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Recently identified eczema comorbidities include anemia, obesity
WAIKOLOA, HAWAII – The list of nonatopic comorbid conditions associated with atopic dermatitis is rapidly expanding.
Just in the past year, published studies have linked pediatric atopic dermatitis to increased risks of obesity, high blood pressure, headaches, anemia, and speech disorders. Meanwhile, adult atopic dermatitis was reported to be associated with increased rates of fracture and cardiovascular disease. And in the dermatologic arena, a link between atopic dermatitis, vitiligo, and alopecia areata was identified, Dr. Lawrence F. Eichenfield noted at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Actually, these reported associations published in 2015-2016 might best be termed “emerging comorbidities,” as they are first reports and thus need confirmation, said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital San Diego.
Much of this work on emerging comorbidities has been done by dermatologist Dr. Jonathan I. Silverberg of Northwestern University, Chicago, and various coinvestigators. They have been prolific.
For example, in a multivariate logistic regression analysis of 207,007 children and adolescents included in the cross-sectional 1997-2013 U.S. National Health Interview Survey, Dr. Silverberg and coinvestigators found that eczema was independently associated with a 1.83-fold increased odds of anemia. They bolstered this observation with an analysis of more than 30,000 children and adolescents in the 1992-2012 National Health and Nutrition Examination Survey (NHANES) in which they found that current eczema was associated with a 1.93-fold increased odds of anemia, particularly microcytic anemia. The underlying mechanism is unknown; however, the investigators noted that chronic inflammation and systemic immunosuppressant drugs have been shown to be associated with anemia (JAMA Pediatr. 2016;170[1]:29-34).
Dr. Silverberg also found in a multivariate logistic regression analysis of data on more than 400,000 pediatric participants in the National Survey of Children’s Health and the National Health Interview Survey that mild and severe eczema were independently associated with 1.79-fold and 2.72-fold, respectively, increased odds of headaches (J Allergy Clin Immunol. 2016 Feb;137[2]:492-9).
Using these same two data sources, with multivariate analysis adjusted for potential confounders, the investigators found that eczema was associated with a 1.81-fold increased risk of speech disorder (J Pediatr. 2016 Jan;168:185-92).
In a case-control study involving 132 children and adolescents with current moderate to severe atopic dermatitis and 143 healthy controls, Dr. Silverberg and coinvestigators found in a logistic regression analysis that atopic dermatitis was independently associated with a doubled risk of having a systolic blood pressure in the 90th percentile or higher – as well as 3.92-fold increased odds of central obesity, as defined by a waist circumference in the 85th percentile or higher (JAMA Dermatol. 2015 Feb;151[2]:144-52).
In a systematic review and meta-analysis of 16 published vitiligo studies and 17 published studies of alopecia areata, Dr. Silverberg and medical student Girish C. Mohan found that patients with vitiligo or alopecia areata were respectively 7.8 and 2.6 times more likely to have atopic dermatitis than controls without those disorders (JAMA Dermatol. 2015 May;151[5]:522-8).
In a logistic regression analysis of data on 34,500 adults with a history of eczema within the prior year who participated in the 2012 National Health Interview Survey, Drs. Nitin Garg and Dr. Silverberg concluded that the results suggested that adult atopic dermatitis is a previously unrecognized risk factor for fracture and other bone or joint injuries causing limitation. Adults with atopic dermatitis were at a 1.67-fold increased risk for such injuries in an analysis controlling for sociodemographics, other forms of atopic disease, and psychiatric and behavioral disorders (JAMA Dermatol. 2015 Jan;151[1]:33-41).
In another large cross-sectional study, Dr. Silverberg found that adults with atopic dermatitis had significantly higher odds of a history of acute MI, coronary artery disease, heart failure, and stroke (Allergy. 2015 Oct;70[10]:1300-8).
Dr. Eichenfield said that while he would like to see these hot-off-the-presses 2015-2016 findings on nonatopic comorbidities backed up by confirmatory studies in other populations, the evidence is stronger for an association between pediatric atopic dermatitis and several mental health disorders. The initial reports came mainly from Europe, but were then supported by a large study by Dr. Eric L. Simpson and coinvestigators at Oregon Health and Science University, Portland.
In their analysis of data on nearly 93,000 noninstitutionalized children and adolescents included in the 2007 National Survey of Children’s Health, the investigators found after controlling for potential confounders that atopic dermatitis was associated with a 1.87-fold increased risk of having attention-deficit/hyperactivity disorder, a 3-fold increased risk of diagnosed autism, an adjusted 1.81-fold increase in depression, and 1.87-fold increased odds of conduct disorder. The Oregon group found a clear dose-dependent relationship between the reported severity of the skin disease and the likelihood of those mental health disorders (J Allergy Clin Immunol. 2013 Feb;131[2]:428-33).
The hope is that emerging strategies to prevent atopic dermatitis or aggressively treat it early on will reduce the risk of many of these comorbid conditions, Dr. Eichenfield said.
SDEF and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – The list of nonatopic comorbid conditions associated with atopic dermatitis is rapidly expanding.
Just in the past year, published studies have linked pediatric atopic dermatitis to increased risks of obesity, high blood pressure, headaches, anemia, and speech disorders. Meanwhile, adult atopic dermatitis was reported to be associated with increased rates of fracture and cardiovascular disease. And in the dermatologic arena, a link between atopic dermatitis, vitiligo, and alopecia areata was identified, Dr. Lawrence F. Eichenfield noted at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Actually, these reported associations published in 2015-2016 might best be termed “emerging comorbidities,” as they are first reports and thus need confirmation, said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital San Diego.
Much of this work on emerging comorbidities has been done by dermatologist Dr. Jonathan I. Silverberg of Northwestern University, Chicago, and various coinvestigators. They have been prolific.
