Asthma

SAN ANTONIO – Regardless of COPD patients’ bronchodilator reversibility at baseline, triple therapy with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) significantly reduced the exacerbation rate versus dual therapies, according to a recent retrospective analysis of a randomized, double-blind study.

Andrew D. Bowser/MDedge News

FF/UMEC/VI, a triple-therapy combination of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2 agonist (ICS/LAMA/LABA), was superior to both LAMA/LABA and ICS/LABA combinations in reducing the rate of moderate to severe exacerbation and lung function, the analysis showed.

The ICS/LAMA/LABA combination, compared with LAMA/LABA, also significantly reduced the rate of severe exacerbations and time to first moderate to severe exacerbations in both reversible and nonreversible patients, Robert Wise, MD, FCCP, of Johns Hopkins University, Baltimore, said at the annual meeting of the American College of Chest Physicians.

The analysis was based on data from IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.

“The results across both reversibility subgroups are consistent with those observed in the intention-to-treat or overall study population and show a similar benefit-to-risk profile of the triple therapy across different subtypes based on bronchodilator reversibility,” Dr. Wise told attendees in a podium presentation.

Reversibility was defined as a difference between pre- and postalbuterol assessment of FEV₁ of equal to or greater than 12% and equal to or greater than 200 mL at screening, Dr. Wise said.

Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction, according to data reported in the meeting abstract.

Severe exacerbation rates dropped by 44% and 31%, respectively, in the reversible and nonreversible patients for triple versus dual therapy, he added.

Triple therapy reduced time to first moderate to severe exacerbation versus dual therapy by 25.6% in reversible and 13.6% in nonreversible COPD patients, the data showed.

The FF/UMEC/VI combination also demonstrated improvements versus UMEC/VI in time to first severe exacerbation for both the reversible and nonreversible groups, as well as improved quality of life in both groups as measured by the St. George Respiratory Questionnaire (SGRQ) in both groups.

Results were somewhat different when comparing the FF/UMEC/VI combination with the FF/VI – the ICS/LABA combination – in this post hoc analysis.

Triple therapy did reduce moderate to severe exacerbations and improved lung function regardless of baseline reversibility. However, for the reversible patients, ICS/LAMA/LABA versus ICS/LABA did not significantly reduce risk specifically of severe exacerbations, time to first moderate to severe exacerbation, or increase odds of being an SGRQ responder, Dr. Wise said.

Nonetheless, these findings taken together imply that this ICS/LAMA/LABA combination provides clinically relevant improvements versus dual therapy across a range of important outcomes regardless of baseline reversibility, according to Dr. Wise and colleagues.

Dr. Wise and coinvestigators provided disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.

SOURCE: Wise R et al. Chest. 2018 Oct. doi: 10.1016/j.chest.2018.08.662

SAN ANTONIO – Regardless of COPD patients’ bronchodilator reversibility at baseline, triple therapy with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) significantly reduced the exacerbation rate versus dual therapies, according to a recent retrospective analysis of a randomized, double-blind study.

Andrew D. Bowser/MDedge News

FF/UMEC/VI, a triple-therapy combination of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2 agonist (ICS/LAMA/LABA), was superior to both LAMA/LABA and ICS/LABA combinations in reducing the rate of moderate to severe exacerbation and lung function, the analysis showed.

The ICS/LAMA/LABA combination, compared with LAMA/LABA, also significantly reduced the rate of severe exacerbations and time to first moderate to severe exacerbations in both reversible and nonreversible patients, Robert Wise, MD, FCCP, of Johns Hopkins University, Baltimore, said at the annual meeting of the American College of Chest Physicians.

The analysis was based on data from IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.

“The results across both reversibility subgroups are consistent with those observed in the intention-to-treat or overall study population and show a similar benefit-to-risk profile of the triple therapy across different subtypes based on bronchodilator reversibility,” Dr. Wise told attendees in a podium presentation.

Reversibility was defined as a difference between pre- and postalbuterol assessment of FEV₁ of equal to or greater than 12% and equal to or greater than 200 mL at screening, Dr. Wise said.

Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction, according to data reported in the meeting abstract.

Severe exacerbation rates dropped by 44% and 31%, respectively, in the reversible and nonreversible patients for triple versus dual therapy, he added.

Triple therapy reduced time to first moderate to severe exacerbation versus dual therapy by 25.6% in reversible and 13.6% in nonreversible COPD patients, the data showed.

The FF/UMEC/VI combination also demonstrated improvements versus UMEC/VI in time to first severe exacerbation for both the reversible and nonreversible groups, as well as improved quality of life in both groups as measured by the St. George Respiratory Questionnaire (SGRQ) in both groups.

Results were somewhat different when comparing the FF/UMEC/VI combination with the FF/VI – the ICS/LABA combination – in this post hoc analysis.

Triple therapy did reduce moderate to severe exacerbations and improved lung function regardless of baseline reversibility. However, for the reversible patients, ICS/LAMA/LABA versus ICS/LABA did not significantly reduce risk specifically of severe exacerbations, time to first moderate to severe exacerbation, or increase odds of being an SGRQ responder, Dr. Wise said.

Nonetheless, these findings taken together imply that this ICS/LAMA/LABA combination provides clinically relevant improvements versus dual therapy across a range of important outcomes regardless of baseline reversibility, according to Dr. Wise and colleagues.

Dr. Wise and coinvestigators provided disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.

SOURCE: Wise R et al. Chest. 2018 Oct. doi: 10.1016/j.chest.2018.08.662

SAN ANTONIO – Regardless of COPD patients’ bronchodilator reversibility at baseline, triple therapy with fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) significantly reduced the exacerbation rate versus dual therapies, according to a recent retrospective analysis of a randomized, double-blind study.

Andrew D. Bowser/MDedge News

FF/UMEC/VI, a triple-therapy combination of an inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta2 agonist (ICS/LAMA/LABA), was superior to both LAMA/LABA and ICS/LABA combinations in reducing the rate of moderate to severe exacerbation and lung function, the analysis showed.

The ICS/LAMA/LABA combination, compared with LAMA/LABA, also significantly reduced the rate of severe exacerbations and time to first moderate to severe exacerbations in both reversible and nonreversible patients, Robert Wise, MD, FCCP, of Johns Hopkins University, Baltimore, said at the annual meeting of the American College of Chest Physicians.

The analysis was based on data from IMPACT, an international, randomized, 52-week study that included more than 10,000 patients with symptomatic COPD, of whom 18% demonstrated reversibility at screening.

“The results across both reversibility subgroups are consistent with those observed in the intention-to-treat or overall study population and show a similar benefit-to-risk profile of the triple therapy across different subtypes based on bronchodilator reversibility,” Dr. Wise told attendees in a podium presentation.

Reversibility was defined as a difference between pre- and postalbuterol assessment of FEV₁ of equal to or greater than 12% and equal to or greater than 200 mL at screening, Dr. Wise said.

Reversible patients had a 40% reduction in the rate of moderate to severe exacerbations for FF/UMEC/VI versus UMEC/VI, while nonreversible patients had a 21% reduction, according to data reported in the meeting abstract.

Severe exacerbation rates dropped by 44% and 31%, respectively, in the reversible and nonreversible patients for triple versus dual therapy, he added.

Triple therapy reduced time to first moderate to severe exacerbation versus dual therapy by 25.6% in reversible and 13.6% in nonreversible COPD patients, the data showed.

