Chapters Transcript Asthma in 2023: Time to get SMART finally? Dr. James Krings, MD, MSCI discusses the latest guidelines and recommended care for Asthma in 2023. I'm gonna go ahead and introduce our next speaker, Doctor James Kris, is it? Criss Pris earned his medical degree at Stanford University School of Medicine in Stanford, California and then did his internal medicine residency at Northwestern University School of Medicine in Chicago, Illinois. He then came to Saint Louis to complete his Masters of Science and Clinical Investigation and his fellowship in Pulmonary and Critical Care Medicine at Washington University School of Medicine where he is currently an Assistant Professor of Medicine in the Division of Pulmonary and Critical Care Medicine. He sees patients at the Center for advanced Medicine at Barnes Jewish Hospital for asthma and chronic COPD. So thank you so much for being with us today and talking with us over asthma, which is probably big right now with all the allergies and everything going around. Take it away. All right. Um So I'm gonna be, I'm gonna be talking about the latest uh guideline recommended care uh for asthma um and uh specifically um for something called smart therapy that stands for single maintenance and reliever therapy. Um That's our uh guideline recommended uh inhaler care for asthma. So, um a uh we do have some disclosures. Um We are uh funded by the NIH and the uh American Lung Association as well as some internal funding. We do do uh industry sponsored studies in our group including uh most notably with astrazeneca, uh astrazeneca is the maker of uh Ben Motor, all uh name brand Symbicort. Uh that we're gonna be talking a fair bit about. Um I don't um think I'm gonna be uh giving any significant uh, bias. Uh, as I'm talking about what is guideline recommended care. Uh, but that is, uh, something I would disclose a little bit about me. Uh, I was born and raised in Saint Louis. Um, I grew up, uh, eating gooey butter cake and, uh, Ted's ice cream. I now, uh, uh, take care of, uh, people with, uh, uh, primarily severe asthma in our, uh, our Monday severe asthma clinic at, uh, at, at, at Barnes Hospital. Um, uh, and the most important thing in my life, of course is, uh, uh, my family and we, this was us just the other day, uh, trying to, uh, get outside and get some, uh, uh, get some sun. So our asthma group, we're very lucky to have a wonderful group of people that we work with, um, including multiple, uh, coordinators, um, and, uh, uh, different, uh, investigators and, and, and trainees that work with us. You'll see, I'll, I'll try to, uh, weave through the people that, uh, uh, work with us and thus and throughout the powerpoint, but you'll see some people from our economics group and our healthcare design studio and some of our community partners that we work with. So what are we gonna talk about today? So uh when I give an asthma talk, I like to first talk, talk about what I call the state of the asthma union. So where are we at on that in asthma? Why, why do we need to care about asthma? Um And then we're gonna discuss the latest evidence-based asthma therapies. Um We'll talk about mild um And is there even intermittent asthma? And what the best treatment is for that? Then we'll talk about smart therapy or single maintenance and reliever therapy and moderate to severe asthma. We'll talk about some of the real world barriers to prescribing the new inhaler therapies and we'll um try to weave in some of the stuff um that we're doing in these areas in our group. There's a Q and A later, I have kind of some practical tips to how to prescribe smart therapy. And my hope would be that this is very pragmatic for people and something that uh people could take into their uh real world practice. Ok. So let's talk about the state of the, the uh the Saint Louis Asthma Union. So my argument is that uh asthma is common, asthma is expensive and we have all sorts of new drugs. Uh and, and asthma, new inhalers and yet the uh outcomes for asthma are not improving for most people. Asthma is marked by humongous uh inequities and our community of Saint Louis epitomizes all of the above. So if we zoom out, look at asthma from a global scale, 450,000 people die of asthma in the world annually. 96% of those are in developing countries in the United States. Uh 25 million uh people uh have been diagnosed with asthma. One in 10 kids have asthma. Costs are uh uh country and direct and indirect costs. Around $80 billion. Uh Depending on the year. Uh anywhere between three and 4000 people will die of asthma. Uh uh asthma results in around uh 14 million missed school days. It's the number one chronic illness reason that uh kids are missing schools, uh uh causes 14 million missed work days. Three and five kids tell us they have to limit their activity because of asthma. Um 71% of people will be misusing their inhalers and one in five people. Uh uh tell us that they can't afford uh their inhalers in the uh in the United States on the left is a, a graph that looks what's happening um at uh cancer mortality in this country. And if you zoom out and look really over the two thousands uh from 1999 to 2020. Uh Thank God the um the, the death rates from uh, cancer are going down every year. And I, that's a, a continued political focus to get that even lower. The, the purple line represents the goal um of the current, uh the current administration, how to get to by the year 2030. If you contrast that on the right with the, the same uh sort of uh timeline look what's happening with asthma mortality uh from the year 2000 to 2020. You can see that even though we have new drugs, the asthma mortality rate is not going down. I fully respect that the scales uh on the Y axis here are dramatically different. Uh But I would still tell you that 11 people are dying of asthma every single day. And the thing with asthma is every single one of those deaths is really preventable with uh with guideline recommended care. So many people that are having uh bad outcomes from asthma are