Miguel Regueiro, MD: Doug, I have 1 question. Well, I’ll start with 1, and then I may ask another to follow up. How do you decide which of the biologics or small molecules to use first for Crohn disease and ulcerative colitis? I know that’s another huge topic, but what’s your decision point for which biologic, which small molecule? How do you decide?
Douglas C. Wolf, MD: There are a lot of factors, and occasionally and it’s more often that the ultimate decision is made by the insurer rather than by us. If someone has luminal Crohn disease without any fistulizing disease, then there are a lot of options. The process of shared decision-making, where we tell patients and their families as much as we can and may use adjunctive video or other web connections to inform them, is the best way.
Some patients end up wanting to go with 1 agent, let’s say adalimumab, because a family member had it and did well. That probably makes some sense because there may be reasons to go with that if someone has done well, but we have a lot of good options. I start getting more selective if someone has fistulizing disease, especially if it’s a more severe type of fistulizing disease. Let’s take some of the most severe rectovaginal fistula in a woman or something that’s rather complicated as an example. Then infliximab is the go-to agent first.
Adalimumab could be used, maybe ustekinumab as well, though there are less data with those agents. Similarly, if someone has many extraintestinal manifestations, going with an anti–TNF [tumor necrosis factor] agent makes the most sense. If you look at the FDA approvals for infliximab and adalimumab, there are 8, 9, or 10 approvals for rheumatoid arthritis, uveitis, and ankylosing spondylitis, so it makes great sense to use these anti-TNFs when there are extraintestinal manifestations.
If a patient is concerned—and some are, as well as their families—about the systemic adverse effects of a biologic, and there’s a relative biologic fear, then going with something like vedolizumab makes great sense because it is selective. Similarly, ustekinumab has a great safety record. If someone has poor IV [intravenous] access or doesn’t want to come in for infusions, then going with primarily a subcutaneous agent like adalimumab as an anti-TNF agent and ustekinumab as a non–anti-TNF agent makes sense. These are just some of the examples of how we decide. After the patient and I figured all out this, then the insurance company tells us what we can really get.
There’s always the opportunity to challenge the decision, and it’s important if I have made patient a choice and we have good rationale for it, and that gets denied. I’ll get on the phone with the insurer, and a majority of the time, I can get that denial overridden. It is not always so, but it occurs a majority of the time, so always stay open for advocacy for your patient.
Miguel Regueiro, MD: Right. That’s an important point. Often, the insurance makes the decision, but in fairness, when you get the medical director on the phone from an insurance company and explain, they’ll acquiesce, or they’ll approve. I understand that this is still a lot of work and a lot of time and effort.
Transcript Edited for Clarity