This webinar was recorded on April 18, 2023
SMART (Single Maintenance and Reliever Therapy) allows people with asthma to use just one medication for both maintenance and reliever therapy. We’ll learn more about this and any new medications on the horizon.
- Dr. Len Bacharier
Sponsored by the American College of Allergy, Asthma and Immunology
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Transcript: While this transcript is believed to be accurate, errors sometimes occur. It remains your responsibility to evaluate the accuracy and completeness of the information in this transcript. This transcript is not intended to substitute for professional medical advice.
Andrea: hello, everyone. We will give you a few seconds to make sure everyone can load on. The wheel may be spinning on your computer, so just hold on tight and we will begin in 20 seconds or so. Thank you. Hello, everyone. We are just waiting a few moments for everyone to get loaded on. We have about 250 people, about hate hundred — about 800 registered for this section. We will just give it a few minutes for everyone to get pulled up on their computer. Hello, everyone. We are just waiting a few more seconds for everyone to get loaded up on the computer. You can see the numbers picking up. We’re getting close here. Thank you everyone for joining us. We will start in probably 10 or 15 seconds. Good afternoon and thank you for joining us today. We have a few housekeeping items before we start today’s program’s top I’m Andrea Jensen, the education specialist for allergy and asthma network. All participants will be on mute for the webinar. We will record today’s webinar and post that on our website within a few days. You can find all of our recorded webinars and any upcoming webinars on our website at allergy asthma network.org. Scroll to the bottom of the page to find our recorded webinars. The webinar will be about one hour in length and that includes time for questions. We will take those questions at the end of the webinar but you can put your missions in the Q&A TAB. You can find that on the bottom of your screen. We have someone monitoring the chat. If you need questions, we will get to as many as — as many of the questions as we can. We do offer CE use for this particular webinar. This webinar is part of our series, advances in allergy and asthma, which is a partnership with the American College of asthma and immunology. Allergy and asthma network offers CME for nurses. The college offers CME’s for this webinar. You will receive any mail within a few days with resources about today’s webinar and a link to access the continuing education credits and certificate of attendance. Have a staff member watching the chat and will try to add the link to the chat so you can download that. We will begin today’s webinar. Smart therapy is single maintenance and reliever therapy, which allows people with asthma to use just one inhaler for both maintenance and reliever therapy. We will learn more about that today. Allergy and asthma network is a grassroots organization started over 35 years ago by a mom who knew other mothers like her needed resources and support. Our mission is to end the needless suffering due to allergies, asthma and related conditions through outreach, education, advocacy, and research. It is my pleasure to introduce our speaker today, Dr. Len Bacharier, that Jamie Robinson and John Morley chair in pediatrics. He is a professor of pediatrics at Vanderbilt University Medical Center. The section chief of pediatric allergy and immunology, the scientific rector for the Center for clinical and translational research and director of the Center for pediatric research. He is a pediatric immunologist with extensive experience in pediatric asthma research, particularly clinical trials. He has led and participated in federally funded multi-center clinical trials in childhood asthma. He has over 200 peer-reviewed manuscripts derived from his projects. He is the sole American pediatrician on the global initiative for asthma science committee and serves as an associate editor for the Journal of allergy and clinical immunology as well as editor of two leading textbooks in the field of immunology. Hopefully I haven’t left anything off. We are so lucky to have you here with us to talk to patients, providers and families about Smart therapy.
