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Phase III studies of Kesimpta shows safety in multiple sclerosis.

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Last updated:15th Oct 2021
Published:15th Oct 2021
Novartis announced data demonstrating the safety of Kesimpta (ofatumumab) over extended exposure (about 3.5 years) in patients with relapsing forms of multiple sclerosis (RMS). LITHIOS Phase IIIb open-label extension study data based on about 3.5 years of exposure demonstrated that mean immunoglobulin G (IgG) levels in patients treated with Kesimpta remained stable, and there was no apparent association between IgG levels and the risk of serious infections.

ALITHIOS Phase IIIb open-label extension study data also showed mean immunoglobulin M (IgM) levels declined over time but remained within the reference range for the majority of patients. The overall incidence of serious infections was low. Additional ALITHIOS data showed 94% (n=139) of COVID-19 cases were mild or moderate in severity in adults treated with the B-cell targeting therapy.

Kesimpta is a targeted B-cell therapy that delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment in multiple sclerosis (MS) These data—presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place virtually, October 13–15, 2021— further support Kesimpta as a potential first-choice treatment option for adults with active RMS, including newly diagnosed patients.

Condition: Multiple Sclerosis
Type: drug

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