Pulmonary Health Hub

Atopic dermatitis (AD) is associated with an increased risk for attention-deficit/hyperactivity disorder (ADHD) in children and adults, and a host of factors and comorbid conditions increase this risk, according to a study published in the British Journal of Dermatology.

Mark A. Strom and his associates at Northwestern University in Chicago examined data from 19 U.S. population-based surveys on 354,416 children ages 2-17 years and 34,613 adults over the age of 18 to determine if childhood and adult AD and the severity of AD were associated with ADHD. Additionally, the investigators sought to identify factors contributing to this association (Br J Dermatol. 2016 Apr 23. doi: 10.1111/bjd.14697).

©Thinglass/Thinkstock

The prevalence of ADHD was 9.4% in children with AD and 7.1% in children without AD. For children, the study results obtained from multivariate models adjusting for age, sex, sociodemographic variables, allergic disease, and health care utilization confirmed the previously established increase in risk for ADHD in those with AD for an adjusted odds ratio of 1.14. Severe AD and sleep disturbance were found to independently and synergistically contribute to the increased risk of ADHD. Also, the presence of AD in the absence of other allergic disease was associated with an increased risk for ADHD. Obesity, headaches, and anemia were found to further increase the risk for ADHD in those with AD.

Results from the adjusted multivariate models also established an increased risk for ADHD among adults with AD, for an adjusted odds ratio of 1.61. The presence of asthma, headaches, and insomnia increased this risk. The analysis additionally revealed that a body mass index indicative of underweight status in adults with AD was protective against the risk for developing ADHD.

Mr. Strom and his associates found a significant decrease in their initial odds ratios when they added outpatient health care visitation to their multivariate models, which resulted in an overall pooled odds ratio for the relationship between AD and ADHD just above statistical significance. They speculated that children with AD or ADHD would be more likely to visit health care providers, which could increase the likelihood for diagnosis of comorbid conditions.

Funding was provided by the Agency for Healthcare Research and Quality and the Dermatology Foundation. The authors reported no conflicts of interest.

[email protected]

Atopic dermatitis (AD) is associated with an increased risk for attention-deficit/hyperactivity disorder (ADHD) in children and adults, and a host of factors and comorbid conditions increase this risk, according to a study published in the British Journal of Dermatology.

Mark A. Strom and his associates at Northwestern University in Chicago examined data from 19 U.S. population-based surveys on 354,416 children ages 2-17 years and 34,613 adults over the age of 18 to determine if childhood and adult AD and the severity of AD were associated with ADHD. Additionally, the investigators sought to identify factors contributing to this association (Br J Dermatol. 2016 Apr 23. doi: 10.1111/bjd.14697).

©Thinglass/Thinkstock

The prevalence of ADHD was 9.4% in children with AD and 7.1% in children without AD. For children, the study results obtained from multivariate models adjusting for age, sex, sociodemographic variables, allergic disease, and health care utilization confirmed the previously established increase in risk for ADHD in those with AD for an adjusted odds ratio of 1.14. Severe AD and sleep disturbance were found to independently and synergistically contribute to the increased risk of ADHD. Also, the presence of AD in the absence of other allergic disease was associated with an increased risk for ADHD. Obesity, headaches, and anemia were found to further increase the risk for ADHD in those with AD.

Results from the adjusted multivariate models also established an increased risk for ADHD among adults with AD, for an adjusted odds ratio of 1.61. The presence of asthma, headaches, and insomnia increased this risk. The analysis additionally revealed that a body mass index indicative of underweight status in adults with AD was protective against the risk for developing ADHD.

Mr. Strom and his associates found a significant decrease in their initial odds ratios when they added outpatient health care visitation to their multivariate models, which resulted in an overall pooled odds ratio for the relationship between AD and ADHD just above statistical significance. They speculated that children with AD or ADHD would be more likely to visit health care providers, which could increase the likelihood for diagnosis of comorbid conditions.

Funding was provided by the Agency for Healthcare Research and Quality and the Dermatology Foundation. The authors reported no conflicts of interest.

[email protected]

Atopic dermatitis (AD) is associated with an increased risk for attention-deficit/hyperactivity disorder (ADHD) in children and adults, and a host of factors and comorbid conditions increase this risk, according to a study published in the British Journal of Dermatology.

Mark A. Strom and his associates at Northwestern University in Chicago examined data from 19 U.S. population-based surveys on 354,416 children ages 2-17 years and 34,613 adults over the age of 18 to determine if childhood and adult AD and the severity of AD were associated with ADHD. Additionally, the investigators sought to identify factors contributing to this association (Br J Dermatol. 2016 Apr 23. doi: 10.1111/bjd.14697).

©Thinglass/Thinkstock

The prevalence of ADHD was 9.4% in children with AD and 7.1% in children without AD. For children, the study results obtained from multivariate models adjusting for age, sex, sociodemographic variables, allergic disease, and health care utilization confirmed the previously established increase in risk for ADHD in those with AD for an adjusted odds ratio of 1.14. Severe AD and sleep disturbance were found to independently and synergistically contribute to the increased risk of ADHD. Also, the presence of AD in the absence of other allergic disease was associated with an increased risk for ADHD. Obesity, headaches, and anemia were found to further increase the risk for ADHD in those with AD.