Dr. Bacharier: thanks for the invitation and very kind introduction. Thanks for everybody for spending some time on a Tuesday afternoon to talk a little bit about new options for our patients with asthma. I think this does fall in line with the asthma and allergy networks mission we heard earlier. These are my disclosures. That are somewhat relevant to today’s session, but all of the conflicts have been identified and mitigated. Before we get into the broader concepts, I find it is helpful for us to come up with and define some terms early on because this is a space that over the last few years has had a few new acronyms injected into the literature, into the discussion and we find folks don’t always use these terms as intended or consistently. So I’m going to try first off to at least get us on the same page when it comes to the terminology of what we are about to talk about. What this really is about is a general concept known as anti-inflammatory reliever Araby or a IR. That’s the concept of using a cortical steroid any time a bronchodilator is administered for the relief of asthma or related symptoms. What we will discuss today are two very different strategies for using the same type of medication. It is really important we precisely define the type of patients we are talking about because the strategies differ substantially based on the level of disease scenario. We will start with a discussion of anti-inflammatory reliever therapy alone and this is a treatment for patients with mild asthma. We will go through these people who received GINA step one or step two care. These are for patients who do not receive a maintenance inhaler or maintenance therapy. But whenever they need a reliever, they take a combination of steroid and bronco dilator for their reliever. March or sometimes called SMART is maintenance reliever therapy. Because there is maintenance in the name, there’s maintenance in the therapy. These are patients who have steps 3, 4, and five level disease receiving a daily controller. Instead of using as needed albuterol for symptom relief, they use the same ICS inhaler for both maintenance therapy and symptom relief. We talk about these details on how to use them over time, but it is important to acknowledge and recognize that not all patients are appropriate or worthy of it. You need to know what level of disease we are talking about. We don’t want to give AIR therapy alone to patients with more moderate or use reliever in patients with more biases. I hope over the coming slides this will become clear. The first point that needs to be emphasized is Formoterol has a rapid onset effect. This has an effect in being a rapid strategy. We have for decades used albuterol, or as it is referred to in the rest of the world, salbutamol. It provides rapid relief of symptoms and bronchial dilation. What we see here is relative to the placebo. If you receive’s albuterol in the squares or in the open — in the open circles — they behave identically. So that Formoterol, when used as a bronchodilator is as effective as is albuterol. Very important first point. We are not giving up anything in the way of reliever rescue by using Formoterol over albuterol for our reliever of choice. This is the GINA 2022 algorithm for how and when to start therapy on how to use these approaches in patients with asthma. This is focused on adolescents and adults because that is where the greatest amount of data are. But we will look at some pediatric data as we go. If you have been following GINA is what we have seen is we have designated two tracks. I track one approach in a track to approach. Track number one is what we call our preferred approach. This is an approach for folks likely to be poorly adherent with a daily controller. That applies to many patients and patients with more mild disease. In them, ICS therapy is recommended even if symptoms are frequent. The data can relate them in straight reduction in resist of exacerbations in patients who receive as-needed inhaled steroids. What you see is in track number one, the reliever of choice is low-dose ICS Formoterol. In patients in symptoms less than four or five days a week, that’s the entirety of their regiment. No daily approach. Just as needed. In patients with more frequent symptoms or nocturnal awakenings, these patients will use MART therapy. Twice daily. When they need a rescue, they use the same product to provide rescue. We consider this to be the preferred approach to the management of asthma. Data that will follow will hopefully support your understanding and thinking about this. Here are the NIH updated guidelines. There’s substantial similarity in steps three and four. Which recommend daily and as needed Formoterol for patients with more moderate disease. These were completed before the data for the more mild patients. For steps one and two, they were not incorporated into these. If they were done today, they could conceivably look different. It is important to remind us what the FDA says about this product. If you read the FDA package, it says it is for the treatment of asthma in patients six years of age and older. And for patients with COPD. It’s not recommended or indicated for mild asthma. We are about to have a discussion that is entirely inconsistent with FDA labeling. However, the discussion we are about to have is highly evidence-based. With observations and tens of thousands individuals in clinical trials and many years of experiencing this outside the U.S. to guide our understanding. This is the reason it is central in GINA . So we are back to the preferred approach for patients 12 and above. The therapy is recommended, as needed to be used as the only medication for asthma and to be administered as a reliever. Anytime symptoms occur, you use this medication. It provides wrong kill dilation and a small steroids. What if we have gone there from our tried old friend and this slide outlines what those factors are. The first one is people who have apparently