Addressing Patient Needs in Seborrheic Dermatitis with Novel Therapies - Episode 6
Dermatologists discuss a groundbreaking agent, roflumilast, filling a void in seborrheic dermatitis (SD) treatment. These experts highlight patient-reported response to this novel treatment and their own experiences in clinical trials with this drug.
Linda Stein Gold, MD: That brings us to talking about what is new, and it’s a new world. We have a very viable new option that actually fills the gap of what we’ve been looking for. We have a topical roflumilast foam. Adelaide, can you tell me, what is roflumilast foam, and why should I care?
Adelaide Hebert, MD: Roflumilast foam was compounded because we needed a product that could be successfully used on hair-bearing skin. And we knew that if we gave a regular cream, the acceptance was going to be extraordinarily poor. That just is not going to work. I wouldn’t accept that. I wouldn’t expect my patients to accept it. So with that in mind, and given that we have so few products, as you alluded to, roflumilast foam came of age. And I think it’s going to be a great advance. We’ve all had experience with it as clinical trialists, and I think it was very well accepted by the patients for whom we used it. In terms of the mechanism of action of roflumilast, we know that it’s a PDE4 inhibitor, and it reduces and controls cyclic AMP levels, so they stay normal. And in doing so, they actually reduce inflammatory cytokines. We know that this is an inflammatory skin condition. We’ve all talked about that. Ideally, we can control the inflammation, which will help repair the barrier and make the patient be less uncomfortable, less scaly, and less troubled by the disease state.
Linda Stein Gold, MD: So you mentioned a PDE4 inhibitor, and that’s not a new, novel concept for dermatology. We’ve seen PDE4 inhibitors before in dermatology. Are they all the same?
Adelaide Hebert, MD: No, fortunately, they’re not all the same. And this was a specially formulated agent in that we know it would have greater capability and greater bioavailability in some of the previous PDE4s that we’ve had for atopic dermatitis.
Linda Stein Gold, MD: So it’s interesting. So this is, as you mentioned, it’s a novel, kind of like topical steroids. When we say we have a topical steroid, it doesn’t mean that every topical steroid is the same. We have different formulations. We have different potencies. We have different vehicles. So this is, as you mentioned, topical PDE4. Love the fact that it’s a foam because for the scalp, vehicle matters so much because some people will want an ointment. Some people will say, “Give me something that doesn’t leave any residue.” We have a vehicle that actually is elegant enough to be used potentially on the face, on the scalp, or on the body. So we have a really interesting study where we looked at roflumilast, 0.3% foam formulation, and compared that [with] the vehicle foam. The exciting thing was we looked at this in kids. So, as you mentioned, it happens in kids. We looked at it all the way down to age 9. It’s a once-daily formulation, which is nice because if you give somebody something once a day, it’s a little bit easier to incorporate into your activities. You can put it on when you want to. [Patients] had to have 20% body surface area or less. And we did the head-to-head study, active drug versus vehicle, applying it once daily for 8 weeks. What’s interesting is we looked at patients who had mild, moderate, or severe disease, which is nice because we’re taking all comers, giving them one thing, once a day, that’s not a steroid. I always use the term one-stop shopping. I like to be able to say, “OK, I’m not giving you one thing for your scalp, one thing for your face, one thing that’s a little bit stronger for your body.” Here’s one medication that you can potentially use in any area that’s involved. And what we found was, when we look at the active drug versus the vehicle, we saw actually a statistically significant separation as early as week 2. And that difference continued over the course of 8 weeks. And we found that highly statistically significant, up to about 80% of patients getting to clear or almost clear. You know, you’ve been doing clinical trials for a while. For 80% clear or almost clear, is that something that you’ve seen before?
Neal Bhatia, MD: That’s a very lofty mark to try to replace in any study. I think the bigger testimonial was that when the trial was over, patients did not want to give this up. They wanted to hang on to it no matter what.
Linda Stein Gold, MD: So this is actually very interesting. I wonder if you all see this as well. So, I know if a drug is going to make it out of clinical trials and be something that’s a winner, on the last day, people either forgot their medicine, they lost their medicine, right? Or I would get things back that had been emptied out at home. Sometimes the bottom’s cut out and squeezed, or the foams.
Neal Bhatia, MD: My favorite line was, “I’ll go back and get it.” [That] never happens.
Linda Stein Gold, MD: Never, never. And so that’s how you know this is a medication that potentially does well.
Neal Bhatia, MD: Which boasts your point about 80%. Because, remember, the patients have to fill out surveys also. But the same investigators seeing the same patients, seeing that change not just in the scale, not just the erythema. But again, when you walk in the door and you see how much better they were, that’s your global assessment that says, OK, now we’re getting somewhere.
Linda Stein Gold, MD: Now what was also interesting, and I’m wondering what you all think about this, is clear or almost clear, we always throw this into a basket together, and I’m not saying that clear is not a really wonderful thing, because that means there’s just maybe a little bit of residual, maybe a little bit of pink left, maybe a touch of scale somewhere, but we saw that about 50% or more patients got to completely clear. Does that [resonate], Shawn?
Shawn Kwatra, MD: Totally resonates, because a lot of the therapeutics we have right now don’t get you that close at all.
Linda Stein Gold, MD: Completely clear is completely clear. That is a hugely high bar, especially when we’re looking at patients who came with mild, moderate, and severe. So, James, earlier you were talking about the impact on quality of life, and a lot of these patients are really, really itchy. When we’re looking at the clinical trial data, is that impactful for you? Do you want to know how they did in terms of itch?
James Song, MD: Yeah, absolutely. For all of our clinical trials, we will have a clinician-reported outcome, whether that’s clear or almost clear, and then we’ll have various patient-reported outcomes. And for seborrheic dermatitis, I think absolutely itch reduction is the right patient-reported outcome to be measuring. That’s very clinically relevant. And what we saw from these studies, it worked very quickly, right? And oftentimes it gets even, the itch reduction happens even before the skin clears as well.
Linda Stein Gold, MD: Yeah, and we saw over 60% of patients getting that 4-point reduction of itch. Shawn, I want to ask you to comment on the itch. When we talk about a 4-point reduction of itch, what does that mean?
Shawn Kwatra, MD: That’s clinically meaningful. So, if someone has a 4-point drop, that matters for their overall quality of life. And another thing I’d say about itch is, it’s a check on our eyes, and us making judgments, that someone does or does not need therapy. So I regularly ask folks, how severe is your itch, just 0 to 10? And I can’t tell you the number of times I’ve thought a rash may not look that bad, but then I hear how severe the itch is, and it’s made me be more aggressive with therapy. So that’s a really important metric that I think we can use as a clinical marker of disease severity.
Linda Stein Gold, MD: It’s interesting because I think we all understand when people have a flaky red scalp, they’re probably scratching their scalp and it’s itchy. But I don’t know that we necessarily think about it all the time in all of our seborrheic dermatitis patients. You know, to say how itchy are you and what’s going on with that.
Transcript was AI-generated and edited for clarity.