Epoch Analysis of On-Treatment Disability Progression Events over Time in the Tysabri Observational Program (TOP)

Heinz Wiendl, Helmut Butzkueven, Ludwig Kappos, Maria Trojano, Fabio Pellegrini, Dominic Paes, Annie Zhang, Shibeshih Belachew and Tysabri ® Observational Program (TOP) Investigators

PLOS ONE, 2016, vol. 11, issue 1, 1-14

Abstract: Objective: To evaluate the effect of natalizumab on disability progression beyond 2 years of treatment in clinical practice. Methods: Analyses included the 496 relapsing-remitting multiple sclerosis (RRMS) patients among 5122 patients in the Tysabri Observational Program (TOP) who had completed 4 continuous years of natalizumab treatment and had baseline (study enrollment) and postbaseline Expanded Disability Status Scale (EDSS) assessments. Proportions of patients with 6-month or 12-month confirmed ≥1.0-point EDSS progression relative to baseline were compared in treatment months 1–24 and 25–48. Sensitivity analyses compared progression rates in months 13–24 and 25–36. Results: Baseline characteristics appeared similar between the overall TOP population (N = 5122), patients who had completed 4 years of natalizumab treatment (n = 469), and patients eligible to complete 4 years in TOP who had discontinued natalizumab after 2 years of treatment (n = 514). Among 4-year completers, the proportion of patients with 6-month and 12-month confirmed EDSS progression decreased between months 1–24 and 25–48 of natalizumab treatment by 42% (from 10.9% to 6.3%; p

Date: 2016
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Persistent link: https://EconPapers.repec.org/RePEc:plo:pone00:0144834

DOI: 10.1371/journal.pone.0144834

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