Are We There Yet? Assessing Treatment Response in Inflammatory Disease

How do prescribers and patients determine whether or not a treatment for psoriasis or eczema provides meaningful response? And what is the right way to make a therapeutic switch? Wendy Cantrell, DNP, CRNP; Joe Gorelick, MSN, FNP-C; David E. Cohen, MD, MPH; and Kara Gooding, MMS, PA-C discuss. Plus, Steve Hawkes, MMS, PA-C shares tips on isotretinoin and Suneel Chilukuri, MD, talks exosomes science.

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Transcript

Transcript is provided as a courtesy only and has not been verified for accuracy.

Host:

Welcome to the Dermalorian Podcast from the Dermatology Education Foundation. With a large and growing menu of biologic and small molecule therapies available to treat inflammatory skin diseases like psoriasis and eczema, prescribers have a lot of options for their patients. Many patients today get substantial and sustained results, but some individuals don't get sufficient response and they require a therapeutic switch.

During a recent expert panel discussion, Dermatology Nurse Practitioners Wendy Cantrell and Joe Gorelick, Dermatologist Dr. David Cohen and Dermatology Physician Assistant Kara Gooding discussed how they assess whether patients are getting sufficient response from treatment.

Wendy Cantrell:

I ask about itch, of course I look at skin, but sometimes patients, their skin could be doing pretty well, but they're still itching and they're still miserable. So again, that shared decision making with your patient on how is their quality of life improved? Sometimes there's some hand holding. I think patients get their hopes up. They think that we have magic erasers or magic wands like Jamie was talking last night is that 1, 2, 3, in 3 days, you're completely better. And for most of our medications, they may start to improve, but sometimes it takes 12, 16, 24 weeks for us to really evaluate efficacy. And sometimes that's hand holding in helping patients to understand realistic expectations and what we know the amount of time it takes to achieve good results.

So I think it's different for each patient. I think you have a better, if you're on a JAK, patients are going to see improvement quicker than they are on the two injectables. And just helping patients understand how long it's going to take and why it takes as long as it does. Topicals really come in clutch sometimes to help patients in that in-between time, so make sure that they have not just abandoned their routine of topicals. I think it's important to make sure that they are continuing to use their topicals.

Joe Gorelick:

Yeah, I love that. And I think to the documentation point and the chart notes in the event that somebody else sees the patient next. One thing that I do every single time I see a patient, an atopic patient, is I ask them two questions. Number one, how itchy are you right now on a scale of one to 10, that's the numerical rating scale. And I stick it in the chart and then I say to them, okay, over the past 24 hours, what was the absolute worst itch that you experienced? And I know that in the chart from their previous visit. That helps me assess in an objective manner where we are, because sometimes it's hard. You ask the patient, how are you doing? Are you itchy? How's your itch? And you go back and forth and it's hard to get a clear answer, but with those particular measurements in the chart, you can really get a quick idea of exactly where they are.

Wendy Cantrell:

And I loved your case from last night where the patient says, I am 95% better. The patient's happy, itch is good. They're moving in the right direction. Clinically, you're maybe 50% better, but patient's happy. So it's worth continuing to wait.

Dr. David Cohen:

Yeah. One of the things I ask is, first of all, I ask, "How are you doing?" Now, I get a lot of different answers, like issues about the family, the weather, and then I listen to the answer and I go, "All right, now, skin-wise, how are you doing?" Keep it pretty broad. And then we'll go through and I usually say, "How are you doing and what are you doing?" So when I ask what are they doing, I'm giving them permission to tell me that they're not following the recommendation, and they all know me pretty well. I don't get worked up if they don't follow my recommendation. I just want to know what they're doing because I'm there to help and my recommendation may not fold into their lifestyle very well. And you see how I document it, what is your approximate percentage of improvement from the first day we met when you were doing really bad? Just give me an estimate.

