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Cladribine tablets in the new multiple sclerosis era.

Fabio Buttari1,2, Ettore Dolcetti2,3, Francesca Romana Rizzo4

  • 1Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.

Therapeutic Advances in Neurological Disorders
|June 23, 2025
PubMed
Summary

Cladribine tablets (CladT) offer a novel approach to treating multiple sclerosis (MS) by selectively modulating the immune system. This therapy effectively reduces neurological damage and disability progression in MS patients.

Keywords:
B cellsT cellscladribine tabletsdisease-modifying therapymultiple sclerosis

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Area of Science:

  • Neuroimmunology
  • Clinical Therapeutics
  • Autoimmune Diseases

Background:

  • Multiple sclerosis (MS) is a chronic autoimmune disease causing central nervous system (CNS) demyelination and irreversible neurological damage.
  • Current disease-modifying therapies (DMTs) aim to manage MS, but advancements are needed for sustained efficacy and improved safety profiles.

Purpose of the Study:

  • To review the therapeutic potential and clinical efficacy of cladribine tablets (CladT) in treating MS.
  • To examine CladT's immune reconstitution mechanism, CNS effects, and impact on long-term outcomes and quality of life.

Main Methods:

  • Systematic review of clinical trials and real-world studies on cladribine tablets for MS treatment.
  • Analysis of CladT's effects on immune cells, CNS markers, lesion activity, and patient-reported outcomes.

Main Results:

  • CladT selectively targets lymphocytes, leading to sustained immune modulation with preserved innate immunity and immunoglobulin levels.
  • CladT reduces MS relapse rates, disability progression, and MRI-detected disease activity, including active and slowly expanding lesions.
  • Evidence suggests CladT penetrates the blood-brain barrier, reducing CSF immunological markers like oligoclonal bands and neurofilament light chain.

Conclusions:

  • Cladribine tablets represent a significant advance in MS management, offering high efficacy and a favorable safety profile.
  • Early, high-efficacy treatment with CladT is crucial for optimizing long-term outcomes and reducing disability accumulation in active MS.
  • Emerging biomarkers may enable personalized treatment strategies, further enhancing CladT's role in the evolving MS therapeutic landscape.