Efficacy

Mavenclad (Cladribine) for Multiple Sclerosis

Mavenclad (cladribine) is an oral medication approved for the treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease, in adults. Clinical trials have demonstrated the efficacy of Mavenclad in reducing the frequency of relapses and slowing the progression of disability in people with MS. The CLARITY study, a key phase III clinical trial, showed that cladribine significantly reduced the annualized relapse rate by 58% compared to placebo. Additionally, the trial indicated that cladribine led to a reduction in the number of lesions observed on MRI scans, which is indicative of decreased disease activity.

Another important measure of efficacy is the proportion of patients who remain relapse-free. In the CLARITY study, a higher percentage of patients treated with Mavenclad remained free of relapses over the course of the 96-week trial period compared to those on placebo. Furthermore, cladribine has been shown to have a sustained effect on relapse rates and MRI lesion activity, which suggests a long-term benefit for patients with MS.

Briumvi (Ublituximab-xiiy) for Multiple Sclerosis

Briumvi (ublituximab-xiiy) is a monoclonal antibody that is administered intravenously and is designed to target and deplete CD20-expressing B cells, which are believed to play a role in the pathogenesis of MS. While Briumvi is not yet approved for the treatment of MS, it has shown promise in clinical trials. The phase III ULTIMATE I and II trials have been pivotal in demonstrating the efficacy of ublituximab-xiiy in reducing disease activity in patients with relapsing forms of MS. These trials have reported that ublituximab-xiiy significantly reduced the annualized relapse rate compared to teriflunomide, a commonly used oral MS therapy.

In addition to the reduction in relapse rates, Briumvi has demonstrated a significant impact on MRI lesion activity. The number of T1 gadolinium-enhancing lesions and new or enlarging T2 lesions were markedly lower in patients treated with ublituximab-xiiy compared to those receiving teriflunomide. These results suggest that Briumvi could offer a robust therapeutic option for patients with relapsing forms of MS, pending regulatory approval and further post-marketing data to confirm its safety and efficacy profile.