Mylan’s generic EpiPen – a price break or marketing maneuver?

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Mylan’s generic EpiPen – a price break or marketing maneuver?

Following weeks of criticism over dramatic price increases on its EpiPen, Mylan said on Aug. 29 that it will offer a generic version of the life-saving allergy treatment. The generic, which the company says will be identical to the brand product, will sell for $300 for a two-pack, which is half the cost of Mylan’s brand name EpiPens. The news did little to dim the ongoing outcry over the price, for which there are no other competitors on the market. Some called it a marketing ploy, while Robert Weissman, president of the consumer group Public Citizen, said the generic price was still too high, writing in the Huffington Post of “the weirdness of a drug company offering a generic version” of its own brand-name product.

KHN offers answers to some key questions related to Mylan’s generic and breaks down what this development could mean for consumers and the marketplace.

When will I be able to get a generic EpiPen?Mylan, which is the company that markets this treatment, says it will have a product out within a few weeks. Pfizer is the firm that actually manufactures EpiPens. The drug used is the product epinephrine but the patent applies to the auto-injector device used to deliver it.

Will it cost me less?

For some patients, yes. Those who are uninsured, pay a percentage of the drug cost as their insurance copayment or have an unmet prescription deductible will likely pay less for the $300 two-pack generic than for the brand-name version. That’s because what they pay is based on the full price. Many other consumer have insurance with flat-dollar drug copayments, ranging from $10 to $100 for every prescription so they are paying far less than the retail price. Insurers generally set lower copayments for generic drugs than brand. So if a consumer’s health insurer makes the generic available and places it in the generic payment “tier,” the cost per prescription also could fall. In some cases, however, there is a possibility that some people who could benefit from the lower cost generic won’t have access to it. An insurer or pharmacy benefit manager, for example, might not add the generic EpiPen to the formulary, or restrict its availability in some way. That’s because some health plans get such large rebates from brand-name companies as to make the brand-name version cost less than the generic, said Adam Fein, president of Pembroke Consulting. But consumers do not benefit from rebates directly. Instead, it goes to the pharmacy manager, insurer or employer.

Are manufacturer rebates good?

It depends. They can help lower the cost of the drug for insurers and employers, helping slow overall spending and keep costs paid by consumers such as premiums and deductibles lower. “If we didn’t have rebates [spending on drugs] would be at least 35 percent higher,” said Richard Evans, co-founder of SSR Health, who does investment research on the pharmaceutical industry.

Even so, some say rebates should be barred in favor of more transparent prices. Stephen Schondelmeyer, director of the Prime Institute, an independent consulting group that monitors pharmaceutical trends, said discounts don’t make him feel good when his health plan is paying about $700 for EpiPens that it paid $80 for five years ago. “We should outlaw rebates,” said Schondelmeyer, who also helps oversee the University of Minnesota’s health plan. “What rebates are really is a way to overcharge the market. … We are giving the drug industry loans to the tune of billions of dollars … and rarely does it get back to the end consumer.”

Are drugmakers even allowed to create generic versions of their own products?

Many major drugmakers also market their drugs as generics. Called “authorized generics,” such products are identical to the drugs approved by the Food and Drug Administration as part of a manufacturer’s New Drug Application. Drugmakers do not need to go back to the FDA for any further approvals in order to market an authorized generic.

Why would drugmakers want to offer a generic to their own product?

Most authorized generics appear on the market just as a competitor launches a generic of its own. In those cases, the move helps brand manufacturers retain some revenue that might otherwise be lost to competitors because the entry of less costly generics generally results in a sharp drop in brand-name sales. Manufacturers are careful not to release the authorized generic much before it loses patent protection, because it doesn’t want it to undercut sales of its more pricey brand-name product.

So why is Mylan doing this?

 

 

Mylan appears to be offering its “authorized generic” in response to complaints about the cost of its brand-name drug, not fear of competition from rivals. It currently controls the market. Pembroke’s Fein said Mylan miscalculated when it raised EpiPen’s price tag from about $100 to $600 over the past decade.

During that time, the firm failed to notice that insurance coverage had changed, Fein said. Instead of flat-dollar copayments, a growing number of consumers now have prescription deductibles they must meet first. That means some consumers are on the hook for the full $600. “They behaved as if everyone had good insurance,” said Fein. And the firm still seems to argue that raising its prices would not hurt most consumers, noting that many had flat copayments of less than $100. But, as the price rose, their insurer or the employer who provides coverage made up the difference, helping fuel premium and deductible increases.

“Premiums are an out-of-pocket cost,” said Schondelmeyer. “That’s what Mylan and other manufacturers have ignored.”

Do authorized generics reduce competition, which is supposed to help lower prices?

Some generic companies argue that is the case, saying a brand-name company jumping in ahead of rivals makes it less attractive for generic makers to bring their own products to market or challenge existing patents held by brand-name companies. But a 2011 Federal Trade Commission report found that authorized generics did not “measurably” reduce the number of patent challenges. The study also said the presence of authorized generics actually resulted in retail generic prices that were 4 to 8 percent lower than they would have been without.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Julie Appleby reports on the health care law’s implementation, health care treatments and costs, trends in health insurance, and policy affecting hospitals and other medical providers. Her stories have appeared in USA Today, the Washington Post, the Philadelphia Inquirer, MSNBC and others. Before joining KHN, Appleby spent 10 years covering the health care industry and policy at USA Today. She also worked at the San Francisco Chronicle, The Financial Times in London and the Contra Costa Times in Walnut Creek, Calif. She serves on the board of the Association of Health Care Journalists and has a Master of Public Health degree.

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Following weeks of criticism over dramatic price increases on its EpiPen, Mylan said on Aug. 29 that it will offer a generic version of the life-saving allergy treatment. The generic, which the company says will be identical to the brand product, will sell for $300 for a two-pack, which is half the cost of Mylan’s brand name EpiPens. The news did little to dim the ongoing outcry over the price, for which there are no other competitors on the market. Some called it a marketing ploy, while Robert Weissman, president of the consumer group Public Citizen, said the generic price was still too high, writing in the Huffington Post of “the weirdness of a drug company offering a generic version” of its own brand-name product.

KHN offers answers to some key questions related to Mylan’s generic and breaks down what this development could mean for consumers and the marketplace.

When will I be able to get a generic EpiPen?Mylan, which is the company that markets this treatment, says it will have a product out within a few weeks. Pfizer is the firm that actually manufactures EpiPens. The drug used is the product epinephrine but the patent applies to the auto-injector device used to deliver it.

Will it cost me less?

For some patients, yes. Those who are uninsured, pay a percentage of the drug cost as their insurance copayment or have an unmet prescription deductible will likely pay less for the $300 two-pack generic than for the brand-name version. That’s because what they pay is based on the full price. Many other consumer have insurance with flat-dollar drug copayments, ranging from $10 to $100 for every prescription so they are paying far less than the retail price. Insurers generally set lower copayments for generic drugs than brand. So if a consumer’s health insurer makes the generic available and places it in the generic payment “tier,” the cost per prescription also could fall. In some cases, however, there is a possibility that some people who could benefit from the lower cost generic won’t have access to it. An insurer or pharmacy benefit manager, for example, might not add the generic EpiPen to the formulary, or restrict its availability in some way. That’s because some health plans get such large rebates from brand-name companies as to make the brand-name version cost less than the generic, said Adam Fein, president of Pembroke Consulting. But consumers do not benefit from rebates directly. Instead, it goes to the pharmacy manager, insurer or employer.

Are manufacturer rebates good?

It depends. They can help lower the cost of the drug for insurers and employers, helping slow overall spending and keep costs paid by consumers such as premiums and deductibles lower. “If we didn’t have rebates [spending on drugs] would be at least 35 percent higher,” said Richard Evans, co-founder of SSR Health, who does investment research on the pharmaceutical industry.

Even so, some say rebates should be barred in favor of more transparent prices. Stephen Schondelmeyer, director of the Prime Institute, an independent consulting group that monitors pharmaceutical trends, said discounts don’t make him feel good when his health plan is paying about $700 for EpiPens that it paid $80 for five years ago. “We should outlaw rebates,” said Schondelmeyer, who also helps oversee the University of Minnesota’s health plan. “What rebates are really is a way to overcharge the market. … We are giving the drug industry loans to the tune of billions of dollars … and rarely does it get back to the end consumer.”

