April Armstrong  00:08

We know that psoriasis is a chronic disease and therefore having an option that only not only acts fast and acts deeply, but also has the mileage really to, to keep our patients keep their disease controlled is very important in the long run.

Gregg Masters  00:27

Welcome, everyone. I’m Gregg Masters, Managing Director of Health Innovation Media and the producer, co-host of the AMCP Podcast Series, Powered by PopHealth Week. This episode is sponsored by UCB pharmaceuticals. Joining me in the virtual studio is my partner, colleague and co-host Fred Goldstein, President of Accountable Health, LLC. On today’s show, our guest is Dr. April Armstrong. And with that brief introduction, Fred, over to you,

Fred Goldstein  00:58

thank you so much, Gregg and Dr. Armstrong, welcome to the AMCP Podcast powered by PopHealth Week.

April Armstrong  01:03

Thank you for having me.

Fred Goldstein  01:05

It’s really a pleasure. I’m looking forward to this conversation. Before we begin for our audience, could you provide us with some of your background expertise?

April Armstrong  01:11

Absolutely, Fred. So I am and general dermatologists with a focus on inflammatory skin diseases, and those include psoriasis and atopic dermatitis. Mainly, I also treat patients with hidradenitis suppurativa, , I really enjoy taking care of patients with inflammatory skin diseases, because I feel that we can really make a difference in terms of not only how their skin looks, but also how they feel just in general, I also spend a big part of my time  doing research, and specifically looking at some of the systemic therapies and how they impact our patients with inflammatory skin diseases.

Fred Goldstein  01:47

And psoriasis, obviously, is an issue that a lot of people maybe aren’t aware of, or don’t talk about a lot. But it does impact people pretty severely. Can you talk about the disease itself?

April Armstrong  01:56

Absolutely. psoriasis is a chronic and systemic inflammatory skin disease, and it can affect children as well as adults. And in the adult population, the prevalence is around 3.2%. And that’s the rate for those living in the United States. And in kids the prevalence rates, ranging anywhere between point one to about point 6%. And in kids, for example, the most kids will present with rises between the age of seven to 10. And in adults, when it’s their first onset, typically, they will present in their 20s, or in their late 40s or 50s. And one thing is that we noted that, regardless whether it’s a child or an adult living with psoriasis, there is a tremendous impact on their quality of life, not just physically but also mentally, and it can affect their work life and their family life as well.

Fred Goldstein  02:50

Right. And that’s I think one of the most important areas that we’re going to focus on is this whole issue of quality of life, as you’re seeing these new approaches come out and new treatments. Obviously, a lot of research has been going on in this area. What are you seeing and how is that changed? How you look at treatments today?

April Armstrong  03:05

Yes, so we are lucky in that we are living in a time where we were really benefiting from a lot of the research that had been done in the past few decades. And in the I will say in about 15 years prior so when I was in training, not to date myself. But when I was in training, our options were fairly limited in terms of the traditional oral therapies. And we only had about two biologics at that time. And since then, our understanding of the pathogenesis of psoriasis really has brought in just more identify more key cytokines that are critical in terms of the psoriasis pathogenesis. And what happens is that once they’ve been identified, then we could then develop therapies against them. And so since then, we’ve had really a myriad of different biologics that have been developed. So to date, for example, there are about 11 approved biologics that we have for the options and and what’s very exciting is that we still have newer biologics that are being developed that that are being even more efficacious. So what we’re seeing is that our expectation for the standard of care has really changed, because our therapies are really getting more efficacious. And and the safety profile for the newer agents also look quite promising.

Fred Goldstein  04:25

And when you talk about efficacious there’s a standard of measure used for for this disease. Can you talk about that?

April Armstrong  04:30

Yes. So there are a number of different measures that we use to really think about evaluate efficacy. And the one that’s used most commonly clinically is body surface area. And with body surface area. Essentially, we are looking at the percent body surface area that are involved by psoriasis. And the rough estimate is that one handprint is about 1% of a patient’s body surface area. So why that’s relevant is that our expectation has really changed in that for example the national psoriasis foundation really want people, the clinicians and patients to be aware that the treatment target now is really 1% body surface area or less and maintaining people to 1% body surface area or less. And why that’s the target is because when that is seen as a target, we can really also at the same time really improve patient’s quality of life when their level of involvement on the skin for psoriasis is limited. Another common measure that’s used, I will say more commonly in clinical trials is PASI or the Psoriasis Area and Severity Index, typically, we are looking at PASI with regards to the relative change to baseline. So for example, oftentimes we’ll hear PASI 75. And what PASI 75 means is really a patient achieving at least 75%, or more improvement, let’s say four months after receiving a therapy compared to the baseline. So the PASI 75, to 75, is actually about talking about at least 75% improvement. So we’ll also hear PASI 90. And that means at least 90% improvement, which as you can see, Fred, it’s a higher bar of improvement than PASI 75. And the ultimate is really PASI 100. And so that’s 100% improvement from baseline. And essentially, it’s the same as achieving clear skin.

