Quality of life gains with Mavenclad sustained for 2 years: Phase 4 trial

The Phase 4 CLARIFY-MS study enrolled 482 people with relapsing MS

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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Treatment with Mavenclad (cladribine) over two years significantly improved physical and mental health aspects of quality of life in people with highly active relapsing multiple sclerosis (MS), according to a final analysis of data from the Phase 4 CLARIFY-MS study.

Mavenclad is an oral medication approved for people with relapsing forms of MS and is designed to reduce inflammatory damage in the brain and spinal cord by targeting immune B-cells and T-cells in circulation.

The study, “Improvements in quality of life over 2 years with cladribine tablets in people with relapsing multiple sclerosis: The CLARIFY-MS study,” was published in the Multiple Sclerosis Journal. The work was funded by Merck KGaA (EMD Serono in North America), which markets Mavenclad.

In clinical trials, the therapy has been shown to reduce relapses and slow disability progression. Treatment with it also reduced the number of brain lesions, or areas of damage, visible on MRI scans.

After its approval, a number of Phase 4 clinical trials were launched to study Mavenclad’s effects in a real-world setting. The primary outcome of CLARIFY-MS study (NCT03369665) was to see if it could also improve quality of life in people with MS.

The two-year study enrolled 482 people with highly active relapsing MS at multiple locations across Europe. All the participants received the approved dosing regimen of Mavenclad, which is given in two treatment courses about a year apart.

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Quality of life gains with Mavenclad at 2 years

Health-related quality of life was assessed using the MS Quality of Life-54 (MSQoL-54) questionnaire, which scores aspects of physical and mental health from 0 to 100. Higher scores in this scale indicate better quality of life.

A one-year interim analysis presented at the 2021 ECTRIMS meeting revealed Mavenclad was well tolerated and improved physical and mental health scores after the first course. This was observed for both previously treated patients and those who’d never received disease-modifying therapies (DMTs).

The quality of life improvements continued to be observed at two years. Overall, MSQoL-54 physical scores increased significantly, by a mean of 4.86 points, from the start of the study to the two-year assessment. Mental health scores also changed significantly, by a mean 4.8 points.

An improvement of at least 5 points is considered a clinically important difference in quality of life scores. In this study, 47.1% of patients achieved such an improvement in physical quality of life, and 44.5% in the mental health aspect.

The greatest improvements were observed in the quality of life domains of limitations owing to physical problems, health distress, and emotional problems.

A total of 134 (27.8%) patients had never received treatment, whereas 348 (72.2%) had been treated with other DMTs. Changes in the MSQoL-54 scores were consistent across the two groups.

Treatment satisfaction at six months — a secondary goal of CLARIFY-MS — was high and remained so over two years. Relapses remained low throughout the study, at an average of 0.13 per year, and most patients didn’t have sustained disability progression.

A total of 78% of patients had treatment-related side effects, but most were mild or moderate in severity. The most common were headache, a reduced number of white blood cells, called lymphocytes, in the blood, and the common cold.

“No new safety signals impacting the established benefit-to-risk profile of [Mavenclad] in people with highly active [relapsing MS] were observed,” wrote the researchers, who said the therapy “significantly improved the mean MSQoL-54 physical and mental health composite scores over 2 years.”

The study was limited by the absence of a control group and by its open-label design, meaning researchers and patients were aware of the treatment being given, the researchers said.