New retrospective analysis of the Phase 3 CLARITY study (NCT00213135) shows that treatment with Mavenclad (cladribine tablets) improved annualized relapse rate and magnetic resonance imaging (MRI) outcomes in patients with relapsing-remitting multiple sclerosis (RRMS), regardless of their age.
Moreover, the effectiveness of Mavenclad was comparable to five standard therapies approved in Europe for multiple sclerosis treatment.
These results were shared recently at the 4th Congress of the European Academy of Neurology (EAN), in Lisbon, Portugal.
The new analysis aimed to investigate if the clinical benefits of Mavenclad — developed by Merck KGaA (known as EMD Serono in the U.S. and Canada) — were maintained irrespective of patient’s age. For that, researchers divided patients into two groups: one aged 50 or younger, and a second group older than 50. Patients in each group were randomized to receive Mavenclad or placebo (control).
Treatment with Mavenclad reduced the risk of relapse compared to placebo by 59% in patients 50 or younger, and by 52% in those older than 50.
Despite the fact that patients younger than 50 showed higher areas of inflammation, detected using an MRI T1-weighted scan — a technique that uses an injected contrast material (gadolinium) to highlight newer, active areas of inflammation – and active T2 lesions (areas of myelin damage) when compared to older patients, treatment with Mavenclad improved the MRI outcomes in both age groups.
Researchers also presented additional results of a so-called Multi-Criteria Decision Analysis, in which they compared the effectiveness of Mavenclad to other approved disease-modifying drugs (DMDs) for MS patients with high disease activity. The goal was to assess the benefit-risk profile of Mavenclad.
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