Novartis has revealed new long-term data for its B-cell targeting therapy Kesimpta, showing that mean immunoglobulin G (IgG) and immunoglobulin M (IgM) were preserved in adults with relapsing multiple sclerosis (MS) receiving the therapy over 3.5 years.
The results come from an ongoing label extension of the ALTHIOS study, which includes 1,703 people living with MS who received Kesimpta (ofatumumab) for up to five years.
Lower serum immunoglobulin levels have been linked to an increased risk of infection – Kesimpta showed no association with risk of serious infection, according to the newly revealed data.
The long-term ALTHIOS findings are consistent with the Phase III ASCLEPIOS trial data, which demonstrated a low overall incidence of infections and no association between decreased immunoglobulin levels and the risk of infections.
“Patient safety is of the utmost importance to Novartis and these long-term results continue to support Kesimpta as a high-efficacy, first-choice treatment with a favourable safety profile for people living with RMS,” said Marcia Kayath, global head medical affairs, Novartis Pharmaceuticals.
“Preservation of immunoglobulin levels is important to fight infections, like COVID-19, so we’re very happy to share long-term data showing Kesimpta had unchanged IgG levels, providing physicians with important information relevant to the long-term benefit/risk of treating with Kesimpta,” she added.
In April, the National Institute for Health and Care Excellence (NICE) recommended Kesimpta for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS).
In its final appraisal document, NICE recommended Kesimpta for the treatment of adult patients with RRMS with active disease, defined by clinical or imaging features.
NICE concluded that Kesimpta is a cost-effective treatment that can be used as a first-line therapy or following the use of other treatments for people with RRMS.