Mark Lebwohl, MD: Let me turn to you, James. Can you tell us about what contraindications you have for the conventional treatment landscape with biologics? Are there any contraindications you have in your mind?
James Song, MD, FAAD: Yeah. Leon and Erin did a good job of taking my thunder from me, but I would say the biologic class in general is so darn safe. You look at the contraindication list, and it’s really minimal compared with some of our systemic agents. I would say first and foremost, if you have a known hypersensitivity to that biologic, don’t use it. Right? It makes common sense, and we see that with all the drugs, not just the biologics, but that’s an obvious contraindication.
Active infections are big. Leon hit on this already. Active TB [tuberculosis], active hepatitis, active HIV, COVID-19 [coronavirus disease 2019]. Make sure these are treated first before we start. I think TB is interesting though because TB reactivation has been reported with a TNF [tumor necrosis factor] class. But we have some data with the newer biologics where some patients actually had treatment-emergent TB. They didn’t even treat those patients for TB. They left them in the trial, and we saw this both in ixekizumab and risankizumab. That’s a paradigm shift into thinking maybe we don’t necessarily have to be screening our patients regularly when they’re on some of these newer agents.
As far as hepatitis B, it’s important to know if it is antigen positive or antigen negative, poor-antibody positive? Because I agree that if they’re antigen positive, you probably want to stay away from the TNF alpha inhibitors. But if they’re antigen negative and they’re core-antibody positive, I’ve had a number of hepatologists who just make me order a DNA load, an LFT [liver function test] every couple of months.
As far as advanced congestive heart failure, which we would define as New York Heart Association [Functional Classification] III or IV, you probably want to avoid a TNF. It’s true what Leon was saying about the ATTACH trial, where they’re looking at infliximab for CHF [congestive heart failure]. It really didn’t show a benefit. It actually did worse, which is why it’s labeled that way. At least in theory, etanercept might help with some of the ventricular function. One can say maybe it will help, maybe it doesn’t. The conservative recommendation is don’t use it in someone who has advanced heart failure.
I think the IL-17 class, as great of a class as it is, you have the inflammatory bowel disease risk. What’s interesting is that psoriasis itself will increase the risk of Crohn disease, right? And some cohorts are 2-fold. The question is, is there risk of new cases of Crohn disease? Is that higher than what we are seeing with some of these IL-17 agents? To this point, it doesn’t necessarily look that way. That’s just important to recognize. Still, I would be cautious of that group.
Brodalumab, which is the IL-17 receptor blocker, is the only 1 that has this black-box warning. But anyone who has active suicidal ideation or a history of suicidal behavior may not want to go on that agent. Unfortunately, with the study design, they allowed certain patients to enroll in that trial, which other trials may have not. But because of that, unfortunately, that’s the way the drug is labeled.
I would say those are probably the main ones. We talked about malignancy. Blood tumors make me a little more nervous than solid tumors—leukemia, lymphoma. Most of these trials did allow people to enroll if they were free of disease for 5 years, right? We have data on that as well. Those are probably the main ones that come to mind.
Mark Lebwohl, MD: Sure. Do any of you have comments or examples that fit with James’s description. I’ll tell you about 1 that I saw today, and this is obviously off-label, not approved. TNF blockers are quite effective for sarcoid. A patient was sent to me who has severe skin sarcoid, but he also has sarcoid of the heart, and he has heart failure. We tried everything. We tried antimalarials, minocycline, a number of other treatments—nothing worked. Finally, he’s really desperate. So I dictated a letter to his cardiologist and his pulmonary doctor, who’s sort of the quarterback of the sarcoidosis, saying, “You know, the adalimumab pivotal trial showed fewer cases of heart failure in the active group than in the placebo group.” They all, unfortunately, got that warning from the infliximab study. And I’m trying to persuade them to allow him to be treated with adalimumab despite the heart failure, because I’m convinced it’s not going to make it worse, and it probably will benefit his sarcoid a lot. We’ll see if they let me do it.
Transcript Edited for Clarity