mild asthma can still have severe or fabled exacerbations. They are unpredictable and often lead to rescue oral work. We become very well aware that even modest exposure, four or five courses, puts patients at risk of diabetes and cataracts. Despite their well entrenched place in asthma lore and guidelines, there’s no evidence for the safety or efficacy of treatment in asthma. If we look at the regular use of SABA, there a very clear effect. This can lead to a vicious cycle and encouraged overuse of because you become more hyper responsive, you take albuterol, you become more hyper responsive intake or more albuterol. It’s also clear the overuse with — is associated with greater risk of exacerbation and mortality. When we see a new patient, we give them SABA, and this trained them that this is their treatment. This is not the ideal strategy. Prior to the approach of ICS/Formoterol, the only approach we had was daily ICS. The problem is patients who have infrequent symptoms tend to be poorly adherent to therapy because they feel a minimal disease. GINA changed recommendations once the evidence base was clear and an alternative was available. That led to the fundamental change document. Bronco dilators alone is no longer recommended. This is based on a pair of studies, two very large brother and sister trials in which I will describe the criteria soon. They took patients and establish their baseline. It is equivalent to albuterol in its ability to be a rescue bronchodilator. About 1200 patients per arm. One group — the final group got twice , 200 micrograms. A daily low-dose and it was a year-long study. Sigma two did not have the as needed. They had 2000 patients who guided as the only therapy in one group that got maintenance therapy twice a day. The key inclusion criteria for patients 12 and above, asthma for at least 12 years, evidence of bronchodilator and needing step to therapy. Patients with substantial smoke exposure were not included and to be randomized, they needed to demonstrate a requirement for ICS based on a three time per week or more use but could not be so poorly controlled that as needed therapy would be considered inappropriate and in Sigma one, there was an EE diary patient requirement. Signal one was almost 4000 patients. They got electronic reminders twice a day to help take maximizing adherence and had four interval visits. Number two is a little more on the pragmatic side. Only two visits and three phone calls, no adherence reminders. Both had electronic monitoring of randomized inhalers and the as needed inhaler was to be used only for symptom relief. The primary outcome for SYGMA one was for a well-controlled asthma week. No more than two days needed for peak flow of 80%. The problem with this outcome is it effectively introduced a systematic bias because if you use the rescue medicine more than two days a week, you have an uncontrolled week. This was the therapy where the only way you got inhaled corticosteroids was if he needed to take it for symptom relief. So there was a bias against this approach that was not recognized during study design but is substantial. SYGMA two is a little more straightforward. If you needed steroids for at least three days, that was the primary outcome. We look at the study population and they were very comparable, 40 years of age on average. In excess of 1.5. Substantial bronchodilator reversibility, about half the patients entered uncontrolled on the bronchodilator alone. About 20%. This differs from many of the biological studies, the minority of patients have an exacerbation. We look at adherence with the blinded bronchodilator inhaler. What you see is about 80% with all the adherence in that study in contrast in SYGMA two. Still a little bit lower but in the mid 60 range. Here is the primary outcome — what you see is the number four well-controlled weeks is greater. This led to a statistically significant advantage and met the primary outcome. It was superior for the well-controlled asthma week. In contrast, the twice a day led to a 10 percentage point more well-controlled asthma weeks and what they found was that it was inferior to twice a day for the well-controlled asthma week. That had the bias for therapy and the primary outcome. There was a non-clinically relevant asthma control scores and if you look at the symptom free days between patients who receive regular ICS, it amounted to an average of 10 days over an entire year. Less than one day a month, more symptom-free days with daily therapy. If we compare a rate of exacerbations annualized, what you see is a 64% reduction in risk in the patients receiving ICS compared to albuterol alone. If you look at time to exacerbation, the as needed group and read and the twice daily group in black or brown, you see there is no difference between the containing approaches and both are clearly superior to as needed. SYGMA two was a non-and figure already trial. Here, the primary outcome was met. It was non-inferior for rate reduction. You can see this in the time to event curves in the lower right-hand corner. They overlap entirely. There is no difference in time to exacerbation between twice daily and as needed. Again in patients with mild asthma. If we compare one into side-by-side, you see them, the rate is about the same. In both studies, the patients receiving in redhead lower rates of exacerbation than patients receiving — not tremendously lower and certainly no worse. Then they asked the question, did it matter how much asthma therapy you are saving prior to entering the studies? Did that influence the clinical outcomes question write the short answer is absolutely not. Those who were receiving daily, what you can see in subgroup number one, the patients did the best, sub group to come you can tell no difference. The pre-study level of medication did not impact the response. We begin to wonder maybe they are just taking a little here and there. But maybe some days it’s going to be worse and they