Atopic Dermatitis

By Michael Zacharisen, M.D.

Physicians play an integral role in the initial diagnosis and management of children with a suspected food allergy. History, some useful laboratory tests, and careful counseling can go a long way to identify these sometimes challenging patients.

A considerable amount of anxiety often surrounds food allergy concerns, and this should be addressed – or at least acknowledged – with patients and their families.

Start with history, the most important diagnostic factor: Ask children and parents about specific symptoms, their timing, and foods the child has ingested. If the child experienced anaphylaxis, then include medication and insect stings in your history taking.

The good news is that 90% of food allergies are caused by a few foods: milk, egg, wheat, soy, peanut, fish, seafood, and nuts. Other triggers are relatively rare.

Allergy skin testing and/or specific immunoglobulin E (IgE) blood tests can support your diagnosis. However, these findings need to be correlated with history because false positive results occur frequently. It is important to realize that the level of specific IgE to a food is not correlated with the severity of a reaction, but instead is correlated with the likelihood of having a single reaction.

Determine if the child's symptoms truly suggest an allergic reaction or instead point to a non–food related cause. Psychological conditions such bulimia, anorexia, or factitious disorder can mimic a food allergy, for example.

Your differential diagnosis also includes structural abnormalities of the GI tract; cystic fibrosis with chronic diarrhea from pancreatic insufficiency; and illness caused by contaminants and additives such as flavorings, dyes, preservatives, or infectious organisms. Also check for exposure to pharmacologic contaminants such as caffeine or tyramine in certain foods.

Rule out lactose intolerance and other disaccharidase deficiencies (especially if the symptoms are limited to the GI tract) and a non-IgE reaction called food protein-induced enterocolitis syndrome (FPIES). An FPIES diagnosis is based on clinical presentation and symptoms because allergy skin testing and specific IgE assays are not helpful.

Also consider gastroesophageal reflux. Children whose symptoms do not improve with proton pump inhibitors might have eosinophilic esophagitis. A food allergen sometimes triggers this condition, and consultation with a gastroenterologist and a biopsy are the best clinical strategies.

Avoidance of the culprit allergen is essential to management. Stress the importance of reading all food labels. Self-injectable epinephrine (such as Mylan Inc.’s EpiPen or EpiPen Jr.) is another essential component. Instruct patients on how and when to use epinephrine, including what to do when anaphylaxis starts in school or in a day care setting. In some cases, it may be appropriate to suggest that the patient wear a medical alert bracelet or necklace.

Education is probably the most important factor in management. Talk to patients and families about prognosis, cross-reactive allergens, and the nutritional needs of patients with multiple food allergies. Keep in mind that if the list of foods to avoid is extensive, this may interfere with normal growth and development. A dietician can help educate families not only on what foods to avoid, but on what foods are encouraged.

Make sure parents are comfortable with your treatment plan. If you are confident in your identification of the culprit food, you can implement a food-elimination diet based on details from the history. Prescribe the appropriate dose of epinephrine and outline an anaphylaxis plan (easily found on the Web site www.foodallergy.org under "Food Allergy Action Plan" in the health professionals section). Allergy medication, including antihistamines, is useful for mild symptoms and hives, but as a wise old allergist once said, "antihistamines cure hives; Epi saves lives!"

Physicians can order in vitro specific IgE blood tests such as Phadia AB’s Pharmacia CAP or UniCAP. These are helpful when performed by a reliable laboratory and may obviate the need for the skin testing of some patients for some foods. These tests are relatively good predictors of peanut, milk, and egg allergies.

In contrast, total IgE and complete blood count assays generally are not helpful. Performance of specific IgE blood tests to foods that are known to be clinically tolerated should be avoided; this just leads to confusion by all parties. In addition, avoid testing for specific IgG to foods because this strategy is not helpful for diagnosis. IgG is a measure of exposure only, and therefore positive results are not uncommon.

Most commonly, I see food-allergic patients post diagnosis to explain the results of previous tests and to develop an ongoing plan for avoidance, which includes strategies in the case of future accidental exposure.

If tolerance is suspected, I discuss with children and parents when to consider a food challenge. Such a protocol is probably best performed at a specialist’s office, particularly if a more comprehensive, double-blind, placebo-controlled challenge is warranted. Food challenges require significant time and resources, including advance preparations in case anaphylaxis occurs.

Also consider referral to a specialist when a food culprit is not easily identified; when there is disparity between diagnostic test findings and patient history; and when the patient and family require more comprehensive education.

This column, "Subspecialist Consult," regularly appears in Pediatric News, an Elsevier publication. Dr. Zacharisen is a professor of pediatrics and medicine specializing in the treatment of allergy, asthma, and clinical immunology at the Medical College of Wisconsin in Milwaukee. He also is on the faculty at the asthma and allergy center at the Children’s Hospital of Wisconsin, also in Milwaukee. Dr. Zacharisen said he had no relevant financial disclosures.

By Michael Zacharisen, M.D.

Physicians play an integral role in the initial diagnosis and management of children with a suspected food allergy. History, some useful laboratory tests, and careful counseling can go a long way to identify these sometimes challenging patients.

A considerable amount of anxiety often surrounds food allergy concerns, and this should be addressed – or at least acknowledged – with patients and their families.

Start with history, the most important diagnostic factor: Ask children and parents about specific symptoms, their timing, and foods the child has ingested. If the child experienced anaphylaxis, then include medication and insect stings in your history taking.

The good news is that 90% of food allergies are caused by a few foods: milk, egg, wheat, soy, peanut, fish, seafood, and nuts. Other triggers are relatively rare.

Allergy skin testing and/or specific immunoglobulin E (IgE) blood tests can support your diagnosis. However, these findings need to be correlated with history because false positive results occur frequently. It is important to realize that the level of specific IgE to a food is not correlated with the severity of a reaction, but instead is correlated with the likelihood of having a single reaction.

Determine if the child's symptoms truly suggest an allergic reaction or instead point to a non–food related cause. Psychological conditions such bulimia, anorexia, or factitious disorder can mimic a food allergy, for example.

Your differential diagnosis also includes structural abnormalities of the GI tract; cystic fibrosis with chronic diarrhea from pancreatic insufficiency; and illness caused by contaminants and additives such as flavorings, dyes, preservatives, or infectious organisms. Also check for exposure to pharmacologic contaminants such as caffeine or tyramine in certain foods.

Rule out lactose intolerance and other disaccharidase deficiencies (especially if the symptoms are limited to the GI tract) and a non-IgE reaction called food protein-induced enterocolitis syndrome (FPIES). An FPIES diagnosis is based on clinical presentation and symptoms because allergy skin testing and specific IgE assays are not helpful.

Also consider gastroesophageal reflux. Children whose symptoms do not improve with proton pump inhibitors might have eosinophilic esophagitis. A food allergen sometimes triggers this condition, and consultation with a gastroenterologist and a biopsy are the best clinical strategies.

Avoidance of the culprit allergen is essential to management. Stress the importance of reading all food labels. Self-injectable epinephrine (such as Mylan Inc.’s EpiPen or EpiPen Jr.) is another essential component. Instruct patients on how and when to use epinephrine, including what to do when anaphylaxis starts in school or in a day care setting. In some cases, it may be appropriate to suggest that the patient wear a medical alert bracelet or necklace.

