No increased risk for breakthrough COVID-19 infection, severe COVID-19, or fatal outcomes among patients receiving ofatumumab for relapsing multiple sclerosis (MS) was found in an updated analysis presented at the 2022 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) held from June 1-4, in National Harbor, Maryland.
SARS-CoV-2 is associated with a severe respiratory infection which can be fatal. Since the beginning of the pandemic, there has been concern and uncertainty about specific risks for patients receiving disease-modifying therapy (DMT).
This analysis is an update of the ALITHIOS study, which sought to evaluate COVID-19 outcomes among patients with MS treated with ofatumumab. This update includes the ongoing, open-label, long-term extension. Data collection began at the start of the pandemic, continuing through January 29, 2021 and until September 25 2021 for the open-label extension. Patients (N=1703) were evaluated for COVID-19 infection rates, disease severity and outcomes, vaccination rates, and breakthrough infection rates.
Patients were aged mean 37.9 (standard deviation [SD], 8.75) years at baseline and 69.8% were women.
In total, 210 patients had confirmed and 35 suspected COVID-19. Most infections were not serious (90.2%) and 9.4% required hospitalization. Stratified by severity, 90.6% were grades 1 or 2, 7.8% were grade 3, and 1.2% were life-threatening, grade 4 infections.
At the time of publication, 2 patients had not recovered from their illness and 2 patients died.
No COVID-19 reinfections were observed.
A third of patients (32.8%) were vaccinated against COVID-19, among whom 476 were fully vaccinated, 74 were partially vaccinated, and 9 had unspecified status.
Breakthrough infection was observed among 1.25% of fully vaccinated and 1.97% of partially vaccinated individuals. All patients with breakthrough infection recovered.
In the long-term extension phase of the trial, there were 90 confirmed cases of COVID-19. Of cases, 10 were serious and no cases were life-threatening or resulted in fatality. Among patients with available data (n=36), 30 were recovering or had sequelae. One mild breakthrough infection was observed.
“Based on these updated data, there does not seem to be an increased risk of severe COVID-19 or fatal outcomes in patients with RMS treated with ofatumumab,” the researchers concluded. “A very small number of vaccinated patients had breakthrough infections, and all recovered.”
Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.
Winthrop K, Delgado S, Habek M, et al. COVID-19 Outcomes and Vaccination Status in Patients With Relapsing Multiple Sclerosis Receiving Ofatumumab. Presented at: CMSC 2022 Annual Meeting; June1-4, 2022; National Harbor, Maryland. Abstract DMT36.