The Latest News in Topicals for Psoriasis

Shiva: My name is Shiva Mozaffarian and joining me today for a topical treatment update is internationally recognized dermatologist, NPF Medical board member, and member of the Board of Directors, Dr. Larry Green from Aesthetic and Dermatology Center in Rockville, MD. Dr. Green has extensive clinical trial experience and overseas a large clinical trial center that performs phase two through phase four trials. As principal investigator, Dr. Green fosters medical innovation through new pharmacological advancements offering his patients access to the latest potential medications, some of which you'll hear about today. Additionally, Dr. Green is a clinical professor of dermatology at George Washington University School of Medicine and received the outstanding Physician of the Year award by the National Psoriasis Foundation for his outstanding achievements and improving psoriatic disease, clinical practice and the lasting impact he's made an improving the quality of life for those living with psoriatic disease.

Welcome, Dr. Green. We're so honored to have you back on again on Psound Bytes. The use of topical therapy remains a key tool for management of psoriasis and is generally the first line of treatment for mild disease and is sometimes used in adjunct therapy in moderate to severe disease. What are some of the traditional choices for topical therapies and in general, how do they work to improve plaque psoriasis?

Dr. Green: So that's a great question. Great way to start. Topical therapies really are the mainstay of psoriasis treatments no matter what kind of psoriasis you have. When you think about it, if you have psoriasis on just one or two areas, which is a three or four, which is mild disease, not much of your body's affected. Or you have psoriasis on a moderate amount, which is maybe 5 or 6 palms of your hand or severe amount, which is more than 10 palms of your hand. Topical therapies have a use. Now these are the people with just a few places in psoriasis we use topical therapies alone. And that's all that they need. There's no reason to give someone a pill or an injection if you just have a few places to treat. Because don't forget, pills or injections go throughout your whole body and even a pill like Tylenol, which we think is the safest in the world, is not the safest in the world. It's always easier and safer to put something just at the site of the action, instead of something that goes through your entire body to get to the site of the action. Now if you have a lot of sites of action then topical therapies don't make sense. That's when we get to the systemic treatments like biologics or some oral therapies that we have for psoriasis. But if you have just a few, that's where topical therapies are good treatment. Now topical treatments though when you think about it can still be used for people with a lot of psoriasis because they can be used in what we call adjunctive therapy and that means that you have a pill or an injection to treat your severe psoriasis because you have psoriasis all over, but when that goes away there's still sometimes a little bit that remains. You're down to like becoming a mild psoriasis person with the use of your severe disease biologic therapy and there topicals can be very useful again. It's sort of like treating mild psoriasis that doesn't have many places that you have psoriasis. So they're useful for all types of people with psoriasis. But they're not so useful if you have a lot by itself. There the psoriasis needs to be brought down to have just a few again with a systemic or biologic therapy or oral pill therapy, and then use the mild therapy. So that's the way we've always thought about topical therapies cause if you're using too much topical treatment, all over your body it's really hard to do and very time consuming and it's hard to get it right every day and put a cream all over these different places. It's much easier to use it on just small, localized areas. So that's the way we think of topical therapy use and the main medicine we use in topical therapies are topical steroids. They've been around for over 70 years to treat psoriasis. Probably before most of you in this podcast were born – so that's how long these medicines have been the mainstay first line treatment for mild, moderate and severe psoriasis (mild by itself, but moderate-to-severe psoriasis in conjunction with an oral or systemic therapy).

Shiva: And what are some of the issues associated with the use of topical corticosteroids?

