Kesimpta® Demonstrates Lasting Benefits in Early-Stage RMS Patients Over Six Years

New research has highlighted the effectiveness of Kesimpta® (ofatumumab) in treating relapsing multiple sclerosis (RMS) over a six-year period, according to an open-label extension study named ALITHIOS. The study demonstrated Kesimpta's sustained efficacy and safety profile in individuals newly diagnosed with RMS within three years. The treatment resulted in a significant reduction in relapses, MRI lesions, and confirmed disability worsening (CDW) events when compared to patients who switched from teriflunomide to Kesimpta.

The first analysis of the study showed a substantial decrease in the annualized relapse rate (ARR) for patients continuously on Kesimpta, and the proportion of participants with no evidence of disease activity (NEDA-3) was maintained over the six years. For those initially treated with teriflunomid and then switched to Kesimpta, there were notable improvements in ARR and MRI lesion activity, although the rates of CDW events remained higher than for those on continuous Kesimpta.

A separate analysis of the entire ALITHIOS study population confirmed these findings, with sustained efficacy and a well-tolerated safety profile for Kesimpta treatment up to six years. The rates of adverse events remained stable, with no increased risks observed over the study period.

Kesimpta is a B-cell therapy that adults with RMS can self-administer, being the first fully human anti-CD20 monoclonal antibody for subcutaneous monthly injections. It has been designed to enhance safety and tolerability while minimizing systemic injection-related reactions. The treatment has demonstrated a rapid reduction in peripheral B-cell depletion and has shown efficacy and favorable safety in RMS patients.

Novartis, the company behind Kesimpta, is dedicated to developing innovative treatments for neurological conditions, including MS. They have a history of over 80 years in addressing such conditions and are focused on ensuring broad access to their therapies.

Multiple sclerosis is a chronic disease that affects approximately 2 million people globally, characterized by myelin destruction and axonal damage in the central nervous system. MS is categorized into different forms based on the presence of relapses and the progression of neurological damage and disability.

Kesimpta has been approved in over 90 countries for the treatment of RMS, with more than 100,000 patients treated as of March 2024. It represents a significant advancement in the management of RMS, offering a self-administered option that has proven effective and well-tolerated in the long term.