Treatment with Ofatumumab Increases Number of Patients Who Achieve No Evidence of Disease Activity for MS

Novartis announced new data from the phase 3 ASCLEPIOS 1/2 trial and the ALITHIOS open-label extension trial showing that continuous treatment with ofatumumab (Kesimpta) for relapsing forms of multiple sclerosis (RMS) significantly increased the odds of achieving no evidence of disease activity (NEDA-3) compared to switching from teriflunomide.1 The data were presented at the European Academy of Neurology Annual Meeting held in Vienna, Austria.¹

“Early initiation of high-efficacy therapies for the treatment of relapsing multiple sclerosis has been shown to improve long-term outcomes versus escalating from lower efficacy therapies,” researcher Ludwig Kappos, MD, from University Hospital Basel, said in a statement. “NEDA-3 is an important endpoint for physicians to consider when deciding to initiate high efficacy therapy. With this latest data from ALITHIOS we can clearly see the benefit of starting [ofatumumab] early versus switching to it later from teriflunomide.”¹

The data show that after 4 years of treatment, 78.8% of those who continuously received ofatumumab achieved NEDA-3, which was defined as having no MS relapses and no disability worsening and no MRI activity when compared to only 51.8% of those who switched from teriflunomide to ofatumumab in the extension phase.¹

The results build on previously presented efficacy data from both studies, demonstrating sustained differences in cumulative responses, MRI lesion activity, and the risk of disability worsening between those who were continuously treated with ofatumumab than those who were switched at a later date.¹

Ofatumumab is currently approved for treatment of RMS in the United States, European Union, United Kingdom, Canada, China, Switzerland, Singapore, Australia, Japan, Argentina, United Arab Emirates, Albania, and India.

According to the Mayo Clinic, MS is a disabling disease of the central nervous system, including the brain and the spinal cord. The cause of MS is unknown, and it is considered an autoimmune disease in which the body’s immune system attacks its own tissues. The immune system malfunction destroys the fatty substances that coats protective nerve fibers.²

Individuals with MS can experience muscle stiffness, muscle spasms, paralysis, problems with bladder, bowel, or sexual functions, mental changes, depression, and epilepsy.²

Ofatumumab is a targeted, precisely dosed, and delivered B-cell therapy that provides the flexibility of self-administration for adults with RMS and is designed to be delivered subcutaneously by a once monthly injection.¹

Reference

1. New Novartis extension phase data show nearly 80% of RMS patients treated with Kesimpta (ofatumumab) had no evidence of disease activity (NEDA-3). Novartis. News release. June 27, 2022. Accessed June 29, 2022. https://www.novartis.com/news/media-releases/new-novartis-extension-phase-data-show-nearly-80-rms-patients-treated-kesimpta-ofatumumab-had-no-evidence-disease-activity-neda-3

2. Mayo Clinic. Multiple sclerosis. Updated January 7, 2022. Accessed June 29, 2022. https://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/symptoms-causes/syc-20350269