Dr. Green: So topical steroids have their limitations, and they've evolved over the last 70 years where we have topical steroids that don’t causes many side effects, but steroids still always have side effects. So let's talk a bit about topical steroids. Topical steroids are broad anti-inflammatory agents, just like pill steroids. One of the examples of pill steroids are Prednisone or Prednisolone. They stop everything that the immune system does. Everything is suppressed and pressed down. So that's why people use topical steroids and also stop from getting infections cause their immune system is all pressed down. So you can't mount an immune response to anything that you need it for necessarily in the same way that you normally do. Topical steroids do the same thing on the skin. So if you're using on a few places, they're gonna be just localized. It's going to be just where you put it. It's not gonna have a systemic effect like you have on the body if you use it all over the body. So that's the reason why we don't use topical steroids all over the body because you'll become like taking a Prednisone pill where you suppress your entire immune system. And it doesn't work, can't function as it normally does. But in one or two places, it won't do that systematically, it’ll do it just locally or three or four places. But that said, even on just a few places, if you overuse topical steroids those steroids can stop us from making collagen. They vasoconstrictive the blood vessels in our skin. So we have these effects that if you overuse them or if you miss how you use them. Say you don't get it exactly on your psoriasis, you get around the psoriasis, it gets to go over normal skin. We can have thinning of the skin, stretch marks can develop, dilated blood vessels can develop, or skin can turn white. All these things can happen on the local level too if steroids are not used correctly. That's why it's so important to listen to your dermatologist when they give you instructions on how to use a topical steroid medication, because if you don't use it correctly things like stretch marks, whitening the skin, dilating blood vessels. All that vasoconstriction of the blood vessels that turns the skin white, but you also get these dilated red blood vessels that can be permanent on their skin. All those things can happen. So it's so important with these medications though lifesaving, they work great. But they have to be used very, very specifically and very much you have to follow the rules.

Shiva: So based on your experience as a dermatologist, what challenges do people with psoriasis face when using topical therapies?

Dr. Green: First of all, they're topical and they're not systemic. It's not as easy as taking a pill. So you have to listen to your dermatologist about how to use them. Topical steroids cannot be used on thin skin areas. It can't be used on the face. It can't be used on the groin or under the arms. And on places like the scalp or palms or soles, they barely even work because the skin is so thick, so they definitely have limitations. They don't work so well in certain areas. They work too well and are too dangerous for other areas. You really have to listen to your dermatologist, and dermatologists will tell you or their assistant will tell you use this on this location for psoriasis for this amount of days and use this on another location for psoriasis for this amount of days, don't use it longer than this. It's very important to listen. And I think that's a big, big challenge. Also you wanna make sure that you don't use it on too many places like we mentioned. Because It's hard to put a topical medicine on a lot of psoriasis places all the time. It's hard to be accurate. You have to get it just on the affected areas and you don't wanna get systemic absorption like we talked about before. You don't want those steroids to be throughout the body and do that broad systemic deep depression of the immune system so your immune system can't work normally like what happens when you take steroid pills.

Shiva: So given the significant use of topical therapies to treat psoriasis, would you agree that it's clear that more novel topical treatments utilizing more precise targeting with minimal side effects is needed to help reduce some of the issues you just mentioned?

Dr. Green: Definitely. Topical steroid therapies have evolved over the years. But they’re still not perfect. There's a lot of issues like I just mentioned. One of the first topical steroids that was embedded back in the 1950s was something called Clobetasol and it's a really strong (in my opinion too strong) that works really quick. It's great for psoriasis, but often times you have those side effects -- whitening of the skin, thinning of the skin, stretch marks that occur, things like that when you use Clobetasol. The other thing that sometimes happens is the psoriasis bounces back after you stop using it because it's like sort of like a steroid pill. The immune system in that area is so suppressed for so long with the Clobetasol because it's so strong that the second it gets a chance to bounce back and bring that psoriasis back it will. So you get that bounce back phenomenon. So that is more limitation with topical steroids and that's why we need to evolve further. So then we started combining topical steroids with a medicine like calcipotriene in the 1990s. We took medicines like Clobetasol and made them not quite as strong. So they don't have all that bounce back phenomena like Clobetasol. So it's like medium strong, but not too strong. And then we combine it with calcipotriene in 1990s, which makes it even safer to use for a longer period of time and limits the side effects of stretch marks that's in the skin and whiteness of the skin. So we found ways to make topical steroids more palatable. We also combined with tazarotene which is the Retin A type cream. The retinoids, Retin A type creams help lessen the thinning of the skin that occur with topical steroids even better than calcipotriene. We still have limitations on when and where to use them. We still can't use them on the face. It has to be very careful in the groin. They can sometimes burn in these areas. So still it's not so easy. We made it easier, but it's not so easy to use these topical steroid therapies. You really have to listen to your dermatologist still to this day. So there's still a need, I think. When we had biologics come out to treat moderate-to-severe psoriasis about 20-25 years ago. And before that, we're using medicines like methotrexate and cyclosporine and light box therapy with PUVA which no one does anymore because it causes too much skin cancer. That's all we had. And they were sort of like topical steroids in a way. They were broad suppressors of the immune system, and they had potential side effects. And then biologics came which are narrow spectrum, immune modulators that suppress immune system just where it needs to be suppressed because it's overexpressed in psoriasis, but the rest of the immune system is unharmed or unaffected. We don't really have that for topical psoriasis until recently. We'll talk about this in a few minutes. But we just had the broad-spectrum medicines for topicals, like the topical steroids that suppress broadly the immune system like we had back in the 20th century until the biologics came out. The biologics gave us that narrow suppression or bringing down the immune system just targeted for what's elevated in psoriasis and the rest of the immune system is not affected. That's what we don't have for topicals and that's where there's a major need.

