TBD Meeting (2932-20)

Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”

The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
 

SAMPRO expansion

In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).

SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.

School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
 

Setting an action plan

The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.

Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.

“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.

“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”

Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
 

Training vital

The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”

Marathon not a sprint

The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”

While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.

Dr. Kakumanu reported no relevant conflicts of interest.

Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”

The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
 

SAMPRO expansion

In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).

SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.

School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
 

Setting an action plan

The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.

Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.

“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.

“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”

Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
 

Training vital

The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”

Marathon not a sprint

The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”

While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.

Dr. Kakumanu reported no relevant conflicts of interest.

Asthma care coordination for children can be improved through a school-based asthma program involving the child’s school, their family, and clinicians, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“Partnerships among schools, families, and clinicians can be powerful agents to improve the recognition of childhood asthma symptoms, asthma diagnosis and in particular management,” Sujani Kakumanu, MD, clinical associate professor of allergy and immunology at the University of Wisconsin–Madison, said in her presentation. “Emergency treatment plans and asthma action plans, as well as comprehensive education for all school personnel and school environmental mitigation plans, are crucial to controlling asthma symptoms in schools.”

The school is a unique location where families and clinicians can affect asthma outcomes because of the consistent amount of time a student spends there each day, Dr. Kakumanu explained, but everyone involved in allergy care for a child should be aware of and attempt to reduce environmental exposures and triggers found in schools that can worsen asthma, such as irritants, cleaning solutions, dust mites, pests, air pollution, and indoor air quality.
 

SAMPRO expansion

In 2016, the AAAAI and National Association of School Nurses provided financial support for the School-based Asthma Management Program (SAMPRO). “The impetus behind this initiative was a recognition that coordination with schools was essential to controlling pediatric asthma care,” Dr. Kakumanu said. Initially focusing on asthma alone, SAMPRO has since expanded to include resources for allergy and anaphylaxis and is known as the School-based Asthma, Allergy & Anaphylaxis Management Program (SA3MPRO).

SA3MPRO’s first tenet is the need for an engaged circle of support that includes families, schools, and clinicians of children with asthma. “Establishing and maintaining a healthy circle of support is a critical component to a school-based asthma partnership. It requires an understanding of how care is delivered in clinics as well as in hospitals and at schools,” Dr. Kakumanu said.

School nurses are uniquely positioned to help address gaps in care for children with asthma during the school day by administering medications and limiting the number of student absences caused by asthma. “In addition, school nurses and school personnel often provide key information to the health system about a student’s health status that can impact their prescriptions and their medical care,” she noted.
 

Setting an action plan

The second SA3MPRO tenet is the development of an asthma action plan by schools for situations when a child presents with urgent asthma symptoms that require quick action. SA3MPRO’s asthma action plan describes a child’s severity of asthma, known asthma triggers and what medications can be delivered at school, and how clinicians and schools can share HIPAA and FERPA-protected information.

Some programs are allowing school nurses to access electronic medical records to share information, Dr. Kakumanu said. UW Health at the University of Wisconsin developed the project, led by Dr. Kakumanu and Robert F. Lemanske Jr., MD, in 2017 that gave school nurses in the Madison Metropolitan School District access to the EMR. Prior to the COVID-19 pandemic, the program was linked to decreased prescriptions of steroids among pediatric clinicians, she said.

“This program allowed the quick and efficient delivery of asthma action plans to schools along with necessary authorizations, prescriptions and a consent to share information electronically. With this information and subsequent authorizations, the school nurses were able to update the school health record, manage symptoms at school as directed by the individualized asthma action plan, and coordinate school resources needed to care for the child asthma symptoms during the school day,” Dr. Kakumanu said.

“This program also addressed a common barrier with school-based partnerships, which was the lack of efficient asynchronous communication, and it did this by including the ability of school nurses and clinicians to direct message each other within a protected EMR,” she added. “In order to continue our support for families, there were also measures to include families with corresponding [EMR] messaging and with communication by phone.”

Barriers in the program at UW Health included needing annual training, sustaining momentum for organizational support and interest, monitoring infrastructure, and maintaining documents. Other challenges were in the management of systems that facilitated messaging and the need to obtain additional electronic consents separately from written consents.
 

Training vital

The third tenet in SA3MPRO is training, which should incorporate a recognition and treatment of asthma symptoms among school staff, students, and families; proper inhaler technique; how medical care will be delivered at the school and by whom; what emergency asthma symptoms look like; and a plan for getting the child to an emergency medical facility. “Regardless of the program that is chosen, asthma education should address health literacy and multiple multicultural beliefs and be delivered in the language that is appropriate for that school and that student body,” Dr. Kakumanu said. “Teachers, janitors, school administrators, and all levels of school personnel should be educated on how to recognize and treat asthma symptoms, especially if a school nurse is not always available on site.”

Marathon not a sprint

The last tenet in SA3MPRO is improving air quality and decreasing environmental exposure to triggers, which involves “the use of environmental recognition and mitigation plans to minimize the effect of allergens, irritants, and air pollutants within the outside and indoor environment that may affect a child with asthma during the school day.”

While these measures may seem daunting, Dr. Kakumanu said the communities that have successfully implemented a SA3MPRO plan are ones that prioritized updated and accurate data, developed a team-based approach, and secured long-term funding for the program. “Important lessons for all of us in this work is remembering that it’s a marathon and not a sprint, and that effective care coordination requires continual and consistent resources,” she said.

Dr. Kakumanu reported no relevant conflicts of interest.

Patients with severe asthma and comorbid atopy, obesity, and depression/anxiety had fewer annual exacerbations after receiving mepolizumab, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”

Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.

The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.

At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.

Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).

In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.

The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).

The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).

The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.

“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”

This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.

Patients with severe asthma and comorbid atopy, obesity, and depression/anxiety had fewer annual exacerbations after receiving mepolizumab, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”

Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.

The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.

At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.

Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).

In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.

The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).

The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).

The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.

“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”

This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.

Patients with severe asthma and comorbid atopy, obesity, and depression/anxiety had fewer annual exacerbations after receiving mepolizumab, according to research from the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Mepolizumab has clearly been shown to improve severe asthma control in many clinical trials, but atopy, obesity, and depression/anxiety affect patients with asthma at an increased rate,” Thomas B. Casale, MD, former AAAAI president and professor of medicine and pediatrics at the University of South Florida in Tampa, said in a presentation at the meeting. “Yet, few studies have examined whether asthma therapy with these comorbidities works.”

Dr. Casale and colleagues performed a retrospective analysis of patients in the United States from the MarketScan Commercial and Medicare Supplemental Database between November 2014 and December 2018 who had atopy, obesity, or depression/anxiety in addition to asthma and were receiving mepolizumab. Atopy in the study was defined as allergic rhinitis, anaphylaxis, atopic dermatitis, conjunctivitis, eosinophilic esophagitis, and food allergies. Patients were at least age 12 years, had at least one diagnosis for asthma, at least one diagnosis code for atopic disease, obesity, or depression/anxiety at baseline, and at least two administrations of mepolizumab within 180 days.

The researchers examined the number of exacerbations, oral corticosteroid (OCS) claims, and OCS bursts per year at 12-month follow-up, compared with baseline. They identified exacerbations by examining patients who had an emergency department or outpatient claim related to their asthma, and a claim for systemic corticosteroids made in the 4 days prior to or 5 days after a visit, or if their inpatient hospital admission contained a primary asthma diagnosis. Dr. Casale and colleagues measured OCS bursts as a pharmacy claim of at least 20 mg of prednisone per day for between 3 and 28 days plus a claim for an emergency department visit related to asthma in the 7 days prior or 6 days after the claim.

At baseline, patients across all groups were mean age 50.5-52.4 years with a Charleson Comorbidity Index score between 1.1 and 1.4, a majority were women (59.0%-72.0%) and nearly all were commercially insured (88.0%-90.0%). Patients who used biologics at baseline and/or used a biologic that wasn’t mepolizumab during the follow-up period were excluded.

Medication claims in the groups included inhaled corticosteroids (ICS) (36.8%-48.6%), ICS/long-acting beta-agonist (LABA) (60.2%-63.0%), LABA/ long-acting muscarinic antagonist (LAMA) (1.2%-3.5%), ICS/LABA/LAMA (21.2%-25.1%), short-acting beta-agonist (SABA) (83.2%-87.7%), LAMA alone (33.5%-42.1%), or leukotriene receptor antagonist (LTRA).

In the non–mutually exclusive group of patients with atopy (468 patients), 28.0% had comorbid obesity and 26.0% had comorbid depression/anxiety. For patients with obesity categorized in a non–mutually exclusive subgroup (171 patients), 79.0% had comorbid atopy and 32.0% had comorbid depression/anxiety. Among patients with non–mutually exclusive depression/anxiety (173 patients), 70.0% had comorbid atopy, while 32.0% had comorbid obesity.

The results showed the mean number of overall exacerbations decreased by 48% at 12 months in the atopic group (2.3 vs. 1.2; P < .001), 52% in the group with obesity (2.5 vs. 1.2; P < .001), and 38% in the depression/anxiety group (2.4 vs. 1.5; P < .001). The mean number of exacerbations leading to hospitalizations decreased by 64% in the atopic group (0.11 vs. 0.04; P < .001), 65% in the group with obesity (0.20 vs. 0.07; P < .001), and 68% in the group with depression/anxiety (0.22 vs. 0.07; P < .001).

The researchers also found the mean number of OCS claims and OCS bursts also significantly decreased over the 12-month follow-up period. Mean OCS claims decreased by 33% for patients in the atopic group (5.5 vs. 3.7; P < .001), by 38% in the group with obesity (6.1 vs. 3.8; P < .001), and by 31% in the group with depression/anxiety (6.2 vs. 4.3; P < .001).

