Selected Podcast
What's New in the Asthma Treatment Pipeline
Katherine Rivera, MD, discusses what's new in the Asthma treatment pipeline, her recent clinical trials, why pediatricians listening could really benefit from this study and why they should refer a patient with Asthma to St. Louis Children's Hospital.
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Learn more about Katherine Rivera, MD
Katherine Rivera, MD
Katherine Rivera, MD is a member of the Division of Allergy, Immunology and Pulmonary Medicine. She is the Medical Director of the Multidisciplinary Technology Dependent Child Clinic and also provides consultative services at Ranken Jordan Pediatric Specialty Hospital. She received her undergraduate degree in general sciences from the University of Puerto Rico, San Juan, PR.Learn more about Katherine Rivera, MD
Transcription:
Melanie Cole, MS (Host): Asthma is a growing problem, especially in children. Here to tell us what’s new in the asthma treatment pipeline is my guest, Dr. Katherine Rivera. She’s a Washington University pediatric pulmonologist at St. Louis Children’s Hospital. Dr. Rivera, what is the prevalence in asthma is children? Why is this important that we know this?
Katherine Rivera, MD (Guest): So, asthma is one of the most common chronic diseases of childhood. In 2016, there 6.1 million children in America diagnosed with asthma. That’s about 8.3%. In Missouri, it was about 8.7% of children that reported having current asthma. Nearly 60% of children with current asthma also have persistent asthma. So, it’s very important to try to find therapies to prevent asthmatic exacerbations and to control the disease.
Host: So, what is the burden of asthma on children?
Dr. Rivera: So, the burden of asthma in children varies, but the statistics show that about 54% of children with asthma report having at least one or more asthma attacks in the previous year. 31% reported an emergency department or urgent care visit. 10% reported a hospitalization. In fact, one of the most common diagnosis for hospitalization in the United States is asthma. About 45% children with asthma also reported having one or more missed school days in 2013. That accounts for about 13.8 million missed school days in total. So that’s about 2.6 days per child. In 2016, we also had, unfortunately, 209 deaths of childhood asthma.
Host: Wow, that is quite a burden of asthma in children. So, what are the current asthma guidelines? What therapies are available now?
Dr. Rivera: So current asthma guidelines to treat the disease vary according to the severity of symptoms and the risk of the patient. What we have right now, when you have intermittent disease, you can use short acting bronchodilators, like Albuterol. When you have more persistent disease, then you need daily treatment. The daily treatments that we have available currently are daily inhaled corticosteroids that come in different strengths. Inhaled corticosteroids plus a long acting beta agonist, which is the next step up in therapy.
We also have leukotriene inhibitors. Another important thing it to treat comorbidities. For example, allergic rhinitis, sinusitis, obesity, obstructive sleep apnea, and depression, which have been shown to increase asthmatic exacerbations and worsen asthma.
There are also newer asthma therapies that have been approved recently by the FDA. So, we have the biologics. The longest one in the market is omalizumab, which is an anti-IGE. That’s indicated for the treatment of moderate to severe persistent uncontrolled asthma in children more than six years of age who also have positive skin tests or reactivity to a perineal air allergen. There’s also been reslizumab and mepolizumab, which are anti-IL-5. So, they are interleukin-5 receptor alpha diuretic cytolytic monoclonal antibodies. It’s indicated also for the add-on on maintenance treatment of patients with severe asthma 12 or more years of age with an eosinophilic phenotype.
Most recently dupilumab was approved. This is an anti-IL13 and anti-IL4. It’s an interleukin receptor alpha antagonist that’s indicated for the maintenance treatment of patients with moderate to severe asthma 12 years of age or older. Also, with an eosinophilic phenotype or oral corticosteroid dependent asthma.
Host: Then tell us a little bit about your study and recruiting for and the details involved with a focus on the current asthma research.
Dr. Rivera: So current asthma research focuses on two things. So, prevention of disease and preventing exacerbation. So those are the two things that we are focusing on right now. At Washington University, we’re a study site for several asthma studies. Right now, we have therapies in the pipeline to help prevent asthma. One of the to prevent asthma studies is called ORBEX. It’s a multi-site national study. ORBEX stands for Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness.
