Importance of Long-Term Data in Plaque Psoriasis

Leon Kircik, MD: I think it’s very important when we consider a treatment option for a chronic inflammatory disease such as atopic dermatitis, psoriasis, or acne, etc…We deal with those a lot in dermatology, but in this case we are focusing on psoriasis to have long-term, not only safety, but also efficacy data. Because we do know that, unfortunately, sometimes patients that are very responsive originally to a drug, the first 6 months or a year, they lose their response to the same drug a year or 2 years later. Now, we really don’t know why that is. Is it because non-compliant patients stop using the drug? Is it because really the drug doesn’t work? But regardless, for one reason or another, it seems to happen. In conditions like this when we don’t have a cure, when people have to use a drug for long term, it’s important to know the long-term safety and efficacy.

And here, with topical roflumilast, I think we have that—not only we have that safety data that puts our minds at ease, unlike topical corticosteroids where we have a limited amount of time to use, we worry about the concerns, we worry that what if the patient is using it on their face, what if the patient is using it in their genital area, what if the patient didn’t tell me about genital psoriasis? It’s ironic. I do want to address genital psoriasis and intertriginous psoriasis since it’s relevant here when it comes to roflumilast, since they do have that in the label. Most of the time, genital psoriasis is quite underdiagnosed and we miss it because patients don’t tell, there is stigma attached to it, they think it might be a venereal disease that they don’t want to discuss with us. But it’s actually psoriasis, and then they use the steroid, and they use it in their genital area, and we don’t even know, sometimes. There were actually some very interesting surveys that showed that 42% of the patients used the steroids in the genital area without letting the doctor know. So, again, the safety of the topical here, roflumilast, becomes very important since there is no limitation or safety concern on the face, the genital area, or other intertriginous area.

A nonsteroidal topical such as roflumilast is going to be very welcome in our new armamentarium for psoriasis treatment. First of all, there’s a big unmet need for topical treatments for psoriasis in the nonsteroidal area. It can be a first-line but it can also be used in combination in our practice with systemic medications, or with other topicals. Sometimes we do need the topical steroids, you need to put that flare out as fast as you can. So, why not use a topical steroid in addition to a topical nonsteroidal? And then we can keep that patient on the topical nonsteroidal. But now, we do have really quite impressive efficacy with roflumilast that there may not be a reason to start the patient with a topical steroid. We may directly go to that topical nonsteroidal that we now have available. But I think the fact that the drug also has intertriginous efficacy history and data, and that is in the label, it makes it quite advantageous for us to start it with topical roflumilast.

In dermatology we do a lot of combination treatments. I say that the drugs are studied as monotherapy to get the drug approved. That’s how the drugs get approved, but when it comes in our hands in clinical treatment, we do use a lot of combinations. I don’t see why not to use it for a patient. For example, if you are using some systemic treatments or biologic, but they have a couple of resistant plaques, why not use an effective topical here such as roflumilast? So, I think the drug can be used as monotherapy, as first-line treatment, but also as a maintenance treatment, as well as a combination treatment with other systemics, or even with other topicals.

Transcript edited for clarity