Results from the adjusted multivariate models also established an increased risk for ADHD among adults with AD, for an adjusted odds ratio of 1.61. The presence of asthma, headaches, and insomnia increased this risk. The analysis additionally revealed that a body mass index indicative of underweight status in adults with AD was protective against the risk for developing ADHD.

Mr. Strom and his associates found a significant decrease in their initial odds ratios when they added outpatient health care visitation to their multivariate models, which resulted in an overall pooled odds ratio for the relationship between AD and ADHD just above statistical significance. They speculated that children with AD or ADHD would be more likely to visit health care providers, which could increase the likelihood for diagnosis of comorbid conditions.

Funding was provided by the Agency for Healthcare Research and Quality and the Dermatology Foundation. The authors reported no conflicts of interest.

[email protected]

Patient age contributes to significant differences in the characteristics and etiology of pulmonary arterial hypertension seen in randomized, controlled trials, including more frequent connective tissue disease–associated disease in older patients, according to a post-hoc analysis of trials.

Additionally, older age was associated with worse baseline functional status, worse outcomes in the 6-minute walk distance, and an overall reduced response to treatment, while hemodynamic severity was higher in younger patients.

“Although registry data have shown that idiopathic PAH [pulmonary arterial hypertension] is increasingly recognized in older populations, our analysis shows that idiopathic etiology was less frequent in the older group. In contrast, CTD [connective tissue disease]–associated PAH accounted for a higher proportion of PAH etiology in the oldest age group,” wrote Jonathan A. Rose of Case Western Reserve University, Cleveland, and his colleagues (Chest. 2016;149[5]:1234-44. doi: 10.1016/j.chest.2015.11.008).

The researchers analyzed seven multicenter, randomized, double-blind, placebo-controlled treatment trials for PAH conducted by United Therapeutics and one open-label extension study that involved following patients being treated with subcutaneous treprostinil for 4 additional years. Data from the open-label extension trial and one of the trials were combined and reported as one trial. All trials excluded patients with a history of left-sided heart disease, pulmonary artery wedge pressure (PAWP) greater than 15 mmHg, or pulmonary vascular resistance (PVR) less than 3 Woods units. The researchers categorized the 2,627 patients included in the trials in the following three age groups: 50 years or younger, 51-64 years, and 65 years or older.

Between 53% and 74% of patients in all trials across all age groups had idiopathic PAH, but older patients comprised a significantly smaller proportion of the patients with idiopathic PAH in three of the trials (P = .004) and a significantly higher percentage of the patients with CTD-associated PAH in all of the trials (P less than .001). Across the trials, CTD-associated PAH occurred in 15%-21% of patients 50 years or younger, 25%-40% of those aged 51-64 years, and 27%-49% of those aged 65 years or older.

From baseline to the end in three of the studies, a smaller change in the 6-minute walk distance was seen in older patients and a higher proportion of older patients had an overall decrease in total 6-minute walk distance. Older age remained associated with this outcome measure when only data from treatment-naive patients or the subgroup of patients with CTD-associated PAH were included.

The association between age and lower baseline functional status was observed in four of the trials; A lower proportion of patients in the oldest age group were classified as being of the World Health Organization functional classes I and II, with 9%-32% of patients aged 65 years or older, 10%-33% in those aged 51-64 years, and 16%-43% of those aged 50 years or younger.

Hemodynamic severity was among the areas in which older patients performed better than younger patients, with the oldest age group having lower baseline mean pulmonary artery pressure (mPAP) and PVR in the two trials that measured hemodynamics.

“The difference in the clinical function and hemodynamics in older patients may reflect different mechanisms of disease. Older patients may have diminished cardiopulmonary reserve, and similar degrees of hemodynamic severity manifest with a larger functional impairment. Alternatively, additional comorbidities in older patients may contribute to a larger extent, and clinical function may not be as directly related to hemodynamic severity,” according to the researchers.

Mortality was generally small in these studies and not significantly different among age groups, except for in the open-label extension study of Subcutaneous Infusion of Treprostinil in Patients with PAH (SC-TRE) and the Study of Intravenous Remodulin in Patients in India with PAH (TRUST) trials, which were combined and reported on as one trial (P = .0004).

Nausea was the only adverse effect found to be associated with age in more than one trial, and the relationship between it and age in two trials were inconsistent. While a higher incidence of nausea was found in the oldest age group in the Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (FREEDOM-M) trial (P = .03), a lower incidence of nausea was found in the oldest age group in the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) trial (P = .02).

The analysis was supported by a grant from the National Institutes of Health. Two of the authors, Jody M. Cleveland and Youlan Rao, Ph.D., reported being employees of United Therapeutics, while Dr. Omar A. Minai, another author of the report, serves on the scientific advisory board of United Therapeutics. The other authors declared no conflicts.

[email protected]

Patient age contributes to significant differences in the characteristics and etiology of pulmonary arterial hypertension seen in randomized, controlled trials, including more frequent connective tissue disease–associated disease in older patients, according to a post-hoc analysis of trials.

Additionally, older age was associated with worse baseline functional status, worse outcomes in the 6-minute walk distance, and an overall reduced response to treatment, while hemodynamic severity was higher in younger patients.

“Although registry data have shown that idiopathic PAH [pulmonary arterial hypertension] is increasingly recognized in older populations, our analysis shows that idiopathic etiology was less frequent in the older group. In contrast, CTD [connective tissue disease]–associated PAH accounted for a higher proportion of PAH etiology in the oldest age group,” wrote Jonathan A. Rose of Case Western Reserve University, Cleveland, and his colleagues (Chest. 2016;149[5]:1234-44. doi: 10.1016/j.chest.2015.11.008).

