This site is intended for healthcare professionals

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

Read time: 1 mins
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;

Condition: Multiple Sclerosis
Type: drug

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.

Related news and insights