uh using sa monotherapy, meaning using something like albuterol, only the people that are having the worst outcomes from asthma are not the people that are prescribed uh multiple inhalers and um are taking biologics. Yeah. In an analysis of asthma death, 46% of patients that died from asthma had not used a single inhaled corticosteroid in the last year. Every inhaled corticosteroid that a patient refills. It decreases the risk of death by 21%. On the right is a graph from the New England Journal of medicine back in 2000 where on the Y axis, they looked at the risk of death on the X axis. They looked at the number of canisters and inhaled corticosteroid. The patients refilled as patients refilled more and more inhaled corticosteroids, their risk of death went dramatically. Now contrast that with a short acting beta agonist and it's quite, it's quite the opposite as people use more beta agonist. Their risk of death goes up. So this is a, a study from the New England Journal of Medicine from 30 years ago where they looked at 355,000 people in Sweden and followed them for nine years. What they found is that for every canister of a short acting beta agonist that they were refilling, their risk of death was going up and up and up. So again, when you see somebody in your clinic that's using albuterol frequently and you look at the refill records and they're not refilling any inhaled corticosteroids that ought to be AAA flag that they're at risk of a bad outcome. According to the CDC, black patients are nearly three times as likely to die from asthma. And our hometown of Saint Louis epitomizes all of this. So this is a uh a uh a figure that we put together for a recent grant where we looked at uh asthma uh morbidity in, in the Saint Louis community uh for people who aren't familiar with Saint Louis um uh the, there's been talk of the famous uh uh uh Delmar divide um where you have the north part of the city that's uh associated with uh um a lower socio-economic status communities. Um And that's uh um uh up towards the top of the, the, the city. And you can see that uh in the um lower left that uh this is where most of our asthma hospitalizations are uh coming from. And that overlaps uh strongly with uh where people identify as black or African American and where uh families are living below the poverty line on the top is a bar graph where we broke people uh out uh by their uh race and ethnicity. And uh every year people identify as black or African American in Saint Louis are around eight times more likely uh to be uh hospitalized for asthma. Uh Saint Louis is an asthma capital. Uh Children in Saint Louis suffer asthma at a rate that's three times the the rest of the country. And um based on a, a recent report, childhood asthma is the number one health care disparity in Saint Louis. So I hope with that background, I've convinced everybody that asthma is a, a big problem. It's a big uh health care in inequity and it's something that we need to do better on. So we need to do better. What can we do better? I recognize that's a complex thing. But some of my uh arguments are that inhalers are incredibly confusing. Uh I think for both doctors and patients inhalers are way too expensive and sometimes difficult uh for people to afford maintenance, not inherent is incredibly common people, even if you're prescribing somebody, a maintenance inhaler, somewhere between 30 70% of the time they're not gonna take it. Um Remember most uh asthma care is happening uh with you guys in primary care and in E DS um where you're also um trying to uh deal with other comorbidities while you're trying to explain how to use an uh an inhaler. Um We know that most encounters don't result in providers using evidence-based um asthma care. And my, my belief and the belief of our group is that prescription of uh smart therapy uh could be beneficial uh in our Saint Louis community. And I will also point out and we'll talk about it a little bit uh that uh smart therapy is covered by uh low health, not a Missouri Medicaid now. So I pulled this up to ask how, what are we doing uh in asthma. So this is all of the different inhalers. This is um from uh 2019. So there's even a couple more than this. We have this up in our uh our Pulmonary uh work room. And I can tell you with 100% confidence that a third year Pulmonary Critical Care fellow does not know every one of these inhalers does not know what's in them, does not know how to tell people how to use them uh correctly. And I also think asthma inhalers are incredibly confusing. So on the left are four very different inhalers in the upper left is Flovent uh or fluticasone. And um as some of you undoubtedly know that's been in the news recently because the uh Glasgow Smith Kline who makes Flovent has pulled uh has stopped making Flovent is now making generic fluticasone that's affected access. The lower left is QR that's also an inhaled corticosteroid looks very similar but has a different delivery device. It's a dry powder red inhaler. Uh So uh can't be uh used with a, a uh spice in the upper right, is proair uh on the lower right is Symbicort. Um and that's uh obviously a combination inhaler. So I just ask you, you ask yourselves if you're prescribing uh these different inhalers. One of these is a maintenance inhaler, one of these is a rescue inhaler. They look darn similar to me. Um And I think people just get uh confused about them. The other thing is don't forget that we also have a over the counter uh inhaler uh and uh pill medicine that I think we, we forget about. Um So, uh that's uh primitive mist or uh inhaled epinephrine. Um And you'll see that, you know, in Walgreens or CV S uh above the um above the pharmacy kind of where they keep the the Sudafed medicines. Um, this is, if you, uh, if you pull it up on, uh, Walmart or Amazon, this is one of the best selling medicines. Um, and uh, this is just uh inhaled uh epinephrine, uh that uh has been associated with bad outcomes. So I, I normally like to do this as a pole but I, I think it's, um, uh, I think