Plaque Psoriasis: Initiating Therapy
Melodie Young, MSN, RN, ANP-C: Douglas, what else do you do as far as your assessments?
Douglas DiRuggiero, PA-C: I think it’s important to note how we define severity, which you have to do in order to run clinical trials. You have to have benchmarks that you set, ranges that you set to define severity. It’s not necessarily how the patients define severity, and we do have trials that show that. Just so we have some definitions for our colleagues, if we’re going to look at body surface area [BSA], 1% body surface area is 1 palm, right? If you can cover 5 spots with your palm, they have 5% body surface area. So we have these defined things. If it’s greater than 10%, it’s considered severe for trial purposes. But if that palm covers just the top of the scalp or the genital area, that could be only 2%, but it could still be significantly severe to the quality of life the person has.
When initiating therapy, we have to think about not just what the parameters of the Physician Global Assessment [PGA] or BSA are, but where is that located and how does it impact their lives? We’ve got some recommendations that are published. Earlier in 2019, the AAD [American Academy of Dermatology] put out some guidelines, and they have more of them that are forthcoming in the early part of the year looking at comorbidities and how to stratify. We know that the National Psoriasis Foundation has guidelines that it put out a year or so ago recommending which ones to use first versus second. But in the more recent guidelines that just came out in early fall, late summer by the International Psoriasis Council, the IPC, I like the way it categorized things. I don’t know if that classification will take traction or not, but they basically just lumped patients into 2 categories: Those who should receive topical or those who should receive systemic.
Melodie Young, MSN, RN, ANP-C: Everybody else.
Douglas DiRuggiero, PA-C: Because what they are recognizing—and this is a group of over 100 dermatologists globally who are putting in these recommendations—is that by just using PASI [Psoriasis Area and Severity Index] scores, you may overlook 3 things. It overlooks the past medical history of the patient if they’ve been on previous treatment, it overlooks the sensitive areas where the BSA is distributed, and it overlooks the quality of life and how the disease impacts the person.
Basically, if your BSA is greater than 10%, if it’s in any highly sensitive areas or if there’s a tremendous burden on the quality of life of the person, you would be a candidate for systemic therapies, which they define as either phototherapy, biologics, orals. If it’s less, then topicals could be an initiating step to see how it works.
We know that topicals are grossly overused. People stay on them for much longer, when they should be shifted to things that can manage their disease. I think these guidelines will get patients on treatment sooner and will help us get things approved through insurance companies as well. They’re the ones who make us step through so many hoops before we can finally land on the treatment that we know is going to clear a patient and improve their quality of life.
Melodie Young, MSN, RN, ANP-C: The older thought process was different. Twenty years ago, we had what we called stair-step therapy, in which you had to start with certain things and show that they did not work before you could move on to the next therapy. Part of that was to get insurance approval. But I really feel like we all, as NPs [nurse practitioners] and PAs [physician assistants], need to understand you don’t have to do that anymore. In fact, I think it’s contraindicated based on the knowledge that we have. The science has shown us that for a person who has different aspects of disease or severity of disease or psychosocial impact, you have the opportunity to access some of these therapies.
Now, in clinical trials, for a biologic to be approved, the FDA sets a standard that the trials have to be done in people who have 10% body surface area or more and a 12 PASI score. PASI is an assessment tool that we use that just tries to put a numeric value to the thickness, scaliness, erythema, and the amount of their body that’s covered. But as we mentioned before, the labeling will be from moderate-to-severe plaque-type psoriasis. Moderate means 3%. If you look at the definition and say, “Well, my person has 3%.” Sometimes, again, we have 1 therapy that has, on the label: 1% body surface area makes them a candidate for psoriatic treatment, for biologic treatment. Just because a person has 1% or 2% or 3%, where is a good place to have 1% body surface area of psoriasis? Where would be a good place that it would be acceptable?
Margaret Bobonich, DNP, FNP-C, DCNP, FAANP: Not 1%…
Melodie Young, MSN, RN, ANP-C: Not in dermatology, when they don’t want 1 big pimple somewhere where they don’t want it. The main thing you have to think about is [not to] prejudge a patient to say, “You’re not a candidate because you don’t have enough body surface area.” You have to think about all your patients being affected by this disease in some way. Rarely will you have a patient who says, “It doesn’t bother me at all. It doesn’t itch. It doesn’t bleed. It really doesn’t bother me.” That will be an incredibly rare experience in your clinical practice. Most of the time they are going to have things that bother them about the disease, which they may or may not communicate to you. There are going to be a lot of things about the disease that bother you, as a clinician, because you know what can happen. You know you have to assess for multiple, other factors. And you’re constantly trying to figure out what therapy is going to be best for them. “Where do I get them started, and how do I keep them moving across their life span, so we have minimal impact from the disease?”
Transcript edited for clarity.
