Study description: TOP is an ongoing, open-label, multinational, multicenter, prospective study observing 6148 patients with RRMS outside of the US receiving 300 mg TYSABRI IV every 4 weeks for 15 years in real-world clinical practice settings. Of the 6148 patients enrolled, 3210 patients have discontinued TYSABRI, and 2117 have withdrawn from TOP. Of the 3210 patients who have discontinued TYSABRI treatment, 1093 remain in TOP. RRMS patients enrolled in TOP are required to be TYSABRI-naïve or to have received ≤3 doses of TYSABRI in their lifetime. This 10-year interim analysis includes data from study initiation (July 2007) through November 1, 2017.
Study limitations3:
The longest evaluation of real-world outcomes in patients treated with TYSABRI to date
OVERALL EXPOSURE (26,060 patient-yearsc; N=6148) |
FIRST 3 YEARS ON TREATMENT (15,773 patient-yearsc; N=6148) |
BEYOND 3 YEARS ON TREATMENT (10,233 patient-yearsc; N=3719) |
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Opportunistic infections other than PML |
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PML, confirmed |
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Malignancy |
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OVERALL EXPOSURE (26,060 patient-yearsc; N=6148) |
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FIRST 3 YEARS ON TREATMENT (15,773 patient-yearsc; N=6148) |
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BEYOND 3 YEARS ON TREATMENT (10,233 patient-yearsc; N=3719) |
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Copyright © 2020 Butzkueven H, et al; licensee BMJ is adapted under CC BY-NC.
cBased on the time from the first dose of natalizumab until the last natalizumab dosing date + 6 months.3
dCalculated as (1000 × number of patients with an event) / (total patient-years of follow-up).3
eExact CIs are calculated based on the Poisson distribution.3
Copyright © 2020 Butzkueven H, et al; licensee BMJ is adapted under CC BY-NC.
gARRs for the year prior to starting natalizumab and the period during which patients were on natalizumab (and ≤84 days after the last dose) were compared using a repeated Poisson model.3
TYSABRI administration early in the treatment course reduced relapses by 88% at Year 1, with low ARR sustained out to 10 years.
The TOP Study was funded by Biogen.