Mavenclad lowers relapse rates, helps RRMS patients reach NEDA-3

Treatment with Mavenclad (cladribine), an approved short-course oral therapy for relapsing forms of multiple sclerosis (MS), significantly reduced patients’ relapse rates and the development of new lesions while keeping disability stable over two years, according to a real-world study in Kuwait.

Among patients who completed the two courses of Mavenclad treatment, 75% had no evidence of disease activity — no relapses, no worsening disability, and no new or enlarging lesions — a status known as NEDA-3.

The percentage with NEDA-3 was higher — 87.5% — among patients given Mavenclad as a first-line disease-modifying therapy (DMT), “suggesting that early initiation of [Mavenclad] treatment is associated with better disease control,” the researchers wrote.

Their study, “A prospective observational longitudinal study with a two-year follow-up of multiple sclerosis patients on Cladribine,” was published in the journal Clinical Neurology and Neurosurgery.

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Mavenclad, by Merck KGaA, works to lower B- and T-cells in the blood

Mavenclad, sold by Merck KGaA (known as EMD Serono in North America), works by reducing the number of B- and T-cells circulating in the bloodstream, lowering disease activity and delaying disability progression.

It is administered in two courses of treatment over two years. Each course consists of two treatment cycles of about two weeks each, generally spaced about one month apart, at the beginning of each treatment year.

The drug was approved in the European Union in 2017 and in the U.S. in 2019 to treat adults with highly active relapsing forms of MS, including those with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).

While Mavenclad was deemed safe and effective in clinical trials, “evidence regarding its effectiveness and safety … in real-world settings remains scarce,” the researchers wrote.

Scientists in Kuwait examined data covering 72 RRMS patients who were followed for at least two years after initiating treatment with Mavenclad. Data was collected between December 2019 and September 2022.

Patients, mostly women (81.9%), had a mean age of 36.3, and were living with the disease for a mean of 7.2 years. The most common causes for initiating Mavenclad were highly active disease or disease breakthrough, defined as a relapse or MRI activity despite treatment.

Forty of these people, 55.6%, completed two treatment courses and then had been followed for a year. Among them, the proportion experiencing no relapses significantly increased after both courses compared with before treatment (85% vs. 25%). Mavenclad’s use also significantly reduced annual relapse rates, from about 0.85 to 0.15 relapses per year.

75% of treated patients showed no evidence of disease activity over 2 years

Similarly, significant drops were observed in the number of new lesions (7.5% vs. 70.8%) and lesions with active inflammation (5% vs. 66.7%). No evidence of disease activity, or NEDA-3, was achieved by 30 of these patients (75%), meaning they had no relapses, disability progression, or new or enlarging lesions while on treatment.

Disability scores, as measured with the Expanded Disability Status Scale (EDSS), remained largely stable over the two years, while eight patients, 20% of the group, showed a lessening in disability and two others, 10%, experienced a worsening in disability.

Some notable differences were seen between the 32 patients given Mavenclad as their first disease-modifying therapy and those who switched to Mavenclad from a previous DMT. For example, no disability progression or MRI activity was found in any of the treatment-naïve patients, while 16.7% of previously treated patients experienced such outcomes.

NEDA-3 rates of attainment also were higher in naïve than previously treated patients (87.5% vs. 66.7%), although the difference failed to reach statistical significance.

The better outcomes observed in treatment-naïve patients suggest “that cladribine might be more effective when used as first-line treatment,” the researchers wrote. “Further real-life studies on larger cohorts with longer follow-ups are needed to address this.”

Patients who had a disease duration of five years or less also tended to have better outcomes than those living with MS for longer. However, MRI activity was similar between the groups and differences in relapse rates, NEDA-3, and total disability failed to reach statistical significance. Only the proportion of patients with disability progression was significantly different between these groups.

Adverse events were reported in 21 people. The most common were fatigue, infection, COVID-19, and low levels of white blood cells. No one stopped treatment due to these side effects.

This study, the first in “a real-world setting that assessed the effectiveness and safety of cladribine tablets [Mavenclad] in the Middle East … showed that cladribine was effective in reducing relapses and MRI activity and stabilizing of EDSS score[s]” of people with RRMS, the researchers wrote.