Unpublished MS drug alemtuzumab clinical trial data
Sourc:The SiteAddtime:2019/7/15 Click:0
Alemtuzumab is a highly effective MS drug that has been approved in more than 60 countries and used by more than 12,000 patients worldwide. However, the risk of secondary autoimmune diseases is almost 50%, some of which are life-threatening diseases such as platelets and kidney disease.
Although knowledge about these adverse reactions has been included in meeting reports and permits submitted to European and US regulatory agencies, key data explaining secondary autoimmune diseases have not been carefully examined after peer review.
Researchers at Queen Mary University (QMUL) in London obtained a Phase III trial data set for alemtuzumab through a free information request from the European Medicines Agency (EMA).
Their analysis, published in JAMA Neurology, provides new insights into the rapid response of the immune system in MS patients taking alemtuzumab.
The researchers found a large number of rapidly recombined immature B cells (a white blood cell involved in the immune system) that they say contribute to creating an environment for secondary autoimmune diseases. According to the researchers, controlling this B cell subset "overshoot" after alemtuzumab administration may limit the risk of secondary autoimmune disease and make it a better drug.
In addition, they saw long-term inhibition, not only memory T cells (another type of white blood cells), but also memory B cells, they said, they explain why alemtuzumab is a new and effective explanation for MS patients.
Dr. Klaus Schmierer, Ph.D., of the Blizard Institute at QMUL, said: "We were very surprised to find that these important information about B-cell dynamics were only partially described and still unpublished, despite observations after a critical phase III trial a few years ago. Analyzed this information.
“This new information will help the effective management of MS patients, first in the decision-making process for disease-adjusted treatment, and secondly in people treated with alemtuzumab to ensure that the risks associated with dangerous side effects are reduced. lowest."