It's been one year since NEA, in collaboration with four peer patient advocacy organizations, hosted the landmark patient-focused drug development (PFDD) meeting dedicated to eczema.
Published On: Jul 6, 2017
Last Updated On: Jul 6, 2017
In March, the U.S. Food and Drug Administration (FDA) approved Dupixent (dupilumab), the first biologic medication for adults with moderate to severe atopic dermatitis (AD). Unlike topical or oral medications, biologics are made from proteins derived from human DNA and administered subcutaneously. They work to curb the immune system’s over-reaction that results in inflammatory skin diseases such as atopic dermatitis. In clinical trials, Dupixent was shown to reduce symptoms of AD such as itching, redness, lichenification (thickened skin), swelling and scratched skin. Clinical research investigator Dr. Paul Yamauchi answered questions about Dupixent in a recent NEA webinar. Please note that portions of this Q&A have been edited for clarity and brevity.
There is no drug that works for everyone. There are people who don’t respond to certain medications. It’s hard because there are other things going on in their system. They might have other kinds of proteins that are being produced that the drugs do not target. Doctors would need a blood test or a skin test to predict which drug would be appropriate for you. But I would say the majority of patients did get a response with Dupixent, and many experienced an improved quality of life.
I’m not sure the exact statistic of that question. But I would say a low percent had absolutely no response to it. With any biologic, there are always patients who do not get any kind of response. The other possibility is that clinical trials are not perfect. An investigator might have misdiagnosed atopic dermatitis for psoriasis or something else, and that’s why there was no benefit. There’s always a possibility that they were misdiagnosed during the clinical trial.
Even if your skin is clear, you should keep doing your shots. It’s a situation similar to taking insulin for diabetes. If your blood sugar is under control, would you stop your insulin? Absolutely not. You’d still take your insulin. It’s not recommended to stop and restart biologics. You might build an antibody against the biologic agent, and it would stop working. So if you don’t want it to stop working, you’ve got to do it continuously and not be haphazard with your dosing. And don’t worry about using it continuously because it’s going to be proven that long-term use is safe as we get more data.
Fortunately, no. Unlike steroids or cyclosporine, if you stop those abruptly, there’s a rebound effect where the disease comes back with a vengeance. With biologics, it comes back in a slow manner. With some biologics, it takes about half a year to lose some of your response, so it is maintained. But again, just because you’re clear doesn’t mean that you should stop it.
There are several biologics that are approved for pediatric conditions like rheumatoid arthritis for as young as 2 years of age. You have to weigh the risks and benefits. If your child is miserable from their atopic dermatitis and you don’t want to use methotrexate or you don’t want to use prednisone, and you don’t want to constantly slather them with topical steroids, then the safest thing is to do something that is more targeted. And that’s a drug like Dupixent. They are doing a pediatric trial with Dupixent. We know from the adult trials that it had a pretty clean safety profile, and so we anticipate the same from the pediatric trial.
Dr. Paul Yamauchi is clinical assistant professor of dermatology at David Geffen School of Medicine at University of California, Los Angeles as well as adjunct associate professor at John Wayne Cancer Institute and a dermatologist at the Dermatology Institute & Skin Care Center in Santa Monica, California.