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- Title
(QOL11) Natalizumab Is Associated with Improvement in Cognitive Processing Speed and Health-Related Quality of Life: STRIVE 4-Year Results.
- Authors
Perumal, Jai; Balabanov, Roumen; Balcer, Laura; Galetta, Steven; Read, Paula; Xiong, Kuangnan; Campagnolo, Denise; Hotermans, Christophe; Lee, Lily; Rutledge, Danette; Fox, Robert J.
- Abstract
Background: Multiple sclerosis (MS) negatively affects cognitive function and quality of life (QoL), interfering with a patient's ability to work, pursue leisure activities, and perform activities of daily living. Natalizumab is a highly effective treatment for patients with relapsing-remitting MS (RRMS) and has been associated with improved cognitive function and QoL. Objectives: To examine 4-year, end-of-study cognitive processing speed and patient-reported QoL outcomes for natalizumab-treated patients with early RRMS. Methods: STRIVE is a completed, 4-year, multicenter, observational, open-label, single-arm study of anti--JC virus antibody--negative patients starting natalizumab <3 years after RRMS diagnosis. Cognitive processing speed was assessed by the Symbol Digit Modalities Test (SDMT). QoL was assessed via the patient-reported Multiple Sclerosis Impact Scale (MSIS-29). Outcomes were assessed annually. Changes from baseline were analyzed via a Wilcoxon signed rank test. Results: At baseline, patients in the intention-to-treat (ITT) population (N = 222) had active disease with a mean (SD) of 1.4 (1.2) relapses in the prior year. Baseline mean (SD) SDMT score was 52.1 (14.0). ITT patients showed improvements in SDMT score from baseline to year 1 (n = 191; mean change from baseline [CFB]: 2.29 [95% CI 0.84, 3.73]; P = .0006) with clinically significant improvements (ie, an increase ≥4 points) in year 2 (n = 158; mean CFB: 4.3 [95% CI 2.4, 6.2]; P < .0001) and year 4 (n = 174; mean CFB: 4.6 [95% CI 2.9, 6.2]; P < .0001). Patients with SDMT data at all time points (N = 145) had clinically significant SDMT improvements in years 2-4 (mean CFB [95% CI]: year 2, 4.4 [2.5, 6.2]; year 3, 4.3 [2.9, 5.8]; year 4, 5.1 [3.4, 6.7]). ITT patients also showed significant improvements in MSIS-29 score starting in year 1 (mean CFB [95% CI]: physical, n = 186; -3.9 [-5.8, -2.1]; P < .0001; psychological, n = 186; -1.7 [-2.8, -0.6]; P = .0012) that were sustained through year 4 (mean CFB [95% CI]: physical, n = 174; -4.7 [-6.9, -2.4]; P < .0001; psychological, n = 172; -2.6 [-3.9, -1.4]; P < .0001). Conclusions: Natalizumab treatment over 4 years was associated with a clinically significant improvement in cognitive processing speed as measured by the SDMT as well as improvement in patient-reported physical and psychological health. The potential for long-lasting (up to 4 years) improvement supports natalizumab's effectiveness in patients with early RRMS.
- Subjects
COGNITION; CONFERENCES &; conventions; HEALTH status indicators; QUALITY of life; TREATMENT effectiveness; NATALIZUMAB
- Publication
International Journal of MS Care, 2020, Vol 22, Issue S2, p65
- ISSN
1537-2073
- Publication type
Article