we can all just uh take it on our own and um and think about what we think the right answer is and I'll, I'll try to argue for what I think the right answer is. So this is a, a 28 year old female with asthma that you see in your clinic. Uh She's had asthma since uh childhood. Her symptoms are very classic as wheezing and a dry cough when exposed to cold air. This is happening for her about three times per week. She is not waking up with any of her symptoms. She did exacerbate uh uh uh one time nine months ago uh requiring uh predniSONE and tells you I've stopped, I stopped taking all of her inhalers because they were expensive and she often forgot them. Anyway. Uh Her fev one is 84% of predicted. She has a positive bronchodilator response. She is covered by Mo Health Nut or Medicaid and you have to now uh prescribe her a new inhaler. So what treatment will you recommend? And why? Uh so one possibility would be to prescribe her uh reliever, albuterol two puffs for symptoms. Possibility too would be to prescribe her low dose maintenance, inhaled corticosteroid and albuterol two puffs with symptoms. Possibility. C uh three would be to prescribe her bide for motor 81 puff for symptoms and no maintenance inhaler or possibility. D would be to prescribe her Buda for motor 161 puff for symptoms and no maintenance inhaler and give people uh about 15 seconds here to think about what the best answer is. All right, I am going to argue to you guys that answer D is the best answer. Um I think the classic answer would be answer B and I'm gonna try to convince you on why I think D is the right answer. So this is what, where we're gonna focus on the treatment of mild asthma. I will tell you uh having given this talk in a lot of different groups, including to um uh different pulmonary and allergy providers. Uh Most people are answering BC or D. Um So a lot of people are uh using the uh the older uh paradigm of a maintenance, inhaled corticosteroids and as needed. Saba, most people recognize that albuterol monotherapy isn't enough uh for this kind of person. And then a lot of uh people, at least in the pulmonary space and allergy space are trying to go to a reliever only I CS for motor uh paradigm. Uh But um they're kind of split between C and D. OK. Let's talk a little bit about mild asthma. So mild asthma is most asthma, 50 to 75% of people that have asthma have so-called. Mild asthma. Remember that mild asthma can still be life-threatening. This comes up uh uh all the time. Uh For me when I work in the uh uh intensive care unit where we'll see something that's uh intubated for their asthma. Um uh uh extremely sick and the residents uh or fellows will be telling me about the case and they'll go and they were only prescribed albuterol. Like, can you believe it, this person is so sick now? Well, that's, that, that's the reality of asthma that um around one third of people that um that uh uh have uh asthma mortality were billed as having asthma uh mild asthma for that. Remember many people with mild asthma are not taking their maintenance inhalers, beta agonist overuse and I CS under use is associated with mortality. I pulled up those graphs before and there's this thing called the Saba paradox. And we'll talk about uh what that is. And I'll argue that there's a simpler way to do things that's gonna combat some of this. Some of these problems with uh maintenance, inhaled corticosteroid uh under use and non adherent. So, what is mild asthma? Well, we have uh two different guideline bodies and asthma, one of them is uh Gina and it becomes complex. What's mild moderate severe. They really say you're not supposed to assess asthma severity until you're already figured out what step of therapy they need. They no longer use this whole concept of intermittent asthma. Uh They'll argue that asthma is a chronic disease, um that may have periods of uh flaring and getting better, flaring and getting better. Um But that's just the normal disease. It's not a that's to be expected. It's not like asthma just goes away in between those periods. They also will point out that calling asthma mild may not be very helpful in clinical practice. And this is something I I try to be careful about when you go in and go. Oh, you just have intermittent and mild asthma. But I still want you to take a me a medicine every day. Is that really realistic when you go in and tell somebody that it's mild or intermittent? But I also want you to take a medicine every day. You're kind of downplaying it while at the same time trying to um get them to be adherent to the maintenance, inhaled corticosteroid. Um Everything does have a definition for every step, but basically what I would say is mild asthma is asthma or people aren't having symptoms every single day. It happens sometimes but not every day. And if we look at the preferred therapy for mild asthma and this is really a step one or two. What you'll notice like Gina recommends is they recommend an as needed low dose I CS for motor all inhaler be used on a reliever basis. That's all they're recommending. And this is the preferred therapy. We'll talk about some of the evidence behind that. This is their preferred track. The alternative track, which was answer uh uh B would be that you could prescribe this person a maintenance I CS and an as needed uh short acting beta agonist. But they will say that the data for this is that this is inferior uh to uh reliever only therapy and we'll talk about this. So this all occurred in 2019 and 2020. 