Novartis Announces New Long-Term Data for Kesimpta in Relapsing Multiple Sclerosis

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On June 23, according to foreign media reports, Novartis announced new long-term data for the B-cell-targeted therapy Kesimpta, showing that mean immunoglobulin G (IgG) and immunoglobulin M (IgM) levels were maintained for over 3.5 years in treated adult patients with relapsing multiple sclerosis (RMS).

These results are derived from the ongoing open-label extension study of the ALTHIOS trial, involving 1,703 patients with relapsing multiple sclerosis (RMS) treated with Kesimpta (ofatumumab) for up to 5 years. According to the newly released data, following subcutaneous administration of Kesimpta, patients' mean serum IgM/IgG levels remained within the reference range. While lower serum immunoglobulin levels are associated with an increased risk of infection, Kesimpta demonstrated no association with an increased risk of serious infections.

The long-term results of the ALTHIOS study were consistent with the Phase III ASCLEPIOS trial data, which demonstrated a low overall incidence of infections and no association between reduced immunoglobulin levels and infection risk. Additionally, the study data showed that in the subgroup of newly diagnosed, treatment-naïve RMS patients, when used as first-line therapy, Kesimpta (ofatumumab) reduced the risk of progression independent of relapse activity (PIRA) by nearly 60% at 3 and 6 months compared with Aubagio (teriflunomide).

Kesimpta is a novel targeted B-cell therapy approved by the U.S. FDA in August 2020 as a subcutaneous injection for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. In the European Union, Kesimpta was approved in March 2021 for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.

Notably, Kesimpta is the first and only targeted B-cell therapy that can be easily self-administered and managed at home via once-monthly subcutaneous injections using the Sensoready autoinjector pen, positioning it as the preferred treatment option for patients with RMS. Compared with the commonly used first-line therapy Aubagio, Kesimpta demonstrates superior efficacy and a comparable safety profile, establishing it as the treatment of choice for a broad RMS patient population.

Reference:

1.Novartis reveals long-term results for MS therapy Kesimpta

2.Kesimpta (ofatumumab) data at AAN showed reduction in disability progression independent of relapse activity in newly diagnosed patients with RMS