Each year, Northwestern Medicine Otolaryngology sees approximately 10,000 patients with sinusitis and performs more than 1,000 sinus surgical procedures using state-of-the-art technology.
In this episode of Better Edge, Robert Kern, MD, chair of the Department of Otolaryngology-Head and Neck Surgery at Northwestern Medicine discusses some of the emerging surgical procedures and biologic therapies and how the Northwestern Medicine Otolaryngology team collaborates with the Division of Allergy and Immunology to provide a comprehensive approach to treatment and management of severe chronic rhinosinusitis.
The Role of Biologic Therapies in the Treatment of Severe Rhinosinusitis
Featured Speaker:
Learn more about Robert Kern, MD
Robert Kern, MD
Robert Kern, MD is the Chair, Department of Otolaryngology - Head and Neck Surgery Professor, Otolaryngology - Head and Neck Surgery.Learn more about Robert Kern, MD
Transcription:
The Role of Biologic Therapies in the Treatment of Severe Rhinosinusitis
Melanie Cole: Each year, Northwestern Medicine otolaryngology sees approximately 10,000 patients with sinusitis and performs more than a thousand sinus surgical procedures using state-of-the-art technology. Welcome back to Better Edge, a Northwestern Medicine Podcast for Physicians. I'm Melanie Cole, and I invite you to listen in, as we discuss the emerging treatment options for the treatment of chronic rhinosinusitis. Joining me is Dr. Robert Kern. He's the Chair of Otolaryngology at Northwestern Medicine. Dr. Kern, it's a pleasure to have you join us again today. Can you start by giving us some background on the standard treatment for nasal and sinus polyps and some of the challenges you've run into when treating these patients?
Dr. Kern: Well certainly, thank you. Chronic rhinosinusitis is an extremely common problem. As some studies show, it affects about 10% of the population. About 1% to perhaps 2% have nasal polyps, which is a particularly problematic form of chronic rhinosinusitis. Now first-line management for mild cases is nasal steroid sprays like Flonase, which can now be obtained over the counter. The next step up would be the use of oral steroids and antibiotics for exacerbations, which are usually virally driven and then progressed to a bacterial infection. If these two things fail and the patient's symptoms are severely problematic, then we would consider other options such as surgery. Now surgery, there is about 500,000 sinus surgeries performed a year. We do a thousand of them actually, which is interesting, but what's done there, there are several things that are done. Sinus surgery, we open the sinuses so they can drain, so there's no mechanical blockage.
The second thing was we debris, the inflamed tissue. The hope is that the tissue that grows back is more normal. And the third thing is we open the sinuses so that nasal steroids can access the sinuses. Now I have the honor and the pleasure to work with a team of people that manage sinusitis. We're a name brand in this area, but not only clinicians, mostly allergists and pulmonologists, but also basic science researchers. And we have a large research program, and that has shown that sinusitis frequently, perhaps 60% of the time has what's called type two inflammation, which is eosinophilic, which is pseudo allergy type of inflammation, but much more severe than plain old allergy. And those patients are very steroid responsive, but they tend to be the patients who fail the normal treatments, like simple nasal sprays or the treatment failures. Those are the people that keep coming back even after you do surgery and they need repeat surgeries. So they tend to be somewhat problematic.
Now what we have to offer now with management of sinusitis, or newer over the last three or four years, some really newer, exciting things to deal with this problem. Two of them are steroid related. One is a product called Sinuva, which we can insert in the office in the patient's sinus cavity that gives off steroids locally. As I mentioned, steroids are very effective, but the problem with steroids are first of all, that if you give them orally, they work great. The problem is that oral steroids have a lot of side effects. And if you give more than two or three bursts a year, you're going to really cause problems. There's multiple problems, osteoporosis, glaucoma, cardiovascular issues, and health economics studies show that when you use more than two doses a year, you're actually costing society money because of downstream problems. So we tend to favor surgery rather than giving people multiple courses of oral steroids.