The researchers analyzed seven multicenter, randomized, double-blind, placebo-controlled treatment trials for PAH conducted by United Therapeutics and one open-label extension study that involved following patients being treated with subcutaneous treprostinil for 4 additional years. Data from the open-label extension trial and one of the trials were combined and reported as one trial. All trials excluded patients with a history of left-sided heart disease, pulmonary artery wedge pressure (PAWP) greater than 15 mmHg, or pulmonary vascular resistance (PVR) less than 3 Woods units. The researchers categorized the 2,627 patients included in the trials in the following three age groups: 50 years or younger, 51-64 years, and 65 years or older.

Between 53% and 74% of patients in all trials across all age groups had idiopathic PAH, but older patients comprised a significantly smaller proportion of the patients with idiopathic PAH in three of the trials (P = .004) and a significantly higher percentage of the patients with CTD-associated PAH in all of the trials (P less than .001). Across the trials, CTD-associated PAH occurred in 15%-21% of patients 50 years or younger, 25%-40% of those aged 51-64 years, and 27%-49% of those aged 65 years or older.

From baseline to the end in three of the studies, a smaller change in the 6-minute walk distance was seen in older patients and a higher proportion of older patients had an overall decrease in total 6-minute walk distance. Older age remained associated with this outcome measure when only data from treatment-naive patients or the subgroup of patients with CTD-associated PAH were included.

The association between age and lower baseline functional status was observed in four of the trials; A lower proportion of patients in the oldest age group were classified as being of the World Health Organization functional classes I and II, with 9%-32% of patients aged 65 years or older, 10%-33% in those aged 51-64 years, and 16%-43% of those aged 50 years or younger.

Hemodynamic severity was among the areas in which older patients performed better than younger patients, with the oldest age group having lower baseline mean pulmonary artery pressure (mPAP) and PVR in the two trials that measured hemodynamics.

“The difference in the clinical function and hemodynamics in older patients may reflect different mechanisms of disease. Older patients may have diminished cardiopulmonary reserve, and similar degrees of hemodynamic severity manifest with a larger functional impairment. Alternatively, additional comorbidities in older patients may contribute to a larger extent, and clinical function may not be as directly related to hemodynamic severity,” according to the researchers.

Mortality was generally small in these studies and not significantly different among age groups, except for in the open-label extension study of Subcutaneous Infusion of Treprostinil in Patients with PAH (SC-TRE) and the Study of Intravenous Remodulin in Patients in India with PAH (TRUST) trials, which were combined and reported on as one trial (P = .0004).

Nausea was the only adverse effect found to be associated with age in more than one trial, and the relationship between it and age in two trials were inconsistent. While a higher incidence of nausea was found in the oldest age group in the Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (FREEDOM-M) trial (P = .03), a lower incidence of nausea was found in the oldest age group in the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) trial (P = .02).

The analysis was supported by a grant from the National Institutes of Health. Two of the authors, Jody M. Cleveland and Youlan Rao, Ph.D., reported being employees of United Therapeutics, while Dr. Omar A. Minai, another author of the report, serves on the scientific advisory board of United Therapeutics. The other authors declared no conflicts.

[email protected]

Patient age contributes to significant differences in the characteristics and etiology of pulmonary arterial hypertension seen in randomized, controlled trials, including more frequent connective tissue disease–associated disease in older patients, according to a post-hoc analysis of trials.

Additionally, older age was associated with worse baseline functional status, worse outcomes in the 6-minute walk distance, and an overall reduced response to treatment, while hemodynamic severity was higher in younger patients.

“Although registry data have shown that idiopathic PAH [pulmonary arterial hypertension] is increasingly recognized in older populations, our analysis shows that idiopathic etiology was less frequent in the older group. In contrast, CTD [connective tissue disease]–associated PAH accounted for a higher proportion of PAH etiology in the oldest age group,” wrote Jonathan A. Rose of Case Western Reserve University, Cleveland, and his colleagues (Chest. 2016;149[5]:1234-44. doi: 10.1016/j.chest.2015.11.008).

The researchers analyzed seven multicenter, randomized, double-blind, placebo-controlled treatment trials for PAH conducted by United Therapeutics and one open-label extension study that involved following patients being treated with subcutaneous treprostinil for 4 additional years. Data from the open-label extension trial and one of the trials were combined and reported as one trial. All trials excluded patients with a history of left-sided heart disease, pulmonary artery wedge pressure (PAWP) greater than 15 mmHg, or pulmonary vascular resistance (PVR) less than 3 Woods units. The researchers categorized the 2,627 patients included in the trials in the following three age groups: 50 years or younger, 51-64 years, and 65 years or older.

Between 53% and 74% of patients in all trials across all age groups had idiopathic PAH, but older patients comprised a significantly smaller proportion of the patients with idiopathic PAH in three of the trials (P = .004) and a significantly higher percentage of the patients with CTD-associated PAH in all of the trials (P less than .001). Across the trials, CTD-associated PAH occurred in 15%-21% of patients 50 years or younger, 25%-40% of those aged 51-64 years, and 27%-49% of those aged 65 years or older.