For example, in a multivariate logistic regression analysis of 207,007 children and adolescents included in the cross-sectional 1997-2013 U.S. National Health Interview Survey, Dr. Silverberg and coinvestigators found that eczema was independently associated with a 1.83-fold increased odds of anemia. They bolstered this observation with an analysis of more than 30,000 children and adolescents in the 1992-2012 National Health and Nutrition Examination Survey (NHANES) in which they found that current eczema was associated with a 1.93-fold increased odds of anemia, particularly microcytic anemia. The underlying mechanism is unknown; however, the investigators noted that chronic inflammation and systemic immunosuppressant drugs have been shown to be associated with anemia (JAMA Pediatr. 2016;170[1]:29-34).
Dr. Silverberg also found in a multivariate logistic regression analysis of data on more than 400,000 pediatric participants in the National Survey of Children’s Health and the National Health Interview Survey that mild and severe eczema were independently associated with 1.79-fold and 2.72-fold, respectively, increased odds of headaches (J Allergy Clin Immunol. 2016 Feb;137[2]:492-9).
Using these same two data sources, with multivariate analysis adjusted for potential confounders, the investigators found that eczema was associated with a 1.81-fold increased risk of speech disorder (J Pediatr. 2016 Jan;168:185-92).
In a case-control study involving 132 children and adolescents with current moderate to severe atopic dermatitis and 143 healthy controls, Dr. Silverberg and coinvestigators found in a logistic regression analysis that atopic dermatitis was independently associated with a doubled risk of having a systolic blood pressure in the 90th percentile or higher – as well as 3.92-fold increased odds of central obesity, as defined by a waist circumference in the 85th percentile or higher (JAMA Dermatol. 2015 Feb;151[2]:144-52).
In a systematic review and meta-analysis of 16 published vitiligo studies and 17 published studies of alopecia areata, Dr. Silverberg and medical student Girish C. Mohan found that patients with vitiligo or alopecia areata were respectively 7.8 and 2.6 times more likely to have atopic dermatitis than controls without those disorders (JAMA Dermatol. 2015 May;151[5]:522-8).
In a logistic regression analysis of data on 34,500 adults with a history of eczema within the prior year who participated in the 2012 National Health Interview Survey, Drs. Nitin Garg and Dr. Silverberg concluded that the results suggested that adult atopic dermatitis is a previously unrecognized risk factor for fracture and other bone or joint injuries causing limitation. Adults with atopic dermatitis were at a 1.67-fold increased risk for such injuries in an analysis controlling for sociodemographics, other forms of atopic disease, and psychiatric and behavioral disorders (JAMA Dermatol. 2015 Jan;151[1]:33-41).
In another large cross-sectional study, Dr. Silverberg found that adults with atopic dermatitis had significantly higher odds of a history of acute MI, coronary artery disease, heart failure, and stroke (Allergy. 2015 Oct;70[10]:1300-8).
Dr. Eichenfield said that while he would like to see these hot-off-the-presses 2015-2016 findings on nonatopic comorbidities backed up by confirmatory studies in other populations, the evidence is stronger for an association between pediatric atopic dermatitis and several mental health disorders. The initial reports came mainly from Europe, but were then supported by a large study by Dr. Eric L. Simpson and coinvestigators at Oregon Health and Science University, Portland.
In their analysis of data on nearly 93,000 noninstitutionalized children and adolescents included in the 2007 National Survey of Children’s Health, the investigators found after controlling for potential confounders that atopic dermatitis was associated with a 1.87-fold increased risk of having attention-deficit/hyperactivity disorder, a 3-fold increased risk of diagnosed autism, an adjusted 1.81-fold increase in depression, and 1.87-fold increased odds of conduct disorder. The Oregon group found a clear dose-dependent relationship between the reported severity of the skin disease and the likelihood of those mental health disorders (J Allergy Clin Immunol. 2013 Feb;131[2]:428-33).
The hope is that emerging strategies to prevent atopic dermatitis or aggressively treat it early on will reduce the risk of many of these comorbid conditions, Dr. Eichenfield said.
SDEF and this news organization are owned by the same parent company.
WAIKOLOA, HAWAII – The list of nonatopic comorbid conditions associated with atopic dermatitis is rapidly expanding.
Just in the past year, published studies have linked pediatric atopic dermatitis to increased risks of obesity, high blood pressure, headaches, anemia, and speech disorders. Meanwhile, adult atopic dermatitis was reported to be associated with increased rates of fracture and cardiovascular disease. And in the dermatologic arena, a link between atopic dermatitis, vitiligo, and alopecia areata was identified, Dr. Lawrence F. Eichenfield noted at the Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.
Actually, these reported associations published in 2015-2016 might best be termed “emerging comorbidities,” as they are first reports and thus need confirmation, said Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital San Diego.
Much of this work on emerging comorbidities has been done by dermatologist Dr. Jonathan I. Silverberg of Northwestern University, Chicago, and various coinvestigators. They have been prolific.
For example, in a multivariate logistic regression analysis of 207,007 children and adolescents included in the cross-sectional 1997-2013 U.S. National Health Interview Survey, Dr. Silverberg and coinvestigators found that eczema was independently associated with a 1.83-fold increased odds of anemia. They bolstered this observation with an analysis of more than 30,000 children and adolescents in the 1992-2012 National Health and Nutrition Examination Survey (NHANES) in which they found that current eczema was associated with a 1.93-fold increased odds of anemia, particularly microcytic anemia. The underlying mechanism is unknown; however, the investigators noted that chronic inflammation and systemic immunosuppressant drugs have been shown to be associated with anemia (JAMA Pediatr. 2016;170[1]:29-34).
