Matthew T Reynolds, PA-C

Matt, we’ve had this great, enriching conversation this evening. This has just been fantastic; I really appreciate it. What advice or practice pearls do you have for other APPs [advanced practice providers] managing patients with plaque psoriasis?

This is a very global question, and I’m glad that you asked it. My number one pearl for all of the APPs that are out there just getting started, or maybe they’ve been in practice for a few years, is just be a true advocate for your patients. Try to put yourself in their shoes, no matter if it’s a plaque psoriasis patient or not. You need to always consider what is going to be the best for them. It may be best for you now to put them on a certain drug or a certain treatment, but I want you to consider all the variables that go along with the patient’s life. Think about how far it takes that patient to drive to your office, think about what they did to get to your care, if they waited 3 months or 6 months. Spend a little extra time with these people and just be more than what they expect you to be. Often, you’re going to find that these patients have not had a true advocate, they’ve not had a true person to be a fighter in their corner. That’s really where you, as the APP, have an opportunity to change the paradigm, change the treatment of that patient who’s coming to your office with plaque psoriasis. The other thing that I always tell everyone, especially as they’re just starting out, is to find someone who’s going to train you, find someone who’s really going to spend the time to make sure that you become a professional, that you become an expert in dermatology. That’s what you’re expecting from yourself, so don’t accept anything less. Find that person who’s going to take you to the next level in your career and you have a true opportunity, you have a true chance to make a difference in people’s lives. You get to see it because you practice in dermatology, but you’re going to feel it too if you exceed expectations from your patients. Those are my 2 main pearls. I think you and I both, because we’ve been at practice a while, could talk about this all night, but I really think those are the 2 main things that I want to impart upon our group listening.

I agree with you so much, Matt. The one thing is that you continue to educate yourself, and every time I have students, no matter from which university, no matter if they’re MP [nursing director] or PA [physician assistant] students, they want to have a dermatologist experience. I’m more than happy to say, “Come.” In fact, next semester I have 3 students from 3 different universities, and I said, “We just have to arrange this so that everybody can have their time.” It’s crucial to support one another. Regarding those patients, yes, walking in their shoes. It never fails to really break my heart when I have patients who have come to me and they’ve had psoriasis for 10-plus years, they’ve been in several dermatology practices, and nobody has given them a jar of triamcinolone. They’re coming to see you, just like you said. They have driven, they’re hoping that someone will be able to help them to understand their physical, as well as their emotional, burden with this disease, which is a heavy burden disease. If you cannot help them and you don’t know how to help them, then find somebody who does. Resource them, help them because there are people who specialize in psoriasis and those who don’t. Dermatology practice is not always the same, but there are so many ways that we can educate one another and support one another and help these patients.

You’re absolutely right, thank you for sharing that.

Thank you, Matt. It has been an absolute pleasure to be with you here this evening.

You as well. Thank you, Jayme, for having me.

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Jayme Heim, MSN, FNP-BC, and Matthew T. Reynolds, PA-C, shares clinical pearls for clinicians managing patients with plaque psoriasis.

Practice Pearls for Advanced Practice Providers Managing Patients With Plaque Psoriasis

Let’s talk about those patients with comorbidities and age-related considerations. When we talk about those and you look at that long-term safety data, is there anything that really says to you, “You know what? It takes those concerns I have, and it really lessens those concerns when we look at that long term safety data”?

In screening these patients and trying to identify who is sicker or at more risk of having complications, for me, knowing that the data is out there that shows that the [interleukin (IL)-23] class as a whole has to be one of the cleanest medications that you can write for these patients. I’ve even used that data to talk to a patient’s oncologist or talk to a patient’s GI [gastroenterologist] specialist or primary care doctor not only to reassure them that we are keeping the patient’s best interest in mind or keeping their overall health in mind, but we have used that data as almost a guiding point in managing these older patients who are a little bit sicker. We know that a lot of these comorbid conditions coexist with psoriasis, so we use that opportunity as well to counsel patients on managing those diseases because it may affect their overall psoriasis treatment outcomes. We counsel the patient’s primary care provider or their other specialists that treating their psoriasis with these molecules may help treat the other associated inflammatory conditions, their comorbid conditions, and make those easier to treat for these patients. When I talk about this, I always think about those patients who have terrible diabetes or terrible cholesterol numbers. I’ve drawn some of these labs myself and in screening labs, trying to identify who’s at most risk. Again, just having that data and knowing that these patients are going to do quite well and at 5 years and with continual data and long-term extension data that is produced, I expect those studies and I expect that data to show a similar level of assurance that these patients are going to do quite well on this class of drugs.

