Asthma

SAN FRANCISCO – Asthma that’s severe and uncontrolled when a patient receives subcutaneous immunotherapy appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Mitchel L. Zoler/MDedge News

While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.

The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.

• Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
• Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
• Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
• Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
• Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.

Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).

Dr. Bernstein had no relevant disclosures.

[email protected]

SAN FRANCISCO – Asthma that’s severe and uncontrolled when a patient receives subcutaneous immunotherapy appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Mitchel L. Zoler/MDedge News

While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.

The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.

• Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
• Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
• Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
• Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
• Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.

Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).

Dr. Bernstein had no relevant disclosures.

[email protected]

SAN FRANCISCO – Asthma that’s severe and uncontrolled when a patient receives subcutaneous immunotherapy appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Mitchel L. Zoler/MDedge News

While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.

The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.

• Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
• Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
• Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
• Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
• Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.

Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).

Dr. Bernstein had no relevant disclosures.

[email protected]

Two years ago, a now 45-year-old woman was diagnosed with asthma based on her history and physical exam findings; she was prescribed an inhaled corticosteroid and a bronchodilator rescue inhaler. She has had no exacerbations since. Should you consider weaning her off the inhalers?

Asthma is a prevalent problem; 8% of adults ages 18 to 64 have the chronic lung disease.² Diagnosis can be challenging, partially because it requires measurement of transient airway resistance, and treatment entails significant costs and possible adverse effects. Without pulmonary function measurement or trials off medication, there is no clinical way to differentiate patients with well-controlled asthma from those who are being treated unnecessarily. Not surprisingly, studies have shown that ruling out active asthma and reducing medication use are cost effective.^3,4 This study followed a cohort of patients to see how many could be weaned off their asthma medications.

STUDY SUMMARY

About one-third of adults with asthma are “undiagnosed” within 5 years

The researchers recruited participants from the general population of the 10 largest cities and surrounding areas in Canada by randomly dialing cellular and landline phone numbers and asking about adult household members with asthma.¹ The researchers focused on those with a recent (<5 years) asthma diagnosis to represent contemporary diagnostic practice and make it easier to collect medical records. Participants lived within 90 minutes of 10 medical centers. Patients were excluded if they were using long-term oral steroids, were pregnant or breastfeeding, were unable to tolerate spirometry or methacholine challenges, or had a smoking history of >10 pack-years.

Of the 701 patients enrolled, 613 (87.4%) completed all study assessments. Patients progressed through a series of spirometry tests and were then tapered off their asthma-controlling medications.

The initial spirometry test confirmed asthma if bronchodilators caused a significant improvement in forced expiratory volume in one second (FEV₁). Patients who showed no improvement took a methacholine challenge 1 week later; if they did well, their maintenance medications were reduced by half. About 1 month later, another methacholine challenge was given; if the patient did well, maintenance medications were stopped and the patient underwent a third methacholine challenge 3 weeks later.

Asthma was confirmed at any methacholine challenge if there was a 20% decrease in FEV₁ from baseline at a methacholine concentration of ≤8 mg/mL; these patients were restarted on appropriate medications. If current asthma was ruled out, follow-up bronchial challenges were repeated at 6 and 12 months.

Results. Among the patients with clinician-diagnosed asthma, 33.1% no longer met criteria for an asthma diagnosis. Of those who no longer had asthma, 44% had previously undergone objective testing of airflow limitation. Another 12 patients (2%) had other serious cardiorespiratory conditions instead of asthma (eg, ischemic heart disease, subglottic stenosis, and bronchiectasis).

Continue to: During the 1-year follow-up period...

During the 1-year follow-up period, 22 (10.8%) of the 203 patients who were initially judged to no longer have asthma had a positive bronchial challenge test; 16 had no symptoms and continued to do well without any asthma medications. Six (3%) presented with respiratory symptoms and resumed treatment with asthma medications, but only 1 (0.5%) required oral corticosteroid therapy.

WHAT’S NEW?

Asthma meds of no benefit for one-third of patients taking them

This study found that one-third of patients with asthma diagnosed in the past 5 years no longer had symptoms or spirometry results consistent with asthma and did well in the subsequent year. For those patients, asthma medications appear to have no benefit. The Global Institute for Asthma recommends stepping down treatment in adults with asthma that is well controlled for 3 months or more.⁵ Patients with objectively confirmed asthma diagnoses were more likely to still have asthma in this study—but more than 40% of patients who no longer had asthma had been objectively proven to have the disease at the time of diagnosis.

CAVEATS

High level of rigor; no randomized trial

This study used a very structured protocol for tapering patients off their medications, including multiple spirometry tests (most including methacholine challenges) and oversight by pulmonologists. It is unclear whether this level of rigor is necessary for weaning in other clinical settings.

Also, this study was not a randomized trial, which is the gold standard for withdrawal of therapy. However, a cohort study is adequate to assess diagnostic testing, and this could be considered a trial of “undiagnosing” asthma in adults. These results are consistent with those of another study of asthma disappearance in patients with and without obesity; in that study, about 30% of patients in either group no longer had a diagnosis of asthma.⁶

Using random dialing is likely to have broadened the pool of patients this study drew upon. Also, there is a possibility that the patients who were lost to follow-up in this study represented those who had worsening symptoms. Some patients with mild asthma may have a waxing and waning course; it is possible that the study period was not long enough to capture this. In this study, only about 3% of patients who had their medications stopped reported worsening of symptoms.

Continue to: CHALLENGES TO IMPLEMENTATION

“Undiagnosis” is unusual

Using objective testing may provide some logistical or financial challenges for patients. Furthermore, “undiagnosing” a chronic disease like asthma is not a clinician’s typical work, and it may take some time and effort to educate and monitor patients throughout the process.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018; 67[11]:704,706-707).

Two years ago, a now 45-year-old woman was diagnosed with asthma based on her history and physical exam findings; she was prescribed an inhaled corticosteroid and a bronchodilator rescue inhaler. She has had no exacerbations since. Should you consider weaning her off the inhalers?

Asthma is a prevalent problem; 8% of adults ages 18 to 64 have the chronic lung disease.² Diagnosis can be challenging, partially because it requires measurement of transient airway resistance, and treatment entails significant costs and possible adverse effects. Without pulmonary function measurement or trials off medication, there is no clinical way to differentiate patients with well-controlled asthma from those who are being treated unnecessarily. Not surprisingly, studies have shown that ruling out active asthma and reducing medication use are cost effective.^3,4 This study followed a cohort of patients to see how many could be weaned off their asthma medications.

STUDY SUMMARY

About one-third of adults with asthma are “undiagnosed” within 5 years

The researchers recruited participants from the general population of the 10 largest cities and surrounding areas in Canada by randomly dialing cellular and landline phone numbers and asking about adult household members with asthma.¹ The researchers focused on those with a recent (<5 years) asthma diagnosis to represent contemporary diagnostic practice and make it easier to collect medical records. Participants lived within 90 minutes of 10 medical centers. Patients were excluded if they were using long-term oral steroids, were pregnant or breastfeeding, were unable to tolerate spirometry or methacholine challenges, or had a smoking history of >10 pack-years.

Of the 701 patients enrolled, 613 (87.4%) completed all study assessments. Patients progressed through a series of spirometry tests and were then tapered off their asthma-controlling medications.

The initial spirometry test confirmed asthma if bronchodilators caused a significant improvement in forced expiratory volume in one second (FEV₁). Patients who showed no improvement took a methacholine challenge 1 week later; if they did well, their maintenance medications were reduced by half. About 1 month later, another methacholine challenge was given; if the patient did well, maintenance medications were stopped and the patient underwent a third methacholine challenge 3 weeks later.

Asthma was confirmed at any methacholine challenge if there was a 20% decrease in FEV₁ from baseline at a methacholine concentration of ≤8 mg/mL; these patients were restarted on appropriate medications. If current asthma was ruled out, follow-up bronchial challenges were repeated at 6 and 12 months.

Results. Among the patients with clinician-diagnosed asthma, 33.1% no longer met criteria for an asthma diagnosis. Of those who no longer had asthma, 44% had previously undergone objective testing of airflow limitation. Another 12 patients (2%) had other serious cardiorespiratory conditions instead of asthma (eg, ischemic heart disease, subglottic stenosis, and bronchiectasis).

Continue to: During the 1-year follow-up period...

During the 1-year follow-up period, 22 (10.8%) of the 203 patients who were initially judged to no longer have asthma had a positive bronchial challenge test; 16 had no symptoms and continued to do well without any asthma medications. Six (3%) presented with respiratory symptoms and resumed treatment with asthma medications, but only 1 (0.5%) required oral corticosteroid therapy.

WHAT’S NEW?

Asthma meds of no benefit for one-third of patients taking them

This study found that one-third of patients with asthma diagnosed in the past 5 years no longer had symptoms or spirometry results consistent with asthma and did well in the subsequent year. For those patients, asthma medications appear to have no benefit. The Global Institute for Asthma recommends stepping down treatment in adults with asthma that is well controlled for 3 months or more.⁵ Patients with objectively confirmed asthma diagnoses were more likely to still have asthma in this study—but more than 40% of patients who no longer had asthma had been objectively proven to have the disease at the time of diagnosis.