But in addition to the side effects, the nasal steroids are great because they don't have those side effects and they are still steroids applied locally. Things like Flonase for instance, the problem is that the nasal sprays like Flonase, the standard sprays, most of this stuff is swallowed. 70% goes back down the throat. So it doesn't access the sinus cavities, which are the diseased organ. So products like Sinuva, but where you insert a device that leaches out steroid over a few months is a wonderful way to try and get around that. The second option that we have is a new option is a product called Exhance, which instead of spraying Flonase or Nasonex or whatever, I don't mean to pick on Flonase, but that's just the most common. But instead of just spraying it into your nose, where it goes down your throat, you actually blow into the delivery device. And this causes the nasal steroid to get access to the majority of the nasal cavity. So this is a way to get around the delivery issues.
Now, in addition to those two, there have been some surgical innovations over the last few years that are becoming more and more common for the really severe patients. We now have the instrumentation to really extensively drill out their sinuses and open up every nook and cranny, it's called a Lothrop L O T H R O P, or draft three procedure. And that allows maximum ventilation of the sinuses and maximum access to saline rinses or steroid rinses or to this Exhance device that I talked about. Now, the very last and the most perhaps exciting advance in sinusitis has been the appearance of biologic therapies. Now, these have been around for asthma for a few years. Xolair, you may be familiar with that and also Nucala, and Visenra and now Dupixent, and there are more coming. Now, what these products do is block type two inflammation. I mentioned that earlier, the type two inflammation is the cause of problems in sinusitis. It's also the cause of problems in asthma, by the way.
And in many cases, severe asthma, but in sinusitis, we now have FDA approval for one of these drugs and probably, two or three or four more in the next few months to a year, perhaps two years. But at any rate, these products block aspects of type two inflammation and for the really severe patients, because we do a team management, I don't manage the biologics that allergists do, but I would in the severe patients, I would do one of those drill out sinus procedures and open up their sinuses fully. Then we would put them on Exhance or on steroid irrigations of some form and watch them closely. And many of them are then also candidates. If they begin to have problems, candidates for one of these biologics. So it's a team management approach. And these biologics, our success rate is just logarithmically better than it was, let's say even two or three years ago. Patients retain their sense of smell, they breathe more clearly their lower airway is better managed and their quality of life is significantly improved.
Host: Wow, absolutely fascinating. Dr. Kern, you've mentioned the interdisciplinary or multidisciplinary approach a few times expand a little bit specifically about this collaboration with the division of allergy and how that provides the comprehensive and time efficient clinical evaluations. Why is this approach so important and how are you guys working together?
Dr. Kern: It's one of the few places in the country this happens, we see patients together and so the patient gets a more convenient evaluation. They only have to make one trip downtown and they get a comprehensive evaluation. Someone looks at not only the mechanical aspects, like what I would do, the plumbing basically, but someone also looks at the biology, the what's going on? What type of inflammation? Would you be a candidate for a biologic, or do you have an immune problem? Some of these patients, not many, but I wouldn't say not many, probably more than we realize having immunodeficiency and the allergists evaluate that. They also evaluate the standard stuff, whether you're allergic to mold or dust or whatever. So it gives a kind of 360 degree evaluation of the patient. And plus, since we partner on the research side, we have added insight in terms of why this patient might be failing or not.
And many of the patients participate in our clinical trials. So we have tissue and mucus on them that's banked that we know quite a bit more about what's going on. And also because of our partnership with allergy, we are frequently sought out by pharmaceutical companies to trial new medications. And so many of our patients because of this have access to clinical trials and the latest that's available that this sort of value of that is in obvious or intuitive if you have cancer, but it's also quite valuable, if you have debilitating sinusitis. Many of these patients are very disabled by their sinusitis. If you think about it, we just like having a severe cold that never went away. That would wear on you over time. So we have the ability to offer people the very cutting edge.