 We’ve talked about those patients who are over 60 years of age. We’ve talked about patients who have a larger BMI [body mass index], over 25. When we look at the clinical information and the studies that have been done so far, can you identify any other patients who should be investigated for this class of medication?

We need to be looking at younger and younger populations for the IL-23 class. Psoriasis can occur at any age. We know that certain children do develop psoriasis at early ages. I think the earliest child that I’ve found with psoriasis that I’ve been able to confirm is 3. Investigating these patients at younger ages is absolutely paramount. We have molecules, we have drugs that we can use right now in this age range, but over time we’re going to find that giving the patients the option of an every 2- or 3-month dosing scheme in the younger patients is going to provide parents with a lot of reassurance. It’s also going to provide those children with a lot of reassurance because their treatments are going to be easier than what we currently have available. For us, we need to continue to identify the true pathway that’s involved with IL-23 and psoriatic arthritis. We need to continue to investigate other comorbid conditions, such as ankylosing spondylitis, as well as the overall role with IL-23 and inflammatory bowel disease and other indications that can follow from that. When I think about that question and new patient populations, the number one thing that I think about is the younger kids who develop psoriasis.

Thank you, Matt. In regard to that, are there any other populations that we can possibly look at to increase the diversity? Within these clinical trials we often see, especially within psoriasis, the mean age is in their 40s, the population is usually Caucasian. What would you like to see regarding diversity?

I think that’s a great question. In our area, we are very fortunate to enroll a high population of darker skin types, so there are more skin types from the Fitzpatrick scale there. As for the African American population, specifically, there are studies that are being specifically designed in skin or color currently, but we need to continue to build our wealth of data in that patient population. We need to continue to investigate also in patients who have special subtypes of psoriasis, such as isolate scalp disease. We need to continue to investigate the male disease component. A specific set of studies for genital data would be wonderful, but the biggest thing that we’re missing from clinical trials data is our minority populations. Having specific studies designated to those groups is going to be essential moving forward as we figure out the IL-23 pathway and its overall role in treatment of plaque psoriasis.

Matthew T. Reynolds, PA-C, comments on how evaluating treatment profiles, comorbidities, age, and population can help the clinician understand plaque psoriasis and improve management strategies.

Considerations When Approaching Treatment for Plaque Psoriasis

There is real-world data regarding the use of IL [interleukin]-23 and those patients over 60 years of age, as well as patients who have a little bit higher BMI [body mass index], patients who have a BMI greater than 25. It’s demonstrated favorable and consistent safety outcomes. Can you comment on the importance of examining treatment outcomes in these patient populations?

 Absolutely. These patients are more typical psoriasis patients. We know that patients who have psoriasis have high rates of morbid obesity. We know that they have high BMIs, and we know that psoriasis as a whole can be bimodal in its transmission in the population. We know that young and older patients can get it, and we know that patients who are well into their 70s and 80s can develop psoriasis at any time. I think it’s important to have this data because it shows more of what we see in clinical practice. In clinical trials, certain patients are just not able to get into these studies. We don’t really get a good snapshot of who these people are or how they behave because we have specific BMI limitations, and we have specific age limit restrictions for our clinical trials that lead to the FDA approval of these great drugs. But now that we have this real-world data and the 5-year data to show what is really going on, I think it’s great to know that the older patients do just as well as the younger patients. We’re not seeing elevated events of MACE [major adverse cardiac events] events. We’re not seeing an increased risk of infection with increasing age. We’re not seeing blood clots or lab work abnormalities that you worry about with some of these older patients. I certainly still do a significant amount of blood work in my practice, as a rule. I feel like it’s just good medicine. We do screening labs, and then we do periodic labs. But for our patients who have high BMIs, we’re worried about overall risk for metabolic syndrome. There’s data now that shows that the IL-23 class does really well in these patients. These patients achieve the same level of PASI [Psoriasis Area and Severity Index] 75, PASI 90, and PASI 100 response rates. Our patients who are not in the metabolic syndrome class but do have high BMIs greater than or equal to 25, they also, thankfully, achieve the same levels of skin clearance rates. You’re not worried about dosing or giving extra medicine to these patients because we have all the data that shows that’s just not the normal, and that’s just not necessary. Most patients who go on these drugs who fit into these 2 categories, advanced age or high BMIs, typically respond similarly to our patients who are not in these categories. That, again, is just a testament to the molecules; it’s a testament to the binding site that has been chosen for these drugs. I think it’s great to have this data on hands and remember that when you look at these patients who walk into your practices.