1 of the benefits of this is that uh patients don't have to take their uh inhaler every single day, they can just take their inhaler as needed. And you also are only prescribing them one inhaler rather than two different inhalers. You're prescribing them A I CS promotor all inhaler to take as needed. Um Just for completeness, this is the Napp guidelines. They still do endorse the concept of intermittent asthma. Um But I will tell you that um uh many of the um experts that were on the other committee were on this committee as well. Um And they, because of the way the, the mandates worked uh in the guideline updates, they were not able to review the concept of intermittent asthma. Um And this has not been reviewed since the data that I um that I'll show you has come out. So, what's the rationale for these new guidelines? Well, we know that spikes in asthma mortality have been associated with beta agonist use without an I CS. So we're really trying to combat this whole idea of, I'm gonna prescribe somebody, a maintenance, inhaled corticosteroid and a short acting beta agonist. And they're gonna go out and not take their maintenance inhalers, short acting beta agonist, do nothing to get rid of airway inflammation. And in fact, if people are regularly using their short acting beta Agnes like albuterol, it can make their airways more inflamed and more uh hyper responsive uh to uh triggers. So with the top, on the top right is a uh a study um from about 20 years ago where they had patients repeatedly take uh a placebo or tribune. It it short acting beta agonist, a bin or they combined both of those and the lower values mean that their airways are more hyper reactive. So when somebody is taking uh tribune or short acting beta agonist repeatedly, their airways do not become less reactive. And if anything, they become more reactive, if you con you contrast with somebody that is taking an inhaled corticosteroid, their airways are gonna become less reactive. So the next time they're around a trigger, whether it be pollen like it is right now or a virus, their airways are gonna be less reactive on the bottom is looking at their eosinophil count or marker of inflammation inside their airways. When people are taking terbutaline or a short acting beta agonist repeatedly, their eosinophil count in their airways goes up. So you're gonna see them become their airways become even more inflamed. And if you contrast that with them getting an inhaled corticosteroid, then their airways are gonna become less inflamed. So let's go to our, our prior patient. This is a real world example. So you have a patient with mild asthma. Remember that case? They told you that they're, they're having trouble remembering to take their maintenance, inhaled corticosteroid and they're really relying on their albuterol inhaler. So this is that person uh at the top, you prescribe them, um you prescribe them a maintenance I CS and a reliever, short acting Beta Agnes like answer B. So the uh X axis is time, the white Y axis has a couple different things here. So the, the black line represents their um their asthma symptoms and the yellow line rec uh um is their uh airway inflammation in their lungs every time you see a blue mark, that means they took their reliever short acting beta agonist. And every time you see a red mark, that means they took their maintenance, inhaled corticosteroid. So time is going on. Maybe it's uh it's April of 2024. The pollen counts up. So they're starting their airways are starting to get more inflamed. Uh their ES NFL counts and their airwaves going up, they're getting more and more asthma symptoms. So, what are you gonna do when you have more asthma symptoms? You're gonna go grab the inhaler that makes you feel better and that inhaler that makes people feel better is their albuterol. So they're gonna take their albuterol. That's all these blue lines. And you know, the thing is they inhaled corticosteroid though. It, you may be told them it's important, it doesn't make them feel better in the moment. It just has a steroid in it. Um, so they, and they, they forget to take it. Um, so they're just continuing to forget and they're continuing to use their albuterol more and more and more. And I just uh demonstrated you in the last slide that um regular use of a short acting beta agonist can make your airways more hyper responsive and more inflamed. So this is just cascading out of control all of a sudden they're going into the, er, and they're getting the course of predniSONE, then their airways become less inflamed and on the go. So contrast this, if we uh combined a uh beta agonist with an inhaled corticosteroid, and we tell people to take that um, as needed for symptoms. So, the same sort of thing, they're exposed to pollen. It's April 2024 their airways are getting more inflamed, but look what they're doing. They're using a combination inhaler on a rescue basis. It's making them feel better because it has a beta agonist in it. And on top of that, it has an inhaled corticosteroid in it. That's making their lungs less inflamed and less hyper responsive. So they become less and less and less inflamed and they're using it more and more because the pollen counts up and they're, they're feeling crummy and look, they could avoid that whole predniSONE course on. They go. So this all sounds good. That's all really theoretical. So let's talk about the studies that back this up. So there was four big studies that back this up in mild asthma. The sigma one sigma two practical and novel start study. They all enrolled people with uh genus step two asthma. And what they found is that when you compare the group that was uh prescribed just a short acting beta agonist alone uh versus um A uh reliever I CS for motor, all the people that were prescribed a reliever I CS for motor, all their risk of exacerbating went down by 2230. And if you say, OK, well, I, you know, I I, but I prescribe people a maintenance I CS plus albuterol. Well, I will tell you that you're don't forget that many of those people are not adherent to their maintenance. Inhaled corticosteroids, you gotta really hope they're adherent. And even in the studies where people were adherent to their maintenance, inhaled corticosteroid, this paradigm of using an I CS for motor all as needed, decreased their risk of exacerbating by about one third as compared to a maintenance I CS plus saba therapy. On top of that, people are only taking their inhaled corticosteroids when they need it. So they're exposed to even less inhaled corticosteroids. There are some caveats in this, this