Six-Year Efficacy of Novartis Kesimpta® in Relapsing MS Treatment-Naïve Patients

Novartis has revealed findings from the ALITHIOS open-label extension study, demonstrating the sustained efficacy of continuous Kesimpta® (ofatumumab) treatment for up to six years in individuals recently diagnosed with relapsing multiple sclerosis (RMS). These individuals, termed “treatment-naïve,” initiated treatment within three years of diagnosis. The study showcased several significant efficacy outcomes, including a 44% reduction in relapses, remarkable reductions in MRI lesions (Gd+ T1 and neT2), and fewer instances of confirmed disability worsening events over three and six months compared to those switching to Kesimpta from teriflunomide. The results of this research will be presented at the American Academy of Neurology (AAN) 2024 Annual Meeting in Denver, Colorado.

Dr. Gabriel Pardo, principal investigator and Founding Director of the Multiple Sclerosis Center of Excellence at Oklahoma Medical Research Foundation, emphasized the long-term benefits observed with Kesimpta, particularly in reducing relapses, suppressing MRI lesion activity, and delaying disability worsening events in treatment-naïve patients.

Norman Putzki, M.D., Development Unit Head, Neuroscience & Gene Therapy at Novartis Pharmaceuticals Corporation, expressed satisfaction with the findings, stating that they contribute to the growing evidence of Kesimpta’s efficacy and safety profile in RMS. Novartis remains committed to addressing the challenges faced by individuals with MS by advancing transformative medicines.

Key findings from the ALITHIOS study include:

  • Continuous Kesimpta treatment led to a significant reduction in the annualized relapse rate (ARR), with a notable decrease observed over the six-year period.
  • Individuals switching from teriflunomide to Kesimpta experienced improvements in various efficacy measures, including ARR and MRI lesion activity, although disability worsening events remained higher compared to those receiving continuous Kesimpta.
  • Both treatment groups demonstrated sustained high rates of no evidence of disease activity (NEDA-3) at the six-year mark.
  • Kesimpta treatment was well-tolerated over the six-year period, with no unexpected safety signals identified.

The study underscores the importance of early intervention with Kesimpta in RMS management, highlighting its potential to provide long-term benefits and improve patient outcomes.

About Kesimpta® (ofatumumab):

Kesimpta is a targeted B-cell therapy administered via a once-monthly subcutaneous injection, offering flexibility and convenience for individuals with RMS. It is the first fully human anti-CD20 monoclonal antibody self-administered by patients. Kesimpta’s mechanism of action involves binding to a specific epitope on the CD20 molecule, leading to potent B-cell lysis and depletion, thus mitigating disease activity in MS.

Novartis continues to lead advancements in neuroscience, focusing on developing innovative treatments for severe neurological conditions like MS. The company remains dedicated to ensuring rapid access and sustainable accessibility to its medicines, aiming to provide tailored treatment options for patients worldwide.

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