And that lady said 95% because her sitting current numerical rating score was one out of 10, and I think at the first visit it was about four or five out of 10, and her max itch score went down in half. So she felt great because she could sleep, but her easy scores were coming down like 50%. You have a lot more to go, a lot more improvement. You're going to readjust that 95% to maybe 95% next time and you'll be 75% better. But that level of enthusiasm comes out when you give people permission to tell you, because some of them will say, "I'm 5% better." And I said, "Are you 5% better? Are you worse? It's okay, you can tell me." They'll tell you exactly how they feel. And any number below 40, 50% should be a signal to you to address something a little bit more. It may not mean changing the therapy. If you are on tralokinumab, ADBRY and you're at week eight or 12 and seeing them, but they're noticing improvement and they're 50%. It's like, well, let's juice this with some topicals because more is going to come out.

Kara Gooding:

One other pearl I have on that was when you're asking, and I do the NRS scores as well, I think it's super important for evaluation on how they're doing, but when you ask a patient what their NRS score, you say, "How itchy have you been on a scale of zero to 10 in the last 24 hours?" How many people in this room have ever gotten an answer? They just say eight or six. It's always a story, right? Well, last night, let's see, what was I doing? Oh, yeah. Well, I was itchy while I was watching TV, but then it got better. So-

Dr. David Cohen:

So yeah, pretty itchy.

Kara Gooding:

So you have to guide them. So I actually trained my medical assistants. I have two phenomenal assistants, and I actually trained them, so they ask the patient in their history so I don't have to go through the whole story.

Dr. David Cohen:

Yeah, there's always a story with the NRS score, it is, but after a few visits, they get trained pretty well. They just don't remember their NRS score from before. And so when you tell them, I'm like, "You're telling me you're doing 5% better, but your peak itch score went from a nine to a five. That's pretty important. Aren't you sleeping a little better?" "Yeah, I'm sleeping a little bit better." Right. Sometimes you have to talk them off the ledge on that 5%.

Wendy Cantrell:

Well, I think that's a great point. And having biologic patients, small molecule patients coming in, and this may seem really simple, but it makes a huge difference, coming in and sitting down on the stool and talking and let them know that you have the time to invest with them, I do find that that helps relationships. These biologic patients become part of your family, you know where their kids are going, you know where... It's the story. You're doing great, fantastic. I'm going to spend the next 10 minutes talking with you about what you're growing this year in your garden. So I think the relationship and them having the freedom to be honest with you and that you expect that and that you're welcome to it, that you want them because we're there to help them get better.

Dr. David Cohen:

So if efficacy is not achieved, what do you do to employ controls, maintain controls?

Kara Gooding:

I think we covered this.

Dr. David Cohen:

We just did this one.

Kara Gooding:

Yeah, we covered this a little bit. But yeah, I think one other thing that we have not mentioned would be to patch test the patient. So if you're struggling and you've gone through a bunch of different agents and you still are struggling to gain control, think about doing some patch testing.

Dr. David Cohen:

That's a great point. Particularly if you have treatment emergent face dermatitis or neck dermatitis. Have they developed allergic contact dermatitis? Remember, these drugs do shift the immune profile. People start using different products as they start getting more clear, they get a little bit more brave with cosmetics that they're adding on, and so they do get exposed to new things.

So if I decide to discontinue and switch, this is how I'm going to try to do this in a nutshell. You're going to have someone on dupilumab or tralokinumab probably out of the gate, right? I'm not suggesting you have to do that, but most of the time you go on systemic, it's going to be one of those two to start, and I do pick one or the other to start. And it's not always dupi. Sometimes, it's tralo. It depends on my mood. It depends on how much head and neck disease they have. There's a lot of things that influence me.

If they've done well and they fail later, that's called a secondary failure. They did well and then they fail later. A primary failure is you start someone on the drug, they never get better, a primary failure. So it's not absolute, but a primary failure is going to suggest to me maybe I'll change class a little faster and then I'll stay in the class. So if someone goes on dupi, just nothing's happening or they're on tralo, it's a big zero, I'll be more likely to put them on a JAK inhibitor, because I have to get some confidence going in this person that this isn't going to be an interminable process for them.