The mean number of OCS bursts also significantly decreased by 40% in the atopic group (2.0 vs. 2.1; P < .001), 48% in the group with obesity (2.3 vs. 1.2; P < .001), and by 37% in the group with depression/anxiety (1.9 vs. 1.2; P < .001). In total, 69% of patients with comorbid atopy, 70.8% of patients with comorbid obesity, and 68.2% of patients with comorbid depression/anxiety experienced a mean decrease in their OCS dose over 12 months.

“These data demonstrate that patients with asthma and atopy, obesity, or depression and anxiety have significantly fewer exacerbations and reduced OCS use in a real-world setting with treatment of mepolizumab,” Dr. Casale said. “Thus, holistic patient care for severe asthma is critical, and mepolizumab provides tangible clinical benefit despite the complexities of medical comorbidities.”

This study was funded by GlaxoSmithKline, and the company also funded graphic design support of the poster. Dr. Casale reports he has received research funds from GlaxoSmithKline. Four authors report being current or former GlaxoSmithKline employees; three authors report holding stock and/or shares of GlaxoSmithKline. Three authors are IBM Watson Health employees, a company GlaxoSmithKline has provided research funding.

Among individuals with asthma and allergies who use cannabis, more than half said they aren’t willing to discuss their use of cannabis with their doctor and their doctor doesn’t ask, according to recent research at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

VladK213/Getty Images

In an online survey of respondents with asthma and allergies in the Allergy & Asthma Network, 88 of 489 (18.0%) reported cannabis use. Of these respondents, 37.5% said they wanted to discuss their cannabis use with their doctor, 51.1% said they would not want to, and 11.4% reported they were unsure. In addition, 40.9% of respondents said their doctor inquired about cannabis use, while 51.1% said their doctor did not bring up cannabis use at all, either through a verbal discussion or on an intake form.

To date, there has not been much research on use of cannabis among patients with allergies and asthma, Joanna S. Zeiger, MS, PhD, of the Canna Research Foundation in Boulder, Colo., said in her presentation. “This is a group with whom route of administration could have broad adverse effects. Smoking or vaping cannabis in this population could lead to increased symptoms of cough and wheeze, as well as increased use of asthma medications and exacerbations of their disease.”

Dr. Zeiger and colleagues recruited 489 respondents for the AAN Pain, Exercise, and Cannabis Experience Survey study through social media channels between May 2020 and September 2020. In the survey, the researchers asked questions about the nature of the respondent’s cannabis use (medical, recreational, or both), the types of cannabinoids used (tetrahydrocannabinol [THC], cannabidiol [CBD], or both), the route of administration (capsule, edible, oil/tincture, smoke, spray, topical, or vaporizer), and subjective effects. Most of the respondents reported using both THC and CBD, with smoking, edibles, and vaping being the most comment route of administration.

Of the 88 respondents who said they currently used cannabis, 60.2% were aged less than 50 years, 72.4% were women, and 71.6% were White. A majority of respondents had been using cannabis for 3 or more years (54.5%) , used it less than one time per day (60.2%), and used it for pain (68.2%). Current asthma was reported in 51 respondents (58.0%), and 39.2% had uncontrolled asthma. Half of those respondents with uncontrolled asthma reported smoking cannabis, and 25.0% reported coughing because of cannabis. Both THC and CBD were used by 47.7% of respondents; 33% reported THC use alone, while 19.3% used CBD alone.

Reported effects of cannabis use

The most common positive effects of using cannabis reported among respondents were that it helped with sleep (66 respondents), calmed them down (60 respondents), reduced pain (60 respondents), or decreased anxiety (59 respondents). Many respondents who reported positive effects were using both THC and CBD. For example, respondents who reported using cannabinoids for calming, 46.7% reported using both, compared with 36.7% who used THC only and 16.7% who used CBD only. Among respondents who reported that cannabis helped them sleep, 51.5% used both THC and CBD.

Regarding adverse effects, there were no significant differences based on use of THC or CBD, but 31.9% of respondents who said they smoked cannabis and 4.9% of respondents who used cannabis through a route of administration that wasn’t smoking reported they coughed with their cannabis use (P < .001). No respondents reported anaphyalaxis, although, among individuals who did not use cannabis, 2.5% reported a cannabis allergy.
 

‘Cannabis allergy is real’

Commenting on the research, Gordon L. Sussman MD, allergist, clinical immunologist, and clinical professor of medicine at the University of Toronto, said the survey is a thorough questionnaire that is likely representative of attitudes about cannabis in the United States and countries where cannabis is not broadly legalized.

Cannabis allergy, however, is not uncommon, and “is something that people should be aware of,” he said. “Cannabis IgE allergy is real, is probably fairly common, and is something that [clinicians] should be asking about routinely.”

One limitation of the research was not knowing the number of people who declined to answer the survey, as there may be a bias in the results toward people who want to answer the questions, compared with those who did not want to answer. “When you do a survey, only a certain number of people are going to answer, and [you also want input from] people that don’t answer,” Dr. Sussman said.

Dr. Sussman acknowledged it can be difficult to get patients to admit cannabis use, even in countries like Canada where it is legal. Surveys like the one administered by Dr. Zeiger and colleagues are “the first step” to getting updated assessments of cannabis attitudes and recommendations. “The next step is doing an international survey, so you get different countries’ viewpoints and perspectives,” he said.

This study was supported by the Allergy & Asthma Network and the Canna Research Foundation. Three authors are affiliated with the Canna Research Foundation. Dr. Sussman reported no financial conflicts of interest. Dr. Sussman participates in the International Cannabis Allergy KAP Collaboration, a group founded by one of the coauthors, William Silvers, MD, but Dr. Sussman was not involved with this study.

Among individuals with asthma and allergies who use cannabis, more than half said they aren’t willing to discuss their use of cannabis with their doctor and their doctor doesn’t ask, according to recent research at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

VladK213/Getty Images

In an online survey of respondents with asthma and allergies in the Allergy & Asthma Network, 88 of 489 (18.0%) reported cannabis use. Of these respondents, 37.5% said they wanted to discuss their cannabis use with their doctor, 51.1% said they would not want to, and 11.4% reported they were unsure. In addition, 40.9% of respondents said their doctor inquired about cannabis use, while 51.1% said their doctor did not bring up cannabis use at all, either through a verbal discussion or on an intake form.

To date, there has not been much research on use of cannabis among patients with allergies and asthma, Joanna S. Zeiger, MS, PhD, of the Canna Research Foundation in Boulder, Colo., said in her presentation. “This is a group with whom route of administration could have broad adverse effects. Smoking or vaping cannabis in this population could lead to increased symptoms of cough and wheeze, as well as increased use of asthma medications and exacerbations of their disease.”

Dr. Zeiger and colleagues recruited 489 respondents for the AAN Pain, Exercise, and Cannabis Experience Survey study through social media channels between May 2020 and September 2020. In the survey, the researchers asked questions about the nature of the respondent’s cannabis use (medical, recreational, or both), the types of cannabinoids used (tetrahydrocannabinol [THC], cannabidiol [CBD], or both), the route of administration (capsule, edible, oil/tincture, smoke, spray, topical, or vaporizer), and subjective effects. Most of the respondents reported using both THC and CBD, with smoking, edibles, and vaping being the most comment route of administration.

Of the 88 respondents who said they currently used cannabis, 60.2% were aged less than 50 years, 72.4% were women, and 71.6% were White. A majority of respondents had been using cannabis for 3 or more years (54.5%) , used it less than one time per day (60.2%), and used it for pain (68.2%). Current asthma was reported in 51 respondents (58.0%), and 39.2% had uncontrolled asthma. Half of those respondents with uncontrolled asthma reported smoking cannabis, and 25.0% reported coughing because of cannabis. Both THC and CBD were used by 47.7% of respondents; 33% reported THC use alone, while 19.3% used CBD alone.

Reported effects of cannabis use

The most common positive effects of using cannabis reported among respondents were that it helped with sleep (66 respondents), calmed them down (60 respondents), reduced pain (60 respondents), or decreased anxiety (59 respondents). Many respondents who reported positive effects were using both THC and CBD. For example, respondents who reported using cannabinoids for calming, 46.7% reported using both, compared with 36.7% who used THC only and 16.7% who used CBD only. Among respondents who reported that cannabis helped them sleep, 51.5% used both THC and CBD.

Regarding adverse effects, there were no significant differences based on use of THC or CBD, but 31.9% of respondents who said they smoked cannabis and 4.9% of respondents who used cannabis through a route of administration that wasn’t smoking reported they coughed with their cannabis use (P < .001). No respondents reported anaphyalaxis, although, among individuals who did not use cannabis, 2.5% reported a cannabis allergy.
 

‘Cannabis allergy is real’

Commenting on the research, Gordon L. Sussman MD, allergist, clinical immunologist, and clinical professor of medicine at the University of Toronto, said the survey is a thorough questionnaire that is likely representative of attitudes about cannabis in the United States and countries where cannabis is not broadly legalized.

Cannabis allergy, however, is not uncommon, and “is something that people should be aware of,” he said. “Cannabis IgE allergy is real, is probably fairly common, and is something that [clinicians] should be asking about routinely.”

One limitation of the research was not knowing the number of people who declined to answer the survey, as there may be a bias in the results toward people who want to answer the questions, compared with those who did not want to answer. “When you do a survey, only a certain number of people are going to answer, and [you also want input from] people that don’t answer,” Dr. Sussman said.

Dr. Sussman acknowledged it can be difficult to get patients to admit cannabis use, even in countries like Canada where it is legal. Surveys like the one administered by Dr. Zeiger and colleagues are “the first step” to getting updated assessments of cannabis attitudes and recommendations. “The next step is doing an international survey, so you get different countries’ viewpoints and perspectives,” he said.