has been understudied and people that are less than 12 years old. A lot of these studies were done outside of the United States where they were using AD P I Bide from overall inhaler. And um those slight they do have um people that aren't using a maintenance inhaled corticosteroid do have more day to day symptoms. One of the uh hypotheses uh uh that I um our group has is that we really ought to be identifying people that are not adherent to their maintenance inhalers and we ought to really be prioritizing a reliever I CS for motor all uh therapy um uh for this group. And that's something that we're working on in our uh in our group with a study that will be coming out um hopefully, uh later this year. And we've al we've also done qualitative work and we're trying to figure out why primary care providers pulmonologists and allergists are or are not prescribing I CS for motor all inhalers as needed. And there's a lot of barriers, there's a lot of complexities to this. So one pulmonologist we interviewed says, well, every insurance has a different formulary and they want different I CS lavas for their patients. So that's the reality and we'll talk about it in a minute. If you're gonna use this, you really have to be prescribing A I CS Lava that has for motor as the long acting beta agonist in it. And that's really a name brand Symbicort. Uh and Uro right now, another person, this is a primary care provider who's been in practice for 20 plus years. They told us that the biggest benefit of these new inhaler approaches is just having one inhaler rather than having two different inhalers. I've lost track of how many times patients have mistaken their maintenance therapy versus the rescue therapy. Talking about the simplicity of just prescribing one inhaler uh for people. These are all these different uh uh themes that came out uh on our interviews with people and this has really been guiding our work on how we're going to implement this therapy better. Um uh We are working with payers. Um And we're working on uh creating tools uh for patients and new asthma action plans uh to help explain. Um uh are, are the new in uh inhaler paradigms. And then we're trying to uh help educate uh providers on how to prescribe these new paradigms. Um I talked a little bit about how, how we really want to rework our asthma action plans uh to integrate um uh these kind of new inhaler approaches that we've just been talking about. Um So for that work. We've been partnering with people uh, in the Sam Fox School, uh, the healthcare design studio and we've been designing new, uh asthma action plans, um, working with, um Epic and, um, you know, getting these, uh integrated into our electronic medical record. Um, I don't know what other people's views of, uh, asthma action plans are, but I often find they're written at too high of a, a grade level and most people honestly, um assuming the provider fills out, they go outside and they throw them away. Um We're trying to rethink that um uh uh I mean, more worthwhile also creating tools. Uh So providers know how to prescribe uh these new inhaler paradigms and the benefits of doing. So, uh that's on the right. Uh What that provider tool looks like on the left is one of our asthma action plans. And then we're, uh we're working uh with uh payers um to understand the benefits of the new inhaler paradigms. Uh This is uh some work we've been doing with um our, uh our, our, our, our partners on the, on the Danforth campus, um and economics and uh trying to demonstrate that um uh even if A, an I CS for Motor all inhaler is a little bit more expensive uh with the prevented uh uh morbidity, uh and the expensive, prevented, expensive, er, stays and hospital stays, it could, in fact, um uh uh uh save the payers money at the end of the day. So um we've been very lucky uh Mo Health Met uh or Medicaid has been very forward thinking and they recognize the benefits of this. So people maybe have seen these flyers come out. Um They are trying to move people towards um uh uh BDA for motor or smart therapy and away from Albuterol. So you'll see that there's a limit um on how many um uh Albuterol refills. Um They will uh Medicaid will pay for uh with three and six months. And the reason being that it's the slides that I pulled up for you before you, before somebody is using Albuterol that often. And that is a humongous marker of a bad asthma outcome that's coming and they really wanna move those people over to um move those people over to smart therapy. Um uh mo health net or uh Medicaid will cover um they will cover uh up to uh three bide for motor all inhalers every month at nearly $0 copay. Um uh And so that, that example I gave you before uh was somebody that would have had uh uh an I CS for motor all inhaler paid for because they were covered by Medicaid or Mobile Health. The other thing I'll uh point out um is that there is another rescue inhaler uh on the horizon. Um It's already making its way into our uh clinical practice. We have samples of it in our uh in our clinic and I'm prescribing it some and that's uh the combo. But aside, and Albuterol, uh this is results from the Mandela uh study that they came out um uh just about uh two years ago now, uh in the New England Journal of Medicine and very similar to uh Bide for motor, all they found that uh using Bide Albuterol on a rescue basis, uh uh decreased people's risk of exacerbating by about 25 to 30%. And this is uh what the brand name is. Supra Buda Albuterol. It was FDA approved for adults uh in January of 2023 and it's slowly making its way onto different formularies. People use this very similar to albuterol instead of using albuterol, they use bide albuterol two puffs as needed. Um The studies of it as a stand alone therapy only on a rescue basis are very limited. Um but it probably does have some of the benefits of uh bide for motor all as needed that I showed you before uh because it contains both of beta agonist as well as an inhaled corticosteroid. So I wanna move into uh moderate to severe asthma uh and