Dr. Silverberg also found in a multivariate logistic regression analysis of data on more than 400,000 pediatric participants in the National Survey of Children’s Health and the National Health Interview Survey that mild and severe eczema were independently associated with 1.79-fold and 2.72-fold, respectively, increased odds of headaches (J Allergy Clin Immunol. 2016 Feb;137[2]:492-9).
Using these same two data sources, with multivariate analysis adjusted for potential confounders, the investigators found that eczema was associated with a 1.81-fold increased risk of speech disorder (J Pediatr. 2016 Jan;168:185-92).
In a case-control study involving 132 children and adolescents with current moderate to severe atopic dermatitis and 143 healthy controls, Dr. Silverberg and coinvestigators found in a logistic regression analysis that atopic dermatitis was independently associated with a doubled risk of having a systolic blood pressure in the 90th percentile or higher – as well as 3.92-fold increased odds of central obesity, as defined by a waist circumference in the 85th percentile or higher (JAMA Dermatol. 2015 Feb;151[2]:144-52).
In a systematic review and meta-analysis of 16 published vitiligo studies and 17 published studies of alopecia areata, Dr. Silverberg and medical student Girish C. Mohan found that patients with vitiligo or alopecia areata were respectively 7.8 and 2.6 times more likely to have atopic dermatitis than controls without those disorders (JAMA Dermatol. 2015 May;151[5]:522-8).
In a logistic regression analysis of data on 34,500 adults with a history of eczema within the prior year who participated in the 2012 National Health Interview Survey, Drs. Nitin Garg and Dr. Silverberg concluded that the results suggested that adult atopic dermatitis is a previously unrecognized risk factor for fracture and other bone or joint injuries causing limitation. Adults with atopic dermatitis were at a 1.67-fold increased risk for such injuries in an analysis controlling for sociodemographics, other forms of atopic disease, and psychiatric and behavioral disorders (JAMA Dermatol. 2015 Jan;151[1]:33-41).
In another large cross-sectional study, Dr. Silverberg found that adults with atopic dermatitis had significantly higher odds of a history of acute MI, coronary artery disease, heart failure, and stroke (Allergy. 2015 Oct;70[10]:1300-8).
Dr. Eichenfield said that while he would like to see these hot-off-the-presses 2015-2016 findings on nonatopic comorbidities backed up by confirmatory studies in other populations, the evidence is stronger for an association between pediatric atopic dermatitis and several mental health disorders. The initial reports came mainly from Europe, but were then supported by a large study by Dr. Eric L. Simpson and coinvestigators at Oregon Health and Science University, Portland.
In their analysis of data on nearly 93,000 noninstitutionalized children and adolescents included in the 2007 National Survey of Children’s Health, the investigators found after controlling for potential confounders that atopic dermatitis was associated with a 1.87-fold increased risk of having attention-deficit/hyperactivity disorder, a 3-fold increased risk of diagnosed autism, an adjusted 1.81-fold increase in depression, and 1.87-fold increased odds of conduct disorder. The Oregon group found a clear dose-dependent relationship between the reported severity of the skin disease and the likelihood of those mental health disorders (J Allergy Clin Immunol. 2013 Feb;131[2]:428-33).
The hope is that emerging strategies to prevent atopic dermatitis or aggressively treat it early on will reduce the risk of many of these comorbid conditions, Dr. Eichenfield said.
SDEF and this news organization are owned by the same parent company.
EXPERT ANALYSIS FROM THE SDEF HAWAII DERMATOLOGY SEMINAR
Staph aureus drives atopic dermatitis
LOS ANGELES – Evidence is building for the hypothesis that impairments in the skin’s microbiome promote Staphylococcus aureus colonization and drive atopic dermatitis, Dr. Donald Y.M. Leung said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The link between the bacteria and atopic dermatitis has long been discussed, but its role in pathogenesis still needs definition, he said.
“We’ve never been able to look at the total bacterial composition of the skin, but now with next-generation sequencing it’s finally possible to look at all the phylla and species. Other investigators have shown that during flares of atopic dermatitis there’s a reduction in bacterial diversity and an increase in staph, with S. aureus being particularly abundant. Then, post-flare, you see see a drop in S. aureus; this clearly suggests (it’s) important,” according to Dr. Leung, head of the division of pediatric allergy and immunology at National Jewish Health in Denver and professor of pediatrics at the University of Colorado.
Staphylococcus aureus is known to secrete virulence factors including cytotoxins, superantigens, lipases, and proteases that activate inflammatory cells and can cause significant skin barrier dysfunction.
The discovery that filaggrin mutations result in structural abnormalities in the skin barrier and are associated with sharply increased rates of atopic dermatitis and peanut allergy have strengthened the association, but filaggrin can’t be the whole story. Mutations in filaggrin are largely confined to individuals of Northern European ancestry; African Americans don’t have filaggrin mutations.
Yet atopic dermatitis is a global phenomenon. Further, a skin barrier defect is not enough to cause atopic dermatitis, Dr. Leung said. But such a defect, whether caused by a filaggrin mutation or something else, allows S. aureus to attach to and colonize the skin. Staph overgrowth or infection then activates an inflammatory cell cascade involving natural killer T cells, mast cells, cytokines, and Langerhans cells. That’s why the most effective treatments for atopic dermatitis address both the need to rebuild the skin barrier as well as the counterproductive immune response, he added.
Elsewhere at the AAAAI meeting, Dr. Andrea L. Jones, of National Jewish Health, presented an analysis of 718 children and adolescents with atopic dermatitis, all of whom had been cultured for S. aureus, in that institution’s database. Methicillin-resistant S. aureus (MRSA) was found in 19%; 57% were positive for methicillin-sensitive S. aureus (MSSA) and 23% lacked S. aureus. Of note, the prevalence of peanut allergy was highest at 78% in the group with MRSA; the prevalence was 39% in those with MSSA and 4% in those without S. aureus.