The FF/UMEC/VI combination also demonstrated improvements versus UMEC/VI in time to first severe exacerbation for both the reversible and nonreversible groups, as well as improved quality of life in both groups as measured by the St. George Respiratory Questionnaire (SGRQ) in both groups.

Results were somewhat different when comparing the FF/UMEC/VI combination with the FF/VI – the ICS/LABA combination – in this post hoc analysis.

Triple therapy did reduce moderate to severe exacerbations and improved lung function regardless of baseline reversibility. However, for the reversible patients, ICS/LAMA/LABA versus ICS/LABA did not significantly reduce risk specifically of severe exacerbations, time to first moderate to severe exacerbation, or increase odds of being an SGRQ responder, Dr. Wise said.

Nonetheless, these findings taken together imply that this ICS/LAMA/LABA combination provides clinically relevant improvements versus dual therapy across a range of important outcomes regardless of baseline reversibility, according to Dr. Wise and colleagues.

Dr. Wise and coinvestigators provided disclosures related to Boehringer Ingelheim, BTG, Chiesi, GlaxoSmithKline, Mereo, Novartis, PneumRx, Prometic, and Pulmonx.

SOURCE: Wise R et al. Chest. 2018 Oct. doi: 10.1016/j.chest.2018.08.662

SAN ANTONIO – It may not always be necessary to tell parents of children with asthma to get rid of the household pet, a recent study suggests.

Andrew D. Bowser/MDedge News

Children with uncontrolled asthma who were provided with guideline-appropriate care had significant improvements in a variety of asthma measures, regardless of whether parents reported pets or smoking at home, according to results of the 4-year, 471-patient prospective study.

Those results suggest that clinicians should be working to make sure the guidelines are being closely followed before, for example, telling parents they need to consider getting rid of the family pet, said Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital, Columbus, Ohio.

“As the guidelines still work, we need to focus and develop the connections with the family to make sure the patients are on the right treatment, and that they’re getting the medications,” Dr. Sheikh said in an interview at the annual meeting of the American College of Chest Physicians.

The prospective cohort study by Dr. Sheikh and his colleagues, presented in a poster session, included children referred to a pediatric asthma center with the diagnosis of uncontrolled asthma. All patients received asthma care according to National Asthma Education and Prevention Program Expert Panel Report 3 guidelines.

Medications were changed as needed, and the asthma action plan was revised accordingly and reviewed with the family at each visit, Dr. Sheikh reported. After a baseline evaluation, clinic visits for the study occurred at 3 months, 6 months, and then at 1, 2, 3, and 4 years.

Out of 471 patients, 258 had pets, and 125 were in homes where smoking took place, according to parent reports.

Asthma control test scores were 15.1 at baseline for children in no-pet households, and 16.5 for those with pets; by the 3-month visit, scores increased to 20.1 and 20.3 for the no-pet and pet groups, and at 4 years, those scores had edged up to 22.2 and 22.7 (P = .371), Dr. Sheikh reported.

Similarly, after care was started, there was no significant difference between the no-pet and pet groups in mean percent of predicted forced expiratory volume in 1 second (FEV₁₎, wheezing, nighttime cough, albuterol use, and other factors over the 4 years of follow-up, he said.

Likewise, looking at the data by nonsmoking vs. smoking households, asthma control test scores at baseline were 16.1 and 15.1, respectively, and at 4 years they were 22.2 and 22.3 (P = .078), with a similar lack of difference in predicted FEV₁, wheezing, and all other factors evaluated.

Getting rid of the family pet may need to be a consideration for some families, but based on these data, that might not be necessary for the majority of families, Dr. Sheikh said in the interview.

“On the other hand, we are not saying that if you are smoking, you should continue to smoke,” he added.

“What we are saying is that smoking is bad, but if your child is not getting better, I don’t want to blame your smoking for it. There may be something else which may be more important than smoking which we are missing – the child may not be getting the medicine, or may not be on the right medicine, or may have other comorbidities.”

Dr. Sheikh and his coinvestigators disclosed that they had no relationships relevant to the study.

SOURCE: Sheikh S et al. CHEST 2018. doi: 10.1016/j.chest.2018.08.666.

SAN ANTONIO – It may not always be necessary to tell parents of children with asthma to get rid of the household pet, a recent study suggests.

Andrew D. Bowser/MDedge News

Children with uncontrolled asthma who were provided with guideline-appropriate care had significant improvements in a variety of asthma measures, regardless of whether parents reported pets or smoking at home, according to results of the 4-year, 471-patient prospective study.

Those results suggest that clinicians should be working to make sure the guidelines are being closely followed before, for example, telling parents they need to consider getting rid of the family pet, said Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital, Columbus, Ohio.

“As the guidelines still work, we need to focus and develop the connections with the family to make sure the patients are on the right treatment, and that they’re getting the medications,” Dr. Sheikh said in an interview at the annual meeting of the American College of Chest Physicians.

The prospective cohort study by Dr. Sheikh and his colleagues, presented in a poster session, included children referred to a pediatric asthma center with the diagnosis of uncontrolled asthma. All patients received asthma care according to National Asthma Education and Prevention Program Expert Panel Report 3 guidelines.

Medications were changed as needed, and the asthma action plan was revised accordingly and reviewed with the family at each visit, Dr. Sheikh reported. After a baseline evaluation, clinic visits for the study occurred at 3 months, 6 months, and then at 1, 2, 3, and 4 years.

Out of 471 patients, 258 had pets, and 125 were in homes where smoking took place, according to parent reports.

Asthma control test scores were 15.1 at baseline for children in no-pet households, and 16.5 for those with pets; by the 3-month visit, scores increased to 20.1 and 20.3 for the no-pet and pet groups, and at 4 years, those scores had edged up to 22.2 and 22.7 (P = .371), Dr. Sheikh reported.

Similarly, after care was started, there was no significant difference between the no-pet and pet groups in mean percent of predicted forced expiratory volume in 1 second (FEV₁₎, wheezing, nighttime cough, albuterol use, and other factors over the 4 years of follow-up, he said.

Likewise, looking at the data by nonsmoking vs. smoking households, asthma control test scores at baseline were 16.1 and 15.1, respectively, and at 4 years they were 22.2 and 22.3 (P = .078), with a similar lack of difference in predicted FEV₁, wheezing, and all other factors evaluated.

Getting rid of the family pet may need to be a consideration for some families, but based on these data, that might not be necessary for the majority of families, Dr. Sheikh said in the interview.

“On the other hand, we are not saying that if you are smoking, you should continue to smoke,” he added.

“What we are saying is that smoking is bad, but if your child is not getting better, I don’t want to blame your smoking for it. There may be something else which may be more important than smoking which we are missing – the child may not be getting the medicine, or may not be on the right medicine, or may have other comorbidities.”

Dr. Sheikh and his coinvestigators disclosed that they had no relationships relevant to the study.

SOURCE: Sheikh S et al. CHEST 2018. doi: 10.1016/j.chest.2018.08.666.

SAN ANTONIO – It may not always be necessary to tell parents of children with asthma to get rid of the household pet, a recent study suggests.

Andrew D. Bowser/MDedge News

Children with uncontrolled asthma who were provided with guideline-appropriate care had significant improvements in a variety of asthma measures, regardless of whether parents reported pets or smoking at home, according to results of the 4-year, 471-patient prospective study.

Those results suggest that clinicians should be working to make sure the guidelines are being closely followed before, for example, telling parents they need to consider getting rid of the family pet, said Shahid Sheikh, MD, FCCP, of Nationwide Children’s Hospital, Columbus, Ohio.