From baseline to the end in three of the studies, a smaller change in the 6-minute walk distance was seen in older patients and a higher proportion of older patients had an overall decrease in total 6-minute walk distance. Older age remained associated with this outcome measure when only data from treatment-naive patients or the subgroup of patients with CTD-associated PAH were included.

The association between age and lower baseline functional status was observed in four of the trials; A lower proportion of patients in the oldest age group were classified as being of the World Health Organization functional classes I and II, with 9%-32% of patients aged 65 years or older, 10%-33% in those aged 51-64 years, and 16%-43% of those aged 50 years or younger.

Hemodynamic severity was among the areas in which older patients performed better than younger patients, with the oldest age group having lower baseline mean pulmonary artery pressure (mPAP) and PVR in the two trials that measured hemodynamics.

“The difference in the clinical function and hemodynamics in older patients may reflect different mechanisms of disease. Older patients may have diminished cardiopulmonary reserve, and similar degrees of hemodynamic severity manifest with a larger functional impairment. Alternatively, additional comorbidities in older patients may contribute to a larger extent, and clinical function may not be as directly related to hemodynamic severity,” according to the researchers.

Mortality was generally small in these studies and not significantly different among age groups, except for in the open-label extension study of Subcutaneous Infusion of Treprostinil in Patients with PAH (SC-TRE) and the Study of Intravenous Remodulin in Patients in India with PAH (TRUST) trials, which were combined and reported on as one trial (P = .0004).

Nausea was the only adverse effect found to be associated with age in more than one trial, and the relationship between it and age in two trials were inconsistent. While a higher incidence of nausea was found in the oldest age group in the Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (FREEDOM-M) trial (P = .03), a lower incidence of nausea was found in the oldest age group in the Treprostinil Sodium Inhalation Used in the Management of Pulmonary Arterial Hypertension (TRIUMPH) trial (P = .02).

The analysis was supported by a grant from the National Institutes of Health. Two of the authors, Jody M. Cleveland and Youlan Rao, Ph.D., reported being employees of United Therapeutics, while Dr. Omar A. Minai, another author of the report, serves on the scientific advisory board of United Therapeutics. The other authors declared no conflicts.

[email protected]

When it comes to predictive demographic and clinical factors associated with abnormal patterns of lung growth and decline in those with persistent, mild-to-moderate asthma in childhood, male sex and childhood levels of lung function as assessed by the forced expiratory volume in 1 second (FEV1) make all the difference, according to the results of a study published in the New England Journal of Medicine.

“Determinants of abnormal patterns of FEV₁ growth and decline are multifactorial and complex, and identification of factors associated with the timing of a decline from the maximal level requires longitudinal data,” said author Michael McGeachie, Ph.D., of Brigham and Women’s Hospital, Boston, and his colleagues.

©Sergey Nivens/thinkstockphotos

To identify these determinants, particularly in those with asthma, Dr. McGeachie and colleagues analyzed longitudinal data from a subset of participants from the Childhood Asthma Management Program (CAMP) cohort who were followed from enrollment at the age of 5 to 12 years, into the third decade of life. The trajectory of lung growth and the decline from maximum growth in this large cohort of persons who had persistent, mild-to-moderate asthma in childhood were compared against those from persons without asthma who were participants in the third National Health and Nutrition Examination Survey. (N Engl J Med. 2016;374:1842-52).

Data from 684 participants from the CAMP cohort were assessed and 25% had normal lung-function growth without an early decline, 26% had normal growth and an early decline, 23% had reduced growth without an early decline, and 26% had reduced growth and an early decline. Results of the multinomial logistic-regression analysis of risk factors for abnormal patterns of lung growth and decline showed that the 26% of participants with reduced growth and an early decline had lower FEV₁ lung function at enrollment and were more likely to be male, compared with those who had normal growth.

Additional study results indicated that 18% of the participants who had reduced lung-function growth, with or without an early decline, met the case definition for chronic obstructive pulmonary disease (COPD) based on the postbronchodilator spirometric criteria at an age of less than 30 years.

Based on their data, Dr. McGeachie and his colleagues said that detection of an abnormal trajectory by means of early and ongoing serial FEV₁ monitoring may help identify children and young adults at risk for abnormal lung-function growth that could lead to chronic airflow obstruction in adulthood.

Funding for this project was provided by grants from the Parker B. Francis Foundation, the National Institutes of Health, the National Human Genome Research Institute, and the Human Frontier Science Program Organization. Dr. McGeachie reported grant support from one of the funding sources during the conduct of the study. Nineteen coauthors reported they had nothing to disclose and the remainder either reported grant support or ties to industry sources.

When it comes to predictive demographic and clinical factors associated with abnormal patterns of lung growth and decline in those with persistent, mild-to-moderate asthma in childhood, male sex and childhood levels of lung function as assessed by the forced expiratory volume in 1 second (FEV1) make all the difference, according to the results of a study published in the New England Journal of Medicine.

“Determinants of abnormal patterns of FEV₁ growth and decline are multifactorial and complex, and identification of factors associated with the timing of a decline from the maximal level requires longitudinal data,” said author Michael McGeachie, Ph.D., of Brigham and Women’s Hospital, Boston, and his colleagues.

