Entyvio exhibits favorable real-world safety profile in biologic-naive IBD patients
SAN ANTONIO — Entyvio was associated with significantly fewer serious adverse events and serious infections compared with anti-TNF therapy in biologic-naive patients with inflammatory bowel disease, according to data from the EVOLVE trial presented at the American College of Gastroenterology Annual Meeting.
Andres Yarur, MD, assistant professor of medicine at the Medical College of Wisconsin, said the findings offer a real-world perspective on how Entyvio (vedolizumab, Takeda) compares to anti-TNF therapy in practice.
“The aim of the EVOLVE trial was to assess real-life experiences of patients who are treated every day in clinical practice with these two kinds of therapies,” he told Healio Gastroenterology and Liver Disease. “Mechanistically, vedolizumab should be safer than anti-TNF, but that needed to be confirmed in a real-life scenario.”
Anti-TNF agents are generally considered safe; however, the field is moving toward more selective treatment options, according to Yarur.
“Targeting therapy to the intestinal immune system has an advantage because it will only block inflammation in the gut as opposed to blocking inflammation in multiple areas of the body. In theory, this will lead to a safer drug profile,” he said. “There are several targeted drugs, but the first one that was approved for gut selection was vedolizumab. It was approved back in 2014 and has been used for both Crohn’s disease and ulcerative colitis.”
Yarur and colleagues examined data on 1,095 biologic-naive patients from 42 sites in the United States, Canada and Greece. Among them, 598 patients received vedolizumab, including 380 with ulcerative colitis and 218 with Crohn’s disease, and 497 patients received anti-TNF therapy, including 224 with ulcerative colitis and 273 with Crohn’s disease. Patients in the vedolizumab group were older (mean age, 47.9 years vs. 39.6 years) and had a longer disease duration (5 years vs. 2 years) compared with patients in the anti-TNF therapy group.
Overall, patients who received anti-TNF therapy had a 60% greater risk for developing serious adverse events (adjusted HR = 0.42; 95% CI, 0.27-0.66) and a 70% greater risk for developing a serious infection (aHR = 0.34; 95% CI, 0.16-0.71) compared with patients who received vedolizumab, according to Yarur. Similar trends were observed when stratifying patients by disease type (Crohn’s disease or ulcerative colitis); however, there was no significant difference in serious adverse events among patients with Crohn’s disease who received vedolizumab vs. anti-TNF therapy.
“But that is only a subgroup analysis,” Yarur noted. “If you take the entire group, which has more statistical power, we do see that there is probably a safer profile for vedolizumab, which really makes sense based on the mechanisms of action of these drugs.”
The findings are consistent with previous data from randomized trials and meta-analyses evaluating the tolerability of vedolizumab in patients with ulcerative colitis and Crohn’s disease, according to the researchers.
“These data support a favorable safety profile of [vedolizumab] in biologic-naive patients with inflammatory bowel disease in real-world clinical practice and bolster the favorable benefit-risk profile of [vedolizumab],” they concluded. – by Stephanie Viguers
Yarur A, et al. P2280. Presented at: American College of Gastroenterology Annual Meeting; Oct. 25-30, 2019; San Antonio.
Disclosure: Yarur reports being a consultant for Takeda Pharmaceuticals. Please see the abstract for all other authors’ relevant financial disclosures.