CAVEATS

High level of rigor; no randomized trial

This study used a very structured protocol for tapering patients off their medications, including multiple spirometry tests (most including methacholine challenges) and oversight by pulmonologists. It is unclear whether this level of rigor is necessary for weaning in other clinical settings.

Also, this study was not a randomized trial, which is the gold standard for withdrawal of therapy. However, a cohort study is adequate to assess diagnostic testing, and this could be considered a trial of “undiagnosing” asthma in adults. These results are consistent with those of another study of asthma disappearance in patients with and without obesity; in that study, about 30% of patients in either group no longer had a diagnosis of asthma.⁶

Using random dialing is likely to have broadened the pool of patients this study drew upon. Also, there is a possibility that the patients who were lost to follow-up in this study represented those who had worsening symptoms. Some patients with mild asthma may have a waxing and waning course; it is possible that the study period was not long enough to capture this. In this study, only about 3% of patients who had their medications stopped reported worsening of symptoms.

Continue to: CHALLENGES TO IMPLEMENTATION

“Undiagnosis” is unusual

Using objective testing may provide some logistical or financial challenges for patients. Furthermore, “undiagnosing” a chronic disease like asthma is not a clinician’s typical work, and it may take some time and effort to educate and monitor patients throughout the process.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018; 67[11]:704,706-707).

Two years ago, a now 45-year-old woman was diagnosed with asthma based on her history and physical exam findings; she was prescribed an inhaled corticosteroid and a bronchodilator rescue inhaler. She has had no exacerbations since. Should you consider weaning her off the inhalers?

Asthma is a prevalent problem; 8% of adults ages 18 to 64 have the chronic lung disease.² Diagnosis can be challenging, partially because it requires measurement of transient airway resistance, and treatment entails significant costs and possible adverse effects. Without pulmonary function measurement or trials off medication, there is no clinical way to differentiate patients with well-controlled asthma from those who are being treated unnecessarily. Not surprisingly, studies have shown that ruling out active asthma and reducing medication use are cost effective.^3,4 This study followed a cohort of patients to see how many could be weaned off their asthma medications.

STUDY SUMMARY

About one-third of adults with asthma are “undiagnosed” within 5 years

The researchers recruited participants from the general population of the 10 largest cities and surrounding areas in Canada by randomly dialing cellular and landline phone numbers and asking about adult household members with asthma.¹ The researchers focused on those with a recent (<5 years) asthma diagnosis to represent contemporary diagnostic practice and make it easier to collect medical records. Participants lived within 90 minutes of 10 medical centers. Patients were excluded if they were using long-term oral steroids, were pregnant or breastfeeding, were unable to tolerate spirometry or methacholine challenges, or had a smoking history of >10 pack-years.

Of the 701 patients enrolled, 613 (87.4%) completed all study assessments. Patients progressed through a series of spirometry tests and were then tapered off their asthma-controlling medications.

The initial spirometry test confirmed asthma if bronchodilators caused a significant improvement in forced expiratory volume in one second (FEV₁). Patients who showed no improvement took a methacholine challenge 1 week later; if they did well, their maintenance medications were reduced by half. About 1 month later, another methacholine challenge was given; if the patient did well, maintenance medications were stopped and the patient underwent a third methacholine challenge 3 weeks later.

Asthma was confirmed at any methacholine challenge if there was a 20% decrease in FEV₁ from baseline at a methacholine concentration of ≤8 mg/mL; these patients were restarted on appropriate medications. If current asthma was ruled out, follow-up bronchial challenges were repeated at 6 and 12 months.

Results. Among the patients with clinician-diagnosed asthma, 33.1% no longer met criteria for an asthma diagnosis. Of those who no longer had asthma, 44% had previously undergone objective testing of airflow limitation. Another 12 patients (2%) had other serious cardiorespiratory conditions instead of asthma (eg, ischemic heart disease, subglottic stenosis, and bronchiectasis).

Continue to: During the 1-year follow-up period...

During the 1-year follow-up period, 22 (10.8%) of the 203 patients who were initially judged to no longer have asthma had a positive bronchial challenge test; 16 had no symptoms and continued to do well without any asthma medications. Six (3%) presented with respiratory symptoms and resumed treatment with asthma medications, but only 1 (0.5%) required oral corticosteroid therapy.

WHAT’S NEW?

Asthma meds of no benefit for one-third of patients taking them

This study found that one-third of patients with asthma diagnosed in the past 5 years no longer had symptoms or spirometry results consistent with asthma and did well in the subsequent year. For those patients, asthma medications appear to have no benefit. The Global Institute for Asthma recommends stepping down treatment in adults with asthma that is well controlled for 3 months or more.⁵ Patients with objectively confirmed asthma diagnoses were more likely to still have asthma in this study—but more than 40% of patients who no longer had asthma had been objectively proven to have the disease at the time of diagnosis.

CAVEATS

High level of rigor; no randomized trial

This study used a very structured protocol for tapering patients off their medications, including multiple spirometry tests (most including methacholine challenges) and oversight by pulmonologists. It is unclear whether this level of rigor is necessary for weaning in other clinical settings.

Also, this study was not a randomized trial, which is the gold standard for withdrawal of therapy. However, a cohort study is adequate to assess diagnostic testing, and this could be considered a trial of “undiagnosing” asthma in adults. These results are consistent with those of another study of asthma disappearance in patients with and without obesity; in that study, about 30% of patients in either group no longer had a diagnosis of asthma.⁶

Using random dialing is likely to have broadened the pool of patients this study drew upon. Also, there is a possibility that the patients who were lost to follow-up in this study represented those who had worsening symptoms. Some patients with mild asthma may have a waxing and waning course; it is possible that the study period was not long enough to capture this. In this study, only about 3% of patients who had their medications stopped reported worsening of symptoms.

Continue to: CHALLENGES TO IMPLEMENTATION

“Undiagnosis” is unusual

Using objective testing may provide some logistical or financial challenges for patients. Furthermore, “undiagnosing” a chronic disease like asthma is not a clinician’s typical work, and it may take some time and effort to educate and monitor patients throughout the process.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2018. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2018; 67[11]:704,706-707).

CORONADO, CALIF. – Otolaryngologists and otolaryngology nurse practitioners at the Cleveland Clinic who have been practicing for 6-10 years are at the highest risk for burnout, while those who have been practicing for more than 10 are at the lowest risk.

The finding comes from a cross-sectional survey published in Otolaryngology–Head and Neck Surgery designed to evaluate the presence of burnout among 52 otolaryngology clinicians and to compare results among faculty, trainees, and advanced practice practitioners.

“Other studies have shown that work-life balance can contribute to burnout symptoms, including low spouse support, having young children at home, and a decreased satisfaction with work-life balance,” Michael S. Benninger, MD, said at the Triological Society’s Combined Sections Meeting. “We wanted to know if there was difference within our group among people at different points in their career.”

In a study led by Katie Geelan-Hansen, MD, Dr. Benninger, who chairs the Head and Neck Institute at the Cleveland Clinic, and his colleagues administered the Maslach Burnout Inventory (MBI) and questions regarding work stressors specific to that department to 52 employees (Otolaryngol Head Neck Surg. 2018;159[2]:254-7). The questions focused on domains of emotional exhaustion, depersonalization, and a sense of personal accomplishment.

Of the 52 surveys distributed, 42 participants (85%) completed the survey. The researchers found that respondents who had worked for 6-10 years had higher MBI scores on emotional exhaustion, compared with their peers who had worked for 5 years or fewer, and those who had worked for more than 10 years (18.18, compared with 15.78 and 14.68, respectively; P = .63). A similar association was observed for MBI scores on depersonalization (15.14, compared with 14.72 and 9.68; P = .07). MBI scores on personal accomplishment were similar between the two groups (39, compared with 38.33 and 40.84; P = .5).

“People who are more mature in their practice tend to have less burnout,” Dr. Benninger said. “That may be because they’ve found a place of homeostasis. They’ve figured out how to maximize their efficiency, and they may have more support.

“The people who tend to be the biggest concern are those 6 -10 years into the field. I recommend that you focus on that group. It’s a transitional time in their careers. It’s a time when there’s some insecurity; they’re being asked to do a lot more.” It remains unclear if male or female respondents had a higher level of burnout, he added, although other surveys have suggested that female physicians have a higher level of burnout, compared with male physicians.

“Our overall evaluation of burnout was lower than what you see from national statistics,” Dr. Benninger said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “We have had a wellness officer [at Cleveland Clinic] for a long time. We have a group of people on our clinic’s board of governors who any staff can go to in order to vent issues on a private basis. All of those things help, but I am seeing an escalating unsatisfaction with the workload and the work environment. We’re looking at other things. Medical scribes seem to make a big difference for people, so we’re advancing scribes throughout our organization. Expectation setting and rewarding people are also important.”

He reported having no relevant financial disclosures.

[email protected]

SOURCE: Benninger MS et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Otolaryngologists and otolaryngology nurse practitioners at the Cleveland Clinic who have been practicing for 6-10 years are at the highest risk for burnout, while those who have been practicing for more than 10 are at the lowest risk.

The finding comes from a cross-sectional survey published in Otolaryngology–Head and Neck Surgery designed to evaluate the presence of burnout among 52 otolaryngology clinicians and to compare results among faculty, trainees, and advanced practice practitioners.

