Long-term data show that early treatment with ofatumumab decreased confirmed disability worsening in nearly all study patients with relapsing multiple sclerosis.
Early and continued 5-year treatment with ofatumumab (Kesimpta; Novartis) was associated with fewer confirmed disability worsening (CDW) events in patients with relapsing multiple sclerosis (RMS), according to new data from the ALITHIOS extension study. In a separate analysis, 5-years of treatment was found to be safe and well-tolerated among patients.
“These longer-term data continue to reinforce the favorable safety profile of [ofatumumab], as well as its ability to slow disease progression, supporting its earlier use in people with relapsing multiple sclerosis,” said Victor Bultó, president, Innovative Medicines US, Novartis Pharmaceuticals Corporation, in a recent press release.
MS is a chronic inflammatory disease that affects nearly 2 million people globally. The disease impacts the central nervous system (CNS), distinguished by myelin destruction and axonal damage in the brain, optic nerves, and spinal cord. MS relapse occurs when there is an increase in clearly defined acute inflammatory attacks due to worsening neurological function and/or worsening neurologic damage and disability.
ALITHIOS is an open-label extension study comparing the efficacy of initial ofatumumab treatment versus later treatment—initial treatment is teriflunomide prior to switching to ofatumumab—for up to 5 years in patients with RMS.
The long-term data from the extension ALITHIOS study showed that patients who received earlier ofatumumab treatment had fewer CDW events, including relapse-associated worsening, than those with later treatment. Further, more than 80% of this patient group did not experience 6-month CDW during the 5-year study period.
“With continuous [ofatumumab] treatment, key indicators of disability progression and brain volume change showed that most patients remained free from disease progression up to 5 years,” said primary investigator Jeffrey A. Cohen, MD, Neurological Institute, Cleveland Clinic, in the press release.
The brain volume change of the initial treatment cohort remained low throughout the 5-year study period. The early treatment arm also had less brain volume loss than those who began treatment with teriflunomide. In the extension study, annual rate of brain volume change (ABVC) was -0.27% and -0.28% per year in the initial and switch groups, respectively, as opposed to -0.34% and -0.42% per year, respectively, during the core phase 3 trials.
Ofatumumab had a consistent safety profile with that of the core phase 3 trials. The most common adverse events (AEs) include infection; 30.3% of patients had COVID-19, 19% nasopharyngitis, 12.8% upper respiratory tract infection, and 12.7% urinary tract infection. Most COVID-19 cases were mild/moderate and nonserious, and patients largely recovered without medication discontinuation.
Ofatumumab is an anti-CD20 monoclonal antibody, a type of B-cell therapy that is delivered via subcutaneous injection once-monthly. Preclinical studies show that ofatumumab may bind to a specific epitope on the CD20 molecule, allowing for the necessary reduction of B cells in the lymph nodes.
“Along with the 5-year safety analysis, these data support this treatment as a well-tolerated, efficacious treatment option for people living with relapsing multiple sclerosis,” Cohen said in the press release.
Novartis. Novartis presents new five-year data on disability outcomes and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis. News Release. April 20, 2023. Accessed on April 21, 2023. https://www.novartis.com/news/media-releases/novartis-presents-new-five-year-data-disability-outcomes-and-safety-kesimpta-ofatumumab-people-living-relapsing-multiple-sclerosis