New Peer-Reviewed Research Shows No Increased Risk of Severe COVID-19 in Adults with Multiple Sclerosis Treated with Novartis’ Kesimpta (ofatumumab)

News on March 21, 2022 /BioValleyBIOON/ -- Novartis recently announced that new data on COVID-19 infections in patients with relapsing multiple sclerosis (RMS) treated with Kesimpta (ofatumumab) have been published in the peer-reviewed journal *Neurology and Therapy*. These data are based on the ongoing, open-label, long-term extension Phase 3b ALITHIOS study, as well as through...NovartisCompiled from post-marketing reports submitted to the global safety database.

In the 3b phase ALITHIOS study of 1,703 participants, 245 individuals (14.3%) reported COVID-19, with most cases being mild (44.1%) or moderate (46.5%), and the vast majority of patients recovered (98.4%).In patients treated with Kesimpta, the overall mortality rate due to COVID-19 (0.8%) and hospitalization rate (9.4%) were lower than the reported rates in the overall MS population (1.97% mortality, 15.5%-21.5% hospitalization).The incidence rate of breakthrough COVID-19 infections among fully vaccinated individuals was 1.5% (n=7/476), all of whom recovered.

This rate is consistent with the reported rate in the general population (approximately 1.5%) during the study period (up to September 25, 2021), and these rates are expected to rise as the efficacy of COVID-19 vaccines declines over time and new variants emerge. After the data cutoff in September 2021, no cases of COVID-19 were reported among individuals who received a booster vaccine (n=27). The current data do not provide any evidence suggesting an increased risk of severe COVID-19 in patients treated with Kesimpta compared to the general population or other MS patients with or without disease-modifying therapies (DMTs).

NovartisLykke Hinsch Gylvin, Global Medical Franchise Head of Neuroscience at Novartis, said, "The positive results regarding COVID-19 are very important for patients with multiple sclerosis who are receiving disease-modifying treatments, especially those who have completed the full vaccination regimen. To date, this is one of the largest studies reporting COVID-19 cases post-vaccination in RMS patients, and we are very pleased with the results announced today. Although early reports during the pandemic raised concerns about the occurrence of COVID-19 in MS patients receiving certain disease-modifying treatments, this data suggests that...Patients treated with Kesimpta show no significant difference in COVID-19 outcomes compared to the general population.。”

Kesimpta is a new targeted B-cell therapy that received FDA approval in August 2020.FDAApproved as a subcutaneous injection for the treatment of adults with relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. In the EU, Kesimpta was approved in March 2021 for the treatment of adult patients with RMS who have active disease as defined by clinical or imaging characteristics.

The active pharmaceutical ingredient of Kesimpta, ofatumumab, is a fully human anti-CD20 monoclonal antibody that works by binding to the CD20 molecule on the surface of B cells and inducing potent B-cell lysis and depletion.

Kesimpta, as a new generation of B-cell depleting agent, has the advantageous safety profile of rapidly depleting B-cells while preserving immunity., while also offering the convenience of once-monthly subcutaneous self-administration. (Bioon.com)

Source of the original text:New peer-reviewed research shows no increased risk of serious COVID-19 infections in Kesimpta (ofatumumab)-treated adults with multiple sclerosis