On September 25, Novartis AG (NVS.US) announced two positive datasets regarding its monoclonal antibody Kesimpta (ofatumumab) in relapsing multiple sclerosis (RMS) studies. One analysis demonstrated that first-line Kesimpta treatment in treatment-naive RMS patients can maintain high efficacy for up to 7 years.

Data from the open-label, single-arm, prospective Phase 3b ARTIOS study showed that patients who continued to experience disease activity after fingolimod or fumarate-based therapies exhibited significantly reduced disease activity after switching to Kesimpta, with an extremely low annualized relapse rate (ARR) of only 0.06 at 96 weeks. The data also revealed that disease activity assessed by magnetic resonance imaging (MRI) was almost completely suppressed, with over 90% of participants showing no evidence of disease activity (NEDA-3). Additionally, no new safety concerns were observed after switching to Kesimpta, regardless of patients' previous disease-modifying treatment (DMT).

Another open-label extension study called ALITHIOS included treatment-naive RMS patients (RDTN) who received continuous first-line Kesimpta treatment. The analysis showed that over 90% of patients achieved NEDA-3 at year 7. Patients demonstrated low ARR and significant MRI disease activity suppression throughout the process, indicating Kesimpta's sustained efficacy. The therapy exhibited favorable safety characteristics in both the overall population and RDTN patients, with no new safety concerns observed.

Kesimpta is a fully humanized monoclonal antibody targeting CD20 that binds to CD20 on B-cell surfaces to eliminate B-cells from blood circulation. It received FDA approval in 2020 for treating relapsing adult multiple sclerosis patients. Kesimpta is the first B-cell targeting therapy that allows patients to self-inject once monthly at home using an autoinjector pen, providing convenient disease management for patients.