will need more rescue. What happens over those days? Is that same visit still a factor? This is an analysis from the SYGMA one study where they look at the severe exacerbation in the three weeks of 2, 4, or six inhalations in 24 hours. What you see is the medium amount of reliever use in the study is actually pretty low. Both of the as needed groups used .3 inhalations per day. The maintenance group used about .16. What you can see in the survival curves on the right is the as needed use reduced for short term risk of severe exacerbation after a day of any rescue use. At two pups, you see it. At six pups come you see it greater. Eight, you see it racist of all. There is clearly an effect the more you take, because the more you need reduces your risk of exacerbation. There were a couple of more studies that followed this up. This is a randomized open label study. In a more pragmatic sense, adults 18-75 only on as needed treated in a randomized fashion with albuterol alone. Sounds a lot like SYGMA one. What you see in the middle panel is there is no difference between the formoterol as rescue and as maintenance. Both are significantly more effective in reducing exacerbations then albuterol alone. For years, we worried about airway inflammation. We were concerned we would leave it undertreated. The sub analysis measures Fino levels at weeks 12 and 52 in the three groups. What you can see is the two groups, the red and the blue lines show suppression relative to the albuterol alone. The two containing groups are nearly overlapping. So there an anti-inflammatory effect even when you use as needed in patients like this with mild asthma. We don’t need to be concerned. What about adolescence? All the adolescent patients, nearly 900 of them who participated in SYGMA one and two, looking at exacerbations as the outcome, suffice it to say the adolescence believed in — behaved in an exacerbation fashion compared to the adults and there were significant reductions in SYGMA one. Comparable rates to twice daily. When you pulled them, they were nearly identical. There’s no reason the fate of adolescents behaves different leave than adults in this treatment. What can we say about the safety? Here’s a post hoc analysis of nearly 7000 patients. Neither were discontinuations. Asthma was the most frequent and more than twice as common. There were two deaths in the trial. There were two deaths in the SYGMA to trial. Neither were considered treatment. What about greater use of — what if you use eight or 12 inhalations a day? This is a sub analysis looking at patients who received more than eight in a given day and more than 12 inhalations in a given day. Looking at how often that occurred, what you see is if you are getting tribute lien alone, 13 patients had a day or only three to 5% on either of the other to use that much and the lowest rate of using eight that day was among patients who received you decimate formoterol. We have meta-analyses that combine these studies together. We have nearly 10,000 patients. But we see is a 55% reduction. A similar risk compared to daily ICS, so you get the same risk of exacerbation. 65% lower and 37% lower compared to daily ICS, so there’s a greater protection for emergency visits using this approach. Furthermore, looking at this by prior treatment, patients taking SABA alone had a less exacerbated — now let’s change gears and talk about the maintenance and reliever. This is the approach of using low-dose ICS as the patient maintenance treatment, usually twice daily. When they need reliever from symptoms of prior exposure, they use the same inhaler instead of albuterol or salbutamol. This has only been studied — it is not indicated for use with salbutamol. The albuterol effect is much too slow to serve as an appropriate acute rescue therapy. What dose should we use? We should only use the low-dose preparations. In Europe, it is the six microgram, in the U.S., it is 4.5 delivered dose. The usual U.S. product. How to prescribe is one, not to inhalation twice daily and one inhalation as needed for reliever symptoms before exercise. Note that the maintenance of those can be increased to two inhalations daily with low run function or other reasons. If we look at GINA with three to five patients, and we look at the efficacy commits very clear in at least one meta-analysis that as needed, in addition reduces the risk of exacerbation with a similar symptom control. When — we will look at this in a moment. There’s something about Formoterol that seems to have this effect even without the use of an ICS, but a long-acting diagnosis is not an appropriate therapy. Even Formoterol is a better reliever in terms of exacerbation. This approach has been studied down to the ages of four to 11. The smart approach with reduced risk of exacerbation when compared to the same dose and adding it twice a day with a relative risk of .38. Released on these data have been recommended in children down to the ages of four or five. As I mentioned earlier, Formoterol is not just a bronchodilator. In no way advocating its use as a standalone inflammatory. But there are data to support it has an exacerbation effect above and beyond what albuterol does. Not nearly as good as when it is combined with ICS, but there is a difference. It has become very clear and we’ve seen these data prepared in patients with mild asthma, there’s a large reduction in risk after 2, 4, 6, 8 inhalations. Using this built-in to the asthma action plan does help reduce patient risk of exacerbation. Across asthma severity, it is clear this approach reduces the risk of severe exacerbations and puts less burden on the patients and family. It’s associated with less urgent health care. A reduced risk of osteoporosis, cataracts, etc.. In MART, this is because the maintenance dose can be lowered. To trace the dose that is necessary. The data show a similar level of control and function. There is yet — there’s less overuse of reliever. It is easy to step up and step