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-analysis of real-world Entyvio outcomes in patients with UC or Crohn’s reported in 33 published studies from May 2014 to January 2017.
These studies covered 2,857 Entyvio-treated patients — 1,532 patients had Crohn’s and 829 had UC — with follow-up periods ranging between 0.5 and 18 months.
Pooled data from real-world clinical practice showed that patients with moderate to severe Crohn’s and UC who received Entyvio had low rates of serious infection, malignancies and infusion-related reactions. This supports the long-term benefit–risk profile of Entyvio, which is consistent with the safety data reported in six clinical trials, researchers said.
Data from a second study, “Real-world use of immunosuppressives among patients with inflammatory bowel disease treated with vedolizumab,” studied 567 U.S. IBD patients receiving Entyvio whose data was stored in the Explorys Universe database.
The analysis revealed that on average, Crohn’s and UC patients started Entyvio therapy 4.5 years after the initial diagnosis.
In this real-world clinical setting population, 45.4 percent of patients had never been treated with IM therapy, and 87 percent of patients treated with Entyvio did not use IM drugs during follow-up. Of those with a history of IM therapy, 61 percent of those who received Entyvio did not continue IM therapy during follow-up.
“These data provide additional insight on the usage patterns, long-term safety profile and outcomes of Entyvio use in real-world clinical practice,” said Mona Khalid, Takeda’s senior director and head of evidence and value generation. “We look forward to the continued expansion of our body of knowledge on the safety profile of Entyvio treatment in ulcerative colitis and Crohn’s disease.”
Besides these two studies, other presentations during UEG Week addressed clinical trial and other real-world features of Entyvio in patients with Crohn’s and UC. These included:
- “Post-marketing safety experience of vedolizumab in patients with pre-existing viral hepatitis,”
- “Risk factors for postoperative infection after lower gastrointestinal surgery in patients with inflammatory bowel disease: findings from a large epidemiological study,”
- “Vedolizumab demonstrates early symptomatic improvement in ulcerative colitis: a GEMINI 1 post hoc analysis,” and
- “Real-world treatment discontinuation, flares, and hospitalisations among inflammatory bowel disease patients within 12 months of initiation of vedolizumab or infliximab.”