Novartis has announced new long-term data from the Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension that demonstrated long-term efficacy and safety of Kesimpta (ofatumumab), with continued reduced risk of disability worsening, for people living with relapsing multiple sclerosis following up to four years of treatment.
Kesimpta maintained a similar safety profile as seen in the pivotal Phase 3 trials up to four years of treatment, with no new safety risks identified over the treatment period. The data will be presented at the American Academy of Neurology (AAN) Annual Meeting being held on April 2–7, 2022 in Seattle, USA and virtually on April 24–26, 2022, Novartis said.
In addition to demonstrating efficacy up to four years of continuous treatment with Kesimpta, participants who switched from teriflunomide to Kesimpta in the extension phase demonstrated pronounced reductions in relapses and MRI lesions. In those receiving Kesimpta for up to four years, immunoglobulin G (IgG) levels remained stable and mean immunoglobulin M (IgM) levels decreased yet remained above the lower limit of normal, and no association between Ig levels and serious infection was observed. The overall rates of adverse events (AEs), serious AEs and overall rate of serious infections were consistent with those observed in the Phase 3 ASCLEPIOS I/II trials and did not increase with treatment up to four years despite the COVID-19 pandemic, the company explained.
Furthermore, data from the ongoing KYRIOS open-label, prospective study showed that people living with multiple sclerosis on Kesimpta can mount an immune response to the COVID-19 mRNA vaccine. All participants in the study who were vaccinated during continuous Kesimpta treatment developed an immune response as soon as one week after initial vaccination. Immune response in participants who received a booster during treatment was similar to those who received a booster before treatment. In a study examining injection-related reactions (IRRs) associated with subcutaneous administration of Kesimpta in the ALITHIOS trial and from post-marketing reports, IRRs were mostly mild to moderate in severity (99%) with no medically confirmed fatal or life-threatening IRRs identified with Kesimpta. These findings were consistent with those from the Phase 3 ASCLEPIOS I/II trials.
“We are pleased to share long-term data of up to four years that support Kesimpta as an efficacious and well-tolerated, first-choice option for people living with relapsing multiple sclerosis. The sustained reductions in disability progression and lesion activity observed in those receiving continuous Kesimpta versus those who switched later from teriflunomide highlight the value of earlier treatment initiation with Kesimpta,” said Lykke Hinsch Gylvin, Neuroscience Global Medical Franchise Head, Novartis Pharmaceuticals. “In addition to these safety and efficacy data, we have presented findings that suggest people taking Kesimpta can mount an immune response to COVID-19 vaccination. During this pandemic, it is critical for people living with multiple sclerosis to have access to safe and efficacious treatments that do not interfere with their vaccine doses. Novartis is committed to continued research in multiple sclerosis with regards to COVID-19 vaccination and these data mark an additional milestone in this commitment.”