Novartis has announced 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 3b 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).
David Martin, Chief Executive Officer, Multiple Sclerosis Trust, said: “Access to a range of different treatment options is important for people living with MS to manage their condition in a way that is best for them and their lifestyle. This data gives reassurance to the MS community that the risk of severe COVID-19 infection in those vaccinated is in line with that reported currently in the general population.”
Dr David Paling, Consultant Neurologist at the Royal Hallamshire Hospital, said: “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.”
Chinmay Bhatt, Managing Director, UK, Ireland & Nordics for Novartis Pharmaceuticals, said: “The last couple of years have been a challenge for people living with MS as they have had to make important decisions with their doctor or nurse on how best to manage their condition during the COVID-19 pandemic.
“At Novartis, we are committed to conducting research to understand the impact of the COVID-19 vaccines and related clinical outcomes in patients treated with our medicines to ensure no person with MS is left behind. We are very pleased with the results of this study which provide reassurance to the healthcare professionals involved in managing MS.”
