Vedolizumab Associated with Ulcerative Colitis Control and Maintenance

Edward Loftus, Jr., MD

A new post-hoc analysis of the VARSITY trial found vedolizumab to be more effective than adalimumab in achieving and maintaining early disease control in patients with moderately to severely active ulcerative colitis.

The benefit of the anti-α₄β₇ integrin antibody was especially pronounced in those without any prior exposure to anti-TNF agents.

These findings were presented at the annual American College of Gastroenterology (2020) conference.

The VARSITY trial, a phase 3b, randomized, double-blind, double-dummy, multicenter, active-controlled active-controlled study, initially demonstrated that vedolizumab led to higher rates of clinical remission and endoscopic improvement than adalimumab.

However, the investigators believed that assessing disease control, defined as a combination of clinical, endoscopic, and histologic remission endpoints, would provide more clinically meaningful measures.

Thus, Edward Loftus, Jr., MD, of Mayo Clinic College of Medicine, Minnesota, and colleagues evaluated the trajectory of changes in disease control between the 2 biologics from week 14 to week 52. They assessed evolution in disease control over this time using the proportion of patients who maintained, improved, or lost treatment benefit.

They also analyzed data according to whether or not patients in either arm were anti-TNF naïve or experienced.

Included in their analysis was a total of 769 patients with ulcerative colitis, all of whom were randomized 1:1 to receive intravenous vedolizumab or subcutaneous adalimumab. A majority of the patients in either arm were male (56.0% adalimumab vs 60.8% vedolizumab), were not using a corticosteroid at baseline (63.7% vs 63.9%), and were anti-TNF naïve (79.0% vs 79.2%).

In the adalimumab group, the median ulcerative colitis duration was 4.5 years. For those who received vedolizumab, the median disease duration was 4.8 years.

Thus, the results showed that at week 14 and at week 52, clinical remission, endoscopic and histologic improvement, as well as overall disease control, were achieved with greater frequency with vedolizumab than with adalimumab.

Furthermore, more patients who received vedolizumab maintained each efficacy outcome and overall disease control between 14-52 versus those who received adalimumab.

These differences between the arms were even more pronounced between the anti-TNF-naïve subgroups.

For example, 18.7% and 16.8% of anti-TNF-naïve vedolizumab users gained and maintained disease control outcomes, respectively—compared with 11.2% and 10.0% of anti-TNF-naïve adalimumab users, respectively. 

As for anti-TNF-experienced vedolizumab users, 13.8% and 9.2% gained and maintained disease control outcomes, respectively. In the anti-TNF-experienced adalimumab subgroup, 7.4% achieved disease control outcome and 4.4% maintained it.

The investigators noted that at week 52, the overall rate of disease control was higher with vedolizumab (47.3% anti-TNF-naïve; 39.0% anti-TNF experienced) than with adalizumab (32.7% anti-TNF-naïve; 24.2% anti-TNF-experienced).

“These data suggest that vedolizumab is superior to adalimumab during both induction treatment evaluated at Week 14 and maintenance treatment evaluated at Week 52,” they wrote. “Most of the observed treatment differences in anti-TNF naïve patients at Week 52 were established with early response to treatment between Week 0 and Week 14.”

The study, “Disease Control and Changes in Individual Treatment Outcomes From Week 14 to Week 52 With Vedolizumab or Adalimumab in Ulcerative Colitis: A VARSITY Trial Post Hoc Analysis, “ was published online by ACG.