ECTRIMS 2024: Mavenclad sustains benefits in relapsing MS
Disease activity, disability slowed for as long as 4 years, data show
A short course of treatment with Mavenclad (cladribine) can provide long-term reductions in disease activity and disability progression for as long as four years in adults with highly active, relapsing forms of multiple sclerosis (MS), according to new data from the MAGNIFY-MS studies.
The majority of patients had low rates of confirmed disability accumulation after two years in the main trial, but PIRA, or progression independent of relapse activity, was particularly reduced in younger patients and in those who had not received previous treatment, the data showed, highlighting the importance of starting treatment early.
“Mavenclad continues to demonstrate its consistent safety profile with sustained benefits, impacting the lives of more than 100,000 people living with MS,” Alexander Kulla, senior vice president and head of the neurology and immunology medical unit at Merck KGaA, which operates as EMD Serono in the U.S. and Canada, said in a company press release.
These and other data from EMD Serono will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), being held Sept. 18-20 in Copenhagen and online.
Mavenclad is a short-course oral treatment that reduces the number of immune cells known to drive MS-related inflammation. It is given over two years in two treatment cycles per year, one month apart. Each cycle consists of one or two tablets a day for four to five days, so patients receive treatment for no more than 10 days each year.
Safety and efficacy trials
Data from multiple clinical trials has demonstrated that treatment with two short courses of Mavenclad consistently results in significantly more patients being free from relapses and MRI lesion activity, as well as free from confirmed disability progression.
To know more about the treatment’s safety and efficacy, EMD Serono conducted several Phase 4 clinical trials, which are studies done in a real-world setting after a treatment is approved by regulatory authorities.
The MAGNIFY-MS (NCT03364036) was a two-year, Phase 4 clinical trial that involved 270 patients with highly active, relapsing MS. Its main goal was to determine when Mavenclad started to exert an effect on the number of unique active lesions on MRI scans, and reductions were observed as early as two months after treatment initiation. A number of other measures were also assessed in the trial.
In a poster titled, “Low rate of progression independent of relapse in patients with relapsing multiple sclerosis treated with cladribine tablets,” researchers shared disability progression data from patients who participated in the two-year trial.
Results indicated that fewer than 1 in 10 patients (8.3%) experienced confirmed disability accumulation (CDA), which is defined as an increase in Expanded Disability Status Scale scores that’s confirmed in a follow-up visit at least six months later.
These CDA events can be associated with a relapse (RAW) or occur independently of relapse activity (PIRA). Consistent with the low CDA rates, the majority of patients were free from both RAW (98.4%) and PIRA (93.3%) after two years, the researchers showed.
PIRA rates were significantly lower in a subgroup of patients who had not received prior treatment before MAGNIFY-MS (3.7% vs. 9% for previously treated patients) and in those who started Mavenclad at age 40 or younger (4.2% vs. 10% for older patients at treatment initiation).
The findings support “the benefit of early initiation of cladribine tablets treatment to reduce total disability accumulation,” the researchers wrote.
Extension study data
Of the 270 patients who entered MAGNIFY-MS, 219 joined its two-year extension study (NCT04783935) , in which the long-term safety and effectiveness of Mavenclad treatment was assessed. Patients received no additional courses of treatment in this extension.
In the poster, “Long-term effectiveness of cladribine tablets over 4 years in relapsing multiple sclerosis: Results from the MAGNIFY-MS Extension study,” researchers showed that most patients had no evidence of disease activity, defined as no relapses, no new or active lesions, and no CDA, during years 3 and 4 combined (54.2%).
Over the four years of follow-up, patients experienced marked reductions in inflammatory and active lesions and had very low relapse rates (0.09 relapses per year). Relapse frequency was even lower in previously untreated patients, at a rate of 0.06 per year.
Finally, cognitive function improved or was stable in the majority of patients (77%-79% depending on the cut-off) over the four-year period.
Nearly two-thirds of patients (64.8%) experienced at least one side effect during the two-year extension, but most side effects (94.4%) were mild to moderate in severity. Three patients (1.4%) had one or more serious side effect related to the treatment.
“The efficacy of Mavenclad has long been established through traditional endpoints from our original pivotal trials and beyond. Now, with additional measures of the impact on neuroinflammation and progression, we can reaffirm and further solidify its long-term efficacy position within the MS treatment landscape,” Kulla said.
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