What’s the difference between primary and secondary failure of a biologic? And why does it matter? Exploring an actual patient case, faculty from the DEF Biologic and Small Molecule NP/PA CME Bootcamp—April Armstrong, MD, MPH; David E. Cohen, MD, MPH; Kara Gooding, MMS, PA-C; and Joe Gorelick, MSN, FNP-C—address these questions and many more. Plus, Mary Beth Hagan, Founder of TITAN Aesthetic Recruiting, gives tips for PAs and NPs interested in cosmetic dermatology, and there are changes coming to iPLEDGE for isotretinoin.
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What’s the difference between primary and secondary failure of a biologic? And why does it matter? Exploring an actual patient case, faculty from the DEF Biologic and Small Molecule NP/PA CME Bootcamp—April Armstrong, MD, MPH; David E. Cohen, MD, MPH; Kara Gooding, MMS, PA-C; and Joe Gorelick, MSN, FNP-C—address these questions and many more. Plus, Mary Beth Hagan, Founder of TITAN Aesthetic Recruiting, gives tips for PAs and NPs interested in cosmetic dermatology, and there are changes coming to iPLEDGE for isotretinoin.
Like what you're hearing? Have a topic you want to hear more about? Hit us up and spread the word on Instagram!
Please note: Errors in transcription may be present.
Welcome to the Dermalorian podcast from the Dermatology Education Foundation. We are so glad you've joined us for season two and are excited to launch a new season full of fresh insights and practical tips when it comes to an inflammatory skin disease. Every case is different and every case can teach a lesson speaking at the in-person, DEF, biologic and small molecule NP/PA CME Bootcamp in Dallas this fall, faculty members shared a wealth of tips based on consideration of a single case. Faculty were dermatologists, Dr. April Armstrong and Dr. David Cohen, DEF, founder dermatology nurse practitioner, Joe Relic and dermatology physician assistant and DEF advisory board member Kara Gooding. She introduced the case of James, a 42-year-old man with psoriasis and psoriatic arthritis who was being treated with secukinumab
And he was completely clear until about three months ago. Now his BSA is about 10% and he has stubborn plaques on his hands back and scalp that are unresponsive to high potency topical steroids, roflumilast 0.3 cream to pin her off 1% cream. His BSA originally was 30%. He's a typical psoriasis patient. He's obese, he smokes and he's otherwise, his past medical history is unremarkable. He's frustrated by the plaques and he wants to discuss other treatment options. His PSA is well controlled and he's previously tried and failed phototherapy, adalimumab, etanercept and ustekinumab. So a couple questions. One, is this a primary or a secondary failure? And then you want to answer that first? Yeah, what do we think? Is he a primary or secondary failure? Second secondary, right. He had been well controlled for 24 months and then it start to creep back up, although it seems like pretty more rapid than I would have imagined.
And then would you consider dose escalation or switching? Right, so that's a great question. So we have a few choices we could dose escalate. He is obese, which actually makes me think likely he will respond to the dose escalation or switching to a different biologic or small molecule. Maybe I'll give my kind of thoughts on this. And so his PSE is well controlled on secukinumab here, so it's not unreasonable to dose escalate him to see how he does. Especially he had responded to secukinumab before and the study I mentioned earlier in the morning actually looked at the exact type of patient and noted that if you dose escalated them to maintenance of 300 milligrams every other week, you can get a large increase in delta a benefit from that. So if the insurance approves it, you can probably do so. Let's say if it doesn't approve the dose escalation, then I probably, given his PSA had been well controlled on IL 17 inhibitor, maybe switched him to another IL 17 inhibitor, maybe ixekizumab for example, in this case small molecule. I would consider that maybe as an addition if I wanted to the whichever biologic you ultimately decide if after observing him on that either escalated dose of secukinumab or a new biologic for a while, if you notice still no improvement, then potentially consider adding the small molecule. So just some of my thoughts in that area.
