Novartis Presents Five-Year Efficacy and Safety Data of Ofatumumab in Relapsing Multiple Sclerosis at EAN 2023

On July 6, at the European Academy of Neurology (EAN) Annual Meeting held from July 1-4 in Hungary, Novartis presented the latest long-term data from the ALITHIOS open-label extension study.

Data Show Long-Term Efficacy of Ofatumumab in Patients with Relapsing Multiple Sclerosis (RMS) Over Five Years

According to reports, data from the ALITHIOS open-label extension study showed that in the group of patients continuously treated with Ocrelizumab, the annualized relapse rate (ARR) dropped below 0.1 in the second year, resulting in a relapse occurring less than once every 10 years, and by the fifth year of continuous treatment, it further decreased to just 0.031. Switching from Teriflunomide to Ocrelizumab treatment significantly reduced ARR (in years 2-3) to 0.056, approaching one relapse every 20 years, and this effect was maintained until the fifth year.

Continuous use of Ofaatumab significantly suppresses MRI lesion activity (Gd+T1 and new/enlarged T2 lesions) and can be maintained up to the 5th year. Switching from Teriflunomide to Ofaatumab can rapidly suppress MRI lesions, consistent with the group continuously using Ofaatumab.

The NEDA-3 achievement rate with continuous use of Ocrelizumab increases year by year, reaching 93.4% in the fifth year. Patients initially treated with Teriflunomide had a lower NEDA-3 achievement rate, but a rapid increase was observed after switching to Ocrelizumab. By the fifth year, nearly 9 out of 10 patients in both groups reached NEDA-3.

The five-year efficacy data, combined with the five-year safety data on the good tolerability of ofatumumab presented at the 2023 American Academy of Neurology (AAN) Annual Meeting, will continue to support the favorable benefit-risk profile of ofatumumab in RMS patients.

About Ofatumumab

Ofatumumab is the world's only fully human anti-CD20 monoclonal antibody, balancing high efficacy and safety. Ofatumumab is the world's only fully human anti-CD20 monoclonal antibody specifically tailored for MS patients, with the lowest immunogenicity and higher safety. The incidence of anti-drug antibodies (ADA) is only 0.2%, greatly avoiding drug ineffectiveness and serious adverse reactions caused by ADA; Ofatumumab achieves equivalent efficacy at a low dose by binding to two specific sites. The initial doses of Ofatumumab are administered at weeks 0, 1, and 2, followed by a monthly injection dose of 20mg; Ofatumumab innovatively uses subcutaneous administration, directly targeting the core site of MS pathogenesis—the lymph nodes. Subcutaneous low-dose administration offers more convenience to patients. Ofatumumab is administered via subcutaneous injection using the Sensoready® pen, with a monthly dose of 20 mg/0.4 ml at home. Due to its ease of use, it aligns with the preferences of most multiple sclerosis patients, facilitating long-term continuous treatment.

Editor: Mu Mian

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