National Institute for Health and Care Excellence (NICE) has recommended cladribine (Mavenclad) as a treatment option for relapsing-remitting multiple sclerosis (RRMS).
Cladribine is recommended for the treatment of highly active multiple sclerosis in adults if the following conditions are fulfilled:
- Rapidly evolving severe RRMS, with a minimum of:
- two relapses in the past year; and
- one T1 gadolinium-enhancing lesion at baseline magnetic resonance imaging (MRI) or a substantial rise in T2-lesion load compared with a previous MRI.
- RRMS that has failed to respond adequately to disease-modifying therapy, defined as one relapse in the past year and disease activity evidenced by MRI.
Recommended cumulative dose for cladribine is 3.5 mg/kg body weight over two years, administered as one treatment course of 1.75 mg/kg per year. One treatment course comprises two weeks (each at the beginning of two consecutive months). Each week consists of four to five days on which a single daily dose of 10 or 20 mg is to be taken.
Evidence from clinical trials has shown cladribine to reduce relapses and retard the progression of disability vs placebo for individuals with RRMS. The cost-effectiveness of cladribine is better than all other treatments; hence, it is suitable for rapidly evolving severe and suboptimally treated RRMS.
The recommendations should not affect patients whose treatment with the drug was started before the publication of the guidance.