Yeah, so I agree. So I would number one dose escalate straight away. Now that's in a glass castle, right? I've got a refrigerator full of samples, so I'm going to give him those samples and say, okay, instead of every fourth Thursday, you're going to give yourself the injections every other Thursday. So that's the dose escalation, increasing the dose over time. But I'm also then going to ask my rep to contact my MSL and get me some literature that I can then provide to the insurance companies. So when I see this patient back after a couple months and he's improved on this escalated dose that when I submit showing improvement, decreased body surface area, he went from a moderate down to a clear, almost clear document in my chart and I submit some literature that shows that dose escalation is effective and safe. That's going to hopefully help me get it approved so that he can stay on dose escalation. We can't keep him on samples forever. The practical component I think is smart and because the psoriatic arthritis is controlled, that's why I would stay in the same with the exact same drug and tri escalation as opposed to changing.
Yeah, I think the best use of the samples is to do dose escalation. It's much harder to argue the point that they've cleared on dose escalation than the theory that they'll improve on dose escalation. And I think when you switch classes and you have good joint control, you do take a higher risk that you might not have the joint control. You'll hear over time, you'll hear this drug did great for my joints but not so good on my skin, and then I switched to this other class and my skin cleared, but my joints didn't feel so good. So if he was doing okay, I would dose escalate. It would take a lot to add a small molecule for me. We still have a lot of traps to run before I'm going to add a second drug as opposed to switching. And so you have, I think II would be the next one. I don't think there was a contraindication for him to go on brodalumab if we needed it. And Brodalumab is dosed every two weeks, so that helps too. And it's a very effective drug. It's just got a higher bar to get it. You need to clear that REMS program and be signed up for it, but once that you get past that, it's pretty effective.
Agreed. And brodalumab, when you look at these analyses that compare the different biologics directly or indirectly, consistently comes up as among the top four biologics. It's always there. I think it's a little underutilized due to its label and the need for REM program, but you only need to sign up once as a provider and then you're basically set
And access. I think that it didn't have the commercial support that we wanted initially and you couldn't use it first line, but as a backup, think of that that drug is very effective and safe in this patient population.
Any questions before we move on?
I think they're having a food coma.
Yeah, no, that chocolate thing almost put me to sleep.
The peanut butter, peanut butter cookie was
Delicious. They
Were warm. All right.
All right. We're going to move into the next section, which is populations of special interests. So for pediatric patients, we have four biologics that are available. So etanercept, ustekinumab, ixekizumab, and secukinumab. I'm not going to read all of this if you want to take a Yep, I see cameras coming out. That's great. This is also in the cheat sheet as well. So you do not have to memorize this because as Dr. Cohen said, no one can memorize, and you don't have to know these. You have a reference where you can look them up, but you have etanercept, which is down to the age of four, and then the other three, which can be utilized down to the age of six, and you can see the different dosing schedules that are available.
Then just before we move on, it's so important to realize most of the time skin's going to come, skin disease is going to come before joints always ask about joints as people age, but the pediatric population that has nail involvement and scalp involvement has a much higher risk of developing joint disease. So it's important that these patients be adequately treated and the systemic inflammation be addressed systemically before you have any progression of joint disease.
Yeah, there's a couple of points I thought on This. One is never waste a pediatric indication when discussing a drug with an adult, right? Not the parent. I meant the adult that may be a little hesitant to go on a drug when they're 40 and 50 and 70 years old and letting them know this was tested in little kids. So I write this for six year olds, and that's amazingly reassuring for people because there really is a lot of work that you have to, that is hard to get that label and it really requires just a whole bunch of work too. And I'd be curious what you guys think is an 8-year-old with moderate to severe psoriasis.
They have some issues they're going to have to deal with that is not someone untreated who might expect to have a normal life expectancy or a normal anything resembling a normal quality of life into adulthood. Their joint disease can be terrible. Their risk of early cardiovascular death is high, and talking to parents about injecting a drug into their little kid for skin problems seems so foreign and imbalance to them. And I think you do have to explain some of the epidemiologic risks associated with leaving things alone. Now, when you are having a conversation with a patient that had moderate to severe disease in the 1990s or eighties or early 2000 and it was cyclosporine and you could go maybe a year or two because you're really going to risk renal failure or kidney or methotrexate with cirrhosis, pulmonary fibrosis, bone marrow suppression, it was a completely legitimate conversation to say, is my life being put at risk from the drug versus the disease?