down and provides a safety net of maintenance. I think these are questions coming into the chat so hopefully this will help put some of this into practical context. Many patients will be unsure about this and wasn’t or it will work. One way to do this is you suggest at a time convenient to them they do something that normally triggers mild as most symptoms and tried out. Do some exercise, do something that you know provokes a little bit of asthma and proved to them that it does just that. You need to emphasize they need to use it instead of their previous Saba. The old blue inhaler, old yellow inhaler, that they’ve become so accustomed to use. If they need to take more, they need to take more not go back to the old medication. Remember as needed can have different meanings to different patients. They probably need to inhaler’s. I advise them to use it before exercise or before or during allergies. It is clearly effective in both situations. Advise patients to rinse and spit out after morning and evening doses, but it’s not practical — I’d don’t think we need to have them run and rinse if they need to use this therapy during the day. What is the maximum dose for adults and adolescents? We prescribe this as they won 60 over four point five. With a maximum of 12 inhalations a day for adults, eight for those under 12. If symptoms persist after a few minutes, take another inhalation but the maximum should be six inhalations. We are back to where we started, the concept of inflammatory reliever. This is a useful table in the references provided here that you can refer to over time that reviews the indications, explanation, age group study and rationale. It is really important and not refer to anti-inflammatory reliever as MART because that’s not what it is. There’s no maintenance involved. The use of albuterol is for mild disease. When used daily, it can be used for more moderate symptoms. We have challenges and implementations and I see this in the chat as well. We have to fundamentally reeducate providers, patients and families. This is a different way of treating asthma. Insurance coverage is a moving and challenging target. First of all, many insurers don’t want to provide more than one inhaler because it is indicated as maintenance therapy and should last 30 days. If they are using it as needed on top of twice a day, and inhaler should last more than 30 days. The reality is many patients are not perfect adherence and many of them last beyond 30 days so they probably do have some extra doses and it does put them at risk of running out of there controller and reliever before insurance will pay for a new canister. We need to work with our patients and the need to understand how to use these medications correctly. We are seeing evidence that insurers and payers are starting to become a little more amenable and flexible to covering ICS as a reliever, so I am hopeful if we have this discussion again in a year, more and more of us will be able to write these prescriptions without having to jump through excessive hoops or come up with alternative strategies. However, for some patients who have a history of frequent exacerbations, they may need to have albuterol at home when they exceed the maximum dose of Formoterol. But we need to educate our patients when to use it and how not to use it. In the last few minutes, I want to give a sense as to what is coming. There’s a product approved by the FDA late last year. A combination of a shortness of albuterol with a low-dose inhaler corticosteroid. This was an effort to get the FDA to agree to anti-inflammatory reliever approach. This was based on a multinational phase three study. They were randomly assigned to receive albuterol as their rescue inhaler. What they found is in adults predominantly, this led to the approval and just adults that it significantly reduced the risk of exacerbation compared to albuterol alone for rescue in patients receiving daily controller therapy. So while it is not approved in the U.S., it is approved by the FDA and will be available later this year. We will have two know how to best use this in the context of the anti-inflammatory reliever paradigm. What you will immediately see is this requires a second inhaler because this is not intended to be used as maintenance therapy. This is purely for reliever. We don’t get down to one inhaler but what we may have is the ability to use an anti-inflammatory reliever per FDA approval. So really, to summarize what we have talked about, even mild asthma Carol — carries exacerbations. It significantly reduces this risk. We have seen ICS/Formoterol is superior to albuterol at all — in all rescue therapies. We should consider MART as an important step up and care for those patients requiring step 3, 4 and five. In my view, MART or SMART needs to be continued — considered in all patients before we consider a biologic. As we saw that reduction that comes from going to non–MART to MART therapy is about a 30% reduction and that’s approaching what you see in Biologics. I’m certain there is a subgroup of patients who are not receiving MART therapy being considered for Biologics who, if they used MART would no longer need a biologic and we need to think about it. This recent approval is going to provide us with additional options in the future for how to use anti-inflammatory relief. It has a bit of complexity to the story but I suspect it will not carry the insurance and pharmacy challenges the current approach has. I encourage you folks to work with your patients, work with your insurers, don’t take no for an answer. This is the best approach to asthma care we have. Not using it because it is not the easiest is leaving our patients exposed to exacerbation risk when we can do better and I encourage folks to work with their pairs, with their insurers, with their patients to incorporate these approaches asthma exacerbations and long-term consequences. I am going to stop there and turn it over to questions. Thank you.
