New five-year disease stability data confirm the long-term efficacy and safety of Mavenclad as a treatment for multiple sclerosis

Merck KGaA announced the presentation of new data for Mavenclad (cladribine tablets), which further characterise the long-term efficacy and safety profile. These data are being shared at the 35th Congress of the European Committee for Treatment and Research In Multiple Sclerosis (ECTRIMS), taking place from 11–13 September, 2019, in Stockholm, Sweden.

Results from a post hoc analysis (EP1573) evaluating five-year disease stability demonstrated sustained efficacy of cladribine tablets on disability progression , as measured by the Expanded Disability Status Scale (EDSS). According to study findings, 75% of patients showed stable or improved EDSS at five years post-treatment. The exploratory analysis was based on patients treated with cladribine tablets in CLARITY and then placebo in CLARITY Extension, with at least one post-baseline EDSS measurement.

Results were presented from a retrospective analysis (P617) of real-world follow-up data from an Italian multiple sclerosis (MS) registry, consisting of patients with clinically isolated syndrome or relapsing forms of MS who received at least one course of Mavenclad in the original clinical trial programme. At five years after receiving the last dose of Mavenclad, nearly two-thirds of patients (64%) had no disability progression and more than half of the patients (57%) were free of relapse.

“These data show us that Mavenclad continues to display sustained efficacy in a majority of patients at five years after starting treatment and that these results are consistent with data we are seeing from real-world experience,” said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry. “As a neurologist, this is important for me to see, as it shows that findings from the clinical development programme of Mavenclad will be borne out in clinical practice.”

In addition, final results (P1390) from the PREMIERE safety registry allowed for a thorough characterisation of the long-term safety profile of Mavenclad and showed no new safety findings. Furthermore, post-marketing data in the first 8,419 patients treated with Mavenclad worldwide were consistent with the safety profile seen in the Mavenclad clinical development programme, with no increase in incidence of adverse events from original clinical programme findings.