So, the primary objective of this study is to evaluate a Broncho-Vaxum, which is a lyophilized bacterial lysate of different bacterias including Haemophilus, Streptococcus, Klebsiella, Staphylococcus, and Moraxella. It’s given to high risk infants for 10 days monthly for two consecutive years can decrease time to occurrence of first episode of wheezing lower respiratory tract illness during a third observation year after the therapy. So, this is one of the studies that we’re currently enrolling for and recruiting.
Another study for asthma prevention is called PAHRK. It’s Preventing Asthma in High Risk Kids. This trial is a randomized double-blind placebo-controlled trials designed to test whether a two-year treatment of preschool children aged two to three years of age had high risk for asthma with omalizumab, which is the anti-IGE that we discussed earlier, for two years will prevent the progression to childhood asthma. So, as you can tell, these two studies are in younger children because we want to prevent the progression or the development of the disease as they grow older.
The last study that we are currently recruiting for here at Wash-U is CRITICAL, which stands for Cockroach Immunotherapy in Children and Adolescents. So overall, there’s evidence that has shown that the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity in inner city children. So, in this study, children aged 6 to 16 who have asthma can be enrolled to receive German cockroach extract immunotherapy for up to three years. The main goal of this study is to see if we can decrease the burden of asthma.
Host: In your research studies, doctor, where does prevention of the disease put into this picture as well as preventing exacerbations?
Dr. Rivera: So, we talk about preventing the development of the disease, so ORBEX and PAHRK. Those are studies where you treat children very early on when they're in their infant period to try to prevent the development of wheezing. Now in terms of preventing exacerbations, we have other studies in the pipeline.
One of the studies that I can talk about is called Vitamin D Kids Asthma. So, this study is to try to see if vitamin D3 prevents severe asthma attacks in children who have a vitamin D insufficiency that are being treated with inhaled corticosteroids. So, these children will receive vitamin D or placebo, and we want to see if vitamin D supplementation will help prevent exacerbations.
Another study that we also are conducting is called MUPPIT. This one is a trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthmatic Exacerbation in Urban Children. So, we talked about mepolizumab before. It’s an anti-IL5. So, the purpose of this study is to see if treatment with mepolizumab along with medicines that are currently being used for a standard asthma care that we also talked about can prevent children from having asthma exacerbations. This is for younger children aged 6 to 11 years of age. Currently mepolizumab is approved in children 12 and older. So, we want to see if the reduction of exacerbations is also seen in the younger school aged children.
The last study that we are currently conducting here is called VOYAGE. So, VOYAGE is a study is to evaluate is dupilumab, that we talked about before is an anti-IL4 and anti-IL13, in children with uncontrolled asthma can helped prevent exacerbation. So, in this study we will be recruiting patients 6 to 12 years of age with uncontrolled persistent asthma. We want to see if the drug is safe and tolerable and we want to evaluate the effect in improving asthma outcomes.
Host: Dr. Rivera, how can patients be referred to being enrolled in one of the asthma research studies that you’ve mentioned here today? Should the pediatricians call you directly or should patients make the phone call? What would you prefer?
Dr. Rivera: So, either. Either will be fine. They can contact me directly, Katherine Rivera, or Linda [Carrier ph?] who’s the PI in all of these studies through our division phone number 314-454-2694. Or they can call our lead coordinator at 314-286-1173. If parents want to call directly, that would be fine as well. They can call the lead coordinator number as well. When they call, we will ask a few screening questions. We will direct them to the coordinator of the study that they meet criteria for.
Host: So, tell us why pediatricians listening will think of a patient he or she has that could benefit from the study so that they’ll refer that patient to you. Wrap it up for us. Tell other physicians what you’d like them to know about your asthma research.
Dr. Rivera: So, if you have a high-risk infant that is at high risk of development of asthma in the future, these are the patients that we want to study. We would like to see if we can prevent asthma from even developing. If you have a patient in clinic that is uncontrolled with the current asthma therapies and is not doing well, these are the patients that we also want to study. We want to know if the new therapies that are out there in the pipeline can help these patients prevent exacerbation.
Host: Thank you so much Dr. Rivera for being on with us today and sharing the information about your studies for other pediatricians so that they can refer a patient to you. Pediatricians, if you have a patient that would be a good candidate for the study, please call 314-454-2694 to discuss your options with Dr. Katherine Rivera or Linda Carrier. Thank you so much for being with us today doctor. To consult with a specialist or to learn more about services offered at St. Louis Children’s Hospital, please call children’s direct physician access line at 1-800-678-HELP. That’s 1-800-678-4357. You're listening to Radio Rounds with St. Louis Children’s Hospital. For more information on resources available at St. Louis Children’s Hospital, you can go to stlouischildrens.org. That’s stlouischildrens.org. This is Melanie Cole. Thanks so much for listening.
