Takeda Pharmaceuticals has recently announced the results from their open-label extension study, titled VISIBLE, which evaluates Entyvio as a treatment for ulcerative colitis. According to BioSpace, these results maintain the known safety profile and continue to show encouraging data.
About Ulcerative Colitis
Ulcerative colitis is a form of inflammatory bowel disease. It is characterized by sores and ulcers in the large intestine, which then lead to symptoms like weight loss, nausea, anemia, cramping, joint pain, fatigue, loose bowel movements, blood in the stool, and rash. Unfortunately, there is no cure for this condition; however, treatment can lead to remission. Doctors often prescribe biologics, corticosteroids, antibiotics, immunomodulators, and aminosalicylates. In very severe cases, surgery may be necessary to remove part of or the entirety of the colon.
Entyvio is a form of biologic that can be administered via IV or subcutaneously. This humanized monoclonal antibody targets the alpha4beta7 integrin, making it unable to bind to MAdCAM-1. This then stops the interaction that results in the inflammation that characterizes ulcerative colitis.
This treatment has already been approved in Europe, Canada, and Australia for adults with moderate to severe cases, and has received marketing authorization in over 70 countries. It is intended for those who have been unsuccessfully treated with conventional therapies or tumor necrosis factor-alpha (TNFα)-antagonists.
About the Trial
The interim data came from the VISIBLE clinical trial program, which intends to evaluate the efficacy and safety of the subcutaneous version of Entyvio. Three Phase 3 trials are included in this program, consisting of two placebo-controlled, double-blind, and randomized trials that evaluate who achieves remission, and an extension study that looks at long-term efficacy and safety.
Takeda recently released data from the open-label extension study, which found that the safety profile was maintained. Clinical benefits were also demonstrated, with participants reaching remission and finding less dependence on corticosteroids. 68.9% of participants were still experiencing remission by week 108.
This data is very exciting and proves that the subcutaneous version of Entyvio is a viable treatment for ulcerative colitis.