Novartis has presented new long-term data from the ALITHIOS open-label extension study at the European Academy of Neurology (EAN) Annual Meeting held in Hungary on July 1-4, 2023.
Data showed the sustained efficacy of continuous Kesimpta (ofatumumab) treatment over five years in patients with relapsing forms of multiple sclerosis (RMS). Patients treated with Kesimpta experienced profoundly suppressed relapse rates, reduced MRI lesions and high rates of no evidence of disease activity (NEDA-3). Patients who switched from teriflunomide to Kesimpta experienced pronounced reductions in relapse rates and MRI lesions. Although significantly fewer patients initially treated with teriflunomide achieved NEDA-3, the numbers increased substantially after switching to Kesimpta.
“Continuous Kesimpta treatment for up to five years showed sustained efficacy with very low relapse rates, profound suppression of MRI lesions and increasing NEDA-3 rates,” said principal investigator Ludwig Kappos, of the research center for Clinical Neuroimmunology and Neuroscience Basel. “Combined with its favourable safety profile, these findings support Kesimpta as a well-tolerated, efficacious treatment option for RMS patients.”
Combined with its favourable safety profile, these findings support Kesimpta as a well-tolerated, efficacious treatment option for RMS patients
- Principal Investigator, Ludwig Kappos
Data from the ALITHIOS open-label extension study showed that annualized relapse rates (ARR) remained low (ARR <0.05) for up to five years in the continuous Kesimpta group after starting treatment. Gd+ T1 MRI and new / enlarging T2 MRI lesions were profoundly suppressed and the NEDA-3 status increased annually, indicating that Kesimpta leads to a decrease in disease activity, which resulted in more than 9 out of 10 patients (93.4%) achieving NEDA-3 at year 5.
At the time of switching from teriflunomide to Kesimpta at year 2 to 3, the switch resulted in a pronounced reduction in ARR and was maintained through five years. Further, switching to Kesimpta led to an increased suppression of MRI lesions, matching the continuous Kesimpta group and NEDA-3 rates increased after switching.
These five-year efficacy data combined with the well-tolerated five-year safety profile of Kesimpta, presented at the American Academy of Neurology (AAN) Meeting 2023, continue to support the favorable benefit-risk profile for Kesimpta in RMS patients.