Immune Repopulation Study Suggests Cladribine Has No Negative Effect on Ability to Fight Injection or Benefit From Vaccination
New research suggests that cladribine (Mavenclad; Merck KGaA, Darmstadt, Germany) treatment for relapsing multiple sclerosis (RMS) does not diminish individuals' ability to fight infection or form antibodies after immunization. The MAGNIFY-MS sub-study (NCT04783935) showed individuals with RMS treated with cladribine (did not have reduction of memory B cells until at least 1 month after cladribine initiation with lowest levels sustained for up to 12 months; naïve B cells began recovering immediately.
“The findings presented at AAN further our understanding of how Mavenclad impacts the immune system, and how it may exert a therapeutic effect in patients with multiple sclerosis while repopulating cells which support immune responses,” said Heinz Wiendl, MD, Department of Neurology with Institute of Translational Neurology, University of Muenster, Germany. “These important data indicate that in addition to addressing MS relapses and progression, patients treated with Mavenclad may be able to simultaneously mount a proper vaccine response – a particularly important finding at this time.”
An observational study published in Therapeutic Advances in Neurological Disorders, shows individuals treated with cladribine were able to generate COVID-19 antibodies after receiving an mRNA vaccine (Pfizer/BioNTech, New York, NY) dispensed 4.4 months after last cladribine dosing (n=23). All participants developed a protective SARS-COV-2 IgG antibody response (antibody titer >1.1 is considered positive; median=7). The antibody response after vaccination was similar to a comparison group of individuals with RMS not using immunomodulatory treatment and to people without MS. Humoral response to the COVID-19 vaccine was independent of lymphocyte count. No unexpected safety findings were seen after the first and second dose of the vaccine.
“Bringing Mavenclad -treated patients into a state where they can live their lives as normally as possible during a global pandemic is of utmost importance to us,” said Danny Bar-Zohar, MD, Global Head of Development for the Healthcare business sector of Merck KGaA, Darmstadt, Germany. “Beyond the convenient oral dosing schedule, proven efficacy, and well-characterized safety profile of Mavenclad, newly generated data now show encouraging initial evidence for these patients’ ability to generate adequate antibody response to COVID-19 vaccination, which is so important for patients.”
These data were presented at the American Academy of Neurology Virtual Annual Meeting April 17-22, 2021.