Are drugmakers even allowed to create generic versions of their own products?

Many major drugmakers also market their drugs as generics. Called “authorized generics,” such products are identical to the drugs approved by the Food and Drug Administration as part of a manufacturer’s New Drug Application. Drugmakers do not need to go back to the FDA for any further approvals in order to market an authorized generic.

Why would drugmakers want to offer a generic to their own product?

Most authorized generics appear on the market just as a competitor launches a generic of its own. In those cases, the move helps brand manufacturers retain some revenue that might otherwise be lost to competitors because the entry of less costly generics generally results in a sharp drop in brand-name sales. Manufacturers are careful not to release the authorized generic much before it loses patent protection, because it doesn’t want it to undercut sales of its more pricey brand-name product.

So why is Mylan doing this?

 

 

Mylan appears to be offering its “authorized generic” in response to complaints about the cost of its brand-name drug, not fear of competition from rivals. It currently controls the market. Pembroke’s Fein said Mylan miscalculated when it raised EpiPen’s price tag from about $100 to $600 over the past decade.

During that time, the firm failed to notice that insurance coverage had changed, Fein said. Instead of flat-dollar copayments, a growing number of consumers now have prescription deductibles they must meet first. That means some consumers are on the hook for the full $600. “They behaved as if everyone had good insurance,” said Fein. And the firm still seems to argue that raising its prices would not hurt most consumers, noting that many had flat copayments of less than $100. But, as the price rose, their insurer or the employer who provides coverage made up the difference, helping fuel premium and deductible increases.

“Premiums are an out-of-pocket cost,” said Schondelmeyer. “That’s what Mylan and other manufacturers have ignored.”

Do authorized generics reduce competition, which is supposed to help lower prices?

Some generic companies argue that is the case, saying a brand-name company jumping in ahead of rivals makes it less attractive for generic makers to bring their own products to market or challenge existing patents held by brand-name companies. But a 2011 Federal Trade Commission report found that authorized generics did not “measurably” reduce the number of patent challenges. The study also said the presence of authorized generics actually resulted in retail generic prices that were 4 to 8 percent lower than they would have been without.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Julie Appleby reports on the health care law’s implementation, health care treatments and costs, trends in health insurance, and policy affecting hospitals and other medical providers. Her stories have appeared in USA Today, the Washington Post, the Philadelphia Inquirer, MSNBC and others. Before joining KHN, Appleby spent 10 years covering the health care industry and policy at USA Today. She also worked at the San Francisco Chronicle, The Financial Times in London and the Contra Costa Times in Walnut Creek, Calif. She serves on the board of the Association of Health Care Journalists and has a Master of Public Health degree.

Following weeks of criticism over dramatic price increases on its EpiPen, Mylan said on Aug. 29 that it will offer a generic version of the life-saving allergy treatment. The generic, which the company says will be identical to the brand product, will sell for $300 for a two-pack, which is half the cost of Mylan’s brand name EpiPens. The news did little to dim the ongoing outcry over the price, for which there are no other competitors on the market. Some called it a marketing ploy, while Robert Weissman, president of the consumer group Public Citizen, said the generic price was still too high, writing in the Huffington Post of “the weirdness of a drug company offering a generic version” of its own brand-name product.

KHN offers answers to some key questions related to Mylan’s generic and breaks down what this development could mean for consumers and the marketplace.

When will I be able to get a generic EpiPen?Mylan, which is the company that markets this treatment, says it will have a product out within a few weeks. Pfizer is the firm that actually manufactures EpiPens. The drug used is the product epinephrine but the patent applies to the auto-injector device used to deliver it.

Will it cost me less?

For some patients, yes. Those who are uninsured, pay a percentage of the drug cost as their insurance copayment or have an unmet prescription deductible will likely pay less for the $300 two-pack generic than for the brand-name version. That’s because what they pay is based on the full price. Many other consumer have insurance with flat-dollar drug copayments, ranging from $10 to $100 for every prescription so they are paying far less than the retail price. Insurers generally set lower copayments for generic drugs than brand. So if a consumer’s health insurer makes the generic available and places it in the generic payment “tier,” the cost per prescription also could fall. In some cases, however, there is a possibility that some people who could benefit from the lower cost generic won’t have access to it. An insurer or pharmacy benefit manager, for example, might not add the generic EpiPen to the formulary, or restrict its availability in some way. That’s because some health plans get such large rebates from brand-name companies as to make the brand-name version cost less than the generic, said Adam Fein, president of Pembroke Consulting. But consumers do not benefit from rebates directly. Instead, it goes to the pharmacy manager, insurer or employer.

Are manufacturer rebates good?

It depends. They can help lower the cost of the drug for insurers and employers, helping slow overall spending and keep costs paid by consumers such as premiums and deductibles lower. “If we didn’t have rebates [spending on drugs] would be at least 35 percent higher,” said Richard Evans, co-founder of SSR Health, who does investment research on the pharmaceutical industry.

Even so, some say rebates should be barred in favor of more transparent prices. Stephen Schondelmeyer, director of the Prime Institute, an independent consulting group that monitors pharmaceutical trends, said discounts don’t make him feel good when his health plan is paying about $700 for EpiPens that it paid $80 for five years ago. “We should outlaw rebates,” said Schondelmeyer, who also helps oversee the University of Minnesota’s health plan. “What rebates are really is a way to overcharge the market. … We are giving the drug industry loans to the tune of billions of dollars … and rarely does it get back to the end consumer.”

Are drugmakers even allowed to create generic versions of their own products?

Many major drugmakers also market their drugs as generics. Called “authorized generics,” such products are identical to the drugs approved by the Food and Drug Administration as part of a manufacturer’s New Drug Application. Drugmakers do not need to go back to the FDA for any further approvals in order to market an authorized generic.

Why would drugmakers want to offer a generic to their own product?

Most authorized generics appear on the market just as a competitor launches a generic of its own. In those cases, the move helps brand manufacturers retain some revenue that might otherwise be lost to competitors because the entry of less costly generics generally results in a sharp drop in brand-name sales. Manufacturers are careful not to release the authorized generic much before it loses patent protection, because it doesn’t want it to undercut sales of its more pricey brand-name product.

So why is Mylan doing this?

 

 

Mylan appears to be offering its “authorized generic” in response to complaints about the cost of its brand-name drug, not fear of competition from rivals. It currently controls the market. Pembroke’s Fein said Mylan miscalculated when it raised EpiPen’s price tag from about $100 to $600 over the past decade.

During that time, the firm failed to notice that insurance coverage had changed, Fein said. Instead of flat-dollar copayments, a growing number of consumers now have prescription deductibles they must meet first. That means some consumers are on the hook for the full $600. “They behaved as if everyone had good insurance,” said Fein. And the firm still seems to argue that raising its prices would not hurt most consumers, noting that many had flat copayments of less than $100. But, as the price rose, their insurer or the employer who provides coverage made up the difference, helping fuel premium and deductible increases.

“Premiums are an out-of-pocket cost,” said Schondelmeyer. “That’s what Mylan and other manufacturers have ignored.”

Do authorized generics reduce competition, which is supposed to help lower prices?

Some generic companies argue that is the case, saying a brand-name company jumping in ahead of rivals makes it less attractive for generic makers to bring their own products to market or challenge existing patents held by brand-name companies. But a 2011 Federal Trade Commission report found that authorized generics did not “measurably” reduce the number of patent challenges. The study also said the presence of authorized generics actually resulted in retail generic prices that were 4 to 8 percent lower than they would have been without.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation. Julie Appleby reports on the health care law’s implementation, health care treatments and costs, trends in health insurance, and policy affecting hospitals and other medical providers. Her stories have appeared in USA Today, the Washington Post, the Philadelphia Inquirer, MSNBC and others. Before joining KHN, Appleby spent 10 years covering the health care industry and policy at USA Today. She also worked at the San Francisco Chronicle, The Financial Times in London and the Contra Costa Times in Walnut Creek, Calif. She serves on the board of the Association of Health Care Journalists and has a Master of Public Health degree.

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Peanut-allergic preschoolers benefit from oral immunotherapy

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Peanut-allergic preschoolers benefit from oral immunotherapy

Early intervention oral immunotherapy (OIT) improved a majority of peanut-allergic preschoolers’ ability to eat peanut protein with no reaction, based on data from a randomized trial of 40 children aged 9-36 months.