Shiva: That's a great segway into our discussion today. You mentioned the need for topical treatments that are easier to use. Is there anything new like that that we can talk about?

Dr. Green: Yes, there is, and this is, I think, Shiva revolutionary in the treatment of topicals is what's happened this summer of 2022. We have two new medications Tapinarof and Roflumilast that are both FDA approved that are non-steroid topical therapies that I think have the chance to revolutionize the treatment of topical disease with psoriasis just like biologics revolutionized the treatment of moderate to severe disease for psoriasis.

Shiva: So we'll talk about both, but let's start with Tapinarof. How is this cream different from the traditional choices you previously mentioned? Is it more targeted? And how does Tapinarof generally work?

Dr. Green: So it's interesting. Tapinarof is really, really unique. It's what we call an aryl hydrocarbon receptor based activator and this is a treatment way that we've never seen before in skin disease. Actually we've never seen before, really, in the treatment of any disease or any condition. It’s a brand-new way of looking at things, in a brand-new way of treatment that that's very, very novel. It was actually discovered in veterinary medicine and the veterinarians saw that this medication helped, maybe antimicrobial and helped reduce inflammation. But it's known to be a homeostatic balancing medicine. In other words, it's not a broad-spectrum anti-inflammatory, but it is broad spectrum in terms of helping the body get back into normalcy. So it doesn't do anything extreme. It just helps the body get back into normalcy into what we call homeostatic balance, which is bringing everything back together in an even fashion so everything in the function of the body are normalized. That's the way Tapinarof works. So it's a cream, it's not a steroid. It brings things into homeostasis. Brings things back in the balance. So if you have something like psoriasis, it's out of balance on the skin, it helps bring it down and make it go away. And that's the way Tapinarof works. So the nice thing about this cream, because it's not a steroid and it's once a day. You can use it anywhere on the body for as long as you need til your psoriasis is completely clear. And that's very simple instructions, but you don't have to worry about getting confused from your doctor's instructions where you can use it? How long you can use it? Use for this amount of time Use it on only on this area. Tapinarof can be used anywhere from head to toe. Once a day til your psoriasis is clear. It does not cause any of the steroid side effects that we mentioned. Thinning of the skin. Dilated blood vessels will occur, whitening of the skin because it's not a steroid. It's just something that brings your body where it's applied back into balance. So I think it's in a way that's revolutionary. You never had anything like that. Certainly nothing with this mechanism of action, but nothing to reduce inflammation of psoriasis bringing it back into balance before. Never had this before, nothing like this. So I think it is in a way revolutionary.

Shiva: So you talked a little bit about where Tapinarof can be used, but what's the dosage?

Dr. Green: So Tapinarof comes in a tube, it's a cream. And like any cream, though, I still don't recommend putting it on everywhere on your body. It's just like with topical steroids. You're not gonna do it right. So I would limit to people with not that many places with psoriasis to treat. It's not replacement for biologics or systemic therapy or oral therapy. Small amounts of psoriasis or people who use biologics, have small amounts of psoriasis left, use Tapinarof anywhere on their body once a day til it's clear. if you don't think your psoriasis is clear, it's OK to keep using this stock. It's not gonna harm you like topical steroids would harm you. One thing though that's interesting Shiva, they noticed about Tapinarof that after you stop using it. Say your psoriasis clears up. You clear up your psoriasis on a certain area and then you stop using it. Psoriasis can stay away for a number of months. So that's the opposite of what we saw remember, I talked back to Clobetasol where you have that bounce back phenomenon and it's too strong. This is quite the opposite. It actually you don't have to treat your psoriasis for a few months. It doesn't come back that quickly. With the use of Tapinarof even if you have to stop using it somehow keeps the body balanced so that psoriasis stays away.