But if someone did great on dupi, doesn't have a problem with the injections, and now they're having treatment emergent head and neck disease, maybe they're having the eyelid dermatitis, conjunctivitis, I'll switch them to tralo, keep them in there. I don't have to have a new conversation. The only conversation is, "Hey, listen, it's twice as many syringes, but the syringes are easy to use because there's less fluid in there." And the whole thing takes about 20, 30 seconds to switch.

When you're switching classes, it's a bigger conversation, but those are going to be for my primary failures or my second secondary failure. By this time next year, we're going to have a third IL-13. We may have OX-40s. We don't know what this is going to look like very much, but that's kind of how I do it.

Host:

Let's take a short break for this episode's Dermalorian clinical clip.

Isotretinoin has a long history of use to manage acne, but prescribers are still learning how to optimize treatment. Dermatology Physician Assistant and DEF Advisory Council Member Steve Hawks shares some tips to better manage patients on the drug.

Steve Hawks :

One of my things that I like to really focus on one of the disease states is acne and isotretinoin has been a great medication and it's evolved to where they have this Lidose technology that's been very good for those people who don't really eat a fatty diet, and that's what's really important for the regular isotretinoin that doesn't have that Lidose technology, they don't eat that fatty diet, then that means they're not absorbing it. If they're not absorbing it, they're not going to get better. So that's a great technology that's out there. If that's available, that's a great medication. If it's not available, then yes, I've had one patient specifically that talked about she just takes three or four scoops of peanut butter with her medication with isotretinoin, and that's great. Avocados are great, but that fatty meal is really crucial to the absorption of that medicine and having it be worthwhile for them.

The side effects, you talked about the side effect profile too. A lot of those side effects is the dryness, the dry eyes, sometimes the nosebleeds, those are pretty common. And so we need to really know how to help those patients get through that. And like we talked about, there's the nasal sprays, the ocean spray or the saline spray is great. Dr Dan's Lip Balm is great. The CeraVe healing ointment, the Cetaphil healing ointment. Aquaphor is great, but making sure those patients really get on those early. And also, I do start my patients at a lower dose for at least a week and a half, sometimes longer until they get used to those symptoms and then we put them back to their normal dosing.

Host:

Let's get back to the panel discussion about assessing therapeutic response and making a switch. The panelists were asked how long they wait to make a switch and Wendy Cantrell kicked off the conversation.

Wendy Cantrell:

I don't. I don't.

Dr. David Cohen:

All right, that's a pretty fast answer.

Wendy Cantrell:

If I have a sample, if I'm going to another biologic, if I have a sample, we'll start it. Or I'll tell them, if I don't have a sample, I'll say, "Continue what you're using until you get it." I don't want them to stop and wait the three to four weeks for us to fight with their insurance for a bit. But if I'm going to switch to a JAK, a lot of times I do what you do and I already have that lab work. If I don't have the lab work, I'll tend to draw the lab work. And if they're trustworthy and I feel like it's okay, it's a individualized patient decision, I'll give them the pills, the samples and say, "We'll call you and let you know your labs are okay. Then you can start taking it." There are some patients, I said, "Do you live close? Maybe early next week, I'll get you to run by and pick up the samples." But I really don't. I don't wait the half-labs.

Dr. David Cohen:

I completely agree. And there's already data to back what you said. Remember, dupi has weekly data. Dupi has weekly data out for years, not like 16 weeks, for years at weekly data. We saw a heads-up where patients went from dupi to the next day onto upadacitinib. They overlapped. So no reason to wait. Have I seen DUPIXENT-induced facial erythema? Yes, many, many times over the years. At any one time, I have 400 people on the drug, actively on the drug. So I see facial induction from dupilumab. You'll see it on eyelids and it could look like just conjunctivitis, eyelid dermatitis, head and neck patchy dermatitis. It looks like seb derm sometimes. It can even look like psoriasis.