“We postulated that targeting newly diagnosed young peanut-allergic children would provide the best opportunity to enhance the clinical effectiveness of OIT as an immunomodulatory and disease-modifying treatment by interrupting allergic priming before its full maturation,” wrote Brian P. Vickery, MD, of the University of North Carolina, Chapel Hill, and his colleagues.

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The children received doses of either 300 mg/day or 3,000 mg/day of peanut protein for an average of 29 months. Overall, 78% of the 37 children in the intent-to-treat analysis met the primary endpoint of unresponsiveness to peanut protein 4 weeks after discontinuing oral immunotherapy (85% of the 300-mg group and 71% of the 3,000-mg group). Peanut-specific levels of IgE dropped significantly in the treatment group, and the treated children were 19 times more likely to eat 5 g of peanut protein without reaction than were 154 untreated matched controls.

Three children discontinued the study because of treatment-related adverse events, but no treatment-related severe adverse events, hospitalizations, or deaths were reported.

The findings suggest “that allergic responses may be more easily and durably corrected in young children, and that in this context, relatively low OIT doses are sufficiently potent in suppressing IgE responses and stimulating IgG4 production,” the researchers said.

Find the full study here in the Journal of Allergy and Clinical Immunology (2016 Aug. doi: 10.1016/j.jaci.2016.05.027).

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Early intervention oral immunotherapy (OIT) improved a majority of peanut-allergic preschoolers’ ability to eat peanut protein with no reaction, based on data from a randomized trial of 40 children aged 9-36 months.

“We postulated that targeting newly diagnosed young peanut-allergic children would provide the best opportunity to enhance the clinical effectiveness of OIT as an immunomodulatory and disease-modifying treatment by interrupting allergic priming before its full maturation,” wrote Brian P. Vickery, MD, of the University of North Carolina, Chapel Hill, and his colleagues.

yktr/ThinkStock

The children received doses of either 300 mg/day or 3,000 mg/day of peanut protein for an average of 29 months. Overall, 78% of the 37 children in the intent-to-treat analysis met the primary endpoint of unresponsiveness to peanut protein 4 weeks after discontinuing oral immunotherapy (85% of the 300-mg group and 71% of the 3,000-mg group). Peanut-specific levels of IgE dropped significantly in the treatment group, and the treated children were 19 times more likely to eat 5 g of peanut protein without reaction than were 154 untreated matched controls.

Three children discontinued the study because of treatment-related adverse events, but no treatment-related severe adverse events, hospitalizations, or deaths were reported.

The findings suggest “that allergic responses may be more easily and durably corrected in young children, and that in this context, relatively low OIT doses are sufficiently potent in suppressing IgE responses and stimulating IgG4 production,” the researchers said.

Find the full study here in the Journal of Allergy and Clinical Immunology (2016 Aug. doi: 10.1016/j.jaci.2016.05.027).

Early intervention oral immunotherapy (OIT) improved a majority of peanut-allergic preschoolers’ ability to eat peanut protein with no reaction, based on data from a randomized trial of 40 children aged 9-36 months.

“We postulated that targeting newly diagnosed young peanut-allergic children would provide the best opportunity to enhance the clinical effectiveness of OIT as an immunomodulatory and disease-modifying treatment by interrupting allergic priming before its full maturation,” wrote Brian P. Vickery, MD, of the University of North Carolina, Chapel Hill, and his colleagues.

yktr/ThinkStock

The children received doses of either 300 mg/day or 3,000 mg/day of peanut protein for an average of 29 months. Overall, 78% of the 37 children in the intent-to-treat analysis met the primary endpoint of unresponsiveness to peanut protein 4 weeks after discontinuing oral immunotherapy (85% of the 300-mg group and 71% of the 3,000-mg group). Peanut-specific levels of IgE dropped significantly in the treatment group, and the treated children were 19 times more likely to eat 5 g of peanut protein without reaction than were 154 untreated matched controls.

Three children discontinued the study because of treatment-related adverse events, but no treatment-related severe adverse events, hospitalizations, or deaths were reported.

The findings suggest “that allergic responses may be more easily and durably corrected in young children, and that in this context, relatively low OIT doses are sufficiently potent in suppressing IgE responses and stimulating IgG4 production,” the researchers said.

Find the full study here in the Journal of Allergy and Clinical Immunology (2016 Aug. doi: 10.1016/j.jaci.2016.05.027).

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Antibiotics overprescribed during asthma-related hospitalizations

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Antibiotics are overprescribed in asthma-related hospitalizations, even though guidelines recommend against prescribing antibiotics during exacerbations of asthma in the absence of concurrent infection, reported Peter K. Lindenauer, MD, MSc, of Baystate Medical Center in Springfield, Mass., and his colleagues.

They examined the hospitalization records of 51,951 individuals admitted to 577 hospitals in the United States between 2013 and 2014 with a principal diagnosis of either asthma or acute respiratory failure combined with asthma as a secondary diagnosis. Each patient type and the timing of antibiotic therapy was noted.

Dr. Peter Lindenauer

A total of 30,226 of the 51,951 patients (58.2%) were prescribed antibiotics at some point during their hospitalization, while 21,248 (40.9%) were prescribed antibiotics on the first day of hospitalization, without “documentation of an indication for antibiotic therapy.”

Macrolides were most commonly prescribed, given to 9,633 (18.5%) of patients, followed by quinolones (8,632, 16.1%), third-generation cephalosporins (4,420, 8.5%), and tetracyclines (1,858, 3.6%). After adjustment for risk variables, chronic obstructive asthma hospitalizations were found to be those most highly associated with receiving antibiotics (odds ratio 1.6, 95% confidence interval 1.5-1.7).

“Possible explanations for this high rate of potentially inappropriate treatment include the challenge of differentiating bacterial from nonbacterial infections, distinguishing asthma from chronic obstructive pulmonary disease in the acute care setting, and gaps in knowledge about the benefits of antibiotic therapy,” the authors posited, adding that these findings “suggest a significant opportunity to improve patient safety, reduce the spread of resistance, and lower spending through greater adherence to guideline recommendations.”

The National Heart, Lung, and Blood Institute and Veterans Affairs Health Services Research and Development funded the study. Dr. Lindenauer and his coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

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Antibiotics are overprescribed in asthma-related hospitalizations, even though guidelines recommend against prescribing antibiotics during exacerbations of asthma in the absence of concurrent infection, reported Peter K. Lindenauer, MD, MSc, of Baystate Medical Center in Springfield, Mass., and his colleagues.

They examined the hospitalization records of 51,951 individuals admitted to 577 hospitals in the United States between 2013 and 2014 with a principal diagnosis of either asthma or acute respiratory failure combined with asthma as a secondary diagnosis. Each patient type and the timing of antibiotic therapy was noted.

Dr. Peter Lindenauer

A total of 30,226 of the 51,951 patients (58.2%) were prescribed antibiotics at some point during their hospitalization, while 21,248 (40.9%) were prescribed antibiotics on the first day of hospitalization, without “documentation of an indication for antibiotic therapy.”

Macrolides were most commonly prescribed, given to 9,633 (18.5%) of patients, followed by quinolones (8,632, 16.1%), third-generation cephalosporins (4,420, 8.5%), and tetracyclines (1,858, 3.6%). After adjustment for risk variables, chronic obstructive asthma hospitalizations were found to be those most highly associated with receiving antibiotics (odds ratio 1.6, 95% confidence interval 1.5-1.7).

“Possible explanations for this high rate of potentially inappropriate treatment include the challenge of differentiating bacterial from nonbacterial infections, distinguishing asthma from chronic obstructive pulmonary disease in the acute care setting, and gaps in knowledge about the benefits of antibiotic therapy,” the authors posited, adding that these findings “suggest a significant opportunity to improve patient safety, reduce the spread of resistance, and lower spending through greater adherence to guideline recommendations.”

The National Heart, Lung, and Blood Institute and Veterans Affairs Health Services Research and Development funded the study. Dr. Lindenauer and his coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

Antibiotics are overprescribed in asthma-related hospitalizations, even though guidelines recommend against prescribing antibiotics during exacerbations of asthma in the absence of concurrent infection, reported Peter K. Lindenauer, MD, MSc, of Baystate Medical Center in Springfield, Mass., and his colleagues.

