麻豆传媒

While infliximab (Remicade) and vedolizumab (Entyvio) were comparable for clinical remission in previously biologic-naive ulcerative colitis patients, infliximab was more likely to result in corticosteroid-free clinical remission as well as endoscopic remission, a post-hoc analysis found.

At 1 year, a similar percentage of ulcerative colitis patients reached clinical remission from infliximab and vedolizumab (39.9% vs 38.6%, respectively) in their respective trials, reported Neeraj Narula, MD, MPH, of McMaster University in Ontario, Canada, and colleagues.

However, in the trials examining infliximab, more patients achieved endoscopic remission with infliximab compared to the trials examining vedolizumab (36.0% vs 25.6%, respectively, P=0.003), and a higher percentage of patients in infliximab trials achieved corticosteroid-free clinical remission (29.5% vs 15.0%, P=0.004), the authors wrote in .

"The higher 1-year success rates with infliximab in patients who are already on corticosteroids, as well as the higher rates of endoscopic remission, may indicate that sicker patients may benefit from this option," Russell Cohen, MD, from the University of Chicago Medicine, told 麻豆传媒.

"As in all patients, balancing medication risks with benefits should be individualized to provide the safest effective treatment," added Cohen, who was not involved in this study.

, the tumor necrosis factor (TNF)-alpha antagonist infliximab and integrin receptor antagonist vedolizumab have become preferred biologics for ulcerative colitis, but clinical remission data on biologic-naive patients has been lacking, the authors said. The trial found vedolizumab superior to other treatment options for biologic-naive ulcerative colitis, but did not compare it with infliximab.

Miguel Regueiro, MD, of the Cleveland Clinic, told 麻豆传媒 that these findings parallel what he sees in his own inflammatory bowel disease practice. He added that infliximab remains the "gold standard" for most ulcerative colitis cases.

"I think that this study is important and suggests that vedolizumab may perform equally to infliximab for symptom-based control of [ulcerative colitis] (clinical remission), but not as well for endoscopic remission or corticosteroid-free remission," said Regueiro, who was also not involved with the research.

Authors aimed to compare results of trials measuring the effectiveness of infliximab and vedolizumab in moderate to severe biologic-naive ulcerative colitis. They examined data from three studies: (n=228), (n=291), and (n=276). While Gemini and VARSITY included refractory patients, the analysis only focused on the biologic-naive group, they noted.

At weeks 0, 2, and 6, 300 mg of vedolizumab was intravenously administered in Gemini and VARSITY, then administered either every month or other month for maintenance. In ACT-1, either 5 mg/kg or 10 mg/kg of infliximab was administered at weeks 0, 2, and 6, and then every 2 months during maintenance.

The primary outcome was clinical remission at 52 weeks, as defined by resolving rectal bleeding and subscore normalization of the "Mayo stool frequency." Other outcomes included clinical remission at 6 weeks, as well as endoscopic remission and corticosteroid-free clinical remission at 1 year.

In total, there were 795 biologic-naive ulcerative colitis patients from three clinical trials. Patients in ACT-1 were a mean age of about 42 and 62.7% were men; in the Gemini-1 and VARSITY, they had a mean age of 40.9, and 58.4% were men.

Patients in the vedolizumab trials were more likely to be using concomitant steroids and had higher albumin levels, while patients in the infliximab trial had more frequent cases of pancolitis and a higher use of immunomodulators.

By week 6, a similar proportion of the biologic-naive patients on infliximab and vedolizumab had reached clinical response (60.5% vs 60.0%, P=0.884) and clinical remission (39.9% vs 38.6%, P=0.736).

"I was somewhat surprised to see comparable 6-week response and remission rates with both infliximab and vedolizumab," Narula told 麻豆传媒. "Many perceive vedolizumab to be slower than infliximab. However, by six weeks it does look like several patients will respond to both therapies."

There were more frequently reported serious infections in patients treated with infliximab than vedolizumab (5.3% vs 0.7%, respectively, P<0.001), but rates of hospitalization were similar in both patients, the authors noted.

Acknowledging limitations, authors cited variations in endoscopic assessments and the fact that not all trials were given "centralized blinded endoscopy scoring." They added variations could potentially exist over time in assessing patient disease activity due to trials occurring in different years: 2005 (infliximab) compared to 2014 and 2020 (vedolizumab).

"In the future, it could be that we use one agent (e.g., infliximab) to induce a remission, and then another agent with an excellent safety profile (e.g., vedolizumab) to maintain a remission," Regueiro said.

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