The prevalence of allergies to wheat, egg, milk, or soybeans in the youths with atopic dermatitis was unrelated to MRSA colonization.
“Our hypothesis – although we need to do a prospective study – is that staph colonization may lead to barrier dysfunction and thus allow environmental allergens to invade through the skin. Interestingly enough, people who weren’t colonized by staph had a very low level of sensitization to peanut,” said Dr. Leung, who was the senior investigator in the study.
Dr. Leung was a coauthor on another study that points to a potential new avenue of treatment in atopic dermatitis. Presented by investigators at the University of California, San Diego, at a recent meeting of the Society for Investigative Dermatology, the study showed that atopic dermatitis is marked by a defect in the commensal skin bacteria which normally keep S. aureus in check.
In that study, the amount of S. aureus growing on a defined area of lesional skin of atopic dermatitis patients was nearly 10-fold greater than that on nonlesional skin and the skin of controls without atopic dermatitis.
Commensal bacteria on lesional skin may possess markedly reduced antimicrobial activity. The NIH-sponsored Atopic Dermatitis Research Network plans to conduct clinical trials to see if transplanting beneficial commensal bacteria will reduce staph colonization in atopic dermatitis patients and thereby result in therapeutic benefit, Dr. Leung noted.
He reported serving on scientific advisory boards for more than half a dozen pharmaceutical companies and receiving numerous research grants from the NIH.
LOS ANGELES – Evidence is building for the hypothesis that impairments in the skin’s microbiome promote Staphylococcus aureus colonization and drive atopic dermatitis, Dr. Donald Y.M. Leung said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The link between the bacteria and atopic dermatitis has long been discussed, but its role in pathogenesis still needs definition, he said.
“We’ve never been able to look at the total bacterial composition of the skin, but now with next-generation sequencing it’s finally possible to look at all the phylla and species. Other investigators have shown that during flares of atopic dermatitis there’s a reduction in bacterial diversity and an increase in staph, with S. aureus being particularly abundant. Then, post-flare, you see see a drop in S. aureus; this clearly suggests (it’s) important,” according to Dr. Leung, head of the division of pediatric allergy and immunology at National Jewish Health in Denver and professor of pediatrics at the University of Colorado.
Staphylococcus aureus is known to secrete virulence factors including cytotoxins, superantigens, lipases, and proteases that activate inflammatory cells and can cause significant skin barrier dysfunction.
The discovery that filaggrin mutations result in structural abnormalities in the skin barrier and are associated with sharply increased rates of atopic dermatitis and peanut allergy have strengthened the association, but filaggrin can’t be the whole story. Mutations in filaggrin are largely confined to individuals of Northern European ancestry; African Americans don’t have filaggrin mutations.
Yet atopic dermatitis is a global phenomenon. Further, a skin barrier defect is not enough to cause atopic dermatitis, Dr. Leung said. But such a defect, whether caused by a filaggrin mutation or something else, allows S. aureus to attach to and colonize the skin. Staph overgrowth or infection then activates an inflammatory cell cascade involving natural killer T cells, mast cells, cytokines, and Langerhans cells. That’s why the most effective treatments for atopic dermatitis address both the need to rebuild the skin barrier as well as the counterproductive immune response, he added.
Elsewhere at the AAAAI meeting, Dr. Andrea L. Jones, of National Jewish Health, presented an analysis of 718 children and adolescents with atopic dermatitis, all of whom had been cultured for S. aureus, in that institution’s database. Methicillin-resistant S. aureus (MRSA) was found in 19%; 57% were positive for methicillin-sensitive S. aureus (MSSA) and 23% lacked S. aureus. Of note, the prevalence of peanut allergy was highest at 78% in the group with MRSA; the prevalence was 39% in those with MSSA and 4% in those without S. aureus.
The prevalence of allergies to wheat, egg, milk, or soybeans in the youths with atopic dermatitis was unrelated to MRSA colonization.
“Our hypothesis – although we need to do a prospective study – is that staph colonization may lead to barrier dysfunction and thus allow environmental allergens to invade through the skin. Interestingly enough, people who weren’t colonized by staph had a very low level of sensitization to peanut,” said Dr. Leung, who was the senior investigator in the study.
Dr. Leung was a coauthor on another study that points to a potential new avenue of treatment in atopic dermatitis. Presented by investigators at the University of California, San Diego, at a recent meeting of the Society for Investigative Dermatology, the study showed that atopic dermatitis is marked by a defect in the commensal skin bacteria which normally keep S. aureus in check.
In that study, the amount of S. aureus growing on a defined area of lesional skin of atopic dermatitis patients was nearly 10-fold greater than that on nonlesional skin and the skin of controls without atopic dermatitis.
Commensal bacteria on lesional skin may possess markedly reduced antimicrobial activity. The NIH-sponsored Atopic Dermatitis Research Network plans to conduct clinical trials to see if transplanting beneficial commensal bacteria will reduce staph colonization in atopic dermatitis patients and thereby result in therapeutic benefit, Dr. Leung noted.
He reported serving on scientific advisory boards for more than half a dozen pharmaceutical companies and receiving numerous research grants from the NIH.
LOS ANGELES – Evidence is building for the hypothesis that impairments in the skin’s microbiome promote Staphylococcus aureus colonization and drive atopic dermatitis, Dr. Donald Y.M. Leung said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The link between the bacteria and atopic dermatitis has long been discussed, but its role in pathogenesis still needs definition, he said.
