Does Ofatumumab require long-term injections?

The importance of B cells in multiple sclerosis has been demonstrated by the emergence of anti-CD20 antibody therapies that deplete B cells. Ofatumumab is the first fully human anti-CD20 monoclonal antibody developed and tested for subcutaneous (SC) self-administration in a monthly dose of 20 mg. Its safety and tolerability allow for home self-administration by patients with multiple sclerosis and its use in a broad range of relapsing multiple sclerosis (RMS) populations with a positive benefit-risk balance.

Compared with previous anti-CD20 monoclonal antibodies, safety and tolerability were further improved and the risk of systemic injection-related reactions (IRRs) was minimized by avoiding doses of ≥30 mg and achieving initial and rapid B-cell depletion by progressively weekly administration of ofatumumab at weeks 0, 1 and 2 (rather than a single high dose) in two phase 2 studies (one intravenous and one subcutaneous). Interim data from an ongoing extension study show that long-term treatment with ofatumumab for up to 4 years was well tolerated by patients with RMS and no new safety risks were identified. In the Phase 3 trial, subcutaneous administration was via a prefilled syringe for more convenient self-administration of a 20 mg dose of ofatumumab and for use in clinical practice.

Ofatumumab’s original drug has been launched in China and has been included in medical insurance. Only patients who meet the indications can be reimbursed. The price is around tens of thousands of yuan, and it is difficult to purchase it in China. The European version of ofatumumab's generic version sold overseas in specifications of 20mg/0.4mL may cost around RMB 16,000 per vial (the price may fluctuate due to the exchange rate), which is expensive. There is currently no generic version of ofatumumab for sale. For more drug information and specific prices, please consult a medical consultant.