©Sergey Nivens/thinkstockphotos

To identify these determinants, particularly in those with asthma, Dr. McGeachie and colleagues analyzed longitudinal data from a subset of participants from the Childhood Asthma Management Program (CAMP) cohort who were followed from enrollment at the age of 5 to 12 years, into the third decade of life. The trajectory of lung growth and the decline from maximum growth in this large cohort of persons who had persistent, mild-to-moderate asthma in childhood were compared against those from persons without asthma who were participants in the third National Health and Nutrition Examination Survey. (N Engl J Med. 2016;374:1842-52).

Data from 684 participants from the CAMP cohort were assessed and 25% had normal lung-function growth without an early decline, 26% had normal growth and an early decline, 23% had reduced growth without an early decline, and 26% had reduced growth and an early decline. Results of the multinomial logistic-regression analysis of risk factors for abnormal patterns of lung growth and decline showed that the 26% of participants with reduced growth and an early decline had lower FEV₁ lung function at enrollment and were more likely to be male, compared with those who had normal growth.

Additional study results indicated that 18% of the participants who had reduced lung-function growth, with or without an early decline, met the case definition for chronic obstructive pulmonary disease (COPD) based on the postbronchodilator spirometric criteria at an age of less than 30 years.

Based on their data, Dr. McGeachie and his colleagues said that detection of an abnormal trajectory by means of early and ongoing serial FEV₁ monitoring may help identify children and young adults at risk for abnormal lung-function growth that could lead to chronic airflow obstruction in adulthood.

Funding for this project was provided by grants from the Parker B. Francis Foundation, the National Institutes of Health, the National Human Genome Research Institute, and the Human Frontier Science Program Organization. Dr. McGeachie reported grant support from one of the funding sources during the conduct of the study. Nineteen coauthors reported they had nothing to disclose and the remainder either reported grant support or ties to industry sources.

When it comes to predictive demographic and clinical factors associated with abnormal patterns of lung growth and decline in those with persistent, mild-to-moderate asthma in childhood, male sex and childhood levels of lung function as assessed by the forced expiratory volume in 1 second (FEV1) make all the difference, according to the results of a study published in the New England Journal of Medicine.

“Determinants of abnormal patterns of FEV₁ growth and decline are multifactorial and complex, and identification of factors associated with the timing of a decline from the maximal level requires longitudinal data,” said author Michael McGeachie, Ph.D., of Brigham and Women’s Hospital, Boston, and his colleagues.

©Sergey Nivens/thinkstockphotos

To identify these determinants, particularly in those with asthma, Dr. McGeachie and colleagues analyzed longitudinal data from a subset of participants from the Childhood Asthma Management Program (CAMP) cohort who were followed from enrollment at the age of 5 to 12 years, into the third decade of life. The trajectory of lung growth and the decline from maximum growth in this large cohort of persons who had persistent, mild-to-moderate asthma in childhood were compared against those from persons without asthma who were participants in the third National Health and Nutrition Examination Survey. (N Engl J Med. 2016;374:1842-52).

Data from 684 participants from the CAMP cohort were assessed and 25% had normal lung-function growth without an early decline, 26% had normal growth and an early decline, 23% had reduced growth without an early decline, and 26% had reduced growth and an early decline. Results of the multinomial logistic-regression analysis of risk factors for abnormal patterns of lung growth and decline showed that the 26% of participants with reduced growth and an early decline had lower FEV₁ lung function at enrollment and were more likely to be male, compared with those who had normal growth.

Additional study results indicated that 18% of the participants who had reduced lung-function growth, with or without an early decline, met the case definition for chronic obstructive pulmonary disease (COPD) based on the postbronchodilator spirometric criteria at an age of less than 30 years.

Based on their data, Dr. McGeachie and his colleagues said that detection of an abnormal trajectory by means of early and ongoing serial FEV₁ monitoring may help identify children and young adults at risk for abnormal lung-function growth that could lead to chronic airflow obstruction in adulthood.

Funding for this project was provided by grants from the Parker B. Francis Foundation, the National Institutes of Health, the National Human Genome Research Institute, and the Human Frontier Science Program Organization. Dr. McGeachie reported grant support from one of the funding sources during the conduct of the study. Nineteen coauthors reported they had nothing to disclose and the remainder either reported grant support or ties to industry sources.

CHICAGO – Using an inhaled long-acting beta agonist and corticosteroid to treat patients with moderate chronic obstructive pulmonary disease who have known cardiovascular disease had no impact on the cardiovascular event rate in the landmark SUMMIT trial, Dr. David E. Newby reported at the annual meeting of the American College of Cardiology.

SUMMIT (the Study to Understand Mortality and Morbidity) was a randomized, double-blind, placebo-controlled, 43-country, four-arm clinical trial in which 16,485 patients with moderate COPD were placed on once-daily inhaled fluticasone furoate/vilanterol 100/25 mcg by dry powder inhaler (Breo Ellipta), either drug alone, or placebo for an average of 2 years. Two-thirds of participants had overt cardiovascular disease; the rest were at high risk as defined by age greater than 60 years plus the presence of two or more cardiovascular risk factors.

This was the first large prospective clinical trial to investigate the impact of respiratory therapy on survival in patients with two commonly comorbid conditions. The incidence of major adverse cardiovascular events – a prespecified secondary endpoint – was of major interest because some other long-acting beta agonists have been linked to increased cardiovascular risk, explained Dr. Newby of the University of Edinburgh.

