Kesimpta lowered relapse, suppressed lesion activity in MS up to 5 years

Key takeaways:

• Two studies included 1,367 patients with MS who were given continuous Kesimpta or switched to Kesimpta.
• Kesimpta lowered relapse rates and suppressed lesion activity for up to 5 years.

For those with relapsing multiple sclerosis, continuous treatment with Kesimpta demonstrated sustained efficacy for annual relapse rates as well as significant suppression of MRI lesion activity for up to 5 years, according to research.

“In the phase 3 ASCLEPIOS I/II trials, ofatumumab reduced clinical and MRI disease activity versus teriflunomide in relapsing multiple sclerosis patients; sustained reductions were observed with extended treatment (up to 4 years) in the ongoing, open-label ALITHIOS extension study,” Ludwig Kappos, MD, of the Research Center for Clinical Neuroimmunology and Neuroscience Basel and the MS Center at the University of Basel in Switzerland, and colleagues wrote.

They recently reported their findings in a presentation at the European Academy of Neurology annual meeting.

Kappos and colleagues sought to report findings in the ALITHIOS I/II studies, which built on the initial ASCLEPIOS I/II trials regarding efficacy of treatment with Kesimpta (ofatumumab, Novartis) in participants for up to 5 years.

Their analysis included participants randomized to switch between teriflunomide in the core studies and ofatumumab (n = 677) in the open-label extension phase, as well as those given ofatumumab (n = 690) in both the core studies and open-label extension with a cutoff date of Sept. 25, 2022. Annualized relapse rates (ARR), MRI lesion activity (Gd+T1 and new/enlarging T2 lesions) and NEDA-3 were analyzed each year of the study up to 5 years in the continuous and switch populations.

According to results, those given continuous ofatumumab maintained low ARR across the entire 5-year period, while those who switched saw a significant reduction from years 2 to 3 (0.15 – 0.07) and then maintained reduction from years 3 to 5 (0.05).

Data additionally showed significant suppression of MRI lesion activity, which was maintained in the continuous ofatumumab group through year 5, and observed from year 3 to year 5 in the switch group. In the continuous ofatumumab group, odds of achieving NEDA-3 increased from year 2 (80%), then achieved maximum at year 5 (93.4%).

“Continuous Kesimpta treatment for up to 5 years showed sustained efficacy with very low relapse rates, profound suppression of MRI lesions and increasing NEDA-3 rates,” Kappos and colleagues wrote in a related release. “Combined with its favorable safety profile, these findings support Kesimpta as a well-tolerated, efficacious treatment option for [relapsing MS] patients.”

Reference:

• Novartis publishes new five-year efficacy data on Kesimpta (ofatumumab) for the treatment of relapsing multiple sclerosis. https://www.novartis.com/news/media-releases/novartis-publishes-new-five-year-efficacy-data-kesimpta-ofatumumab-treatment-relapsing-multiple-sclerosis. Published June 30, 2023. Accessed Aug. 8, 2023.