How effective is Mavenclad for MS?

In March 2019, the FDA approved Mavenclad (cladribine), a purine antimetabolite used for the treatment of relapsing forms of multiple sclerosis (MS) in adults 18 years of age and older. Mavenclad is used in relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Mavenclad is not recommended for MS patients with clinically isolated syndrome or as a first-line agent due to its safety profile.

• Mavenclad was studied in CLARITY, a Phase 3, double-blind study and compared to a placebo (treatment with no active drug).
• The effectiveness of Mavenclad was shown in a 96 week (~2 year) clinical trial with 1,326 patients with relapsing forms of MS who had at least one relapse in the previous 12 months.
• In the study, Mavenclad significantly decreased the number of relapses (the primary endpoint of the study) when compared to a placebo (an inactive treatment). Over the 96 weeks, 81% of patients who took Mavenclad were relapse-free compared to 63% of those who took a placebo.
• Mavenclad also decreased 3-month progression of disability due to MS, measured by expanded disability status scale (EDSS), when compared to placebo. Results showed 87% of patients on Mavenclad had no confirmed EDSS progression compared to 81% of patients taking a placebo, a 33% risk reduction.

Mavenclad helps to reduce immune system cells (T and B cells) that can attack nerves and lead to inflammation in MS. The number of these cells will begin to recover after each yearly Mavenclad administration. This may take several months and your levels of immune system cells may not go back to pretreatment levels.