Optimizing Treatment Strategies to Manage Inflammatory Bowel Disease - Episode 6
Important patient factors to consider other than severity of disease when choosing a therapeutic agent for inflammatory bowel disease.
Remo Panaccione, MD, FRCPC: Jessica, we have a lot of choices to make when we are treating our patients and I think that sometimes, when we are at the podium, people think that we have the answer regarding which drug to use when treating particular patients. If we are talking about moderate to severe disease, whether it is ulcerative colitis or Crohn’s disease, what are some of the other factors that you use to pick 1 therapy over another? What influences you?
Jessica Allegretti, MD, MPH: Yes. I think part of Bill’s point earlier, too, is the importance of looking at not only disease activity, which is how they are today in front of you, [but also] their disease severity and their overall prognosis. Was this a patient who was diagnosed very early? Do they have a very severe phenotype or a lot of bowel involvement? Do they have a lot of extraintestinal manifestations or perianal disease? I would say there are several known prognostic factors that suggest that someone is going to have a bad course. And so, if you assess the patient in totality, when they’re in front of you, you can start to tease out at least if they need Remicade [infliximab], for example. I like Marla Dubinsky, MD. Marla Dubinsky always says, “Have you earned Remicade? Are you sick enough that you need that upfront, or is the patient really on the cusp of more moderate ulcerative colitis?” Maybe we are starting with vedolizumab [Entyvio], which I tend to like to use as a first-line treatment for my ulcerative colitis patients if they are not very ill but certainly need a biologic therapy.
I think you really have to take all of those factors into consideration—the patient’s individual risk factors and their personal preferences, too. You have to have these discussions with the patient about how they would like to receive the medication. What are their individual comorbidities? Are there indications that maybe steer you away from something? For example, do they have a substantial cancer history, blood clotting history, or other factors that may lean you 1 way or the other? It is not 1 size fits all. I think you really have to do this on an individual basis, based on the patient’s disease course thus far, its course at the time they are seeing you, their overall prognosis, and their individual risk factors and preferences because it really does have to be shared decision making.
William Sandborn, MD: It is interesting. Let’s say you have ulcerative colitis and you get infliximab and you have a primary nonresponse and then you get tofacitinib [Xeljanz] and you respond and then lose response. You get used to ustekinumab [Stelara] and you do not respond. You have not had vedolizumab yet, but we know that vedolizumab works less well. For patients who have failed with TNF [tumor necrosis factor] blockers, it is really unlikely to work, especially with somebody who has failed 3 other mechanisms. As you are contemplating surgery for this patient, should you force them to go through vedolizumab treatment, which is a “Hail Mary” strategy? It is unlikely to work, to control their symptoms, or to give you healing. Well, if you had to pay for it, if you were the payer, you probably would not want to pay for that. We often do it, but it is not a form of value-based care. On the other hand, for the patient that Jessica was talking about—you are choosing your first drug and you want the patient to accept a biologic intervention because you think they are at enough risk that they need that. The safety profile is such that if the payers are not getting in the way and let you do your job, you can do a clinical prediction model to see if there is a high likelihood the patient is going to respond to vedolizumab. It can be monotherapy—that is what newly diagnosed or recently diagnosed patients are likely to accept and that is the perfect place for vedolizumab. It is actually not right to give a TNF blocker that really you should be giving an immune-suppressive with, but patients often do not accept it; the doctors do not accept it, and so then they get monotherapy with the TNF blockers and it does not work. Then, you are on the vedolizumab, but it doesn’t work as well so you made these compromises. It is funny; there is 1 place where vedolizumab is the perfect drug for the patients. There is another place where it is really not a good drug and yet, we get it wrong for a variety of reasons all the time.
Edward Loftus Jr., MD: Back to your point, Bill. Parambir S. Dulai, MBBS, showed, with clinical decision support tools, the place of vedolizumab and Crohn’s. And then there was that abstract—Marla Dubinsky was the first author at the DDW (Digestive Disease Week) conference this year. They went back to the GEMINI II study and they were able to break out see the CDAI [Crohn’s Disease Activity Index] scores. The moderate patients were at, I think under 330, and the anti-TNF naive patients—
those patients had a quite a robust response to vedolizumab, so that by week 6, they were already significantly better than treatment with placebo. Like you said, there are these subgroups of patients that are going to respond.
Remo Panaccione, MD, FRCPC: It appears if you say you prefer first-line strategies, I think we are moving to drugs that you can use as monotherapy that we believe are safe, right? Unless there is another reason in the company that the disease keeps, whether it’s fistulizing disease, extra-intestinal manifestations as Bill suggested, another IMID (Immunomodulatory imide drug) that’s present. I think we have seen a certain change, if you can get access to the drug, and to some of the newer mechanisms of action. One of the things I think Bill pointed out that is really important, though, is that I think we have seen this pendulum swing back [and] forth—at least in Canada. I do not know what it is like in the United States, where individuals are using anti-TNF therapy as monotherapy again, and I think that is not the way to use anti-TNF. If you are going to use anti-TNF as part of your practice, you should use it in the best manner possible because if you don’t, you are going to burn through it. Then you get into the problems of that we have with second-line therapy.
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Transcript edited for clarity.