Melanie Cole, MS (Host): Asthma is a growing problem, especially in children. Here to tell us what’s new in the asthma treatment pipeline is my guest, Dr. Katherine Rivera. She’s a Washington University pediatric pulmonologist at St. Louis Children’s Hospital. Dr. Rivera, what is the prevalence in asthma is children? Why is this important that we know this?
Katherine Rivera, MD (Guest): So, asthma is one of the most common chronic diseases of childhood. In 2016, there 6.1 million children in America diagnosed with asthma. That’s about 8.3%. In Missouri, it was about 8.7% of children that reported having current asthma. Nearly 60% of children with current asthma also have persistent asthma. So, it’s very important to try to find therapies to prevent asthmatic exacerbations and to control the disease.
Host: So, what is the burden of asthma on children?
Dr. Rivera: So, the burden of asthma in children varies, but the statistics show that about 54% of children with asthma report having at least one or more asthma attacks in the previous year. 31% reported an emergency department or urgent care visit. 10% reported a hospitalization. In fact, one of the most common diagnosis for hospitalization in the United States is asthma. About 45% children with asthma also reported having one or more missed school days in 2013. That accounts for about 13.8 million missed school days in total. So that’s about 2.6 days per child. In 2016, we also had, unfortunately, 209 deaths of childhood asthma.
Host: Wow, that is quite a burden of asthma in children. So, what are the current asthma guidelines? What therapies are available now?
Dr. Rivera: So current asthma guidelines to treat the disease vary according to the severity of symptoms and the risk of the patient. What we have right now, when you have intermittent disease, you can use short acting bronchodilators, like Albuterol. When you have more persistent disease, then you need daily treatment. The daily treatments that we have available currently are daily inhaled corticosteroids that come in different strengths. Inhaled corticosteroids plus a long acting beta agonist, which is the next step up in therapy.
We also have leukotriene inhibitors. Another important thing it to treat comorbidities. For example, allergic rhinitis, sinusitis, obesity, obstructive sleep apnea, and depression, which have been shown to increase asthmatic exacerbations and worsen asthma.
There are also newer asthma therapies that have been approved recently by the FDA. So, we have the biologics. The longest one in the market is omalizumab, which is an anti-IGE. That’s indicated for the treatment of moderate to severe persistent uncontrolled asthma in children more than six years of age who also have positive skin tests or reactivity to a perineal air allergen. There’s also been reslizumab and mepolizumab, which are anti-IL-5. So, they are interleukin-5 receptor alpha diuretic cytolytic monoclonal antibodies. It’s indicated also for the add-on on maintenance treatment of patients with severe asthma 12 or more years of age with an eosinophilic phenotype.
Most recently dupilumab was approved. This is an anti-IL13 and anti-IL4. It’s an interleukin receptor alpha antagonist that’s indicated for the maintenance treatment of patients with moderate to severe asthma 12 years of age or older. Also, with an eosinophilic phenotype or oral corticosteroid dependent asthma.
Host: Then tell us a little bit about your study and recruiting for and the details involved with a focus on the current asthma research.
Dr. Rivera: So current asthma research focuses on two things. So, prevention of disease and preventing exacerbation. So those are the two things that we are focusing on right now. At Washington University, we’re a study site for several asthma studies. Right now, we have therapies in the pipeline to help prevent asthma. One of the to prevent asthma studies is called ORBEX. It’s a multi-site national study. ORBEX stands for Oral Bacterial Extract for the Prevention of Wheezing Lower Respiratory Tract Illness.
So, the primary objective of this study is to evaluate a Broncho-Vaxum, which is a lyophilized bacterial lysate of different bacterias including Haemophilus, Streptococcus, Klebsiella, Staphylococcus, and Moraxella. It’s given to high risk infants for 10 days monthly for two consecutive years can decrease time to occurrence of first episode of wheezing lower respiratory tract illness during a third observation year after the therapy. So, this is one of the studies that we’re currently enrolling for and recruiting.
