VIDEO: Considerations for biologic therapies in atopic dermatitis

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So first and foremost, moderate to severe disease, so we'll just start there. I don't don't generally consider it for milder disease. Now, one caveat even there is how do we measure disease severity? There are a number of metrics.

There are scales, like the EASI scale, Eczema Area and Severity Index, used all the time. It's the lingua franca of clinical trials. So it's what we have to use as providers if insurers are gonna pay for these new expensive drugs, we have to say, okay, they have, if not an EASI score, then an Investigator Global Assessment Score, zero to four. It's gotta be either three or four, moderate or severe, if an insurer's gonna even consider covering one of these newer expensive medications. But things like the EASI score, Area Severity Index, right? So the area of involvement, the body surface area, that's a huge thing that insurers like to see, can be misleading.

There are variants of eczema, one called Nummular Eczema, which has much more focal, almost coin shaped spots. They're intensely itchy but smaller. They're not these large plaques that you can calculate as, oh gosh, that's 10% of the body surface area affected. They're very small, but incredibly itchy, incredibly impactful. And so it's challenging even in that regard in terms of the, well, I only use it for moderate to severe patients. You have to be careful with that.

But with that said, the four biologics now in question, Dupilumab, Tralokinumab, Lebrikizumab, Nemolizumab, as a pediatric provider, there's only one that's approved below the age of 12 right now. And that's Dupilumab, and that's approved down to six months of age. The others are being studied in younger age groups to be sure, but right now in a younger child, there's really only one choice. Not only because it's approved down to that age because it was the first on the block, and therefore we've got the most experience with it. And pediatric providers, all providers, but pediatric providers in particular are very conservative in their need to see medications used over time and safe over time before they introduce them to a child. And so for me, Dupilumab is still the first line for most patients. Now over 12, you have other options, and Dupilumab is not a perfect drug. It doesn't work in everyone, number one. And it can have side effects like any medication. So if a patient who develops significant conjunctivitis, one of the more common adverse effects associated with Dupilumab, well, I might think about one of the other medications.

Now two of them, Tralokinumab, Lebrikizumab have that same risk, but one of 'em doesn't Nemolizumab, so maybe that's, that might bend me in that direction. So it's a matter of sort of thinking about the medication, the age, your comfort level with it, and then matching that to a patient's own comorbidities. A patient has eczema and bad asthma, a certain type of asthma, well, Dupilumab's FDA approved to treat both. You might be able to kill two birds with one stone. Patient has really bad vernal conjunctivitis. So 8% of patients with atopic dermatitis have preexisting ocular conditions, one of the comorbidities. Well, that may be a patient where you might not want to use an IL-4 or IL-13 blocker that might risk exacerbating the eye concern. So that's the sort of thought process as a part of shared decision making that I go through.

Yeah, that's primarily it, is age and comorbidities because all of the biologics are injectables. So they're all subcutaneously delivered. And as a pediatric provider that can be, that can be a barrier. As soon as you start talking about the medication being a shot, that can be a deal breaker for some.

The flip side of that is we do not need to monitor laboratories for biologics without any specific reason to do so. And so, yes, it's a shot, delivered as I said earlier, Dupilumab either once a month or every two weeks. The others, a little bit different, at least in that Nemolizumab for instance is a once a month injection. The others have a path to titrating to a lower, lower frequency of injection. So all of these things are things that we consider in terms of positioning the biologics.

As I alluded, we don't, unless there's a specific concern or comorbidity or reason to do so, we don't monitor laboratories. The FDA does not require us to monitor laboratories, even in infants six months of age and older. Which surprised me actually because there were actually not that many infants in the clinical trial upon which the FDA approval was based, which you can look at it two ways. There's not much evidence for its use in the six month to 2-year-old population. The flip side being the FDA generally is a pretty conservative institution themselves and did not recommend laboratory monitoring even in that age group, which is in a sense a reflection of the safety profile in the older kids.

So I look at it both ways, but, so don't check labs. I do see kids back. I usually expect in patients who start biologics, and there's a little variability here, but two to three weeks, they're starting to see some significant improvement, which is great. And if you look at the curves, that's where they're in the steep part of the curve improving. Round about three to four months, it seems like that curve levels off, and so don't expect a heck of a lot more after that point in terms of improvement. Now you can absolutely still use your topical medications when you're using the biologics.

In fact, you absolutely should continue to moisturize. That's one of the things I see in kids in particular. This patient population we're talking about, they've usually been, they've had it, the condition for a long time. They've been using topical medications for a long time. They've never enjoyed using topical medications. And so they finally don't have to as much 'cause they're better, and so sometimes we'll see them start to get better, better, better then start to backslide a little bit. And oftentimes when I ask them what they're doing topically, they're like, nothing. I'm like, well, please, let's restart your moisturizers because those are gonna still have an important role for patients with atopic dermatitis. But don't have to use topical steroids or any of the non-steroids that we use, but can, and in fact, one of the biologics that was FDA approved was FDA approved with the concomitant use of topical steroids, Nemolizumab. So just something to bear in mind, but doesn't mean you have to.