Novartis has announced five-year data from the ALITHIOS open-label extension study of Kesimpta (ofatumumab) for the treatment of relapsing multiple sclerosis.
A targeted B-cell therapy, Kesimpta is an anti-CD20 monoclonal antibody designed to be self-administered once in a month.
The extension study compared patients who continuously received treatment with Kesimpta for up to five years against patients who switched later from teriflunomide to Kesimpta.
Favorable outcomes of reduced risk of disability progression and low brain volume change were observed in patients who continuously received Kesimpta for up to five years versus teriflunomide.
Previous treatment with Kesimpta in RMS patients, who continued in the ALITHIOS trial for up to five years, was associated with lesser confirmed disability worsening (CDW) events, including relapse associated worsening, progression independent of relapse activity, against those who switched from teriflunomide later.
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Over the same period, more than 80% of subjects remained free of six-month CDW.
A separate analysis showed no new or increased safety risks in patients treated up to five years with Kesimpta. The treatment was also found to be well-tolerated.
Novartis Pharmaceuticals Innovative Medicines US president Victor Bultó said: “These longer-term data continue to reinforce the favorable safety profile of Kesimpta, as well as its ability to slow disease progression, supporting its earlier use in people with relapsing multiple sclerosis.
“Novartis remains committed to the multiple sclerosis community in our continued study of Kesimpta and to supporting those living with MS and their families throughout their journey.”
In addition to safety data, the overall rate of serious infections remained stable with no increased risk over the five-year period.
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