Considerations for Biologic Treatments in Pediatric Patients with Atopic Dermatitis

Opinion
Video

Expert dermatologists highlight the burden of atopic dermatitis in young children and examine the clinical data for dupilumab, a biologic treatment for this age group.

Raj Chovatiya, MD, PhD: To revisit an earlier issue, we talked about some exciting updates with biologics, where we have drugs that have a favorable safety profile and approvals going down all the way to the youngest children in infancy. A new question in my mind, for children that young, is how do you figure out that they’re the right patient for biologic therapy? Because you have several new challenges in that pediatric age group. It’s about not just the therapy working but also all the external factors—giving a shot, making sure there’s adherence, etc. Do you have any thoughts on that, George?

George Han, MD, PhD: It’s for the little children. I don’t think we’ve captured enough of what this disease process does to them globally. I have atopic dermatitis [AD]. My older daughter does too. But my younger 1 doesn’t, and she’ll absentmindedly start scratching. I wonder about the attention span of children being able to focus and concentrate on things with atopic dermatitis distracting them.

Raj Chovatiya, MD, PhD: That’s an important point.

George Han, MD, PhD: We don’t have a good grip on the cost of not treating them well. For those patients who go through the emollient, if you’ve tried the short-term potent topical steroid therapy regimens and they aren’t turning around, there’s not much reason to hesitate. The biggest holdup I have for younger children is that parents ask, “When can we stop?” To some degree, this is something everybody asks. I tell those patients and parents that we hope that your child will outgrow this. In many cases, that’s possible. I don’t want to put you on a medicine that you don’t need. That’s the last thing I want to do. But we have to do it together. We come to an agreement and say that if they’re itch-free and rash-free a year or 2 from now, then we’ll gradually back off in the hopes that we can eventually get your child off the medicine. That helps persuade patients to get on because they’re scared of that commitment. Even though we think these are very safe medicines, and we have good data across many years, these are their children, so parents get apprehensive.

Raj Chovatiya, MD, PhD: In the opportunities I’ve had to push that age limit down, I’ve highlighted that the greatest risk is not treating the disease. Based on a lot of that data, that causes folks to revisit whether they truly feel that they’re a good candidate for the medication. Whatever needle phobia or general medication phobia exists ends up largely disappearing. Has your experience been like that too Vivian? Do you have any challenges in figuring out the best time to recommend biologic therapy for your younger pediatric patients?

Vivian Shi, MD, FAAD: It’s a lot harder for parents to keep a child on topicals day after day, year after year. Just like for the adult age group, my recommendation for going systemic is when topicals are not adequate or impossible. For impossible, imagine an active squirmy toddler or baby. Topicals are particularly burdensome for them. Providers don’t talk about the cream burden enough with their families. If a child splits their time in more than 1 household, then the regimen complexity multiplies.

I completely agree with George that inadequately treated children with AD could have profound disturbances in their physical and mental development with more mood issues as they grow up, more behavioral issues like attention deficit disorder, and difficulty in school performance and extracurricular activities. I have a lower threshold and start talking about systemic treatments, but we also don’t involve children early enough in the shared decision process. Of course, you can’t involve a 6-month-old, but when my son was 10 months old, he had a preference for eczema cream vs ointment even before verbalizing it. Involving the children early on in shared decision-making is paramount because they’re going to grow more confident with the treatment they’ll be on for longer as they grow older and probably will have less of that false expectation that they’re definitely going to grow out of their eczema and get better over time. Learning early is better preparation for the longer term.

Raj Chovatiya, MD, PhD: Arming yourself with the data is the most important thing. Parents often have more questions that the adults you’re treating. They’ll say, “Give me the numbers. Does this work? What does that mean? Is this safe?” Looking at a few figures published The Lancet in 2022, this was the phase 3 program that looked at individuals 6 months to 6 years. The data at week 16, looking at patients who were clear or almost clear for biologic and nonbiologic, was almost 30% vs about 4%. You’re thinking about multifold more individuals who were treated with the biologic therapy, with the active getting better and a similar rate of adverse events, 60% to 70%. The worrisome adverse effects that you might think about were quite low and consistent with every other trial seen at adolescence, adults, and any other trial program. There’s some value in figuring out how to contextualize those numbers in ways that are easy to understand and that drive home that point. Are there any tricks that you picked up when you were trying to take complicated trial data and make them approachable? As a parent, you’re worried about your kid, and you want to make the best choice.

George Han, MD, PhD: It’s even harder to explain these clinical trial data to other physicians. We have to keep in mind that the point of a clinical trial is to prove the medicine is superior to placebo; that’s it. It’s not meant to say in what cases a treatment is a success. It’s interesting that individuals have taken treatment success in a controlled clinical trial to mean success in treating in real life, because that’s not the case, especially if our measures are a little imperfect.

I see it both ways. If you tell a patient the chance to get almost clear is around 30%, then they’re going to be say, “There’s a 70% chance of my child failing this medicine?” That’s where the real-life experience comes in: almost everybody feels so much better. The time it takes for the skin to clear might lag behind that a little. Occasionally they’ll still be itchy, and you’ll still need to moisturize them, but their quality of life is going to be much better. That’s the tough part when we look at the AD trials. It’s difficult enough to compare trials in something like psoriasis, which is more monomorphic. In AD, they’re all over the place. We need to point that out—it’s much better than placebo—and emphasize that the safety looks very good. It’s important to give them real-world experience of patients having their lives changed by this medicine.

Transcript Edited for Clarity

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