give you guys another uh case and we'll uh we'll talk about what we think the best answer is here. So this is a uh a 43 year old male uh who's had asthma since he was a kid. He sees you due to a loss of asthma control since he moved to Saint Louis. Uh He is managed on fluticasone salmeterol. A brand name Advair. He's prescribed 100/50 microgram one puff B ID dose. It's a low dose uh fluticasone salmeterol. You go into Epic and you review his refills of his inhalers and you find out he's very adherent to it. He's using his fluticasone cell metol about 90% of the time. However, despite good adherence to his maintenance inhaler, he's exacerbated three times in the last year. All of those were treated uh at in urgent care uh with predniSONE courses. His asthma control test for AC T score is 21. Um That's a scale from uh 5 to 25 and that would say he's not having many day to day symptoms. Um He has asthma symptoms weekly but not nighttime awakenings. His peripheral eosinophil count is 0.4. His IgE level is 20. Uh What treatment strategy would you recommend? And why? So a would be, you're gonna step up his fluticasone salmeterol or ad Advair from the 100 to the 50. So from low dose to moderate dose and you're gonna tell him to continue to take Albuterol Pr N or you're gonna flip them over to Buda for motor all 80. Tell him to take two puffs twice daily and two puffs pr N or you're gonna flip him over to be last night for motor 160 have him take one puff twice daily. And one puff as needed. Or you're gonna begin paperwork for a biolog shake or refer him, uh to allergy or pulmonary, uh, to get a biolog shake. So I'll leave this slide up for a minute and people can think about their answers and we'll go over what we think the best one is. All right. I'm gonna, um, I'm gonna argue the, uh, the, the preferred answer would be answer c and that's a, a flip over uh to uh true smart therapy, smart therapy, single maintenance and reliever therapy. So the same maintenance therapy is the reliever therapy and that's BDA motor. Um And the correct dose of that is the 160. Uh And we'll talk about that here in a minute. I will tell you uh for anybody that's 12 years old or older uh with smart therapy, the correct answer is always uh Buda, I for motor, all 160 and outside of little kids that are 4 to 11 years old, that's the only time you would consider the 80 dose uh for smart therapy. So this was our pole that never worked um to get you to the next line. Ok. So this is what, what are the guidelines recommending? So we've done, done with step one and two and we're moving on to step 34 and five. And that's where really this person's fall and this is where there's really great concordance of uh of the recommendations and the asthma guidelines on the top is the the Gina recommendations and they will talk about it. Step 34 and five, they're really recommending the preferred treatment of smart therapy, single maintenance and reliever therapy. This is the Napp guidelines. This is from the NIH um another set of asthma guidelines. Very similarly look, they're gonna recommend preferred is smart therapy for these people. So what is smart therapy? Why is it, why, why are people recommending it? Well, smart therapy is where you use the same inhaler for both maintenance and rescue use. It combines both a beta agonist and a fast onset uh long acting beta agonist together. When this stuff has been reviewed, they are recommending uh smart therapy based on a high certainty of evidence. Smart therapy has now been studied in more than 22,000 patients with asthma and demonstrated clear superiority over traditional therapy depending on the study. Uh smart will reduce somebody's risk of exacerbating by anywhere between 30 40%. Um And I, I do always put that caveat out there that most of the studies were done outside of the United States. However, I will uh also point out that the US based guidelines have reviewed this and and uh think that the data extrapolates fairly well. Other thing to emphasize is the long acting beta agonist and smart has got to be Formoterol. And the reason is is that Formoterol has a quick onset. So if you were prescribing somebody um something like fluticasone salmeterol or fluticasone vantol. Those are Advair and Brio, those lo a long acting beta agonist take longer to start working. So they will, they won't work within a couple of minutes like for motor or albuterol. So if you're asking somebody to use it on a rescue basis, they need to feel better. Like now um within minutes, they can't wait uh 20 minutes for the long acting beta agonists to start working. Hence why it has to be for motor all. So this is a meta analysis that was uh in Jama in 2022. And this is the exact case that uh we had so that I showed you a couple of slides ago. They took uh they took um uh studies where they looked at people that were, had lost control um on their dose of uh uh an inhaled corticosteroid long acting beta agonist. And they randomized them to one of two groups. One was they stepped up their inhaled corticosteroid dose from, let's say low to medium dose from medium to high dose. And then the other group, they, they kept the dose the same, but they flipped them over to smart therapy. So basically their reliever therapy and their maintenance therapy was the same. Um And what they found is that the people that were flipped over to smart therapy, their risk of uh having another exacerbation was decreased by 32%. And that's as compared to stepping out up the dose of their inhaled corticosteroid. So this is a good point to emphasize. One of the ways that smart works smart is not just about going up on the inhaled corticosteroid dose. Smart is about um getting people an inhaled corticosteroid when they need it the most. So when do they need it the most when they're having symptoms, when their airways are more inflamed and so they're constantly titrating their inhaled corticosteroid dose themselves when they're using their rescue inhaler more, they're getting more inhaled corticosteroid. Then maybe the