This study was supported by the Allergy & Asthma Network and the Canna Research Foundation. Three authors are affiliated with the Canna Research Foundation. Dr. Sussman reported no financial conflicts of interest. Dr. Sussman participates in the International Cannabis Allergy KAP Collaboration, a group founded by one of the coauthors, William Silvers, MD, but Dr. Sussman was not involved with this study.

Among individuals with asthma and allergies who use cannabis, more than half said they aren’t willing to discuss their use of cannabis with their doctor and their doctor doesn’t ask, according to recent research at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

VladK213/Getty Images

In an online survey of respondents with asthma and allergies in the Allergy & Asthma Network, 88 of 489 (18.0%) reported cannabis use. Of these respondents, 37.5% said they wanted to discuss their cannabis use with their doctor, 51.1% said they would not want to, and 11.4% reported they were unsure. In addition, 40.9% of respondents said their doctor inquired about cannabis use, while 51.1% said their doctor did not bring up cannabis use at all, either through a verbal discussion or on an intake form.

To date, there has not been much research on use of cannabis among patients with allergies and asthma, Joanna S. Zeiger, MS, PhD, of the Canna Research Foundation in Boulder, Colo., said in her presentation. “This is a group with whom route of administration could have broad adverse effects. Smoking or vaping cannabis in this population could lead to increased symptoms of cough and wheeze, as well as increased use of asthma medications and exacerbations of their disease.”

Dr. Zeiger and colleagues recruited 489 respondents for the AAN Pain, Exercise, and Cannabis Experience Survey study through social media channels between May 2020 and September 2020. In the survey, the researchers asked questions about the nature of the respondent’s cannabis use (medical, recreational, or both), the types of cannabinoids used (tetrahydrocannabinol [THC], cannabidiol [CBD], or both), the route of administration (capsule, edible, oil/tincture, smoke, spray, topical, or vaporizer), and subjective effects. Most of the respondents reported using both THC and CBD, with smoking, edibles, and vaping being the most comment route of administration.

Of the 88 respondents who said they currently used cannabis, 60.2% were aged less than 50 years, 72.4% were women, and 71.6% were White. A majority of respondents had been using cannabis for 3 or more years (54.5%) , used it less than one time per day (60.2%), and used it for pain (68.2%). Current asthma was reported in 51 respondents (58.0%), and 39.2% had uncontrolled asthma. Half of those respondents with uncontrolled asthma reported smoking cannabis, and 25.0% reported coughing because of cannabis. Both THC and CBD were used by 47.7% of respondents; 33% reported THC use alone, while 19.3% used CBD alone.

Reported effects of cannabis use

The most common positive effects of using cannabis reported among respondents were that it helped with sleep (66 respondents), calmed them down (60 respondents), reduced pain (60 respondents), or decreased anxiety (59 respondents). Many respondents who reported positive effects were using both THC and CBD. For example, respondents who reported using cannabinoids for calming, 46.7% reported using both, compared with 36.7% who used THC only and 16.7% who used CBD only. Among respondents who reported that cannabis helped them sleep, 51.5% used both THC and CBD.

Regarding adverse effects, there were no significant differences based on use of THC or CBD, but 31.9% of respondents who said they smoked cannabis and 4.9% of respondents who used cannabis through a route of administration that wasn’t smoking reported they coughed with their cannabis use (P < .001). No respondents reported anaphyalaxis, although, among individuals who did not use cannabis, 2.5% reported a cannabis allergy.
 

‘Cannabis allergy is real’

Commenting on the research, Gordon L. Sussman MD, allergist, clinical immunologist, and clinical professor of medicine at the University of Toronto, said the survey is a thorough questionnaire that is likely representative of attitudes about cannabis in the United States and countries where cannabis is not broadly legalized.

Cannabis allergy, however, is not uncommon, and “is something that people should be aware of,” he said. “Cannabis IgE allergy is real, is probably fairly common, and is something that [clinicians] should be asking about routinely.”

One limitation of the research was not knowing the number of people who declined to answer the survey, as there may be a bias in the results toward people who want to answer the questions, compared with those who did not want to answer. “When you do a survey, only a certain number of people are going to answer, and [you also want input from] people that don’t answer,” Dr. Sussman said.

Dr. Sussman acknowledged it can be difficult to get patients to admit cannabis use, even in countries like Canada where it is legal. Surveys like the one administered by Dr. Zeiger and colleagues are “the first step” to getting updated assessments of cannabis attitudes and recommendations. “The next step is doing an international survey, so you get different countries’ viewpoints and perspectives,” he said.

This study was supported by the Allergy & Asthma Network and the Canna Research Foundation. Three authors are affiliated with the Canna Research Foundation. Dr. Sussman reported no financial conflicts of interest. Dr. Sussman participates in the International Cannabis Allergy KAP Collaboration, a group founded by one of the coauthors, William Silvers, MD, but Dr. Sussman was not involved with this study.

The monoclonal antibody omalizumab, already approved to treat allergic asthma and urticaria, has been shown to improve symptoms of patients who have chronic rhinosinusitis and nasal polyps (CRSwNP), according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“When you give this drug to patients who have nasal polyposis and concomitant asthma, you are effectively treating both the upper and lower airway disease components,” Jonathan Corren, MD, of the University of California, Los Angeles, said in an interview. “Typically, people with nasal polyp disease have worse nasal disease than people without asthma. In addition, asthma is also generally worse in patients with nasal polyposis,” he added.

Dr. Corren reported results of a subset of patients with corticosteroid-refractory CRSwNP and comorbid asthma enrolled in phase III, placebo-controlled, 24-week, trials of omalizumab, POLYP1 (n = 74) and POLYP2 (n = 77). The analysis excluded patients who were on oral steroids or high-dose steroid inhaler therapy so the effectiveness of omalizumab could be evaluated without interfering factors, Dr. Corren explained. As a result, the study population consisted of patients with mild to moderate asthma. Dr. Corren is also principal investigator of the POLYP1 trial.

The analysis compared changes in Asthma Quality of Life Questionnaire (AQLQ) and sino-nasal outcome test (SNOT-22) measures after 24 weeks of treatment with those seen with placebo.

“With regard to asthma outcomes, we found there was a significant increase in the odds ratio that patients who received omalizumab would achieve a minimal, clinically important improvement in their asthma quality of life,” Dr. Corren said .

The study estimated the odds ratio for minimal clinically important difference in AQLQ at 24 weeks was 3.9 (95% confidence interval, 1.5-9.7; P = .0043), which Dr. Corren called “quite significant.” SNOT-22 scores showed a mean improvement of 23.3 from baseline to week 24, compared with a worsening of 8.4 in placebo (P = .0001).

Omalizumab is approved for treatment of perennial allergies and urticaria. Chronic rhinosinusitis with nasal polyps would be a third indication if the Food and Drug Administration approves it, Dr. Corren noted.

Genentech sponsored the subset analysis. Hoffmann-La Roche, Genentech’s parent company, is sponsor of the POLYP1 and POLYP2 trials. Dr. Corren disclosed financial relationships with Genentech.

SOURCE: Corren J et al. AAAAI, Session 4608, Abstract 813.

The monoclonal antibody omalizumab, already approved to treat allergic asthma and urticaria, has been shown to improve symptoms of patients who have chronic rhinosinusitis and nasal polyps (CRSwNP), according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“When you give this drug to patients who have nasal polyposis and concomitant asthma, you are effectively treating both the upper and lower airway disease components,” Jonathan Corren, MD, of the University of California, Los Angeles, said in an interview. “Typically, people with nasal polyp disease have worse nasal disease than people without asthma. In addition, asthma is also generally worse in patients with nasal polyposis,” he added.

Dr. Corren reported results of a subset of patients with corticosteroid-refractory CRSwNP and comorbid asthma enrolled in phase III, placebo-controlled, 24-week, trials of omalizumab, POLYP1 (n = 74) and POLYP2 (n = 77). The analysis excluded patients who were on oral steroids or high-dose steroid inhaler therapy so the effectiveness of omalizumab could be evaluated without interfering factors, Dr. Corren explained. As a result, the study population consisted of patients with mild to moderate asthma. Dr. Corren is also principal investigator of the POLYP1 trial.

The analysis compared changes in Asthma Quality of Life Questionnaire (AQLQ) and sino-nasal outcome test (SNOT-22) measures after 24 weeks of treatment with those seen with placebo.

“With regard to asthma outcomes, we found there was a significant increase in the odds ratio that patients who received omalizumab would achieve a minimal, clinically important improvement in their asthma quality of life,” Dr. Corren said .

The study estimated the odds ratio for minimal clinically important difference in AQLQ at 24 weeks was 3.9 (95% confidence interval, 1.5-9.7; P = .0043), which Dr. Corren called “quite significant.” SNOT-22 scores showed a mean improvement of 23.3 from baseline to week 24, compared with a worsening of 8.4 in placebo (P = .0001).

Omalizumab is approved for treatment of perennial allergies and urticaria. Chronic rhinosinusitis with nasal polyps would be a third indication if the Food and Drug Administration approves it, Dr. Corren noted.

Genentech sponsored the subset analysis. Hoffmann-La Roche, Genentech’s parent company, is sponsor of the POLYP1 and POLYP2 trials. Dr. Corren disclosed financial relationships with Genentech.

SOURCE: Corren J et al. AAAAI, Session 4608, Abstract 813.

The monoclonal antibody omalizumab, already approved to treat allergic asthma and urticaria, has been shown to improve symptoms of patients who have chronic rhinosinusitis and nasal polyps (CRSwNP), according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“When you give this drug to patients who have nasal polyposis and concomitant asthma, you are effectively treating both the upper and lower airway disease components,” Jonathan Corren, MD, of the University of California, Los Angeles, said in an interview. “Typically, people with nasal polyp disease have worse nasal disease than people without asthma. In addition, asthma is also generally worse in patients with nasal polyposis,” he added.