Education is probably the most important factor in management. Talk to patients and families about prognosis, cross-reactive allergens, and the nutritional needs of patients with multiple food allergies. Keep in mind that if the list of foods to avoid is extensive, this may interfere with normal growth and development. A dietician can help educate families not only on what foods to avoid, but on what foods are encouraged.

Make sure parents are comfortable with your treatment plan. If you are confident in your identification of the culprit food, you can implement a food-elimination diet based on details from the history. Prescribe the appropriate dose of epinephrine and outline an anaphylaxis plan (easily found on the Web site www.foodallergy.org under "Food Allergy Action Plan" in the health professionals section). Allergy medication, including antihistamines, is useful for mild symptoms and hives, but as a wise old allergist once said, "antihistamines cure hives; Epi saves lives!"

Physicians can order in vitro specific IgE blood tests such as Phadia AB’s Pharmacia CAP or UniCAP. These are helpful when performed by a reliable laboratory and may obviate the need for the skin testing of some patients for some foods. These tests are relatively good predictors of peanut, milk, and egg allergies.

In contrast, total IgE and complete blood count assays generally are not helpful. Performance of specific IgE blood tests to foods that are known to be clinically tolerated should be avoided; this just leads to confusion by all parties. In addition, avoid testing for specific IgG to foods because this strategy is not helpful for diagnosis. IgG is a measure of exposure only, and therefore positive results are not uncommon.

Most commonly, I see food-allergic patients post diagnosis to explain the results of previous tests and to develop an ongoing plan for avoidance, which includes strategies in the case of future accidental exposure.

If tolerance is suspected, I discuss with children and parents when to consider a food challenge. Such a protocol is probably best performed at a specialist’s office, particularly if a more comprehensive, double-blind, placebo-controlled challenge is warranted. Food challenges require significant time and resources, including advance preparations in case anaphylaxis occurs.

Also consider referral to a specialist when a food culprit is not easily identified; when there is disparity between diagnostic test findings and patient history; and when the patient and family require more comprehensive education.

This column, "Subspecialist Consult," regularly appears in Pediatric News, an Elsevier publication. Dr. Zacharisen is a professor of pediatrics and medicine specializing in the treatment of allergy, asthma, and clinical immunology at the Medical College of Wisconsin in Milwaukee. He also is on the faculty at the asthma and allergy center at the Children’s Hospital of Wisconsin, also in Milwaukee. Dr. Zacharisen said he had no relevant financial disclosures.

By Michael Zacharisen, M.D.

Physicians play an integral role in the initial diagnosis and management of children with a suspected food allergy. History, some useful laboratory tests, and careful counseling can go a long way to identify these sometimes challenging patients.

A considerable amount of anxiety often surrounds food allergy concerns, and this should be addressed – or at least acknowledged – with patients and their families.

Start with history, the most important diagnostic factor: Ask children and parents about specific symptoms, their timing, and foods the child has ingested. If the child experienced anaphylaxis, then include medication and insect stings in your history taking.

The good news is that 90% of food allergies are caused by a few foods: milk, egg, wheat, soy, peanut, fish, seafood, and nuts. Other triggers are relatively rare.

Allergy skin testing and/or specific immunoglobulin E (IgE) blood tests can support your diagnosis. However, these findings need to be correlated with history because false positive results occur frequently. It is important to realize that the level of specific IgE to a food is not correlated with the severity of a reaction, but instead is correlated with the likelihood of having a single reaction.

Determine if the child's symptoms truly suggest an allergic reaction or instead point to a non–food related cause. Psychological conditions such bulimia, anorexia, or factitious disorder can mimic a food allergy, for example.

Your differential diagnosis also includes structural abnormalities of the GI tract; cystic fibrosis with chronic diarrhea from pancreatic insufficiency; and illness caused by contaminants and additives such as flavorings, dyes, preservatives, or infectious organisms. Also check for exposure to pharmacologic contaminants such as caffeine or tyramine in certain foods.

Rule out lactose intolerance and other disaccharidase deficiencies (especially if the symptoms are limited to the GI tract) and a non-IgE reaction called food protein-induced enterocolitis syndrome (FPIES). An FPIES diagnosis is based on clinical presentation and symptoms because allergy skin testing and specific IgE assays are not helpful.

Also consider gastroesophageal reflux. Children whose symptoms do not improve with proton pump inhibitors might have eosinophilic esophagitis. A food allergen sometimes triggers this condition, and consultation with a gastroenterologist and a biopsy are the best clinical strategies.

Avoidance of the culprit allergen is essential to management. Stress the importance of reading all food labels. Self-injectable epinephrine (such as Mylan Inc.’s EpiPen or EpiPen Jr.) is another essential component. Instruct patients on how and when to use epinephrine, including what to do when anaphylaxis starts in school or in a day care setting. In some cases, it may be appropriate to suggest that the patient wear a medical alert bracelet or necklace.

Education is probably the most important factor in management. Talk to patients and families about prognosis, cross-reactive allergens, and the nutritional needs of patients with multiple food allergies. Keep in mind that if the list of foods to avoid is extensive, this may interfere with normal growth and development. A dietician can help educate families not only on what foods to avoid, but on what foods are encouraged.

Make sure parents are comfortable with your treatment plan. If you are confident in your identification of the culprit food, you can implement a food-elimination diet based on details from the history. Prescribe the appropriate dose of epinephrine and outline an anaphylaxis plan (easily found on the Web site www.foodallergy.org under "Food Allergy Action Plan" in the health professionals section). Allergy medication, including antihistamines, is useful for mild symptoms and hives, but as a wise old allergist once said, "antihistamines cure hives; Epi saves lives!"

Physicians can order in vitro specific IgE blood tests such as Phadia AB’s Pharmacia CAP or UniCAP. These are helpful when performed by a reliable laboratory and may obviate the need for the skin testing of some patients for some foods. These tests are relatively good predictors of peanut, milk, and egg allergies.

In contrast, total IgE and complete blood count assays generally are not helpful. Performance of specific IgE blood tests to foods that are known to be clinically tolerated should be avoided; this just leads to confusion by all parties. In addition, avoid testing for specific IgG to foods because this strategy is not helpful for diagnosis. IgG is a measure of exposure only, and therefore positive results are not uncommon.

Most commonly, I see food-allergic patients post diagnosis to explain the results of previous tests and to develop an ongoing plan for avoidance, which includes strategies in the case of future accidental exposure.

If tolerance is suspected, I discuss with children and parents when to consider a food challenge. Such a protocol is probably best performed at a specialist’s office, particularly if a more comprehensive, double-blind, placebo-controlled challenge is warranted. Food challenges require significant time and resources, including advance preparations in case anaphylaxis occurs.

Also consider referral to a specialist when a food culprit is not easily identified; when there is disparity between diagnostic test findings and patient history; and when the patient and family require more comprehensive education.

This column, "Subspecialist Consult," regularly appears in Pediatric News, an Elsevier publication. Dr. Zacharisen is a professor of pediatrics and medicine specializing in the treatment of allergy, asthma, and clinical immunology at the Medical College of Wisconsin in Milwaukee. He also is on the faculty at the asthma and allergy center at the Children’s Hospital of Wisconsin, also in Milwaukee. Dr. Zacharisen said he had no relevant financial disclosures.

