Identifying the Appropriate Patients for Atopic Dermatitis Treatments

Peter L. Salgo, MD: Let’s take a look a little bit more to see if we can parse some of this out. If we have to use the evidence we’ve got, and we want to establish a potential role for disease-modifying therapy in either mild to moderate or moderate to severe disease, how do you do that with these new agents? Which agent goes which way? How do you make these decisions?

Cheryl Allen, BS Pharm, MBA: I think we have to identify these moderate to severe patients and then begin to parse those out and treat those patients.

Peter L. Salgo, MD: Without, right now, giving you the criteria for this, I’m just going to say this patient, patient A, is mild to moderate. Of these new therapies, which of these two would be more applicable to mild to moderate as opposed to severe? Would it be the ointment or would it be the injection?

Cheryl Allen, BS Pharm, MBA: Dupilumab is moderate to severe, so that would be the one. I think it all evolves around education. As the doctor told us, the patients first start with the creams, keeping the skin moist. Then, we go to topical steroids, and it’s on and off of steroids. So, to your point about step therapy through some of the previous treatments, that, in my mind, establishes the moderate to severe. That’s how you begin to identify those.

Ed Pezalla, MD, MPH: And I totally agree. I think that’s really a very good way of finding the right patients here. If they just aren’t getting by, if they can’t get relief from their symptoms and from the disorder by what’s being done now, then they’re clearly a good candidate for something more. And then, the question is, are they that far off from the patients who were studied in the trial? Well, they probably shouldn’t be unless they have some major comorbidity that we really have to sit down and think about in terms of safety, and this is no longer a monetary problem. At that point, this is a problem of risk-benefit for that individual patient, and it is something the patient and the physician have to work out. In the absence of that, then a really good marker for patients having more severe disease is just not responding to current therapy.

Cheryl Allen, BS Pharm, MBA: Right.

Peter L. Salgo, MD: Let me see if I heard you correctly. I’m going to come back to you for a moment to try to parse this out a little bit more, but somebody with mild to moderate who needs to move to something else, would you move first to the topical therapy and then you might move on to dupilumab and the injectable therapy? Would that be how you think about it?

Cheryl Allen, BS Pharm, MBA: That’s an interesting concept. I’m not so sure. I think it’s really, and I sit here at the representative of specialty pharmacy, up to the doctor who’s been treating that patient.

Peter L. Salgo, MD: Does that make sense?

Jonathan Silverberg, MD, PhD, MPH: Yes and no. There are moderate to severe patients who will respond to topical steroids. If you catch it early enough and you treat aggressively enough, if they do well, then I think we would all agree, why would we put them on a systemic agent and expose them to any of that risk? Even if there’s a better risk profile for the newer drugs, it’s still some risk we don’t want. And you’re just getting to your issue of, how do you define some of these? As dermatologists, we just know what a mild patient is. You just look like, “Alright, we could get by with a topical agent.”

Peter L. Salgo, MD: It’s a Supreme Court definition of obscenity.

Jonathan Silverberg, MD, PhD, MPH: Exactly. And this is, like, the worst thing for a payer here. But when you look at the mild patient, you say, “Okay, this is a patient who would probably do quite well with topical agents.” And we would start with something: a topical steroid or, if they’re contraindicated or if we had access to it, something like these new PDE-4 inhibitors. And, for the most part, those patients will do quite well on the topicals. When you see some patients walk in—and they’re just so extensive, the lesions themselves are so severe—we’ll start with a topical steroid. But even at this juncture where we have limited options, I will have a conversation with the patient at that point, saying, “We’ll start with a 3-week trial of topical steroids, and we’ll give it solid effort. But I want you to know the options because probably a month from now, we’re going to be starting a systemic agent when these fail.” So, you just have that sense.

Jeffrey D. Dunn, PharmD, MBA: And see, that’s where we’re going to want a discussion. It’s about that severe patient who hasn’t tried something else. Where does this fit? I’m not sure how big of a patient population that is. You might have a better sense for how many patients are not self-treating or haven’t used generics. I think a lot of this will be a moot point. We’ll cover these drugs because they’re better. The question is, who is the patient? And if it’s to set up where you try topical generic TCIs or generic steroids, they’ll be in their history. So, a lot of this is going to be a moot point. The issue is those patients who haven’t tried those other things.

Jonathan Silverberg, MD, PhD, MPH: Right. I don’t know any provider that’s going to want to jump to a biologic agent prior to using even super potent topical steroids, but, certainly, midpotency topical steroids.

Peter L. Salgo, MD: If I heard you correctly, and I think this is a major statement, it isn’t that you think the drugs aren’t good or that they don’t work. But, that the patient population eligible for them needs to be better defined. Is that fair?

Jeffrey D. Dunn, PharmD, MBA: That’s fair.