Multiple sclerosis (Houndmills, Basingstoke, England) · 2026
Long-term efficacy of cladribine tablets: Results from the MAGNIFY-MS Extension study.
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De Stefano Nicola, Vermersch Patrick, Wiendl Heinz, Barkhof Frederik, Montalban Xavier, Achiron Anat, Derfuss Tobias, Chan Andrew, Prat Alexandre, Leocani Letizia, Schmierer Klaus, Sellebjerg Finn, Nolting Axel, Petit Caroline, Guala Dimitri, Sponton Laura, Gardner Lidia, Hodgkinson Suzanne
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: Two years of short-course CladT provided sustained clinical and cognitive benefits, supporting the potential for treatment-free remission in RMS.
CLINICALTRIALS: gov Identifier: NCT04783935. Date registered: 3 March, 2021.
METHODS: 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.
RESULTS: 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.
CONCLUSION: Two years of short-course CladT provided sustained clinical and cognitive benefits, supporting the potential for treatment-free remission in RMS.
CLINICALTRIALS: gov Identifier: NCT04783935. Date registered: 3 March, 2021.