“As the guidelines still work, we need to focus and develop the connections with the family to make sure the patients are on the right treatment, and that they’re getting the medications,” Dr. Sheikh said in an interview at the annual meeting of the American College of Chest Physicians.

The prospective cohort study by Dr. Sheikh and his colleagues, presented in a poster session, included children referred to a pediatric asthma center with the diagnosis of uncontrolled asthma. All patients received asthma care according to National Asthma Education and Prevention Program Expert Panel Report 3 guidelines.

Medications were changed as needed, and the asthma action plan was revised accordingly and reviewed with the family at each visit, Dr. Sheikh reported. After a baseline evaluation, clinic visits for the study occurred at 3 months, 6 months, and then at 1, 2, 3, and 4 years.

Out of 471 patients, 258 had pets, and 125 were in homes where smoking took place, according to parent reports.

Asthma control test scores were 15.1 at baseline for children in no-pet households, and 16.5 for those with pets; by the 3-month visit, scores increased to 20.1 and 20.3 for the no-pet and pet groups, and at 4 years, those scores had edged up to 22.2 and 22.7 (P = .371), Dr. Sheikh reported.

Similarly, after care was started, there was no significant difference between the no-pet and pet groups in mean percent of predicted forced expiratory volume in 1 second (FEV₁₎, wheezing, nighttime cough, albuterol use, and other factors over the 4 years of follow-up, he said.

Likewise, looking at the data by nonsmoking vs. smoking households, asthma control test scores at baseline were 16.1 and 15.1, respectively, and at 4 years they were 22.2 and 22.3 (P = .078), with a similar lack of difference in predicted FEV₁, wheezing, and all other factors evaluated.

Getting rid of the family pet may need to be a consideration for some families, but based on these data, that might not be necessary for the majority of families, Dr. Sheikh said in the interview.

“On the other hand, we are not saying that if you are smoking, you should continue to smoke,” he added.

“What we are saying is that smoking is bad, but if your child is not getting better, I don’t want to blame your smoking for it. There may be something else which may be more important than smoking which we are missing – the child may not be getting the medicine, or may not be on the right medicine, or may have other comorbidities.”

Dr. Sheikh and his coinvestigators disclosed that they had no relationships relevant to the study.

SOURCE: Sheikh S et al. CHEST 2018. doi: 10.1016/j.chest.2018.08.666.

SAN ANTONIO – Interventions that address variations in inflammation type and metabolism unique to obese patients with asthma or COPD might prove useful for improving their management, Cherry Wongtrakool, MD, of Emory University, Atlanta, said in a presentation at the annual meeting of the American College of Chest Physicians.

Obese patients with asthma or COPD typically have metabolic and inflammatory profiles that differ from those of nonobese patients with the disorders. Obesity is associated with the development of asthma as well as its severity and the risk for exacerbations. Obese patients with asthma are less likely to have controlled disease or to respond to medication.

The variations in asthma related to obesity even can be traced to infancy for some. Children with rapid weight gain after birth, for example, have an increased risk for developing asthma. In the recently published Boston Birth Cohort study, more than 500 babies from urban, low income families were followed from birth until age 16. Babies with rapid weight gain at 4 months and at 24 months had an increased risk for developing asthma by age 16. Even after adjusting for multiple risk factors, the increased risk for developing asthma persisted in these obese infants.

Higher BMIs during infancy may affect lung development, which continues up to age 5-8 years, Dr. Wongtrakool said. Obesity may affect immune system development. Asthma may develop when persistent inflammation during infancy gets a second hit from genetic factors or from risk factors such as atopy or maternal smoking.

Dr. Wongtrakool noted that obese patients with asthma, unlike nonobese asthma patients, tend to have non-TH2 inflammation. Their TH1/TH2 ratio in stimulated T cells is higher and is directly associated with insulin resistance. Similar to obese patients without asthma, they have higher levels of circulating TNF-alpha, interferon-gamma inducible protein 10, and monocyte chemoattractant protein-1 (MCP-1). They are more likely to have insulin resistance, low high-density lipid levels, differences in gut microbiota, increased leptin, decreased adiponectin, increased asymmetric dimethylarginine, and decreased exhaled nitrous oxide (NO).

In broncheoalveolar lavage samples, obese asthma patients have more cells that secrete interleukin-17, Dr. Wontrakool said. TH17-associated inflammation also has an influence in asthma with obesity. A recent study of 30 obese and lean asthma patients found a difference in metabolites measured in breath samples of obese people with asthma, compared with lean people with asthma and obese people without asthma.

In terms of metabolites in their breath, obese asthma patients clustered together and differed from lean patients with asthma and obese patients without asthma.

Obese people with asthma also differ in their gut microbiota, having more firmicutes species and decreased bacteroides species. Studies in mice indicate that these species have a role in body weight and that altering gut microbiota via fecal transplant was associated with weight loss when obese mice received fecal transplants from lean mice, and vice versa.

In the Supplemental Nutrition in Asthma Control (SNAC) study, preadolescents with asthma were given a nutrition bar designed by researchers at the Children’s Hospital Oakland (Calif.) Research Institute. The children also received asthma education and exercise classes, but the intervention was not designed to reduce weight. FVC and FEV₁ improved in all study participants, but those participants in the low inflammation subgroup had the most pronounced improvements in FVC and FEV₁ after 2 months.

Dr. Wongtrakool called the study “intriguing,” as it indicates asthma patients with lower level inflammation appear more likely to benefit from nutritional supplementation.

In another study of 55 obese adult asthma patients, a hypocaloric diet, access to a nutritionist and psychologist, and exercise classes were associated with improved asthma control and an improved inflammatory and metabolic profile.

In a British registry of the outcomes of bariatric surgery for obesity, patients who also had asthma had a decrease in asthma prevalence in the year after surgery that persisted over 5 years.

The association of COPD with obesity has been less studied than asthma and COPD, but metabolic syndrome appears to be on the rise in these patients. In a study performed over a decade ago, 47% of COPD patients met the definition of metabolic syndrome; a more recent study found 77% of COPD patients met the standard.

Admission glucose levels also have been found to influence the severity of COPD exacerbation. With higher blood glucose levels, there was a higher risk of mortality—from 12% in those with glucose levels of less than 6.0 mmol/l to 31% among those with glucose levels exceeding 9.0 mmol/l, one study showed.

Bariatric surgery may reduce the risk of acute exacerbations of COPD in obese patients, another recent study found. In a study of 480 obese patients with COPD who underwent bariatric surgery, their 28% presurgical risk of acute exacerbations of COPD was cut in half by 12 months after surgery, and the reduction persisted at 24 months.

SAN ANTONIO – Interventions that address variations in inflammation type and metabolism unique to obese patients with asthma or COPD might prove useful for improving their management, Cherry Wongtrakool, MD, of Emory University, Atlanta, said in a presentation at the annual meeting of the American College of Chest Physicians.

Obese patients with asthma or COPD typically have metabolic and inflammatory profiles that differ from those of nonobese patients with the disorders. Obesity is associated with the development of asthma as well as its severity and the risk for exacerbations. Obese patients with asthma are less likely to have controlled disease or to respond to medication.

The variations in asthma related to obesity even can be traced to infancy for some. Children with rapid weight gain after birth, for example, have an increased risk for developing asthma. In the recently published Boston Birth Cohort study, more than 500 babies from urban, low income families were followed from birth until age 16. Babies with rapid weight gain at 4 months and at 24 months had an increased risk for developing asthma by age 16. Even after adjusting for multiple risk factors, the increased risk for developing asthma persisted in these obese infants.

