Expert Perspectives on the Optimal Management of Inflammatory Bowel Disease - Episode 12
The significance of conducting future head-to-head trials of therapies used to treat inflammatory bowel disease and implications for treating ulcerative colitis (UC) with vedolizumab based on recent data demonstrated when the drug was tested in a first-ever head-to-head biologic clinical study in UC.
Stephen Hanauer, MD: One of the problems that we’ve had to date is that all of our drugs, for regulatory approval, are tested vs placebo. It’s an efficient way of demonstrating a safe and effective drug, at least short term. But it doesn’t allow us to compare agents. I mentioned the network meta-analyses before. Most recently, however, we have had a head-to-head trial in the setting of ulcerative colitis [UC] that compared vedolizumab to adalimumab. What’s your perspective of that trial and how has that impacted your practice?
Marla Dubinsky, MD: I want to remind everybody that was really to look at, in a patient predominately naïve to anti-TNF therapy, which of either vedolizumab or adalimumab was superior. Based on the primary end point at week 52, vedolizumab was superior when it came to remission compared to adalimumab. We saw that. However, as I noted, that was predominantly driven by the fact that these [patients] were naïve to infliximab. What this told us is that there may be a place for deciding sequence, and this is what I’m always thinking about, where is the best place for a non-infliximab therapy? This gets back to that whole speed concept, and where do you place these therapies?
This showed me, and this has applied to my practice, that if the patient is naïve to anti-TNF, they’re moderate, moderate to severe, but lower end of the moderate to severe, and they haven’t gotten “the bubble in my head saying” they earn infliximab, or needed tofacitinib for speed, needing hospitalization, then I use vedolizumab as my go-to ulcerative colitis therapy. Now, I’ve started to also introduce the use of ustekinumab for ulcerative colitis because we now have that available, and we talked about the durability. I put them at the same level for safety, and I just say, “This is how this drug works, and this is how this drug works. One’s intravenous [IV]; one’s IV followed by subq [subcutaneous]. What would you prefer?” I don’t impose my ways on a patient when I believe all are on the table.
Transcript Edited for Clarity