“We’ve never been able to look at the total bacterial composition of the skin, but now with next-generation sequencing it’s finally possible to look at all the phylla and species. Other investigators have shown that during flares of atopic dermatitis there’s a reduction in bacterial diversity and an increase in staph, with S. aureus being particularly abundant. Then, post-flare, you see see a drop in S. aureus; this clearly suggests (it’s) important,” according to Dr. Leung, head of the division of pediatric allergy and immunology at National Jewish Health in Denver and professor of pediatrics at the University of Colorado.
Staphylococcus aureus is known to secrete virulence factors including cytotoxins, superantigens, lipases, and proteases that activate inflammatory cells and can cause significant skin barrier dysfunction.
The discovery that filaggrin mutations result in structural abnormalities in the skin barrier and are associated with sharply increased rates of atopic dermatitis and peanut allergy have strengthened the association, but filaggrin can’t be the whole story. Mutations in filaggrin are largely confined to individuals of Northern European ancestry; African Americans don’t have filaggrin mutations.
Yet atopic dermatitis is a global phenomenon. Further, a skin barrier defect is not enough to cause atopic dermatitis, Dr. Leung said. But such a defect, whether caused by a filaggrin mutation or something else, allows S. aureus to attach to and colonize the skin. Staph overgrowth or infection then activates an inflammatory cell cascade involving natural killer T cells, mast cells, cytokines, and Langerhans cells. That’s why the most effective treatments for atopic dermatitis address both the need to rebuild the skin barrier as well as the counterproductive immune response, he added.
Elsewhere at the AAAAI meeting, Dr. Andrea L. Jones, of National Jewish Health, presented an analysis of 718 children and adolescents with atopic dermatitis, all of whom had been cultured for S. aureus, in that institution’s database. Methicillin-resistant S. aureus (MRSA) was found in 19%; 57% were positive for methicillin-sensitive S. aureus (MSSA) and 23% lacked S. aureus. Of note, the prevalence of peanut allergy was highest at 78% in the group with MRSA; the prevalence was 39% in those with MSSA and 4% in those without S. aureus.
The prevalence of allergies to wheat, egg, milk, or soybeans in the youths with atopic dermatitis was unrelated to MRSA colonization.
“Our hypothesis – although we need to do a prospective study – is that staph colonization may lead to barrier dysfunction and thus allow environmental allergens to invade through the skin. Interestingly enough, people who weren’t colonized by staph had a very low level of sensitization to peanut,” said Dr. Leung, who was the senior investigator in the study.
Dr. Leung was a coauthor on another study that points to a potential new avenue of treatment in atopic dermatitis. Presented by investigators at the University of California, San Diego, at a recent meeting of the Society for Investigative Dermatology, the study showed that atopic dermatitis is marked by a defect in the commensal skin bacteria which normally keep S. aureus in check.
In that study, the amount of S. aureus growing on a defined area of lesional skin of atopic dermatitis patients was nearly 10-fold greater than that on nonlesional skin and the skin of controls without atopic dermatitis.
Commensal bacteria on lesional skin may possess markedly reduced antimicrobial activity. The NIH-sponsored Atopic Dermatitis Research Network plans to conduct clinical trials to see if transplanting beneficial commensal bacteria will reduce staph colonization in atopic dermatitis patients and thereby result in therapeutic benefit, Dr. Leung noted.
He reported serving on scientific advisory boards for more than half a dozen pharmaceutical companies and receiving numerous research grants from the NIH.
AT 2016 AAAAI ANNUAL MEETING
FDA approves reslizumab as add-on drug for adults with severe asthma
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.
The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.
In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.
The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.
Teva Pharmaceuticals is marketing the drug as Cinqair.
Reslizumab especially effective in eosinophilic asthma with nasal polyps
LOS ANGELES – The interleukin-5 inhibitor reslizumab showed particularly strong efficacy in patients with severe eosinophilic asthma accompanied by chronic sinusitis and nasal polyps, as well as in patients age 65 and older, in separate analyses presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Both presentations were post hoc, pooled analyses of two published 52-week, double-blind, pivotal phase III randomized trials of IV reslizumab at 3.0 mg/kg or placebo every 4 weeks on top of standard background therapy. The trials included a combined total of close to 1,000 patients aged 12-75 years with baseline blood eosinophil counts of at least 400 cells/mcL and inadequately controlled asthma despite being on at least moderate-dose inhaled corticosteroids. The primary endpoint – frequency of clinical asthma exacerbations – was positive in both trials, with a reduction of 54% with reslizumab compared to placebo (Lancet Respir Med. 2015 May;3[5]:355-66).
Reslizumab is a humanized monoclonal antibody of the IgG4/K isotype. On the basis of the phase III trials and other data, last December the Food and Drug Administration’s Pulmonary-Allergy Drug Advisory Committee voted 11-3 to recommend approval of the biologic in 18- to 75-year-olds with inadequately controlled eosinophilic asthma. A decision by the federal agency is expected imminently.
The two post hoc analyses were conducted to highlight the biologic’s performance in clinically important but previously understudied patient subgroups, according to investigators.
Dr. Steven F. Weinstein compared 52-week outcomes in 250 patients with chronic sinusitis, including 150 who also had nasal polyps, in juxtaposition to the total two-study population of 953 eosinophilic asthma patients. Of note, aspirin sensitivity was present in 37% of those with chronic sinusitis with nasal polyps (CSwNP) compared to 11% of total participants in the two phase III trials. The CSwNP group had higher blood eosinophil levels, too: an average of 884 cells/mcL, compared with 655/mcL in the study population as a whole.
The frequency of clinical asthma exacerbations was 3.22 episodes in 52 weeks in CSwNP patients on placebo and 0.56 in those given reslizumab, for an 83% reduction in the active treatment arm. In the overall study population, the frequency was 1.81 episodes with placebo versus 0.84 with reslizumab, for a less robust but still highly significant 54% reduction. The reduction in exacerbations among all subjects with chronic sinusitis who received reslizumab was intermediate at 70%, going from 2.81 episodes in controls to 0.83 with biologic therapy.
