Entyvio Continues to Show Benefits for Inflammatory Bowel Disease
The types of drugs that are used to treat IBD include anti-inflammatory drugs, corticosteroids, and/or immunosuppressant medications. Recently, real-world data has confirmed the clinical trial data showing the efficacy, safety, and tolerability of one medication that is used for both UC and Crohn’s disease. This is good news considering that when most medications first hit the market, long term effects, both good and bad can be uncertain.
Entyvio, or vedolizumab, is an immunosuppressant drug that is used for IBD patients who have not responded to other treatments. It is typically only used for patients with moderate to severe IBD.
Previous clinical trials were very promising, but now we have results from real-world usage that confirm the clinical trial data.
Vedolizumab works to prevent the movement of white blood cells into the gut. This prevents inflammation which is the root cause of IBD symptoms. The drug was developed by Takeda Pharmaceutical out of Japan. At least 60 countries have approved it for treatment of moderate to severe IBD. In 2014 the Food and Drug Administration (FDA) as well as the European Commission, approved it for marketing for patients who do not respond to, or have issues taking other more traditional IBD medications. The medication is currently in the approval process with Japan’s Ministry of Health, Labor, and Welfare.
The findings of a recent study showed that the real-world effects of the medication seem to be in line with clinical trial results. These findings were presented at the 25th United European Gastroenterology (UEG) week in Barcelona, Spain.
Why is this type of data important?
Real-world data is important because it tells how a drug will actually affect the population in the long term. It offers additional information to the clinical trial data that is used to determine whether or not a drug can hit the market in the first place. Clinical trials often establish whether or not a drug is safe and efficacious enough to warrant giving it to the general public, but this hardly means that the research is done. There are many cases where, based on clinical trials, a drug has been approved for public administration, but is then removed from the market after real-world data comes out and shows that it has consequences that were not seen in clinical trials. It is because of these potential hidden consequences that drugs need to continue to be evaluated after market approval.
As Dr. Stefan Schreiber, professor of medicine and gastroenterology at Christian Albrechts University in Kiel, Germany, said, “Real-world data furthers our understanding of the efficacy and safety signals we see in placebo-controlled registration trials, which have strict selection criteria and may not be illustrative of the patient population seen in clinical practice.”
The study that was presented at UEG week and is titled, “Real world safety of vedolizumab in inflammatory bowel disease: a meta-analysis,” involved an international team of researchers conducting a systematic review and meta-analysis of the effects of the medication on patients with IBD.
Read on to learn more about Entyvio and its implications for the future of IBD treatment.