Real-world treatment results showed that Takeda’s Entyvio (vedolizumab) was better than an anti-tumor necrosis factor-alpha therapy at alleviating moderate to severe ulcerative colitis or Crohn’s disease, according to several studies.
They showed that Entyvio, a biologic, did a better job than anti-TNF-alpha therapy at healing the mucus that lines intestines and of achieving endoscopic remission — an end to inflammation that a doctor can spot with a scope.
Researchers presented the studies at the 13th Congress of the European Crohn’s and Colitis Organization in Vienna, Feb. 14-17.
In one study, the U.S. Victory consortium compared Entyvio and anti-TNF-alpha’s ability to treat 334 ulcerative colitis and 538 Crohn’s patients. The consortium, whose name stands for Vedolizumab for Health OuTComes in InflammatORY Bowel Diseases, is a partnership of 10 leading U.S. inflammatory bowel disease centers.
Half the patients in each disease group received Entyvio and the other half anti-TNF-alpha treatment. Men accounted for 49% of ulcerative colitis patients and 44% of Crohn’s patients. Patients’ mean age was 35 years.
Researchers matched the disease characteristics of the two groups before treatment started.
The team used three effectiveness measures. One was mucus healing. The yardstick for ulcerative colitis patients was a Mayo endoscopic score of 0 or 1. The yardstick for Crohn’s patients was no ulcers or intestinal tissue damage.
A second effectiveness measure was disease remission, with the yardstick being no symptoms according to the Physician Global Assessment scale.
The third effectiveness measure was achieving remission without steroids.
A key finding was that Entyvio increased the 12-month mucus healing of ulcerative colitis patients by 50%, versus 42% for anti-TNF-alpha therapy — a result that was statistically significant. Entyvio also achieved a 54% increase in remission, compared with 37% with anti-TNF-alpha therapy. And it led to higher steroid-free remission rates, although the increase didn’t reach statistical significance.
Another finding was that Entyvio achieved statistically significant higher 12-month cumulative rates of mucus healing in Crohn’s patients, compared with anti-TNF alpha therapy. The figures were 50% versus 41%.
Entyvio-treated Crohn’s patients also had higher remission rates — 38% versus 34% — and steroid-free remission rates — 26% versus 18%. The differences were not statistically significant, however.
Researchers adjusted the results to account for patients’ frequency on steroid or immunomodulator therapies. This included the number of anti-TNF alpha inhibitors that patients had used before. In Crohn’s patients, they also adjusted results to account for the location of the disease — isolated small bowel, ileocolonic, or isolated colonic.
Researchers delivered the ulcerative colitis results in a poster presentation titled “Comparative effectiveness of vedolizumab and TNF-antagonist therapy in ulcerative colitis: a multicentre consortium propensity score- matched analysis.”
The Crohn’s information came in an oral presentation titled “Comparative effectiveness of vedolizumab and tumour necrosis factor-antagonist therapy in Crohn’s disease: a multicentre consortium propensity score-matched analysis.”
Researchers also presented the interim findings of a real-word Canadian study called EVOLVE. The study’s goal was to assess Entyvio’s ability to treat ulcerative colitis and Crohn’s patients who had never taken a biologic.
About half of Entyvio-treated ulcerative colitis patients and a quarter of Crohn’s patients achieved remission after six months. About two-thirds of the patients achieved mucus healing, and two-thirds were also able to discontinue corticosteroid therapy.
Another presentation that researchers made at the conference covered the Phase 3b VERSIFY trial. It was titled “A phase 3b open-label multicentre study (VERSIFY) of the efficacy of vedolizumab on endoscopic healing in moderately to severely active Crohn’s disease (CD).”
The study involved 101 patients with moderate to severe Crohn’s who had failed to respond to corticosteroids, immunomodulators, or an anti-TNF alpha inhibitor.
Fifty-five percent of the 101 patients had failed to respond to treatment with a TNF antagonist. Researchers categorized 46% as having severe activity at the start of the trial.
Patients received 300 mg of Entyvio intravenously at weeks 0, 2, and 6, then every eight weeks after that for a total of 26 weeks. Then they went through another 26-week extension period.
After the first 26 weeks, Entyvio led to endoscopic remission in 20% of patients who had never been treated with an anti-TNF alpha therapy and to an improved condition in 28%. Twenty-four percent of patients achieved complete mucus healing.
In patients who had been treated with Entyvio before, the rate of endoscopic remission was 6% and complete mucus healing 7%
Millennium Pharmaceuticals, which Takeda bought in 2008, was the company that developed Entyvio. It works by blocking the interaction between immune cells and gastrointestinal tract endothelial cells. The interaction fuels the chronic inflammation seen in inflammatory bowel disease patients.
The U.S. Food and Drug Administration approved Entyvio as a treatment for moderate to severe ulcerative colitis and Crohn’s on May 20, 2014.
“The growing trend to develop real-world data such as these results is very helpful in augmenting the information acquired from clinical [trial] studies and giving physicians a better indication of what patients in our offices might expect,” Dr. Brian Feagan, a gastroenterologist and director of clinical trials at the Robarts Research Institute in London, Ontario, said in a press release.
“This new information about achieving mucosal healing and clinical remission compared to other biologic therapies helps support the unique role of ENTYVIO in treating patients with ulcerative colitis and Crohn’s disease,” he added.
“Takeda is committed to putting patients at the center of everything we do, so investing in developing this real-world data about the effectiveness of ENTYVIO outside of clinical trials is very important for us,” said Kieran Leahy, interim general manager of Takeda Canada.
The results provide “a different and valuable perspective for physicians and patients,” Leahy said. “We are pleased that this new data will help give Canadian physicians an even broader perspective of the potential benefits of ENTYVIO to treat inflammatory bowel disease.”
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