Clinical asthma exacerbations were defined as the use of systemic steroids by patients not already on such medication or at least a twofold increase in doses of inhaled or systemic corticosteroids for at least 3 days.
The placebo-subtracted improvement in lung function from baseline to 52 weeks in reslizumab-treated patients was 326 mL in the CSwNP group, 235 mL in all patients with chronic sinusitis, and 109 mL in the overall study population, according to Dr. Weinstein, an allergist-immunologist practicing in Huntington Beach, Calif.
A 0.5-point improvement on the validated Asthma Quality of Life Questionnaire (AQLQ) is accepted by researchers as the minimum for demonstrating clinically significant benefit. The 52-week placebo-subtracted improvement on this measure was 0.69 points in the reslizumab-treated CSwNP group, 0.47 in the total cohort of asthmatics with chronic sinusitis, and 0.27 points in the overall reslizumab-treated population.
Similarly, the average placebo-subtracted improvement on the Asthma Control Questionnaire–6 was 1.45 points in reslizumab-treated patients with CSwNP, a sixfold greater response than seen in the total study population, Dr. Weinstein noted.
The same pattern of greater-than-average efficacy on both primary and secondary study endpoints was seen with reslizumab in the 77 patients aged 65 years and older included in the two phase III trials compared with those age 18-64, according to Dr. David Bernstein, professor of medicine and environmental health at the University of Cincinnati.
Although older patients made up only a small fraction of total subjects in the two trials, it was important to examine how reslizumab performed in such patients because asthma affects an estimated 7% of Americans age 65 and up, and rates of both asthma hospitalization and mortality are higher than in younger patients, he noted.
Older and younger asthma patients in the two trials had comparable baseline characteristics. Yet in the older cohort the reduction in frequency of asthma exacerbations with reslizumab as compared to placebo was 67%, while in the younger patients it was only 53%.
Improvements in symptoms and quality of life as measured on the AQLQ, the Asthma Control Questionnaire–7, and the Asthma Symptom Utility Index were consistently larger in the reslizumab-treated older as compared to younger patients. On all three measures, only the older reslizumab-treated group successfully hurdled the bar defining minimal clinically significant improvement.
The two post hoc analyses were funded by Teva Pharmaceuticals. Both investigators serve on advisory boards for Teva and multiple other pharmaceutical companies.
LOS ANGELES – The interleukin-5 inhibitor reslizumab showed particularly strong efficacy in patients with severe eosinophilic asthma accompanied by chronic sinusitis and nasal polyps, as well as in patients age 65 and older, in separate analyses presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Both presentations were post hoc, pooled analyses of two published 52-week, double-blind, pivotal phase III randomized trials of IV reslizumab at 3.0 mg/kg or placebo every 4 weeks on top of standard background therapy. The trials included a combined total of close to 1,000 patients aged 12-75 years with baseline blood eosinophil counts of at least 400 cells/mcL and inadequately controlled asthma despite being on at least moderate-dose inhaled corticosteroids. The primary endpoint – frequency of clinical asthma exacerbations – was positive in both trials, with a reduction of 54% with reslizumab compared to placebo (Lancet Respir Med. 2015 May;3[5]:355-66).
Reslizumab is a humanized monoclonal antibody of the IgG4/K isotype. On the basis of the phase III trials and other data, last December the Food and Drug Administration’s Pulmonary-Allergy Drug Advisory Committee voted 11-3 to recommend approval of the biologic in 18- to 75-year-olds with inadequately controlled eosinophilic asthma. A decision by the federal agency is expected imminently.
The two post hoc analyses were conducted to highlight the biologic’s performance in clinically important but previously understudied patient subgroups, according to investigators.
Dr. Steven F. Weinstein compared 52-week outcomes in 250 patients with chronic sinusitis, including 150 who also had nasal polyps, in juxtaposition to the total two-study population of 953 eosinophilic asthma patients. Of note, aspirin sensitivity was present in 37% of those with chronic sinusitis with nasal polyps (CSwNP) compared to 11% of total participants in the two phase III trials. The CSwNP group had higher blood eosinophil levels, too: an average of 884 cells/mcL, compared with 655/mcL in the study population as a whole.
The frequency of clinical asthma exacerbations was 3.22 episodes in 52 weeks in CSwNP patients on placebo and 0.56 in those given reslizumab, for an 83% reduction in the active treatment arm. In the overall study population, the frequency was 1.81 episodes with placebo versus 0.84 with reslizumab, for a less robust but still highly significant 54% reduction. The reduction in exacerbations among all subjects with chronic sinusitis who received reslizumab was intermediate at 70%, going from 2.81 episodes in controls to 0.83 with biologic therapy.
Clinical asthma exacerbations were defined as the use of systemic steroids by patients not already on such medication or at least a twofold increase in doses of inhaled or systemic corticosteroids for at least 3 days.
The placebo-subtracted improvement in lung function from baseline to 52 weeks in reslizumab-treated patients was 326 mL in the CSwNP group, 235 mL in all patients with chronic sinusitis, and 109 mL in the overall study population, according to Dr. Weinstein, an allergist-immunologist practicing in Huntington Beach, Calif.
A 0.5-point improvement on the validated Asthma Quality of Life Questionnaire (AQLQ) is accepted by researchers as the minimum for demonstrating clinically significant benefit. The 52-week placebo-subtracted improvement on this measure was 0.69 points in the reslizumab-treated CSwNP group, 0.47 in the total cohort of asthmatics with chronic sinusitis, and 0.27 points in the overall reslizumab-treated population.