Fred Goldstein  06:24

And so, you know, I think about this from an individual approach and a population health based approach, you really, with the newer treatment modalities able to get to these higher levels of clearance of the surface area of the skin that’s covered by these plaques.

April Armstrong  06:39

Yes, absolutely. And in fact, what’s interesting is that when when we use PASI, 75, so at least 75% improvement, and that has been used for a long time as a as a sort of a standard measure. with a newer biologics, with that measure, you actually aren’t able to distinguish as much the performance, so you actually have to use a higher bar a more stringent measure. So when we look at the trials these days, we are really actually seem PASI 90, oftentimes, and sometimes PASI 100 used as a criteria to distinguish among the highly performing medications, because they’re a bit more sensitive in terms of that that particular distinction.

Fred Goldstein  07:20

And I know, I’ve been researching this more new to the field for me to look at this. And there are really some areas you look at, which is how rapidly that treatment approach works. And then how it’s able to last over time, as well as the depth of that response. So can you talk through those three measures and how important those are, perhaps, particularly from groups that may be saying, you know, why should I be looking at funding or paying for various treatments versus others?

April Armstrong  07:47

Sure, absolutely, Fred. So when we think about those key clinical attributes, and as you really nicely alluded to, we’re oftentimes looking at rapidity of response, the depth of response and the durability of response. So I’ll talk about those kind of three different components. In terms of the rapidity of response, we need to oftentimes remind ourselves the patients that were in initiating these therapies on, they are patients with a moderate to severe plaque psoriasis. So oftentimes, they have really extensive involvement to start out with, and they’ve been living with this for a while. But this has really had a really tremendous impact on their quality of life and their and their just physical comfort level. So it’s really important to achieve rapid response such that our patients can really see that this medication, whichever it may be, have the promise of really getting them a lot more clear. And also, the rapidity of response is important because it establishes a trust factor between the clinician and as well as the patient and also patients experience with the medication. And it’s really considered sort of the the first impression that the patient gets from the medication, and that it also encourages the patient to actually stay on the medication. So this is really important. So that’s the rapidity of response. And the depth of response is, is a slightly different concepts. Oftentimes we think of repetitive mostly in terms of a kind of a time domain. When we think about the depth is really the amplitude, how how deep is the response. And this really has a lot to do with a number of factors for the medication, its mechanism of action, its dosing, for example. And in all this contributes to the depth of the response that we see. This is very important, especially we’re talking about trying to decide in the real world setting among the different options that our dermatologists and other providers can can offer to our patients. And picking one that will have the greatest depth of response will give our patients the most likelihood of achieving the skin clearance as well as, for example, joint relief as well, if they have arthritis, psoriatic arthritis, so the depth of responses is definitely very important. And then finally, durable response durability. and durability is something that is very important for long term management. We know that psoriasis is a chronic disease, and therefore having an option that only not only acts fast, and acts deeply, but also has the mileage really to, to keep our patients keep their disease controlled, is very important in the long run. So I will say durability, highly important, will prevent patients from switching off the drug as well. And I think all these three factors really contribute to our clinical decision making when we have that conversation with our patients regarding what therapy may be best for them.

Fred Goldstein  10:53

And I think about this issue of rapidity and seeing the impact and knowing from a patient perspective, when we look at other diseases like hypertension, or something where maybe you’re taking a medication that you don’t really feel it. So this really is something that importantly gives a patient a true sense of something’s happening. So I’m going to keep going. Is that really the way you look at this?

April Armstrong  11:13

Absolutely, Fred, I oftentimes say that the skin is our best biomarker, because you know, when we’re managing skin diseases, patients, as well as us can see objectively how a medication is working. So with such a visible disease, having the rapidity and the durability, where everyone can see how the skin is doing is critically important

Fred Goldstein  11:37

When you look at those three different examples of what the medications do. Is there one that you look at that perhaps is more important than the others? Or do you sort of write them all about the same?

April Armstrong  11:47

Wow, that’s a that’s an interesting question its kind of like how do you rate your children? But I do think that’s a very important question. If I were forced to pick, I will say depth and durability. And the reason for that, I do think rapidity is very important. But psoriasis is a long term condition, and therefore how a medication performs in terms of its long term performance, and how well it’s able to hold that depth of response in our patients is is critically important. So I would say if I were to pick among the three, I will pick depth and durability. And and I’m picking those two, because they’re really talking about different domains. So so we’ll pick those two.

