162. Long-term Effectiveness of Cladribine Tablets over 4 years in Relapsing Multiple Sclerosis: Results from the MAGNIFY-MS Extension Study
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Authors
De Stefano N.
Vermersch P.
Wiendl H.
Barkhof F.
Montalban X.
Achiron A.
Derfuss T.
Chan A.
Prat A.
Leocani L.
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2024
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Conference Proceedings
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Background/Objective(s): MAGNIFY-MS (NCT03364036) was a 2-year, phase IV study in which eligible patients (n=270) with highly active relapsing multiple sclerosis received cladribine tablets (CladT). MAGNIFY-MS Extension is a 2-year follow-up study that aimed to evaluate the long-term effectiveness of CladT up to 4 years after the initial dose. Material(s) and Method(s): Patients were included in MAGNIFY-MS Extension if they received >=1 dose of CladT in MAGNIFY-MS and had magnetic resonance imaging (MRI) data available from month-18 or month-24 of the parent study. Expanded Disability Status Scale and relapse data were also required from month-24. Visits occurred at month-36 and month-48. Per EU label, patients were not scheduled to receive CladT in Years 3 or 4 after treatment initiation. Primary endpoint: proportion of patients with no evidence of disease activity (NEDA-3) in Years 3 and 4 combined (defined as no qualifying relapses, no 6-month confirmed disability progression 6mCDP], and no new T1 Gd+ and/or active T2 MRI lesions). Data were analysed for all participants combined; subgroups included treatment-naive (Tx-naive) and treatment-experienced (Tx-exp) patients. Result(s): 219 patients entered the MAGNIFY-MS extension study (females, 64.8%; mean age, 40.4 years; Tx-naive, 40.6%; MRI lesions Baseline Period]: T1 Gd+, 50.2%; active T2, 42.9%). During the extension period, the Kaplan-Meier estimated NEDA-3 rate (95% CI) was 78.6% (72.5, 83.5) in Year 3, 79.2% (72.3, 84.6) in Year 4, and 54.2% (47.3, 60.7) during Years 3 and 4 combined (crude event rates for individual components, free from: relapse, 80.8%; 6mCDP, 84.5%; MRI activity, 53.0%). For the 219 patients enrolled, the annualised qualified relapse rate (ARR, 95% CI) for the parent study was 0.09 (0.06, 0.12) and for the extension period was 0.08 (0.06, 0.11). The ARR was 0.09 (0.07, 0.11) over 4 years. Efficacy results were consistent for Tx-naive and Tx-exp subgroups. There were 142 patients (64.8%) with >=1 adverse event (AE) during the extension study (94.4% were mild to moderate), 13 (5.9%) had >=1 serious AE, and 3 (1.4%) had >=1 any serious treatment-related AE. No new safety signals were seen. Conclusion(s): The findings from MAGNIFY-MS Extension confirm the long-term (4-year) high efficacy of CladT. Without CladT dosing in Years 3 and 4, NEDA-3 in both years was around 80%. The long-term safety profile of CladT was consistent with earlier safety data.
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Multiple Sclerosis and Related Disorders