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ABN Abstracts 2022
Poster presentations
153 ChariotMS – cladribine to halt deterioration in people with advanced multiple sclerosis (pwAMS)
  1. Klaus Schmierer1,2,
  2. David Baker1,
  3. Tanjil Nawaz3,
  4. Kimberley Allen-Philbey1,2,
  5. Frederik Barkhof4,5,
  6. Jeremy Chataway6,7,
  7. Richard Hooper3,
  8. Borislava Mihaylova3,
  9. Jeremy Hobart8,
  10. Sue Pavitt9
  1. 1The Blizard Institute, Queen Mary University of London
  2. 2Clinical Board Medicine, The Royal London Hospital, Barts Health NHS Trust
  3. 3Pragmatic Clinical Trial Unit, Queen Mary University of London
  4. 4Department of Radiology, VU University Medical Center, Amsterdam, The Netherlands
  5. 5UCL Institutes of Neurology and of Healthcare Engineering, London
  6. 6Queen Square Multiple Sclerosis Centre, UCL Institute of Neurology
  7. 7NIHR, University College London Hospitals Biomedical Research Centre, London
  8. 8Faculty of Medicine and Dentistry, Institute of Translational and Stratified Medicine, Plymouth
  9. 9School of Dentistry, University of Leeds

Abstract

Background Disease-modifying treatments (DMT) have transformed the management of people with MS. However, those with an EDSS>6.5 (pwAMS) are considered not suitable for DMT due to (i) a focus on ambulation as outcome measure, (ii) the assumption that in pwAMS, inflammation plays no role, and (iii) a disregard for potentially length-dependent neuro-axonal damage. Cladribine tablets (Mavenclad®) is an effective, convenient, relatively safe DMT licensed for people with highly-active relapsing MS. Cladrib- ine depletes B (less so T) cell subsets, particularly memory B cells, putatively key for disease control in MS.

Aims To test efficacy, safety and cost-effectiveness of cladribine tablets in pwAMS (EDSS 6.5-8.5), expand mechanistic understanding of cladribine and provide evidence for NHS adoption.

Methods Randomised, double-blind, placebo-controlled phase IIb trial. Primary outcome measure, 9-hole peg test speed at 104 weeks vs baseline. Sample size calculations indicated n=200 required to detect 15% treatment effect in 9HPT peg-speed with 90% power at 5% significance and 20% drop-out.

Results Nine/20 trial sites currently open for recruitment. Five participants already enrolled. Full recruit- ment predicted in Q1/2023.

Conclusions ChariotMS is the first DMT-trial focussing on pwAMS. If successful, ChariotMS could expand the DMT landscape to include pwAMS, and provide a platform for add-on therapies.

https://doi.org/10.1136/jnnp-2022-abn2.197

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