Higher BMIs during infancy may affect lung development, which continues up to age 5-8 years, Dr. Wongtrakool said. Obesity may affect immune system development. Asthma may develop when persistent inflammation during infancy gets a second hit from genetic factors or from risk factors such as atopy or maternal smoking.

Dr. Wongtrakool noted that obese patients with asthma, unlike nonobese asthma patients, tend to have non-TH2 inflammation. Their TH1/TH2 ratio in stimulated T cells is higher and is directly associated with insulin resistance. Similar to obese patients without asthma, they have higher levels of circulating TNF-alpha, interferon-gamma inducible protein 10, and monocyte chemoattractant protein-1 (MCP-1). They are more likely to have insulin resistance, low high-density lipid levels, differences in gut microbiota, increased leptin, decreased adiponectin, increased asymmetric dimethylarginine, and decreased exhaled nitrous oxide (NO).

In broncheoalveolar lavage samples, obese asthma patients have more cells that secrete interleukin-17, Dr. Wontrakool said. TH17-associated inflammation also has an influence in asthma with obesity. A recent study of 30 obese and lean asthma patients found a difference in metabolites measured in breath samples of obese people with asthma, compared with lean people with asthma and obese people without asthma.

In terms of metabolites in their breath, obese asthma patients clustered together and differed from lean patients with asthma and obese patients without asthma.

Obese people with asthma also differ in their gut microbiota, having more firmicutes species and decreased bacteroides species. Studies in mice indicate that these species have a role in body weight and that altering gut microbiota via fecal transplant was associated with weight loss when obese mice received fecal transplants from lean mice, and vice versa.

In the Supplemental Nutrition in Asthma Control (SNAC) study, preadolescents with asthma were given a nutrition bar designed by researchers at the Children’s Hospital Oakland (Calif.) Research Institute. The children also received asthma education and exercise classes, but the intervention was not designed to reduce weight. FVC and FEV₁ improved in all study participants, but those participants in the low inflammation subgroup had the most pronounced improvements in FVC and FEV₁ after 2 months.

Dr. Wongtrakool called the study “intriguing,” as it indicates asthma patients with lower level inflammation appear more likely to benefit from nutritional supplementation.

In another study of 55 obese adult asthma patients, a hypocaloric diet, access to a nutritionist and psychologist, and exercise classes were associated with improved asthma control and an improved inflammatory and metabolic profile.

In a British registry of the outcomes of bariatric surgery for obesity, patients who also had asthma had a decrease in asthma prevalence in the year after surgery that persisted over 5 years.

The association of COPD with obesity has been less studied than asthma and COPD, but metabolic syndrome appears to be on the rise in these patients. In a study performed over a decade ago, 47% of COPD patients met the definition of metabolic syndrome; a more recent study found 77% of COPD patients met the standard.

Admission glucose levels also have been found to influence the severity of COPD exacerbation. With higher blood glucose levels, there was a higher risk of mortality—from 12% in those with glucose levels of less than 6.0 mmol/l to 31% among those with glucose levels exceeding 9.0 mmol/l, one study showed.

Bariatric surgery may reduce the risk of acute exacerbations of COPD in obese patients, another recent study found. In a study of 480 obese patients with COPD who underwent bariatric surgery, their 28% presurgical risk of acute exacerbations of COPD was cut in half by 12 months after surgery, and the reduction persisted at 24 months.

SAN ANTONIO – Interventions that address variations in inflammation type and metabolism unique to obese patients with asthma or COPD might prove useful for improving their management, Cherry Wongtrakool, MD, of Emory University, Atlanta, said in a presentation at the annual meeting of the American College of Chest Physicians.

Obese patients with asthma or COPD typically have metabolic and inflammatory profiles that differ from those of nonobese patients with the disorders. Obesity is associated with the development of asthma as well as its severity and the risk for exacerbations. Obese patients with asthma are less likely to have controlled disease or to respond to medication.

The variations in asthma related to obesity even can be traced to infancy for some. Children with rapid weight gain after birth, for example, have an increased risk for developing asthma. In the recently published Boston Birth Cohort study, more than 500 babies from urban, low income families were followed from birth until age 16. Babies with rapid weight gain at 4 months and at 24 months had an increased risk for developing asthma by age 16. Even after adjusting for multiple risk factors, the increased risk for developing asthma persisted in these obese infants.

Higher BMIs during infancy may affect lung development, which continues up to age 5-8 years, Dr. Wongtrakool said. Obesity may affect immune system development. Asthma may develop when persistent inflammation during infancy gets a second hit from genetic factors or from risk factors such as atopy or maternal smoking.

Dr. Wongtrakool noted that obese patients with asthma, unlike nonobese asthma patients, tend to have non-TH2 inflammation. Their TH1/TH2 ratio in stimulated T cells is higher and is directly associated with insulin resistance. Similar to obese patients without asthma, they have higher levels of circulating TNF-alpha, interferon-gamma inducible protein 10, and monocyte chemoattractant protein-1 (MCP-1). They are more likely to have insulin resistance, low high-density lipid levels, differences in gut microbiota, increased leptin, decreased adiponectin, increased asymmetric dimethylarginine, and decreased exhaled nitrous oxide (NO).

In broncheoalveolar lavage samples, obese asthma patients have more cells that secrete interleukin-17, Dr. Wontrakool said. TH17-associated inflammation also has an influence in asthma with obesity. A recent study of 30 obese and lean asthma patients found a difference in metabolites measured in breath samples of obese people with asthma, compared with lean people with asthma and obese people without asthma.

In terms of metabolites in their breath, obese asthma patients clustered together and differed from lean patients with asthma and obese patients without asthma.

Obese people with asthma also differ in their gut microbiota, having more firmicutes species and decreased bacteroides species. Studies in mice indicate that these species have a role in body weight and that altering gut microbiota via fecal transplant was associated with weight loss when obese mice received fecal transplants from lean mice, and vice versa.

In the Supplemental Nutrition in Asthma Control (SNAC) study, preadolescents with asthma were given a nutrition bar designed by researchers at the Children’s Hospital Oakland (Calif.) Research Institute. The children also received asthma education and exercise classes, but the intervention was not designed to reduce weight. FVC and FEV₁ improved in all study participants, but those participants in the low inflammation subgroup had the most pronounced improvements in FVC and FEV₁ after 2 months.

Dr. Wongtrakool called the study “intriguing,” as it indicates asthma patients with lower level inflammation appear more likely to benefit from nutritional supplementation.

In another study of 55 obese adult asthma patients, a hypocaloric diet, access to a nutritionist and psychologist, and exercise classes were associated with improved asthma control and an improved inflammatory and metabolic profile.

In a British registry of the outcomes of bariatric surgery for obesity, patients who also had asthma had a decrease in asthma prevalence in the year after surgery that persisted over 5 years.

The association of COPD with obesity has been less studied than asthma and COPD, but metabolic syndrome appears to be on the rise in these patients. In a study performed over a decade ago, 47% of COPD patients met the definition of metabolic syndrome; a more recent study found 77% of COPD patients met the standard.

Admission glucose levels also have been found to influence the severity of COPD exacerbation. With higher blood glucose levels, there was a higher risk of mortality—from 12% in those with glucose levels of less than 6.0 mmol/l to 31% among those with glucose levels exceeding 9.0 mmol/l, one study showed.