season, it's a different season. The pollen counts go down. They don't need their inhaled corticosteroid as often. They're just taking it on a maintenance basis. Hopefully they're adherent sometimes. Um And then their dose of inhaled corticosteroid goes down there. This is an article that we wrote in our group about all of the barriers, how we need to increase knowledge. We need to um uh get insurance covering uh uh smart therapy more. We need to figure out what we're gonna do with people's nebulizers. Figure out what we're gonna do with asthma action plans and costs and incentives. We also argued that how we need to get these kind of bad asthma medicines that are associated uh with morbidity and mortality and have no inhaled corticosteroids in them off the market. So some helpful tips and this is just in the last 5 to 10 minutes. I just want to give some practical tips for people on how to prescribe uh smart therapy that I hope are worthwhile uh to people. So how does smart work? And we just emphasize this minute ago, it is about providing an inhaled corticosteroid when needed. It is not about just more inhaled corticosteroids and it also combats the so-called sava paradox. So in fact, we think that smart therapy may be even better and people that you notice are not adherent to their maintenance inhaler because then every time they're taking their rescue inhaler, they're at least getting some inhaled corticosteroid does an I CS for motor work as quickly as a Saba. Yes. Uh For motor all works within minutes just like albuterol. But the lava must be for motor and that's why it has to be um uh it has to either be Symbicort or Dulera. So what, what dose of I CS for motor should I use based on the studies? Uh Anybody that's 12 years plus you ought to use Bide for Motor all or uh name brand Symbicort, 1 60/4 0.51 puff daily or B ID and one puff with symptoms. Then if they're uncontrolled, then you can increase it to two puffs B ID, et cetera. There is, you can extrapolate this data to Dulera. Uh That's Mutaz for motor, all the dose of Dulera is the 100/6, the equivalency doing BAC and Moaz would mean that you ought to use the 100 dose of the, uh, of Dulera. Should I ever use Saba monotherapy? Well, if you, if you read the Xena guidelines, they'll, they'll say no, they never recommend saba monotherapy. And that's because they demonstrated that I CS for motor all was better preventing exacerbations and people that were having symptoms as frequently as only twice a month. And don't forget that you're behaviorally training people to regard their albuterol inhaler as a rescue inhaler as opposed to their I CS for Motor all inhaler. How do you prescribe reliever only I CS for motor and mild asthma? Well, you're gonna tell people to take 1 to 2 puffs of bide for motor all um uh daily and as as needed, don't forget that you may get a call from a pharmacist because there are, people are still getting used to this whole idea of BAC for motor all being a reliever therapy. And the other technical thing here is that Symbicort and Dulera do expire uh after three months. So if you have somebody that's really rarely using a rescue uh therapy, that might be another problem. Should the dose for the relief be one or two puffs of Buda from motor. Um And the answer is one puff because one puff of Buda from motor all is equivalent to two puffs of albuterol. Um uh As far as uh the re relaxing the airways opening up the airways, how much uh I CS from motor all can be taken safely with smart. This comes up all the time. People are like, how many puffs of, uh, PAC from motor? All can I take in a day? And we say, well, you take one puff at a time and then you wait a few minutes and you can take another if you're using more than six in a row or you're using more than 12 puffs in a day. That is a marker that your asthma is markedly out of control and you, uh, probably ought to be seeking a higher medical care, calling your doctor. Um, and then the max for Dulera is eight puffs in a day. How safe is that? That makes people nervous hearing about taking, uh, uh, 12 puffs of, uh, beside for motor all in a day. So this was a study that, uh, came out, uh, about a year and a half ago where they had people repeatedly take albuterol 0, 30 60 90 minutes on a nebulizer. This is like replicating somebody that's losing control of their asthma and going to the, er, alternatively they had people take beside from motor all repeatedly, uh, just like they were, uh, going to the, er, and this ended up being, uh, 12 puffs in a day. They looked at their fev one, they looked at the potassium and they looked at their heart rate. People that were taking the albuterol frequently their potassium dropped even more, uh, than the Buda for motor and their heart rate went up even more than Buda nine for motor. And I'll also point out to you that this has now been studied in 22,000 people and there has been no safety concerns based on a recent Cochrane review or the guideline review can smart be prescribed with other I CS lava combos. So quick answer is no. Um uh All of the studies have been with Bide uh for motor all. So you really don't wanna be prescribing somebody something like uh fluticasone ferol Brio and uh I CS for motor on a reliever basis because that hasn't been studied. You might have trouble getting that paid for. Um What about people that can't remember? They don't know when they have asthma symptoms. They're confused. Well, I'd say they're still getting their maintenance inhaler with smart and those are often people that are not the most adherent to their maintenance therapy anyway. So I still think smart is very reasonable. How do I go down on some of these dose? I prescribed somebody smart but I wanna start tapering their dose. We don't taper down on the dose of Simcor. It's always that 1 60/4 0.5 dose, but you decrease the number of puffs that you recommend they take in a day. Does phenotyping have you any role? No, there's no role for phenotyping. It doesn't matter whether eosinophil count or anything else