Long-Term Treatment with Kesimpta Shows Sustained Efficacy in Recently Diagnosed, Treatment-Naïve Patients with Relapsing MS

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Results from the open-label ALITHIOS extension study demonstrated the long-term efficacy of first-line, continuous treatment with Kesimpta (ofatumumab; Novartis) for up to six years in recently diagnosed, treatment-naïve (RDTN) patients with relapsing multiple sclerosis (RMS).¹ Kesimpta is a CD20-directed cytolytic monoclonal antibody (mAB) that treats relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug was the first self-administered mAb approved by the FDA for a once-monthly subcutaneous injection for RMS.²

“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,” Norman Putzki, MD, Development Unit Head, Neuroscience & Gene Therapy, Development, Novartis Pharmaceuticals Corporation, said in a press release.¹

MS is a chronic inflammatory disease affecting approximately 2 million people worldwide. The chronic inflammatory disease of the central nervous system causes myelin destruction and axonal damage in the brain, optic nerves, and spinal cord.

The first analysis of the ALITHIOS extension study showed that the annualized relapse rate (ARR) observed in RDTN patients with RMS who were administered continuous Kesimpta during Phase III trials dropped by 52.0% from 0.104 to 0.050, which translates to an adjusted ARR of one relapse per 20 years. There were 44% fewer relapses in RDTN patients administered continuous Kesimpta compared with patients who switched from teriflunomide, with decreases of 96.4% and 82.7% in MRI lesions (Gd+ T1 and neT2), respectively; and 24.5% and 21.6% fewer three- and six-month confirmed disability worsening events, respectively.

The data also show that rates of three- and six-month progression independent of relapse activity in patients administered first-line Kesimpta were lower compared with those who switched from teriflunomide. The increase in the number of patients administered continuous first-line Kesimpta who showed no evidence of disease activity was maintained for up to six years, according to the study.

Among RDTN patients with RMS who were initially randomly assigned to receive teriflunomide, investigators observed improvements across several efficacy outcomes following the switch to Kesimpta, which included a 71.3% drop in ARR. In terms of MRI lesion activity, there was 98.5% decrease in Gd+ T1 and a 93% decrease in neT2.

For confirmed disability worsening events, three- and six-month data were higher in the cohort of patients administered continuous Kesimpta, which shows that patients who switched did not experience the same efficacy benefit as those administered first-line Kesimpta, according to the investigators. Among both patient cohorts, nine of ten participants achieved no evidence of disease activity at six years.

In terms of safety, long-term Kesimpta was found to be well-tolerated and there were no unexpected safety signals reported. Overall adverse event (AE) and serious AE rates after six years of Kesimpta treatment were consistent with the core Phase III trials and the extension study. The most frequently reported AEs were infections that included COVID-19 (34.3%), nasopharyngitis (20.6%), upper respiratory tract infection (14.9%), and urinary tract infection (14.4%).

“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,” principal investigator Gabriel Pardo, MD, founding director of the Multiple Sclerosis Center of Excellence at Oklahoma Medical Research Foundation, said in a press release. “While measurable improvements were also seen in patients switching to Kesimpta later on, the delay in irreversible disability worsening was not fully realized in the switch group compared to those starting on Kesimpta first, reinforcing the value of introducing the treatment to patients earlier.”¹

References

1. Novartis Kesimpta® six-year efficacy data show substantial benefits in recently diagnosed treatment- naïve people with relapsing multiple sclerosis. News release. Novartis. April 17, 2024. Accessed April 18, 2024. https://www.novartis.com/news/media-releases/novartis-kesimpta-six-year-efficacy-data-show-substantial-benefits-recently-diagnosed-treatment-naive-people-relapsing-multiple-sclerosis

2. Kesimpta. Prescribing information. Novartis; 2020. Accessed April 18, 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125326s070lbl.pdf