Fred Goldstein  12:30

Right, that makes some sense. And from a patient perspective, what are some of the key challenges that the patients face?

April Armstrong  12:37

I think from the patient perspective, there are a number of challenges that they face. Number one is just understanding these biologics from their perspective, how do they work, and it’s important as clinicians that we explain to them in a way that’s interpretable to them, and really addressing their concerns when it comes to how they work, they oftentimes do have questions about what are the side effects? And so I spend a lot of time talking about, for example, what are some of the common side effects that they may experience, but I put that in the context of what happens in the clinical trials to patients who, for example, received placebo. So I find that this is really important to to discuss putting the AEs or Adverse Events in the context of what’s happening. Yeah, you know, what are the rates in the general population, for example, and also in patients who haven’t received the medications? Very importantly, probably one of the most important factors in the patient’s mind is whether they are able to access these medications. So cost concerns and I would say that probably ranks the top if not the, among the top three things that’s in their mind, they often say, Okay, this is great. Now, you’re, you’re you’re telling me about this medication that may work really well. But you know, will I really be able to get it in my going to be able to afford this medication? So those are some of the key challenges when when I discuss with them regarding a biologic.

Fred Goldstein  14:04

Right. And that really sort of leads us into this idea of the health plans themselves. And what should health plans or payers be considering to seek to obviously maximize the outcomes for their patients, their members,

Gregg Masters  14:18

and if you’re just tuning in, you’re listening to the AMCP Podcast Series Powered by  PopHealth Week. This episode is sponsored by UCB pharmaceuticals. Our guest is Dr. April Armstrong professor of Dermatology and Associate Dean for clinical research at the Keck School of Medicine at the University of Southern California. For more information on UCB pharmaceuticals, go to www.ucb-usa.com and do visit the AMCP Podcast Series Powered by PopHealth week at www.AMCP.org/podcast

April Armstrong  15:00

I think that when when the health plans are thinking about their members and thinking about the members with psoriasis, it’s important to recognize that patients with moderate to severe plaque psoriasis, not only are dealing with the psoriasis, but also dealing with a number of different comorbidities and comorbid conditions. And those can include, for example, psoriatic arthritis, which can occur in about a third of the patients with psoriasis. In addition to that the patients oftentimes suffer from some of the mental health comorbidities, or cardiovascular comorbidities, which there’s good data showing psoriasis is independently associated with those different comorbidities. So that can take a toll with regards to the patients needing to, for example, take time off of work in order to attend those other appointments. And I think considering these various comorbidities is really important that and also knowing that treating psoriasis adequately can have shown in many studies have shown us have shown a decrease in these other comorbidities that I talked about. One thing I wanted to just emphasize is that my team actually did a study several years ago looking at some of the costs related to managing psoriasis patients. And what we noted was that the direct psoriasis costs ranged really, you know, between 50 billion to 60 billion dollars a year. And these are direct costs. So these are really worth thinking about medication cost visit costs, and indirect costs for psoriasis patients due to let’s say, work lost is between anywhere between 24 to 35 billion dollars. So these are really quite large numbers. And when we really account for these and some of the other additional, more intangible costs that the annual cost at that time, this study was done in 2013, was estimated the total annual cost for patients with psoriasis attributable to psoriasis, all the direct indirect and potential intangible costs is really around 112 billion dollars. So when we think about these numbers, and they certainly seem astronomical to me, and then how to bring that down to the individual patient level, I can really see great benefit in terms of good control of psoriasis, and therefore really decreasing not only their psoriasis, psoriasis severity, but also the comorbidities and the improvement in their quality of life and their work productivity overall.

Fred Goldstein  15:27

Yeah, I think that point you raised is really critical. It’s about improving their, you’re seeing studies that show you improve their quality of life, they end up more productive work, they’re healthier. And so there’s a broader impact to treatment than just the disease itself. And that’s where we’re beginning to see health plans and others employers with self insured groups looking at how do I focus on maximizing the health and productivity of my workforce? And obviously, this is a lot larger than I had initially recognized. So I really appreciate you going through those numbers. Are there new things that people should be looking at or considering or things that you’re excited about that may be coming down the pike?

April Armstrong  18:11

when we’re thinking about psoriasis therapy, there are a number of different new therapies that are coming down the pipe, maybe, maybe I’ll talk about the different classes that that are that may be some that are coming down. So when we’re thinking about the biologic realm, for example, there are there’s a new therapy that will target both IL 17 or interleukin 17, eight as well as interleukin 17 F in the oral psoriasis realm, we have medications that are targeting some of the intracellular processes, for example, looking at tyrosine kinase and how we can inhibit that to decrease also the inflammatory response. So we’ll have oral therapies that will also new oral therapies that will be available to our patients with psoriasis as well. And then on the topical realm, there are having developments around nonsteroidal topical agents that can also help our psoriasis patients with regards to how we can manage the more limited psoriasis with with novel topical agents. So as you can see, we have a number of different exciting developments in all the different areas of classes of medications that we use. And I will say the future looks quite bright for patients with psoriasis.

