Entyvio Associated With Lowest Risk of Adverse Events in Patients with UC, Study Finds

Inflammatory bowel disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), is characterized by chronic inflammation along the intestinal tract that can increase the risk for developing dysplasia and colorectal cancer. Other IBD complications include an increased risk of hospitalization, surgery and infections.

Tumor necrosis factor (TNF) inhibitors remain the preferred first-line treatment to stave off inflammation and reduce the risk of the complications from IBD. They have, however, been associated with increased infection rates, and several other biologics have been approved in the past two decades to treat moderate to severe CD and UC.

Choosing a starting biologic treatment can be challenging, as some patients may not respond to the first treatment. Even when patients respond well, there is the distinct possibility of that response wearing off. When that happens patients are typically switched to a second-line biologic.

To evaluate the adverse clinical outcomes associated with different sequencing of advanced therapies in patients with IBD, Noa Krugliak Cleveland, M.D.. from the Inflammatory Bowel Disease Center at University of Chicago Medicine and her colleagues conducted a retrospective cohort study of adults with CD or UC who received different biologic treatment sequences. The results were published in the September 2024 issue of BMC Gastroenterology.

Noa Krugliak Cleveland, M.D.

The study, called ROTARY part B, used electronic health records from the Optum Clinical Database and included data from 1,273 patients with CD and 779 patients with UC who received at least two biologics between January 1, 2013, and February 29, 2020.

First-line biologics analyzed in the study included Humira (adalimumab), Remicade (infliximab), Stelara (ustekinumab), and Entyvio (vedolizumab). Second-line biologics included Remicade and Humira. The researchers analyzed the rates of adverse clinical outcomes, including IBD-related hospitalization or surgery, dysplasia, colorectal cancer, and infection, based on different biologic treatment sequencing.

The results showed that in patients with UC, starting treatment with Entyvio, which is an integrin receptor antagonist, followed by Humira, resulted in the lowest overall incidence of adverse events. For patients with CD, the lowest overall incidence of surgery was seen in those who received Entyvio as a first-line treatment followed by Humira. The highest overall incidences of hospitalization and surgery were seen in CD patients who used Stelara as a first-line treatment and then switched to Remicade.

Cleveland and his colleagues concluded that using Entyvio as a first-line biologic treatment followed by Humira is associated with fewer adverse clinical outcomes versus using TNF inhibitors or Stelara as a first-line treatment followed by another TNF inhibitor.

These results align with a previous study that found Entyvio to be more effective than TNF inhibitors when used as first-line therapy in patients with UC.

The researchers propose that their results guide clinicians in deciding first- and second-line biologic treatment for patients with IBD. They wrote, “…these data provide important insights into the impact of different sequences of biologic treatments on adverse clinical outcomes in IBD and provide guidance to clinicians when choosing sequences of biologics for treating patients with moderate to severe CD or UC.”

This study was funded by Takeda Pharmaceuticals, maker of Entyvio.