Host: Well, I'd like you, before we wrap up Dr. Kern to expand a little on what's on the horizon and future advances, you've talked about your procedures. You've talked about how you work together with allergy and biologics. Are there any other game-changers that you'd like to mention for other providers?
Dr. Kern: I don't think there's anything imminent of any more of these biologics that are going to be coming online to treat sinusitis, but even more than that in development, there are some that are going to be able to stop the process very early on. We think that sinusitis caused by inhaling different exogenous agents. We don't even know exactly what they are, but they may be bacteria, fungi, mixtures of pollutants, etcetera. And they interact with aligning your nose. And in some patients typically in their forties, this is an adult onset problem. They develop these chronic inflammation, the research that we're doing and partnering with big pharma. And there are ways that perhaps inhibit this right from the start. And that will be the goal in the future. The more immediate step is we are also doing studies to look at the mucus in the nose, and that will allow us to provide more individualized treatment for these patients. Like which biologic should they have, or are you the kind of patient that maybe should have antibiotics for more long-term? Or are you the kind of person that we should jump ahead to surgery? Because we know all this other stuff isn't going to work. The studying the mucus in these patients is really, that's going to be the fingerprint, like a blood test for the guiding your sinusitis or the biopsy for your cancer. This will guide the mucus will function as the lead end point
Host: We wrap up. What would you like other providers to know about treatment options available at Northwestern Medicine, for the management of chronic rhinosinusitis? And when you feel it's important that they refer to this interdisciplinary approach?
Dr. Kern: Certainly, we're happy to see anyone. And we do offer because of the nature of the practice here, we're surrounded by 800,000 people. We do primary care ENT as well. So I do minimally invasive procedures for patients with mild problems, but certainly for your severe patients, particularly your patients with aspirin allergy, those are the worst. And we see a lot of those patients. And those are the people that I would like you to consider sending to us in particular, because the comprehensive management aggressive surgery followed by one of these biologics has made an enormous difference in these patients. So rather than ending with five or six surgeries in a year, we can keep it to one. But again, we're happy to see anyone, but those particularly problematic ones like the aspirin allergy patients, please consider sending them to us.
Host: Thank you so much, Dr. Kern, what a great guest as always that you are to refer your patient, please visit our website at nm.org/ent to get connected with one of our providers. That concludes this episode of Better Edge, a Northwestern Medicine Podcast for Physicians. Please remember to subscribe, rate, and review this podcast and all the other Northwestern Medicine podcasts. I'm Melanie Cole.
The Role of Biologic Therapies in the Treatment of Severe Rhinosinusitis
Melanie Cole: Each year, Northwestern Medicine otolaryngology sees approximately 10,000 patients with sinusitis and performs more than a thousand sinus surgical procedures using state-of-the-art technology. Welcome back to Better Edge, a Northwestern Medicine Podcast for Physicians. I'm Melanie Cole, and I invite you to listen in, as we discuss the emerging treatment options for the treatment of chronic rhinosinusitis. Joining me is Dr. Robert Kern. He's the Chair of Otolaryngology at Northwestern Medicine. Dr. Kern, it's a pleasure to have you join us again today. Can you start by giving us some background on the standard treatment for nasal and sinus polyps and some of the challenges you've run into when treating these patients?
Dr. Kern: Well certainly, thank you. Chronic rhinosinusitis is an extremely common problem. As some studies show, it affects about 10% of the population. About 1% to perhaps 2% have nasal polyps, which is a particularly problematic form of chronic rhinosinusitis. Now first-line management for mild cases is nasal steroid sprays like Flonase, which can now be obtained over the counter. The next step up would be the use of oral steroids and antibiotics for exacerbations, which are usually virally driven and then progressed to a bacterial infection. If these two things fail and the patient's symptoms are severely problematic, then we would consider other options such as surgery. Now surgery, there is about 500,000 sinus surgeries performed a year. We do a thousand of them actually, which is interesting, but what's done there, there are several things that are done. Sinus surgery, we open the sinuses so they can drain, so there's no mechanical blockage.