They examined the hospitalization records of 51,951 individuals admitted to 577 hospitals in the United States between 2013 and 2014 with a principal diagnosis of either asthma or acute respiratory failure combined with asthma as a secondary diagnosis. Each patient type and the timing of antibiotic therapy was noted.

Dr. Peter Lindenauer

A total of 30,226 of the 51,951 patients (58.2%) were prescribed antibiotics at some point during their hospitalization, while 21,248 (40.9%) were prescribed antibiotics on the first day of hospitalization, without “documentation of an indication for antibiotic therapy.”

Macrolides were most commonly prescribed, given to 9,633 (18.5%) of patients, followed by quinolones (8,632, 16.1%), third-generation cephalosporins (4,420, 8.5%), and tetracyclines (1,858, 3.6%). After adjustment for risk variables, chronic obstructive asthma hospitalizations were found to be those most highly associated with receiving antibiotics (odds ratio 1.6, 95% confidence interval 1.5-1.7).

“Possible explanations for this high rate of potentially inappropriate treatment include the challenge of differentiating bacterial from nonbacterial infections, distinguishing asthma from chronic obstructive pulmonary disease in the acute care setting, and gaps in knowledge about the benefits of antibiotic therapy,” the authors posited, adding that these findings “suggest a significant opportunity to improve patient safety, reduce the spread of resistance, and lower spending through greater adherence to guideline recommendations.”

The National Heart, Lung, and Blood Institute and Veterans Affairs Health Services Research and Development funded the study. Dr. Lindenauer and his coauthors did not report any relevant financial disclosures.

dchitnis@frontlinemedcom.com

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Key clinical point: Antibiotics are overprescribed in asthma-related hospitalizations.

Major finding: Among patients hospitalized for asthma, 58.2% had received antibiotics without any documentation or indication for such therapy.

Data source: Retrospective study of 51,951 patients in 577 U.S. hospitals from 2013 to 2014.

Disclosures: The National Heart, Lung, and Blood Institute and Veterans Affairs Health Services Research and Development funded the study. The researchers reported no relevant financial disclosures.

Nonpharmacologic AD therapy: Strongest evidence supports moisturizers

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BOSTON – Moisturizers are “a cornerstone” of therapy for children with atopic dermatitis, according to Julie V. Schaffer, MD.

Moisturizers improve skin hydration, increase the time between flares, and reduce xerosis and pruritus, Dr. Schaffer of Hackensack (N.J.) University Medical Group said at the American Academy of Dermatology summer meeting.

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In 2014, the AAD released guidelines that “very strongly” recommended moisturizers as an important nonpharmacologic intervention for patients with AD, stating that moisturizer use decreases disease severity and can reduce the need for pharmacologic intervention, she said.

In fact, the recommendation for moisturizer was based on “strength A, level 1 evidence,” she noted.

The role of bathing is a bit less clear; bathing is suggested as part of treatment and maintenance, but no standard exists with respect to frequency or duration for those with AD (evidence level: III, strength of recommendation: C). In general, the AAD recommends daily or less frequent bathing in warm water for 5-10 minutes, but surveys suggest that bathing recommendations vary widely among specialists and primary care providers, Dr. Schaffer said.

She noted that she sometimes sees children who have been told to bathe only once a week.

“They will come in just covered with disgusting gunk and it can’t be good for them,” she said. Bathing, especially if they have crusting and scaling, removes irritants and potential allergens, and provides hydration. It can also improve penetration of topical medications, as well as tolerance of those medications so that they burn less.

“So I give a thumbs up to daily bathing,” she said.

It is generally agreed that moisturizers should be applied soon after bathing (after applying medication) to improve skin hydration in patients with AD, Dr. Schaffer said.

The AAD says that moisturizers should be applied liberally and frequently, but the ideal frequency and type of moisturizer remains “a bit of an art form rather than a precise science,” she added.

The ideal moisturizer is one that is safe, effective, and free of fragrance, irritants, and potential sensitizers, she said, noting that “an individualized approach to moisturizer and vehicle selection can be very helpful.”

For young children, it is important that the product doesn’t sting; an ointment may be preferable in this population. Preteens and teenagers may dislike greasiness, so that is an important consideration, she said.

Dr. Schaffer pointed out that lotion formulations typically have water content that is too high to be helpful for patients with substantial xerosis. Creams or ointments may be a better bet, but take care to avoid contamination in large jars of such products, she advised.

“I’ve had a couple times when patients were getting recurrent infections, and we traced it down to a nasty jar that had a little too much bacteria in it,” she said, noting that using a clean scoop or pump can help prevent contamination.

As for cleansers, the “pretty clear winner” is a nonsoap cleanser, Dr. Schaffer said.

The AAD recommends limited use of hypoallergenic, fragrance-free, nonsoap cleansers with neutral to low pH, but the evidence is insufficient for recommending the addition of bath oils, emollients, oatmeal, and most other additives to bath water, as well as for the use of acidic spring water, she said (evidence level: III, strength of recommendation: C). An exception is bleach baths, as adding a small amount of bleach to bath water has been shown to improve symptoms, but the other products have not been shown to be beneficial.

The AAD notes that wet wrap therapy, either with or without a topical corticosteroid, can be recommended for patients with moderate to severe AD, as this can decrease disease severity and water loss during flares (evidence level: II, strength of recommendation: B).

Use moisturizer in newborns at risk for AD

Moisturizers don’t just help improve atopic dermatitis in children, they may also prevent the condition in at risk newborns.

Parents of a child with eczema who are concerned about the condition developing in their next child may find hope in the findings from two studies published in 2014, Dr. Schaffer said.

In a study of 124 newborns at high risk for AD who were randomized to daily emollient therapy or usual infant skin care started by age 3 weeks, the incidence of AD over 6 months was 43% in the control group, vs. 22% in the emollient group, a relative risk reduction of 50% (J Allergy Clin Immunol. 2014 Oct;134[4]:818-23). Parents in the emollient therapy group were allowed to choose between sunflower oil, Cetaphil cream, or Aquaphor Healing Ointment.

 

 

In a similar Japanese study of 118 high risk infants who were randomized to daily treatment with an emulsion-type emollient or usual skin care starting the first week of life, the AD/eczema rates at 32 weeks were 47% and 32% in the control and emollient groups, respectively (J Allergy Clin Immunol. 2014 Oct;134[4], 824-30). Both groups were allowed to use petroleum jelly.

“So that is something you can potentially make a recommendation for,” she said.

Dr. Schaffer reported having no conflicts of interest.

sworcester@frontlinemedcom.com

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BOSTON – Moisturizers are “a cornerstone” of therapy for children with atopic dermatitis, according to Julie V. Schaffer, MD.

Moisturizers improve skin hydration, increase the time between flares, and reduce xerosis and pruritus, Dr. Schaffer of Hackensack (N.J.) University Medical Group said at the American Academy of Dermatology summer meeting.

BananaStock (thinkstockphotos)

In 2014, the AAD released guidelines that “very strongly” recommended moisturizers as an important nonpharmacologic intervention for patients with AD, stating that moisturizer use decreases disease severity and can reduce the need for pharmacologic intervention, she said.

In fact, the recommendation for moisturizer was based on “strength A, level 1 evidence,” she noted.

The role of bathing is a bit less clear; bathing is suggested as part of treatment and maintenance, but no standard exists with respect to frequency or duration for those with AD (evidence level: III, strength of recommendation: C). In general, the AAD recommends daily or less frequent bathing in warm water for 5-10 minutes, but surveys suggest that bathing recommendations vary widely among specialists and primary care providers, Dr. Schaffer said.

She noted that she sometimes sees children who have been told to bathe only once a week.

“They will come in just covered with disgusting gunk and it can’t be good for them,” she said. Bathing, especially if they have crusting and scaling, removes irritants and potential allergens, and provides hydration. It can also improve penetration of topical medications, as well as tolerance of those medications so that they burn less.

“So I give a thumbs up to daily bathing,” she said.

It is generally agreed that moisturizers should be applied soon after bathing (after applying medication) to improve skin hydration in patients with AD, Dr. Schaffer said.

The AAD says that moisturizers should be applied liberally and frequently, but the ideal frequency and type of moisturizer remains “a bit of an art form rather than a precise science,” she added.

