Video
Dupilumab for Atopic Dermatitis: Safety & Efficacy Explored
Author(s):
Reactions to the efficacy and safety of dupilumab treatment for atopic dermatitis as demonstrated by clinical trial data and real-world experience.
Melodie Young, MSN, RN, ANP-C [Mindful Dermatology and Modern Research Associates Dallas, Texas]: Could either of you speak to side effects or warnings that you would give patients as far as expectations, safety, and efficacy for the short-term and the long-term? Speak to some of the experiences your patients have enjoyed about this medication. As you said, after they see what it can do, suddenly they're on-board and have become a billboard for you and how you've helped them with this medication.
Susan Tofte, DNP, MS, FNP-C [Oregon Health & Science University, Portland, Oregon]: I did clinical trials with dupilumab and we had patients in our trials with conjunctivitis, and that is on the package insert as a possibility. We did refer our patients to ophthalmology. There really were no long-lasting effects. One of my patients who's on this drug in my regular clinic has lifelong AD (atopic dermatitis) and has conjunctivitis from it, and she says that there is no way she is going to go off this drug because she's not itchy. I don't think any of us can underestimate the improvement in quality-of-life issues around lack of sleep because of this drug, involving waking up, sleep disruption, some itching and scratching. This drug is a huge game changer for patients with severe disease that are chronically rubbing, scratching, experiencing sleep disruption, and all of that. Her eyes may have a little bit of conjunctivitis, but she's managed to see an ophthalmologist, and she is so much happier. I've heard patients say that their skin is peaceful for the first time in their life. They’re not a 100% clear, but they're also not itching. That's been probably the biggest, best thing about this drug. Other than conjunctivitis, pretty isolated injection site reactions are what I've seen.
Douglas DiRuggiero, DMSc, PA-C [Skin Cancer and Cosmetic Dermatology Center, Rome, Georgia]: Conjunctivitis is the largest one that's talked about with this treatment. I think the caveat to all of this is that we don’t see as many serotypes to the actual chronic inflammation of the orbit itself, which can be a very serious illness. Inflammation of the palpebral fissure and those areas can be managed and usually gets better with time. The reason that we counsel our patients towards this medication is because we now know that this is a systemic disease. Even when a patient perceives that they're not flared and that their disease is under good control, we can biopsy normal-appearing skin on an atopic patient and still see that there's evidence of atopic dermatitis cytokines; that there are inflammatory cytokines in that scan; that the skin is not normal even though it looks normal.
You can do biopsies of the lesions of AD and compare it to the areas that look normal; you can see that the areas that we think are normal are still inflamed and still ready to erupt. The key is breaking this mindset that's been here for a couple of decades of just treating when it flares, and instead, realizing that this needs to be treated on an ongoing basis, and that's what these medications do. Based on adult data, 50% or more patients say that every day they worry about when their next flare-up is going to happen, if they're controlled. Patients with moderate atopic dermatitis average between 8 to 10 significant flares a year. Patients with severe atopic dermatitis, between 11 to 15 significant flares in a year. That's one a month or more. When we put them on these systemic medications and get them down to no flares or 1 or 2 mild flares, they sleep at night; they go out, and they change the clothes they wear, they go for job interviews that they wouldn't have gone for before—they do all of these things because they feel confident and they feel like they're not always worried about what's going to happen on Monday morning. I look clear now on Friday, but will I erupt over the weekend? That's just a great way to make us look like heroes, by having access to these medications and by helping our patients out.
Melodie Young, MSN, RN, ANP-C: Even with the flares, they still are diseased, and they have patches. If they have itches and lichenified areas but then a flare, I would consider those patients with moderate to severe cases. Then the flare just literally takes them over the edge where it's unbearable. They're talking about a quality-of-life change, just the time and energy into putting on so many different topical therapies and doing so much extra skin care. Patients will tell you it's just wonderful to get on dupilumab and not have that sawtooth, up-down, better-bad type of lifestyle—to be able to say that almost every day is predictable, that my skin is going to be quiet. It's going to be comfortable; I'm not going to be miserable. I'm going to sleep. In the clinical trials for dupilumab, 1 out of 4 patients reported this to be a problem before they use the medication. Having the itchy, dry symptom wasn't always found in the same patient. I'm so glad that with so many clinical trials for atopic dermatitis going on that most of them include getting ophthalmic reviews before a patient starts to see if we can't figure this out, and to see what we need to do other than referring to ophthalmology and recommending more rewetting drops and additional artificial tears.
Keri Holyoak, PA-C, MPH: No, I would agree. We don't advise live vaccines in conjunction with dupilumab. I always screen for parasitic infections or for those patients that travel to endemic areas with that being common.
Melodie Young, MSN, RN, ANP-C: Perfect.
Susan Tofte, DNP, MS, FNP-C: Because I'm part of our research team, yesterday I gave an injection to a toddler who's in a trial. I believe it's a dupilumab trial, and it's an injection that takes 3 of us to hold him down. But you know what? The parents are so motivated because his skin is better. He's not waking them up at night and having a less restful sleep. It's going to be hard to give injections to kids. I think that's a given, but I think the parents are willing to do it because their children’s skin is getting better, and it's helping them to grow better when their skin is not so inflamed.
Melodie Young, MSN, RN, ANP-C: Absolutely. A better quality of life for everyone. Not everyone’s experience is the same. Not everyone has an injection site reaction, and they've just come out with a new device to help with self-injection.
Keri Holyoak, PA-C, MPH: I’ll give a little pearl here. In pediatrics, the stomach seems to be the less painful site. If you're having multiple injection site reactions, you've got to get that angle correct. You need to inject at a 45-degree angle.
Melodie Young, MSN, RN, ANP-C: You can use ice before you inject. We've used over-the-counter Lidocaine to try to help under occlusion. We've tried several pearls in people who were hesitant. Most of the time, it's just in the beginning, and then, as they see the disease change and their skin normalize within a couple of weeks, they're convinced.
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Transcript Edited for Clarity