Dr. Corren reported results of a subset of patients with corticosteroid-refractory CRSwNP and comorbid asthma enrolled in phase III, placebo-controlled, 24-week, trials of omalizumab, POLYP1 (n = 74) and POLYP2 (n = 77). The analysis excluded patients who were on oral steroids or high-dose steroid inhaler therapy so the effectiveness of omalizumab could be evaluated without interfering factors, Dr. Corren explained. As a result, the study population consisted of patients with mild to moderate asthma. Dr. Corren is also principal investigator of the POLYP1 trial.

The analysis compared changes in Asthma Quality of Life Questionnaire (AQLQ) and sino-nasal outcome test (SNOT-22) measures after 24 weeks of treatment with those seen with placebo.

“With regard to asthma outcomes, we found there was a significant increase in the odds ratio that patients who received omalizumab would achieve a minimal, clinically important improvement in their asthma quality of life,” Dr. Corren said .

The study estimated the odds ratio for minimal clinically important difference in AQLQ at 24 weeks was 3.9 (95% confidence interval, 1.5-9.7; P = .0043), which Dr. Corren called “quite significant.” SNOT-22 scores showed a mean improvement of 23.3 from baseline to week 24, compared with a worsening of 8.4 in placebo (P = .0001).

Omalizumab is approved for treatment of perennial allergies and urticaria. Chronic rhinosinusitis with nasal polyps would be a third indication if the Food and Drug Administration approves it, Dr. Corren noted.

Genentech sponsored the subset analysis. Hoffmann-La Roche, Genentech’s parent company, is sponsor of the POLYP1 and POLYP2 trials. Dr. Corren disclosed financial relationships with Genentech.

SOURCE: Corren J et al. AAAAI, Session 4608, Abstract 813.

Pediatric patients with allergic rhinoconjunctivitis (AR/C) who received ragweed sublingual immunotherapy (SLIT) tablets had improvements in their comorbid asthma during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.

Photo courtesy Oak Ridge National Laboratory

David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV₁) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.

The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.

Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (­–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.

This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.

“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”

Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.

“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”

Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.

This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.

SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.

Pediatric patients with allergic rhinoconjunctivitis (AR/C) who received ragweed sublingual immunotherapy (SLIT) tablets had improvements in their comorbid asthma during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.

Photo courtesy Oak Ridge National Laboratory

David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV₁) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.

The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.

Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (­–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.

This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.

“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”

Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.

“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”

Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.

This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.

SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.

Pediatric patients with allergic rhinoconjunctivitis (AR/C) who received ragweed sublingual immunotherapy (SLIT) tablets had improvements in their comorbid asthma during ragweed pollen season, compared with placebo, according to recent research that was to be presented as an abstract for the American Academy of Allergy, Asthma & Immunology annual meeting. The AAAAI canceled its annual meeting and provided abstracts and access to presenters for press coverage.

Photo courtesy Oak Ridge National Laboratory

David I. Bernstein, MD, professor emeritus in the division of immunology, allergy and rheumatology at the University of Cincinnati and principal investigator at the Bernstein Clinical Research Center, examined exploratory endpoints of an international, double-blind, placebo-controlled trial evaluating ragweed SLIT tablets (Ragwitek; Merck) in 1,022 children with AR/C. The children enrolled were aged 5-17 years with ragweed AR/C, with 42.7% of the group having a history of asthma and the rest without asthma. Participants were included if they had a predicted first expiratory volume in 1 second (FEV₁) of ≥ 80% and if they required high-dose inhaled corticosteroids (ICS) to control their asthma or had severe, unstable, or uncontrolled asthma. The children were randomized to receive a 12 Amb a 1-unit dose of the ragweed SLIT tablet or placebo each day for 28 weeks.

The primary outcome was the total combined score (TCS), which was the sum of the daily symptom score and medication scores during ragweed season, but researchers also examined three exploratory endpoints. All patients were evaluated for their average asthma daily symptom score at the peak of ragweed pollen season and during the entire season, which was measured on a 0-3 scale based on symptoms of cough, wheeze, and chest tightness or shortness of breath. Within a subgroup of 406 participants with asthma, Dr. Bernstein and colleagues examined use of average daily short-acting beta agonists (SABA), and the number of times per week a participant would use a SABA at night at the peak of ragweed season as well as across the whole season.

Researchers found the TCS improved by 38% during ragweed pollen season in the group receiving ragweed SLIT tablets (least-square [LS] mean TCS, 7.12), compared with placebo (LS mean TCS, 4.39; P < .001). Among the asthma exploratory outcomes, asthma daily symptom scores improved by 30.7% during the peak of the season (–46.9% vs. –9.6%; LS mean difference, –0.13) and by 23.1% during the whole season (­–38.7% vs. –2.3%; LS mean difference, –0.09), compared with the placebo group. The mean number of daily puffs of rescue medication also decreased by 68.1% in the peak of ragweed season (–87.6% vs. –39.0%; LS mean difference, −0.14) and by 61.4% during the whole season (–80.9% vs. −32.9%; LS mean difference, –0.12) among participants taking ragweed SLIT tablets, compared with placebo. Participants in the group receiving ragweed SLIT tablets also had fewer nights awake using rescue medication, with a relative improvement of 75.1% during peak season (−99.3% vs. −35.2%; LS mean difference, −0.08) and 52.2% during the whole season (−80.4% vs. −3.7%; LS mean difference, −0.03), compared with the placebo group.

This magnitude of difference in the number of nocturnal awakenings in the treated group, compared with the placebo group, is similar to what researchers have seen in trials evaluating ICS or mometasone/formoterol, Dr. Bernstein said in an interview.

“Even though the magnitude in terms of difference in asthma symptoms and requirements for short-acting beta agonists was less than that of other studies of other drugs, it may reflect the fact these participants have less severe asthma,” said Dr. Bernstein. “But, there was an effect, and we did see some interesting differences between the placebo group and the treated group. This, I think, does generate at least a hypothesis that this could be an effective treatment for seasonal asthma, which would require future studies to determine that.”

Dr. Bernstein said that there were no adverse events from ragweed SLIT tablets unique to children with or without asthma, and although the data from this study cannot be compared directly to an adult population, there appeared to be a greater effect size for children than in trials evaluating adults. Compared with treatment options like subcutaneous immunotherapy, ragweed SLIT tablets may offer a relatively safer and more effective option for children and their parents, he said.

“The problem with kids is that they don’t particularly like the idea of getting injections. There’s a lot of needle-type injection phobia,” Dr. Bernstein said. “For a child who has maybe one or two major problem pollen seasons like during the ragweed and grass, they could do this.”

Ragwitek was approved by the Food and Drug Administration in 2014 for the treatment of adults with allergic rhinitis. Dr. Bernstein noted that Merck submitted this trial to the Food and Drug Administration as evidence of its effectiveness in children to secure a pediatric indication for the treatment.

This trial was funded by Merck, the developers of Ragwitek. The authors received medical writing and editing assistance from Scott Medical Communications, which was funded by ALK. Dr. Bernstein reports being on the advisory board for ALK America and GlaxoSmithKline; a consultant for Gerson-Lehman and Guidepoint Global; and received grant support from Aimmune, ALK, Amgen, AstraZeneca, Avillion, Biocryst, Boehringer Ingelheim, Cipla, Genentech, GlaxoSmithKline, Gossamer, Leo, Lupin, Menlo, Merck, Mylan, Novartis, Novum, Pearl, Regeneron, Shire, and TEVA. The other authors reported no relevant conflicts of interest.

SOURCE: Bernstein D et al. AAAAI 2020, Abstract 270.

Olfactory decline in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery is linked to superior turbinate eosinophilia, according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

© Siri Stafford/Thinkstock

“Superior turbinate eosinophilia is highly associated with the olfactory decline in CRS patients 3 months after endoscopic sinus surgery,” Dawei Wu, MD, of Beijing Anzhen Hospital, Capital Medical University in Beijing, China, said in an interview.

There has been some research in the literature pointing to the link between CRS-associated olfactory dysfunction and superior turbinate eosinophilia. In a 2017 study, Lavin et al. found eosinophil markers in the superior turbinate tissue were elevated in patients with CRS with nasal polyps. One of the gene expressions of the eosinophil marker Charcot Leyden crystal protein (CLC) was inversely associated with olfactory threshold, which led the researchers to believe there was a link between olfactory decline and superior turbinate eosinophilia in these patients (Laryngoscope. 2017 Oct;127[10]:2210-2218).

Olfactory decline associated with CRS is the most common reason for loss of smell in ear, nose, and throat clinics, Dr. Wu said, but predicting this olfactory decline after endoscopic sinus surgery can be clinically challenging.

“The distinct feature of this smell disorder is the fluctuation in olfactory dysfunction which is mainly due to the recurrence of inflammation within the olfactory cleft. Notably, the level of eosinophils within the olfactory cleft significantly and positively correlated with the degree of olfactory dysfunction in patients with CRS both pre- and postoperatively,” he said.

Dr. Wu and colleagues conducted a prospective study to determine whether there was a link in CRS patients between preoperative superior turbinate eosinophilia and olfactory dysfunction after endoscopic sinus surgery. “We aimed to explore potential predictors of postoperative olfactory decline,” Dr. Wu said.

Overall, the investigators enrolled 78 patients with CRS in the study, where they received an olfactory assessment prior to and 3 months after endoscopic sinus surgery. The investigators used Sniffin’ Sticks (Burghardt; Wedel, Germany), a 12-item psychophysical smell test that uses everyday odors to conduct the olfactory assessment. If patients had a decrease in their threshold-discrimination-identification (TDI) score after surgery, they were determined to have olfactory deterioration. Prior to surgery, investigators measured olfactory cleft opacification using CT, with the olfactory cleft endoscopy scale used after surgery. The investigators also sampled patients’ superior turbinates at the time of surgery.

