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.
The results from five neurologists in Europe treating MS patients showed that Mavenclad tablets have a comparable benefit-risk profile to that of the five other DMDs in MS patients with high disease activity.
“The presentation of these data highlight our ongoing commitment to understanding the full benefit-risk profile of Cladribine Tablets in a broad range of patients. Post hoc data from the CLARITY study, coupled with results from a Multi-Criteria Decision Analysis, which are based on expert physician assessment and practice-relevant treatment considerations, form a potentially useful tool for physicians in countries where Cladribine Tablets is approved to evaluate therapy options for patients with high disease activity,” Luciano Rossetti, head of global R&D for the biopharma business of Merck KGaA, said in a press release.
In a different presentation, researchers showed how the Magnetic Resonance Imaging in MS (MAGNIMS) score at year 1 was able to predict the long-term risk of a clinical disease activity event or disability progression in patients treated with Rebif (interferon beta-1a).
In patients with a MAGNIMS score of zero, disease activity took longer than those with a score of one or two. The median time of disease progression, measured by the Expanded Disability Status Scale (EDSS), also was longer in patients with a year 1 MAGNIMS score of zero compared to those with a score of one (7.5 years vs 4.0 years, respectively), or even a score of two (2.5 years).
In another presentation, Merck KGaA presented results from its sponsored survey on MS in the 21st Century joint patient-physician steering group. The results showed that while 87.7% of the clinicians reported their patients were involved in the treatment decision-process, only 38.9% of the patients felt involved. These data suggest that the dialogue between clinicians and MS patients is an area that needs improvements.