Transcript
Announcer:
This is On the Frontlines of Pediatric Skin Health on ReachMD. Here’s your host, Dr. Brian McDonough.
Dr. McDonough:
You're listening to On the Frontlines of Pediatric Skin Health on ReachMD, and I'm Dr. Brian McDonough. Today, I'm joined by Dr. Mercedes Gonzalez to discuss challenges and opportunities in treating moderate-to-severe atopic dermatitis in pediatric patients. Dr. Gonzalez is a Clinical Assistant Professor at the FIU Herbert Wertheim School of Medicine and the Philip Frost Department of Dermatology at the Miller School of Medicine in Miami. She also serves as the Medical Director at Pediatric Skin Research. Dr. Gonzalez, welcome to the program.
Dr. Gonzalez:
Thank you so much. It's a pleasure to be here with you, Dr. McDonough.
Dr. McDonough:
Well, Dr. Gonzalez, to give us an overview, how would you define moderate-to-severe atopic dermatitis in pediatric patients, and what clinical signs tell you that topicals alone may no longer be enough?
Dr. Gonzalez:
Really, what makes them moderate to severe in my eyes is the inability of optimized topical treatments to induce a prolonged period of remission. So it's really about the length of time they can last with clear skin after having used optimized topical treatment.
And what do I mean by that? Optimized topical treatments means that you choose the right strength potency topical treatment, whether it's a steroid or not. Now, we have lots of non-steroid options that we can choose from. So you choose your right strength cream to get the eczematous lesion and the eczematous dermatitis to 100 percent clear skin. And that's key. You want to make sure you're getting to 100 percent clear smooth skin. Then, you use either a nonsteroidal treatment or a moisturizer as active maintenance in the area of recently cleared skin. And then you observe how long that skin stays clear.
When someone has mild disease, you can get the skin clear, under control, and maintain it clear either with a nonsteroidal treatment or a moisturizer used daily.
You can get it clear and maintain it clear for a meaningful period of time. What does that mean? That varies from patient to patient. But, in general, a meaningful period is months—two or three months where the parent and the family is not having to think about eczema in their daily life. That's a meaningful period of clear skin.
But those patients that, every week, for example, are using their optimized topical treatments and they're clearing the skin, but are having to reach into that drawer again for that medicated, more potent topical treatment to treat a flare, that's where it becomes moderate to severe. It’s that inability to maintain that prolonged clear skin. And so those patients that are going back to it every one to two weeks, that's where we run into moderate to severe.
It's really about that burden of disease and that constant reminder that eczema is present in the family. When you're talking about a pediatric patient with moderate-to-severe disease, it's a disease of the whole family. It's not just that one patient suffering. It's very different than an adult. It's mom, dad, any caregiver, teachers at school—everybody's affected by that child's disease.
And so when you can't get that prolonged period where that eczema is not a part of the daily equation, that's when it's moderate to severe.
Dr. McDonough:
Knowing that, what are the most common challenges families face when relying on topical therapies, particularly in more advanced disease?
Dr. Gonzalez:
The treatment routine itself becomes a burden when it's moderate-to-severe disease, because many times, you need multiple different therapies to achieve and maintain clearance. So you'll usually need stronger potency treatment to clear the flare, and usually, we'll give a different one for the face and a different one for the body. So that's two right there.
And then once that skin clears—you've used a stronger potency one to clear the skin—you have to use something that's less potent and non-steroidal on a daily basis in that previously cleared skin to maintain that spot clear. So that right there is a third treatment that you're having to use on those previously flared areas daily.
And then, in addition to that, you need to use a moisturizer head to toe to seal it in. And in addition to that, you need to make sure you're using gentle cleansers in the bath. So right there, we have about five different treatments that, if you travel, for example, you're going to need to take with you.
In a young child, it requires parent or caregiver assistance for that to happen on a daily basis. And then it's that fear of forgetting. So not only is it the burden of having to do it, you then have the burden of fear, of stress. What if I forget a couple of days? What if I don't do it perfectly a couple of days? My kid's going to flare the next day. So it's a tremendous burden, the treatment routine itself.
And not to mention the cost burden, right? All of these products cost a lot of money, and we’re fighting with insurance companies many times for approval.
So the routine itself becomes a burden. And then, once the child gets a little bit older, they start playing a role in their own care, and that's when it becomes even harder, because kids are very busy. They have many activities, they have school, they want to be a normal kid, and they don't want to have to stop and apply all these treatments. And so, many times, the adherence to the regimen that I prescribe is not done. I would say 100 percent of the time, it's not done 100 percent correctly. I would say that's the case. And so we aim for more than 80 percent adherence. But the adherence, when it's a moderate-to-severe patient is much, much more challenging.
Dr. McDonough:
So when you reach the tipping point, how do you approach the decision to escalate care, and what factors guide your choice of next-line therapy?