PORTLAND, Ore. – Approximately half of 207 patients with mild to moderate atopic dermatitis were clear or almost clear of disease after using EpiCeram skin barrier emulsion for 3 weeks, either alone or in combination with treatment, according to a report of an open-label study.

At the end of 3 weeks, the mean atopic dermatitis (AD) investigator global assessment (IGA) score improved from a baseline of 2.50 on a 5-point scale to 1.47. The mean pruritus score improved from 2.35 to 1.46 on a 5-point scale.

At week 3 after applying the emulsion twice daily to affected sites, 62% of subjects with baseline mild disease (defined as an IGA score of 2) were rated on the IGA scale as clear (a score of 0) or almost clear (a score of 1); 46% of those with moderate disease (an IGA score of 3 at baseline) were rated as clear or almost clear at the end of the study, said Dr. Leon Kircik, a dermatologist at Indiana University Medical Center, Bloomington, and his associates.

When Promius Pharma LLC’s EpiCeram skin barrier emulsion was used alone, 56% of subjects had clear or almost clear IGA scores at the end of week 3; 48% achieved those results when it was used in combination, usually with topical corticosteroids.

The study, not yet published, does not analyze who in the disease severity subgroups improved using EpiCeram alone, and who improved when it was used in combination. The trial had no placebo group.

Results were similar for the 59 pediatric patients in the trial (age range, 1 month–16 years), according to a subgroup analysis presented in poster form by Dr. Kircik at the annual meeting of the Society for Pediatric Dermatology.

At the end of 3 weeks, 62% of EpiCeram monotherapy pediatric patients had clear or almost clear IGA scores; 50% who used EpiCeram in combination with another treatment achieved those results. Pruritus scores were roughly halved among pediatric patients overall, said Dr. Kircik.

The study proved EpiCeram “to be an effective and versatile agent that can be used with or without additional AD therapy to provide good clinical efficacy and high levels of investigator and patient satisfaction,” said Dr. Kircik.

EpiCeram emulsion contains ceramide, cholesterol, and free fatty acids in a molar ratio of 3:1:1. It was cleared for marketing by the Food and Drug Administration in 2006.

Subjects in the trial were recruited from 50 dermatology practices across the country; 49% were assessed by investigators to have mild disease at baseline, 51% moderate disease; 81% reported one or more AD flares per month at baseline.

All subjects were EpiCeram naive. Their mean age was 34 years, and 65% were women, the majority white. The median duration of AD diagnosis was 5 years.

At baseline, current AD medications were stopped and subjects were given EpiCeram along with an add-on prescription, selected at the discretion of their dermatologist-investigator, to use if their AD worsened. Most prescriptions were for topical corticosteroids; three were for Protopic (tacrolimus), and two for an oral antihistamine, according to the report.

Subjects were instructed to apply EpiCeram to affected areas, as well as to antecubital, popliteal, or other predisposed regions, approximately every 12 hours.

At assessment 3 weeks later, 71% of subjects reported using EpiCeram every day, 22% “most every day,” and 7% occasionally; 29% used the additional medication.

The report does not break-down efficacy results by reported usage.

Six subjects reported a total of seven adverse events, including erythema, skin irritation, pruritus, paresthesia, and pain. An additional nine subjects reported worsening AD.

EpiCeram’s effects satisfied 75% of subjects and 77% of investigators; 78% of subjects believed that their AD had improved, at least a little, since baseline, according to the report.

“In this study, it seems that clinical efficacy alone did not contribute to satisfaction, as rates of satisfaction were higher than the rate for clinical success,” the authors noted.

When Dr. Eric Simpson, a dermatologist and AD expert from the Oregon Health and Science University in Portland, was asked to comment on the study, he said, “I think some people with mild to moderate disease can improve with EpiCeram, but it is difficult to draw conclusions without a vehicle control.”

He noted that 20%-25% of AD patients in placebo-controlled trials improve with just vehicle alone. Given the response rates in the EpiCeram trial, “I think these people probably did get better. The question is if they would have gotten better with moisturizer alone.”

Dr. Simpson said he is likely to try EpiCeram when he can’t use the calcineurin inhibitors Protopic or Elidel (pimecrolimus) because these agents burn patients too much on application, if a patient has skin cancer, or for some other reason. Such situations give him “a good opportunity to try it,” he said.

The study was funded by EpiCeram’s distributor, Promius Pharma LLC. Dr. Kircik and his associate Dr. Del Rosso are consultants and speakers for Promius Pharma. Dr. Kircik’s associate Daniel Aversa is a Promius Pharma employee. Dr. Simpson disclosed that he participated in research funded by Ceragenix Pharmaceuticals Inc., the original developer of EpiCeram.

PORTLAND, Ore. – Approximately half of 207 patients with mild to moderate atopic dermatitis were clear or almost clear of disease after using EpiCeram skin barrier emulsion for 3 weeks, either alone or in combination with treatment, according to a report of an open-label study.

At the end of 3 weeks, the mean atopic dermatitis (AD) investigator global assessment (IGA) score improved from a baseline of 2.50 on a 5-point scale to 1.47. The mean pruritus score improved from 2.35 to 1.46 on a 5-point scale.

At week 3 after applying the emulsion twice daily to affected sites, 62% of subjects with baseline mild disease (defined as an IGA score of 2) were rated on the IGA scale as clear (a score of 0) or almost clear (a score of 1); 46% of those with moderate disease (an IGA score of 3 at baseline) were rated as clear or almost clear at the end of the study, said Dr. Leon Kircik, a dermatologist at Indiana University Medical Center, Bloomington, and his associates.

When Promius Pharma LLC’s EpiCeram skin barrier emulsion was used alone, 56% of subjects had clear or almost clear IGA scores at the end of week 3; 48% achieved those results when it was used in combination, usually with topical corticosteroids.

The study, not yet published, does not analyze who in the disease severity subgroups improved using EpiCeram alone, and who improved when it was used in combination. The trial had no placebo group.

Results were similar for the 59 pediatric patients in the trial (age range, 1 month–16 years), according to a subgroup analysis presented in poster form by Dr. Kircik at the annual meeting of the Society for Pediatric Dermatology.

At the end of 3 weeks, 62% of EpiCeram monotherapy pediatric patients had clear or almost clear IGA scores; 50% who used EpiCeram in combination with another treatment achieved those results. Pruritus scores were roughly halved among pediatric patients overall, said Dr. Kircik.

The study proved EpiCeram “to be an effective and versatile agent that can be used with or without additional AD therapy to provide good clinical efficacy and high levels of investigator and patient satisfaction,” said Dr. Kircik.

EpiCeram emulsion contains ceramide, cholesterol, and free fatty acids in a molar ratio of 3:1:1. It was cleared for marketing by the Food and Drug Administration in 2006.

Subjects in the trial were recruited from 50 dermatology practices across the country; 49% were assessed by investigators to have mild disease at baseline, 51% moderate disease; 81% reported one or more AD flares per month at baseline.

All subjects were EpiCeram naive. Their mean age was 34 years, and 65% were women, the majority white. The median duration of AD diagnosis was 5 years.

At baseline, current AD medications were stopped and subjects were given EpiCeram along with an add-on prescription, selected at the discretion of their dermatologist-investigator, to use if their AD worsened. Most prescriptions were for topical corticosteroids; three were for Protopic (tacrolimus), and two for an oral antihistamine, according to the report.

Subjects were instructed to apply EpiCeram to affected areas, as well as to antecubital, popliteal, or other predisposed regions, approximately every 12 hours.

