Vedolizumab Emerges as Option in IBD After Anti-TNF Failure

Damian McNamara

February 16, 2018

VIENNA — Vedolizumab improves mucosal healing in people with Crohn's disease and ulcerative colitis who failed or became intolerant to previous anti-tumor necrosis factor (TNF) therapy, research from the Hungarian Vedolizumab Study Group indicates.

"The management of anti-TNF-alpha-resistant patients presents a great clinical and therapeutic challenge. In these difficult cases, the gut-specific vedolizumab might be an alternative solution," said investigator Renáta Bor, MD, from the University of Szeged in Hungary, who presented results from observational multicenter study here at the European Crohn's and Colitis Organisation 2018 Congress.

The 106 study participants underwent a baseline colonoscopy at week 0, just before the first infusion of vedolizumab. The induction period ran from week 2 to week 6, and mucosal healing — the primary study outcome — was assessed at week 14.

At baseline, the only significant difference between patient groups was concomitant medication use. For example, significantly more patients with Crohn's disease than with ulcerative colitis were taking azathioprine.

Clinical response and clinical remission rates were secondary end points.

Table. Outcomes at Week 14

Outcome Patients With Crohn's Disease, % (n = 47) Patients With Ulcerative Colitis, % (n = 59)
Improvement in endoscopic score 17 55
Rate of complete mucosal healing 8 10
Decrease in Crohn's Disease Activity Index score 64 86


Clinical response improved from baseline in both patient groups.

There was no significant difference in remission or steroid remission between the patient groups, Bor reported, "with similarly high rates in both the Crohn's disease and ulcerative colitis groups."

"Vedolizumab induction is a safe and effective therapeutic option in our difficult-to-treat population," she said. "This result suggests that vedolizumab induction therapy is beneficial, especially in ulcerative colitis patients."

The results are pretty compelling, to see a response in patients who have failed anti-TNFs already.

The findings are "surprising, exciting, and interesting," said Miguel Regueiro, MD, from the University of Pittsburgh Medical Center. "I think it goes against a little bit of what we thought before, that if they were resistant to anti-TNF, vedolizumab is not going to work as well. So the results are pretty compelling, to see a response in patients who have failed anti-TNFs already," he told Medscape Medical News.

In Hungary, all newly initiated vedolizumab therapy needs to be approved by a steering committee of five specialists in inflammatory bowel disease. As a result, vedolizumab is used primarily in difficult clinical settings, mainly for anti-TNF failures or intolerance or for patients with a medical history of cancer, Bor explained.

Bor has disclosed no relevant financial relationships. Rigerio is a consultant and on the advisory board for Takeda.

European Crohn's and Colitis Organisation (ECCO) 2018 Congress: Abstract DOP007. Presented February 15, 2018.

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