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Plaque Psoriasis Treatment: Roflumilast Phase III Results


Experts in plaque psoriasis discuss the primary endpoint data responses of roflumilast in the DERMIS-1/DERMIS-2 trials.

Linda Stein Gold, MD: What about the primary end point? Did they reach it, and what happened?

Jennifer Soung, MD: Remember, patients are applying the topical once daily and at week 8, over 40% of patients achieve almost clearness. That was IGA’s [investigator global assessment] success in both studies and you start to see a difference as early as week 2. Something that I remind my patients about is that these topical nonsteroidals work a little more slowly than topical steroids. I say that because I want to make sure that they’re using it. If you’re only going to use it for a week, they may stop too early and then not see the efficacy.

Linda Stein Gold, MD: Jennifer, I agree with you and I like to use the clinical trial data as I explain what the patients should expect. Usually I say, we look at these not in days, but more in weeks and sometimes, in months. But if I say, “week 4,” “week 6,” or “week 8,” they understand. I agree with you that a lot of patients, if they don’t see something the first week, then they’re out. So I say, “You’re going to see something, but it should be a little less flaky and it should be a little less red or thick.” But I agree, you must set appropriate expectations.

Jennifer Soung, MD: It’s so important because some patients might quit too early and then, I’m disappointed because these results are quite impressive. When we look at the IGA specifically at the intertriginous area, we’re looking at 70% of patients having clearer, or almost clear skin after 8 weeks of treatment. That’s really amazing for a topical nonsteroidal. When I think about the treatment options we had in the past, a lot of times I was concerned about possible adverse effects and they were mildly effective and often only effective in areas that had thinner skin where I thought the absorption might be a little bit more.

Linda Stein Gold, MD: I agree with you. The problem in the past is that we’d send our patients away, especially if they have intertriginous disease or facial involvement, sensitive involvement, groin involvement, and half of them don’t tell us that they have these special areas. A lot of us don’t think to say, OK, I need you to undress completely when they come in complaining about their elbows and knees. Yet we know that a high percentage of patients actually do have genital involvement. We know that patients are using whatever we gave them for their elbows and everywhere else. It’s confusing and we want to set them up for success. It’s nice to say, “Here’s 1 medicine that you are safe to use wherever you have plaque psoriasis.” It’s a win-win.

Jennifer Soung, MD: That is huge. Many of our patients are embarrassed because they think that they have a sexually transmitted disease, or some infection, and don’t realize psoriasis can affect all parts of the body.

Linda Stein Gold, MD: Absolutely.

Jennifer Soung, MD: Something else that my patients find distressing is the itch. A lot of times when we think that psoriasis is not as itchy when we compare it with atopic dermatitis, but certainly, that is the primary complaint that our patients with plaque psoriasis have.

Linda Stein Gold, MD: I agree with you. We expect our atopic patients to be itching like mad, but it’s our patients with psoriasis too. Studies have shown that they hate the scaliness, and they hate the way it looks. That’s a given, but they also hate the way it makes them feel, and the itching can be unbearable.

Transcript edited for clarity

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