#ACTRIMS2022 – Mavenclad Best at Reducing Relapses: Real-world Data

People with multiple sclerosis (MS) who are treated with Mavenclad (cladribine) are less likely to experience a disease relapse than those who are treated with Gilenya (fingolimod), Tecfidera (dimethyl fumarate), or Aubagio (teriflunomide), according to an analysis of real-world data.

The findings were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2022, held Feb. 24-26 in Florida.

Other data presented at ACTRIMS showed that treatment with Mavenclad can delay the progression from clinically isolated syndrome (CIS) — which is suggestive of multiple sclerosis — to clinically definite MS. The research was funded by EMD Serono (known as Merck KGaA outside the U.S. and Canada), which markets Mavenclad. 

Mavenclad is a widely approved oral therapy for relapsing forms of MS, including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (SPMS).

Scientists at EMD Serono and other institutions compared the efficacy of Mavenclad to that of three other approved oral MS therapies: Gilenya, Tecfidera, or Aubagio. Their poster was titled “Real-World Comparative Effectiveness and Persistence of Cladribine Tablets and Other Oral Disease-Modifying Treatments for Multiple Sclerosis from GLIMPSE: Results from the MSBase Registry.”

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For the analysis, the researchers used real-world data gathered from the MSBase Registry, an international online registry for neurologists studying MS and similar conditions.

“It is important in a lifelong disease like MS to continue assessing the efficacy and safety of available treatment options in the real world,” Helmut Butzkueven, PhD, a co-author of the poster from Monash University, in Australia, said in a press release.

“This is where the MSBase Registry, using standardized data records from over 79,000 people with MS around the world, can provide information that is not possible to obtain in a randomized clinical trial,” Butzkueven said.

The analysis included 633 patients taking Mavenclad, as well as 1,195 given Gilenya, 912 on Tecfidera, and 735 on Aubagio. In all groups, the average age was in the late 30s or early 40s, the average disease duration was about a decade, and about three-quarters of patients were female. Close to 90% of patients in all groups had RRMS.

The researchers then matched patients given Mavenclad with patients on other treatments based on age, sex, disability status — as assessed with the Expanded Disability Status Scale (EDSS) — pre-treatment relapses, number of prior treatments, and country. Median follow-up time ranged from 11 to 13 months.

Results showed that, over the follow-up period, people on Mavenclad experienced an average of 0.09 relapses per year, compared with an average annual relapse rate of 0.15 for Gilenya, 0.15 for Tecfidera, and 0.17 for Aubagio.

The time to first relapse also was significantly longer with Mavenclad — by 40% compared with Gilenya, 42% compared with Tecfidera, and 67% compared with Aubagio. Time to treatment discontinuation or a switch to another therapy was similarly longer on Mavenclad than other therapies.

“Mavenclad had better relapse outcomes and longer treatment persistence compared to other oral” treatments, Butzkueven concluded.

When a person experiences a first attack of MS-like disease, it is termed CIS. A diagnosis of definitive MS cannot be made until the person has at least one more such attack (hence the “multiple” in “multiple sclerosis”).

Mavenclad is currently not recommended for treating CIS, but in a separate presentation at ACTRIMS, researchers assessed whether treatment with Mavenclad could delay the progression from CIS to definitive MS. The poster was titled “Primary Results from 8-11 Years of Follow-up in the CLASSIC-MS Study Show Long-term Efficacy for Patients Who Received Cladribine Tablets in ORACLE MS.”

This analysis included data from people who had participated in the Phase 3 clinical trial ORACLE-MS (NCT00725985), which tested a standard treatment regimen of Mavenclad (two courses of oral treatment over two years) against a placebo in patients with CIS. The patients were further followed in a Phase 4 extension study called CLASSIC-MS (NCT03961204).

A total of 227 patients were examined, including 156 who received Mavenclad during ORACLE-MS, and 71 who were given a placebo and never exposed to Mavenclad.

After a median follow-up time of 9.5 years since the last treatment dose in ORACLE-MS, 42.9% of patients treated with Mavenclad converted to clinically definite MS, compared with 70.4% of those given placebo. Over half (53.2%) of patients given Mavenclad have been relapse-free throughout the entire study, compared to 28.2% of those given placebo.

“With a median follow-up of almost 10 years since last study dose, [Mavenclad] was found to delay the conversion to clinically definite MS, and enable more of the treated population to remain relapse-free,” said Gavin Giovannoni, PhD, a professor at Queen Mary University of London, who presented the data at ACTRIMS.

Regardless of Mavenclad treatment status, the vast majority of study participants have mild disability after nearly a decade, though rates of patients needing mobility aid were somewhat lower among patients treated with Mavenclad.

“The overall message is that exposure to [Mavenclad] after the first [MS-like] event has a big impact on disability worsening in the future,” Giovannoni said.

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the ACTRIMS Forum 2022 Feb. 24–26. Go here to see the latest stories from the conference.