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.
References
- Mavenclad (cladribine). Product Label. EMD Serono, Inc. Rockland, MA. April 2019. Accessed August 12, 2020 at https://www.emdserono.com/us-en/pi/mavenclad-pi.pdf
- EMD Serono. Mavenclad website. Accessed August 12, 2020 at https://www.mavenclad.com
- Dosing Guide. Mavenclad (cladribine) Tablets. EMD Serono. April 2019. Accessed August 12, 2020 at https://www.mavenclad.com/content/dam/web/healthcare/neurology/united-states/pdfs/MAVENCLAD_Dosing_Guide_4.29.pdf
Read next
What are 8 key Mavenclad side effects to watch out for?
8 key side effects with Mavenclad use include a risk of cancer, birth defects in an unborn baby, a severe brain infection called PML, liver toxicity, other types of infections like shingles, tuberculosis or hepatitis, allergic reactions, heart failure and low white blood cell counts. Continue reading
How quickly does Mavenclad work?
Over 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 when compared to a placebo. Continue reading
Is Mavenclad a chemotherapy drug?
No, Mavenclad is not a chemotherapy (cancer) drug. It is an oral purine antimetabolite approved for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Mavenclad tablets are taken by mouth and are given as two yearly treatment courses. Continue reading
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Drug information
- Mavenclad Information for Consumers
- Mavenclad prescribing info & package insert (for Health Professionals)
- Side Effects of Mavenclad (detailed)
- Mavenclad user reviews (4)
Related support groups
- Mavenclad (9 questions, 3 members)
- Multiple Sclerosis (98 questions, 557 members)