“Other studies have shown that work-life balance can contribute to burnout symptoms, including low spouse support, having young children at home, and a decreased satisfaction with work-life balance,” Michael S. Benninger, MD, said at the Triological Society’s Combined Sections Meeting. “We wanted to know if there was difference within our group among people at different points in their career.”

In a study led by Katie Geelan-Hansen, MD, Dr. Benninger, who chairs the Head and Neck Institute at the Cleveland Clinic, and his colleagues administered the Maslach Burnout Inventory (MBI) and questions regarding work stressors specific to that department to 52 employees (Otolaryngol Head Neck Surg. 2018;159[2]:254-7). The questions focused on domains of emotional exhaustion, depersonalization, and a sense of personal accomplishment.

Of the 52 surveys distributed, 42 participants (85%) completed the survey. The researchers found that respondents who had worked for 6-10 years had higher MBI scores on emotional exhaustion, compared with their peers who had worked for 5 years or fewer, and those who had worked for more than 10 years (18.18, compared with 15.78 and 14.68, respectively; P = .63). A similar association was observed for MBI scores on depersonalization (15.14, compared with 14.72 and 9.68; P = .07). MBI scores on personal accomplishment were similar between the two groups (39, compared with 38.33 and 40.84; P = .5).

“People who are more mature in their practice tend to have less burnout,” Dr. Benninger said. “That may be because they’ve found a place of homeostasis. They’ve figured out how to maximize their efficiency, and they may have more support.

“The people who tend to be the biggest concern are those 6 -10 years into the field. I recommend that you focus on that group. It’s a transitional time in their careers. It’s a time when there’s some insecurity; they’re being asked to do a lot more.” It remains unclear if male or female respondents had a higher level of burnout, he added, although other surveys have suggested that female physicians have a higher level of burnout, compared with male physicians.

“Our overall evaluation of burnout was lower than what you see from national statistics,” Dr. Benninger said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “We have had a wellness officer [at Cleveland Clinic] for a long time. We have a group of people on our clinic’s board of governors who any staff can go to in order to vent issues on a private basis. All of those things help, but I am seeing an escalating unsatisfaction with the workload and the work environment. We’re looking at other things. Medical scribes seem to make a big difference for people, so we’re advancing scribes throughout our organization. Expectation setting and rewarding people are also important.”

He reported having no relevant financial disclosures.

[email protected]

SOURCE: Benninger MS et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Otolaryngologists and otolaryngology nurse practitioners at the Cleveland Clinic who have been practicing for 6-10 years are at the highest risk for burnout, while those who have been practicing for more than 10 are at the lowest risk.

The finding comes from a cross-sectional survey published in Otolaryngology–Head and Neck Surgery designed to evaluate the presence of burnout among 52 otolaryngology clinicians and to compare results among faculty, trainees, and advanced practice practitioners.

“Other studies have shown that work-life balance can contribute to burnout symptoms, including low spouse support, having young children at home, and a decreased satisfaction with work-life balance,” Michael S. Benninger, MD, said at the Triological Society’s Combined Sections Meeting. “We wanted to know if there was difference within our group among people at different points in their career.”

In a study led by Katie Geelan-Hansen, MD, Dr. Benninger, who chairs the Head and Neck Institute at the Cleveland Clinic, and his colleagues administered the Maslach Burnout Inventory (MBI) and questions regarding work stressors specific to that department to 52 employees (Otolaryngol Head Neck Surg. 2018;159[2]:254-7). The questions focused on domains of emotional exhaustion, depersonalization, and a sense of personal accomplishment.

Of the 52 surveys distributed, 42 participants (85%) completed the survey. The researchers found that respondents who had worked for 6-10 years had higher MBI scores on emotional exhaustion, compared with their peers who had worked for 5 years or fewer, and those who had worked for more than 10 years (18.18, compared with 15.78 and 14.68, respectively; P = .63). A similar association was observed for MBI scores on depersonalization (15.14, compared with 14.72 and 9.68; P = .07). MBI scores on personal accomplishment were similar between the two groups (39, compared with 38.33 and 40.84; P = .5).

“People who are more mature in their practice tend to have less burnout,” Dr. Benninger said. “That may be because they’ve found a place of homeostasis. They’ve figured out how to maximize their efficiency, and they may have more support.

“The people who tend to be the biggest concern are those 6 -10 years into the field. I recommend that you focus on that group. It’s a transitional time in their careers. It’s a time when there’s some insecurity; they’re being asked to do a lot more.” It remains unclear if male or female respondents had a higher level of burnout, he added, although other surveys have suggested that female physicians have a higher level of burnout, compared with male physicians.

“Our overall evaluation of burnout was lower than what you see from national statistics,” Dr. Benninger said at the meeting, which was jointly sponsored by the Triological Society and the American College of Surgeons. “We have had a wellness officer [at Cleveland Clinic] for a long time. We have a group of people on our clinic’s board of governors who any staff can go to in order to vent issues on a private basis. All of those things help, but I am seeing an escalating unsatisfaction with the workload and the work environment. We’re looking at other things. Medical scribes seem to make a big difference for people, so we’re advancing scribes throughout our organization. Expectation setting and rewarding people are also important.”

He reported having no relevant financial disclosures.

[email protected]

SOURCE: Benninger MS et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Among a large cohort of children referred for polysomnography, the presence of asthma reduced the likelihood of severe obstructive sleep apnea (OSA), while the presence of obesity increased it.

deyangeorgiev/thinkstockphotos.com

“We have a good idea that obesity and asthma independently increase the risk of OSA, but a lot of the time in the pediatric population, these risk factors are found comorbid,” Ajay Narayanan at the Triological Society’s Combined Sections Meeting. “For this study we asked, how does the presence of asthma change the likelihood of having severe OSA in a cohort of obese patients? Knowing that both asthma and obesity independently increase the risk for OSA, we hypothesized that when they were comorbid, asthma would have a synergistic effect with obesity, causing severe OSA.”

Mr. Narayanan, a third-year student at the University of Texas Southwestern Medical Center, Dallas, and his colleagues performed a retrospective chart review of 367 children aged 9-17 years referred for a full-night polysomnography (PSG) for suspicion of having OSA. Demographic variables recorded included race, body mass index, rhinitis, gastroesophageal reflux disease, and tonsillar hypertrophy. Sleep variables recorded included apnea hypopnea index (AHI), sleep efficiency, rapid eye movement, and the peripheral capillary oxygen saturation (SpO₂₎ nadir. The primary outcome was severe OSA defined as an AHI of 10 or greater on the PSG. They used logistic modeling to determine the association between asthma, obesity, and severe OSA.

The mean age of the study population was 14 years, 56% were male, and 43% were Hispanic. Of the 367 patients, 77 were neither obese nor asthmatic, 93 were nonobese but were asthmatic, 102 were obese but were nonasthmatic, and 95 were both obese and asthmatic. PSG results confirmed that obesity was associated with more signs of sleep apnea. For example, the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, while the obese, nonasthmatic group had a mean AHI of 19 events per hour. “We observed a similar trend amongst our asthmatic population,” Mr. Narayanan said. “We observed an increase in the mean AHI amongst our asthmatic kids when we added obesity to the picture. Surprisingly, we found that asthma was associated with having fewer signs of sleep apnea.” Specifically, while the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, those in the nonobese, asthmatic group had a mean of 5.6 events per hour (P = .005). “The finding was similar amongst our obese kids,” he said. “We saw a decrease in the mean AHI of our obese kids when we added asthma to the picture.”

On logistic regression analysis using obesity and asthma as independent variables, the researchers found that obesity increased the risk of severe OSA by 2.4-fold, but asthma decreased the odds of having severe OSA by about half (0.55). On multiple logistic regression controlling for commonly associated factors such as tonsillar hypertrophy, black race, and Hispanic ethnicity, obesity increased the risk of severe OSA by 2.2-fold, while asthma decreased the odds of having severe OSA by about half (0.51).

“In trying to explain this finding, we can turn to how these diseases are treated,” Mr. Narayanan said. “I say this because of the proven association between preexisting asthma and new onset OSA. Some of the reasons for this association include the tendency for airway collapsibility and systemwide inflammation seen in asthma, which then might contribute to the development of OSA. If we treat asthma symptoms early on, it might prevent the progression to sleep apnea down the line.”

Considering how prevalent comorbid asthma and OSA is, he continued, “we need to confirm that it is in fact well-controlled asthma that is associated with lowering the risk of severe OSA. Once we do this, we can ask the question: Can we use asthma pharmacotherapy to treat OSA? Some studies have shown that inhaled corticosteroids and montelukast (Singulair) may be effective treatment options for kids with OSA, but there’s definitely room for more research in this field, [such as determining] which patients would most benefit from this pharmacotherapy.” The researchers reported having no financial disclosures.

[email protected]

SOURCE: Narayanan A et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Among a large cohort of children referred for polysomnography, the presence of asthma reduced the likelihood of severe obstructive sleep apnea (OSA), while the presence of obesity increased it.

deyangeorgiev/thinkstockphotos.com

“We have a good idea that obesity and asthma independently increase the risk of OSA, but a lot of the time in the pediatric population, these risk factors are found comorbid,” Ajay Narayanan at the Triological Society’s Combined Sections Meeting. “For this study we asked, how does the presence of asthma change the likelihood of having severe OSA in a cohort of obese patients? Knowing that both asthma and obesity independently increase the risk for OSA, we hypothesized that when they were comorbid, asthma would have a synergistic effect with obesity, causing severe OSA.”

