Novartis announces promising long-term data on Kesimpta for relapsing multiple sclerosis

In a significant revelation, Novartis Pharmaceuticals Corporation has announced the latest findings from the ALITHIOS open-label extension study. The data underscores the sustained efficacy of Kesimpta (ofatumumab), particularly for recently diagnosed, treatment-naïve individuals with relapsing multiple sclerosis (RMS). This group, defined as those who began treatment within three years of their initial diagnosis, experienced substantial long-term benefits during continuous Kesimpta treatment for up to six years.

The results, slated for presentation at the American Academy of Neurology (AAN) 2024 Annual Meeting in Denver, Colorado, from April 13-18, reveal a 44% reduction in relapse rates and significant decreases in MRI lesions—96.4% in Gd+ T1 and 82.7% in neT2 lesions. Additionally, there were 24.5% and 21.6% fewer events of 3- and 6-month confirmed disability worsening (CDW), respectively, compared to those who switched from teriflunomide to Kesimpta.

Gabriel Pardo, M.D., Founding Director of the Multiple Sclerosis Center of Excellence at Oklahoma Medical Research Foundation and principal investigator of the study, emphasized the clear benefits: “Our analysis of treatment-naïve people who were recently diagnosed with relapsing multiple sclerosis found that first-line use of Kesimpta for up to six years provided long-term benefits, including fewer relapses, profoundly suppressed MRI lesion activity, and fewer disability worsening events.”

Norman Putzki, M.D., Development Unit Head, Neuroscience & Gene Therapy at Novartis, also commented on the findings, stating, “We are extremely pleased to share the new data from ALITHIOS, which adds to the growing body of evidence of Kesimpta as an efficacious and well-tolerated option for people living with RMS.”

The initial analysis from the ALITHIOS study highlighted the continued low annualized relapse rate (ARR) during the extension phase, which further reduced from 0.104 during the core Phase III trials to 0.050. This corresponds to an adjusted ARR of one relapse every 20 years. The efficacy was not only sustained but also saw participants exhibiting no evidence of disease activity (NEDA-3) maintained up to the six-year mark.

In terms of safety, Kesimpta treatment was well-tolerated across the six-year period with a consistent safety profile. The rates of adverse events, including serious infections and malignancies, remained stable with no increased risks identified.

Multiple sclerosis is a chronic inflammatory disease that affects approximately 2 million people worldwide. It involves the destruction of myelin and axonal damage within the central nervous system. Kesimpta, a self-administered once-monthly injection, is a fully human anti-CD20 monoclonal antibody designed for high efficacy and safety in RMS treatment.

With more than 100,000 patients treated as of March 2024 and approval in over 90 countries, Kesimpta represents a significant advancement in the treatment landscape for relapsing forms of multiple sclerosis, enabling patients to manage their condition effectively with minimal hospital visits.

The sustained efficacy and safety profile of Kesimpta, as detailed in the ALITHIOS study, solidify its role as a cornerstone in the management of relapsing multiple sclerosis. This could potentially set a new standard in treatment expectations and quality of life for patients.