Andrea: thank you. Absolutely fantastic data that shows how effective this is. The challenge for all of us on the line today will be working with insurance companies, working with pharmacies because this is a change in thinking and this will take some time, especially for people who have had asthma all their life and treated the same way. This is a very new idea. A little bit of a challenge ahead for us. Let’s look at some of the questions we have in the chat. A lot of questions about will this be covered on insurance and will there be a push for Medicaid to approve this without a medical necessity?
Dr. Bacharier: I don’t anticipate there will be a federal level judgment on this. But there are states I know local Medicaid, local insurers, after being pressured by folks like us have adopted this as a covered strategy. If you look right now — for the longest time, we’ve known this is the right way to go. This was not in the NIH guidelines. It is now in both of them because the literature are so clear as to this is the preferred approach. I think it is going to be harder and harder for payers to not follow the guidelines, but they are not going to do it unless we exert consistent, firm pressure that this is how we should be treated for patients. This is not a fringe strategy. This is not somebody’s idea. This is well evidenced therapy. I will hope folks who pay for health care will acknowledge is still going to be cost saving compared to the cost of exacerbation, both short and long-term.
Andrea: that is one thing we need to keep in mind. Since it is asthma awareness month, allergy network will be hosting allergy and asthma day on Capitol Hill. If any of you want to get involved, this is something we will be talking to our representatives about and explaining not only the data behind it but the intricate cost savings with having a flareup. It’s incredibly expensive cannot compared to very frightening. When thing to look at is a lot of advocacy work to do on this. Our next question is someone is asking, and I have heard this asked before. What about Formoterol used with SMART therapy?
Dr. Bacharier: it is a good and common question no one knows the answer to. Should it work? Yes, it should. Does it work? We just don’t know. So we really do make our recommendation based on specific agents rather than class recommendation. Part of it is advocacy, part of it is safety. Most of the safety and efficacy data — how dosing in this fashion with more than the standard number of doses per day will relate to the side effect profile is just not known. The Formoterol component should behave as expected but the ICS component is a bit uncertain. GINA does not recommend any of the products that have not been studied and demonstrated used in this way.
Andrea: that makes sense. With clearly senior data that it is effective. We had someone ask if SMART can be used for COPD or emphysema.
Dr. Bacharier: it has not been studied to my knowledge. To my knowledge and has not been studied.
Andrea: I’ve had people ask about slides for the presentation. Since this is a credentialed webinar, we did not share the slides for that but the webinar will be on our website either tomorrow or the next day, you can listen to it and record it. Someone says how do you incorporate use of ICS/Formoterol for patients hospitalized with exacerbations? Do you continue rescue albuterol or transition to ICS/Formoterol? Can you limit the use of systemic steroids started by — ICS/Formoterol — that was a long question.
Dr. Bacharier: there are data that support the use of ICS/Formoterol. I don’t know if data is supporting its use during a hospitalization and I would not use it as an oral steroid with patients with severe enough exacerbations to require steroids. If you are able to start it and train patients on this therapy and send them home with it, as they are completing their steroids, that is — but that has not been studied in patients who have exacerbations severe enough to warrant hospitalization.
Andrea: people are asking how do used or to educate some of these patients about this change in protocol? This is a big one for a lot of people.
Dr. Bacharier: it is a fundamental change but we’ve been doing this for a long time. We tell them here is your inhaled steroid, here’s your controller. Here is your reliever, take this when you have symptoms. This is an approach where you can consolidate that into a single inhaler and say this is your asthma medicine. Take this one in the morning, take this one in the evening. It simplifies, it really does. I really do think it requires knowing and that’s always so available during visits. This is a fundamental retraining of all of us. You need to know how to use these medications appropriately. These are not trivial steps but what I hope I have convinced you of is there is a distinct benefit. We are not just trading apples for apples. We are going from men OK strategy with albuterol as rescue to a far better strategy with ICS for motor all as a strategy. Your patience will be better off and that’s the reason we should be very intentional and consistent in trying to get our patients comfortable with this approach because in the end, they are going to benefit from it. The data are as clear as anything we will ever see and I will highlight again that we will look at the data for Biologics and severe asthma and we were blown away by how effective they are they reduce the risk of exacerbations by 30%. It is pretty good and at a fraction of the cost. A fraction of the cost. These are big effects. These are really substantial and that is the reason we should be very transformative in our thinking and really committed to getting payers on board and patients on board because if we do this, we will hand out less prednisone, Wilson fewer to the emergency department and we will end up in a much better place.
