Efficacy

Kesimpta (Ofatumumab) Efficacy in Multiple Sclerosis

Kesimpta (ofatumumab) is a targeted B-cell therapy approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS), which include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. As a CD20-directed cytolytic antibody, Kesimpta works by depleting B cells that are believed to play a role in the damaging inflammatory processes of MS, thereby reducing the frequency of relapses and slowing the progression of the disease. Clinical trials have demonstrated the efficacy of Kesimpta in reducing the annualized relapse rate (ARR) when compared to teriflunomide, another MS medication, with a significant reduction in relapse rates observed in patients treated with Kesimpta.

In addition to the reduction in ARR, Kesimpta has also shown efficacy in slowing the progression of disability, which is a critical aspect of MS treatment. In clinical studies, Kesimpta was associated with a lower risk of confirmed disability progression sustained for 3 and 6 months compared to teriflunomide. Moreover, Kesimpta has demonstrated a significant reduction in the number of new or enlarging T2 and gadolinium-enhancing lesions on MRI scans, indicating a decrease in disease activity.

Tyruko (Natalizumab-sztn) Efficacy in Multiple Sclerosis

Tyruko (natalizumab-sztn) is a biosimilar to the original natalizumab product and is used in the treatment of relapsing forms of multiple sclerosis (MS). Natalizumab, the active ingredient in Tyruko, is a monoclonal antibody that binds to the cell adhesion molecule α4-integrin and inhibits the migration of leukocytes across the blood-brain barrier. This action reduces the inflammation and damage in the central nervous system that characterizes MS. The efficacy of natalizumab in reducing the ARR and delaying the progression of disability in patients with relapsing MS has been well established through clinical trials and real-world data.

In clinical studies, natalizumab has shown a significant reduction in ARR compared to placebo, with patients receiving natalizumab experiencing fewer relapses. Furthermore, natalizumab treatment has been associated with a delay in the progression of disability, as measured by the Expanded Disability Status Scale (EDSS). Patients treated with natalizumab also exhibited fewer new or enlarging T2 hyperintense lesions and fewer gadolinium-enhancing lesions on MRI, indicating a lower level of MS disease activity. It is important to note that while Tyruko is expected to be similar in efficacy to the original natalizumab product, specific clinical data on Tyruko should be referred to for precise efficacy outcomes.