At assessment 3 weeks later, 71% of subjects reported using EpiCeram every day, 22% “most every day,” and 7% occasionally; 29% used the additional medication.

The report does not break-down efficacy results by reported usage.

Six subjects reported a total of seven adverse events, including erythema, skin irritation, pruritus, paresthesia, and pain. An additional nine subjects reported worsening AD.

EpiCeram’s effects satisfied 75% of subjects and 77% of investigators; 78% of subjects believed that their AD had improved, at least a little, since baseline, according to the report.

“In this study, it seems that clinical efficacy alone did not contribute to satisfaction, as rates of satisfaction were higher than the rate for clinical success,” the authors noted.

When Dr. Eric Simpson, a dermatologist and AD expert from the Oregon Health and Science University in Portland, was asked to comment on the study, he said, “I think some people with mild to moderate disease can improve with EpiCeram, but it is difficult to draw conclusions without a vehicle control.”

He noted that 20%-25% of AD patients in placebo-controlled trials improve with just vehicle alone. Given the response rates in the EpiCeram trial, “I think these people probably did get better. The question is if they would have gotten better with moisturizer alone.”

Dr. Simpson said he is likely to try EpiCeram when he can’t use the calcineurin inhibitors Protopic or Elidel (pimecrolimus) because these agents burn patients too much on application, if a patient has skin cancer, or for some other reason. Such situations give him “a good opportunity to try it,” he said.

The study was funded by EpiCeram’s distributor, Promius Pharma LLC. Dr. Kircik and his associate Dr. Del Rosso are consultants and speakers for Promius Pharma. Dr. Kircik’s associate Daniel Aversa is a Promius Pharma employee. Dr. Simpson disclosed that he participated in research funded by Ceragenix Pharmaceuticals Inc., the original developer of EpiCeram.

PORTLAND, Ore. – Approximately half of 207 patients with mild to moderate atopic dermatitis were clear or almost clear of disease after using EpiCeram skin barrier emulsion for 3 weeks, either alone or in combination with treatment, according to a report of an open-label study.

At the end of 3 weeks, the mean atopic dermatitis (AD) investigator global assessment (IGA) score improved from a baseline of 2.50 on a 5-point scale to 1.47. The mean pruritus score improved from 2.35 to 1.46 on a 5-point scale.

At week 3 after applying the emulsion twice daily to affected sites, 62% of subjects with baseline mild disease (defined as an IGA score of 2) were rated on the IGA scale as clear (a score of 0) or almost clear (a score of 1); 46% of those with moderate disease (an IGA score of 3 at baseline) were rated as clear or almost clear at the end of the study, said Dr. Leon Kircik, a dermatologist at Indiana University Medical Center, Bloomington, and his associates.

When Promius Pharma LLC’s EpiCeram skin barrier emulsion was used alone, 56% of subjects had clear or almost clear IGA scores at the end of week 3; 48% achieved those results when it was used in combination, usually with topical corticosteroids.

The study, not yet published, does not analyze who in the disease severity subgroups improved using EpiCeram alone, and who improved when it was used in combination. The trial had no placebo group.

Results were similar for the 59 pediatric patients in the trial (age range, 1 month–16 years), according to a subgroup analysis presented in poster form by Dr. Kircik at the annual meeting of the Society for Pediatric Dermatology.

At the end of 3 weeks, 62% of EpiCeram monotherapy pediatric patients had clear or almost clear IGA scores; 50% who used EpiCeram in combination with another treatment achieved those results. Pruritus scores were roughly halved among pediatric patients overall, said Dr. Kircik.

The study proved EpiCeram “to be an effective and versatile agent that can be used with or without additional AD therapy to provide good clinical efficacy and high levels of investigator and patient satisfaction,” said Dr. Kircik.

EpiCeram emulsion contains ceramide, cholesterol, and free fatty acids in a molar ratio of 3:1:1. It was cleared for marketing by the Food and Drug Administration in 2006.

Subjects in the trial were recruited from 50 dermatology practices across the country; 49% were assessed by investigators to have mild disease at baseline, 51% moderate disease; 81% reported one or more AD flares per month at baseline.

All subjects were EpiCeram naive. Their mean age was 34 years, and 65% were women, the majority white. The median duration of AD diagnosis was 5 years.

At baseline, current AD medications were stopped and subjects were given EpiCeram along with an add-on prescription, selected at the discretion of their dermatologist-investigator, to use if their AD worsened. Most prescriptions were for topical corticosteroids; three were for Protopic (tacrolimus), and two for an oral antihistamine, according to the report.

Subjects were instructed to apply EpiCeram to affected areas, as well as to antecubital, popliteal, or other predisposed regions, approximately every 12 hours.

At assessment 3 weeks later, 71% of subjects reported using EpiCeram every day, 22% “most every day,” and 7% occasionally; 29% used the additional medication.

The report does not break-down efficacy results by reported usage.

Six subjects reported a total of seven adverse events, including erythema, skin irritation, pruritus, paresthesia, and pain. An additional nine subjects reported worsening AD.

EpiCeram’s effects satisfied 75% of subjects and 77% of investigators; 78% of subjects believed that their AD had improved, at least a little, since baseline, according to the report.

“In this study, it seems that clinical efficacy alone did not contribute to satisfaction, as rates of satisfaction were higher than the rate for clinical success,” the authors noted.

When Dr. Eric Simpson, a dermatologist and AD expert from the Oregon Health and Science University in Portland, was asked to comment on the study, he said, “I think some people with mild to moderate disease can improve with EpiCeram, but it is difficult to draw conclusions without a vehicle control.”

He noted that 20%-25% of AD patients in placebo-controlled trials improve with just vehicle alone. Given the response rates in the EpiCeram trial, “I think these people probably did get better. The question is if they would have gotten better with moisturizer alone.”

Dr. Simpson said he is likely to try EpiCeram when he can’t use the calcineurin inhibitors Protopic or Elidel (pimecrolimus) because these agents burn patients too much on application, if a patient has skin cancer, or for some other reason. Such situations give him “a good opportunity to try it,” he said.

The study was funded by EpiCeram’s distributor, Promius Pharma LLC. Dr. Kircik and his associate Dr. Del Rosso are consultants and speakers for Promius Pharma. Dr. Kircik’s associate Daniel Aversa is a Promius Pharma employee. Dr. Simpson disclosed that he participated in research funded by Ceragenix Pharmaceuticals Inc., the original developer of EpiCeram.

Ki-Young Suh, MD

The relationship between food and atopic dermatitis (AD) is complex. A common misunderstanding is that food allergies have a significant impact on the course of AD, resulting in uncontrolled attempts at elimination diets and undertreatment of the skin itself. Studies have shown that only a small portion of cutaneous reactions to food in the form of late, eczematous eruptions will directly exacerbate AD in young infants who have moderate-tosevere AD. Given the low frequency of food allergies actually inducing flares of AD, the focus should return to appropriate skin therapy, and identification of true food allergies should be reserved for recalcitrant AD in children in whom the suspicion for food allergy is high. A different relationship between food and AD involves delaying or preventing AD in high-risk infants by exclusive breastfeeding during the first 4 months of life. Finally, the skin barrier defect in AD may allow for easier and earlier sensitization of food and airborne allergens; therefore, exposure of food proteins on AD skin may act as a risk factor for development of food allergies.