Andrea: absolutely. One of your slides mentioned not only does this prove it is effective but those that are taking prednisone, there’s an increase in diabetes, cataracts and other fun things down the road. So thank you for that. That’s fantastic. We have a question that asks is there regulation for cortical aid receptors when given simultaneously?
Dr. Bacharier: what has been shown is unopposed data analysis resultant down regulation of the baiter receptor. That has been well established. There are data that when given, though regulation is substantial. That is another reason to not use unopposed SABA, especially in mild asthma. That’s part of the underlying rationale. If you have enough airway reactivity that things are symptomatic, you almost certainly have airway inflammation that needs to be attended to as well and therefore, a single puff of a medication that provides both bronco dilation and anti-inflammation would stand to reason would be superior and the data clearly supported.
Andrea: thank you. I’m checking the chat and we have a few questions along the same line and people are asking how often is too often when it comes to using this as an inhaler? Is every two hours too often?
Dr. Bacharier: it depends for how long. It’s really about that. As we saw, use it as much as you need it as long as it is helping you. Just like we do with albuterol. We would use it the same way. You don’t want to use more than six inhalations on a given occasion. You take a puff, you’re not better, take a second puff, you’re not that much better, take a third puff, you’re not that much better. Six is the high point. In children, you don’t want to take more than eight day. In adults, you don’t want to take more than 12 total a day. That is where the studies drew the line. There are actually not compelling data that taking more than that is fundamentally dangerous because you are taking so much inhaled corticosteroid with it. But if you are not getting the relief you need, asthma exacerbations occur and we need to treat them in the usual way. This approach does reduce it and as you saw in those figures, if you have a day where you needed eight puffs of albuterol, you would have said I suspect this patient is going to exacerbate in the next few weeks. If they were taking albuterol, they would. If they were taking ICS/Formoterol, they probably won’t. Those two groups behave differently. So you are providing short term symptom relief and slightly longer term exacerbation risk reduction by using this therapy. We don’t want them to take 20 puffs in a day. We want to give them a ceiling. But if you need that much, you should have been seeking care regardless of whether you are using Formoterol or albuterol.
Andrea: it can be a little confusing for some of these people. Someone was asking about the side effects. If they were taking that much ICS and seeing puffiness in the face were other things going on.
Dr. Bacharier: the beauty of this therapy as you take as much as you need. If you need more, you take more and when you need less you take less. The strategies that look at this really do show the patients who use anti-inflammatory reliever actually use less ICS than those who are on fixed daily dosing. The side effect profile is reassuring and when we have seen with these therapies over time. Because it is rare you need multiple days of this. You may need a day here and there but not very many as you saw. Precious few patients had multiple inhalation over a year. More than eight puffs a day, at least once, pretty uncommon.
Andrea: I am glad you emphasized that because that’s something people had in mind that people will be doing this all day, every day. Sporadic use for these patients is what they need and what is working for them. We have a lot of other questions, but unfortunately, we are out of time. If you could go to the very last slide, we do have another webinar coming up. This will be on May 10 and this is about food allergies. One of the things we will do is when we send out an email after the webinar, we will send out information after that. I had several of you asking if we have a SMART action plan. We do and we can include the link for that as we are sending out the follow-ups. Any parting words before we end the webinar?
Dr. Bacharier: I appreciate everybody joining. I hope this was helpful and leads to better outcomes for all of our patients. I can tell you the GINA guidelines are coming in the next couple of weeks. Most of what I said is in there, so you can use that to reinforce or clarify any points we discussed today.
Andrea: once again, we are recording this and I know I along with all of you will be reviewing this once the recorded session — I know some of you have your hands raised. I’m so sorry we are out of time. Feel free to look out for the email that will have all the information that you need. You are getting a lot of handclapping and hearts and a lot of thank you’s in the chat. Thank you again.
Dr. Bacharier: my pleasure. Have a great day, everyone.