Tysabri (natalizumab) is safe and shows robust, real-world effectiveness at reducing the frequency of relapses in people with relapsing-remitting multiple sclerosis (RRMS), 10 years of data from a large, observational study report.
Findings were reported in “Long-term safety and effectiveness of natalizumab treatment in clinical practice: 10 years of real-world data from the Tysabri Observational Program (TOP),” a study published in the Journal of Neurology, Neurosurgery & Psychiatry.
The Tysabri Observational Program (TOP; NCT00493298), which began more than 10 years ago, is the largest ongoing study of Tysabri’s use by RRMS patients. Following people for up to 15 years, it gathers effectiveness and safety data on those who started treatment with Tysabri in routine clinical practice.
Five-year interim TOP data, covering 4,821 patients, showed that Tysabri consistently reduced the rate of relapses and disability in RRMS patients, with no new safety concerns reported.
Investigators here reported 10-year interim data from the study, extending “the previous five-year interim analysis with a larger population [1,327 more people] and longer duration of natalizumab exposure [eight or more years].”
They also evaluated the potential impact of attrition bias on data supporting effectiveness, comparing results from a group of patients who remained on Tysabri for at least eight years to findings among those who stopped using it before that timepoint. (Attrition bias refers to an unequal loss of members within different groups in a trial that causes an imbalance — a bias in findings about those groups.)
Analyses focused on assessing the annualized relapse rates (ARRs), and disability progression — using the Expanded Disability Status Scale (EDSS) — in those who remained on Tysabri over the entire course of the study and in those who stopped treatment but continued being monitored within TOP.
Between July 2007 and Nov. 1, 2017, a total of 6,148 RRMS patients from 17 most European countries were enrolled in TOP (mean age at baseline, or study start, 37.1), and using Tysabri for a median of 3.3 years.
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