The results showed 23 of 78 patients (29.49%) had olfactory decline at 3 months after endoscopic sinus surgery. Those patients with olfactory decline had significantly higher tissue, blood eosinophil levels, and TDI scores before surgery, compared with patients with CRS who did not have any loss of smell. Patients with olfactory decline also had olfactory cleft opacification and olfactory cleft endoscopy scale scores, compared with patients who had no loss of smell after surgery.

One factor that predicted olfactory decline in these patients was an absolute count of 23.5 eosinophils per high-power field in the superior turbinate, researchers said (area under the ROC curve, 0.901). “Continuous elimination of the eosinophilic inflammation within the olfactory cleft in CRS patients with olfactory dysfunction may prevent the olfactory fluctuation after endoscopic sinus surgery,” Dr. Wu said.

Dr. Wu reports no relevant conflicts of interest.

SOURCE: Wu D et al. AAAAI. Abstract L7.

Olfactory decline in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery is linked to superior turbinate eosinophilia, according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

© Siri Stafford/Thinkstock

“Superior turbinate eosinophilia is highly associated with the olfactory decline in CRS patients 3 months after endoscopic sinus surgery,” Dawei Wu, MD, of Beijing Anzhen Hospital, Capital Medical University in Beijing, China, said in an interview.

There has been some research in the literature pointing to the link between CRS-associated olfactory dysfunction and superior turbinate eosinophilia. In a 2017 study, Lavin et al. found eosinophil markers in the superior turbinate tissue were elevated in patients with CRS with nasal polyps. One of the gene expressions of the eosinophil marker Charcot Leyden crystal protein (CLC) was inversely associated with olfactory threshold, which led the researchers to believe there was a link between olfactory decline and superior turbinate eosinophilia in these patients (Laryngoscope. 2017 Oct;127[10]:2210-2218).

Olfactory decline associated with CRS is the most common reason for loss of smell in ear, nose, and throat clinics, Dr. Wu said, but predicting this olfactory decline after endoscopic sinus surgery can be clinically challenging.

“The distinct feature of this smell disorder is the fluctuation in olfactory dysfunction which is mainly due to the recurrence of inflammation within the olfactory cleft. Notably, the level of eosinophils within the olfactory cleft significantly and positively correlated with the degree of olfactory dysfunction in patients with CRS both pre- and postoperatively,” he said.

Dr. Wu and colleagues conducted a prospective study to determine whether there was a link in CRS patients between preoperative superior turbinate eosinophilia and olfactory dysfunction after endoscopic sinus surgery. “We aimed to explore potential predictors of postoperative olfactory decline,” Dr. Wu said.

Overall, the investigators enrolled 78 patients with CRS in the study, where they received an olfactory assessment prior to and 3 months after endoscopic sinus surgery. The investigators used Sniffin’ Sticks (Burghardt; Wedel, Germany), a 12-item psychophysical smell test that uses everyday odors to conduct the olfactory assessment. If patients had a decrease in their threshold-discrimination-identification (TDI) score after surgery, they were determined to have olfactory deterioration. Prior to surgery, investigators measured olfactory cleft opacification using CT, with the olfactory cleft endoscopy scale used after surgery. The investigators also sampled patients’ superior turbinates at the time of surgery.

The results showed 23 of 78 patients (29.49%) had olfactory decline at 3 months after endoscopic sinus surgery. Those patients with olfactory decline had significantly higher tissue, blood eosinophil levels, and TDI scores before surgery, compared with patients with CRS who did not have any loss of smell. Patients with olfactory decline also had olfactory cleft opacification and olfactory cleft endoscopy scale scores, compared with patients who had no loss of smell after surgery.

One factor that predicted olfactory decline in these patients was an absolute count of 23.5 eosinophils per high-power field in the superior turbinate, researchers said (area under the ROC curve, 0.901). “Continuous elimination of the eosinophilic inflammation within the olfactory cleft in CRS patients with olfactory dysfunction may prevent the olfactory fluctuation after endoscopic sinus surgery,” Dr. Wu said.

Dr. Wu reports no relevant conflicts of interest.

SOURCE: Wu D et al. AAAAI. Abstract L7.

Olfactory decline in patients with chronic rhinosinusitis (CRS) after endoscopic sinus surgery is linked to superior turbinate eosinophilia, according to recent research released as an abstract from the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

© Siri Stafford/Thinkstock

“Superior turbinate eosinophilia is highly associated with the olfactory decline in CRS patients 3 months after endoscopic sinus surgery,” Dawei Wu, MD, of Beijing Anzhen Hospital, Capital Medical University in Beijing, China, said in an interview.

There has been some research in the literature pointing to the link between CRS-associated olfactory dysfunction and superior turbinate eosinophilia. In a 2017 study, Lavin et al. found eosinophil markers in the superior turbinate tissue were elevated in patients with CRS with nasal polyps. One of the gene expressions of the eosinophil marker Charcot Leyden crystal protein (CLC) was inversely associated with olfactory threshold, which led the researchers to believe there was a link between olfactory decline and superior turbinate eosinophilia in these patients (Laryngoscope. 2017 Oct;127[10]:2210-2218).

Olfactory decline associated with CRS is the most common reason for loss of smell in ear, nose, and throat clinics, Dr. Wu said, but predicting this olfactory decline after endoscopic sinus surgery can be clinically challenging.

“The distinct feature of this smell disorder is the fluctuation in olfactory dysfunction which is mainly due to the recurrence of inflammation within the olfactory cleft. Notably, the level of eosinophils within the olfactory cleft significantly and positively correlated with the degree of olfactory dysfunction in patients with CRS both pre- and postoperatively,” he said.

Dr. Wu and colleagues conducted a prospective study to determine whether there was a link in CRS patients between preoperative superior turbinate eosinophilia and olfactory dysfunction after endoscopic sinus surgery. “We aimed to explore potential predictors of postoperative olfactory decline,” Dr. Wu said.

Overall, the investigators enrolled 78 patients with CRS in the study, where they received an olfactory assessment prior to and 3 months after endoscopic sinus surgery. The investigators used Sniffin’ Sticks (Burghardt; Wedel, Germany), a 12-item psychophysical smell test that uses everyday odors to conduct the olfactory assessment. If patients had a decrease in their threshold-discrimination-identification (TDI) score after surgery, they were determined to have olfactory deterioration. Prior to surgery, investigators measured olfactory cleft opacification using CT, with the olfactory cleft endoscopy scale used after surgery. The investigators also sampled patients’ superior turbinates at the time of surgery.

The results showed 23 of 78 patients (29.49%) had olfactory decline at 3 months after endoscopic sinus surgery. Those patients with olfactory decline had significantly higher tissue, blood eosinophil levels, and TDI scores before surgery, compared with patients with CRS who did not have any loss of smell. Patients with olfactory decline also had olfactory cleft opacification and olfactory cleft endoscopy scale scores, compared with patients who had no loss of smell after surgery.

One factor that predicted olfactory decline in these patients was an absolute count of 23.5 eosinophils per high-power field in the superior turbinate, researchers said (area under the ROC curve, 0.901). “Continuous elimination of the eosinophilic inflammation within the olfactory cleft in CRS patients with olfactory dysfunction may prevent the olfactory fluctuation after endoscopic sinus surgery,” Dr. Wu said.

Dr. Wu reports no relevant conflicts of interest.

SOURCE: Wu D et al. AAAAI. Abstract L7.

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

A small-molecule kinase inhibitor that targets a gene mutation complicit in systemic mastocytosis has been found to reduce symptoms by about 30%, according to early results of a clinical trial scheduled to be presented at the American Academy of Allergy, Asthma, and Immunology annual meeting. The AAAAI canceled the meeting and provided abstracts and access to presenters for press coverage.

“This correlates with reduction from very severe to moderate or from moderate to mild category, and all the reductions in symptoms were statistically significant,” Cem Akin, MD, of the University of Michigan, Ann Arbor, said in an interview. He reported on part 1 of the phase 2 PIONEER trial of the kinase inhibitor avapritinib, described as a potent and highly selective inhibitor of the KIT D816V mutation that affects 90% of patients with systemic mastocytosis.

Currently, Dr. Akin noted, patients with indolent or smoldering systemic mastocytosis must rely on over-the-counter antihistamines used for seasonal allergies. “These patients use antihistamines in higher doses because mastocytosis patients have higher counts of mast cells that release histamines that cause a variety of symptoms,” he said. Symptoms, which can occur suddenly, include flushing and reactions that resemble allergic or anaphylactic reactions.

The purpose of the part 1 study was to evaluate three different dosing levels of avapritinib vs. placebo: 25, 50, and 100 mg. Ten patients were in each dosing group and nine were in the placebo group. The primary outcome was reduction in total symptom scores at 16 weeks as measured by the Indolent SM Symptom Assessment Form. “All three dose groups showed significant reductions in total symptom scores as well as specific symptoms that were most bothersome to the patient, whether skin symptoms or GI or neurocognitive symptoms,” Dr. Akin said. “All three doses were effective; the average reduction was about 30% compared to baseline.” Specifically, 25-mg dosing showed an average 30% reduction, 50-mg dosing showed an average 19% reduction, and 100-mg dosing showed an average 35% reduction.

The researchers determined that the 25-mg daily dose was the most effective and safest, with no patients on the dose reporting grade 3 adverse events, Dr. Akin said. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 AEs, according to study results.* The 25-mg daily dose will be evaluated in part 2 of the trial. The trial is estimated to enroll 112 total patients, according to the ClinicalTrials.gov filing. In part 3, patients who complete parts 1 or 2, including those initially randomized to placebo, may participate in a long-term open-label extension, receiving 25 mg avapritinib plus best supportive care.

“This is targeting a population whose symptoms are not controlled by antihistamines, based on a minimum total symptom score according to diaries they fill out, and they have to be on at least two different systemic medications – antihistamine or proton-pump inhibitor and leukotriene inhibitor – and they still have significant symptoms,” Dr. Akin said. He estimated that this describes about two-thirds of his patients with indolent or smoldering systematic mastocytosis.