Mr. Narayanan, a third-year student at the University of Texas Southwestern Medical Center, Dallas, and his colleagues performed a retrospective chart review of 367 children aged 9-17 years referred for a full-night polysomnography (PSG) for suspicion of having OSA. Demographic variables recorded included race, body mass index, rhinitis, gastroesophageal reflux disease, and tonsillar hypertrophy. Sleep variables recorded included apnea hypopnea index (AHI), sleep efficiency, rapid eye movement, and the peripheral capillary oxygen saturation (SpO₂₎ nadir. The primary outcome was severe OSA defined as an AHI of 10 or greater on the PSG. They used logistic modeling to determine the association between asthma, obesity, and severe OSA.

The mean age of the study population was 14 years, 56% were male, and 43% were Hispanic. Of the 367 patients, 77 were neither obese nor asthmatic, 93 were nonobese but were asthmatic, 102 were obese but were nonasthmatic, and 95 were both obese and asthmatic. PSG results confirmed that obesity was associated with more signs of sleep apnea. For example, the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, while the obese, nonasthmatic group had a mean AHI of 19 events per hour. “We observed a similar trend amongst our asthmatic population,” Mr. Narayanan said. “We observed an increase in the mean AHI amongst our asthmatic kids when we added obesity to the picture. Surprisingly, we found that asthma was associated with having fewer signs of sleep apnea.” Specifically, while the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, those in the nonobese, asthmatic group had a mean of 5.6 events per hour (P = .005). “The finding was similar amongst our obese kids,” he said. “We saw a decrease in the mean AHI of our obese kids when we added asthma to the picture.”

On logistic regression analysis using obesity and asthma as independent variables, the researchers found that obesity increased the risk of severe OSA by 2.4-fold, but asthma decreased the odds of having severe OSA by about half (0.55). On multiple logistic regression controlling for commonly associated factors such as tonsillar hypertrophy, black race, and Hispanic ethnicity, obesity increased the risk of severe OSA by 2.2-fold, while asthma decreased the odds of having severe OSA by about half (0.51).

“In trying to explain this finding, we can turn to how these diseases are treated,” Mr. Narayanan said. “I say this because of the proven association between preexisting asthma and new onset OSA. Some of the reasons for this association include the tendency for airway collapsibility and systemwide inflammation seen in asthma, which then might contribute to the development of OSA. If we treat asthma symptoms early on, it might prevent the progression to sleep apnea down the line.”

Considering how prevalent comorbid asthma and OSA is, he continued, “we need to confirm that it is in fact well-controlled asthma that is associated with lowering the risk of severe OSA. Once we do this, we can ask the question: Can we use asthma pharmacotherapy to treat OSA? Some studies have shown that inhaled corticosteroids and montelukast (Singulair) may be effective treatment options for kids with OSA, but there’s definitely room for more research in this field, [such as determining] which patients would most benefit from this pharmacotherapy.” The researchers reported having no financial disclosures.

[email protected]

SOURCE: Narayanan A et al. Triological CSM, Abstracts.

CORONADO, CALIF. – Among a large cohort of children referred for polysomnography, the presence of asthma reduced the likelihood of severe obstructive sleep apnea (OSA), while the presence of obesity increased it.

deyangeorgiev/thinkstockphotos.com

“We have a good idea that obesity and asthma independently increase the risk of OSA, but a lot of the time in the pediatric population, these risk factors are found comorbid,” Ajay Narayanan at the Triological Society’s Combined Sections Meeting. “For this study we asked, how does the presence of asthma change the likelihood of having severe OSA in a cohort of obese patients? Knowing that both asthma and obesity independently increase the risk for OSA, we hypothesized that when they were comorbid, asthma would have a synergistic effect with obesity, causing severe OSA.”

Mr. Narayanan, a third-year student at the University of Texas Southwestern Medical Center, Dallas, and his colleagues performed a retrospective chart review of 367 children aged 9-17 years referred for a full-night polysomnography (PSG) for suspicion of having OSA. Demographic variables recorded included race, body mass index, rhinitis, gastroesophageal reflux disease, and tonsillar hypertrophy. Sleep variables recorded included apnea hypopnea index (AHI), sleep efficiency, rapid eye movement, and the peripheral capillary oxygen saturation (SpO₂₎ nadir. The primary outcome was severe OSA defined as an AHI of 10 or greater on the PSG. They used logistic modeling to determine the association between asthma, obesity, and severe OSA.

The mean age of the study population was 14 years, 56% were male, and 43% were Hispanic. Of the 367 patients, 77 were neither obese nor asthmatic, 93 were nonobese but were asthmatic, 102 were obese but were nonasthmatic, and 95 were both obese and asthmatic. PSG results confirmed that obesity was associated with more signs of sleep apnea. For example, the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, while the obese, nonasthmatic group had a mean AHI of 19 events per hour. “We observed a similar trend amongst our asthmatic population,” Mr. Narayanan said. “We observed an increase in the mean AHI amongst our asthmatic kids when we added obesity to the picture. Surprisingly, we found that asthma was associated with having fewer signs of sleep apnea.” Specifically, while the nonobese, nonasthmatic group had a mean AHI of 11 events per hour, those in the nonobese, asthmatic group had a mean of 5.6 events per hour (P = .005). “The finding was similar amongst our obese kids,” he said. “We saw a decrease in the mean AHI of our obese kids when we added asthma to the picture.”

On logistic regression analysis using obesity and asthma as independent variables, the researchers found that obesity increased the risk of severe OSA by 2.4-fold, but asthma decreased the odds of having severe OSA by about half (0.55). On multiple logistic regression controlling for commonly associated factors such as tonsillar hypertrophy, black race, and Hispanic ethnicity, obesity increased the risk of severe OSA by 2.2-fold, while asthma decreased the odds of having severe OSA by about half (0.51).

“In trying to explain this finding, we can turn to how these diseases are treated,” Mr. Narayanan said. “I say this because of the proven association between preexisting asthma and new onset OSA. Some of the reasons for this association include the tendency for airway collapsibility and systemwide inflammation seen in asthma, which then might contribute to the development of OSA. If we treat asthma symptoms early on, it might prevent the progression to sleep apnea down the line.”

Considering how prevalent comorbid asthma and OSA is, he continued, “we need to confirm that it is in fact well-controlled asthma that is associated with lowering the risk of severe OSA. Once we do this, we can ask the question: Can we use asthma pharmacotherapy to treat OSA? Some studies have shown that inhaled corticosteroids and montelukast (Singulair) may be effective treatment options for kids with OSA, but there’s definitely room for more research in this field, [such as determining] which patients would most benefit from this pharmacotherapy.” The researchers reported having no financial disclosures.

[email protected]

SOURCE: Narayanan A et al. Triological CSM, Abstracts.

The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.

The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.

Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.

This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.

[email protected]

The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.

The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.

Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.

This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.

[email protected]

The Food and Drug Administration has approved a generic version of the Advair Diskus, a complex device-drug combination containing fluticasone propionate and salmeterol inhalation powder.

The generic device will be available in three strengths: fluticasone propionate 100 mcg/ salmeterol 50 mcg, fluticasone propionate 250 mcg/ salmeterol 50 mcg and fluticasone propionate 500 mcg/ salmeterol 50 mcg, according to the FDA announcement. It will be marketed by Mylan as Wixela Inhub and will launch in late February, according to a statement from Mylan.

Advair Diskus is among the most commonly used treatments for asthma and for chronic obstructive pulmonary disease (COPD), so it’s hoped this approval will increase access to the therapy, FDA officials said in a statement.

This approval is part of the FDA’s “longstanding commitment to advance access to lower cost, high quality generic alternatives,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “People living with asthma and COPD know too well the critical importance of having access to the treatment they need to feel better. Today’s approval will bring more competition to the market which will ultimately benefit the patients who rely on this drug.”

Wixela Inhub is indicated for twice-daily treatment of asthma in patients aged 4 years and older who are not adequately controlled by long-term asthma control treatments or whose disease warrants treatment with a combination of inhaled corticosteroids and long-acting beta agonists. It also is indicated for maintenance of COPD and reduction of COPD exacerbations.

[email protected]

I appreciated the PURL, “Should you reassess your patient’s asthma diagnosis?” (J Fam Pract. 2018;67:704-707) that reminded clinicians to taper asthma controller medications in asymptomatic patients. The articles cited^1,2 by Drs. Stevermer and Hayes documented that one-third of the adults enrolled in the respective study with physician-diagnosed asthma did not have objective evidence for asthma and were either over-diagnosed or had remitted. These articles also contained evidence that: 1) over-diagnosis was likely much more common than remission,¹ and 2) there was a significant temporal trend towards increasing over-diagnosis/remission during the last several decades. The authors of the cited article¹ suggested that the temporal trend could be explained by increased public awareness of respiratory symptoms, more aggressive marketing of asthma medications, and a lack of objective measurement of reversible airway obstruction in primary care. These assertions deserve careful consideration as we strive to diagnose asthma appropriately.