The second thing was we debris, the inflamed tissue. The hope is that the tissue that grows back is more normal. And the third thing is we open the sinuses so that nasal steroids can access the sinuses. Now I have the honor and the pleasure to work with a team of people that manage sinusitis. We're a name brand in this area, but not only clinicians, mostly allergists and pulmonologists, but also basic science researchers. And we have a large research program, and that has shown that sinusitis frequently, perhaps 60% of the time has what's called type two inflammation, which is eosinophilic, which is pseudo allergy type of inflammation, but much more severe than plain old allergy. And those patients are very steroid responsive, but they tend to be the patients who fail the normal treatments, like simple nasal sprays or the treatment failures. Those are the people that keep coming back even after you do surgery and they need repeat surgeries. So they tend to be somewhat problematic.
Now what we have to offer now with management of sinusitis, or newer over the last three or four years, some really newer, exciting things to deal with this problem. Two of them are steroid related. One is a product called Sinuva, which we can insert in the office in the patient's sinus cavity that gives off steroids locally. As I mentioned, steroids are very effective, but the problem with steroids are first of all, that if you give them orally, they work great. The problem is that oral steroids have a lot of side effects. And if you give more than two or three bursts a year, you're going to really cause problems. There's multiple problems, osteoporosis, glaucoma, cardiovascular issues, and health economics studies show that when you use more than two doses a year, you're actually costing society money because of downstream problems. So we tend to favor surgery rather than giving people multiple courses of oral steroids.
But in addition to the side effects, the nasal steroids are great because they don't have those side effects and they are still steroids applied locally. Things like Flonase for instance, the problem is that the nasal sprays like Flonase, the standard sprays, most of this stuff is swallowed. 70% goes back down the throat. So it doesn't access the sinus cavities, which are the diseased organ. So products like Sinuva, but where you insert a device that leaches out steroid over a few months is a wonderful way to try and get around that. The second option that we have is a new option is a product called Exhance, which instead of spraying Flonase or Nasonex or whatever, I don't mean to pick on Flonase, but that's just the most common. But instead of just spraying it into your nose, where it goes down your throat, you actually blow into the delivery device. And this causes the nasal steroid to get access to the majority of the nasal cavity. So this is a way to get around the delivery issues.
Now, in addition to those two, there have been some surgical innovations over the last few years that are becoming more and more common for the really severe patients. We now have the instrumentation to really extensively drill out their sinuses and open up every nook and cranny, it's called a Lothrop L O T H R O P, or draft three procedure. And that allows maximum ventilation of the sinuses and maximum access to saline rinses or steroid rinses or to this Exhance device that I talked about. Now, the very last and the most perhaps exciting advance in sinusitis has been the appearance of biologic therapies. Now, these have been around for asthma for a few years. Xolair, you may be familiar with that and also Nucala, and Visenra and now Dupixent, and there are more coming. Now, what these products do is block type two inflammation. I mentioned that earlier, the type two inflammation is the cause of problems in sinusitis. It's also the cause of problems in asthma, by the way.
And in many cases, severe asthma, but in sinusitis, we now have FDA approval for one of these drugs and probably, two or three or four more in the next few months to a year, perhaps two years. But at any rate, these products block aspects of type two inflammation and for the really severe patients, because we do a team management, I don't manage the biologics that allergists do, but I would in the severe patients, I would do one of those drill out sinus procedures and open up their sinuses fully. Then we would put them on Exhance or on steroid irrigations of some form and watch them closely. And many of them are then also candidates. If they begin to have problems, candidates for one of these biologics. So it's a team management approach. And these biologics, our success rate is just logarithmically better than it was, let's say even two or three years ago. Patients retain their sense of smell, they breathe more clearly their lower airway is better managed and their quality of life is significantly improved.