Dr. Gonzalez:
We talk about how difficult it is to keep up with, and that I know that it's very difficult to adhere to that treatment regimen 100 percent. I talk about how, if we move to a systemic therapy, they wouldn't have to travel with all those topical treatments. They wouldn't have to worry about missing a day of doing the treatments correctly. I also ask, what are the things that your child may be avoiding or not doing? What are the things that your family is not doing? Are you choosing vacations based on how the child's skin will react? And especially if the child starts in the elementary-school or middle-school age, if they have moderate-to-severe atopic dermatitis that is not adequately treated, they will start choosing different activities based on how their skin's going to react. And parents sometimes are not aware of that.
I do bring that up because, fortunately, now, we have options that work from the inside, so that it doesn't have to be that way. And that's very clearly what I say. Life does not have to be this way. He can be a child without eczema and make decisions not based on his eczema. And so those are the things that I bring up now, that seven years ago when we didn't have these nice, safer, targeted options, maybe weren't part of the conversation. But certainly today, they are.
Dr. McDonough:
For those just tuning in, you're listening to On the Frontlines of Pediatric Skin Health on ReachMD. I'm Dr. Brian McDonough, and I'm speaking with Dr. Mercedes Gonzalez about therapeutic decision-making for children with moderate-to-severe atopic dermatitis.
So, Dr. Gonzalez, with the expansion of systemic and targeted therapies, how is the treatment landscape changing for pediatric patients who don't respond adequately to topicals?
Dr. Gonzalez:
So fortunately, now, we have so many options that are not broad immune suppressants. So if you're under 11 years of age, there is one targeted treatment option. That's dupilumab. It's a targeted IL-4/IL-13 antibody that targets the source of the type II inflammation. If you're 12 years of age and older, there are many more options, including two oral medications and about four biologic targeted treatment options for patients with moderate-to-severe atopic dermatitis.
We're looking forward to the future. There are many ongoing studies that are looking to expand the age indication of those other biologics and oral medications down to younger ages. So in the near-term future, hopefully—I'm thinking several years—we'll have more options, down to two years of age for our patients.
But really, with the availability of these targeted therapies, we're starting them earlier. In my practice, that's what I'm seeing. I'm not waiting until that fourth or fifth visit. I'm doing it either on the first or second visit, where I see the treatment itself has become a burden, where families are making decisions based on the eczema, and where we're unable to get prolonged meaningful periods of clear skin despite optimized topical therapy. That's when I'm introducing the conversation of moving to a systemic agent.
Dr. McDonough:
And with that in mind, how do you balance efficacy, safety, and long-term disease control when considering these newer therapies in children?
Dr. Gonzalez:
So safety is a priority, of course, right? In pediatrics, that's my number one, and parents' number one as well. And fortunately, the targeted biologic therapies that we're now using as first-line systemic agents in these patients have a great safety track record.
And with all the new indications and all the new studies, there are no new safety signals, and that's very reassuring. Dupilumab has the indication down to six months of age in atopic dermatitis, and then down to one year of age in eosinophilic esophagitis, which adds to the number of younger patients having been treated with this medication and showing no new safety signals.
In addition, the way it works is that it's not a broad immunosuppressant. It's a very targeted immune suppressant. And so that's very reassuring as well. And then with the safety profile, there's really no increased risk of serious infections there. It's a small risk. Herpes reactivation, injection site reactions, and conjunctivitis are the main side effects that we discuss. When we discuss safety, it has a nice clean safety profile.
Then it's about long-term disease control and getting eczema out of the equation. We want to take eczema out of the equation of the family and get that child to be a child without moderate-to-severe atopic dermatitis. We want them to be just a regular child, who doesn’t have to worry about using the topical treatments constantly and is able to travel and participate in activities just like any other child.
Dr. McDonough:
Finally, Dr. Gonzalez, looking ahead, what do you see as the biggest opportunity to improve outcomes for children with moderate-to-severe atopic dermatitis?
Dr. Gonzalez:
There's still lots of opportunities in the field. This is a field that's still very young, and when it comes to children specifically, despite the fact that these are great medicines, they are delivered via injections, and that's tough. And I see over and over again, patients who I've started on these injection systemic biologic therapies, and then about six to eight months later, they’re coming in saying, "We just can't do it. Every time it's his time for the injection, it's just a struggle. It's a stress. There's stress leading up to the day of the injection. It's very difficult. We can't do this anymore."
And so parents and families are wanting to stop the medicine that's working so well for the skin and has been highly effective in taking the eczema out of the equation. Now, they want stop because the process has become a problem. And so there's a big need for fewer injections. Medications that can last longer. There are some technologies out there that are going to make the antibody last longer in the system so that it can be delivered less frequently.
In addition, making these medications in oral formulations, I think, would improve adherence and would be able to reach many more patients.
And then I'm also excited for the potential for these medications, if they're started earlier—these targeted biologic medications that are started earlier—to prevent the atopic march. Their ability to prevent asthma, allergic rhinitis, that would really be the holy grail, where we have controlled this disease early on and then prevented the sequalae.
Dr. McDonough:
Those are great comments for us to think on as we come to the end of our program. A big thank you to my guest, Dr. Mercedes Gonzalez, for sharing her insights on when and how to move beyond topical therapies in children with moderate-to-severe atopic dermatitis. Dr. Gonzalez, we appreciate you being here today.
Dr. Gonzalez:
Thank you so much. It was my pleasure.
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