Over-diagnosis/remission is almost certainly not as prevalent (33%) as the authors of the cited articles^1,2 reported. The reason is simple selection bias: 1) the cited study² excluded asthma patients who smoked >10 pack-years (it enrolled 701 asthma patients and excluded 812 asthma patients with a >10 pack-year smoking history), and 2) this study likely did not include asthma patients with the asthma-COPD overlap syndrome, which is treated as asthma and comprises an additional 30% of our patients with chronic airflow limitation (the asthma-COPD spectrum).³ Asthma patients who smoke and/or have the overlap syndrome are prone to severe asthma that is refractory to inhaled corticosteroids.^3,4

In addition to making the correct diagnosis, it is equally important to be aware of efficacious therapies for severe refractory asthma that primary care clinicians can easily use. There is now good evidence that azithromycin is efficacious for severe refractory asthma⁵ and should be considered prior to referral for immunomodulatory asthma therapies.⁶

David L. Hahn, MD, MS
Madison, Wis

1. Aaron SD, Vandemheen KL, Boulet LP, et al; Canadian Respiratory Clinical Research Consortium. Overdiagnosis of asthma in obese and nonobese adults. CMAJ. 2008;179:1121-1131.

2. Aaron SD, Vandemheen KL, FitzGerald JM, et al; Canadian Respiratory Research Network. Reevaluation of diagnosis in adults with physician-diagnosed asthma. JAMA. 2017;317:269-279.

3. Gibson PG, Simpson JL. The overlap syndrome of asthma and COPD: what are its features and how important is it? Thorax. 2009;64:728-735.

4. Stapleton M, Howard-Thompson A, George C, et al. Smoking and asthma. J Am Board Fam Med. 2011;24;313-322.

5. Gibson PG, Yang IA, Upham JW, et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial. Lancet. 2017:390659-668.

6. Hahn DL, Grasmick M, Hetzel S, et al; AZMATICS (AZithroMycin-Asthma Trial In Community Settings) Study Group. Azithromycin for bronchial asthma in adults: an effectiveness trial. J Am Board Fam Med. 2012;25:442-459.

Continue to: Authors' response...

Authors’ response:

We appreciate Dr. Hahn’s observations about the PURL¹ on overdiagnosis of asthma. This article focused on the results of a prospective, multicenter cohort study² that evaluated the feasibility of tapering, and in many patients, stopping asthma medications. We agree that if the study had included people diagnosed with asthma who also had smoked at least 10 pack-years or who also had COPD, the proportion of those who would eventually no longer meet diagnostic criteria for asthma would be lower than in this study. We are uncertain of the relative proportion of cases that were overdiagnosis, when compared with true remission of disease, as only 43% of those no longer meeting the diagnostic criteria for asthma had evidence of prior lung function testing, whether by formal spirometry, serial peak function testing, or bronchial challenge testing.

We agree that using efficacious therapies for severe refractory asthma is essential, but the selection of those therapies was outside the scope of this PURL.

James J. Stevermer, MD, MSPH; Alisa Hayes, MD
Columbia, Mo

1. Stevermer JJ, Hayes A. Should you reassess your patient’s asthma diagnosis? J Fam Pract. 2018;67:704-707.

2. Aaron SD, Vandemheen KL, FitzGerald JM, et al; Canadian Respiratory Research Network. Reevaluation of diagnosis in adults with physician-diagnosed asthma. JAMA. 2017;317:269-279.

I appreciated the PURL, “Should you reassess your patient’s asthma diagnosis?” (J Fam Pract. 2018;67:704-707) that reminded clinicians to taper asthma controller medications in asymptomatic patients. The articles cited^1,2 by Drs. Stevermer and Hayes documented that one-third of the adults enrolled in the respective study with physician-diagnosed asthma did not have objective evidence for asthma and were either over-diagnosed or had remitted. These articles also contained evidence that: 1) over-diagnosis was likely much more common than remission,¹ and 2) there was a significant temporal trend towards increasing over-diagnosis/remission during the last several decades. The authors of the cited article¹ suggested that the temporal trend could be explained by increased public awareness of respiratory symptoms, more aggressive marketing of asthma medications, and a lack of objective measurement of reversible airway obstruction in primary care. These assertions deserve careful consideration as we strive to diagnose asthma appropriately.

Over-diagnosis/remission is almost certainly not as prevalent (33%) as the authors of the cited articles^1,2 reported. The reason is simple selection bias: 1) the cited study² excluded asthma patients who smoked >10 pack-years (it enrolled 701 asthma patients and excluded 812 asthma patients with a >10 pack-year smoking history), and 2) this study likely did not include asthma patients with the asthma-COPD overlap syndrome, which is treated as asthma and comprises an additional 30% of our patients with chronic airflow limitation (the asthma-COPD spectrum).³ Asthma patients who smoke and/or have the overlap syndrome are prone to severe asthma that is refractory to inhaled corticosteroids.^3,4

In addition to making the correct diagnosis, it is equally important to be aware of efficacious therapies for severe refractory asthma that primary care clinicians can easily use. There is now good evidence that azithromycin is efficacious for severe refractory asthma⁵ and should be considered prior to referral for immunomodulatory asthma therapies.⁶

David L. Hahn, MD, MS
Madison, Wis

1. Aaron SD, Vandemheen KL, Boulet LP, et al; Canadian Respiratory Clinical Research Consortium. Overdiagnosis of asthma in obese and nonobese adults. CMAJ. 2008;179:1121-1131.

2. Aaron SD, Vandemheen KL, FitzGerald JM, et al; Canadian Respiratory Research Network. Reevaluation of diagnosis in adults with physician-diagnosed asthma. JAMA. 2017;317:269-279.

3. Gibson PG, Simpson JL. The overlap syndrome of asthma and COPD: what are its features and how important is it? Thorax. 2009;64:728-735.

4. Stapleton M, Howard-Thompson A, George C, et al. Smoking and asthma. J Am Board Fam Med. 2011;24;313-322.

5. Gibson PG, Yang IA, Upham JW, et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial. Lancet. 2017:390659-668.

6. Hahn DL, Grasmick M, Hetzel S, et al; AZMATICS (AZithroMycin-Asthma Trial In Community Settings) Study Group. Azithromycin for bronchial asthma in adults: an effectiveness trial. J Am Board Fam Med. 2012;25:442-459.

Continue to: Authors' response...

Authors’ response:

We appreciate Dr. Hahn’s observations about the PURL¹ on overdiagnosis of asthma. This article focused on the results of a prospective, multicenter cohort study² that evaluated the feasibility of tapering, and in many patients, stopping asthma medications. We agree that if the study had included people diagnosed with asthma who also had smoked at least 10 pack-years or who also had COPD, the proportion of those who would eventually no longer meet diagnostic criteria for asthma would be lower than in this study. We are uncertain of the relative proportion of cases that were overdiagnosis, when compared with true remission of disease, as only 43% of those no longer meeting the diagnostic criteria for asthma had evidence of prior lung function testing, whether by formal spirometry, serial peak function testing, or bronchial challenge testing.

We agree that using efficacious therapies for severe refractory asthma is essential, but the selection of those therapies was outside the scope of this PURL.

James J. Stevermer, MD, MSPH; Alisa Hayes, MD
Columbia, Mo

1. Stevermer JJ, Hayes A. Should you reassess your patient’s asthma diagnosis? J Fam Pract. 2018;67:704-707.

2. Aaron SD, Vandemheen KL, FitzGerald JM, et al; Canadian Respiratory Research Network. Reevaluation of diagnosis in adults with physician-diagnosed asthma. JAMA. 2017;317:269-279.

I appreciated the PURL, “Should you reassess your patient’s asthma diagnosis?” (J Fam Pract. 2018;67:704-707) that reminded clinicians to taper asthma controller medications in asymptomatic patients. The articles cited^1,2 by Drs. Stevermer and Hayes documented that one-third of the adults enrolled in the respective study with physician-diagnosed asthma did not have objective evidence for asthma and were either over-diagnosed or had remitted. These articles also contained evidence that: 1) over-diagnosis was likely much more common than remission,¹ and 2) there was a significant temporal trend towards increasing over-diagnosis/remission during the last several decades. The authors of the cited article¹ suggested that the temporal trend could be explained by increased public awareness of respiratory symptoms, more aggressive marketing of asthma medications, and a lack of objective measurement of reversible airway obstruction in primary care. These assertions deserve careful consideration as we strive to diagnose asthma appropriately.

Over-diagnosis/remission is almost certainly not as prevalent (33%) as the authors of the cited articles^1,2 reported. The reason is simple selection bias: 1) the cited study² excluded asthma patients who smoked >10 pack-years (it enrolled 701 asthma patients and excluded 812 asthma patients with a >10 pack-year smoking history), and 2) this study likely did not include asthma patients with the asthma-COPD overlap syndrome, which is treated as asthma and comprises an additional 30% of our patients with chronic airflow limitation (the asthma-COPD spectrum).³ Asthma patients who smoke and/or have the overlap syndrome are prone to severe asthma that is refractory to inhaled corticosteroids.^3,4

In addition to making the correct diagnosis, it is equally important to be aware of efficacious therapies for severe refractory asthma that primary care clinicians can easily use. There is now good evidence that azithromycin is efficacious for severe refractory asthma⁵ and should be considered prior to referral for immunomodulatory asthma therapies.⁶

David L. Hahn, MD, MS
Madison, Wis

1. Aaron SD, Vandemheen KL, Boulet LP, et al; Canadian Respiratory Clinical Research Consortium. Overdiagnosis of asthma in obese and nonobese adults. CMAJ. 2008;179:1121-1131.