Shiva: Dr. Green, can you talk to us a little bit about the clinical trial results? How effective is Tapinarof?

Dr. Green: It's a good question. It's hard to compare clinical trial results to another medicine when it was the only studied by itself. So in other words, clinical trial results show Tapinarof is safe to use on patients 18 or over, anywhere on the body. On the eyelid, on their hand, palms, on their elbows, on their groin, anywhere on the body. The only place that may be a little difficult still is the scalp because it is a cream. So I have no information on that, but everywhere else it can be used. In the clinical trial it showed that if you use it every day, the psoriasis, so a large percent of patients, 40-45% of patients, after just a number of weeks, have the psoriasis clear, almost clear. But the clinical trial results did show that unique remittive effect that when you stop using it, the psoriasis stays away in that spot where you used it for a number of months. But I can't compare it to topical steroids because it wasn't studied against topical steroids. So it's hard to say does it work the same, as quick as Clobetasol. I can't answer that question, but I can say it doesn't have that bounce back phenomenon.

Shiva: So let's switch to Roflumilast which is a topical PDE 4 inhibitor. How does Roflumilast differ from Tapinarof and the other topicals you previously mentioned?

Dr. Green: So Roflumilast I think is another revolutionary medicine to treat people with mild psoriasis or severe psoriasis who take biologics and just have mild psoriasis left on a few places. Roflumilast is a PDE4 inhibitor. What does that mean? I don't know if anyone listening to this podcast has heard of the pill called Apremilast. Apremilast is another PDE4 inhibitor we use in a pill form. So this is a mechanism of action that's not unique to us. We're familiar with it, but Roflumilast is actually much more potent than Apremilast. And this medicine, we just use it topically. We don't want to put all over the body, just like Tapinarof, just like any topical steroid just meant for mild disease or severe disease who has just a few places left in sort of like mild disease cause your using a biologic. It's a once-a-day product just like Tapinarof and you can put it anywhere on the body, head to toe. Again, cream is not so easy to put on the scalp, but you put on your eye lids, you can put on your palms, you can put on your soles. You can put it on the elbows, knees, groin. Any place you have psoriasis once a day til you're clear. Same instructions as Tapinarof. But it's a mechanism of action we're familiar with the PDE4 mechanism of action like Apremilast, the pill version. And that's a nice mechanism of action because it's not a broad-spectrum sort of immunosuppressive agent like steroids. It's very targeted immunosuppression sort of like a biologic does to suppress the part of the immune system that's overactive in psoriasis. So we have a targeted therapy in a pill with Apremilast. Now we have it in a cream where it's much more potent, but it's being used as a cream not as a pill. So we wanna make sure the place you're using it is much more potent. So they work very differently, but both Roflumilast and Tapinarof have the same instructions once a day on every area you wanna apply it til you're clear. Any place on the body. It couldn't be much simpler and that's why I really think both of these medicines are so revolutionary compared to what we have before the summer of 2022, where it's complex and you have to listen to what your dermatologist says. It's much simpler now.

Shiva: And how effective is Roflumilast? What did the clinical trial results indicate?

Dr. Green: So just like with Tapinarof, it's hard to say how effective it is because in the clinical trials it wasn't compared to like a Clobetasol cream. But I can tell you in just a number of weeks there are large amount of patients who are clear, almost clear after using Roflumilast anywhere on the body. Every single place head to toe. So just like Tapinarof it was very effective. How effective compared to current topical steroids I can't answer til we do head to heads trials which have not been done yet. But these products work. And they work and people have been very happy using them alone. And in my mind, there's no reason to use them with anything else, like a topical steroid to say work well enough on their own.

