Cladribine Tablets: A Review in Relapsing MS.

Area of Science:

• Neuroimmunology
• Pharmacology
• Clinical Neurology

Background:

• Multiple sclerosis (MS) is a chronic autoimmune disease targeting the central nervous system.
• Lymphocytes play a critical role in MS pathogenesis.
• Existing treatments for MS often involve frequent or injectable administration.

Purpose of the Study:

• To evaluate the efficacy and tolerability of cladribine tablets (Mavenclad) as an oral disease-modifying drug (DMD) for highly active relapsing MS.
• To assess the long-term outcomes of cladribine tablets in MS patients.

Main Methods:

• Phase 3 CLARITY trial and its extension study.
• Oral administration of cladribine tablets in two short courses, one year apart.
• Assessment of clinical relapse, disability progression, MRI-assessed disease activity, and health-related quality of life (HR-QOL).

Main Results:

• Cladribine tablets significantly reduced clinical relapse, disability progression, and MRI activity compared to placebo over 96 weeks.
• No additional clinical benefit was observed from continuing treatment beyond the initial two courses.
• Benefits were particularly notable in patients with high disease activity (HDA) relapsing MS.
• An acceptable tolerability profile was observed, with no increased risk of overall infection or malignancy.

Conclusions:

• Cladribine tablets are an effective, convenient, short-course oral treatment option for adults with highly active relapsing MS.
• The established dosing regimen provides sustained efficacy with an acceptable safety profile.
• Further active comparisons and longer-term follow-up data are warranted.