2. Aaron SD, Vandemheen KL, FitzGerald JM, et al; Canadian Respiratory Research Network. Reevaluation of diagnosis in adults with physician-diagnosed asthma. JAMA. 2017;317:269-279.

3. Gibson PG, Simpson JL. The overlap syndrome of asthma and COPD: what are its features and how important is it? Thorax. 2009;64:728-735.

4. Stapleton M, Howard-Thompson A, George C, et al. Smoking and asthma. J Am Board Fam Med. 2011;24;313-322.

5. Gibson PG, Yang IA, Upham JW, et al. Effect of azithromycin on asthma exacerbations and quality of life in adults with persistent uncontrolled asthma (AMAZES): a randomised, double-blind, placebo-controlled trial. Lancet. 2017:390659-668.

6. Hahn DL, Grasmick M, Hetzel S, et al; AZMATICS (AZithroMycin-Asthma Trial In Community Settings) Study Group. Azithromycin for bronchial asthma in adults: an effectiveness trial. J Am Board Fam Med. 2012;25:442-459.

Continue to: Authors' response...

Authors’ response:

We appreciate Dr. Hahn’s observations about the PURL¹ on overdiagnosis of asthma. This article focused on the results of a prospective, multicenter cohort study² that evaluated the feasibility of tapering, and in many patients, stopping asthma medications. We agree that if the study had included people diagnosed with asthma who also had smoked at least 10 pack-years or who also had COPD, the proportion of those who would eventually no longer meet diagnostic criteria for asthma would be lower than in this study. We are uncertain of the relative proportion of cases that were overdiagnosis, when compared with true remission of disease, as only 43% of those no longer meeting the diagnostic criteria for asthma had evidence of prior lung function testing, whether by formal spirometry, serial peak function testing, or bronchial challenge testing.

We agree that using efficacious therapies for severe refractory asthma is essential, but the selection of those therapies was outside the scope of this PURL.

James J. Stevermer, MD, MSPH; Alisa Hayes, MD
Columbia, Mo

1. Stevermer JJ, Hayes A. Should you reassess your patient’s asthma diagnosis? J Fam Pract. 2018;67:704-707.

2. Aaron SD, Vandemheen KL, FitzGerald JM, et al; Canadian Respiratory Research Network. Reevaluation of diagnosis in adults with physician-diagnosed asthma. JAMA. 2017;317:269-279.

CORONADO, CALIF. – Eosinophilic chronic rhinosinusitis with nasal polyposis decreases quality of life improvement after sinus surgery in patients with concurrent asthma, results from a retrospective study demonstrated.

They also have significantly higher Lund-Kennedy endoscopy and Lund-McKay CT scores, compared with control groups.

“Patients with concurrent asthma and chronic sinusitis require more aggressive management than nonasthmatics,” one of the study authors, Aykut A. Unsal, DO, said in an interview in advance of the Triological Society’s Combined Sections Meeting. “Additionally, the degree of improvement of not only their sinusitis but possibly their asthma following medical/surgical treatment will also be limited if that patient also suffers from nasal polyps and/or eosinophilia. These patients will ultimately become more difficult to manage.”

In order to examine the relationship of eosinophilia and nasal polyps on quality of life (QOL) in patients with asthma who have chronic rhinosinusitis (CRS) who were treated with surgery, Dr. Unsal and his associates reviewed the records of 457 patients with a diagnosis of CRS who underwent sinus surgery in the department of otolaryngology at the Medical College of Georgia, Augusta. The researchers subdivided patients based on the presence or absence of an asthma diagnosis and further subdivided them based on tissue eosinophilia and nasal polyposis. Next, they compared the Sinonasal Outcome Test (SNOT-22), Lund-Kennedy endoscopy scores, and Lund-McKay CT scores preoperatively and postoperatively at 6 months – 1 year and at 2, 3, 4, and 5 years. They performed a T-test analysis to determine statistical significance.

Of the 457 patients included in the analysis, 92 had asthma and eosinophilic CRS with nasal polyps (eCRScNP), 20 had asthma and eosinophilic CRS without nasal polyps (eCRSsNP), 8 had asthma and noneosinophilic CRS with nasal polyps (neCRScNP), and 16 had asthma and noneosinophilic CRS without nasal polyps (neCRSsNP). The researchers observed that patients in the eCRScNP group showed no difference in QOL preoperatively, but their QOL declined significantly at the 1- and 2-year analysis (P less than .03). No significant QOL improvement appeared in the eCRSsNP group until 4 years (P less than .008), and there was no significant QOL difference among the neCRS groups regardless of nasal polyposis. A statistical difference in endoscopy scores was seen among patients in the preoperative neCRScNP group (P less than .001) and in the eCRScNP group from preoperatively until 5 years postoperatively (P less than .03). Finally, statistical significance appeared in preoperative CT scores analysis among patients in the eCRScNP group (P less than .001).

Dragana991/Getty Images

[email protected]

CORONADO, CALIF. – Eosinophilic chronic rhinosinusitis with nasal polyposis decreases quality of life improvement after sinus surgery in patients with concurrent asthma, results from a retrospective study demonstrated.

They also have significantly higher Lund-Kennedy endoscopy and Lund-McKay CT scores, compared with control groups.

“Patients with concurrent asthma and chronic sinusitis require more aggressive management than nonasthmatics,” one of the study authors, Aykut A. Unsal, DO, said in an interview in advance of the Triological Society’s Combined Sections Meeting. “Additionally, the degree of improvement of not only their sinusitis but possibly their asthma following medical/surgical treatment will also be limited if that patient also suffers from nasal polyps and/or eosinophilia. These patients will ultimately become more difficult to manage.”

In order to examine the relationship of eosinophilia and nasal polyps on quality of life (QOL) in patients with asthma who have chronic rhinosinusitis (CRS) who were treated with surgery, Dr. Unsal and his associates reviewed the records of 457 patients with a diagnosis of CRS who underwent sinus surgery in the department of otolaryngology at the Medical College of Georgia, Augusta. The researchers subdivided patients based on the presence or absence of an asthma diagnosis and further subdivided them based on tissue eosinophilia and nasal polyposis. Next, they compared the Sinonasal Outcome Test (SNOT-22), Lund-Kennedy endoscopy scores, and Lund-McKay CT scores preoperatively and postoperatively at 6 months – 1 year and at 2, 3, 4, and 5 years. They performed a T-test analysis to determine statistical significance.

Of the 457 patients included in the analysis, 92 had asthma and eosinophilic CRS with nasal polyps (eCRScNP), 20 had asthma and eosinophilic CRS without nasal polyps (eCRSsNP), 8 had asthma and noneosinophilic CRS with nasal polyps (neCRScNP), and 16 had asthma and noneosinophilic CRS without nasal polyps (neCRSsNP). The researchers observed that patients in the eCRScNP group showed no difference in QOL preoperatively, but their QOL declined significantly at the 1- and 2-year analysis (P less than .03). No significant QOL improvement appeared in the eCRSsNP group until 4 years (P less than .008), and there was no significant QOL difference among the neCRS groups regardless of nasal polyposis. A statistical difference in endoscopy scores was seen among patients in the preoperative neCRScNP group (P less than .001) and in the eCRScNP group from preoperatively until 5 years postoperatively (P less than .03). Finally, statistical significance appeared in preoperative CT scores analysis among patients in the eCRScNP group (P less than .001).

Dragana991/Getty Images

[email protected]

CORONADO, CALIF. – Eosinophilic chronic rhinosinusitis with nasal polyposis decreases quality of life improvement after sinus surgery in patients with concurrent asthma, results from a retrospective study demonstrated.

They also have significantly higher Lund-Kennedy endoscopy and Lund-McKay CT scores, compared with control groups.

“Patients with concurrent asthma and chronic sinusitis require more aggressive management than nonasthmatics,” one of the study authors, Aykut A. Unsal, DO, said in an interview in advance of the Triological Society’s Combined Sections Meeting. “Additionally, the degree of improvement of not only their sinusitis but possibly their asthma following medical/surgical treatment will also be limited if that patient also suffers from nasal polyps and/or eosinophilia. These patients will ultimately become more difficult to manage.”

In order to examine the relationship of eosinophilia and nasal polyps on quality of life (QOL) in patients with asthma who have chronic rhinosinusitis (CRS) who were treated with surgery, Dr. Unsal and his associates reviewed the records of 457 patients with a diagnosis of CRS who underwent sinus surgery in the department of otolaryngology at the Medical College of Georgia, Augusta. The researchers subdivided patients based on the presence or absence of an asthma diagnosis and further subdivided them based on tissue eosinophilia and nasal polyposis. Next, they compared the Sinonasal Outcome Test (SNOT-22), Lund-Kennedy endoscopy scores, and Lund-McKay CT scores preoperatively and postoperatively at 6 months – 1 year and at 2, 3, 4, and 5 years. They performed a T-test analysis to determine statistical significance.