*For a PDF of the full article, click on the link to the left of this introduction.

Ki-Young Suh, MD

The relationship between food and atopic dermatitis (AD) is complex. A common misunderstanding is that food allergies have a significant impact on the course of AD, resulting in uncontrolled attempts at elimination diets and undertreatment of the skin itself. Studies have shown that only a small portion of cutaneous reactions to food in the form of late, eczematous eruptions will directly exacerbate AD in young infants who have moderate-tosevere AD. Given the low frequency of food allergies actually inducing flares of AD, the focus should return to appropriate skin therapy, and identification of true food allergies should be reserved for recalcitrant AD in children in whom the suspicion for food allergy is high. A different relationship between food and AD involves delaying or preventing AD in high-risk infants by exclusive breastfeeding during the first 4 months of life. Finally, the skin barrier defect in AD may allow for easier and earlier sensitization of food and airborne allergens; therefore, exposure of food proteins on AD skin may act as a risk factor for development of food allergies.

*For a PDF of the full article, click on the link to the left of this introduction.

Ki-Young Suh, MD

The relationship between food and atopic dermatitis (AD) is complex. A common misunderstanding is that food allergies have a significant impact on the course of AD, resulting in uncontrolled attempts at elimination diets and undertreatment of the skin itself. Studies have shown that only a small portion of cutaneous reactions to food in the form of late, eczematous eruptions will directly exacerbate AD in young infants who have moderate-tosevere AD. Given the low frequency of food allergies actually inducing flares of AD, the focus should return to appropriate skin therapy, and identification of true food allergies should be reserved for recalcitrant AD in children in whom the suspicion for food allergy is high. A different relationship between food and AD involves delaying or preventing AD in high-risk infants by exclusive breastfeeding during the first 4 months of life. Finally, the skin barrier defect in AD may allow for easier and earlier sensitization of food and airborne allergens; therefore, exposure of food proteins on AD skin may act as a risk factor for development of food allergies.

*For a PDF of the full article, click on the link to the left of this introduction.

MIAMI – Food allergies in children appear to be increasing in prevalence, can be diagnosed based on history and testing, and are often best managed using a multidisciplinary approach and careful follow-up, Dr. Vivian Hernandez-Trujillo said.

Counsel patients and families on how to recognize symptoms and avoid certain allergens. Also educate them to prepare for future emergencies, including instruction on the use of self-injected epinephrine. Unfortunately, even if a child has had only mild allergic reactions, there is no guarantee the next episode will not be more serious, Dr. Hernandez-Trujillo said.

Although children can have allergic reactions to any food, six types are responsible for 90% of reactions. These are milk, eggs, peanuts, wheat, soy, and tree nuts.

“Cow’s milk, eggs, and soy [reactions] are most common in kids. And allergies to peanuts, tree nuts, seafood, and seeds tend to persist – that is a take-home message,” Dr. Hernandez-Trujillo said at a pediatric update sponsored by Miami Children’s Hospital.

Diagnosis relies on “history, history, and history.” A personal and family history of allergy, exposure to common allergenic foods, and the presence of other allergic diseases such as asthma or rhinitis are important considerations. Risk, for example, is four times greater with a positive family history of asthma. Diet diaries also are very important, particularly when working with an allergist and nutritionist. “I always involve nutritionists – we are a team,” said Dr. Hernandez-Trujillo, director of the division of allergy and immunology at the hospital.

Elimination diets, skin testing, in vitro assays, and food challenges also have roles in diagnosis, she said.

The length of time between ingestion and symptoms can help to distinguish between the two main types of allergic reactions to food protein: IgE mediated and non–IgE mediated. IgE-mediated reactions can produce signs and symptoms within 20 minutes versus 2 hours to several days for non-IgE reactions.

IgE-type reactions can be more serious, even life threatening, because they include anaphylaxis. An estimated 150 people die each year of fatal food anaphylaxis. "This is a striking number,” Dr. Hernandez-Trujillo said. Respiratory symptoms are prominent. “Cutaneous symptoms may not be present – if they are not there, it may be very frightening,” she added.

Factors that increase the risk for fatal anaphylaxis include a history of severe reactions, underlying asthma, delayed use of epinephrine, and symptom denial among adolescents and young adults.

Caution is warranted in children younger than 1 year because of a higher rate of false-negative skin test results, Dr. Hernandez-Trujillo said. “It is still worth testing them if you catch a positive.”

Skin prick testing has a negative predictive value of 95% or more, but a positive predictive value of only 50%. Although this testing is not recommended for screening, selective use for a suspected food makes sense, Dr. Hernandez-Trujillo said. She added, “We never do intradermals. They are risky and have a high false-positive rate.”

If a test for a specific IgE antibody is negative, reintroduce food, Dr. Hernandez-Trujillo said. If there is a positive antibody assay, start an elimination diet.

Symptoms of non-IgE allergic food hypersensitivity – protracted vomiting and/or diarrhea, dehydration – can resolve within 72 hours of food avoidance.

Elimination diets of 1-6 weeks are very important with non–IgE-mediated disease as well. Eliminate the suspected food, if known, or put the patient on a very strict elemental diet, she recommended. Oral challenge testing should be done only under physician supervision with emergency medications available, Dr. Hernandez-Trujillo.

When it comes to management of food allergy, “I frequently consult a nutritionist,” she said. A decision on whether to rechallenge a patient depends on the type of food allergy, the severity of symptoms experienced in the past, and the specific allergen involved. A periodic reevaluation for tolerance is helpful, she said. Tolerance is suggested if concentrations of food-specific IgE levels decrease over time.

An estimated 2.2 million school-aged children have food allergy (J. Allergy Clin. Immunol. 2001;107:191-3). Although public perception of prevalence is higher at around 20%-25%, oral challenge testing puts the figures between 6% and 8% for infants and young children and 2.0%-3.5% for adults. Children with atopic dermatitis, latex allergy, and certain allergies to pollen will experience higher rates, Dr. Hernandez-Trujillo said.

“Prevalence does seem to be increasing,” she said.

Dr. Hernandez-Trujillo said she had no relevant financial disclosures.

MIAMI – Food allergies in children appear to be increasing in prevalence, can be diagnosed based on history and testing, and are often best managed using a multidisciplinary approach and careful follow-up, Dr. Vivian Hernandez-Trujillo said.

Counsel patients and families on how to recognize symptoms and avoid certain allergens. Also educate them to prepare for future emergencies, including instruction on the use of self-injected epinephrine. Unfortunately, even if a child has had only mild allergic reactions, there is no guarantee the next episode will not be more serious, Dr. Hernandez-Trujillo said.

Although children can have allergic reactions to any food, six types are responsible for 90% of reactions. These are milk, eggs, peanuts, wheat, soy, and tree nuts.

“Cow’s milk, eggs, and soy [reactions] are most common in kids. And allergies to peanuts, tree nuts, seafood, and seeds tend to persist – that is a take-home message,” Dr. Hernandez-Trujillo said at a pediatric update sponsored by Miami Children’s Hospital.

Diagnosis relies on “history, history, and history.” A personal and family history of allergy, exposure to common allergenic foods, and the presence of other allergic diseases such as asthma or rhinitis are important considerations. Risk, for example, is four times greater with a positive family history of asthma. Diet diaries also are very important, particularly when working with an allergist and nutritionist. “I always involve nutritionists – we are a team,” said Dr. Hernandez-Trujillo, director of the division of allergy and immunology at the hospital.

