Linda Stein Gold, MD, and Jennifer Soung, MD, provides an overview of the safety profile and topical vehicle of roflumilast for the treatment of plaque psoriasis.
LindaStein Gold, MD: One thing that we touched on is the adverse effect profile. Is this something that we worry about any systemic absorption? Do we worry about systemic side effects? You mentioned that this drug is significantly more potent than what we found in the past. We know that the side effect profile is not much different than the vehicle itself. A few things that we think about with a PD-4 inhibitor, like headaches, diarrhea, but these were mild and generally resolved with time and people were not dropping out because of systemic adverse effects. What is more important is the tolerability issue. We know that we have a topical ointment that we use twice a day for atopic dermatitis. Now, we have a topical cream that we use once a day for psoriasis, yet the side effect profile in terms of tolerability were really well tolerated. In my experience, we have this drug available so that we can write a prescription for it, but also to use it in clinical trials. I didn't have anybody who had a tolerability stinger burning. What about in your practice?
Jennifer Soung, MD: I was so impressed and I'm happy that you brought up the vehicle because it is a very elegant formulation and feels nice. I'm impressed at how it also hydrates the skin as well. It's important to choose a topical that your patients like the way it feels. Otherwise, they're not going to use it. That's one important key point in feature of topical roflumilast. I even tried it on my own skin just to see what it feels like. I always like to see what it feels like for my patients. When you refer to safety, what's so amazing about this drug, because we're familiar with the mechanism of action, is that roflumilast is already approved as an oral, so it has a well-established safety profile. We know what to expect if you were taking oral. We see a little bit of diarrhea, because with any topical, you can get a little bit of systemic absorption, but we already know that. You can see that the overall rates were very low.
LindaStein Gold, MD: That's the good news. Now, they did a year-long study, and the good news was that there were no new safety signals that came about that were not already identified in the phase 3, 8-week-long studies. Now, the good news is that this drug is currently undergoing clinical trials with a different vehicle, and in this case, it's a foam formulation. Jennifer, I know that we have both looked at this in clinical trials. Can you talk a little bit about its use especially for scalp psoriasis as well as for the body with the foam formulation?
Jennifer Soung, MD: It's going to be so amazing to have a nonsteroid option for the scalp. What impressed me so much in the scalp study that I saw firsthand in my patients was that it was able to penetrate those thick micaceous skin, especially in those patients who had bad plaque psoriasis of the scalp. A lot of times, for a nonsteroid topical, I don't expect it to work. I'm using a keratolytic, lots of shampoos to get rid of the scales so that my high-potency steroid will work. In this situation, I was impressed that the foam formulation was absorbed and had very impressive results for the patients.
LindaStein Gold, MD: I agree with you. When you look at treatments, algorithms from the past, they talk about scalp psoriasis and there's like 15 steps to debris that scalp of the scale in order to start your medication. Now, we have a topical that you can just put on and they did study it in more moderate and severe patients, and we saw good results. We saw up to almost 60% of patients getting to clear, or almost clear, on the scalp and there was really nice itch data. When we talk about itch with the scalp, the scalp keratinizes. You see people sitting there scratching, and their psoriasis is just getting worse and worse. Getting that itch under control is really important. In terms of safety, are there any safety signals that we need to worry about with the foam at this point?
Jennifer Soung, MD: There are no new safety signals. It’s nice to see even in a different formulation where we expect foam to absorb more and there is great tolerability.
LindaStein Gold, MD: That's great. We should expect to see that FDA-approved in the near future.
Transcript edited for clarity