Of the 457 patients included in the analysis, 92 had asthma and eosinophilic CRS with nasal polyps (eCRScNP), 20 had asthma and eosinophilic CRS without nasal polyps (eCRSsNP), 8 had asthma and noneosinophilic CRS with nasal polyps (neCRScNP), and 16 had asthma and noneosinophilic CRS without nasal polyps (neCRSsNP). The researchers observed that patients in the eCRScNP group showed no difference in QOL preoperatively, but their QOL declined significantly at the 1- and 2-year analysis (P less than .03). No significant QOL improvement appeared in the eCRSsNP group until 4 years (P less than .008), and there was no significant QOL difference among the neCRS groups regardless of nasal polyposis. A statistical difference in endoscopy scores was seen among patients in the preoperative neCRScNP group (P less than .001) and in the eCRScNP group from preoperatively until 5 years postoperatively (P less than .03). Finally, statistical significance appeared in preoperative CT scores analysis among patients in the eCRScNP group (P less than .001).

Dragana991/Getty Images

[email protected]

Benralizumab is safe and effective for the treatment of uncontrolled asthma out to 2 years, according findings of the BORA trial, an extension study of the phase 3 SIROCCO and CALIMA trials. The study follows up and reinforces previously reported 1-year data and was reported by William W. Busse, MD, of University of Wisconsin, Madison, and his colleagues in the Lancet Respiratory Medicine.

Courtesy University of Wisconsin Health System

Benralizumab is a monoclonal antibody that targets interleukin-5 receptor alpha. It causes rapid deletion of eosinophils through cell-mediated cytotoxicity. A 30-mg dose of benralizumab every 8 weeks is approved for severe asthma treatment in Canada, Europe, Japan, the United States, and other countries.

In the second year of treatment, there were no new adverse events associated with depleted eosinophils, and the frequency of opportunistic infections was similar to that observed in the first year.

Eosinophilic inflammation occurs in about half of asthma cases and is associated with greater severity.

The 48-week SIROCCO trial, the 56-week CALIMA trial, and the 28-week ZONDA trial tested the effect of benralizumab 30 mg given every 4 weeks or 8 weeks, combined with high-dosage inhaled steroids and long-acting beta₂-agonists. The 8-week dose of the drug reduced annual exacerbations by 51%, compared with placebo in the SIROCCO trial and by 28% in the CALIMA trial. In the ZONDA trial, benralizumab reduced oral glucocorticoid use by 75%, compared with placebo, and by 25% from baseline.

The BORA extension trial included participants in the previous three trials. In the current report, researchers presented results from the analysis from BORA participants recruited from the SIROCCO and CALIMA trials. Data from participants from all three trials will be reported in the future.

The analysis included 1,576 patients who continued to receive benralizumab after being assigned to the treatment arm in SIROCCO or CALIMA, or who had received placebo were randomized to benralizumab on the 4-week (n = 783; 265 from placebo) or 8-week dose (n = 793; 281 from placebo) schedule.

A total of 166 patients, or about 10% in each group, discontinued treatment. The frequency of any serious adverse event (SAE) ranged between 10% and 11% in all groups. SAEs associated with infections ranged from 1% to 3%, indicating that there were no significant differences in SAE frequencies between those who were originally assigned to placebo and those who originally received benralizumab. That suggests no safety differences between receiving the drug for 1 year or 2 years.

A total of 1,046 subjects had blood eosinophil counts of 300 cells per mcL or greater at baseline; 72% of these patients had no asthma exacerbations during the BORA study. This was true for 74% of patients in the 8-week treatment arm.

The crude asthma exacerbation rate for patients who received benralizumab in SIROCCO or CALIMA was 0.48 in the 4-week arm, compared with placebo (95% confidence interval, 0.42-0.56) and 0.46 in the 8-week arm (95% CI, 0.39-0.53). For patients who started out on placebo, the crude exacerbation rate during BORA was 0.53 in the 4-week group (95% CI, 0.43-0.65) and 0.57 in the 8-week group (95% CI, 0.47-0.68).

Patients who started on benralizumab had similar exacerbation frequencies during year 1 and year 2.

AstraZeneca and Kyowa Hakko Kirin funded the studies. The authors have received fees from AstraZeneca and other pharmaceutical companies, and some are employees of AstraZeneca.

SOURCE: Busse WW et al. Lancet Respir Med. 2019 Jan 1;7(1):46-59.

Benralizumab is safe and effective for the treatment of uncontrolled asthma out to 2 years, according findings of the BORA trial, an extension study of the phase 3 SIROCCO and CALIMA trials. The study follows up and reinforces previously reported 1-year data and was reported by William W. Busse, MD, of University of Wisconsin, Madison, and his colleagues in the Lancet Respiratory Medicine.

Courtesy University of Wisconsin Health System

Benralizumab is a monoclonal antibody that targets interleukin-5 receptor alpha. It causes rapid deletion of eosinophils through cell-mediated cytotoxicity. A 30-mg dose of benralizumab every 8 weeks is approved for severe asthma treatment in Canada, Europe, Japan, the United States, and other countries.

In the second year of treatment, there were no new adverse events associated with depleted eosinophils, and the frequency of opportunistic infections was similar to that observed in the first year.

Eosinophilic inflammation occurs in about half of asthma cases and is associated with greater severity.

The 48-week SIROCCO trial, the 56-week CALIMA trial, and the 28-week ZONDA trial tested the effect of benralizumab 30 mg given every 4 weeks or 8 weeks, combined with high-dosage inhaled steroids and long-acting beta₂-agonists. The 8-week dose of the drug reduced annual exacerbations by 51%, compared with placebo in the SIROCCO trial and by 28% in the CALIMA trial. In the ZONDA trial, benralizumab reduced oral glucocorticoid use by 75%, compared with placebo, and by 25% from baseline.

The BORA extension trial included participants in the previous three trials. In the current report, researchers presented results from the analysis from BORA participants recruited from the SIROCCO and CALIMA trials. Data from participants from all three trials will be reported in the future.

The analysis included 1,576 patients who continued to receive benralizumab after being assigned to the treatment arm in SIROCCO or CALIMA, or who had received placebo were randomized to benralizumab on the 4-week (n = 783; 265 from placebo) or 8-week dose (n = 793; 281 from placebo) schedule.

A total of 166 patients, or about 10% in each group, discontinued treatment. The frequency of any serious adverse event (SAE) ranged between 10% and 11% in all groups. SAEs associated with infections ranged from 1% to 3%, indicating that there were no significant differences in SAE frequencies between those who were originally assigned to placebo and those who originally received benralizumab. That suggests no safety differences between receiving the drug for 1 year or 2 years.

A total of 1,046 subjects had blood eosinophil counts of 300 cells per mcL or greater at baseline; 72% of these patients had no asthma exacerbations during the BORA study. This was true for 74% of patients in the 8-week treatment arm.

The crude asthma exacerbation rate for patients who received benralizumab in SIROCCO or CALIMA was 0.48 in the 4-week arm, compared with placebo (95% confidence interval, 0.42-0.56) and 0.46 in the 8-week arm (95% CI, 0.39-0.53). For patients who started out on placebo, the crude exacerbation rate during BORA was 0.53 in the 4-week group (95% CI, 0.43-0.65) and 0.57 in the 8-week group (95% CI, 0.47-0.68).

Patients who started on benralizumab had similar exacerbation frequencies during year 1 and year 2.

AstraZeneca and Kyowa Hakko Kirin funded the studies. The authors have received fees from AstraZeneca and other pharmaceutical companies, and some are employees of AstraZeneca.

SOURCE: Busse WW et al. Lancet Respir Med. 2019 Jan 1;7(1):46-59.

Benralizumab is safe and effective for the treatment of uncontrolled asthma out to 2 years, according findings of the BORA trial, an extension study of the phase 3 SIROCCO and CALIMA trials. The study follows up and reinforces previously reported 1-year data and was reported by William W. Busse, MD, of University of Wisconsin, Madison, and his colleagues in the Lancet Respiratory Medicine.

Courtesy University of Wisconsin Health System

Benralizumab is a monoclonal antibody that targets interleukin-5 receptor alpha. It causes rapid deletion of eosinophils through cell-mediated cytotoxicity. A 30-mg dose of benralizumab every 8 weeks is approved for severe asthma treatment in Canada, Europe, Japan, the United States, and other countries.

In the second year of treatment, there were no new adverse events associated with depleted eosinophils, and the frequency of opportunistic infections was similar to that observed in the first year.

Eosinophilic inflammation occurs in about half of asthma cases and is associated with greater severity.

The 48-week SIROCCO trial, the 56-week CALIMA trial, and the 28-week ZONDA trial tested the effect of benralizumab 30 mg given every 4 weeks or 8 weeks, combined with high-dosage inhaled steroids and long-acting beta₂-agonists. The 8-week dose of the drug reduced annual exacerbations by 51%, compared with placebo in the SIROCCO trial and by 28% in the CALIMA trial. In the ZONDA trial, benralizumab reduced oral glucocorticoid use by 75%, compared with placebo, and by 25% from baseline.

The BORA extension trial included participants in the previous three trials. In the current report, researchers presented results from the analysis from BORA participants recruited from the SIROCCO and CALIMA trials. Data from participants from all three trials will be reported in the future.