The ideal moisturizer is one that is safe, effective, and free of fragrance, irritants, and potential sensitizers, she said, noting that “an individualized approach to moisturizer and vehicle selection can be very helpful.”

For young children, it is important that the product doesn’t sting; an ointment may be preferable in this population. Preteens and teenagers may dislike greasiness, so that is an important consideration, she said.

Dr. Schaffer pointed out that lotion formulations typically have water content that is too high to be helpful for patients with substantial xerosis. Creams or ointments may be a better bet, but take care to avoid contamination in large jars of such products, she advised.

“I’ve had a couple times when patients were getting recurrent infections, and we traced it down to a nasty jar that had a little too much bacteria in it,” she said, noting that using a clean scoop or pump can help prevent contamination.

As for cleansers, the “pretty clear winner” is a nonsoap cleanser, Dr. Schaffer said.

The AAD recommends limited use of hypoallergenic, fragrance-free, nonsoap cleansers with neutral to low pH, but the evidence is insufficient for recommending the addition of bath oils, emollients, oatmeal, and most other additives to bath water, as well as for the use of acidic spring water, she said (evidence level: III, strength of recommendation: C). An exception is bleach baths, as adding a small amount of bleach to bath water has been shown to improve symptoms, but the other products have not been shown to be beneficial.

The AAD notes that wet wrap therapy, either with or without a topical corticosteroid, can be recommended for patients with moderate to severe AD, as this can decrease disease severity and water loss during flares (evidence level: II, strength of recommendation: B).

Use moisturizer in newborns at risk for AD

Moisturizers don’t just help improve atopic dermatitis in children, they may also prevent the condition in at risk newborns.

Parents of a child with eczema who are concerned about the condition developing in their next child may find hope in the findings from two studies published in 2014, Dr. Schaffer said.

In a study of 124 newborns at high risk for AD who were randomized to daily emollient therapy or usual infant skin care started by age 3 weeks, the incidence of AD over 6 months was 43% in the control group, vs. 22% in the emollient group, a relative risk reduction of 50% (J Allergy Clin Immunol. 2014 Oct;134[4]:818-23). Parents in the emollient therapy group were allowed to choose between sunflower oil, Cetaphil cream, or Aquaphor Healing Ointment.

 

 

In a similar Japanese study of 118 high risk infants who were randomized to daily treatment with an emulsion-type emollient or usual skin care starting the first week of life, the AD/eczema rates at 32 weeks were 47% and 32% in the control and emollient groups, respectively (J Allergy Clin Immunol. 2014 Oct;134[4], 824-30). Both groups were allowed to use petroleum jelly.

“So that is something you can potentially make a recommendation for,” she said.

Dr. Schaffer reported having no conflicts of interest.

sworcester@frontlinemedcom.com

BOSTON – Moisturizers are “a cornerstone” of therapy for children with atopic dermatitis, according to Julie V. Schaffer, MD.

Moisturizers improve skin hydration, increase the time between flares, and reduce xerosis and pruritus, Dr. Schaffer of Hackensack (N.J.) University Medical Group said at the American Academy of Dermatology summer meeting.

BananaStock (thinkstockphotos)

In 2014, the AAD released guidelines that “very strongly” recommended moisturizers as an important nonpharmacologic intervention for patients with AD, stating that moisturizer use decreases disease severity and can reduce the need for pharmacologic intervention, she said.

In fact, the recommendation for moisturizer was based on “strength A, level 1 evidence,” she noted.

The role of bathing is a bit less clear; bathing is suggested as part of treatment and maintenance, but no standard exists with respect to frequency or duration for those with AD (evidence level: III, strength of recommendation: C). In general, the AAD recommends daily or less frequent bathing in warm water for 5-10 minutes, but surveys suggest that bathing recommendations vary widely among specialists and primary care providers, Dr. Schaffer said.

She noted that she sometimes sees children who have been told to bathe only once a week.

“They will come in just covered with disgusting gunk and it can’t be good for them,” she said. Bathing, especially if they have crusting and scaling, removes irritants and potential allergens, and provides hydration. It can also improve penetration of topical medications, as well as tolerance of those medications so that they burn less.

“So I give a thumbs up to daily bathing,” she said.

It is generally agreed that moisturizers should be applied soon after bathing (after applying medication) to improve skin hydration in patients with AD, Dr. Schaffer said.

The AAD says that moisturizers should be applied liberally and frequently, but the ideal frequency and type of moisturizer remains “a bit of an art form rather than a precise science,” she added.

The ideal moisturizer is one that is safe, effective, and free of fragrance, irritants, and potential sensitizers, she said, noting that “an individualized approach to moisturizer and vehicle selection can be very helpful.”

For young children, it is important that the product doesn’t sting; an ointment may be preferable in this population. Preteens and teenagers may dislike greasiness, so that is an important consideration, she said.

Dr. Schaffer pointed out that lotion formulations typically have water content that is too high to be helpful for patients with substantial xerosis. Creams or ointments may be a better bet, but take care to avoid contamination in large jars of such products, she advised.

“I’ve had a couple times when patients were getting recurrent infections, and we traced it down to a nasty jar that had a little too much bacteria in it,” she said, noting that using a clean scoop or pump can help prevent contamination.

As for cleansers, the “pretty clear winner” is a nonsoap cleanser, Dr. Schaffer said.

The AAD recommends limited use of hypoallergenic, fragrance-free, nonsoap cleansers with neutral to low pH, but the evidence is insufficient for recommending the addition of bath oils, emollients, oatmeal, and most other additives to bath water, as well as for the use of acidic spring water, she said (evidence level: III, strength of recommendation: C). An exception is bleach baths, as adding a small amount of bleach to bath water has been shown to improve symptoms, but the other products have not been shown to be beneficial.

The AAD notes that wet wrap therapy, either with or without a topical corticosteroid, can be recommended for patients with moderate to severe AD, as this can decrease disease severity and water loss during flares (evidence level: II, strength of recommendation: B).

Use moisturizer in newborns at risk for AD

Moisturizers don’t just help improve atopic dermatitis in children, they may also prevent the condition in at risk newborns.

Parents of a child with eczema who are concerned about the condition developing in their next child may find hope in the findings from two studies published in 2014, Dr. Schaffer said.

In a study of 124 newborns at high risk for AD who were randomized to daily emollient therapy or usual infant skin care started by age 3 weeks, the incidence of AD over 6 months was 43% in the control group, vs. 22% in the emollient group, a relative risk reduction of 50% (J Allergy Clin Immunol. 2014 Oct;134[4]:818-23). Parents in the emollient therapy group were allowed to choose between sunflower oil, Cetaphil cream, or Aquaphor Healing Ointment.

 

 

In a similar Japanese study of 118 high risk infants who were randomized to daily treatment with an emulsion-type emollient or usual skin care starting the first week of life, the AD/eczema rates at 32 weeks were 47% and 32% in the control and emollient groups, respectively (J Allergy Clin Immunol. 2014 Oct;134[4], 824-30). Both groups were allowed to use petroleum jelly.

“So that is something you can potentially make a recommendation for,” she said.

Dr. Schaffer reported having no conflicts of interest.

sworcester@frontlinemedcom.com

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EXPERT ANALYSIS FROM THE AAD SUMMER ACADEMY 2016

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Food allergy testing only rarely needed for AD patients

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BOSTON – Between 15% and 30% of children with moderate to severe atopic dermatitis also have food allergies, but the allergies are a trigger for AD in only a small subset of patients, according to Mercedes E. Gonzalez, MD.

In most cases, allergy testing is not indicated, she said at the American Academy of Dermatology summer meeting.

©Julián Rovagnati/Fotolia.com

She described a scenario involving a parent who is concerned that a food allergy is causing her child’s AD. The child has had no hives, no lip swelling, and no other signs of immediate hypersensitivity. In such a case, the best approach is to treat with topical therapies and follow the patient clinically.

“Allergy testing independent of history is not recommended,” she said.

However, in cases involving a significant concern about food allergy, such as the presence of hives or urticaria, or when the child has severe dermatitis that is not improving with optimized topical therapies, an assessment can be undertaken, said Dr. Gonzalez of the University of Miami.

She recommended limited food allergy testing – for common culprits such as cow’s milk, eggs, wheat, soy, and peanuts – in children younger than age 5 years with moderate to severe AD, if the AD persists despite optimized topical treatment and/or a history of immediate and reproducible reaction after ingestion of a specific food.

