New real-world MAVENCLAD data show sustained effectiveness and benefit on quality-of-life measures in RMS patients

On 13 Oct 2021, Merck announced new interim real-world data on MAVENCLAD (cladribine tablets) that show patients with relapsing multiple sclerosis (RMS) experienced a significant improvement in quality-of-life (QoL) scores after the first course of treatment in Year 1 with MAVENCLAD. Additionally, late-breaking real-world MAVENCLAD data evaluating long-term mobility and disability status suggested sustained benefit beyond the last treatment course and a reduced need for a wheelchair or ambulatory device among MAVENCLAD-treated patients. These data were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). A new interim analysis from the open-label Phase IV CLARIFY-MS study demonstrated improvements in QoL measures in 426 patients with RMS early in the treatment course (Year 1). After completing half the recommended cumulative dose of MAVENCLAD over two years, improvements from baseline were observed for physical and mental health composite scores (nominal p less than 0.0001) as measured by the Quality of Life-54 questionnaire. Safety data were consistent with the safety profile seen in the MAVENCLAD clinical development programme. Also presented were late-breaking final data from the Phase IV CLASSIC-MS, a follow-up study, which showed that 90.0% of patients with RMS treated with cladribine tablets did not need to use a wheelchair or were not confined to bed (ie, with an Expanded Disability Status Scale less than 7) after a median follow-up of 10.9 years (range 9.3-14.9). Additionally, 81.2% of cladribine tablets-treated patients did not require an ambulatory device. CLASSIC-MS investigated the long-term efficacy in 435 patients with RMS - 90.6% of whom were exposed to cladribine tablets during the CLARITY and CLARITY Extension trials. The study focused on long-term mobility and disability - two areas of importance as MS can cause problems with movement, balance and coordination that can worsen over time. An independent study, presented by Prof Adi Vaknin-Dembinsky, MD, PhD, Senior Neurologist, Hadassah Medical Center at the Hebrew University, Jerusalem, Israel, evaluated antibody response after a complete course of the Pfizer/BioNTech mRNA COVID-19 vaccine in healthy controls and patients with MS (untreated, or treated with MAVENCLAD or interferon beta-1a). Consistent with previously reported data, MAVENCLAD-treated patients, as well as those treated with interferon beta-1a, who received the Pfizer/BioNTech mRNA COVID-19 vaccine were found to mount a positive serology response (AU/mL more than 19), similar to that of healthy controls. Specifically, all patients with MS treated with MAVENCLAD (n=30) had a positive serology response against the spike protein two to three weeks after vaccination (mean=226.3 plus-minus 121.4). In the study, the shortest interval between vaccination and the last dose of MAVENCLAD was 12 weeks. Original source: Merck KGaA, website: https://www.merckgroup.com/en, Copyright Merck KGaA 2021.
research and development; antiviral vaccines; beta-1a interferon; cladribine; MAVENCLAD; messenger RNA; BioNTech; Merck; [...]