Five-Year Data from ALITHIOS Study on MS Disability Presented at AAN 2023

According to long-term results of a study presented at the American Academy of Neurology (AAN) 2023 Annual Meeting, participants with relapsing multiple sclerosis (MS) treated continuously with ofatumumab (Kesimpta; Novartis, Cambridge, MA) experienced less disability progression than those first treated with teriflunomide who later switched to ofatumumab. More than 80% of participants continuously treated with ofatumumab remained free of 6-month confirmed disability worsening and experienced less brain volume loss evident on MRI scans (< 1.5% loss) over 5 years than others. Ofatumumab was well-tolerated with the most common adverse event being infection, including COVID-19 (30.3%).

ALITHIOS (NCT03650114) is an open-label, single-arm, multi-center extension study that evaluated the safety, tolerability, and effectiveness of ofatumumab in participants with relapsing MS. The primary outcome measure was the number of participants who had an adverse event or abnormal laboratory value, vital signs, or ECG results or suicidal ideation over 5 years. ALITHIOS began on December 28, 2018, and is expected to end on March 14, 2030. Participants were included if they were over 18 years old and had completed a previous Novartis ofatumumab clinical MS study which dosed ofatumumab 20 mg subcutaneously every 4 weeks.

"With continuous Kesimpta treatment, key indicators of disability progression and brain volume change showed that most patients remained free from disease progression up to five years," said principal investigator Jeffrey A. Cohen, MD, of the Neurological Institute at Cleveland Clinic.