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Publications

Journal Article Ahead of print 1 citation

PubMed: 42548205 DOI: 10.1177/13524585261467624

Long-term efficacy of cladribine tablets: Results from the MAGNIFY-MS Extension study.

Mult Scler

Authors: Nicola De Stefano, Patrick Vermersch, Heinz Wiendl, Frederik Barkhof, Xavier Montalban, Anat Achiron, Tobias Derfuss, Andrew Chan, Alexandre Prat, Letizia Leocani, Klaus Schmierer, Finn Sellebjerg, Axel Nolting, Caroline Petit, Dimitri Guala, Laura Sponton, Lidia Gardner, Suzanne Hodgkinson

Affiliations

  • Department of Medicine, Surgery and Neuroscience, University of Siena, Siena, Italy.
  • Université de Lille, Inserm U1172 LilNCog, CHU Lille, FHU Precise, Lille, France.
  • Department of Neurology, Institute of Translational Neurology, University of Münster, Münster, Germany; Department of Neurology and Neurophysiology, Freiburg University, Freiburg, Germany.
  • Department of Radiology and Nuclear Medicine, Amsterdam UMC, Vrije Universiteit, Amsterdam, The Netherlands; Queen Square Institute of Neurology and UCL Hawkes Institute, University College London, London, UK.
  • Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d'Hebron, Barcelona, Spain.
  • Multiple Sclerosis Center, Sheba Academic Medical Center, Ramat Gan, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
  • Department of Neurology, University Hospital Basel, Basel, Switzerland.
  • Department of Neurology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
  • Department of Neurosciences, Université de Montréal, Montréal, QC, Canada.
  • Experimental Neurophysiology, University Vita-Salute San Raffaele, Milan, Italy.
  • The Blizard Institute, Centre for Neuroscience, Surgery and Trauma, Faculty of Medicine & Dentistry, Queen Mary University of London, London, UK; Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, UK.
  • Danish MS Center, Department of Neurology, Copenhagen University Hospital-Rigshospitalet, Glostrup, Denmark; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
  • Global Patient Safety/Safety Strategy, Merck Healthcare KGaA, Darmstadt, Germany.
  • Clinical Measurement Sciences, Merck Healthcare KGaA, Darmstadt, Germany.
  • Clinical Measurement Sciences, Merck AB, Solna, Sweden.
  • Neurology & Immunology Medical Unit, EMD Serono Research & Development Institute, Inc. Billerica, MA, USA.
  • Ingham Institute for Applied Medical Research, University of New South Wales Medicine and Liverpool Hospital, Sydney, NSW, Australia.

Abstract

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.

MeSH

Multiple Sclerosis, Safety, Tablets, Cladribine, Therapeutics, Wounds And Injuries, Cognition