First thing, treat it like you'd see a patient walking in with that from scratch, low potency topical steroids. I happen to be a fan of Desonide ointment. Doesn't have a lot of sensitizers and Desonide's not a sensitizing corticosteroid. I'm not a big hydrocortisone fan, because Tixocortol pivalate is a pretty common sensitizer. So I use Desonide for a weak or two even on the eyelids. And then what I do it's kind of a trick. I like Tacrolimus for this.

So I'll say, "Okay, a week of Desonide at night by itself." On date, the next week, "Here's your Desonide, here's your Tacrolimus. I want you to put a little bit of Tacrolimus into your Desonide." So over the course of the week, "Here's your Desonide, here's your Tacrolimus. I want you to do this." So at the end of week two, you're just on tacrolimus.

This way, I get around the burning. You're slowly working them in and the Tacrolimus will work often. Topical ruxolitinib is great for head and neck induced dermatitis from dupilumab. Then the other thing is, if they're doing very well otherwise, start lowering the dose, meaning increase the frequency. Tell them, "Let's go to every three weeks and see how you do." Remember that gal I showed you? So continue, solo continue trial. It gives you some data to lower the frequency to get rid of that. The balance is if I go too low, is the body eczema coming back? So starts go slow.

Any other differences? And I know, Joe, you mentioned that we have these other drugs coming out on the market, and maybe those will be pretty useful too. I do deploy them, because I have samples of them. The Zoryve and Vtama.

Joe Gorelick:

Yeah, I think, right now what I do is rux cream, the sample's a 5 gram tube of the sample. And for eyelids, that's enough to generally get it to calm down a couple times a day, the safety is well established, that usually will take care of it. Because the prescription likely will not be covered. And then I don't have to do the mixing of the TCI with the steroid and patient doesn't have to pay another copay or two for extra prescriptions. So samples are useful. And as Dr. Cohen alluded to, you have two other options that are currently being used FDA approved for psoriasis that will gain AD approval. So start playing with those in your practice, see where they fit in.

Dr. David Cohen:

And by the way, those head and neck disorders, when you biopsy them, they do come back, psoriasiform spongiotic dermatitis. They are very seborrheic-like, and they're approved for that, right? Certainly ZORYVE, roflumilast is approved for seborrheic dermatitis.

Host:

Want to learn more about managing inflammatory skin diseases with biologic and small molecule therapies? Check out the in-person Biologic and Small Molecules CME Bootcamp in Huntington Beach on November 9th, or join the advanced virtual program on December 1st. Details are available at dermnppa.org.

Now, for our Dermalorian Derm Decoder, where dermatologist Dr. Suneel Chilukuri gives an update on the emerging science of exosomes.

Dr. Suneel Chilukuri:

In terms of exosomes and what we know so far, we're literally just at the tip of the iceberg. We're just discovering that there's this, what we used to be called waste products, they're doing so much more. And as there's better regulation, we're hoping that we can have proper clinical trials. Right now, there's 12 different players inside this space. Out of those 12 players, when they were all asked for MCAS, which is the International Plastic Surgery and Dermatology meeting, what we found is only six of those companies responded to the questionnaire, do you want to submit your papers and research? Only six. Out of those six, only one actually had peer-reviewed publications. So it's the Wild, Wild West out there. I know people are making a lot of claims, but it's a question of can they back up these claims? And for all of you out there, we know that you're scientists like I am, and we want to make sure that it's not just nonsense, it's not something that we're imagining, it's something that we can do reproducibly and execute every single time.

Host:

That's an important lesson to keep in mind.

Thanks for listening to the Dermalorian Podcast from the Dermatology Education Foundation. Share it with your peers and catch up on past episodes wherever you stream podcasts. We'll catch you next time.