Elimination diets, skin testing, in vitro assays, and food challenges also have roles in diagnosis, she said.

The length of time between ingestion and symptoms can help to distinguish between the two main types of allergic reactions to food protein: IgE mediated and non–IgE mediated. IgE-mediated reactions can produce signs and symptoms within 20 minutes versus 2 hours to several days for non-IgE reactions.

IgE-type reactions can be more serious, even life threatening, because they include anaphylaxis. An estimated 150 people die each year of fatal food anaphylaxis. "This is a striking number,” Dr. Hernandez-Trujillo said. Respiratory symptoms are prominent. “Cutaneous symptoms may not be present – if they are not there, it may be very frightening,” she added.

Factors that increase the risk for fatal anaphylaxis include a history of severe reactions, underlying asthma, delayed use of epinephrine, and symptom denial among adolescents and young adults.

Caution is warranted in children younger than 1 year because of a higher rate of false-negative skin test results, Dr. Hernandez-Trujillo said. “It is still worth testing them if you catch a positive.”

Skin prick testing has a negative predictive value of 95% or more, but a positive predictive value of only 50%. Although this testing is not recommended for screening, selective use for a suspected food makes sense, Dr. Hernandez-Trujillo said. She added, “We never do intradermals. They are risky and have a high false-positive rate.”

If a test for a specific IgE antibody is negative, reintroduce food, Dr. Hernandez-Trujillo said. If there is a positive antibody assay, start an elimination diet.

Symptoms of non-IgE allergic food hypersensitivity – protracted vomiting and/or diarrhea, dehydration – can resolve within 72 hours of food avoidance.

Elimination diets of 1-6 weeks are very important with non–IgE-mediated disease as well. Eliminate the suspected food, if known, or put the patient on a very strict elemental diet, she recommended. Oral challenge testing should be done only under physician supervision with emergency medications available, Dr. Hernandez-Trujillo.

When it comes to management of food allergy, “I frequently consult a nutritionist,” she said. A decision on whether to rechallenge a patient depends on the type of food allergy, the severity of symptoms experienced in the past, and the specific allergen involved. A periodic reevaluation for tolerance is helpful, she said. Tolerance is suggested if concentrations of food-specific IgE levels decrease over time.

An estimated 2.2 million school-aged children have food allergy (J. Allergy Clin. Immunol. 2001;107:191-3). Although public perception of prevalence is higher at around 20%-25%, oral challenge testing puts the figures between 6% and 8% for infants and young children and 2.0%-3.5% for adults. Children with atopic dermatitis, latex allergy, and certain allergies to pollen will experience higher rates, Dr. Hernandez-Trujillo said.

“Prevalence does seem to be increasing,” she said.

Dr. Hernandez-Trujillo said she had no relevant financial disclosures.

MIAMI – Food allergies in children appear to be increasing in prevalence, can be diagnosed based on history and testing, and are often best managed using a multidisciplinary approach and careful follow-up, Dr. Vivian Hernandez-Trujillo said.

Counsel patients and families on how to recognize symptoms and avoid certain allergens. Also educate them to prepare for future emergencies, including instruction on the use of self-injected epinephrine. Unfortunately, even if a child has had only mild allergic reactions, there is no guarantee the next episode will not be more serious, Dr. Hernandez-Trujillo said.

Although children can have allergic reactions to any food, six types are responsible for 90% of reactions. These are milk, eggs, peanuts, wheat, soy, and tree nuts.

“Cow’s milk, eggs, and soy [reactions] are most common in kids. And allergies to peanuts, tree nuts, seafood, and seeds tend to persist – that is a take-home message,” Dr. Hernandez-Trujillo said at a pediatric update sponsored by Miami Children’s Hospital.

Diagnosis relies on “history, history, and history.” A personal and family history of allergy, exposure to common allergenic foods, and the presence of other allergic diseases such as asthma or rhinitis are important considerations. Risk, for example, is four times greater with a positive family history of asthma. Diet diaries also are very important, particularly when working with an allergist and nutritionist. “I always involve nutritionists – we are a team,” said Dr. Hernandez-Trujillo, director of the division of allergy and immunology at the hospital.

Elimination diets, skin testing, in vitro assays, and food challenges also have roles in diagnosis, she said.

The length of time between ingestion and symptoms can help to distinguish between the two main types of allergic reactions to food protein: IgE mediated and non–IgE mediated. IgE-mediated reactions can produce signs and symptoms within 20 minutes versus 2 hours to several days for non-IgE reactions.

IgE-type reactions can be more serious, even life threatening, because they include anaphylaxis. An estimated 150 people die each year of fatal food anaphylaxis. "This is a striking number,” Dr. Hernandez-Trujillo said. Respiratory symptoms are prominent. “Cutaneous symptoms may not be present – if they are not there, it may be very frightening,” she added.

Factors that increase the risk for fatal anaphylaxis include a history of severe reactions, underlying asthma, delayed use of epinephrine, and symptom denial among adolescents and young adults.

Caution is warranted in children younger than 1 year because of a higher rate of false-negative skin test results, Dr. Hernandez-Trujillo said. “It is still worth testing them if you catch a positive.”

Skin prick testing has a negative predictive value of 95% or more, but a positive predictive value of only 50%. Although this testing is not recommended for screening, selective use for a suspected food makes sense, Dr. Hernandez-Trujillo said. She added, “We never do intradermals. They are risky and have a high false-positive rate.”

If a test for a specific IgE antibody is negative, reintroduce food, Dr. Hernandez-Trujillo said. If there is a positive antibody assay, start an elimination diet.

Symptoms of non-IgE allergic food hypersensitivity – protracted vomiting and/or diarrhea, dehydration – can resolve within 72 hours of food avoidance.

Elimination diets of 1-6 weeks are very important with non–IgE-mediated disease as well. Eliminate the suspected food, if known, or put the patient on a very strict elemental diet, she recommended. Oral challenge testing should be done only under physician supervision with emergency medications available, Dr. Hernandez-Trujillo.

When it comes to management of food allergy, “I frequently consult a nutritionist,” she said. A decision on whether to rechallenge a patient depends on the type of food allergy, the severity of symptoms experienced in the past, and the specific allergen involved. A periodic reevaluation for tolerance is helpful, she said. Tolerance is suggested if concentrations of food-specific IgE levels decrease over time.

An estimated 2.2 million school-aged children have food allergy (J. Allergy Clin. Immunol. 2001;107:191-3). Although public perception of prevalence is higher at around 20%-25%, oral challenge testing puts the figures between 6% and 8% for infants and young children and 2.0%-3.5% for adults. Children with atopic dermatitis, latex allergy, and certain allergies to pollen will experience higher rates, Dr. Hernandez-Trujillo said.

“Prevalence does seem to be increasing,” she said.

Dr. Hernandez-Trujillo said she had no relevant financial disclosures.

Dr. Stephen E. Wolverton on why short-course use of corticosteroids is not a cause of osteonecrosis. Damian McNamara reports from Miami.

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Dr. Stephen E. Wolverton on why short-course use of corticosteroids is not a cause of osteonecrosis. Damian McNamara reports from Miami.

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Dr. Stephen E. Wolverton on why short-course use of corticosteroids is not a cause of osteonecrosis. Damian McNamara reports from Miami.

