Entyvio (vedolizumab) is a treatment for moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD), both types of inflammatory bowel disease (IBD). It is produced by Millennium Pharmaceuticals (part of Takeda Pharmaceuticals), and is administered as an injection into the vein every eight weeks.

How Entyvio works

In IBD, the normal immune response is over-active in the gastrointestinal (GI) tract – the digestive system. This results in the GI tract becoming inflamed, which can result in swelling, blockage, and infections.

The inflammation can be caused by an excess of white blood cells, gathering in the GI tract. These white blood cells enter the GI tract by an interaction between a protein found on their surface and a protein on the walls of the blood vessels surrounding the GI tract. Like a key entering a lock, this highly specific interaction opens a “door”, allowing that white blood cell to enter the GI tract.

It works by blocking this interaction, meaning that the white blood cell cannot access the GI tract, therefore, reducing the damage.

Entyvio in clinical trials

Entyvio has been assessed in many clinical trials. Takeda led four key Phase 3 clinical trials worldwide called GEMINI, to assess the safety and efficacy of Entyvio in patients with IBS. These are GEMINI I (NCT00783718), GEMINI II (NCT00783692), GEMINI III (NCT01224171), and GEMINI-LTS (NCT00790933). The patients’ clinical response was assessed using the Mayo Score for UC and the Crohn’s Disease Activity Index (CDAI) for CD. Patients were administered an Entyvio injection once every eight weeks.

GEMINI I assessed the efficacy of Entyvio in patients with UC that had tried at least one conventional IBD therapy. By week 52, 42 percent of patients treated with Entyvio had maintained clinical remission of UC, compared to only 16 percent in the placebo group. Other measures such as mucosal healing were significantly higher in the Entyvio group compared to the placebo group (52 percent versus 24 percent).

Both GEMINI II and III tested Entyvio in CD patients, over a 52-week (GEMINI II) and 10-week (GEMINI III) time period. In GEMINI II, there was a significantly higher proportion of patients achieving clinical remission by week 6 in the Entyvio group compared to the placebo group (15 percent versus 7 percent). However, no significant difference was seen in GEMINI III. At 52 weeks, there was a significant difference in the number of patients in clinical remission in GEMINI III, as 39 percent of Entyvio-treated patients achieved clinical remission compared to 22 percent of patients treated with placebo.

GEMINI-LTS is a long-term open-label study to assess the effect of Entyvio therapy over an extended period. It is currently ongoing and is expected to be completed by July 2017.

Initial results have been published in the scientific journal Gut, confirming that the treatment appeared safe in the long term and had positive effects on GI tract healing in UC patients.

Other information

Entyvio was approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe UC and CD on May 20, 2014.

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