“This is a disease that also takes a psychological toll,” he said. “This is a problem that starts in the bone marrow; it is similar to a hematological stem-cell disorder that affects the mast cell progenitor and it’s caused by a mutation that has not been particularly targeted until this drug,” he said. While most of these patients live with a benign mastocytosis their entire lives, the symptoms can be debilitating to the point where the disease disrupts and restricts social activities and comprises their quality of life, he said.

“This is a groundbreaking therapy that will change the way we think about mastocytosis treatment going forward,” Dr. Akin said. “It’s the first time we are actually targeting the underlying mutation that’s causing the disease, in terms of reducing directly that mutation as opposed to just treating the symptoms in indolent disease.”

Scheduled session moderator Anil Nanda, MD, of the Asthma and Allergy Center in Lewisville, Texas, said the findings are encouraging. “As a practicing allergist and immunologist in the community, it is very exciting to have a potential new treatment option for indolent or smoldering systemic mastocytosis,” he said via email. “Patients appreciate new options in therapy.”

Dr. Akin, the primary investigator, receives funding from and serves as a consultant for Blueprint Medicines, which sponsored the trial. He also disclosed a financial relationship with Novartis.

SOURCE: Akin C et al. AAAAI 2020, Presentation L5.

*Correction, 4/6/2020: An earlier version of this story misstated the percentage of grade 3 adverse events. In total 20% and 40% of the 50- and 100-mg dose groups, respectively, reported grade 3 adverse events.  

Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage

“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.

Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).

“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”

Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.

Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).

After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).

“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”

Dr. Robinson reported no relevant financial disclosures.

SOURCE: Robinson L. AAAAI 2020, Abstract L1

Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage

“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.

Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).

“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”

Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.

Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).

After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).

“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”

Dr. Robinson reported no relevant financial disclosures.

SOURCE: Robinson L. AAAAI 2020, Abstract L1

Infants who are hospitalized for severe bronchiolitis and receive acid-suppressant medications may be at risk of developing allergic disease by age 3 years, according to recent research released as an abstract for the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage

“Among children with a history of severe bronchiolitis during infancy, exposure to acid-suppressant medications during infancy further increases the risk of developing recurrent wheeze by age 3 years,” Lacey B. Robinson, MD, of the division of rheumatology, allergy, and immunology in the department of medicine at Massachusetts General Hospital in Boston, said in an interview.

Bronchiolitis is a risk factor in infants for developing conditions such as recurrent wheeze and childhood asthma in early childhood. Acid-suppressant medications like proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) may further increase the risk of allergic disease. One study by Mitre et al. published in JAMA Pediatrics showed use of acid-suppressant medications in infants up to 6 months raised the risk of allergic disease (JAMA Pediatr. 2018;172[6]:e180315). Some studies suggest between 30% and 50% of infants diagnosed with bronchiolitis requiring hospitalization will develop asthma by age 5 years (J Allergy Clin Immunol Pract. 2017 Jan - Feb;5[1]:92-6).

“Children with severe bronchiolitis during infancy are at a high risk of developing recurrent wheeze and subsequent asthma. There is limited evidence to suggest that exposure to acid suppressant medications [such as proton pump inhibitors and histamine-2 receptor antagonists] prenatally and during early childhood increases the risk of childhood asthma,” Dr. Robinson said. “It is not known if exposure to acid suppressant medications during infancy further increases the risk of developing recurrent wheeze among high-risk children, such as in those with a history of severe bronchiolitis during infancy.”

Dr. Robinson and colleagues performed a multicenter, prospective cohort study of 921 infants who were hospitalized for severe bronchiolitis between 2011 and 2014. The investigators reviewed the medical records of the infants for acid suppressant medication use, as well as parent report of acid suppressant medication use, during an infant’s first 12 months. Overall, 879 children were analyzed after excluding for patients who developed recurrent wheeze prior to receiving acid suppressant medications, as well as patients with incomplete data. The investigators used the National Institutes of Health Guidelines for the Diagnosis and Management of Asthma (EPR-3) to define recurrent wheeze. A Cox-proportional hazard model was used to analyze the time to event, which was stratified by age and adjusted for confounders.

Infants with a history of severe bronchiolitis were at greater risk of developing recurrent wheeze by age 3 years after being exposed to acid-suppressant medications, compared with infants who were not exposed, Dr. Robinson said. Of the 879 infants in the final analysis, 159 (18%) received acid-suppressant medications, and 68 of 159 patients (43%) went on to develop recurrent wheeze, compared with 206 of 720 infants (29%) who were not exposed (unadjusted hazard ratio, 1.63; 95% confidence interval, 1.24-2.14).

After adjustment for confounders such as gender, race and ethnicity; gestational age; delivery type; severity of bronchiolitis; respiratory syncytial virus (RSV) infection status; maternal atopy; use of acid-suppressant medications during pregnancy; median household income; and insurance status, the association between recurrent wheeze and acid-suppressant medication use during infancy remained (adjusted HR, 1.54; 95% CI, 1.15-2.07).

“More research is needed on this important topic including studies in other populations,” such as in healthy children, Dr. Robinson said. “We encourage future research on this important and understudied topic, including further research on the potential underlying mechanisms of this association.”

Dr. Robinson reported no relevant financial disclosures.

SOURCE: Robinson L. AAAAI 2020, Abstract L1

Insurance and specialty pharmacy delays in authorizing new biologic prescriptions for severe allergies leave waiting patients at risk of asthma attacks, hospitalizations, emergency department visits and prednisone shots and their known side effects, according to a single-center study that was to have been presented at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage.

The study of 80 patients in State College, Pa., found that they waited an average of 44 days from when their doctor submitted the preauthorization request to the insurance company until the practice received the shipment for dispensing to the patient, investigator Faoud Ishmael, MD, PhD, of Mount Nittany Medical Group said in an interview. “The implication here is that these are really the most severe patients who, you would argue, need their medications the quickest, and it’s taking longer to get them than it would an inhaler,” Dr. Ishmael said.

The study focused on patients with severe asthma (n = 60) or urticarial (n = 20) who received a new prescription of monoclonal antibody therapy from March 2014 to August 2019. For asthma treatments, the average time was 45.8 days; for urticaria, 40.6 days (P = .573), Dr. Ishmael said. The researchers divided the total amount of time into two components: insurance plan review and approval (P = .654, and specialty pharmacy review and dispensing of the medicine, each of which averaged 22.8 days (P = .384), he said.

He also noted wide disparity in the range of approval times. “The shortest approval time was 1 day, and the longest 97 days,” Dr. Ishmael said. “It’s interesting that we had this really broad spread.”

What’s more, the study found no trend for the delays among insurers and specialty pharmacies, Dr. Ishmael added. “When these prescriptions get submitted, it’s like a black box,” he said. “It really seems arbitrary why some of them take so long and some of them don’t.” The findings were independent of type of coverage, whether commercial or government, or even specific insurance plans. “It’s more the process that is flawed rather than one insurance company being the bad guy,” he said.

The study also looked at what happened to patients while they were waiting for their prescriptions to be delivered. “What we found is that over half of asthmatics had an exacerbation – 51% had at least one asthma attack where they needed prednisone,” Dr. Ishmael said (P = .0015), “and we had three patients admitted to the hospital over that time frame when they were waiting for the drugs.” One of those patients had been admitted twice, making four total hospitalizations. Preliminary data analysis showed that about 40% of the patients who had attacks went to the emergency department.

For asthmatics who needed prednisone, the average dose was 480 mg (P = .284) – “a pretty substantial number,” in Dr. Ishmael’s words. He noted that a large portion of the study patients were obese, with a mean body mass index of 33 kg/m². Other comorbidities prevalent in the study population were hypertension and type 2 diabetes. “Prednisone is something that could worsen all of those conditions, so it’s not a trivial issue,” he said.

The study, however, didn’t evaluate costs of the interventions during the delay period vs. the costs of the medications themselves. Of the 80 prescriptions Dr. Ishmael and coauthors submitted, only one was rejected, that person being a smoker, he said. “I understand these are expensive medicines, but it’s counterproductive to delay them because in the long run the insurance company ends up paying for the hospitalization and the drug rather than just the drug,” he said.

Timothy Craig, DO, of Penn State Health Allergy, Asthma, and Immunology and professor of medicine and pediatrics at Penn State College of Medicine, both in Hershey, said he was surprised at the brevity of the delays reported in Dr. Ishmael’s study. “They do much better than we do with preauthorization,” he said, noting that, in his experience, these approvals take much longer. He added that his own research has found faulty insurance plan algorithms are at the heart of these delays. “We need more studies to clarify how much this is interfering with patient care and how much risk they’re putting patients in,” he said.

The COVID-19 pandemic poses a double-edged sword for physicians managing patients with severe asthma, Dr. Craig noted. “Their asthma care is important, especially if they do test for COVID-19,” he said. On the other hand, doctors and nurses attending to COVID-19 patients will have less time to haggle with payers to expedite coverage for biologics for their severe asthma patients, he said. “I hope the flexibility is there, especially at this time to allow people to get on the biologics and stay on them,” he said.

Dr. Ishmael said these findings have serious implications because biologics are getting prescribed ever more frequently for asthma and hives. Steps his practice has taken to streamline the process include following the payer’s approval guidelines as closely as possible. This sometimes can mean making sure a patient with severe asthma has been maximized on controller medications before submitting the biologic prescription, he said. Another step is to use drug company programs to remove barriers to coverage.

Nonetheless, the approval process can be daunting even when taking those steps, he said. “Those guidelines that constitute approval may vary a lot from one insurer to another; and sometimes those guidelines are different from the criteria that studies may have used when these drugs were being evaluated in clinical trials,” he said. It would be helpful, he said, if payers used the National Heart, Lung and Blood institute and the Global Initiative for Asthma guidelines for biologics.

