Novartis presents new five-year data on Kesimpta

Novartis announced new long-term data from the ALITHIOS open-label extension study showing that up to five years, patients treated earlier and continuously with Kesimpta had fewer disability worsening events and low brain volume change versus those who started on teriflunomide and were later switched to Kesimpta. A separate analysis showed that treatment with Kesimpta for up to five years was well-tolerated, with no new or increased safety risks identified. These data will be presented at the American Academy of Neurology, AAN, Annual Meeting held in Boston and virtually on April 22-27, 2023. Additionally, brain volume change remained low with Kesimpta treatment over five years, and overall, patients initially randomized to Kesimpta had lower levels of brain volume loss at year five than those initially randomized to teriflunomide. The separate analysis of the ALITHIOS extension data showed consistent safety results of Kesimpta for people with RMS following up to five years of treatment2. The overall rates of adverse events and serious AEs were consistent with the core Phase III trials. Most COVID-19 cases were mild to moderate in severity and non-serious, and 98.6% of patients treated with Kesimpta recovered, recovered with sequalae, or were recovering from COVID-192. Most infections resolved without discontinuing Kesimpta treatment. The overall rate of serious infections also remained stable with no increased risk over five years. Mean serum immunoglobulin G levels remained stable up to five years of treatment and the majority of patients had lgG levels above the lower limit of normal. There were six fatal cases due to serious infections.