Similarly, the average placebo-subtracted improvement on the Asthma Control Questionnaire–6 was 1.45 points in reslizumab-treated patients with CSwNP, a sixfold greater response than seen in the total study population, Dr. Weinstein noted.
The same pattern of greater-than-average efficacy on both primary and secondary study endpoints was seen with reslizumab in the 77 patients aged 65 years and older included in the two phase III trials compared with those age 18-64, according to Dr. David Bernstein, professor of medicine and environmental health at the University of Cincinnati.
Although older patients made up only a small fraction of total subjects in the two trials, it was important to examine how reslizumab performed in such patients because asthma affects an estimated 7% of Americans age 65 and up, and rates of both asthma hospitalization and mortality are higher than in younger patients, he noted.
Older and younger asthma patients in the two trials had comparable baseline characteristics. Yet in the older cohort the reduction in frequency of asthma exacerbations with reslizumab as compared to placebo was 67%, while in the younger patients it was only 53%.
Improvements in symptoms and quality of life as measured on the AQLQ, the Asthma Control Questionnaire–7, and the Asthma Symptom Utility Index were consistently larger in the reslizumab-treated older as compared to younger patients. On all three measures, only the older reslizumab-treated group successfully hurdled the bar defining minimal clinically significant improvement.
The two post hoc analyses were funded by Teva Pharmaceuticals. Both investigators serve on advisory boards for Teva and multiple other pharmaceutical companies.
LOS ANGELES – The interleukin-5 inhibitor reslizumab showed particularly strong efficacy in patients with severe eosinophilic asthma accompanied by chronic sinusitis and nasal polyps, as well as in patients age 65 and older, in separate analyses presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Both presentations were post hoc, pooled analyses of two published 52-week, double-blind, pivotal phase III randomized trials of IV reslizumab at 3.0 mg/kg or placebo every 4 weeks on top of standard background therapy. The trials included a combined total of close to 1,000 patients aged 12-75 years with baseline blood eosinophil counts of at least 400 cells/mcL and inadequately controlled asthma despite being on at least moderate-dose inhaled corticosteroids. The primary endpoint – frequency of clinical asthma exacerbations – was positive in both trials, with a reduction of 54% with reslizumab compared to placebo (Lancet Respir Med. 2015 May;3[5]:355-66).
Reslizumab is a humanized monoclonal antibody of the IgG4/K isotype. On the basis of the phase III trials and other data, last December the Food and Drug Administration’s Pulmonary-Allergy Drug Advisory Committee voted 11-3 to recommend approval of the biologic in 18- to 75-year-olds with inadequately controlled eosinophilic asthma. A decision by the federal agency is expected imminently.
The two post hoc analyses were conducted to highlight the biologic’s performance in clinically important but previously understudied patient subgroups, according to investigators.
Dr. Steven F. Weinstein compared 52-week outcomes in 250 patients with chronic sinusitis, including 150 who also had nasal polyps, in juxtaposition to the total two-study population of 953 eosinophilic asthma patients. Of note, aspirin sensitivity was present in 37% of those with chronic sinusitis with nasal polyps (CSwNP) compared to 11% of total participants in the two phase III trials. The CSwNP group had higher blood eosinophil levels, too: an average of 884 cells/mcL, compared with 655/mcL in the study population as a whole.
The frequency of clinical asthma exacerbations was 3.22 episodes in 52 weeks in CSwNP patients on placebo and 0.56 in those given reslizumab, for an 83% reduction in the active treatment arm. In the overall study population, the frequency was 1.81 episodes with placebo versus 0.84 with reslizumab, for a less robust but still highly significant 54% reduction. The reduction in exacerbations among all subjects with chronic sinusitis who received reslizumab was intermediate at 70%, going from 2.81 episodes in controls to 0.83 with biologic therapy.
Clinical asthma exacerbations were defined as the use of systemic steroids by patients not already on such medication or at least a twofold increase in doses of inhaled or systemic corticosteroids for at least 3 days.
The placebo-subtracted improvement in lung function from baseline to 52 weeks in reslizumab-treated patients was 326 mL in the CSwNP group, 235 mL in all patients with chronic sinusitis, and 109 mL in the overall study population, according to Dr. Weinstein, an allergist-immunologist practicing in Huntington Beach, Calif.
A 0.5-point improvement on the validated Asthma Quality of Life Questionnaire (AQLQ) is accepted by researchers as the minimum for demonstrating clinically significant benefit. The 52-week placebo-subtracted improvement on this measure was 0.69 points in the reslizumab-treated CSwNP group, 0.47 in the total cohort of asthmatics with chronic sinusitis, and 0.27 points in the overall reslizumab-treated population.
Similarly, the average placebo-subtracted improvement on the Asthma Control Questionnaire–6 was 1.45 points in reslizumab-treated patients with CSwNP, a sixfold greater response than seen in the total study population, Dr. Weinstein noted.
The same pattern of greater-than-average efficacy on both primary and secondary study endpoints was seen with reslizumab in the 77 patients aged 65 years and older included in the two phase III trials compared with those age 18-64, according to Dr. David Bernstein, professor of medicine and environmental health at the University of Cincinnati.
Although older patients made up only a small fraction of total subjects in the two trials, it was important to examine how reslizumab performed in such patients because asthma affects an estimated 7% of Americans age 65 and up, and rates of both asthma hospitalization and mortality are higher than in younger patients, he noted.
Older and younger asthma patients in the two trials had comparable baseline characteristics. Yet in the older cohort the reduction in frequency of asthma exacerbations with reslizumab as compared to placebo was 67%, while in the younger patients it was only 53%.
Improvements in symptoms and quality of life as measured on the AQLQ, the Asthma Control Questionnaire–7, and the Asthma Symptom Utility Index were consistently larger in the reslizumab-treated older as compared to younger patients. On all three measures, only the older reslizumab-treated group successfully hurdled the bar defining minimal clinically significant improvement.
