Real-world Data Continues Showing Benefits of Takeda’s Entyvio for IBD Patients

Real-world Data Continues Showing Benefits of Takeda’s Entyvio for IBD Patients
Real-world data demonstrates the safety, tolerability, and efficacy of Entyvio (vedolizumab) in treating ulcerative colitis (UC) and Crohn's disease, confirming previous data collected in clinical trials. These findings were the focus of two poster presentations during the recent 25th United European Gastroenterology (UEG) Week in Barcelona, Spain. Entyvio, developed by Japan's Takeda Pharmaceutical, reduces inflammation in the intestinal mucosa by blocking immune cells from entering inflamed tissue. At least 60 countries have approved it to treat adults with moderate to severe UC and Crohn's. The U.S. Food and Drug Administration (FDA) and the European Commission approved the marketing of Entyvio in 2014 for patients who fail to respond, are intolerant, or have developed resistance to anti-TNFalfa therapies. Takeda is currently seeking approval from Japan's Ministry of Health, Labor and Welfare. Various clinical trials have extensively explored Entyvio's safety and efficacy. However, this evaluation system may not reflect the real-world impact of a therapy in the general IBD population. This highlights the importance of long-term assessments of a therapy impact upon regulatory approval. "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,” Dr. Stefan Schreiber, professor of medicine and gastroenterology at Christian Albrechts University in Kiel, Germany, said in a press release. In the study, “Real world safety of vedolizumab in inflammatory bowel disease: a meta-analysis,” an international team of researchers conducted a systematic review and meta-a
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