#ECTRIMS2021 – Real-world Data Support Mavenclad Benefits in Relapsing MS

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by Marta Figueiredo, PhD |

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Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the virtual 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Oct. 13–15. Go here to see the latest stories from the conference.

Mavenclad (cladribine) improves life quality for people with relapsing multiple sclerosis starting in the first year of treatment, and continues to slow disability progression a decade after its last treatment course, real-world data show.

These findings were presented in two Merck KGaA-funded posters at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), running virtually through Oct. 15. Merck, known as EMD Serono in North America, is the developer of Mavenclad.

“Those living with MS know the effect of a treatment goes beyond what is shown in MRIs or in bloodwork,” and many “express that the impact on physical and mental well-being is just as important,” Jeannette Lechner-Scott, PhD, senior staff specialist in the department of neurology and a conjoint professor at the University of Newcastle, in Australia, said in a press release.

“The quality-of-life outcomes from the CLARIFY-MS study support that Mavenclad positively impacts these measures early in the treatment course,” Lechner-Scott added.

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Mavenclad is an oral, short-course disease-modifying therapy (DMT) approved for active and relapsing forms of MS that consists of no more than 10 days of treatment per year over two years. It works by reducing the number of the circulating immune cells that drive inflammation and neurodegeneration in MS patients.

Mavenclad’s safety and efficacy in people with relapsing MS was demonstrated in several Phase 2 and 3 trials and extension studies, of which some followed patients for more than 10 years.

While previous trials also showed a quality-of-life improvement in Mavenclad-treated patients over those given a placebo, this difference did not reach statistical significance, likely due to the limited number of patients included in these analyses.

The ongoing, European CLARIFY-MS Phase 4 trial (NCT03369665) was designed to further evaluate the effects of Mavenclad at its approved, two-year treatment regimen on life quality in 482 adults with highly active and relapsing MS.

Quality of life is being assessed through the Multiple Sclerosis Quality of Life-54 (MSQoL-54) questionnaire. Treatment satisfaction is also being measured at six and 12 months.

Lechner-Scott and colleagues now analyzed the study’s interim, one-year data, which were presented by Alessandra Solari, MD, of the Foundation IRCCS Carlo Besta Neurological Institute in Italy. The poster was titled, “Improvements in QoL at 1 year in patients treated with cladribine tablets for highly active relapsing MS: an interim analysis of CLARIFY-MS.”

Results from the 426 patients with available MSQoL-54 data showed a significant improvement in their physical and mental health scores after the first Mavenclad treatment course.

Notably, similar trends were observed among patients who had no prior treatment and among those previously treated with DMTs. The researchers also found no evidence of an impact of the pandemic on patients’ quality of life.

Treatment satisfaction was comparable between months six and 12, and Mavenclad’s safety data were consistent with that reported in previous trials, with no new safety concerns identified.

There were also no new severe or opportunistic infections that “could have an impact on the established benefit:risk profile” of Mavenclad in MS, the researchers wrote.

In a second poster, “Long-term efficacy for patients receiving cladribine tablets in CLARITY/CLARITY extension: Primary results from 9–15 years of follow-up in the CLASSIC-MS study,” Gavin Giovannoni, PhD, a professor of neurology at Barts and The London School of Medicine and Dentistry, presented long-term, real-world data from the CLASSIC-MS Phase 4 trial (NCT03961204).

CLASSIC-MS is evaluating the long-term treatment outcomes and its durability beyond the approved, two-year regimen among relapsing MS patients who previously participated in Mavenclad Phase 3 trials.

Its primary and main secondary goals are to assess long-term mobility and disability beyond the treatment courses that patients received in the parent trials.

The mobility goal was defined as the proportion of patients who were not using a wheelchair or bedridden in the three months prior to a first visit in CLASSIC-MS, while the disability outcome was defined as not needing walking aids at any time since the last dose.

Giovannoni shared CLASSIC-MS data regarding the 435 patients who participated in the placebo-controlled CLARITY Phase 3 trial (NCT00213135), including 345 who enrolled in the trial’s extension study (NCT00641537) and were again randomly assigned to Mavenclad or a placebo.

A total of 394 (90.6%) patients were treated Mavenclad — of whom 160 completed the two-year regimen — at some point in the trials, while 41 (9.4%) had never been exposed to the medication. Patients had received their last dose in either of the CLARITY trials a median of 10.9 years earlier.

Results showed that a significantly greater proportion of Mavenclad-treated patients were not using a wheelchair or were not confined to bed, compared with those given a placebo (90% vs. 77.8%).

Patients who received Mavenclad were also more likely to not require walking aids relative to those given a placebo (81.2% vs. 75.6%).

In addition, what is “really exciting,” Giovannoni said, is that Mavenclad-treated patients “were less likely to receive further DMTs,” with 55.8% of those previously exposed to Mavenclad not receiving a subsequent DMT, compared with 26.8% of those who were never exposed.

With a median follow-up of 11 years, these findings suggest that Mavenclad’s efficacy “is sustained in terms of long-term mobility and disability status in patients with relapsing multiple sclerosis,” Giovannoni concluded.

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