The two post hoc analyses were funded by Teva Pharmaceuticals. Both investigators serve on advisory boards for Teva and multiple other pharmaceutical companies.
AT 2016 AAAAI ANNUAL MEETING
Nemolizumab improved most common symptoms in moderate, severe atopic dermatitis
WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.
“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”
Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.
The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.
The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.
Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).
The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.
Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.
Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.
CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.
On Twitter @whitneymcknight
WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.
“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”
Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.
The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.
The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.
Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).
The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.
Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.
Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.
CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.
On Twitter @whitneymcknight
WASHINGTON – Nemolizumab, an anti-interleukin-31 receptor A monoclonal antibody, was shown to rapidly and consistently improve pruritus, dermatitis, and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis in a phase II, randomized, double-blind, placebo-controlled trial.
“The patients notice that the itch is gone very quickly, sometimes within days, even before their dermatitis starts to heal,” said Dr. Jon M. Hanifin, one of the treatment’s investigators. “It’s very exciting.”
Dr. Hanifin, a researcher at Oregon Health & Science University, Portland, made his comments while presenting the data during the late-breaking clinical research session at this year’s annual meeting of the American Academy of Dermatology.
The novel treatment, currently known as CIM331 (Chugai) targets elevated levels of interleukin-31, a cytokine that has been implicated in the pathophysiology of atopic dermatitis (AD) and pruritus.
The multicenter, multi-dose study assigned 264 patients, primarily in their mid-30s, with moderate-to-severe AD, uncontrolled by topical treatments, to either placebo or 0.1 mg/kg, 0.5 mg/kg, or 2.0 mg/kg CIM331 every 4 weeks. The study completion rate was 82%.
Using a visual analog scale of 0 to 10, with 10 characterized as “the worst imaginable,” at week 12, patients in the three study groups reported −41.5%, −61.2%, and −60.5% reductions in pruritus vs. −20.1% for placebo (P less than .01 for all).
The “significant reductions” in itch began as early as week 1, particularly in the group treated with the 2-mg/kg dose. Dr. Hanifin said that the patients had a very high mean pruritis score, and some had as much as half of their body surface area affected by AD.
Rescue medications such as topical corticosteroids were not permitted until after at least 1 month of treatment. Patients given rescue therapies were required to have both itch and dermatitis. “This was kind of a tough thing to get through, but [patients] did okay,” Dr. Hanifin said.
Patients treated with the 0.5-mg/kg dose showed the most improvement from baseline in Eczema Area and Severity Index scores at week 12 at −44.6%, compared with −20.9% for placebo. Across the study arms, the proportion of static Investigator’s Global Assessment of 1 or less was 20.9% vs. 4.7% for placebo. Additionally, Dr. Hanifin said sleep latency in the study groups was improved by half and there was an increase in total overall sleep time.
CIM331 was well tolerated, with the most common adverse events being exacerbation of AD and nasopharyngitis. “The risk of immune suppression seemed to be low,” Dr. Hanifin said.
On Twitter @whitneymcknight
AT AAD 2016
Key clinical point: Nemolizumab rapidly and consistently improved pruritus, dermatitis and sleep disturbance in patients with previously uncontrolled moderate-to-severe atopic dermatitis.
Major finding: At week 12, patients treated with nemolizumab reported reductions in pruritus of −41.5% for 0.1 mg/kg, −61.2% for 0.5 mg/kg, and −60.5% 2.0 mg/kg vs. −20.1% for placebo (P less than .01 for all).
Data source: Randomized, double-blind, placebo-controlled, multi-center, multi-dose phase II study of 264 patients with moderate-to-severe atopic dermatitis.
Disclosures: This trial was sponsored by Chugai Pharmaceuticals.
Infant Egg Introduction Can Prevent Sensitization at 12 Months
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
AT 2016 AAAAI ANNUAL MEETING
Infant Egg Introduction Can Prevent Sensitization at 12 Months
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
AT 2016 AAAAI ANNUAL MEETING
Infant egg introduction can prevent sensitization at 12 months
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.
“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.
Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.
At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).
About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.
Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.
The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.
Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.
The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.
The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.
The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.
The work was funded by the Australian government, among others. The investigators have no disclosures.
AT 2016 AAAAI ANNUAL MEETING
Key clinical point: If at-risk infants have negative skin prick tests (SPTs) at 4 months, tell their moms to introduce egg into their weaning diets.
Major finding: At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 children (20%) in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03).
Data source: Randomized clinical trial or 244 infants at risk for egg allergy.
Disclosures: The work was funded by the Australian government, among others. The investigators have no disclosures.
AAAAI: Albuterol Dry Powder Inhaler Offers Simplified Approach for Young Kids
LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.
A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.
The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.
“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.
The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.
The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.
Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.
No adverse events attributable to the study drug were seen.
The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.
LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.
A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.
The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.
“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.
The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.
The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.
Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.
No adverse events attributable to the study drug were seen.
The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.
LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.
A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.
The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.
“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.
The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.
The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.
Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.
No adverse events attributable to the study drug were seen.
The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.
AT 2016 AAAAI ANNUAL MEETING
AAAAI: Albuterol Dry Powder Inhaler Offers Simplified Approach for Young Kids
LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.
A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.
The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.
“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.
The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.
The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.
Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.
No adverse events attributable to the study drug were seen.
The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.
LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.
A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.
The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.
“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.
The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.
The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.
Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.
No adverse events attributable to the study drug were seen.
The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.
LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.
A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.
The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.
“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.
The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.
The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.
Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.
No adverse events attributable to the study drug were seen.
The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.
AT 2016 AAAAI ANNUAL MEETING
