Review of Current and Novel Treatment Pathways to Manage Plaque Psoriasis - Episode 9
Drs Kircik and Stein Gold address roflumilast and tapinarof as new topical agents for the management of plaque psoriasis.
Linda F. Stein Gold, MD: Let’s talk about what’s new in psoriasis. There’s been an explosion of new treatment options in the topical, biologic, and oral arenas. Let’s give some background on what we can expect in the near future. The good news is that we have some new topical drugs that aren’t steroids, and they work. Leon, I’m going to throw this over to you. Can you talk to us about roflumilast? What is it? Is it what we’ve seen before? Or is it something a little different?
Leon H. Kircik, MD:Absolutely. It’s an exciting time to be a dermatologist, especially when it comes to topical treatments for psoriasis and AD [atopic dermatitis]. Roflumilast is 1 that’s quite versatile. It’s a PD4 inhibitor, but it’s not your grandfather’s PD4 inhibitor. It’s 250 to 300 times more powerful than what we have on the market. We do have the psoriasis studies DERMIS-1 and DERMIS-2. If I remember correctly, the IGA [Investigator’s Global Assessment] success rate is around 40%. One study is about 38%; the other is 42%. Let’s say 40% IGA PASI 75 [75% reduction in the Psoriasis Area and Severity Index] is close to that. It reminds me of the PASI 75 from 20 years ago. It’s very exciting to have a topical that has a high PASI 75, a high IGA that works really well. In addition, it’s the only topical that that has good data on intertriginous psoriasis. We’re in big need of something that works for intertriginous psoriasis. As you know, we’re always concerned about using topical steroids. We cannot use in those areas. We have good data on intertriginous psoriasis. Those 2 treatments, roflumilast and tapinarof, are going to revolutionize topical treatment of psoriasis.
Linda F. Stein Gold, MD: Let’s talk more about roflumilast. Mark, at [Icahn School of Medicine at] Mount Sinai, you’ve done some work looking at topical PD4s in sensitive areas and inverse psoriasis. Do you think roflumilast is going to make a big difference?
Mark Lebwohl, MD:Yes, a major difference. First, as Leon said, it’s equivalent in efficacy to potent topical steroids, but it has no steroid adverse effects, does not cause stretch marks, and does not cause atrophy. In exactly the areas we get in trouble with, steroids, you can use this harmlessly on the face and groin long term without worrying about it.
Linda F. Stein Gold, MD: Great. Jerry, when we look at the roflumilast efficacy and safety, we see a signal for headache and diarrhea. Do you feel like there might be a little systemic absorption?
Jerry Bagel, MD, MS:Yes, especially if we’re using it in larger body surface areas, but we shouldn’t. Topical treatment has its place, but I don’t believe in large surface areas. If we keep it localized, under 10% body surface area, maybe under 5% body surface area, we shouldn’t have much of a problem.
Linda F. Stein Gold, MD: We know that taking it orally doesn’t make that much of a difference. Some have a headache or diarrhea. We know that apremilast, even though this is a potent drug, is a perfectly safe drug systemically.
Mark Lebwohl, MD:Just to put it in perspective, we’re not seeing the diarrhea that you’re seeing with apremilast. It’s much less. It’s not a big issue. Unlike roflumilast, which results in diarrhea in a lot of patients that then it goes away once you stop the cream.
Linda F. Stein Gold, MD: Mark, are you comfortable using this on larger body surface areas?
Mark Lebwohl, MD:It will be somewhat cost prohibitive on larger body surface areas, but, I wouldn’t hesitate to use it on larger body surface areas.
Linda F. Stein Gold, MD: It’s great for a nonsteroidal option. This is revolutionary. Leon, you mentioned tapinarof. It’s not mechanism of action but also not a steroid. Talk to us about this 1.
Leon H. Kircik, MD:This is another exciting drug that’s also being tested, not only in psoriasis but also for atopic dermatitis. We already have the results for psoriasis studies. They’re very exciting. They’re similar or better than the PASI 75 results 20 years ago. That cracks me up—what we had and where we came in 20 years with topicals. It’s a whole new mechanism of action. It’s very exciting. There’s minimal adverse-effect profile. Folliculitis is the only 1 that has a signal. I always say, we’re in the business of dermatology. We know how to treat folliculitis. It’s not a big whoop. We know what to do with it. It’s not something I have to worry about or refer outside. This is another topical that’s going to make a big difference in the treatment of psoriasis. It’s not a steroid, which we yearn for. That’s a big unmet need.
Linda F. Stein Gold, MD: Thanks. Mark, we saw with this drug that some patients were able to get to completely clear skin and then had a drug holiday that lasted about 4 months. Does that mean anything?
Mark Lebwohl, MD:Yes, very much. In their trial, if anyone cleared completely, they just stopped the drug. Then they followed them, and they stayed clear for months. If I remember correctly, the duration of remission was 115 days on average. That’s extraordinary. It’s almost 4 months off therapy with nothing coming back. For patients who achieved clear or almost clear—not the ones who were completely clear, but almost clear—they kept them on the treatment. They perfectly maintained the amount of remission they had achieved for months after while maintained on the drug. With topical steroids, we can’t do that. If you use an atopical steroid chronically, and patients end up with stretch marks and other adverse effects that we don’t want to see. When I write an atopical steroid prescription, I write, “Apply twice daily for 2 or 4 weeks and then twice a week.” Now we can write, "Supply twice daily as needed.” That’s what we’re going to be seeing with these drugs.
Leon H. Kircik, MD:I had patients on that trial who were clear 5 months after both treatments.
Linda F. Stein Gold, MD: As did I. For these nonsteroidals, it’s great to simplify the regimen. Here’s a medicine you can use on your face. You can use it on the skin fold, you can use it on the hands, feet, elbows, or knees. This will make a major difference for our patients.
Thank you, Mark, Jerry, and Leon, for this rich and informative discussion. Thank you for watching this HCPLive® Peer Exchange. If you enjoyed the content, please subscribe to our e-newsletters to receive upcoming Peer Exchanges and other great content right in your in-box.
This transcript has been edited for clarity.