is, you don't have to do any blood tests does smart involve more cost. Well, it probably doesn't for the payer. And if you have somebody that's covered currently uh by Mo Health Med or Medi Missouri Medicaid, these people, they can get up to three bide for motor all inhalers in a month. We're uh still working with other payers. Um It depends on the formulary for the, for the particular person, whether or not there's an I CS for Motor all on there. And we'll also point out that bide for motor all is going generic and that's increasingly on more, uh, on more formularities. What about people with exercise induced asthma? Exercise, induced symptoms? I would also argue for you for these people. You ought to be prescribing them. Bide for motor. All. This was a study here where we had people uh, take, um, a bide for motor before exercise. Albuterol before exercise or they were taking a maintenance I CS, uh plus, uh Albuterol as needed. The people that dropped the most, drop their fev the most during exercise were the people that were taking, uh Albuterol only before exercise. People that were taking bide for motor all before exercise dropped your fev one less. And this is kind of getting at that whole idea that when you're just taking, um, uh, an as needed short acting Beta Agnes, your airways are only gonna be more hyper responsive than ever. So I told you about these new asthma plans we'll have out soon uh We're creating a website right now. Uh That's gonna have all of this stuff. We are partnering with community health centers um uh through the integrated health network and we're rolling out an implement implementation uh program to try to get more and more people using uh smart therapy uh in community health centers. Uh And I'll end there. Um I put up uh my email address. I'm happy to connect with anybody uh uh Down the road. This is also our, our labs uh uh email address uh and happy to answer uh anything I can or connect with people at a later time. Thank you so much. Um Looks like there was a question, I'm not an expert. So it may have been um answered. What do you think about butter Bide Espera inhaler? Yeah, let, let, let me uh let me talk. But so Chris Ra, you mentioned the rapid onset of for motors, what is ideal for the lava? Uh Unfortunately, only sell meals on our formulary. Should we therefore not uh take the as needed the I CS Lava approach and continue to use. So, OK, so this is, this is tough, this is, this comes up um This comes up a lot. So I think there's part of that, I mean, on a more global basis. It's, it's advocating, I would say that this, this particular formula is not covering what's guideline recommended. So, so some of this is working with payers and advocacy to try to get what's guideline recommended on their formulary. The other possibility is, um, uh having somebody uh use beside Albuterol or brand name, uh air supra uh on a rescue basis that is still not um on uh most formularies uh as well, but there is a uh, a coupon card for that, um, online where, um, for the first year it ought to cost people uh anywhere from 0 to $15 per inhaler. And based on the Mandela results that would be uh superior to just taking Albuterol as a rescue therapy. Um But no, you could, you could not prescribe somebody that has the, the long acting Beta Agnes being salmeterol, you could not prescribe that person. True smart therapy. I hope that answered what you were asking. Did you see the other question on their occurrence? Yeah. What do you think of the uh PSN Albuterol super inhaler? Well, I think it's, I, I it's good. I mean, II, I prescribe it. I think there's a couple of complexities with it. It's less studied than uh p aside for motor all. I think one of the benefits of True smart therapy where it's the same maintenance and reliever therapy is the simplicity of it. Um And the fact that you can kind of step up and step down and you're using, always using the same maintenance and reliever therapy with air supra. It's only a reliever therapy. So you're prescribing people two different inhalers. Um We'll see what happens with cost uh on Beta night albuterol. Um It's still uh making its way onto formularies. And um I think the way the drug company is working with that now is they're, they're giving out these coupon cards for a year. But what happens at the end of that year? I don't know. Um um uh yeah, so I, I would say I prefer if I can to prescribe smart therapy with Beside for motor all. But just like the example Chris gave in the um in the last uh in the last thing he asked, I would say um for somebody that uh Buda for motor all uh is not on their formulary. I think it's better than to sell butter all as a therapy. And you're gonna see more on this topic. This is, this is an air, the other drug companies are coming out with competitors, the air supra. Um There's just more and more on this topic. The days of using Albuterol as a reliever therapy are, are probably uh coming to an end. We're getting short on time. But there was one more question in the chat. Are you going based on symptoms alone? Not based on peak flows? What about using peak flows instead of symptoms or we then the Asma are mandated? Yeah. So I think part of this is this is a massive, this is a big paradigm shift. It's the biggest paradigm shift that that's happened in asthma in, you know, 20 years. So part of this is working with pharmacists, it's working with schools to learn about uh the new um uh inhaler paradigms. And um it's gonna be new asthma plans that integrate uh smart therapy and working through all of that peak flows, I think for people that need help. Uh Well, uh recognizing it's a very reasonable thing to do. I work primarily with adults who don't like to use peak flow meters. But I think it's a very reasonable uh sort of thing to do. All right. I think we've answered all the questions and we are at time anyway. So thank you so much for um that wonderful talk. Created by Presenters James Krings, MD, MSCI Assistant Professor of Medicine, Pulmonary & Critical Care View full profile