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MIAMI – Obstetricians may be lacking adequate information on the proper management of pregnancies affected by epidermolysis bullosa, findings from a survey suggested.

Of 195 Australian obstetricians who responded to the survey, 111 (57%) said information on epidermolysis bullosa (EB) is needed in prenatal clinics, Dr. Lizbeth Intong reported at the annual meeting of the American Academy of Dermatology.

Of the 195 (7%) respondents, 14 had encountered a pregnancy affected by EB; only 6 (43%) of the 14 said they conducted a literature search for information on the disease to help in their patient management, and only 4 (29%) comanaged their EB patients with a dermatologist, said Dr. Intong, a dermatologist at St. George Hospital in Sydney.

Mothers who had given birth to babies with EB, and mothers with EB who had given birth were also surveyed as part of the study. A total of 58 mothers who had babies with EB responded, and they had a total of 130 babies, including 67 (52%) born with EB.

Most babies were born by normal vaginal delivery, with a 5:1 ratio of normal vaginal deliveries to cesarean sections; the more severe the EB type, the more blistering was seen at birth.

Forty-one mothers with EB also responded to the survey. These mothers gave birth to a total of 104 babies, including 50 (48%) born with EB, mostly by normal vaginal delivery. In this group there was a 4:1 ratio of normal vaginal deliveries to C-sections.

Two of the mothers with EB reported that their condition worsened during pregnancy, and two said it improved; EB-related problems that were reported included blistering at the site of the adhesive tape used during an epidural and nipple blistering during breastfeeding, which led to a switch from breastfeeding to bottle feeding “There is an obvious need for information about EB in [prenatal] clinics,” Dr. Intong said, adding that based on the survey results, she now advises that normal vaginal delivery (no forceps or vacuum assistance) is generally safe, that C-section should be considered in severe cases to reduce birth trauma, that nonadhesive tapes and dressings be used on mothers with EB, and that mothers with EB receive counseling about proper care during breastfeeding, such as the use of nipple shields to help prevent blistering.

Dr. Intong said she had no conflicts of interest to disclose.

MIAMI – Obstetricians may be lacking adequate information on the proper management of pregnancies affected by epidermolysis bullosa, findings from a survey suggested.

Of 195 Australian obstetricians who responded to the survey, 111 (57%) said information on epidermolysis bullosa (EB) is needed in prenatal clinics, Dr. Lizbeth Intong reported at the annual meeting of the American Academy of Dermatology.

Of the 195 (7%) respondents, 14 had encountered a pregnancy affected by EB; only 6 (43%) of the 14 said they conducted a literature search for information on the disease to help in their patient management, and only 4 (29%) comanaged their EB patients with a dermatologist, said Dr. Intong, a dermatologist at St. George Hospital in Sydney.

Mothers who had given birth to babies with EB, and mothers with EB who had given birth were also surveyed as part of the study. A total of 58 mothers who had babies with EB responded, and they had a total of 130 babies, including 67 (52%) born with EB.

Most babies were born by normal vaginal delivery, with a 5:1 ratio of normal vaginal deliveries to cesarean sections; the more severe the EB type, the more blistering was seen at birth.

Forty-one mothers with EB also responded to the survey. These mothers gave birth to a total of 104 babies, including 50 (48%) born with EB, mostly by normal vaginal delivery. In this group there was a 4:1 ratio of normal vaginal deliveries to C-sections.

Two of the mothers with EB reported that their condition worsened during pregnancy, and two said it improved; EB-related problems that were reported included blistering at the site of the adhesive tape used during an epidural and nipple blistering during breastfeeding, which led to a switch from breastfeeding to bottle feeding “There is an obvious need for information about EB in [prenatal] clinics,” Dr. Intong said, adding that based on the survey results, she now advises that normal vaginal delivery (no forceps or vacuum assistance) is generally safe, that C-section should be considered in severe cases to reduce birth trauma, that nonadhesive tapes and dressings be used on mothers with EB, and that mothers with EB receive counseling about proper care during breastfeeding, such as the use of nipple shields to help prevent blistering.

Dr. Intong said she had no conflicts of interest to disclose.

MIAMI – Obstetricians may be lacking adequate information on the proper management of pregnancies affected by epidermolysis bullosa, findings from a survey suggested.

Of 195 Australian obstetricians who responded to the survey, 111 (57%) said information on epidermolysis bullosa (EB) is needed in prenatal clinics, Dr. Lizbeth Intong reported at the annual meeting of the American Academy of Dermatology.

Of the 195 (7%) respondents, 14 had encountered a pregnancy affected by EB; only 6 (43%) of the 14 said they conducted a literature search for information on the disease to help in their patient management, and only 4 (29%) comanaged their EB patients with a dermatologist, said Dr. Intong, a dermatologist at St. George Hospital in Sydney.

Mothers who had given birth to babies with EB, and mothers with EB who had given birth were also surveyed as part of the study. A total of 58 mothers who had babies with EB responded, and they had a total of 130 babies, including 67 (52%) born with EB.

Most babies were born by normal vaginal delivery, with a 5:1 ratio of normal vaginal deliveries to cesarean sections; the more severe the EB type, the more blistering was seen at birth.

Forty-one mothers with EB also responded to the survey. These mothers gave birth to a total of 104 babies, including 50 (48%) born with EB, mostly by normal vaginal delivery. In this group there was a 4:1 ratio of normal vaginal deliveries to C-sections.

Two of the mothers with EB reported that their condition worsened during pregnancy, and two said it improved; EB-related problems that were reported included blistering at the site of the adhesive tape used during an epidural and nipple blistering during breastfeeding, which led to a switch from breastfeeding to bottle feeding “There is an obvious need for information about EB in [prenatal] clinics,” Dr. Intong said, adding that based on the survey results, she now advises that normal vaginal delivery (no forceps or vacuum assistance) is generally safe, that C-section should be considered in severe cases to reduce birth trauma, that nonadhesive tapes and dressings be used on mothers with EB, and that mothers with EB receive counseling about proper care during breastfeeding, such as the use of nipple shields to help prevent blistering.

Dr. Intong said she had no conflicts of interest to disclose.

NEW ORLEANS - Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU between 2003 and 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University in Chicago and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The study findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.
Skin biopsies from 27 patients, including 14 responders, 12 nonresponders, and 1 partial responder, showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

"Colchicine was particularly effective in patients with neutrophilic urticaria," the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

"Colchicine has a relatively safe profile in chronic idiopathic urticaria," the researchers noted.

Dr. Georgy had no financial conflicts to disclose.

NEW ORLEANS - Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU between 2003 and 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University in Chicago and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The study findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.
Skin biopsies from 27 patients, including 14 responders, 12 nonresponders, and 1 partial responder, showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

"Colchicine was particularly effective in patients with neutrophilic urticaria," the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

"Colchicine has a relatively safe profile in chronic idiopathic urticaria," the researchers noted.

Dr. Georgy had no financial conflicts to disclose.

NEW ORLEANS - Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU between 2003 and 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University in Chicago and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The study findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.
Skin biopsies from 27 patients, including 14 responders, 12 nonresponders, and 1 partial responder, showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

"Colchicine was particularly effective in patients with neutrophilic urticaria," the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

"Colchicine has a relatively safe profile in chronic idiopathic urticaria," the researchers noted.

