Recommendations for monitoring a 24-year-old woman treated with biologic therapy to manage inflammatory bowel disease to evaluate treatment efficacy.
Joseph Feuerstein, MD: Dr Hanauer, as Dr Sands mentioned, this patient is pretty sick overall. Which biologic treatment would you select initially for this patient?
Stephen B. Hanauer, MD: As Dr Sands mentioned, this patient is really high into the moderate to severe because, No. 1, 80 cm is over 2 feet of disease. That would be a lot of bowel that would need to be resected surgically if she needs it. Second, she already has stricture fibrosis. We need to understand that none of our therapies reverses strictures. So I would treat this patient with our most effective regimen from the onset, which would be a combination of infliximab and a thiopurine. I would also cautiously monitor her biomarkers, as Dr Ungaro mentioned, and probably get into some form of therapeutic monitoring to make sure she’s treated in an optimal manner. Because after this, we don’t know whether any of the other therapies are going to be effective if she fails treatment in this setting.
Joseph Feuerstein, MD: Thank you. Dr Sands, with regard to that initial treatment, at what time point would you evaluate the overall efficacy of the therapy? How would you do that in this case?
Bruce E. Sands, MD: You’re evaluating at multiple time points in different ways. You want to see that the patient is getting better and feeling better relatively quickly. However, objective evidence that the bowel is healing up may take a bit longer. You might expect symptomatic relief within days, or certainly a few weeks—and outside about 8 weeks with the regimen that Dr Hanauer described—but assessment of mucosal healing, either by cross-sectional imaging or endoscopy, will lag quite a bit. Typically, we wouldn’t want to have a full assessment of that until 6 or even 9 months. In between, though, there are other things you can do to monitor. We’ve mentioned biomarkers, such as fecal calprotectin, C-reactive protein, and sedimentation rate. Which you use depends on which ones the patient registered as being elevated before you initiated treatment. That gives you a good thing to follow as you go along.
Joseph Feuerstein, MD: Thank you. Dr Ungaro, 1 of the challenges we face in practice is overall cost and insurance coverage of therapy. How does that factor into your decision-making in cases like this?
Ryan Ungaro, MD: We want to go with what’s most effective for our individual patients, but it’s a reality that there are insurance coverage issues. The good thing in this case is that, in my experience, the anti–TNFs [tumor necrosis factors] generally have the best coverage among the biologics, especially as a first-line agent. Occasionally, the insurance company may push back on 1 agent over another. You can try to argue that with them through things like peer-to-peers. But I usually tell patients up front, especially if they’re not necessarily as sick as this patient: “In your situation, I would choose drug X. But drug Y and Z are also good options. It’s possible that your insurance company may come back and say they only provide for drug Z.” At least up front, you’re not saying, “You definitely need this 1 drug.” This case notwithstanding because this is a very sick patient. But for a lot of our patients, we can have a little more luxury of saying, “We’d like to try one of the newer agents first,” with the expectation that their insurance company may push back on that. It’s important to set that up in the beginning so that when they come back to you, they’re not saying, “You said I have to be on this drug. This is a disaster.”
The last thing to mention is that a lot of these agents often have different patient-assistance programs that the companies offer. The 1 limitation is that it’s primarily only for those with commercial insurance. Sometimes you can run into issues if you have a patient with only Medicare or only Medicaid, but there are various patient-assistance programs that you can look into for them.
Transcript edited for clarity.