Novartis Highlights Seven-Year Efficacy of At-Home Injectable CD20-Targeted Therapy Kesimpta in Relapsing Multiple Sclerosis

(Source:WuXi AppTec）

Source: WuXi AppTec

Novartis today announced two new positive data sets from studies on its monoclonal antibody Kesimpta (ofatumumab) in relapsing multiple sclerosis (RMS). One of the analysesShow that in treatment-naive RMS patients,First-line treatment with Kesimpta can maintain high efficacy for up to 7 years.

Data from the open-label, single-arm, prospective Phase 3b study ARTOIS indicate that patients who continue to experience disease activity after treatment with fingolimod or fumarate-based therapies,After switching to Kesimpta, disease activity significantly decreased, with an extremely low annualized relapse rate (ARR) of just 0.06 at 96 weeks. Data also showed 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).Moreover, no new safety issues were observed after switching to Kesimpta, regardless of the last disease-modifying treatment (DMT) the patients had received previously.

Another open-label extension study named ALITHIOS enrolled treatment-naive RMS patients (RDTN) who received first-lineKesimptaContinuous treatment. Analysis shows,Over 90% of patients achieved NEDA-3 at Year 7.The patient showed low ARR and significant suppression of MRI disease activity during the process, demonstratingKesimptaDurable efficacy. Meanwhile, this therapy has demonstrated a favorable safety profile in both the overall population and RDTN patients, with no new safety concerns observed.

KesimptaIt is a fully humanized monoclonal antibody targeting CD20, which achieves the effect of clearing B cells from the bloodstream by binding to CD20 on the surface of B cells.It was obtained in 2020FDA ApprovalTreats adult patients with relapsing multiple sclerosis. The press release noted that Kesimpta isThe first B-cell targeted therapy that allows patients to self-administer once a month at home via an auto-injector pen provides convenience for patients in managing their condition.

References:

[1] New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies. Retrieved September 24, 2025 from https://www.globenewswire.com/news-release/2025/09/24/3155199/0/en/New-Novartis-data-further-support-benefits-of-Kesimpta-in-relapsing-MS-following-switch-from-oral-disease-modifying-therapies.html