Host: Wow, absolutely fascinating. Dr. Kern, you've mentioned the interdisciplinary or multidisciplinary approach a few times expand a little bit specifically about this collaboration with the division of allergy and how that provides the comprehensive and time efficient clinical evaluations. Why is this approach so important and how are you guys working together?
Dr. Kern: It's one of the few places in the country this happens, we see patients together and so the patient gets a more convenient evaluation. They only have to make one trip downtown and they get a comprehensive evaluation. Someone looks at not only the mechanical aspects, like what I would do, the plumbing basically, but someone also looks at the biology, the what's going on? What type of inflammation? Would you be a candidate for a biologic, or do you have an immune problem? Some of these patients, not many, but I wouldn't say not many, probably more than we realize having immunodeficiency and the allergists evaluate that. They also evaluate the standard stuff, whether you're allergic to mold or dust or whatever. So it gives a kind of 360 degree evaluation of the patient. And plus, since we partner on the research side, we have added insight in terms of why this patient might be failing or not.
And many of the patients participate in our clinical trials. So we have tissue and mucus on them that's banked that we know quite a bit more about what's going on. And also because of our partnership with allergy, we are frequently sought out by pharmaceutical companies to trial new medications. And so many of our patients because of this have access to clinical trials and the latest that's available that this sort of value of that is in obvious or intuitive if you have cancer, but it's also quite valuable, if you have debilitating sinusitis. Many of these patients are very disabled by their sinusitis. If you think about it, we just like having a severe cold that never went away. That would wear on you over time. So we have the ability to offer people the very cutting edge.
Host: Well, I'd like you, before we wrap up Dr. Kern to expand a little on what's on the horizon and future advances, you've talked about your procedures. You've talked about how you work together with allergy and biologics. Are there any other game-changers that you'd like to mention for other providers?
Dr. Kern: I don't think there's anything imminent of any more of these biologics that are going to be coming online to treat sinusitis, but even more than that in development, there are some that are going to be able to stop the process very early on. We think that sinusitis caused by inhaling different exogenous agents. We don't even know exactly what they are, but they may be bacteria, fungi, mixtures of pollutants, etcetera. And they interact with aligning your nose. And in some patients typically in their forties, this is an adult onset problem. They develop these chronic inflammation, the research that we're doing and partnering with big pharma. And there are ways that perhaps inhibit this right from the start. And that will be the goal in the future. The more immediate step is we are also doing studies to look at the mucus in the nose, and that will allow us to provide more individualized treatment for these patients. Like which biologic should they have, or are you the kind of patient that maybe should have antibiotics for more long-term? Or are you the kind of person that we should jump ahead to surgery? Because we know all this other stuff isn't going to work. The studying the mucus in these patients is really, that's going to be the fingerprint, like a blood test for the guiding your sinusitis or the biopsy for your cancer. This will guide the mucus will function as the lead end point
Host: We wrap up. What would you like other providers to know about treatment options available at Northwestern Medicine, for the management of chronic rhinosinusitis? And when you feel it's important that they refer to this interdisciplinary approach?
Dr. Kern: Certainly, we're happy to see anyone. And we do offer because of the nature of the practice here, we're surrounded by 800,000 people. We do primary care ENT as well. So I do minimally invasive procedures for patients with mild problems, but certainly for your severe patients, particularly your patients with aspirin allergy, those are the worst. And we see a lot of those patients. And those are the people that I would like you to consider sending to us in particular, because the comprehensive management aggressive surgery followed by one of these biologics has made an enormous difference in these patients. So rather than ending with five or six surgeries in a year, we can keep it to one. But again, we're happy to see anyone, but those particularly problematic ones like the aspirin allergy patients, please consider sending them to us.
Host: Thank you so much, Dr. Kern, what a great guest as always that you are to refer your patient, please visit our website at nm.org/ent to get connected with one of our providers. That concludes this episode of Better Edge, a Northwestern Medicine Podcast for Physicians. Please remember to subscribe, rate, and review this podcast and all the other Northwestern Medicine podcasts. I'm Melanie Cole.