.9%). A higher proportion of patients without than with baseline Gd+ lesions (54.7% vs 31.9%) achieved NEDA at year 2 (OR: 2.89; 95% CI: 1.35-6.18; P=0.006). At year 2, patients with baseline EDSS score ≤2 had a significantly higher chance of achieving NEDA than those with baseline EDSS score >2 (OR: 2.33; 95% CI: 1.08-5.04; P=0.032). At year 2, a higher proportion of patients experienced 24-week-confirmed EDSS improvement than worsening
(28.4% vs 14.1%). The serious adverse event profile up to year 2 was consistent with natalizumab's well-established safety profile.
Conclusions: These 2-year results support the effectiveness of natalizumab in maintaining NEDA in early RRMS patients.
Disclosure: Supported by Biogen.
JP: fees from Acorda, Biogen, Genzyme, and Teva.
RJF: consulting fees from Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, Teva, and XenoPort; advisory board fees from Biogen and Novartis; grant/research support from Novartis.
RB: consulting fees from Biogen, Sanofi, and Teva; grant/research support from Biogen.
SM, QD, CH, JW, LL: employees of and hold stock and/or stock options in Biogen.
LB: consulting fees from Biogen and Genzyme.
SG: consulting fees from Biogen.