One of the goals of the researchers is to present their findings to payers, “to let them know, here are some of the hang-ups and the real risks associated with delaying these medications,” Dr. Ishmael said.

“When specialists especially prescribe these therapies, there’s usually a valid reason,” he said. “We really need to do something about the current process – if there are ways to make it more transparent, faster.”

Dr. Ishmael has no relevant financial relationships to disclose.

SOURCE: Ishmael F et al. AAAAI 2020. Session 3609, Presentation 558.

Insurance and specialty pharmacy delays in authorizing new biologic prescriptions for severe allergies leave waiting patients at risk of asthma attacks, hospitalizations, emergency department visits and prednisone shots and their known side effects, according to a single-center study that was to have been presented at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage.

The study of 80 patients in State College, Pa., found that they waited an average of 44 days from when their doctor submitted the preauthorization request to the insurance company until the practice received the shipment for dispensing to the patient, investigator Faoud Ishmael, MD, PhD, of Mount Nittany Medical Group said in an interview. “The implication here is that these are really the most severe patients who, you would argue, need their medications the quickest, and it’s taking longer to get them than it would an inhaler,” Dr. Ishmael said.

The study focused on patients with severe asthma (n = 60) or urticarial (n = 20) who received a new prescription of monoclonal antibody therapy from March 2014 to August 2019. For asthma treatments, the average time was 45.8 days; for urticaria, 40.6 days (P = .573), Dr. Ishmael said. The researchers divided the total amount of time into two components: insurance plan review and approval (P = .654, and specialty pharmacy review and dispensing of the medicine, each of which averaged 22.8 days (P = .384), he said.

He also noted wide disparity in the range of approval times. “The shortest approval time was 1 day, and the longest 97 days,” Dr. Ishmael said. “It’s interesting that we had this really broad spread.”

What’s more, the study found no trend for the delays among insurers and specialty pharmacies, Dr. Ishmael added. “When these prescriptions get submitted, it’s like a black box,” he said. “It really seems arbitrary why some of them take so long and some of them don’t.” The findings were independent of type of coverage, whether commercial or government, or even specific insurance plans. “It’s more the process that is flawed rather than one insurance company being the bad guy,” he said.

The study also looked at what happened to patients while they were waiting for their prescriptions to be delivered. “What we found is that over half of asthmatics had an exacerbation – 51% had at least one asthma attack where they needed prednisone,” Dr. Ishmael said (P = .0015), “and we had three patients admitted to the hospital over that time frame when they were waiting for the drugs.” One of those patients had been admitted twice, making four total hospitalizations. Preliminary data analysis showed that about 40% of the patients who had attacks went to the emergency department.

For asthmatics who needed prednisone, the average dose was 480 mg (P = .284) – “a pretty substantial number,” in Dr. Ishmael’s words. He noted that a large portion of the study patients were obese, with a mean body mass index of 33 kg/m². Other comorbidities prevalent in the study population were hypertension and type 2 diabetes. “Prednisone is something that could worsen all of those conditions, so it’s not a trivial issue,” he said.

The study, however, didn’t evaluate costs of the interventions during the delay period vs. the costs of the medications themselves. Of the 80 prescriptions Dr. Ishmael and coauthors submitted, only one was rejected, that person being a smoker, he said. “I understand these are expensive medicines, but it’s counterproductive to delay them because in the long run the insurance company ends up paying for the hospitalization and the drug rather than just the drug,” he said.

Timothy Craig, DO, of Penn State Health Allergy, Asthma, and Immunology and professor of medicine and pediatrics at Penn State College of Medicine, both in Hershey, said he was surprised at the brevity of the delays reported in Dr. Ishmael’s study. “They do much better than we do with preauthorization,” he said, noting that, in his experience, these approvals take much longer. He added that his own research has found faulty insurance plan algorithms are at the heart of these delays. “We need more studies to clarify how much this is interfering with patient care and how much risk they’re putting patients in,” he said.

The COVID-19 pandemic poses a double-edged sword for physicians managing patients with severe asthma, Dr. Craig noted. “Their asthma care is important, especially if they do test for COVID-19,” he said. On the other hand, doctors and nurses attending to COVID-19 patients will have less time to haggle with payers to expedite coverage for biologics for their severe asthma patients, he said. “I hope the flexibility is there, especially at this time to allow people to get on the biologics and stay on them,” he said.

Dr. Ishmael said these findings have serious implications because biologics are getting prescribed ever more frequently for asthma and hives. Steps his practice has taken to streamline the process include following the payer’s approval guidelines as closely as possible. This sometimes can mean making sure a patient with severe asthma has been maximized on controller medications before submitting the biologic prescription, he said. Another step is to use drug company programs to remove barriers to coverage.

Nonetheless, the approval process can be daunting even when taking those steps, he said. “Those guidelines that constitute approval may vary a lot from one insurer to another; and sometimes those guidelines are different from the criteria that studies may have used when these drugs were being evaluated in clinical trials,” he said. It would be helpful, he said, if payers used the National Heart, Lung and Blood institute and the Global Initiative for Asthma guidelines for biologics.

One of the goals of the researchers is to present their findings to payers, “to let them know, here are some of the hang-ups and the real risks associated with delaying these medications,” Dr. Ishmael said.

“When specialists especially prescribe these therapies, there’s usually a valid reason,” he said. “We really need to do something about the current process – if there are ways to make it more transparent, faster.”

Dr. Ishmael has no relevant financial relationships to disclose.

SOURCE: Ishmael F et al. AAAAI 2020. Session 3609, Presentation 558.

Insurance and specialty pharmacy delays in authorizing new biologic prescriptions for severe allergies leave waiting patients at risk of asthma attacks, hospitalizations, emergency department visits and prednisone shots and their known side effects, according to a single-center study that was to have been presented at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage.

The study of 80 patients in State College, Pa., found that they waited an average of 44 days from when their doctor submitted the preauthorization request to the insurance company until the practice received the shipment for dispensing to the patient, investigator Faoud Ishmael, MD, PhD, of Mount Nittany Medical Group said in an interview. “The implication here is that these are really the most severe patients who, you would argue, need their medications the quickest, and it’s taking longer to get them than it would an inhaler,” Dr. Ishmael said.

The study focused on patients with severe asthma (n = 60) or urticarial (n = 20) who received a new prescription of monoclonal antibody therapy from March 2014 to August 2019. For asthma treatments, the average time was 45.8 days; for urticaria, 40.6 days (P = .573), Dr. Ishmael said. The researchers divided the total amount of time into two components: insurance plan review and approval (P = .654, and specialty pharmacy review and dispensing of the medicine, each of which averaged 22.8 days (P = .384), he said.

He also noted wide disparity in the range of approval times. “The shortest approval time was 1 day, and the longest 97 days,” Dr. Ishmael said. “It’s interesting that we had this really broad spread.”

What’s more, the study found no trend for the delays among insurers and specialty pharmacies, Dr. Ishmael added. “When these prescriptions get submitted, it’s like a black box,” he said. “It really seems arbitrary why some of them take so long and some of them don’t.” The findings were independent of type of coverage, whether commercial or government, or even specific insurance plans. “It’s more the process that is flawed rather than one insurance company being the bad guy,” he said.

The study also looked at what happened to patients while they were waiting for their prescriptions to be delivered. “What we found is that over half of asthmatics had an exacerbation – 51% had at least one asthma attack where they needed prednisone,” Dr. Ishmael said (P = .0015), “and we had three patients admitted to the hospital over that time frame when they were waiting for the drugs.” One of those patients had been admitted twice, making four total hospitalizations. Preliminary data analysis showed that about 40% of the patients who had attacks went to the emergency department.

For asthmatics who needed prednisone, the average dose was 480 mg (P = .284) – “a pretty substantial number,” in Dr. Ishmael’s words. He noted that a large portion of the study patients were obese, with a mean body mass index of 33 kg/m². Other comorbidities prevalent in the study population were hypertension and type 2 diabetes. “Prednisone is something that could worsen all of those conditions, so it’s not a trivial issue,” he said.

The study, however, didn’t evaluate costs of the interventions during the delay period vs. the costs of the medications themselves. Of the 80 prescriptions Dr. Ishmael and coauthors submitted, only one was rejected, that person being a smoker, he said. “I understand these are expensive medicines, but it’s counterproductive to delay them because in the long run the insurance company ends up paying for the hospitalization and the drug rather than just the drug,” he said.

Timothy Craig, DO, of Penn State Health Allergy, Asthma, and Immunology and professor of medicine and pediatrics at Penn State College of Medicine, both in Hershey, said he was surprised at the brevity of the delays reported in Dr. Ishmael’s study. “They do much better than we do with preauthorization,” he said, noting that, in his experience, these approvals take much longer. He added that his own research has found faulty insurance plan algorithms are at the heart of these delays. “We need more studies to clarify how much this is interfering with patient care and how much risk they’re putting patients in,” he said.

The COVID-19 pandemic poses a double-edged sword for physicians managing patients with severe asthma, Dr. Craig noted. “Their asthma care is important, especially if they do test for COVID-19,” he said. On the other hand, doctors and nurses attending to COVID-19 patients will have less time to haggle with payers to expedite coverage for biologics for their severe asthma patients, he said. “I hope the flexibility is there, especially at this time to allow people to get on the biologics and stay on them,” he said.

Dr. Ishmael said these findings have serious implications because biologics are getting prescribed ever more frequently for asthma and hives. Steps his practice has taken to streamline the process include following the payer’s approval guidelines as closely as possible. This sometimes can mean making sure a patient with severe asthma has been maximized on controller medications before submitting the biologic prescription, he said. Another step is to use drug company programs to remove barriers to coverage.