Shiva: So in addition to clearing the skin, roflumilast also improved the severity of itch, one of the more common symptoms of psoriasis. Can you tell us a little bit about those results?

Dr. Green: Yes, Roflumilast definitely improved itch very early on and people have used it in the clinical trials. And actually Tapinarof did also. But Roflumilast has data that shows the itch in just the first few weeks itch of the spots significantly reduced. But I don't wanna take away from Tapinarof, both reduce itch very well, both reduce all the signs and symptoms of psoriasis well.

Shiva: And are there any adverse effects or cautions when using either of these topicals?

Dr. Green: So nothing is perfect. There are potential adverse events and I'll mention them quickly, but believe me, these are nothing like the risks of using topical steroids or tacrolimus which we didn't mention that's a medicine we use off label to treat psoriasis on the face and ears because there was nothing FDA approved. So let's start with Tapinarof. Very rarely and uncommonly people who use Tapinarof can get an irritation in the hair follicles that’s called a folliculitis reaction. It's not a folliculitis like your hair follicles are infected or anything like that. It's just an irritation folliculitis. This can go away, but sometimes the hair follicles get a little on edge, and they have little scaly and a little red. That usually just goes away on its own. Sometimes you can use a topical steroid for a few days to treat it, but it's not a big deal. Roflumilast doesn't have that side effect at all. But with Roflumilast what was noticed is if you use too much of it, it can be like taking the pill version which is Apremilast, but it's a higher dose and you can get symptoms like nausea and diarrhea. And that was seen in a few people who just use a small amount of Roflumilast, but very, very unusual. So the larger percent body surface area you use it on, the more likely this to happen with Roflumilast. So the take home message with Roflumilast, it's true for any topical don't use on too many places. Because you don't want to use Roflumilast on too many places at once anyway, so you shouldn't have to worry about that potential adverse event.

Shiva: Earlier you addressed some of the challenges associated with topicals. How has delivery of the latest topicals changed to meet those needs?

Dr. Green: Wow. So, I think these are revolutionary. It's changed the paradigm the way that we treat psoriasis probably completely. Before the summer of 2022 I would prescribe topical steroids, and I would say OK, here's tacrolimus, use it on the face and ears once a day, five days maximum, and you can't use it again for a few more weeks. If it comes back, sometimes you can use it twice a week for maintenance. Here's calcipotriene betamethasone, use it on your elbows and you can’t use it on the groin. The maximum you can use it is two or three weeks. On the palms maybe for four weeks, but then you have to stop. Sometimes you can use it twice a week for maintenance, but it depends on how the psoriasis looks. So that was my conversation with patients. Summer of 2022 comes I say to my patients, here’s a cream, use it once a day til your psoriasis clears wherever you have psoriasis. Don’t worry about anything else. To me, that changes everything and how things are much simpler and much easier for our patients with these two medications.

Shiva: Thank you, Dr. Green, for talking to us about these topicals and for being here today. Do you have any final comments you'd like to share with our listeners?

Dr. Green: Yes, thank you for asking Shiva. I think it's so important that everyone talk to their dermatologist about treatment, about topicals, about what's best for them and make decisions with your dermatologist and find what's gonna work best for you. And we talked about it, these two new revolutionary medications. Talk to your dermatologist about them, but maybe your dermatologist has other ideas. Maybe you have too much body surface to use them as a primary therapy. Maybe they need to be as adjunctive therapy with other conditions. But the bottom line is I think it’s so important to partner with the dermatologist to make decisions and work together to make sure your psoriasis does not control your life at all. You control your psoriasis and you don't have to think about it. And that's what some of these new therapies give us the opportunity to do.

Shiva: Thank you Dr. Green, for providing such an amazing update on the latest developments in topical therapies. It's so nice to see new topical options available for treating psoriasis. If you're searching for more information about treating your psoriasis inside and out, contact our patient navigation center by calling 800-723-9166, option one or by emailing education at psoriasis.org. And finally thank you to our sponsors who provided support on behalf of this Psound Bytes episode through unrestricted educational grants Amgen, AbbVie, Bristol Myers Squibb and Janssen.

The Latest News in Topicals for Psoriasis

Psound Bytes™ Transcript: Episode 181

Release date: November 29, 2022

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