Food elimination diets based solely on the findings of food allergy test results are not recommended for managing AD, she noted.

If a patient has true immunoglobulin E–mediated allergy they should practice avoidance to prevent potential serious health sequelae, Dr. Gonzalez said.

When testing is done, keep in mind that skin prick tests and serum-specific IgE levels have high negative predictive values above 95%, but low specificity and positive predictive values of 40%-60%, she pointed out. Positive tests should be verified with a food elimination diet or oral food challenge.

Also, most children develop tolerance to the foods over time and should be retested, Dr. Gonzalez said.

Early peanut introduction advised in infants with AD

There is no need to delay the introduction of peanuts into the diet of an infant at high risk for atopic dermatitis, Dr. Gonzalez said.

A 2015 consensus communication from the American Academy of Pediatrics and numerous other organizations, including the American Academy of Allergy, Asthma & Immunology and the Society of Pediatric Dermatology, offering interim guidance on the topic calls for introduction of peanut products into the diets of high-risk infants in countries where peanut allergy is present, she said.

High-risk infants were defined in the study as those with egg allergy and/or severe eczema.

The guidance, which the AAP “endorses and accepts as its policy” pending more formal guidelines currently in development, was based largely on findings from the LEAP (Learn Early About Peanut Allergy) trial – a 5-year randomized, controlled trial of 640 high-risk infants aged 4-11 months. The trial showed that 17.2% of infants who avoided peanuts had peanut allergy at 5 years, compared with 3.2% of those with peanut consumption three times weekly, a relative risk reduction of 81% (N Engl J Med. 2015; 372:803-13).

In infants with egg allergy or severe eczema, an evaluation by an allergist or dermatologist familiar with the guidance may be warranted to assist in implementing the suggestions, Dr. Gonzalez said.

Dr. Gonzalez reported receiving honoraria for serving as a speaker and/or advisory board member for Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

sworcester@frontlinemedcom.com

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BOSTON – Between 15% and 30% of children with moderate to severe atopic dermatitis also have food allergies, but the allergies are a trigger for AD in only a small subset of patients, according to Mercedes E. Gonzalez, MD.

In most cases, allergy testing is not indicated, she said at the American Academy of Dermatology summer meeting.

©Julián Rovagnati/Fotolia.com

She described a scenario involving a parent who is concerned that a food allergy is causing her child’s AD. The child has had no hives, no lip swelling, and no other signs of immediate hypersensitivity. In such a case, the best approach is to treat with topical therapies and follow the patient clinically.

“Allergy testing independent of history is not recommended,” she said.

However, in cases involving a significant concern about food allergy, such as the presence of hives or urticaria, or when the child has severe dermatitis that is not improving with optimized topical therapies, an assessment can be undertaken, said Dr. Gonzalez of the University of Miami.

She recommended limited food allergy testing – for common culprits such as cow’s milk, eggs, wheat, soy, and peanuts – in children younger than age 5 years with moderate to severe AD, if the AD persists despite optimized topical treatment and/or a history of immediate and reproducible reaction after ingestion of a specific food.

Food elimination diets based solely on the findings of food allergy test results are not recommended for managing AD, she noted.

If a patient has true immunoglobulin E–mediated allergy they should practice avoidance to prevent potential serious health sequelae, Dr. Gonzalez said.

When testing is done, keep in mind that skin prick tests and serum-specific IgE levels have high negative predictive values above 95%, but low specificity and positive predictive values of 40%-60%, she pointed out. Positive tests should be verified with a food elimination diet or oral food challenge.

Also, most children develop tolerance to the foods over time and should be retested, Dr. Gonzalez said.

Early peanut introduction advised in infants with AD

There is no need to delay the introduction of peanuts into the diet of an infant at high risk for atopic dermatitis, Dr. Gonzalez said.

A 2015 consensus communication from the American Academy of Pediatrics and numerous other organizations, including the American Academy of Allergy, Asthma & Immunology and the Society of Pediatric Dermatology, offering interim guidance on the topic calls for introduction of peanut products into the diets of high-risk infants in countries where peanut allergy is present, she said.

High-risk infants were defined in the study as those with egg allergy and/or severe eczema.

The guidance, which the AAP “endorses and accepts as its policy” pending more formal guidelines currently in development, was based largely on findings from the LEAP (Learn Early About Peanut Allergy) trial – a 5-year randomized, controlled trial of 640 high-risk infants aged 4-11 months. The trial showed that 17.2% of infants who avoided peanuts had peanut allergy at 5 years, compared with 3.2% of those with peanut consumption three times weekly, a relative risk reduction of 81% (N Engl J Med. 2015; 372:803-13).

In infants with egg allergy or severe eczema, an evaluation by an allergist or dermatologist familiar with the guidance may be warranted to assist in implementing the suggestions, Dr. Gonzalez said.

Dr. Gonzalez reported receiving honoraria for serving as a speaker and/or advisory board member for Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

sworcester@frontlinemedcom.com

BOSTON – Between 15% and 30% of children with moderate to severe atopic dermatitis also have food allergies, but the allergies are a trigger for AD in only a small subset of patients, according to Mercedes E. Gonzalez, MD.

In most cases, allergy testing is not indicated, she said at the American Academy of Dermatology summer meeting.

©Julián Rovagnati/Fotolia.com

She described a scenario involving a parent who is concerned that a food allergy is causing her child’s AD. The child has had no hives, no lip swelling, and no other signs of immediate hypersensitivity. In such a case, the best approach is to treat with topical therapies and follow the patient clinically.

“Allergy testing independent of history is not recommended,” she said.

However, in cases involving a significant concern about food allergy, such as the presence of hives or urticaria, or when the child has severe dermatitis that is not improving with optimized topical therapies, an assessment can be undertaken, said Dr. Gonzalez of the University of Miami.

She recommended limited food allergy testing – for common culprits such as cow’s milk, eggs, wheat, soy, and peanuts – in children younger than age 5 years with moderate to severe AD, if the AD persists despite optimized topical treatment and/or a history of immediate and reproducible reaction after ingestion of a specific food.

Food elimination diets based solely on the findings of food allergy test results are not recommended for managing AD, she noted.

If a patient has true immunoglobulin E–mediated allergy they should practice avoidance to prevent potential serious health sequelae, Dr. Gonzalez said.

When testing is done, keep in mind that skin prick tests and serum-specific IgE levels have high negative predictive values above 95%, but low specificity and positive predictive values of 40%-60%, she pointed out. Positive tests should be verified with a food elimination diet or oral food challenge.

Also, most children develop tolerance to the foods over time and should be retested, Dr. Gonzalez said.

Early peanut introduction advised in infants with AD

There is no need to delay the introduction of peanuts into the diet of an infant at high risk for atopic dermatitis, Dr. Gonzalez said.

A 2015 consensus communication from the American Academy of Pediatrics and numerous other organizations, including the American Academy of Allergy, Asthma & Immunology and the Society of Pediatric Dermatology, offering interim guidance on the topic calls for introduction of peanut products into the diets of high-risk infants in countries where peanut allergy is present, she said.

High-risk infants were defined in the study as those with egg allergy and/or severe eczema.

The guidance, which the AAP “endorses and accepts as its policy” pending more formal guidelines currently in development, was based largely on findings from the LEAP (Learn Early About Peanut Allergy) trial – a 5-year randomized, controlled trial of 640 high-risk infants aged 4-11 months. The trial showed that 17.2% of infants who avoided peanuts had peanut allergy at 5 years, compared with 3.2% of those with peanut consumption three times weekly, a relative risk reduction of 81% (N Engl J Med. 2015; 372:803-13).

In infants with egg allergy or severe eczema, an evaluation by an allergist or dermatologist familiar with the guidance may be warranted to assist in implementing the suggestions, Dr. Gonzalez said.

Dr. Gonzalez reported receiving honoraria for serving as a speaker and/or advisory board member for Pierre Fabre Dermatologie, Anacor Pharmaceuticals, Encore Dermatology, and PuraCap Pharmaceutical.

sworcester@frontlinemedcom.com

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EXPERT ANALYSIS FROM AAD SUMMER ACADEMY 2016

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Pilot program helps children better understand food allergies

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Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.

At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.

After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.

The authors stated that they had no financial conflicts of interest.

Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018

acruz@frontlinemedcom.com

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Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.

At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.