Fred Goldstein  19:28

Where would you recommend doctor I’m trying to people, potentially, you know, how plans are these large self insured employer groups? Where should they turn? or could they turn to get a little more information as they begin to decide how to set up their benefits packages and look at this?

April Armstrong  19:43

That’s a great question. I think that’s a that’s a difficult question. I think that when they are considering the different resources, I would say certainly the national psoriasis foundation is a good resource for just getting some general information about about some of the disease burden that I talked about some of the comorbidities that I also spoke about. And so hopefully that will be a starting place that they can take a look.

Fred Goldstein  20:12

Fantastic. Are there any other things you think from a payer perspective they should take a look at?

April Armstrong  20:18

I think from a payer perspective, it’s important to look at some of the literature with regards to evaluating long term health consequences and long term costs for caring for patients with psoriasis. And I think that when we are looking at some of those numbers, I think, hopefully, it will be informative with regards to how disease control itself can in many psoriasis patients, especially their younger, that you can potentially alter their disease trajectory, and also their really their life trajectory as well.

Fred Goldstein  20:54

And it’s interesting, you mentioned children, we haven’t spent a lot of time on the show is talking about pediatric care and kids, is there any difference when you look at it from a pediatric versus an adult perspective?

April Armstrong  21:04

So when we’re thinking about pediatric patients, a few things, I think that may be relevant to our discussion is that pediatric care, it’s not just the child, but also really the family, the parents, the caretakers. So a lot of indirect costs lost with regards to needing to take time off work to go to the appointments. And another thing that’s very important about pediatric patients is that kids can be kind of cruel to each other. So there’s a there’s quite a bit of literature on bullying of, of kids with psoriasis, and the mental health component can take a great toll, because they are younger, and they are more impressionable. So I will say in that patient population, really early intervention is the key and adequate treatment of their disease of the psoriasis is really key.

Fred Goldstein  21:55

And obviously, as you just brought up, I mean, I was thinking the same thing for the children, you know, unfortunately, bullying or things like that, is to also think about that, again, in the broader perspective, from a quality of life and mental health perspective, and potentially, they need to provide some sort of counseling or other help for those children as well.

April Armstrong  22:12

That’s absolutely right, Fred, and I think that we are, we really need to be aware of things that our kids are going through, especially teens, sometimes I I know, in my practice, they can be many of them can be a little bit reticent, but but they they can be really experiencing some of those mental health impacts that we’ve spoken about. So it’s really important to make sure that they feel supported and connected, and that we actively address those aspects of mental health.

Fred Goldstein  22:43

Oh, fantastic. I really appreciate this. Are there any areas that you’re researching now, that’s, that’s kind of interesting, or things like that?

April Armstrong  22:51

Yeah. So our research group focus on a number of different aspects of psoriasis care from number one, just understanding the safety profile of the various medications to how we can deliver care to our patients with with inflammatory skin diseases, a bit better our work has focused on for example, just one area focused on the use of telehealth tele dermatology to care for patients with psoriasis from rural areas, for example, or, or areas that are geographically separated from centers that have specialized psoriasis clinics. Certainly, I will say COVID, the pandemic has really put telemedicine to the front and center so we can really see the potential for that for following our patients who may not be able to, for example, come in to see us regularly due to logistic concerns or otherwise.

Fred Goldstein  23:47

Yeah, fantastic that you mentioned telehealth, obviously a big area now of growth in the throughout the healthcare system. So Dr. Armstrong, I’d like to thank you so much for joining us on the AMCP podcast powered by pop Health Week. It’s been a pleasure.

April Armstrong  23:59

Thank you for having me, Fred.

Fred Goldstein  24:01

And back to you, Greg.

Gregg Masters  24:02

And thank you, Fred. That is the last word on today’s broadcast. I want to thank Dr. April Armstrong, Professor of Dermatology and the Associate Dean for clinical research at the Keck School of Medicine at USC. For more information on UCB pharmaceuticals, go to www. ucb-usa.com. For the AMCP Podcast Series Powered by PopHealth week, my co host Fred Goldstein and Dr. April Armstrong, this is Gregg Masters encouraging you to follow and subscribe to this series at www.AMCP.org/podcast and please consider subscribing to this series and if you enjoy the content do like the show on your favorite podcast platform.