The primary endpoint in SUMMIT was all-cause mortality. The 12.2% relative risk reduction in the fluticasone furoate/vilanterol group, compared with placebo, didn’t achieve statistical significance. Neither did the 7.4% reduction in the secondary composite endpoint of cardiovascular death, MI, stroke, unstable angina, or TIA seen in the corticosteroid/LABA group, which is reassuring from a safety standpoint, he noted.

A positive result was seen for another secondary endpoint: the rate of lung function decline as measured by forced expiratory volume in 1 second. The rate of decline was 8 mL/year less with fluticasone furoate/vilanterol, compared with placebo.

The Breo Ellipta group also had significantly lower rates of moderate or severe COPD exacerbations, hospitalization for exacerbations, and improved quality of life as measured by the St. George’s Respiratory Questionnaire – COPD total score at 12 months.

The SUMMIT trial was sponsored by GlaxoSmithKline. The presenter is a consultant to GSK and eight other pharmaceutical companies.

[email protected]

CHICAGO – Using an inhaled long-acting beta agonist and corticosteroid to treat patients with moderate chronic obstructive pulmonary disease who have known cardiovascular disease had no impact on the cardiovascular event rate in the landmark SUMMIT trial, Dr. David E. Newby reported at the annual meeting of the American College of Cardiology.

SUMMIT (the Study to Understand Mortality and Morbidity) was a randomized, double-blind, placebo-controlled, 43-country, four-arm clinical trial in which 16,485 patients with moderate COPD were placed on once-daily inhaled fluticasone furoate/vilanterol 100/25 mcg by dry powder inhaler (Breo Ellipta), either drug alone, or placebo for an average of 2 years. Two-thirds of participants had overt cardiovascular disease; the rest were at high risk as defined by age greater than 60 years plus the presence of two or more cardiovascular risk factors.

This was the first large prospective clinical trial to investigate the impact of respiratory therapy on survival in patients with two commonly comorbid conditions. The incidence of major adverse cardiovascular events – a prespecified secondary endpoint – was of major interest because some other long-acting beta agonists have been linked to increased cardiovascular risk, explained Dr. Newby of the University of Edinburgh.

The primary endpoint in SUMMIT was all-cause mortality. The 12.2% relative risk reduction in the fluticasone furoate/vilanterol group, compared with placebo, didn’t achieve statistical significance. Neither did the 7.4% reduction in the secondary composite endpoint of cardiovascular death, MI, stroke, unstable angina, or TIA seen in the corticosteroid/LABA group, which is reassuring from a safety standpoint, he noted.

A positive result was seen for another secondary endpoint: the rate of lung function decline as measured by forced expiratory volume in 1 second. The rate of decline was 8 mL/year less with fluticasone furoate/vilanterol, compared with placebo.

The Breo Ellipta group also had significantly lower rates of moderate or severe COPD exacerbations, hospitalization for exacerbations, and improved quality of life as measured by the St. George’s Respiratory Questionnaire – COPD total score at 12 months.

The SUMMIT trial was sponsored by GlaxoSmithKline. The presenter is a consultant to GSK and eight other pharmaceutical companies.

[email protected]

CHICAGO – Using an inhaled long-acting beta agonist and corticosteroid to treat patients with moderate chronic obstructive pulmonary disease who have known cardiovascular disease had no impact on the cardiovascular event rate in the landmark SUMMIT trial, Dr. David E. Newby reported at the annual meeting of the American College of Cardiology.

SUMMIT (the Study to Understand Mortality and Morbidity) was a randomized, double-blind, placebo-controlled, 43-country, four-arm clinical trial in which 16,485 patients with moderate COPD were placed on once-daily inhaled fluticasone furoate/vilanterol 100/25 mcg by dry powder inhaler (Breo Ellipta), either drug alone, or placebo for an average of 2 years. Two-thirds of participants had overt cardiovascular disease; the rest were at high risk as defined by age greater than 60 years plus the presence of two or more cardiovascular risk factors.

This was the first large prospective clinical trial to investigate the impact of respiratory therapy on survival in patients with two commonly comorbid conditions. The incidence of major adverse cardiovascular events – a prespecified secondary endpoint – was of major interest because some other long-acting beta agonists have been linked to increased cardiovascular risk, explained Dr. Newby of the University of Edinburgh.

The primary endpoint in SUMMIT was all-cause mortality. The 12.2% relative risk reduction in the fluticasone furoate/vilanterol group, compared with placebo, didn’t achieve statistical significance. Neither did the 7.4% reduction in the secondary composite endpoint of cardiovascular death, MI, stroke, unstable angina, or TIA seen in the corticosteroid/LABA group, which is reassuring from a safety standpoint, he noted.

A positive result was seen for another secondary endpoint: the rate of lung function decline as measured by forced expiratory volume in 1 second. The rate of decline was 8 mL/year less with fluticasone furoate/vilanterol, compared with placebo.

The Breo Ellipta group also had significantly lower rates of moderate or severe COPD exacerbations, hospitalization for exacerbations, and improved quality of life as measured by the St. George’s Respiratory Questionnaire – COPD total score at 12 months.

The SUMMIT trial was sponsored by GlaxoSmithKline. The presenter is a consultant to GSK and eight other pharmaceutical companies.

[email protected]

LOS ANGELES – A peanut protein–bearing skin patch known as the Viaskin Peanut gave a continued strong performance for treatment of peanut allergy in children during the second year of an international study of this novel form of epicutaneous immunotherapy.