After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.

The authors stated that they had no financial conflicts of interest.

Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018

acruz@frontlinemedcom.com

Elementary school students had improved attitudes toward food allergies and felt more confident in taking action during a food allergy emergency after completing an education program on the subject, results of a pilot study in Japan suggest.

At present there is no standard school curriculum for children regarding food allergy, wrote Dr. Kiwako Yamamoto-Hanada of the National Center for Child Health and Development, Tokyo, and associates, so they developed such a program consisting of two 60-minute sessions. A total of 36 elementary school children, 8 of whom had a history of food allergies, filled out questionnaires before and after participating in the program.

After completing the program, 79% of the students stated that it should be included in the school curriculum. Students also demonstrated improved knowledge about food allergies, with a greater percentage knowing what an EpiPen is (100% vs. 0%), understanding that food allergy is related to death (100% vs. 43%), and feeling confident that they could take immediate action if they saw a food allergy emergency (61% vs. 4%). “This is the first report to find that a [food allergy] program for elementary schoolchildren was well tolerated and that perceptions and attitudes toward [food allergies] improved,” the investigators wrote.

The authors stated that they had no financial conflicts of interest.

Read the full story here: http://dx.doi.org/10.1016/j.anai.2016.06.018

acruz@frontlinemedcom.com

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FROM ANNALS OF ALLERGY, ASTHMA & IMMUNOLOGY

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Routine screening unwarranted in siblings of food-allergic children

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FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE

Siblings of children with food allergy should not be screened routinely for such allergies before food introduction, results of a large cohort study suggest.

In a study of 478 food-allergic children and 642 of their siblings, 53% of the siblings were sensitized without clinical reactivity and only 13.6% were found to have a clinically reactive food allergy, wrote Ruchi S. Gupta, MD, of Northwestern University, Chicago, and her associates.

The investigators noted that their findings support current guidelines from the National Institute of Allergy and Infectious Diseases to not screen siblings based on another sibling having a food allergy.

“Given the lack of a dramatically increased risk of food allergy in siblings, compared with that of the general population, as well as the high rate of what are falsely positive diagnostic test results among siblings of a food allergic child, [these siblings] should not have routine screening for food allergy before food introduction,” the investigators concluded. “Such siblings are likely to be mislabeled as allergic when they are actually tolerant to the food, which may lead to an increased risk of developing allergy via avoidance,” and both quality of life and nutrition may be adversely impacted.

Dr. Gupta has received research support from Mylan, Food Allergy Research and Education, and United Health Care.

Read the full study here (http://dx.doi.org/10.1016/j.jaip.2016.04.009)

acruz@frontlinemedcom.com

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FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE

Siblings of children with food allergy should not be screened routinely for such allergies before food introduction, results of a large cohort study suggest.

In a study of 478 food-allergic children and 642 of their siblings, 53% of the siblings were sensitized without clinical reactivity and only 13.6% were found to have a clinically reactive food allergy, wrote Ruchi S. Gupta, MD, of Northwestern University, Chicago, and her associates.

The investigators noted that their findings support current guidelines from the National Institute of Allergy and Infectious Diseases to not screen siblings based on another sibling having a food allergy.

“Given the lack of a dramatically increased risk of food allergy in siblings, compared with that of the general population, as well as the high rate of what are falsely positive diagnostic test results among siblings of a food allergic child, [these siblings] should not have routine screening for food allergy before food introduction,” the investigators concluded. “Such siblings are likely to be mislabeled as allergic when they are actually tolerant to the food, which may lead to an increased risk of developing allergy via avoidance,” and both quality of life and nutrition may be adversely impacted.

Dr. Gupta has received research support from Mylan, Food Allergy Research and Education, and United Health Care.

Read the full study here (http://dx.doi.org/10.1016/j.jaip.2016.04.009)

acruz@frontlinemedcom.com

FROM THE JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY: IN PRACTICE

Siblings of children with food allergy should not be screened routinely for such allergies before food introduction, results of a large cohort study suggest.

In a study of 478 food-allergic children and 642 of their siblings, 53% of the siblings were sensitized without clinical reactivity and only 13.6% were found to have a clinically reactive food allergy, wrote Ruchi S. Gupta, MD, of Northwestern University, Chicago, and her associates.

The investigators noted that their findings support current guidelines from the National Institute of Allergy and Infectious Diseases to not screen siblings based on another sibling having a food allergy.

“Given the lack of a dramatically increased risk of food allergy in siblings, compared with that of the general population, as well as the high rate of what are falsely positive diagnostic test results among siblings of a food allergic child, [these siblings] should not have routine screening for food allergy before food introduction,” the investigators concluded. “Such siblings are likely to be mislabeled as allergic when they are actually tolerant to the food, which may lead to an increased risk of developing allergy via avoidance,” and both quality of life and nutrition may be adversely impacted.

Dr. Gupta has received research support from Mylan, Food Allergy Research and Education, and United Health Care.

Read the full study here (http://dx.doi.org/10.1016/j.jaip.2016.04.009)

acruz@frontlinemedcom.com

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MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Dr. Erin Warshaw

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

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MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Dr. Erin Warshaw

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

MINNEAPOLIS – When it comes to allergic contact dermatitis in children, the answer is sometimes hiding in plain sight. Cleansers, moisturizers, shampoos, detergents – all can contain ingredients that provoke significant reactions, yet many of these ingredients are not on the most common testing panels.

Erin Warshaw, MD, professor of dermatology at the University of Minnesota, reviewed common but often unsuspected causes of allergic dermatitis in the pediatric population at the annual meeting of the Society for Pediatric Dermatology.

Dr. Erin Warshaw

Even some hypoallergenic and frequently recommended products can contain preservatives and other ingredients that provoke allergic reactions, according to Dr. Warshaw. A chief culprit is methylisothiazolinone (MI), a preservative that came into common use as formaldehyde has been gradually phased out.

“If there’s anything I could emphasize from this talk, it’s MI, MI, MI. This is the major epidemic of our time in the contact dermatitis world,” Dr. Warshaw said. Upcoming publications, she added, will place MI in the top five most common contact allergens. “MI is in everything, including things you would think would be hypoallergenic,” she said. She recommended looking at ingredient labels with a keen eye when making testing decisions.

Despite MI’s status as a frequent culprit, it’s not an allergen that appears on common test kits, Dr. Warshaw pointed out. For example, it’s absent from one of the most commonly used test kits, the Thin-Layer Rapid Use Epicutaneous Patch (T.R.U.E. test).

The T.R.U.E. test, said Dr. Warshaw, has reasonable sensitivity – it can detect 71% of relevant positive patch tests (RPPTs) in children. However, she added, a recent study showed that about 23% of children reacted to a supplemental allergen. “That’s significant. One quarter of these individuals only reacted to a preservative … or a sunscreen, or an acrylate. These aren’t on the T.R.U.E. test.”

Decyl glucoside is another frequent culprit that is not included in commercial patch test kits. “It’s really an important emerging allergen,” said Dr. Warshaw, noting that it commonly cross-reacts with coco and lauryl glucoside, frequently found in fragrance-free products. “It’s always humbling when we find the allergen in the product we’ve recommended to our patients.”

Other important allergens not on the T.R.U.E. test include propolis, tocopherol, oxybenzone, and many surfactants and botanicals.

In order to avoid a confounding reaction to aluminum, Dr. Warshaw recommends testing using plastic-backed test chambers, such as IQ chambers, rather than Finn chambers, which are aluminum backed.

When working with families to track down allergens in the pediatric population, Dr. Warshaw adjusts her approach from what she would use for adults.

“What do I do differently in kids? First of all, I set expectations for children and parents,” she said. Some of the most frequent parental questions deal with food allergies, so she allots time to explain the rationale for not testing for food allergens when allergic contact dermatitis is suspected.

For many patients, “I try and frame that there is probably baseline eczema, and our goal is to try to figure out if there is an allergy in addition to that that is contributing to the flares,” she said. She makes sure to convey that “all it takes is one exposure every 3 weeks; that will keep this reaction going.”

However, she’s judicious in interpreting equivocal results. “I feel a responsibility not to label children with an allergy” if results are unclear. Finally, providing enough time is key, said Dr. Warshaw, who allots an hour for reviewing final testing results.