I agree with you, Matt. I did a real-world study, and we had quite a few patients who were over the age of 65 and patients who were in their 70s. There were no increased treatment adverse events related to infection or anything like that. Also, I’ve had patients in the study who were well over 300 pounds who responded very well to IL-23 medication. It’s great when you have real-world studies, especially phase 4 studies, where these are patients who you’ve seen right in your practice, they’re not limited in their inclusion exclusion, and they really are real-world patients. You’re seeing real-world results from them, and that’s extremely important.

When we talk about the challenges we face in the management of older patients, you had mentioned earlier that having an in-office injection is not under the pharmacist benefit. The Medicare Part B and being able to come in and having some access because it’s more under the medical benefit, not under the pharmacist benefit; it has that J-code attached to it. What do you consider is the greatest challenge for those older patients suffering with plaque psoriasis?

Thankfully, in our area, the challenges are just managing their other comorbid conditions. That’s why we choose this class of drugs for these patients. When we have these patients, especially when they need dosing every 3 months, we take that as an opportunity to treat all of their other stuff. Usually, these older patients have low grades of skin cancer, they have other rashes, they have other dermatitis that you’re treating, so it’s a great opportunity to follow your patients closely. Obviously, we do appreciate the fact that we can bill that under the Medicare Part B benefit. That’s great for us because we’re doing a lot of work for the patient, we’re making sure they get their drug, we’re purchasing it for them, we’re making sure it’s on site and ready to go for their appointment, we’re making sure they get it on time. I think that helps them to achieve those high levels of skin clearance rates because they are getting the highest level of care that they can get with these drugs. For our patients who are a little bit sicker, they’re a little bit in the advanced age, they have a lot of other comorbid conditions, the challenges are making sure that you don’t overload them, you don’t overtreat them. I think it’s easy to prescribe any of the new biologic agents for these patients. I like to be nice to these patients and make it as easy as possible, and I think that the every-3-months dosing for these older patients with the in-office administration, specifically, is a perfect paring for us in treating these psoriasis patients.

I agree with you. The other thing that I thought about when you were talking is that, especially with patients who are a little more vulnerable just because of age or because of multiple comorbidities, we’re able to keep an eye on them. We monitor them, we know that they’re safe, and I think that that’s important, too.

Jayme Heim, MSN, FNP-BC, and Matthew T. Reynolds, PA-C, discuss implications of real-world data on the use of IL-23 inhibitors in treatment of plaque psoriasis for older patients.

Using IL-23 Inhibitors in Patients Over 60 Years of Age With Plaque Psoriasis

What are the implications of long-term data, especially in patients who may not have responded to initial treatment? What is that long-term data? What does that tell us about those patients who may not have responded to other medications?

I think for us, those patients who didn’t respond to other medicines in the past, if they end up switching to the IL [interleukin]-23 class, they will achieve high skin scores, high skin clearance rates by the nature of the mechanism of the drug. Then over time, these patients will achieve skin clearance rates that they were never able to achieve on other mechanisms or other drugs that they’ve previously been put on. In my practice, I’ve had patients who have been on multiple therapies leading up to their time point of becoming my patient, and we’ve switched them to the IL-23 class, and we’ve finally hit the right button for them. But these patients who have been on other therapies for years and either had terrible adverse events, or terrible skin clearance rates, or have had injection site reactions, they finally switched to this class and get to the point where they don’t have any of those problems. They don’t have those adverse events, and they’re getting to the point where they’re finally clear. Then once again they stay on these drugs for years, they become one of your favorite patients.

