New Data Presented at ACTRIMS Forum 2021 Indicate MAVENCLAD®-treated RMS Patients Mount Protective Antibody Response to Common Vaccines

- MAGNIFY-MS retrospective analysis demonstrates patients develop protective antibody levels for at least six months following seasonal influenza and varicella zoster vaccines, irrespective of vaccine timing relative to MAVENCLAD dosing - Initial findings from the CLOCK-MS vaccine sub-study show protective influenza antibody levels at four weeks post-vaccination in MS patients taking MAVENCLAD - In both studies, protective antibody levels were maintained or increased independent of lymphocyte counts ROCKLAND, Mass., Feb. 25, 2021 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced the presentation of a new analysis from the MAGNIFY-MS study on MAVENCLAD® (cladribine) tablets in patients with relapsing multiple sclerosis (RMS) at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021, being held virtually February 25-27, 2021. The data indicate that RMS patients receiving MAVENCLAD are able to mount a response to seasonal influenza and varicella zoster vaccination. "Understanding vaccine efficacy in MS patients is particularly important in the face of the current pandemic and the growing availability of COVID-19 vaccines," said Klaus Schmierer, Professor of Neurology at Queen Mary University of London and The Royal London Hospital, UK. "Whilst this new information is based on a small cohort of patients receiving influenza and varicella zoster vaccines, it provides physicians with preliminary evidence that patients taking MAVENCLAD are able to mount and maintain effective vaccine responses." In the U.S., the MAVENCLAD label states that all immunizations should be administered according to immunization guidelines prior to starting MAVENCLAD. The retrospective analysis was conducted to evaluate the protective antibody response to seasonal influenza (n=12) and varicella zoster virus (VZV) vaccination (n=3) in patients treated with MAVENCLAD. Blood samples taken before and after vaccination were examined. In patients who received the seasonal influenza vaccine, protective antibody levels were maintained or increased for at least six months independent of lymphocyte counts measured at the time of vaccination in year 1 or 2 of MAVENCLAD treatment. In patients who received the VZV vaccine before year 1 initiation of MAVENCLAD, protective VZV antibody levels were maintained over six months post-initiation with MAVENCLAD, despite lymphocyte depletion. These results were consistent irrespective of when the patients received the vaccine relative to their MAVENCLAD treatment. In the CLOCK-MS vaccine sub-study analysis, three relapsing remitting multiple sclerosis (RRMS) patients had received at least one dose of MAVENCLAD prior to receiving an influenza vaccine. Protective antibody levels were increased at four weeks post-vaccination in all three patients. Two of these patients, who had received treatment with MAVENCLAD two and four months prior to vaccination, were experiencing lymphopenia around the time of vaccination. "In an ever changing world where a pandemic will likely be present for the foreseeable future, it is critical to assess the impact of common non-live vaccinations in those taking disease modifying therapies," said Maria Rivas, MD, Chief Medical Officer, EMD Serono. "We are committed to communicating timely real-world evaluations of our therapies to help answer relevant questions raised by the MS community."

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