And back then we didn't know the disease shortened people's lives and gave them heart attacks. So it was all about the drug risk. Now the conversation cannot be like, I think I'm just going to let the disease ride. I'm afraid of the drug. It's like, no, you have a load of trouble associated with this problem and not treating has real consequences that go far beyond the appearance of this thing. So you have to deal with it. And the risks associated with the treatment are so small compared the real risks of disease. So I'm wondering what your thoughts are on
That. We paused for the Dermalorian derm decoder. Many NPS and PAs working in dermatology are interested in providing aesthetic treatments, but finding the right training can be a challenge. In a recent Dermalorian webinar, Mary Beth Hagen, founder of TITAN Aesthetic Consulting shared her insights
For all of you who are existing dermatology, nurse practitioners or physician assistants. You have some things if you want to add aesthetics to your practice, that might make it a little bit easier for you than the average provider who is not within a dermatology practice. You already have a job. You may and probably already have patient demand in your existing practice. You may have in-clinic mentors that you can work with and that can help you be able to answer questions and study and learn and give you resources. And the other thing is there might be dermatologist procedure resistance. And what I mean to that is there may be opportunities for patients to be able to do some more cash medicine or some more things that you could offer that maybe somebody doesn't want to try Accutane, but they're quite willing to look at maybe popping up some of the scars with a dermal filler.
So there may be some different opportunities that you may have in an existing dermatology practice. There are also may be some things that might be a little challenging when you have a full-time job really going back and relearning facial anatomy from an injectable standpoint. There's a lot to learn there. There are so many products. When Joe started, when I started in this, there was one filler. I mean it was Restylane. Juvederm wasn't out yet. You had Botox cosmetic. Dysport wasn't out yet. I used to joke, it was the wrestling rep, the Botox rep and the Oji rep and all the laser people. And you never knew them because once they sold something, they never showed up again. Now I'm joking. So all jokes, but what we're looking at now is there's so many more products and to integrate cash procedures with the existing therapeutic procedures, it may be a learning opportunity not only for you but for some people and within the office as well.
And then learning to sell sometimes is challenging. And we talk a little bit at Titan about how there is truly a difference between selling and educating because educating is making sure that you have all that information for the patient, but the patient still has to buy or agree to pay for some of these aesthetic products that are cash only. And so it's different education and selling process and communication process with the patient. So I just want to think through some of the things that might be easy for you and some of the things that might be a bit more challenging. And one of the things that seems to constantly be challenging for anybody out there who wants to learn something new is how do we evaluate what training options are available? And if any of you guys have ever Googled Botox training or aesthetic injectable training or aesthetic training, there are four companies that come up right away.
Three of the four are owned by non-medical providers. And it's pretty interesting to see what they offer, how they sell and what they charge. And so what we look at within TIGHT is trying to offer a little bit of credentialing for and evaluating for you. And one of the things that we really try to encourage people to look at is what are the credentials of the person who is going to train you? And I don't just mean are they a doctor? Are they an NP? Are they a PA, are they an RN? What is their credentials? What are their credentials in terms of how long have they been doing this? Where have they trained? Are they a trainer for a large national organization? Have they studied and done this specialty for many years? Because the thing that scares me right now is how many people will go to these weekend training courses and then come home and six weeks later they've decided they're running their own training company. So really ask those questions before you decide to get training to make sure that whoever is going to be leading the training, writing the curriculum really has the background and the expertise to be able to do it safely and do it
Well. You are listening to the Dermalorian podcast from the Dermatology Education Foundation. Let's get back to the conversation with the biologic and small molecule bootcamp faculty as Dr. Armstrong discusses risks of untreated inflammatory skin diseases.
Yeah, I completely agree with that. I would say there's oftentimes a lot of hesitation actually for the parent to start their child on a biologic, rightfully so. It's scary. And so I see it. It's something that I kind of work on over some visits. We know that younger kids are at, people who are younger who have moderate to severe psoriasis are at the greatest risk for developing depression and suicidality later on. So I tell the parents, it's really important that we address this because we talk a lot about molecular scar of psoriasis, but what about the mental scarring that the child is experiencing? I actually try to, and I say, if this was my child, this is what I would do. And parents are different. And I say, but don't worry. I don't want to push anything onto you, but I do think this may be something your child could benefit from.
