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New analysis shows that Kesimpta treated adults with relapsing remitting multiple sclerosis are not at increased risk of severe COVID-19 infections.- Novartis

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Published:31st Mar 2022

Novartis announces that the peer-reviewed journal Neurology and Therapy has published new data on COVID-19 infections in people living with relapsing remitting multiple sclerosis (RRMS) treated with Kesimpta (ofatumumab).

This data was compiled from the ongoing, single-arm, open-label, long-term extension phase IIIb ALITHIOS study and from post-marketing reports submitted through the Novartis Global Safety Database.

Of the 1703 participants in ALITHIOS, 245 (14.4%) reported COVID-19, most cases were mild (44.1%) or moderate (46.5%) and the vast majority of patients had either recovered or were recovering or recovered with sequelae (98.4%). The overall fatal outcome (0.8%) and hospitalization rates (9.4%) due to COVID-19 in ofatumumab-treated patients were lower than the rates reported in the general MS population (1.97% fatal outcome and 15.5%-21.5% hospitalisation). Breakthrough COVID-19 infections occurred in 1.5% of fully vaccinated participants (n = 7/476), from which all recovered. No cases of COVID-19 were reported after receiving a booster vaccination (n = 27) as per the data cut-off. The current data does not suggest any evidence of increased risk of severe COVID-19 in ofatumumab-treated patients compared to the reported data from the general population or other MS patients treated with or without disease-modifying therapies (DMTs).

Dr David Paling, Consultant Neurologist at the Royal Hallamshire Hospital: “COVID-19 has had a huge impact on people living with MS and has complicated decisions about treatment. This study of the outcomes of people who developed COVID-19 whilst on ofatumumab from the ALITHIOS study will allow my colleagues and I to reassure people with MS about their risks, and have informed discussions about treatment choices based on really accurate evidence.”

See-.Cross AH, Delgado S, Habek M, et al." COVID-19 Outcomes and Vaccination in People with Relapsing Multiple Sclerosis Treated with Ofatumumab". Neurol Ther. 2022; https://doi.org/10.1007/s40120-022-00341-z..

Condition: Multiple Sclerosis
Type: drug

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