Disease-modifying therapy for atopic dermatitis and unmet therapeutic needs

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Peter Lio, MD: Shannon is quietly waiting to tell us about the first true systemic therapy in the United States approved by the FDA for the treatment of moderate to severe atopic dermatitis that could modify the disease. Shannon, can you tell us a bit more about dupilumab and some of the other biologics that are hopefully coming out very soon that we’re seeing for atopic dermatitis?

Shannon M. Rotolo, PharmD, BCPS: Yes. Dupilumab is the FDA approved reference in this category. Jamie [McConaha] mentioned earlier in his discussion of the mechanism or pathoimmunology of the disease that IL-4 and IL-13 were 2 critical components. Dupilumab targets both, which is ideal for this condition. There is an approved dosage up to the age of 6 years and up to 15 kg, but the dosage is based on both age and weight for our pediatric and adolescent patients with the final adult dose being one dose. single load of 600 mg followed by a dose of 300 mg every 2 weeks.

This dosing regimen is both a potential benefit and a disadvantage. Every 2 weeks is certainly more convenient than some daily therapies, but it can be much more difficult in terms of patient adherence. An important tip that I always give people is to put a reminder in your phone or circle a calendar, as this schedule can be difficult. For people who are able to find a way that works for them to commit to this timeline, there are definitely benefits in terms of membership. We discussed the benefit of being very focused on what we’re trying to look for in this total stunt.

Some other considerations with this drug, as we mentioned earlier, are cost or access, which can definitely be a consideration. I know we’ll get to that later. It is a refrigerated medicine, so it is essential to ensure that patients have stable housing or some other way to store this medicine. This can be a disadvantage compared to other options. It takes a bit of training to make patients feel comfortable with injections. In our pediatric population, needle phobia can be a concern, and in adults as well. We’ve seen that during this pandemic when it comes to vaccinations and things like that. It has given us all a renewed awareness of the amount of needle phobia that we also see in adults.

Disposal of the drug can also be a concern. It is important to ensure that patients have a sharps container, so that they have a safe place to throw it away. In terms of side effects, for some patients this has a much more favorable side effect profile. Jamie earlier discussed some of the side effects we see with certain systemic therapies. In comparison, dupilumab, although it has its own side effects, avoids many of those others that we would be concerned about with some of the oral medications. With any injection, especially with dupilumab, we are concerned about the reaction at the injection site, both with the formulation of this drug and its large volume for a subcutaneous drug. I certainly hear a lot of patients say that they have a small swollen spot or that they have redness, irritation, swelling, or pain at the site of the injection.

Another 1 that I like to point out to patients is eye side effects; these can be limiting. About 10% of patients experience side effects related to their eyes. Sometimes it’s as easy as dry eyes, and all he’ll need is some rewet drops. I always prefer to have an ophthalmologist or the patient’s regular ophthalmologist to assess it so that I don’t miss anything more serious. These are the big takeaways for me with dupilumab in terms of where it fits in therapy and when we could potentially use it.

Peter Lio, MD: It was fantastic. Thank you. I like every point you made. I also like that point — I haven’t heard people discuss it, but because it’s a refrigerated drug, you need to make sure they have a stable family situation. For some patients, this is not an option. There are setbacks but also advantages. For the right patient, this can be a very good choice, especially when we think of the alternative. Sometimes we have a patient for whom we are trying to find the best team and the best team. If it’s a multi-specialty team, they say, “We don’t know about this dupilumab; this is new. ”I’m going to say,“ What about cyclosporine? ”Then everyone quickly changes their tune and says,“ OK, dupilumab sounds good. ”That’s fantastic. Thank you.

Shannon M. Rotolo, PharmD, BCPS: Absoutely. I haven’t talked about it yet, but there is off-label use of omalizumab, or Xolair, which isn’t necessarily commonly used off-label, but it does happen. Pharmacists who are listening, if you see that, this is something that we only have in the United States: the FDA labeling for chronic idiopathic urticaria, asthma, and more recently as well. for nasal polyps. This medicine is sometimes used in other countries. It has been examined in the ADAPT trial for children 4 to 19 years old, with results similar to those seen in other disease states and dosing based on IgE and weight. But it is not commonly used in the United States.

Peter Lio, MD: Thank you. This is a great look at some of the things we have that are commonly used for atopic dermatitis. I will summarize by saying that we still have some way to go.

An estimated 2 million patients are still moderate to severe, uncontrolled in the United States alone, and we know we are not meeting all of their needs. Everything from milder medications, which have fewer side effects, for worried or problematic patients, to things that are potentially given by mouth instead of injections for those who might have needle phobia, up to different topical agents. As we’ve seen, we only have a few categories, and it might not meet everyone’s needs. We don’t even have anything for the itchy rash of atopic dermatitis, so the itchy rash is this whole unexplored frontier of potential and we have a lot of itchy patients. While it seems like a lot is happening – I’m thankful that there is – there is finally development and movement. But we still have a long way to go.

This transcript has been edited for clarity.


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