The clinical response rate in 6- to 11-year-olds after 1 year of treatment with the 250-mcg dose of peanut protein in the medical device was 57% in the phase IIb, double-blind, 22-site, international VIPES trial, as reported last year.

©mates/Fotolia.com

After an additional year of treatment with the 250-mcg Viaskin Peanut in the open-label extension study known as OLFUS-VIPES, this rate climbed to 80%. Safety and tolerability of the device therapy remained excellent, Dr. Hugh A. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In adolescents and adults, however, the clinical response – while significantly better than placebo in VIPES – was less robust than in children, and it remained stable from year 1 to year 2. This is believed to be due to the greater plasticity of the immune system in children, observed Dr. Sampson, director of the Jaffe Food Allergy Institute at Kravis Children’s Hospital at Mount Sinai in New York and chief scientific officer at DBV Technologies, which is developing the Viaskin Peanut.

The ongoing phase III trial uses the 250-mcg dose of peanut protein – the highest of several doses studied in VIPES and OLFUS-VIPES – and is restricted to peanut-allergic children ages 4-11 years. Doses of peanut protein greater than 250 mcg will be explored in separate studies of adolescents and adults.

The clinical response rate in children on the 250-mcg Viaskin Peanut rose from 57% after 1 year to 80% – that is, 16 of 20 subjects – after 2 years. A clinical response in VIPES and OLFUS-VIPES was defined as nonreactivity to a dose of at least 1,000 mg of peanut protein – the equivalent of four peanuts – during a formal double-blind food challenge or at least a tenfold increase in the eliciting dose, compared to the original eliciting dose.

In VIPES, one-third of children on the 250-mcg device therapy for 1 year could tolerate at least 1,000 mg of peanut protein; after an additional year of open-label therapy, 60% of children were able to do so.

Among 6- to 11-year-olds, the median cumulative reactive dose of peanut protein was 44 mg at baseline, 444 mg after 12 months of using the 250-mcg Viaskin Peanut, and 1,444 mg at 2 years.

The children’s immunologic response to the Viaskin Peanut was impressive: A 40% reduction from baseline in peanut IgE at 2 years, along with a ninefold increase in protective peanut-specific IgG4.

The skin patch consists of a dried allergen – in this case, peanut protein – which is made electrostatically adherent to a membrane on a Band-Aid–like chamber. A set of patches is placed on noneczematous skin on a child’s back and on the inner upper arm of older patients. Moisture emitted from the skin gradually causes the protein allergen to solubilize and get absorbed into the outer layer of the skin. It is then picked up by antigen-presenting Langerhans cells and transported to regional lymph nodes for deactivation. The patches are changed daily.

“It appears that we need to look at the skin as a tolerogenic organ when it’s uninflamed,” Dr. Sampson observed.

Compliance with treatment was in excess of 96% in both VIPES and OLFUS-VIPES. There have been no serious treatment-related adverse events and no need for the use of epinephrine. Side effects have been limited to occasional mild to moderate application site reactions easily managed with antihistamines and/or topical steroids, according to Dr. Sampson.

The double-blind VIPES study included 207 subjects with documented peanut allergy. OLFUS-VIPES, which will continue for 1 additional year of open-label therapy, includes 171 of the original 207, including 97 children, 49 adolescents, and 25 adults up to age 55 years.

“We’ll see if there’s continued improvement in children through the third year or it levels off, but based upon the immunologic parameters I think it’s having continued effect,” the pediatric allergist said.

[email protected]

LOS ANGELES – A peanut protein–bearing skin patch known as the Viaskin Peanut gave a continued strong performance for treatment of peanut allergy in children during the second year of an international study of this novel form of epicutaneous immunotherapy.

The clinical response rate in 6- to 11-year-olds after 1 year of treatment with the 250-mcg dose of peanut protein in the medical device was 57% in the phase IIb, double-blind, 22-site, international VIPES trial, as reported last year.

©mates/Fotolia.com

After an additional year of treatment with the 250-mcg Viaskin Peanut in the open-label extension study known as OLFUS-VIPES, this rate climbed to 80%. Safety and tolerability of the device therapy remained excellent, Dr. Hugh A. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In adolescents and adults, however, the clinical response – while significantly better than placebo in VIPES – was less robust than in children, and it remained stable from year 1 to year 2. This is believed to be due to the greater plasticity of the immune system in children, observed Dr. Sampson, director of the Jaffe Food Allergy Institute at Kravis Children’s Hospital at Mount Sinai in New York and chief scientific officer at DBV Technologies, which is developing the Viaskin Peanut.

The ongoing phase III trial uses the 250-mcg dose of peanut protein – the highest of several doses studied in VIPES and OLFUS-VIPES – and is restricted to peanut-allergic children ages 4-11 years. Doses of peanut protein greater than 250 mcg will be explored in separate studies of adolescents and adults.

The clinical response rate in children on the 250-mcg Viaskin Peanut rose from 57% after 1 year to 80% – that is, 16 of 20 subjects – after 2 years. A clinical response in VIPES and OLFUS-VIPES was defined as nonreactivity to a dose of at least 1,000 mg of peanut protein – the equivalent of four peanuts – during a formal double-blind food challenge or at least a tenfold increase in the eliciting dose, compared to the original eliciting dose.

In VIPES, one-third of children on the 250-mcg device therapy for 1 year could tolerate at least 1,000 mg of peanut protein; after an additional year of open-label therapy, 60% of children were able to do so.