The take-home points? It’s worthwhile to patch test children, since over half of children will have at least one RPPT. Also, contact dermatitis can be an overlay on preexisting allergic dermatitis, so patch testing can still be helpful for these children. Supplemental allergens are important in patch testing, “especially in children with a negative test to a screening series,” Dr. Warshaw said.

She recommended accessing the Contact Allergen Management Program (CAMP) database, found on the American Contact Dermatitis Society website. The list is a searchable database that generates a list of “safe” products that don’t contain a given allergen. This resource is available for society members, but a member’s access code can be shared among faculty members at academic institutions, she said. Patients can also be given unique codes that will give them access for life, so they can use the CAMP database on a computer or via a smartphone app.

Dr. Warshaw reported no relevant financial disclosures.

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LABA achieves better asthma control when combined with FDC inhaler

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Long-acting beta-2 agonists achieve better asthma control when added to inhaled corticosteroids in a fixed-dose combination, compared with use of a LABA as a separate inhaler, according to Steve Turner, MD, and his associates.

At baseline, 35% of children in the FDC ICS (fixed-dose combination inhaled corticosteroids)/LABA cohort and in the separate ICS+LABA cohort had achieved overall asthma control. After 2 years, 43% of children in the FDC ICS/LABA cohort had achieved overall asthma control, compared with 37% of children in the separate ICS+LABA cohort. The adjusted odds ratio for overall asthma control in the separate ICS+LABA cohort was 0.77.

The adjusted relative risk of acute respiratory events for the separate ICS+LABA cohort was 1.21, compared with the FDC ICS/LABA cohort, and the aRR for severe exacerbations was 1.31 for the separate ICS+LABA cohort. More children in the separate ICS+LABA cohort were treated with antibiotics; however, the incidence of thrush was higher in the FDC ICS/LABA cohort.

“This small effect may be partly explained by improvement in all outcomes in both groups as the children became older. An additional factor may be that adherence was relatively poor for all participants (22%-33%), and poor adherence is associated with poor control. This may have led to the decision to step up and also to a relatively disappointing response to treatment,” the investigators wrote.

Find the full study in the Journal of Allergy and Clinical Immunology (doi:10.1016/j.jaip.2016.06.009).

lfranki@frontlinemedcom.com

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Long-acting beta-2 agonists achieve better asthma control when added to inhaled corticosteroids in a fixed-dose combination, compared with use of a LABA as a separate inhaler, according to Steve Turner, MD, and his associates.

At baseline, 35% of children in the FDC ICS (fixed-dose combination inhaled corticosteroids)/LABA cohort and in the separate ICS+LABA cohort had achieved overall asthma control. After 2 years, 43% of children in the FDC ICS/LABA cohort had achieved overall asthma control, compared with 37% of children in the separate ICS+LABA cohort. The adjusted odds ratio for overall asthma control in the separate ICS+LABA cohort was 0.77.

The adjusted relative risk of acute respiratory events for the separate ICS+LABA cohort was 1.21, compared with the FDC ICS/LABA cohort, and the aRR for severe exacerbations was 1.31 for the separate ICS+LABA cohort. More children in the separate ICS+LABA cohort were treated with antibiotics; however, the incidence of thrush was higher in the FDC ICS/LABA cohort.

“This small effect may be partly explained by improvement in all outcomes in both groups as the children became older. An additional factor may be that adherence was relatively poor for all participants (22%-33%), and poor adherence is associated with poor control. This may have led to the decision to step up and also to a relatively disappointing response to treatment,” the investigators wrote.

Find the full study in the Journal of Allergy and Clinical Immunology (doi:10.1016/j.jaip.2016.06.009).

lfranki@frontlinemedcom.com

Long-acting beta-2 agonists achieve better asthma control when added to inhaled corticosteroids in a fixed-dose combination, compared with use of a LABA as a separate inhaler, according to Steve Turner, MD, and his associates.

At baseline, 35% of children in the FDC ICS (fixed-dose combination inhaled corticosteroids)/LABA cohort and in the separate ICS+LABA cohort had achieved overall asthma control. After 2 years, 43% of children in the FDC ICS/LABA cohort had achieved overall asthma control, compared with 37% of children in the separate ICS+LABA cohort. The adjusted odds ratio for overall asthma control in the separate ICS+LABA cohort was 0.77.

The adjusted relative risk of acute respiratory events for the separate ICS+LABA cohort was 1.21, compared with the FDC ICS/LABA cohort, and the aRR for severe exacerbations was 1.31 for the separate ICS+LABA cohort. More children in the separate ICS+LABA cohort were treated with antibiotics; however, the incidence of thrush was higher in the FDC ICS/LABA cohort.

“This small effect may be partly explained by improvement in all outcomes in both groups as the children became older. An additional factor may be that adherence was relatively poor for all participants (22%-33%), and poor adherence is associated with poor control. This may have led to the decision to step up and also to a relatively disappointing response to treatment,” the investigators wrote.

Find the full study in the Journal of Allergy and Clinical Immunology (doi:10.1016/j.jaip.2016.06.009).

lfranki@frontlinemedcom.com

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SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News
Ms. Kavita Darji

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

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SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News
Ms. Kavita Darji

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

SCOTTSDALE, ARIZ. – Serum vitamin D level was not significantly associated with atopic dermatitis or disease severity in a single-center study of more than 600 children and adolescents.

However, “we did observe a strong correlation between average serum vitamin D levels and skin type, as well as body mass index,” said Kavita Darji, a medical student at Saint Louis (Mo.) University, who presented the findings in a poster at the annual meeting of the Society for Investigative Dermatology. Those findings challenge the logic of following universal definitions of vitamin D deficiency, especially given the phenotypic heterogeneity of patients in the United States, she added in an interview.

Amy Karon/Frontline Medical News
Ms. Kavita Darji

Serum vitamin D testing is one of most common laboratory assays in this country, but clinicians still debate the risks and benefits of supplementing children and adolescents who test below the Endocrine Society’s threshold for sufficiency (30.0 ng/mL).

To identify factors affecting vitamin D levels, Ms. Darji and her associates reviewed electronic medical charts for patients under age 22 years at Saint Louis University medical centers between 2009 and 2014. The cohort of 655 patients was primarily white (64%) or black (29%), and was nearly equally balanced by gender; their average age was 10 years. The researchers analyzed only the first vitamin D serum measurement for each patient, and defined deficiency as a level under 20 ng/mL, insufficiency as a level between 20 and 29.9 ng/mL, and sufficiency as a level of at least 30 ng/mL.

Serum vitamin D levels were slightly lower among atopic patients, compared with those without atopy, but the difference did not reach statistical significance (about 25 ng/mL vs. about 38 ng/mL; P greater than .05). “We also did not find an association between AD severity and vitamin D level,” Ms. Darji reported. Instead, race and body mass index were the most significant predictors of vitamin D deficiency, probably because these factors directly affect cutaneous photo-induced vitamin D synthesis and the sequestration of fat-soluble vitamins in adipose tissue, she said.

Using the standard definitions, more than 50% of black patients were vitamin D deficient, while less than 30% had sufficient vitamin D levels. In contrast, about 25% of white patients were vitamin D deficient, while nearly 40% had sufficient vitamin D levels (P less than .0001 for proportions of deficiency by race). Furthermore, only about 10% of obese children (those who exceeded the 99th percentile of BMI for age) had sufficient vitamin D levels, compared with more than 40% of underweight children and about 30% of normal-weight children (P less than .00001).

Since vitamin D deficiency was more common among black and obese patients, “maybe they could benefit from a different cut-off value than the standard 30 ng per mL that we used,” Ms. Darji said. “The question is, do they really require these supplements? It may be beneficial to look at the unique characteristics of each patient before supplementing, because the risks of supplementation are considerable in terms of bone health and cardiovascular disease.”

Vitamin D levels did not vary significantly by gender or by month or season measured, Ms. Darji noted. She reported no funding sources and had no disclosures.

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AT THE 2016 SID ANNUAL MEETING

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Key clinical point: Serum vitamin D was not a significant marker for pediatric atopic dermatitis or disease severity.

Major finding: The average serum vitamin D level was lower among patients with atopic dermatitis than healthy children, but the difference did not reach statistical significance.

Data source: A single-center retrospective review of electronic medical records from 655 patients aged 21 years and younger (average age, 10 years).

Disclosures: Ms. Darji reported no funding sources and had no disclosures.