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Long-term efficacy of cladribine tablets: Results from the MAGNIFY-MS Extension study
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DOI：10.1177/13524585261467624.png)
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Abstract
En 中文
<jats:sec>
<jats:title>Background:</jats:title>
<jats:p>The Phase IV MAGNIFY-MS Extension study evaluated the long-term efficacy and durability of cladribine tablets (CladT) in participants with highly active relapsing multiple sclerosis (RMS) during treatment-free Years (Y) 3 and 4.</jats:p>
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<jats:sec>
<jats:title>Methods:</jats:title>
<jats:p>Data were analysed for all participants and by subgroups (treatment-naïve vs experienced). Time to no evidence of disease activity (NEDA-3) and first confirmed Symbol Digit Modalities Test (SDMT) score change (⩾4/8 point improvement or ⩽4/8 point worsening) were assessed using Kaplan–Meier analysis. SDMT changes were confirmed if sustained across two visits ⩾166 days apart; others were classified as stable. Percentage brain volume change (PBVC) was analysed using the SIENA-XL method.</jats:p>
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<jats:title>Results:</jats:title>
<jats:p>Of 270 MAGNIFY-MS participants, 219 entered MAGNIFY-MS Extension (64.8% female; mean age ± standard deviation: 40.4 ± 9.45 years). NEDA-3 rates were 78.6% (Y3), 79.2% (Y4) and 54.2% (Y3–Y4 combined). At Y4, 83.1% had no T1 gadolinium-enhancing lesions, 67.4% had no active T2 lesions, and the annualised relapse rate was 0.09. Mean annualised PBVC was <0.4% in Y4. SDMT scores were 4/8-point stable or improved in 79.0%/88.1% of participants, and 84.5% had no 6-month confirmed disability progression.</jats:p>
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<jats:title>Conclusion:</jats:title>
<jats:p>Two years of short-course CladT provided sustained clinical and cognitive benefits, supporting the potential for treatment-free remission in RMS.</jats:p>
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<jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="https://ClinicalTrials.gov">ClinicalTrials.gov</jats:ext-link>
Identifier: NCT04783935. Date registered: 3 March, 2021
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