Nonetheless, the approval process can be daunting even when taking those steps, he said. “Those guidelines that constitute approval may vary a lot from one insurer to another; and sometimes those guidelines are different from the criteria that studies may have used when these drugs were being evaluated in clinical trials,” he said. It would be helpful, he said, if payers used the National Heart, Lung and Blood institute and the Global Initiative for Asthma guidelines for biologics.

One of the goals of the researchers is to present their findings to payers, “to let them know, here are some of the hang-ups and the real risks associated with delaying these medications,” Dr. Ishmael said.

“When specialists especially prescribe these therapies, there’s usually a valid reason,” he said. “We really need to do something about the current process – if there are ways to make it more transparent, faster.”

Dr. Ishmael has no relevant financial relationships to disclose.

SOURCE: Ishmael F et al. AAAAI 2020. Session 3609, Presentation 558.

Patients with both type 2 diabetes and asthma who were on glucagonlike peptide receptor–1 (GLP-1R) agonists for glucose control had lower levels of a key biomarker of airway inflammation than similar patients on other types of glucose-control medications, according to results of a study to have been presented at the annual meeting of the American Academy of Asthma, Allergy, and Immunology. The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage.

The findings from this study potentially replicated findings in humans that have been reported in preclinical trials.

“Our work showed that type 2 diabetics with asthma who were treated with GLP-1 receptor agonists had lower levels of periostin, and this provides really one of the first human data to show that these drugs may impact key inflammation pathways in the airway,” Dinah Foer, MD, of Brigham and Women’s Hospital, Boston, said in an interview. She described periostin as “a known critical inducer of airway mucous production and airway responsiveness.”

The study retrospectively evaluated serum samples from the Partners HealthCare Biobank of 161 adults with both asthma and type 2 diabetes, 42 of whom were on GLP-1R agonists and 119 of whom were taking non-GLP-1R agonist diabetes medications. The study used the Partners Healthcare EHR to identify eligible patients.

The study found that periostin levels were significantly decreased in GLP-1R agonist users: 19.1 ng/mL (standard deviation, +8.7) versus 27.4 ng/mL (SD, +14) in the non-GLP-1R agonist group (P = .001), Dr. Foer said. The other known mediators of asthma inflammatory pathways that were measured – interleukin-6, IL-8, sCD163, total IgE, and sST2 (soluble suppression of tumorigenesis–2) – showed no differences between the two groups, Dr. Foer said.

She said that this was the first human study to show similar results to preclinical models of asthma pathways. “What was interesting to us was that our findings were robust even when we controlled for covariates,” she added.

These findings lay the groundwork for further research into the potential therapeutic role GLP-1R agonists in asthma, Dr. Foer said. “This supports using periostin as a biomarker for novel therapeutic use of GLP-1R [agonists] in asthma,” she said. “At this point further study is needed to understand the clinical impact of GPL-1R [agonists] in asthma both for patients with type 2 diabetes and potentially in the future for patients who don’t have type 2 diabetes or metabolic disease.”

She added: “I don’t think we’re there yet; this is just one foot forward.”

The next step for researchers involves analyzing outcomes in asthmatics with type 2 diabetes on GLP-1R agonist therapy using a larger sample size as well as patients with asthma and metabolic disease, Dr. Foer said. The goal would be to identify corresponding biomarkers.

“There’s a terrific conversation in the field about the relationships between metabolism and asthma,” she said. “What our data contributes to that is, it suggests a role for metabolic pathways, specifically as it’s related GLP-1R [agonist] signaling pathways in regulating airway inflammation.”

Mark Moss, MD, associate professor of allergy & immunology at the University of Wisconsin–Madison, who was to serve as the moderator of the session, was positive about the GLP-1R agonist findings. He said in an interview: “This is promising research that provides a possible new target for the treatment of asthma.”

Dr. Foer disclosed that she has no relevant financial relationships.

SOURCE: Foer D et al. AAAAI Session 462, Abstract 784.

Patients with both type 2 diabetes and asthma who were on glucagonlike peptide receptor–1 (GLP-1R) agonists for glucose control had lower levels of a key biomarker of airway inflammation than similar patients on other types of glucose-control medications, according to results of a study to have been presented at the annual meeting of the American Academy of Asthma, Allergy, and Immunology. The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage.

The findings from this study potentially replicated findings in humans that have been reported in preclinical trials.

“Our work showed that type 2 diabetics with asthma who were treated with GLP-1 receptor agonists had lower levels of periostin, and this provides really one of the first human data to show that these drugs may impact key inflammation pathways in the airway,” Dinah Foer, MD, of Brigham and Women’s Hospital, Boston, said in an interview. She described periostin as “a known critical inducer of airway mucous production and airway responsiveness.”

The study retrospectively evaluated serum samples from the Partners HealthCare Biobank of 161 adults with both asthma and type 2 diabetes, 42 of whom were on GLP-1R agonists and 119 of whom were taking non-GLP-1R agonist diabetes medications. The study used the Partners Healthcare EHR to identify eligible patients.

The study found that periostin levels were significantly decreased in GLP-1R agonist users: 19.1 ng/mL (standard deviation, +8.7) versus 27.4 ng/mL (SD, +14) in the non-GLP-1R agonist group (P = .001), Dr. Foer said. The other known mediators of asthma inflammatory pathways that were measured – interleukin-6, IL-8, sCD163, total IgE, and sST2 (soluble suppression of tumorigenesis–2) – showed no differences between the two groups, Dr. Foer said.

She said that this was the first human study to show similar results to preclinical models of asthma pathways. “What was interesting to us was that our findings were robust even when we controlled for covariates,” she added.

These findings lay the groundwork for further research into the potential therapeutic role GLP-1R agonists in asthma, Dr. Foer said. “This supports using periostin as a biomarker for novel therapeutic use of GLP-1R [agonists] in asthma,” she said. “At this point further study is needed to understand the clinical impact of GPL-1R [agonists] in asthma both for patients with type 2 diabetes and potentially in the future for patients who don’t have type 2 diabetes or metabolic disease.”

She added: “I don’t think we’re there yet; this is just one foot forward.”

The next step for researchers involves analyzing outcomes in asthmatics with type 2 diabetes on GLP-1R agonist therapy using a larger sample size as well as patients with asthma and metabolic disease, Dr. Foer said. The goal would be to identify corresponding biomarkers.

“There’s a terrific conversation in the field about the relationships between metabolism and asthma,” she said. “What our data contributes to that is, it suggests a role for metabolic pathways, specifically as it’s related GLP-1R [agonist] signaling pathways in regulating airway inflammation.”

Mark Moss, MD, associate professor of allergy & immunology at the University of Wisconsin–Madison, who was to serve as the moderator of the session, was positive about the GLP-1R agonist findings. He said in an interview: “This is promising research that provides a possible new target for the treatment of asthma.”

Dr. Foer disclosed that she has no relevant financial relationships.

SOURCE: Foer D et al. AAAAI Session 462, Abstract 784.

Patients with both type 2 diabetes and asthma who were on glucagonlike peptide receptor–1 (GLP-1R) agonists for glucose control had lower levels of a key biomarker of airway inflammation than similar patients on other types of glucose-control medications, according to results of a study to have been presented at the annual meeting of the American Academy of Asthma, Allergy, and Immunology. The AAAAI canceled their annual meeting and provided abstracts and access to presenters for press coverage.

The findings from this study potentially replicated findings in humans that have been reported in preclinical trials.

“Our work showed that type 2 diabetics with asthma who were treated with GLP-1 receptor agonists had lower levels of periostin, and this provides really one of the first human data to show that these drugs may impact key inflammation pathways in the airway,” Dinah Foer, MD, of Brigham and Women’s Hospital, Boston, said in an interview. She described periostin as “a known critical inducer of airway mucous production and airway responsiveness.”

The study retrospectively evaluated serum samples from the Partners HealthCare Biobank of 161 adults with both asthma and type 2 diabetes, 42 of whom were on GLP-1R agonists and 119 of whom were taking non-GLP-1R agonist diabetes medications. The study used the Partners Healthcare EHR to identify eligible patients.

The study found that periostin levels were significantly decreased in GLP-1R agonist users: 19.1 ng/mL (standard deviation, +8.7) versus 27.4 ng/mL (SD, +14) in the non-GLP-1R agonist group (P = .001), Dr. Foer said. The other known mediators of asthma inflammatory pathways that were measured – interleukin-6, IL-8, sCD163, total IgE, and sST2 (soluble suppression of tumorigenesis–2) – showed no differences between the two groups, Dr. Foer said.

She said that this was the first human study to show similar results to preclinical models of asthma pathways. “What was interesting to us was that our findings were robust even when we controlled for covariates,” she added.

These findings lay the groundwork for further research into the potential therapeutic role GLP-1R agonists in asthma, Dr. Foer said. “This supports using periostin as a biomarker for novel therapeutic use of GLP-1R [agonists] in asthma,” she said. “At this point further study is needed to understand the clinical impact of GPL-1R [agonists] in asthma both for patients with type 2 diabetes and potentially in the future for patients who don’t have type 2 diabetes or metabolic disease.”

She added: “I don’t think we’re there yet; this is just one foot forward.”

The next step for researchers involves analyzing outcomes in asthmatics with type 2 diabetes on GLP-1R agonist therapy using a larger sample size as well as patients with asthma and metabolic disease, Dr. Foer said. The goal would be to identify corresponding biomarkers.

“There’s a terrific conversation in the field about the relationships between metabolism and asthma,” she said. “What our data contributes to that is, it suggests a role for metabolic pathways, specifically as it’s related GLP-1R [agonist] signaling pathways in regulating airway inflammation.”

Mark Moss, MD, associate professor of allergy & immunology at the University of Wisconsin–Madison, who was to serve as the moderator of the session, was positive about the GLP-1R agonist findings. He said in an interview: “This is promising research that provides a possible new target for the treatment of asthma.”

Dr. Foer disclosed that she has no relevant financial relationships.

SOURCE: Foer D et al. AAAAI Session 462, Abstract 784.