Data from the ALITHIOS open-label extension and Phase IIIb OLIKOS trials highlight the sustained efficacy of Kesimpta (ofatumumab) in mitigating disability progression and disease activity among patients with relapsing multiple sclerosis (RMS). These findings, presented at the European Committee for Treatment and Research in Multiple Sclerosis 2024 Annual Meeting, underscore the potential benefits of early and continuous treatment with Kesimpta.
Impact on Disability Progression
The OLIKOS trial, a US-based, single-arm study, revealed that first-line treatment with Kesimpta for up to six years resulted in less disability and disease progression in patients recently diagnosed (≤3 years) with RMS and treatment-naïve patients compared to those who switched from Aubagio (teriflunomide). Specifically, at 12 months, clinically stable patients with RMS who switched from intravenous (IV) anti-CD20 therapy to Kesimpta showed no new gadolinium-enhancing T1 lesions compared to baseline.
Benefits in Treatment-Naïve Patients
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. Notably, 83.4% of treatment-naïve patients administered continuous Kesimpta were more likely to remain free from six-month confirmed disability worsening compared to 76.3% of patients who switched from Aubagio to Kesimpta. Furthermore, 88.9% of treatment-naïve patients on continuous Kesimpta were more likely to be free of progression independent of relapse activity events compared to 83.3% of those switching from Aubagio.
OLIKOS Trial Details
The OLIKOS trial included 102 clinically stable RMS patients who transitioned from prior IV anti-CD20 therapy—99% from Ocrevus (ocrelizumab)—to Kesimpta. Among 84 patients with MRI results, no new Gd+ T1 lesions were observed at 12 months, meeting the study’s primary endpoint. Additionally, 98% of patients did not develop new or enlarging T2 lesions at 12 months, an exploratory endpoint.
Safety Profile
In terms of safety, treatment-emergent adverse events (TEAEs) were consistent with those reported in the Phase III ASCLEPIOS clinical trials, with no new safety signals identified. The most commonly reported (≥10%) TEAEs included COVID-19, headache, fatigue, and urinary tract infection.
Expert Commentary
According to Amit Bar-Or, MD, director of the Center for Neuroinflammation and Neurotherapeutics at the University of Pennsylvania, the data indicate that individuals recently diagnosed with relapsing multiple sclerosis who received first-line Kesimpta experienced fewer disability worsening events and a greater likelihood of being progression-free. He emphasized that the reduction of disability accumulation observed early in the disease course supports earlier adoption of Kesimpta.
About Kesimpta
Kesimpta is a CD20-directed cytolytic monoclonal antibody (mAB) approved for the treatment of RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. It is administered as a once-monthly subcutaneous injection and was the first self-administered mAB approved by the FDA for RMS.
