Contributions
Abstract: P891
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Natalizumab treatment early in the relapsing-remitting multiple sclerosis (RRMS) disease course may improve clinical outcomes. STRIVE is a multicentre, observational, open-label, single-arm study of anti-JC virus antibody negative patients starting natalizumab < 3 years after RRMS diagnosis.
Objective: To examine no evidence of disease activity (NEDA) status, cognitive function, and health-related quality of life (HRQoL) over 3 years of natalizumab treatment in patients with early RRMS.
Methods: NEDA was defined as no Expanded Disability Status Scale (EDSS) worsening (a score increase of ≥1.5 from a baseline [BL] of 0, ≥1.0 from a BL of 1.0-5.5, or ≥0.5 from a BL ≥6.0, confirmed over ≥24 weeks), relapses, gadolinium-enhancing lesions, or new/enlarging T2-hyperintense lesions. Clinical NEDA was defined as no 24-week-confirmed EDSS worsening or relapses. The Kaplan-Meier method was used to estimate time to 24-week-confirmed EDSS worsening and improvement (a score decrease of ≥1.0 from a BL ≥2.0). The Symbol Digit Modalities Test (SDMT) and the Multiple Sclerosis Impact Scale-29 (MSIS-29) were assessed at BL and yearly thereafter. Changes from BL (CFBs) to year 3 were analysed via Wilcoxon signed-rank tests.
Results: At BL, the intent-to-treat population (N=222) had early RRMS with a mean (standard deviation [SD]) time since diagnosis of 1.6 (0.8) years, a mean (SD) EDSS score of 2.0 (1.1), and a mean (SD) of 1.4 (1.2) relapses in the prior year. A total of 50% of the patients had not used prior disease-modifying therapies. At year 3, 55 of 164 patients (33.5%) maintained NEDA (95% CI: 26.3%, 40.8%) and 107 of 171 patients (62.6%) maintained clinical NEDA (95% CI: 55.3%, 69.8%). At year 3, the cumulative probabilities of 24-week-confirmed EDSS worsening and improvement were 19.5% and 36.2%, respectively. From BL to year 3, patients exhibited significant improvements in SDMT score (n=153; mean CFB [95% CI]: 3.6 [2.0, 5.2]; P< 0.001) and in MSIS-29 (n=147) physical score (mean CFB [95% CI]: −4.8 [−7.1, −2.5]; P< 0.001), psychological score (mean CFB [95% CI]: −2.2 [−3.5, −0.9]; P=0.001), and quality-of-life score (mean CFB [95% CI]: −7.0 [−10.3, −3.7]; P< 0.001).
Conclusions: In patients with early RRMS, natalizumab treatment over 3 years was associated with NEDA maintenance and improved cognitive and HRQoL outcomes. These results are consistent with previous work showing natalizumab's effectiveness when initiated early in the RRMS disease course.
Disclosure: Supported by Biogen.
JP: fees from Acorda, Biogen, Genzyme, Teva.
RJF: consulting fees from Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, Teva, XenoPort; advisory board fees from Biogen, Novartis; grant/research support from Novartis.
RB: consulting fees from Biogen, Sanofi, Teva; grant/research support from Biogen.
LB: consulting fees from Biogen, Genzyme.
SG: consulting fees from Biogen.
CS, SS, CH, LL: employees of and may hold stock and/or stock options in Biogen.
Abstract: P891
Type: Poster Sessions
Abstract Category: Therapy - Immunomodulation/Immunosuppression
Introduction: Natalizumab treatment early in the relapsing-remitting multiple sclerosis (RRMS) disease course may improve clinical outcomes. STRIVE is a multicentre, observational, open-label, single-arm study of anti-JC virus antibody negative patients starting natalizumab < 3 years after RRMS diagnosis.
Objective: To examine no evidence of disease activity (NEDA) status, cognitive function, and health-related quality of life (HRQoL) over 3 years of natalizumab treatment in patients with early RRMS.
Methods: NEDA was defined as no Expanded Disability Status Scale (EDSS) worsening (a score increase of ≥1.5 from a baseline [BL] of 0, ≥1.0 from a BL of 1.0-5.5, or ≥0.5 from a BL ≥6.0, confirmed over ≥24 weeks), relapses, gadolinium-enhancing lesions, or new/enlarging T2-hyperintense lesions. Clinical NEDA was defined as no 24-week-confirmed EDSS worsening or relapses. The Kaplan-Meier method was used to estimate time to 24-week-confirmed EDSS worsening and improvement (a score decrease of ≥1.0 from a BL ≥2.0). The Symbol Digit Modalities Test (SDMT) and the Multiple Sclerosis Impact Scale-29 (MSIS-29) were assessed at BL and yearly thereafter. Changes from BL (CFBs) to year 3 were analysed via Wilcoxon signed-rank tests.
Results: At BL, the intent-to-treat population (N=222) had early RRMS with a mean (standard deviation [SD]) time since diagnosis of 1.6 (0.8) years, a mean (SD) EDSS score of 2.0 (1.1), and a mean (SD) of 1.4 (1.2) relapses in the prior year. A total of 50% of the patients had not used prior disease-modifying therapies. At year 3, 55 of 164 patients (33.5%) maintained NEDA (95% CI: 26.3%, 40.8%) and 107 of 171 patients (62.6%) maintained clinical NEDA (95% CI: 55.3%, 69.8%). At year 3, the cumulative probabilities of 24-week-confirmed EDSS worsening and improvement were 19.5% and 36.2%, respectively. From BL to year 3, patients exhibited significant improvements in SDMT score (n=153; mean CFB [95% CI]: 3.6 [2.0, 5.2]; P< 0.001) and in MSIS-29 (n=147) physical score (mean CFB [95% CI]: −4.8 [−7.1, −2.5]; P< 0.001), psychological score (mean CFB [95% CI]: −2.2 [−3.5, −0.9]; P=0.001), and quality-of-life score (mean CFB [95% CI]: −7.0 [−10.3, −3.7]; P< 0.001).
Conclusions: In patients with early RRMS, natalizumab treatment over 3 years was associated with NEDA maintenance and improved cognitive and HRQoL outcomes. These results are consistent with previous work showing natalizumab's effectiveness when initiated early in the RRMS disease course.
Disclosure: Supported by Biogen.
JP: fees from Acorda, Biogen, Genzyme, Teva.
RJF: consulting fees from Actelion, Biogen, Genentech, Mallinckrodt, MedDay, Novartis, Teva, XenoPort; advisory board fees from Biogen, Novartis; grant/research support from Novartis.
RB: consulting fees from Biogen, Sanofi, Teva; grant/research support from Biogen.
LB: consulting fees from Biogen, Genzyme.
SG: consulting fees from Biogen.
CS, SS, CH, LL: employees of and may hold stock and/or stock options in Biogen.