I agree. I think that a large amount of those patients who do respond to IL-23 continue to be responders to IL-23 over that longer course of time. Where before, we saw with other classes of medications, especially the TNF [tumor necrosis factor] inhibitors, that we were wondering, when was this going to stop? We also see some of those patients who did respond for an extremely long period of time, but most of those patients did have that problem with antibodies. So, we’re just not seeing that with the IL-23 class of medications, which is wonderful because our patients often want to know when they go on medication, how long is this medication going to work for me? Especially if they’ve been a patient who has been in another class of medication.

 We really don’t worry about neutralizing antibodies with this class, which is great. We know that they exist in other classes of drugs and specific ones, but it’s great to not have that as a problem.

Now, like we talked about, not all patients will stay on therapy, especially because maybe they don’t respond. Not everybody responds to every medication. Even with the IL-23s, when you have a patient in your office, how do you know when to go ahead and change that patient if you don’t feel that they’re responding, or if they don’t feel they’re responding?

That’s always hard because with certain patients, you know that they’re going to have higher skin scores, they’re going to have higher BMI [body mass index] rates, they’re going to have other things that are working against you. Some patients just have medications in their regimen that are essential that you cannot change, and you’re going to have to work around them. Personally, with the IL-23 class, I try to not switch patients before 3 months; I try to set expectations for most of my patients who we’re going to try to go to 6 months. I have some patients who are at 12 weeks or we’re going into 16 weeks, and we’re still not seeing a whole lot of efficacies. Certain patients just take a little bit longer time. We all know that with the IL-23 class, we’re not with a sprint drug, we’re with a marathon drug. The benefit of these drugs is more in the future versus in the immediate future. I try to counsel my patients and set expectations that I do expect them to start showing some signs of improvement by their first-month follow-up. But I expect them to have significant improvement by their 3-month follow-up. I’m not going to let my patients suffer. I am going to switch them when I do think that they need to be on a different class or we’re just not in the right direction. But generally, the 3- to 6-month window is where I typically fall as far as changing therapy or abandoning therapy.

I think for me too is when a patient comes in and they’ll say, “I took my injection, I’m not seeing anything different.” Their plaques are starting to form again, and they’re just really not responding. For me, that really is a time point, if they’re just really not responding anymore, that we need to have that discussion on switching medication. Would you say that as an APP [advanced practice provider], do you think that patients pretty much want to stay on medication or want to switch, or it’s the other way around, where the APP says, “You know what, you’re really not doing well on this medication”? What has been your experience, and what do you usually do?

 There’s a wide range of patients who are out there, too. Some patients really expect to be totally clear after 1 shot, and they think that they’re going to just have this miraculous cure. Again, I like to set expectations, but I will tell the patient if I think that they’re not responding appropriately, if I truly feel that we’re not making the progress that I expect. When I treat patients with psoriasis with biologic therapy, I tell them, “I’m trying to hit a home run here. I’m trying to swing for the fences.” I think that’s what I expect, and I think that’s what you should expect, too. I will listen to them if they feel like they’re not doing well if they come in and tell me that they’re flaring significantly between injections and they’re miserable for 2-4 weeks before their next shot. I hear that. That tells me a lot. Thankfully, we have a lot of flexibility with dosing with this class because of the safety and the mechanism of action. I try to make it a team approach; I try to let the patient have their say, and then we provide the guidance and the medical reasoning that’s necessary to change or to alter treatment. I typically will be the first one to say, “Hey, this is not right.” I try to train everyone else who works with me to be the same way, to be an aggressive fighter for your patients, and to set those expectations clearly.

Experts in psoriasis examine the implications of long-term data for IL-23 inhibitors, especially in patients who have not responded to initial treatment of plaque psoriasis.

Matthew T Reynolds, PA-C

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