Bariatric surgery may reduce the risk of acute exacerbations of COPD in obese patients, another recent study found. In a study of 480 obese patients with COPD who underwent bariatric surgery, their 28% presurgical risk of acute exacerbations of COPD was cut in half by 12 months after surgery, and the reduction persisted at 24 months.

Interruptions of patients’ refills for combination inhaled corticosteroid medication caused by the Medicare Part D formulary switch may have resulted in increased exacerbations and hospitalizations, according to a study that will be presented at the CHEST 2018 annual meeting.

Katie Devane, PhD, and her colleagues examined pharmacy records of 44,832 patients aged 12 years and older who had received a combination inhaled corticosteroid (budesonide/formoterol) and a long-acting beta-agonist medication in 2016-2017. They were followed to track their refills, medication switches, and use of other medications such as oral corticosteroids, antibiotics, and rescue inhalers.

After the Medicare Part D formulary switch on Jan. 1, 2017, many of these patients experienced disruption of their refills. About half of the patients attempted to get a refill of their inhaled corticosteroid prescription but only 46% were approved. One-third of the patients studied did not replace their medication, 12% switched to monotherapy, and 17% had no inhaled medication, the study found.

The investigators concluded that the formulary block resulted in many patients going without optimal medication and potentially led to more exacerbations and ER visits.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31877-4/fulltext

The study will be presented in the session Improving Care in COPD, Monday, Oct. 8, 2:15 p.m., Convention Center Room 207A.

Interruptions of patients’ refills for combination inhaled corticosteroid medication caused by the Medicare Part D formulary switch may have resulted in increased exacerbations and hospitalizations, according to a study that will be presented at the CHEST 2018 annual meeting.

Katie Devane, PhD, and her colleagues examined pharmacy records of 44,832 patients aged 12 years and older who had received a combination inhaled corticosteroid (budesonide/formoterol) and a long-acting beta-agonist medication in 2016-2017. They were followed to track their refills, medication switches, and use of other medications such as oral corticosteroids, antibiotics, and rescue inhalers.

After the Medicare Part D formulary switch on Jan. 1, 2017, many of these patients experienced disruption of their refills. About half of the patients attempted to get a refill of their inhaled corticosteroid prescription but only 46% were approved. One-third of the patients studied did not replace their medication, 12% switched to monotherapy, and 17% had no inhaled medication, the study found.

The investigators concluded that the formulary block resulted in many patients going without optimal medication and potentially led to more exacerbations and ER visits.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31877-4/fulltext

The study will be presented in the session Improving Care in COPD, Monday, Oct. 8, 2:15 p.m., Convention Center Room 207A.

Interruptions of patients’ refills for combination inhaled corticosteroid medication caused by the Medicare Part D formulary switch may have resulted in increased exacerbations and hospitalizations, according to a study that will be presented at the CHEST 2018 annual meeting.

Katie Devane, PhD, and her colleagues examined pharmacy records of 44,832 patients aged 12 years and older who had received a combination inhaled corticosteroid (budesonide/formoterol) and a long-acting beta-agonist medication in 2016-2017. They were followed to track their refills, medication switches, and use of other medications such as oral corticosteroids, antibiotics, and rescue inhalers.

After the Medicare Part D formulary switch on Jan. 1, 2017, many of these patients experienced disruption of their refills. About half of the patients attempted to get a refill of their inhaled corticosteroid prescription but only 46% were approved. One-third of the patients studied did not replace their medication, 12% switched to monotherapy, and 17% had no inhaled medication, the study found.

The investigators concluded that the formulary block resulted in many patients going without optimal medication and potentially led to more exacerbations and ER visits.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31877-4/fulltext

The study will be presented in the session Improving Care in COPD, Monday, Oct. 8, 2:15 p.m., Convention Center Room 207A.

Children with asthma who are provided with care and medication per National Asthma Education and Prevention Program guidelines can improve over time, despite the presence of environmental factors such as second-hand tobacco smoke and domestic pets, according to a study presented at the CHEST 2018 annual meeting.

A study conducted at the Nationwide Children’s Hospital in Columbus, Ohio, included 395 children aged 2-17 years with a diagnosis of uncontrolled asthma. These children were then treated using the NAEPP guidelines for acute care needs and symptom control. In this sample of patients, 25% were exposed to second-hand smoke, and 55% had a cat or dog in the home.

The investigators followed these patients and observed improvement of symptoms. But in a comparison of those with and without the potentially problematic environmental factors, improvement was independent of the presence of these factors. The findings suggest that NAEPP-recommended treatment of asthma is more important than are some environmental factors.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31862-2/fulltext.

The findings will be presented in the session on Obstructive Lung Diseases, Wednesday, Oct. 10, at 1:00 p.m.
 

Children with asthma who are provided with care and medication per National Asthma Education and Prevention Program guidelines can improve over time, despite the presence of environmental factors such as second-hand tobacco smoke and domestic pets, according to a study presented at the CHEST 2018 annual meeting.

A study conducted at the Nationwide Children’s Hospital in Columbus, Ohio, included 395 children aged 2-17 years with a diagnosis of uncontrolled asthma. These children were then treated using the NAEPP guidelines for acute care needs and symptom control. In this sample of patients, 25% were exposed to second-hand smoke, and 55% had a cat or dog in the home.

The investigators followed these patients and observed improvement of symptoms. But in a comparison of those with and without the potentially problematic environmental factors, improvement was independent of the presence of these factors. The findings suggest that NAEPP-recommended treatment of asthma is more important than are some environmental factors.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31862-2/fulltext.

The findings will be presented in the session on Obstructive Lung Diseases, Wednesday, Oct. 10, at 1:00 p.m.
 

Children with asthma who are provided with care and medication per National Asthma Education and Prevention Program guidelines can improve over time, despite the presence of environmental factors such as second-hand tobacco smoke and domestic pets, according to a study presented at the CHEST 2018 annual meeting.

A study conducted at the Nationwide Children’s Hospital in Columbus, Ohio, included 395 children aged 2-17 years with a diagnosis of uncontrolled asthma. These children were then treated using the NAEPP guidelines for acute care needs and symptom control. In this sample of patients, 25% were exposed to second-hand smoke, and 55% had a cat or dog in the home.

The investigators followed these patients and observed improvement of symptoms. But in a comparison of those with and without the potentially problematic environmental factors, improvement was independent of the presence of these factors. The findings suggest that NAEPP-recommended treatment of asthma is more important than are some environmental factors.

View the study abstract here: https://journal.chestnet.org/article/S0012-3692(18)31862-2/fulltext.

The findings will be presented in the session on Obstructive Lung Diseases, Wednesday, Oct. 10, at 1:00 p.m.
 

PARIS – A global registry to track the safety and efficacy of bronchial thermoplasty for the treatment of severe asthma shows benefits comparable to those previously reported in randomized trials, according to 1-year results presented at the annual congress of the European Respiratory Society.

Ted Bosworth/MDedge News

Bronchothermoplasty has been Food and Drug Administration approved since 2010, but joint 2014 guidelines from the ERS and the American Thoracic Society (ATS) recommended that this procedure be restricted to patients participating in a registry, making these findings an important part of an ongoing assessment, according to Alfons Torrego Fernández, MD, of the pulmonology service at Hospital de la Santa Creu i Sant Pau, Barcelona.

The BT Global Registry (BTGR), created at the end of 2014, involves 18 centers in Europe, South Africa, and Australia. Dr. Fernandez provided data on 123 of the 157 patients enrolled by the end of 2016. All had at least 1 year of follow-up.

