Mavenclad helps MS patients keep cognitive skills sharp over 2 years
Study also showed treatment stabilized employment status for most participants
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- Mavenclad (cladribine) stabilizes or improves cognitive function in relapsing multiple sclerosis (MS) patients.
- This treatment also helps maintain employment status for most highly active MS patients over two years.
- Mavenclad is designed to reduce inflammatory damage in the brain and spinal cord.
Among people with relapsing forms of multiple sclerosis (MS) and highly active disease, Mavenclad (cladribine) treatment resulted in stable or better cognitive function over two years.
That’s according to new data from the Phase 4 CLARIFY-MS study (NCT03369665), which also demonstrated that Mavenclad can stabilize employment status for most people with full-time or part-time jobs.
“The stability in overall cognitive function and employment status … adds to the previously reported positive [health-related quality of life] findings for [Mavenclad] in people with highly active RMS, supporting its overall benefits in MS treatment,” researchers wrote.
The study, “Stability in Cognition and Employment in People with Relapsing Multiple Sclerosis Treated with Cladribine Tablets: Two-year Phase IV CLARIFY-MS Study,” was published in Neurology and Therapy. Merck KGaA (known as EMD Serono in North America), which markets Mavenclad, funded the work.
Mavenclad aims to reduce inflammatory damage in brain, spinal cord
People with MS often experience cognitive impairment that may negatively impact their work performance and quality of life.
Mavenclad is a short-course oral treatment approved for people with relapsing forms of MS. It is designed to reduce inflammatory damage in the brain and spinal cord by targeting immune B- and T-cells, which drive inflammatory attacks in MS.
In the clinical trials that supported its approval, Mavenclad was shown to reduce disease relapses, slow the development of lesions, and delay disability progression. However, these trials have not fully examined Mavencland’s effects on cognitive function and employment status.
Verbal learning and memory improved after two years
The CLARIFY-MS trial was designed to evaluate the treatment’s effects on health-related quality of life in a real-world setting. It enrolled 482 people with highly active relapsing MS, who received the approved dosing regimen of Mavenclad — two treatment courses over two years, one course per year, with no more than 10 treatment days per course.
Previous results from CLARIFY-MS showed that Mavenclad significantly improved physical and mental health aspects of quality of life over two years. In this study, researchers assessed the effects of treatment on cognitive function and employment status.
Cognitive function was assessed at baseline and after one and two years of treatment using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), a recommended cognitive assessment tool for MS. BICAMS includes the SMDT test, which evaluates information processing speed, as well as a test to measure verbal learning and memory, and another to assess visuospatial learning and memory.
Results showed that information-processing speed and visuospatial learning and memory remained generally stable, while verbal learning and memory improved after two years.
Most CLARIFY-MS participants had increased or stable information processing speed at [two years], as determined using clinically meaningful 4- and 8-point changes in SDMT scores. Overall, the cognitive function and employment status of [Mavenclad]-treated participants with highly active [relapsing MS] remained stable over 2 years.
In the SDMT test, most participants showed either increased or stable information-processing speed after two years. In particular, 35.5% of participants had a clinically meaningful 4-point change in SDMT scores, and 17% had an 8-point change. A 4-point change in SDMT score is considered clinically significant at the group level, while an 8-point change is considered more reliable at the individual level.
The effects were similar for patients who had previously received other disease-modifying therapies before enrolling in the study and those who didn’t, suggesting that “overall cognitive function was largely preserved in both [treatment-naïve] and [treatment]-experienced people with highly active RMS.”
Patients’ employment status was mostly stable, with no major differences after two years. Overall, 209 of the 229 patients who were employed full-time and 56 of the 59 with part-time jobs before starting Mavenclad retained their employment after two years.
“Most CLARIFY-MS participants had increased or stable information processing speed at [two years], as determined using clinically meaningful 4- and 8-point changes in SDMT scores. Overall, the cognitive function and employment status of [Mavenclad]-treated participants with highly active [relapsing MS] remained stable over 2 years,” the researchers concluded.
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