Another study for asthma prevention is called PAHRK. It’s Preventing Asthma in High Risk Kids. This trial is a randomized double-blind placebo-controlled trials designed to test whether a two-year treatment of preschool children aged two to three years of age had high risk for asthma with omalizumab, which is the anti-IGE that we discussed earlier, for two years will prevent the progression to childhood asthma. So, as you can tell, these two studies are in younger children because we want to prevent the progression or the development of the disease as they grow older.
The last study that we are currently recruiting for here at Wash-U is CRITICAL, which stands for Cockroach Immunotherapy in Children and Adolescents. So overall, there’s evidence that has shown that the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity in inner city children. So, in this study, children aged 6 to 16 who have asthma can be enrolled to receive German cockroach extract immunotherapy for up to three years. The main goal of this study is to see if we can decrease the burden of asthma.
Host: In your research studies, doctor, where does prevention of the disease put into this picture as well as preventing exacerbations?
Dr. Rivera: So, we talk about preventing the development of the disease, so ORBEX and PAHRK. Those are studies where you treat children very early on when they're in their infant period to try to prevent the development of wheezing. Now in terms of preventing exacerbations, we have other studies in the pipeline.
One of the studies that I can talk about is called Vitamin D Kids Asthma. So, this study is to try to see if vitamin D3 prevents severe asthma attacks in children who have a vitamin D insufficiency that are being treated with inhaled corticosteroids. So, these children will receive vitamin D or placebo, and we want to see if vitamin D supplementation will help prevent exacerbations.
Another study that we also are conducting is called MUPPIT. This one is a trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthmatic Exacerbation in Urban Children. So, we talked about mepolizumab before. It’s an anti-IL5. So, the purpose of this study is to see if treatment with mepolizumab along with medicines that are currently being used for a standard asthma care that we also talked about can prevent children from having asthma exacerbations. This is for younger children aged 6 to 11 years of age. Currently mepolizumab is approved in children 12 and older. So, we want to see if the reduction of exacerbations is also seen in the younger school aged children.
The last study that we are currently conducting here is called VOYAGE. So, VOYAGE is a study is to evaluate is dupilumab, that we talked about before is an anti-IL4 and anti-IL13, in children with uncontrolled asthma can helped prevent exacerbation. So, in this study we will be recruiting patients 6 to 12 years of age with uncontrolled persistent asthma. We want to see if the drug is safe and tolerable and we want to evaluate the effect in improving asthma outcomes.
Host: Dr. Rivera, how can patients be referred to being enrolled in one of the asthma research studies that you’ve mentioned here today? Should the pediatricians call you directly or should patients make the phone call? What would you prefer?
Dr. Rivera: So, either. Either will be fine. They can contact me directly, Katherine Rivera, or Linda [Carrier ph?] who’s the PI in all of these studies through our division phone number 314-454-2694. Or they can call our lead coordinator at 314-286-1173. If parents want to call directly, that would be fine as well. They can call the lead coordinator number as well. When they call, we will ask a few screening questions. We will direct them to the coordinator of the study that they meet criteria for.
Host: So, tell us why pediatricians listening will think of a patient he or she has that could benefit from the study so that they’ll refer that patient to you. Wrap it up for us. Tell other physicians what you’d like them to know about your asthma research.
Dr. Rivera: So, if you have a high-risk infant that is at high risk of development of asthma in the future, these are the patients that we want to study. We would like to see if we can prevent asthma from even developing. If you have a patient in clinic that is uncontrolled with the current asthma therapies and is not doing well, these are the patients that we also want to study. We want to know if the new therapies that are out there in the pipeline can help these patients prevent exacerbation.
Host: Thank you so much Dr. Rivera for being on with us today and sharing the information about your studies for other pediatricians so that they can refer a patient to you. Pediatricians, if you have a patient that would be a good candidate for the study, please call 314-454-2694 to discuss your options with Dr. Katherine Rivera or Linda Carrier. Thank you so much for being with us today doctor. To consult with a specialist or to learn more about services offered at St. Louis Children’s Hospital, please call children’s direct physician access line at 1-800-678-HELP. That’s 1-800-678-4357. You're listening to Radio Rounds with St. Louis Children’s Hospital. For more information on resources available at St. Louis Children’s Hospital, you can go to stlouischildrens.org. That’s stlouischildrens.org. This is Melanie Cole. Thanks so much for listening.