Effects of Vedolizumab Induction Therapy for Patients With Crohn’s Disease in Whom Tumor Necrosis Factor Antagonist Treatment Failed. Sands BE, Feagan BG, Rutgeerts P et al. Gastroenterology 2014;147: 618-627.
We know that patients who develop IBD in childhood often have a tricky course and try several different treatments to keep their IBD in remission. Some patients will have tried drugs like infliximab and adalimumab (anti-Tumour Necrosis Factor or anti-TNF drugs) and these may have stopped working. We are always keen to have new drugs in the battle to keep IBD under control.
This paper presents the results of a trial of a new drug called Vedolizumab which is an antibody to a different molecule called anti-α4β7 integrin which is also involved in gut inflammation. The study looks at the effect on adult patients who have previously had infliximab +/or adalimumab but still have active Crohn’s disease. It is a randomised (selected patients randomly allocated), placebo-controlled (compares test drug to a control/dummy drug with no effect), double-blind (neither patients nor researchers know if they get placebo or actual drug) trial across many countries and hospitals.
There were 315 patients who had previously had anti-TNF drugs. They looked at remission (disease under control) and response (disease improved).
- At 6 weeks there was no significant difference between those who received the drug and those who received placebo
- But at 10 weeks there was a difference; 26.6% patients on Vedolizumab were in remission compared to 12.1% of placebo patients.
- At both 6 and 10 weeks after starting the trial, the Vedolizumab patients had significantly greater improvement in their disease activity compared to the placebo group.
Less than 1% of patients had a serious infection or serious adverse event during the trial and these events were not different between the drug and placebo groups.
So what can we conclude? Vedolizumab seems generally safe and is modestly effective at bringing Crohn’s disease into remission. The effects may take some time to achieve in patients who previously failed anti-TNF therapy. Vedolizumab may be a new option for patients with difficult Crohn’s disease.