Compared with the year prior to bronchial thermoplasty, the proportion of patients with severe exacerbations in the year following this procedure fell from 90.3% to 59.6%, a 34% reduction (P less than .001). The proportion of patients requiring oral corticosteroids fell from 47.8% to 23.5%, a reduction of more than 50%.

Relative to the year prior to bronchial thermoplasty, “there was also a reduction in emergency room visits [21.1% vs. 54.6%] and hospitalizations [20.2% vs. 43%] as well as a reduction in the need for asthma maintenance medications,” Dr. Fernandez reported.

On the Asthma Control Questionnaire (ACQ), quality of life (QOL) was improved on average by 1.2 points from the prior year (4.48 vs. 3.26; P less than .05), according to Dr. Fernandez. The proportion of patients who achieved at least a 0.5-point increase in the ACQ, a level that Dr. Fernandez said is considered clinically relevant, was 67.1%.

However, when lung function measures such as forced expiratory volume in one second and fractional exhaled nitric oxide taken 1 year after bronchothermoplasty were compared with the same measures taken prior to this treatment, there was no significant improvement, according to Dr. Fernandez.

Bronchial thermoplasty involves the use of thermal energy delivered through a bronchoscope to reduce airway smooth muscle mass, thereby eliminating a source of airway restriction. Although nearly 70% of severe asthma patients in this BTGR derived an improvement in quality of life, 30% did not. Asked if the registry has provided any insight about who does or does not respond, Dr. Fernandez acknowledged that this is “the key question,” but added that “no specific profile or biomarker” has yet been identified.

“These are early results, but a 2-year follow-up is planned,” he said.

Although the technical aspects of bronchial thermoplasty “are quite well standardized,” Dr. Fernandez acknowledged that there might be a learning curve that favors experienced operators. He reported that outcomes between high- and low-volume centers in BTGR have not yet been compared. However, he maintained that “these results in real-life patients confirm that severe asthma patients can benefit” from this therapy as shown previously in sham-controlled trials.

Dr. Fernandez reported having no conflicts of interest. The registry is funded by Boston Scientific.
 

PARIS – A global registry to track the safety and efficacy of bronchial thermoplasty for the treatment of severe asthma shows benefits comparable to those previously reported in randomized trials, according to 1-year results presented at the annual congress of the European Respiratory Society.

Ted Bosworth/MDedge News

Bronchothermoplasty has been Food and Drug Administration approved since 2010, but joint 2014 guidelines from the ERS and the American Thoracic Society (ATS) recommended that this procedure be restricted to patients participating in a registry, making these findings an important part of an ongoing assessment, according to Alfons Torrego Fernández, MD, of the pulmonology service at Hospital de la Santa Creu i Sant Pau, Barcelona.

The BT Global Registry (BTGR), created at the end of 2014, involves 18 centers in Europe, South Africa, and Australia. Dr. Fernandez provided data on 123 of the 157 patients enrolled by the end of 2016. All had at least 1 year of follow-up.

Compared with the year prior to bronchial thermoplasty, the proportion of patients with severe exacerbations in the year following this procedure fell from 90.3% to 59.6%, a 34% reduction (P less than .001). The proportion of patients requiring oral corticosteroids fell from 47.8% to 23.5%, a reduction of more than 50%.

Relative to the year prior to bronchial thermoplasty, “there was also a reduction in emergency room visits [21.1% vs. 54.6%] and hospitalizations [20.2% vs. 43%] as well as a reduction in the need for asthma maintenance medications,” Dr. Fernandez reported.

On the Asthma Control Questionnaire (ACQ), quality of life (QOL) was improved on average by 1.2 points from the prior year (4.48 vs. 3.26; P less than .05), according to Dr. Fernandez. The proportion of patients who achieved at least a 0.5-point increase in the ACQ, a level that Dr. Fernandez said is considered clinically relevant, was 67.1%.

However, when lung function measures such as forced expiratory volume in one second and fractional exhaled nitric oxide taken 1 year after bronchothermoplasty were compared with the same measures taken prior to this treatment, there was no significant improvement, according to Dr. Fernandez.

Bronchial thermoplasty involves the use of thermal energy delivered through a bronchoscope to reduce airway smooth muscle mass, thereby eliminating a source of airway restriction. Although nearly 70% of severe asthma patients in this BTGR derived an improvement in quality of life, 30% did not. Asked if the registry has provided any insight about who does or does not respond, Dr. Fernandez acknowledged that this is “the key question,” but added that “no specific profile or biomarker” has yet been identified.

“These are early results, but a 2-year follow-up is planned,” he said.

Although the technical aspects of bronchial thermoplasty “are quite well standardized,” Dr. Fernandez acknowledged that there might be a learning curve that favors experienced operators. He reported that outcomes between high- and low-volume centers in BTGR have not yet been compared. However, he maintained that “these results in real-life patients confirm that severe asthma patients can benefit” from this therapy as shown previously in sham-controlled trials.

Dr. Fernandez reported having no conflicts of interest. The registry is funded by Boston Scientific.
 

PARIS – A global registry to track the safety and efficacy of bronchial thermoplasty for the treatment of severe asthma shows benefits comparable to those previously reported in randomized trials, according to 1-year results presented at the annual congress of the European Respiratory Society.

Ted Bosworth/MDedge News

Bronchothermoplasty has been Food and Drug Administration approved since 2010, but joint 2014 guidelines from the ERS and the American Thoracic Society (ATS) recommended that this procedure be restricted to patients participating in a registry, making these findings an important part of an ongoing assessment, according to Alfons Torrego Fernández, MD, of the pulmonology service at Hospital de la Santa Creu i Sant Pau, Barcelona.

The BT Global Registry (BTGR), created at the end of 2014, involves 18 centers in Europe, South Africa, and Australia. Dr. Fernandez provided data on 123 of the 157 patients enrolled by the end of 2016. All had at least 1 year of follow-up.

Compared with the year prior to bronchial thermoplasty, the proportion of patients with severe exacerbations in the year following this procedure fell from 90.3% to 59.6%, a 34% reduction (P less than .001). The proportion of patients requiring oral corticosteroids fell from 47.8% to 23.5%, a reduction of more than 50%.

Relative to the year prior to bronchial thermoplasty, “there was also a reduction in emergency room visits [21.1% vs. 54.6%] and hospitalizations [20.2% vs. 43%] as well as a reduction in the need for asthma maintenance medications,” Dr. Fernandez reported.

On the Asthma Control Questionnaire (ACQ), quality of life (QOL) was improved on average by 1.2 points from the prior year (4.48 vs. 3.26; P less than .05), according to Dr. Fernandez. The proportion of patients who achieved at least a 0.5-point increase in the ACQ, a level that Dr. Fernandez said is considered clinically relevant, was 67.1%.

However, when lung function measures such as forced expiratory volume in one second and fractional exhaled nitric oxide taken 1 year after bronchothermoplasty were compared with the same measures taken prior to this treatment, there was no significant improvement, according to Dr. Fernandez.

Bronchial thermoplasty involves the use of thermal energy delivered through a bronchoscope to reduce airway smooth muscle mass, thereby eliminating a source of airway restriction. Although nearly 70% of severe asthma patients in this BTGR derived an improvement in quality of life, 30% did not. Asked if the registry has provided any insight about who does or does not respond, Dr. Fernandez acknowledged that this is “the key question,” but added that “no specific profile or biomarker” has yet been identified.

“These are early results, but a 2-year follow-up is planned,” he said.

