Breakthrough Findings on BRIUMVI® and Long-Term Effects in MS
Long-Term Benefits of BRIUMVI® in Relapsing Multiple Sclerosis
Recently, TG Therapeutics, Inc. (NASDAQ: TGTX) shared promising five-year data from the ULTIMATE I & II Phase 3 trials regarding BRIUMVI® (ublituximab-xiiy) at a major conference. This data emphasizes BRIUMVI’s efficacy and safety in treating people with relapsing forms of multiple sclerosis (RMS).
Progress and Efficacy in Clinical Trials
At the five-year mark, it was reported that a remarkable 92% of patients remained free from disability progression after commencing treatment with BRIUMVI. During this period, patients experienced incredibly low annualized relapse rates, with a striking decrease to 0.020, which translates to an average of one relapse every fifty years of treatment.
Expert Insights
Dr. Bruce Cree from UCSF Weill Institute highlighted the significance of these findings, noting that such sustained clinical efficacy is vital for both patients and healthcare professionals when exploring robust therapeutic options. This data reaffirms BRIUMVI’s potential in transforming the lives of people affected by RMS.
Company Perspective
Michael S. Weiss, Chairman and CEO of TG Therapeutics, remarked on the encouraging outcomes. He indicated that the long-term benefits, particularly for patients who started treatment early, were far superior compared to those who transitioned from another treatment, teriflunomide. These results solidify BRIUMVI's place as a reliable treatment for RMS.
Sustained Safety Profile
The safety profile of BRIUMVI has remained consistent throughout the five years of treatment. Notably, there have been no new safety signals reported, reinforcing confidence in its long-term use. Patients also experienced stable immunoglobulin levels, indicating no increased risk of serious infections associated with prolonged treatment.
Data Highlights from Clinical Insights
- The annualized relapse rates noticeably declined over the five-year span, showcasing a persistent therapeutic effect.
- Patients switching from teriflunomide to BRIUMVI saw a dramatic 58.4% reduction in relapse rates in the first year of the extension trial.
- 8% of patients reported confirmed disability progression after five years, in stark contrast to 14.3% among those switching from teriflunomide.
- 17% of patients treated continuously with BRIUMVI showed significant improvement in disability at the five-year mark.
- No new concerning safety signals have emerged, indicating stability and safety throughout extended treatment.
Understanding BRIUMVI®
BRIUMVI is a unique monoclonal antibody designed to target CD20-expressing B-cells, a key component in the pathology of RMS. By utilizing advanced glycoengineering techniques, it maximizes efficacy while minimizing the required dosage, making it a promising option for adults suffering from RMS.
Ongoing Research and Development
TG Therapeutics continues to expand its research on BRIUMVI and its applications for various B-cell conditions. Their commitment to developing effective therapies for RMS and other related diseases demonstrates their dedication to enhancing patient outcomes and quality of life.
Frequently Asked Questions
What is BRIUMVI® used for?
BRIUMVI is prescribed for treating adults with relapsing forms of multiple sclerosis, including relapsing-remitting and active secondary progressive MS.
How effective is BRIUMVI® according to recent studies?
Recent studies report that 92% of patients remained free from disability progression and exhibited low annual relapse rates after five years of treatment.
What does the long-term safety profile of BRIUMVI® look like?
BRIUMVI has shown a consistent safety profile over five years, with no new safety concerns emerging during treatment.
What are the main benefits of switching to BRIUMVI® from teriflunomide?
Patients switching to BRIUMVI experienced a considerable reduction in relapse rates, indicating better management of their condition.
How does BRIUMVI® work in the body?
BRIUMVI targets CD20-expressing B-cells to achieve effective depletion, which is crucial in managing autoimmune activity in MS.
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