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

PloS One
Heinz WiendlTysabri® Observational Program (TOP) Investigators

Abstract

To evaluate the effect of natalizumab on disability progression beyond 2 years of treatment in clinical practice. 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. 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 < 0.01) and 52% (from 9.5% to 4.6%; p < 0.01), respectively. Few patients had 6-month or 12-month confirmed ...Continue Reading

References

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Citations

Sep 2, 2017·Therapeutic Advances in Neurological Disorders·Barry A Singer
Apr 3, 2020·Journal of Neurology, Neurosurgery, and Psychiatry·Helmut ButzkuevenUNKNOWN Tysabri Observational Program (TOP) Investigators
Jan 8, 2021·Frontiers in Neurology·Inmaculada TobosoLuisa M Villar

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Clinical Trials Mentioned

NCT00493298

Software Mentioned

TOP

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