Kesimpta Shows Promise in Reducing Relapsing Multiple Sclerosis Disability, Progression

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Data from the ALITHIOS open-label extension and Phase IIIb OLIKOS trials demonstrated the efficacy of Kesimpta (ofatumumab) in reducing disability progression and disease activity in patients with relapsing multiple sclerosis (RMS).¹

The OLIKOS trial found that first-line treatment with Kesimpta for up to six years produced less disability and disease progression in patients recently diagnosed (≤3 years) with RMS and treatment-naïve patients with RMS compared to patients who switched from Aubagio (teriflunomide). The US-based, single-arm OLIKOS trial found that at 12 months, all clinically stable patients with RMS who switched from intravenous (IV) anti-CD20 therapy to Kesimpta had no new gadolinium-enhancing T1 lesions compared to baseline.

“We continue to study the efficacy and safety of Kesimpta in different populations of people living with relapsing multiple sclerosis as part of our mission to advance care,” Norman Putzki, MD, PhD, global development unit head, Neuroscience & Gene Therapy, Novartis International AG, said in a press release.¹

Kesimpta is a CD20-directed cytolytic monoclonal antibody (mAB) for the treatment of RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Kesimpta was the first self-administered mAb approved by the FDA for a once-monthly subcutaneous injection for RMS.²

Findings from the overall ALITHIOS patient population demonstrated that continuous use of Kesimpta led to numerically fewer six-month confirmed disability worsening and progression independent of relapse activity events for up to six years compared to patients who switched from Aubagio. Investigators stated that these benefits were more pronounced in the treatment-naïve subgroup of patients, who were defined as starting treatment within three years of their RMS diagnosis.

A total of 83.4% of treatment-naïve patients administered continuous Kesimpta were found more likely to remain free from six-month confirmed disability worsening compared to 76.3% of patients who switched from Aubagio to Kesimpta. Further, 88.9% of treatment-naïve patients administered continuous Kesimpta were more likely to be free of progression independent of relapse activity events compared to 83.3% of those switching from Aubagio to Kesimpta.

The OLIKOS trial analyzed 102 clinically stable RMS patients who switched from prior use of IV anti-CD20 therapy—99% from Ocrevus (ocrelizumab)—to Kesimpta. Among 84 patients with MRI results, investigators did not observe any new Gd+ T1 lesions at 12 months, which was the study’s primary endpoint. Further, 98% of patients did not develop new or enlarging T2 lesions at 12 months, which was an exploratory endpoint in the trial.

In terms of safety, treatment-emergent adverse events (TEAEs) were reported at a similar frequency as were reported in the Phase III ASCLEPIOS clinical trials and no new safety signals were identified. The most commonly reported (≥10%) TEAEs included COVID-19, headache, fatigue, and urinary tract infection.

The findings from these studies are set to be presented at the European Committee for Treatment and Research in Multiple Sclerosis 2024 Annual Meeting from September 18-20.

“These data showed that people recently diagnosed with relapsing multiple sclerosis who received first-line Kesimpta had fewer disability worsening events and greater likelihood of being progression-free,” said lead investigator Amit Bar-Or, MD, director of the Center for Neuroinflammation and Neurotherapeutics at the University of Pennsylvania, in a press release. “The reduction of disability accumulation observed early in the disease course supports earlier adoption of Kesimpta.”¹

References

1. New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients. News release. Novartis. September 18, 2024. https://www.novartis.com/news/media-releases/new-novartis-data-relapsing-ms-reinforce-benefits-kesimpta-first-line-and-switch-patients

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