Cladribine tablets: a potential new short-course annual treatment for relapsing multiple sclerosis

Abstract

Cladribine, a synthetic deoxyadenosine analog, is an oral immunomodulatory agent that produces targeted, sustained reduction of T and B lymphocytes. This mechanism of action provides the rationale for use in relapsing–remitting multiple sclerosis (MS) in a short-course annual dosing regimen. Based on the results of a pivotal Phase III study, therapy with cladribine tablets has the potential to become a licensed oral disease-modifying medication for relapsing forms of MS. This article will review the key points regarding MS and its pathogenesis, and discuss current unmet treatment needs. In particular the review provides an overview of emerging potential new oral MS therapies with a focus on the mechanism of action, chemistry, pharmacokinetics, pharmacodynamics, clinical efficacy and safety of cladribine tablets. Assessments and conclusions will include a speculative 5-year outlook.

Keywords::

• annual treatment
• cladribine tablets
• disease-modifying drug
• immunomodulatory effects
• multiple sclerosis
• oral therapy
• treatment adherence

Acknowledgments

The author thanks Jason Gardner, PhD (Merck Serono S.A. − Geneva, Switzerland, an affiliation of Merck KGaA, Darmstadt, Germany) for obtaining CLARITY study information contained in congress posters and abstracts with the relevant CLARITY study published data.

Financial & competing interests disclosure

This study was supported by NIH Grant # DA023448. This is manuscript number MEM-20419 from The Scripps Research Institute. Jack C Sipe has received personal compensation for consulting services from Merck Serono International S.A., Geneva Switzerland and EMD Serono, USA. There was no author personal compensation for the writing and production of this article. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Writing assistance was utilized in the production of this manuscript. The author thanks Mary Goodsell and staff of ACUMED^® for assistance in manuscript preparation and editing, funded by Merck Serono – S.A., Geneva, Switzerland.