Although the technical aspects of bronchial thermoplasty “are quite well standardized,” Dr. Fernandez acknowledged that there might be a learning curve that favors experienced operators. He reported that outcomes between high- and low-volume centers in BTGR have not yet been compared. However, he maintained that “these results in real-life patients confirm that severe asthma patients can benefit” from this therapy as shown previously in sham-controlled trials.

Dr. Fernandez reported having no conflicts of interest. The registry is funded by Boston Scientific.
 

PARIS – Severe asthma patients with chronic rhinosinusitis (CRS), nasal polyposis (NP), or both derive more protection from severe exacerbations with the monoclonal antibody dupilumab than do those who do not have these comorbidities, according to a post hoc analysis of a phase 3 trial presented at the annual congress of the European Respiratory Society.

Ted Bosworth/MDedge News

“Dupilumab reduced rates of severe exacerbations and improved FEV₁ [forced expiratory volume in 1 second] in patients in asthma patients with or without CRS/NP. In those with CRS/NP, dupilumab reduced symptoms associated with these comorbidities,” reported Ian Pavord, MBBS, statutory chair in respiratory medicine at University of Oxford (England).

The data were drawn from the phase 3 Liberty Asthma Quest trial, which was published earlier this year in the New England Journal of Medicine (2018;378:2486-96). In that study, both the 200-mg and 300-mg dose of dupilumab (Dupixent) administered every 2 weeks was associated with about a 50% reduction in the annualized rate of severe exacerbations relative to placebo (P less than .001 for both doses).

In this new post hoc analysis, response in the 382 patients who entered the study with a history of CRS/NP was compared with the 1,520 without CRS/NP. In the CRS/NP patients, the reductions relative to placebo in the rates of severe exacerbations, defined as 3 or more days of systemic glucocorticoids or visit to an emergency department leading to treatment with systemic glucocorticoids, were 63% and 61% for the 200-mg and 300-mg doses of dupilumab, respectively (both P less than .001).

In the non-CRS/NP arms, the reductions relative to placebo were 42% and 40%, respectively (both P less than .001). The greater relative reductions in the CRS/NP patients were achieved even though they were older (mean age approximately 52 vs. 47 years for non-CRS/NP patients), had a significantly greater number of exacerbations in the past year (P = .027), and had higher baseline fractional exhaled nitric oxide and eosinophil levels (both P less than .001), Dr. Pavord reported.

“The greater asthma severity in the CRS/NP patients in this trial is consistent with that reported previously by others,” Dr. Pavord said.

Although the greater asthma severity may have provided a larger margin for benefit, Dr. Pavord also reported that there were improvements in CRS/NP-specific symptoms as measured with the 22-item Sino-Nasal Outcome Test (SNOT-22). By week 12, the total score reduction in SNOT-22 was approximately 15 points (P less than .05) from baseline for both the 200-mg and 300-mg dupilumab doses. This was significantly greater (P less than .05) relative to modest SNOT-22 reductions in the placebo arms (P less than .05). After 52 weeks, the reduction In SNOT-22 scores were sustained, providing an even greater statistical advantage over placebo (P less than .001).

In addition to greater protection against severe exacerbations and CRS/NP-specific symptoms, dupilumab may offer specific improvements on CRS/NP pathology, according to Dr. Pavord. Although imaging was not part of this study, he noted in particular that previous studies with dupilumab as well as other biologics have shown shrinkage of nasal polyps with treatment.

Dupilumab was similarly well tolerated in those with and without CRS/NP. The most common adverse event was injection site reactions in both groups, Dr. Pavord said.

Calling CRS and NP “important comorbidities” in severe asthma patients, Dr. Pavord said that this analysis should be reassuring for those who with CRS/NP who are being considered for dupilumab. Already approved for treatment of atopic dermatitis, dupilumab, which binds to interleukin-4 (IL-4) and IL-13 receptors, is currently under review for the treatment of moderate to severe asthma.

Dr. Pavord has financial relationships with Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Knapp, Merck Sharpe, Novartis, Knapp Teva, RespiVert, and Schering-Plough.

PARIS – Severe asthma patients with chronic rhinosinusitis (CRS), nasal polyposis (NP), or both derive more protection from severe exacerbations with the monoclonal antibody dupilumab than do those who do not have these comorbidities, according to a post hoc analysis of a phase 3 trial presented at the annual congress of the European Respiratory Society.

Ted Bosworth/MDedge News

“Dupilumab reduced rates of severe exacerbations and improved FEV₁ [forced expiratory volume in 1 second] in patients in asthma patients with or without CRS/NP. In those with CRS/NP, dupilumab reduced symptoms associated with these comorbidities,” reported Ian Pavord, MBBS, statutory chair in respiratory medicine at University of Oxford (England).

The data were drawn from the phase 3 Liberty Asthma Quest trial, which was published earlier this year in the New England Journal of Medicine (2018;378:2486-96). In that study, both the 200-mg and 300-mg dose of dupilumab (Dupixent) administered every 2 weeks was associated with about a 50% reduction in the annualized rate of severe exacerbations relative to placebo (P less than .001 for both doses).

In this new post hoc analysis, response in the 382 patients who entered the study with a history of CRS/NP was compared with the 1,520 without CRS/NP. In the CRS/NP patients, the reductions relative to placebo in the rates of severe exacerbations, defined as 3 or more days of systemic glucocorticoids or visit to an emergency department leading to treatment with systemic glucocorticoids, were 63% and 61% for the 200-mg and 300-mg doses of dupilumab, respectively (both P less than .001).

In the non-CRS/NP arms, the reductions relative to placebo were 42% and 40%, respectively (both P less than .001). The greater relative reductions in the CRS/NP patients were achieved even though they were older (mean age approximately 52 vs. 47 years for non-CRS/NP patients), had a significantly greater number of exacerbations in the past year (P = .027), and had higher baseline fractional exhaled nitric oxide and eosinophil levels (both P less than .001), Dr. Pavord reported.

“The greater asthma severity in the CRS/NP patients in this trial is consistent with that reported previously by others,” Dr. Pavord said.

Although the greater asthma severity may have provided a larger margin for benefit, Dr. Pavord also reported that there were improvements in CRS/NP-specific symptoms as measured with the 22-item Sino-Nasal Outcome Test (SNOT-22). By week 12, the total score reduction in SNOT-22 was approximately 15 points (P less than .05) from baseline for both the 200-mg and 300-mg dupilumab doses. This was significantly greater (P less than .05) relative to modest SNOT-22 reductions in the placebo arms (P less than .05). After 52 weeks, the reduction In SNOT-22 scores were sustained, providing an even greater statistical advantage over placebo (P less than .001).

In addition to greater protection against severe exacerbations and CRS/NP-specific symptoms, dupilumab may offer specific improvements on CRS/NP pathology, according to Dr. Pavord. Although imaging was not part of this study, he noted in particular that previous studies with dupilumab as well as other biologics have shown shrinkage of nasal polyps with treatment.

Dupilumab was similarly well tolerated in those with and without CRS/NP. The most common adverse event was injection site reactions in both groups, Dr. Pavord said.

Calling CRS and NP “important comorbidities” in severe asthma patients, Dr. Pavord said that this analysis should be reassuring for those who with CRS/NP who are being considered for dupilumab. Already approved for treatment of atopic dermatitis, dupilumab, which binds to interleukin-4 (IL-4) and IL-13 receptors, is currently under review for the treatment of moderate to severe asthma.