Let me see you in two, three months. Let's see what you think. And then if you have any questions, here's some literature, but bring all your questions back because if we don't address their concerns, they will not go on. But I can say the vast majority of kids who have gone on these biologics, their parents are typically so thankful afterwards, they're like, oh my gosh, this really changed their lives. And part of that discussion is the benefit risk discussion That's very important and it takes a little while, but I do have to say the reward is tremendous. And the one thing that they often have time they have, they have is how long will my child stay on this medicine? Right. Very good question. We don't have a good answer at this time right now, but what I will say is, let's get your child completely clear or in good control and let's see. Then we can think about potentially some customization. Obviously this will be off-label and then see what may be the minimal amount of drug that your child needs to maintain that response. And I say, if your child still have a little bit left, that means that we probably still have not achieved that goal before we can start the conversation about weaning. And I say their psoriasis will tell us, we can see it on the skin. So
Can I also just bring up one other question for the panel, and it's been my experience that the sooner you can get someone on a systemic drug for psoriasis from the point of onset of disease, it seems the easier to control and the more likely I might get a dur response, even post stopping the drug. And I think waiting too long and being too patient is a problem. I don't like waiting too long. Of course, if it's a guttate flare and you're going to get 'em over that, that's one thing. But the longer you wait, I think the harder they become to treat and they sometimes degrade and they start gaining weight and they start withdrawing socially. I think even the strongest personality cannot get past 30, 40% total body surface area involving their face and groin. That's a really tough thing. And when you're 18 and 20, it's really hard. And those are peak times people get psoriasis.
Yeah. Few thoughts on this. Number one is there's this concept of cumulative life impairment. What that means is that a person may be able to deal with these annoyances, but if it's a chronic disease, basically it adds up over time. And so our ability to cope with either chronic disease or other stressors in life, there's this balance. And no matter how strong you are, if you, over a long period of time as they creep up as a stressors, in this case, psoriasis is. And as that creep up, your ability to cope with them, ultimately, we all have a limit. Right? It's kind of like you go to work. I mean, totally different example, but let's say you go to work and there's a lot of congestion, right? LA traffic, you're late, and then suddenly you get a flat tire and then someone spills up to a point, even the most patient person just like this is terrible.
But imagine it's talk about going postal at a certain point. Exactly. Exactly. But getting to the point is that for people who have psoriasis a younger age, that's why it's so important to intervene earlier. And also there's rationale to intervene earlier from a scientific point of view. So there are these resonant memory T cells, which kind of remembers where your psoriasis plaques are, right? So they're like, okay, we always hone in there. We always home there. And then people who've had over a period of time, they actually start to have different populations affect different areas. So if you're able to intervene early, it shows that the duration of diseases really matters because it's easier to treat when they only had a disease for a certain period of time, given the same severity. So if you had one person come to you with 30%, the other person come to you with 30% BSA, one person had it for one year, the other person had it for 12 years, and then studies have shown that the person who had it for one year, it's much easier to treat at that stage. That's the point. Yeah, because there hasn't been this immunologic evolution. Yeah. Don't give the pound tub of triamcinolone as a long-term solution. You give the tub of triamcinolone waiting for the PA to clear.
Speaking of stress, prescribers of isotretinoin may find that the process will become less stressful soon. For this episode's Dermalorian clinical clip, here's an update on the I pledge Risk evaluation and mitigation strategy program, or REMS for isotretinoin prescribing last month. The FDA ordered the Isotretinoin Product Manufacturer's Group, or IPMG to institute changes to the I pledge program. Updates include removal of the 19 day lockout for patients if they do not obtain isotretinoin within the first seven day prescription window. Additionally, after initial enrollment, patients who cannot become pregnant do not require ongoing counseling on fetal exposure risk. The FDA is also making the use of home pregnancy testing for patients during and after isotretinoin treatment, a permanent part of the I pledge monitoring IPMG has 180 days from the date of the FDA letter to implement these and other mandated changes. That's it for this edition of the Dermalorian podcast from the Dermatology Education Foundation. Catch up on season one anywhere you listen to podcasts, and be sure to tell your colleagues to tune in too. Thanks for joining us.
Transcript is a draft and has not been fully edited; errors in transcription may be present.