The analysis included 1,576 patients who continued to receive benralizumab after being assigned to the treatment arm in SIROCCO or CALIMA, or who had received placebo were randomized to benralizumab on the 4-week (n = 783; 265 from placebo) or 8-week dose (n = 793; 281 from placebo) schedule.

A total of 166 patients, or about 10% in each group, discontinued treatment. The frequency of any serious adverse event (SAE) ranged between 10% and 11% in all groups. SAEs associated with infections ranged from 1% to 3%, indicating that there were no significant differences in SAE frequencies between those who were originally assigned to placebo and those who originally received benralizumab. That suggests no safety differences between receiving the drug for 1 year or 2 years.

A total of 1,046 subjects had blood eosinophil counts of 300 cells per mcL or greater at baseline; 72% of these patients had no asthma exacerbations during the BORA study. This was true for 74% of patients in the 8-week treatment arm.

The crude asthma exacerbation rate for patients who received benralizumab in SIROCCO or CALIMA was 0.48 in the 4-week arm, compared with placebo (95% confidence interval, 0.42-0.56) and 0.46 in the 8-week arm (95% CI, 0.39-0.53). For patients who started out on placebo, the crude exacerbation rate during BORA was 0.53 in the 4-week group (95% CI, 0.43-0.65) and 0.57 in the 8-week group (95% CI, 0.47-0.68).

Patients who started on benralizumab had similar exacerbation frequencies during year 1 and year 2.

AstraZeneca and Kyowa Hakko Kirin funded the studies. The authors have received fees from AstraZeneca and other pharmaceutical companies, and some are employees of AstraZeneca.

SOURCE: Busse WW et al. Lancet Respir Med. 2019 Jan 1;7(1):46-59.

Just like exposure to secondhand smoke, exposure to secondhand aerosols from e-cigarettes is associated with an increased risk of asthma exacerbations in children, according to a review of the 11,830 kids with asthma in the 2016 Florida Youth Tobacco survey.

diego_cervo/Thinkstock

Every year, the Florida Department of Health surveys public school children aged 11-17 years about various tobacco issues. In 2016, almost 12% of the asthmatic children in the survey said they vaped. Almost half were exposed to secondhand smoke, and a third reported exposure to secondhand vaping aerosols within the past 30 days. Overall, 21% reported an asthma attack in the past 12 months.

Using data from the Florida survey, the investigators crunched the numbers and found that secondhand aerosol exposure increased the odds of an asthma attack by 27%, independent of exposure to secondhand smoke and whether children smoked or vaped themselves (adjusted odds ratio, 1.27; 95% confidence interval, 1.11-1.47).

“Health professionals may wish to counsel asthmatic youth and their families regarding the potential risks of ENDS [electronic nicotine delivery system] use and exposure to ENDS aerosols.” Providers “may also consider including ENDS aerosol exposure as a possible trigger in asthma self-management/action plans and updating asthma home environment assessments to include exposure to ENDS aerosols,” said investigators led by medical student Jennifer Bayly, a research fellow at the National Institute on Minority Health and Health Disparities in Bethesda, Md.

About 4% of adults in the United States and 11% of high school students vape, and almost 10% of U.S. adolescents reported living with an ENDS user in 2014. Given the data, “it is likely that a substantial number of asthmatic youth are exposed,” the investigators said.

The study adds to a growing body of evidence linking e-cigarettes to asthma. There’s moderate evidence for increased cough and wheezing in adolescents who use e-cigarettes, plus an association with e-cigarette use and increased asthma exacerbations. The new study, however, is likely the first to look specifically at secondhand exposure among asthmatic children. Ingredients in vaping aerosols, including flavorings, propylene glycol, and vegetable glycerin, are physiologically active in the lungs, and may be lung irritants.

Overall, about half of the respondents were female, and two-thirds were 11-13 years old. About a third identified as Hispanic, a third as white, and just over a fifth as black. Three-quarters of the sample lived in large or midsized metropolitan areas, and close to two-thirds in stand-alone homes. Participants were considered exposed to secondhand aerosols if they reported that in the past month they were in a room or car with someone who was vaping.

The work was funded by the National Institutes of Health. The investigators had no disclosures.

[email protected]

SOURCE: Bayly JE et al. CHEST®. 2018 Oct 22. doi: 10.1016/j.chest.2018.10.005.

Just like exposure to secondhand smoke, exposure to secondhand aerosols from e-cigarettes is associated with an increased risk of asthma exacerbations in children, according to a review of the 11,830 kids with asthma in the 2016 Florida Youth Tobacco survey.

diego_cervo/Thinkstock

Every year, the Florida Department of Health surveys public school children aged 11-17 years about various tobacco issues. In 2016, almost 12% of the asthmatic children in the survey said they vaped. Almost half were exposed to secondhand smoke, and a third reported exposure to secondhand vaping aerosols within the past 30 days. Overall, 21% reported an asthma attack in the past 12 months.

Using data from the Florida survey, the investigators crunched the numbers and found that secondhand aerosol exposure increased the odds of an asthma attack by 27%, independent of exposure to secondhand smoke and whether children smoked or vaped themselves (adjusted odds ratio, 1.27; 95% confidence interval, 1.11-1.47).

“Health professionals may wish to counsel asthmatic youth and their families regarding the potential risks of ENDS [electronic nicotine delivery system] use and exposure to ENDS aerosols.” Providers “may also consider including ENDS aerosol exposure as a possible trigger in asthma self-management/action plans and updating asthma home environment assessments to include exposure to ENDS aerosols,” said investigators led by medical student Jennifer Bayly, a research fellow at the National Institute on Minority Health and Health Disparities in Bethesda, Md.

About 4% of adults in the United States and 11% of high school students vape, and almost 10% of U.S. adolescents reported living with an ENDS user in 2014. Given the data, “it is likely that a substantial number of asthmatic youth are exposed,” the investigators said.

The study adds to a growing body of evidence linking e-cigarettes to asthma. There’s moderate evidence for increased cough and wheezing in adolescents who use e-cigarettes, plus an association with e-cigarette use and increased asthma exacerbations. The new study, however, is likely the first to look specifically at secondhand exposure among asthmatic children. Ingredients in vaping aerosols, including flavorings, propylene glycol, and vegetable glycerin, are physiologically active in the lungs, and may be lung irritants.

Overall, about half of the respondents were female, and two-thirds were 11-13 years old. About a third identified as Hispanic, a third as white, and just over a fifth as black. Three-quarters of the sample lived in large or midsized metropolitan areas, and close to two-thirds in stand-alone homes. Participants were considered exposed to secondhand aerosols if they reported that in the past month they were in a room or car with someone who was vaping.

The work was funded by the National Institutes of Health. The investigators had no disclosures.

[email protected]

SOURCE: Bayly JE et al. CHEST®. 2018 Oct 22. doi: 10.1016/j.chest.2018.10.005.

Just like exposure to secondhand smoke, exposure to secondhand aerosols from e-cigarettes is associated with an increased risk of asthma exacerbations in children, according to a review of the 11,830 kids with asthma in the 2016 Florida Youth Tobacco survey.

diego_cervo/Thinkstock

Every year, the Florida Department of Health surveys public school children aged 11-17 years about various tobacco issues. In 2016, almost 12% of the asthmatic children in the survey said they vaped. Almost half were exposed to secondhand smoke, and a third reported exposure to secondhand vaping aerosols within the past 30 days. Overall, 21% reported an asthma attack in the past 12 months.

Using data from the Florida survey, the investigators crunched the numbers and found that secondhand aerosol exposure increased the odds of an asthma attack by 27%, independent of exposure to secondhand smoke and whether children smoked or vaped themselves (adjusted odds ratio, 1.27; 95% confidence interval, 1.11-1.47).

“Health professionals may wish to counsel asthmatic youth and their families regarding the potential risks of ENDS [electronic nicotine delivery system] use and exposure to ENDS aerosols.” Providers “may also consider including ENDS aerosol exposure as a possible trigger in asthma self-management/action plans and updating asthma home environment assessments to include exposure to ENDS aerosols,” said investigators led by medical student Jennifer Bayly, a research fellow at the National Institute on Minority Health and Health Disparities in Bethesda, Md.

About 4% of adults in the United States and 11% of high school students vape, and almost 10% of U.S. adolescents reported living with an ENDS user in 2014. Given the data, “it is likely that a substantial number of asthmatic youth are exposed,” the investigators said.

The study adds to a growing body of evidence linking e-cigarettes to asthma. There’s moderate evidence for increased cough and wheezing in adolescents who use e-cigarettes, plus an association with e-cigarette use and increased asthma exacerbations. The new study, however, is likely the first to look specifically at secondhand exposure among asthmatic children. Ingredients in vaping aerosols, including flavorings, propylene glycol, and vegetable glycerin, are physiologically active in the lungs, and may be lung irritants.

Overall, about half of the respondents were female, and two-thirds were 11-13 years old. About a third identified as Hispanic, a third as white, and just over a fifth as black. Three-quarters of the sample lived in large or midsized metropolitan areas, and close to two-thirds in stand-alone homes. Participants were considered exposed to secondhand aerosols if they reported that in the past month they were in a room or car with someone who was vaping.

The work was funded by the National Institutes of Health. The investigators had no disclosures.

[email protected]

SOURCE: Bayly JE et al. CHEST®. 2018 Oct 22. doi: 10.1016/j.chest.2018.10.005.