Dr. Pavord has financial relationships with Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Knapp, Merck Sharpe, Novartis, Knapp Teva, RespiVert, and Schering-Plough.

PARIS – Severe asthma patients with chronic rhinosinusitis (CRS), nasal polyposis (NP), or both derive more protection from severe exacerbations with the monoclonal antibody dupilumab than do those who do not have these comorbidities, according to a post hoc analysis of a phase 3 trial presented at the annual congress of the European Respiratory Society.

Ted Bosworth/MDedge News

“Dupilumab reduced rates of severe exacerbations and improved FEV₁ [forced expiratory volume in 1 second] in patients in asthma patients with or without CRS/NP. In those with CRS/NP, dupilumab reduced symptoms associated with these comorbidities,” reported Ian Pavord, MBBS, statutory chair in respiratory medicine at University of Oxford (England).

The data were drawn from the phase 3 Liberty Asthma Quest trial, which was published earlier this year in the New England Journal of Medicine (2018;378:2486-96). In that study, both the 200-mg and 300-mg dose of dupilumab (Dupixent) administered every 2 weeks was associated with about a 50% reduction in the annualized rate of severe exacerbations relative to placebo (P less than .001 for both doses).

In this new post hoc analysis, response in the 382 patients who entered the study with a history of CRS/NP was compared with the 1,520 without CRS/NP. In the CRS/NP patients, the reductions relative to placebo in the rates of severe exacerbations, defined as 3 or more days of systemic glucocorticoids or visit to an emergency department leading to treatment with systemic glucocorticoids, were 63% and 61% for the 200-mg and 300-mg doses of dupilumab, respectively (both P less than .001).

In the non-CRS/NP arms, the reductions relative to placebo were 42% and 40%, respectively (both P less than .001). The greater relative reductions in the CRS/NP patients were achieved even though they were older (mean age approximately 52 vs. 47 years for non-CRS/NP patients), had a significantly greater number of exacerbations in the past year (P = .027), and had higher baseline fractional exhaled nitric oxide and eosinophil levels (both P less than .001), Dr. Pavord reported.

“The greater asthma severity in the CRS/NP patients in this trial is consistent with that reported previously by others,” Dr. Pavord said.

Although the greater asthma severity may have provided a larger margin for benefit, Dr. Pavord also reported that there were improvements in CRS/NP-specific symptoms as measured with the 22-item Sino-Nasal Outcome Test (SNOT-22). By week 12, the total score reduction in SNOT-22 was approximately 15 points (P less than .05) from baseline for both the 200-mg and 300-mg dupilumab doses. This was significantly greater (P less than .05) relative to modest SNOT-22 reductions in the placebo arms (P less than .05). After 52 weeks, the reduction In SNOT-22 scores were sustained, providing an even greater statistical advantage over placebo (P less than .001).

In addition to greater protection against severe exacerbations and CRS/NP-specific symptoms, dupilumab may offer specific improvements on CRS/NP pathology, according to Dr. Pavord. Although imaging was not part of this study, he noted in particular that previous studies with dupilumab as well as other biologics have shown shrinkage of nasal polyps with treatment.

Dupilumab was similarly well tolerated in those with and without CRS/NP. The most common adverse event was injection site reactions in both groups, Dr. Pavord said.

Calling CRS and NP “important comorbidities” in severe asthma patients, Dr. Pavord said that this analysis should be reassuring for those who with CRS/NP who are being considered for dupilumab. Already approved for treatment of atopic dermatitis, dupilumab, which binds to interleukin-4 (IL-4) and IL-13 receptors, is currently under review for the treatment of moderate to severe asthma.

Dr. Pavord has financial relationships with Aerocrine, Almirall, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Knapp, Merck Sharpe, Novartis, Knapp Teva, RespiVert, and Schering-Plough.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

The prevalence of pediatric asthma is lowest in Oregon and highest in Alabama, according to estimates from the American Lung Association.

Oregon’s rate comes in at 557 per 10,000 population under the age of 18 years, just ahead of Montana at 574 per 10,000 and Iowa at 577. The prevalence of pediatric asthma in Alabama is 1,315 per 10,000, with North Carolina (1,149), Connecticut (1,107), Hawaii (1,026), and New York (1,005) joining it as members of the over-1,000 club. (MDedge News used the ALA’s estimates for persons under age 18 years with asthma in each state and Census Bureau estimates for population to calculate an unadjusted rate for each state.)

The ALA analysis was based on data from the Behavioral Risk Factor Behavioral System surveys for 2016 (31 states), 2015 (District of Columbia, Louisiana, New Hampshire, Texas), 2014 (Alabama, Maryland, North Carolina, Tennessee, West Virginia), 2012 (North Dakota and Wyoming), and 2011 (Iowa). National data were used for eight states (Alaska, Arkansas, Colorado, Delaware, Idaho, South Carolina, South Dakota, Virginia) that had no data available.

[email protected]

The prevalence of pediatric asthma is lowest in Oregon and highest in Alabama, according to estimates from the American Lung Association.

Oregon’s rate comes in at 557 per 10,000 population under the age of 18 years, just ahead of Montana at 574 per 10,000 and Iowa at 577. The prevalence of pediatric asthma in Alabama is 1,315 per 10,000, with North Carolina (1,149), Connecticut (1,107), Hawaii (1,026), and New York (1,005) joining it as members of the over-1,000 club. (MDedge News used the ALA’s estimates for persons under age 18 years with asthma in each state and Census Bureau estimates for population to calculate an unadjusted rate for each state.)

The ALA analysis was based on data from the Behavioral Risk Factor Behavioral System surveys for 2016 (31 states), 2015 (District of Columbia, Louisiana, New Hampshire, Texas), 2014 (Alabama, Maryland, North Carolina, Tennessee, West Virginia), 2012 (North Dakota and Wyoming), and 2011 (Iowa). National data were used for eight states (Alaska, Arkansas, Colorado, Delaware, Idaho, South Carolina, South Dakota, Virginia) that had no data available.

[email protected]

The prevalence of pediatric asthma is lowest in Oregon and highest in Alabama, according to estimates from the American Lung Association.

Oregon’s rate comes in at 557 per 10,000 population under the age of 18 years, just ahead of Montana at 574 per 10,000 and Iowa at 577. The prevalence of pediatric asthma in Alabama is 1,315 per 10,000, with North Carolina (1,149), Connecticut (1,107), Hawaii (1,026), and New York (1,005) joining it as members of the over-1,000 club. (MDedge News used the ALA’s estimates for persons under age 18 years with asthma in each state and Census Bureau estimates for population to calculate an unadjusted rate for each state.)

The ALA analysis was based on data from the Behavioral Risk Factor Behavioral System surveys for 2016 (31 states), 2015 (District of Columbia, Louisiana, New Hampshire, Texas), 2014 (Alabama, Maryland, North Carolina, Tennessee, West Virginia), 2012 (North Dakota and Wyoming), and 2011 (Iowa). National data were used for eight states (Alaska, Arkansas, Colorado, Delaware, Idaho, South Carolina, South Dakota, Virginia) that had no data available.

[email protected]

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.

Click here to read the supplement.

What can be done to address the burden of asthma beyond pharmacotherapy? A panel of experts discuss steps for addressing sensitization to allergens that trigger increased asthma burden.

Topics Include:

• Identifying Patients with Allergic Components of Asthma
• Identifying and Addressing Allergen Exposure in Daily Practice
• The Opportunity for Payers and Health Systems for Supporting Trigger Avoidance Education

Click here to read the supplement.