Among 6- to 11-year-olds, the median cumulative reactive dose of peanut protein was 44 mg at baseline, 444 mg after 12 months of using the 250-mcg Viaskin Peanut, and 1,444 mg at 2 years.

The children’s immunologic response to the Viaskin Peanut was impressive: A 40% reduction from baseline in peanut IgE at 2 years, along with a ninefold increase in protective peanut-specific IgG4.

The skin patch consists of a dried allergen – in this case, peanut protein – which is made electrostatically adherent to a membrane on a Band-Aid–like chamber. A set of patches is placed on noneczematous skin on a child’s back and on the inner upper arm of older patients. Moisture emitted from the skin gradually causes the protein allergen to solubilize and get absorbed into the outer layer of the skin. It is then picked up by antigen-presenting Langerhans cells and transported to regional lymph nodes for deactivation. The patches are changed daily.

“It appears that we need to look at the skin as a tolerogenic organ when it’s uninflamed,” Dr. Sampson observed.

Compliance with treatment was in excess of 96% in both VIPES and OLFUS-VIPES. There have been no serious treatment-related adverse events and no need for the use of epinephrine. Side effects have been limited to occasional mild to moderate application site reactions easily managed with antihistamines and/or topical steroids, according to Dr. Sampson.

The double-blind VIPES study included 207 subjects with documented peanut allergy. OLFUS-VIPES, which will continue for 1 additional year of open-label therapy, includes 171 of the original 207, including 97 children, 49 adolescents, and 25 adults up to age 55 years.

“We’ll see if there’s continued improvement in children through the third year or it levels off, but based upon the immunologic parameters I think it’s having continued effect,” the pediatric allergist said.

[email protected]

LOS ANGELES – A peanut protein–bearing skin patch known as the Viaskin Peanut gave a continued strong performance for treatment of peanut allergy in children during the second year of an international study of this novel form of epicutaneous immunotherapy.

The clinical response rate in 6- to 11-year-olds after 1 year of treatment with the 250-mcg dose of peanut protein in the medical device was 57% in the phase IIb, double-blind, 22-site, international VIPES trial, as reported last year.

©mates/Fotolia.com

After an additional year of treatment with the 250-mcg Viaskin Peanut in the open-label extension study known as OLFUS-VIPES, this rate climbed to 80%. Safety and tolerability of the device therapy remained excellent, Dr. Hugh A. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In adolescents and adults, however, the clinical response – while significantly better than placebo in VIPES – was less robust than in children, and it remained stable from year 1 to year 2. This is believed to be due to the greater plasticity of the immune system in children, observed Dr. Sampson, director of the Jaffe Food Allergy Institute at Kravis Children’s Hospital at Mount Sinai in New York and chief scientific officer at DBV Technologies, which is developing the Viaskin Peanut.

The ongoing phase III trial uses the 250-mcg dose of peanut protein – the highest of several doses studied in VIPES and OLFUS-VIPES – and is restricted to peanut-allergic children ages 4-11 years. Doses of peanut protein greater than 250 mcg will be explored in separate studies of adolescents and adults.

The clinical response rate in children on the 250-mcg Viaskin Peanut rose from 57% after 1 year to 80% – that is, 16 of 20 subjects – after 2 years. A clinical response in VIPES and OLFUS-VIPES was defined as nonreactivity to a dose of at least 1,000 mg of peanut protein – the equivalent of four peanuts – during a formal double-blind food challenge or at least a tenfold increase in the eliciting dose, compared to the original eliciting dose.

In VIPES, one-third of children on the 250-mcg device therapy for 1 year could tolerate at least 1,000 mg of peanut protein; after an additional year of open-label therapy, 60% of children were able to do so.

Among 6- to 11-year-olds, the median cumulative reactive dose of peanut protein was 44 mg at baseline, 444 mg after 12 months of using the 250-mcg Viaskin Peanut, and 1,444 mg at 2 years.

The children’s immunologic response to the Viaskin Peanut was impressive: A 40% reduction from baseline in peanut IgE at 2 years, along with a ninefold increase in protective peanut-specific IgG4.

The skin patch consists of a dried allergen – in this case, peanut protein – which is made electrostatically adherent to a membrane on a Band-Aid–like chamber. A set of patches is placed on noneczematous skin on a child’s back and on the inner upper arm of older patients. Moisture emitted from the skin gradually causes the protein allergen to solubilize and get absorbed into the outer layer of the skin. It is then picked up by antigen-presenting Langerhans cells and transported to regional lymph nodes for deactivation. The patches are changed daily.

“It appears that we need to look at the skin as a tolerogenic organ when it’s uninflamed,” Dr. Sampson observed.

Compliance with treatment was in excess of 96% in both VIPES and OLFUS-VIPES. There have been no serious treatment-related adverse events and no need for the use of epinephrine. Side effects have been limited to occasional mild to moderate application site reactions easily managed with antihistamines and/or topical steroids, according to Dr. Sampson.

The double-blind VIPES study included 207 subjects with documented peanut allergy. OLFUS-VIPES, which will continue for 1 additional year of open-label therapy, includes 171 of the original 207, including 97 children, 49 adolescents, and 25 adults up to age 55 years.

“We’ll see if there’s continued improvement in children through the third year or it levels off, but based upon the immunologic parameters I think it’s having continued effect,” the pediatric allergist said.

[email protected]