Kesimpta(ofatumumab)

Kesimpta (ofatumumab) is approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The drug is administered as a 20 mg subcutaneous injection, with an initial dosing schedule of 20 mg at week 0, 1, and 2, followed by monthly injections starting at week 4. Ofatumumab was previously approved in 2009 for chronic lymphocytic leukemia (CLL).

Efficacy findings include a significant reduction in the Annualized Relapse Rate (ARR), with reductions of 50.5% and 58.5% (p-value <0.001 for ARR). There was also a 97.5% reduction in T1 GdE Lesions (p-value <0.001). Additionally, Kesimpta demonstrated a 34.4% reduction in 3-month confirmed disability worsening and a 32.5% reduction in 6-month confirmed disability worsening.

Common safety findings include nasopharyngitis (17.6% incidence) and injection site reactions (16.3% incidence). Other reported incidences include influenza (6.2% and 6.3%), nausea (6.2% and 6.8%), diarrhea (5.8%), and depression (5.0%). A decrease in blood immunoglobulin M was observed in 1.7% of patients, and 7% of patients had bilirubin values above the upper limit of normal.