Dr. Georgy had no financial conflicts to disclose.

Vitamin D insufficiency may be linked to allergies and asthma in children, according to Dr. Daniel A. Searing.  Heidi Splete reports from the annual meeting of the American Academy of Allergy, Asthma & Immunology.

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Vitamin D insufficiency may be linked to allergies and asthma in children, according to Dr. Daniel A. Searing.  Heidi Splete reports from the annual meeting of the American Academy of Allergy, Asthma & Immunology.

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Vitamin D insufficiency may be linked to allergies and asthma in children, according to Dr. Daniel A. Searing.  Heidi Splete reports from the annual meeting of the American Academy of Allergy, Asthma & Immunology.

View Video Now.

MIAMI – Long-term use of tacrolimus ointment in children with atopic dermatitis is associated with a low rate of serious adverse events, according to interim data from a prospective study.

The safety profile shown thus far is consistent with the established profile for tacrolimus ointment (Protopic), and it is hoped that these findings will encourage dermatologists to continue enrolling pediatric patients in this ongoing phase IV safety study, Dr. Joyce Rico said in a poster presentation at the annual meeting of the American Academy of Dermatology.

The interim report focused on 4,800 patients enrolled in APPLES (A Prospective Pediatric Longitudinal Evaluation Study) between May 2005 and September 2009. The investigators seek to enroll 8,000 children in the multinational, observational cohort study, said Dr. Rico, vice president of medical science at Astellas Pharma Inc., Chicago.

That is the number needed to accurately identify an increase in the risk of malignancy associated with tacrolimus treatment over the course of the 10-year study, but the investigators are also evaluating other serious adverse events.

Such events occurred in about 5% of the participants, who had a median age of 6 years at enrollment. Most of the serious events were asthma, occurring in 1% of patients, and infectionsincluding pneumonia, bronchitis, cellulitis, gastroenteritis, and tonsillitis – occurring in nearly 2% of patients. There was one report of a malignancy – a peripheral glioneuronal tumor – not typically associated with immunosuppression, Dr. Rico noted.

The malignancy rate in APPLES is half that seen in the general U.S. population, based on data from the Surveillance, Epidemiology, and End Results database, she said.

About 40% of children in APPLES had mild disease at baseline and about 60% reported moderate or severe disease. Treatment is either 0.03% ointment (the dosage approved for children) or off-label 0.1% ointment (the dosage approved for adults); most are being treated with 0.1% ointment. The median cumulative duration of time since initial treatment application is 2.8 years per patient.

“The serious adverse events profile we’re seeing is consistent with what was observed during the clinical development program,” Dr. Rico said, noting that, although the results are encouraging, enrollment of the full 8,000 patients is needed to adequately address the long-term safety of tacrolimus treatment in children.

“I encourage you and your colleagues to continue to enroll patients ... It’s going to take the dermatology community continuing to help us to reach that goal,” she concluded.

Dr. Rico is employed by Astellas, the maker of Protopic and sponsor of the study.

MIAMI – Long-term use of tacrolimus ointment in children with atopic dermatitis is associated with a low rate of serious adverse events, according to interim data from a prospective study.

The safety profile shown thus far is consistent with the established profile for tacrolimus ointment (Protopic), and it is hoped that these findings will encourage dermatologists to continue enrolling pediatric patients in this ongoing phase IV safety study, Dr. Joyce Rico said in a poster presentation at the annual meeting of the American Academy of Dermatology.

The interim report focused on 4,800 patients enrolled in APPLES (A Prospective Pediatric Longitudinal Evaluation Study) between May 2005 and September 2009. The investigators seek to enroll 8,000 children in the multinational, observational cohort study, said Dr. Rico, vice president of medical science at Astellas Pharma Inc., Chicago.

That is the number needed to accurately identify an increase in the risk of malignancy associated with tacrolimus treatment over the course of the 10-year study, but the investigators are also evaluating other serious adverse events.

Such events occurred in about 5% of the participants, who had a median age of 6 years at enrollment. Most of the serious events were asthma, occurring in 1% of patients, and infectionsincluding pneumonia, bronchitis, cellulitis, gastroenteritis, and tonsillitis – occurring in nearly 2% of patients. There was one report of a malignancy – a peripheral glioneuronal tumor – not typically associated with immunosuppression, Dr. Rico noted.

The malignancy rate in APPLES is half that seen in the general U.S. population, based on data from the Surveillance, Epidemiology, and End Results database, she said.

About 40% of children in APPLES had mild disease at baseline and about 60% reported moderate or severe disease. Treatment is either 0.03% ointment (the dosage approved for children) or off-label 0.1% ointment (the dosage approved for adults); most are being treated with 0.1% ointment. The median cumulative duration of time since initial treatment application is 2.8 years per patient.

“The serious adverse events profile we’re seeing is consistent with what was observed during the clinical development program,” Dr. Rico said, noting that, although the results are encouraging, enrollment of the full 8,000 patients is needed to adequately address the long-term safety of tacrolimus treatment in children.

“I encourage you and your colleagues to continue to enroll patients ... It’s going to take the dermatology community continuing to help us to reach that goal,” she concluded.

Dr. Rico is employed by Astellas, the maker of Protopic and sponsor of the study.

MIAMI – Long-term use of tacrolimus ointment in children with atopic dermatitis is associated with a low rate of serious adverse events, according to interim data from a prospective study.

The safety profile shown thus far is consistent with the established profile for tacrolimus ointment (Protopic), and it is hoped that these findings will encourage dermatologists to continue enrolling pediatric patients in this ongoing phase IV safety study, Dr. Joyce Rico said in a poster presentation at the annual meeting of the American Academy of Dermatology.

The interim report focused on 4,800 patients enrolled in APPLES (A Prospective Pediatric Longitudinal Evaluation Study) between May 2005 and September 2009. The investigators seek to enroll 8,000 children in the multinational, observational cohort study, said Dr. Rico, vice president of medical science at Astellas Pharma Inc., Chicago.

That is the number needed to accurately identify an increase in the risk of malignancy associated with tacrolimus treatment over the course of the 10-year study, but the investigators are also evaluating other serious adverse events.

Such events occurred in about 5% of the participants, who had a median age of 6 years at enrollment. Most of the serious events were asthma, occurring in 1% of patients, and infectionsincluding pneumonia, bronchitis, cellulitis, gastroenteritis, and tonsillitis – occurring in nearly 2% of patients. There was one report of a malignancy – a peripheral glioneuronal tumor – not typically associated with immunosuppression, Dr. Rico noted.

The malignancy rate in APPLES is half that seen in the general U.S. population, based on data from the Surveillance, Epidemiology, and End Results database, she said.

About 40% of children in APPLES had mild disease at baseline and about 60% reported moderate or severe disease. Treatment is either 0.03% ointment (the dosage approved for children) or off-label 0.1% ointment (the dosage approved for adults); most are being treated with 0.1% ointment. The median cumulative duration of time since initial treatment application is 2.8 years per patient.

“The serious adverse events profile we’re seeing is consistent with what was observed during the clinical development program,” Dr. Rico said, noting that, although the results are encouraging, enrollment of the full 8,000 patients is needed to adequately address the long-term safety of tacrolimus treatment in children.

“I encourage you and your colleagues to continue to enroll patients ... It’s going to take the dermatology community continuing to help us to reach that goal,” she concluded.

Dr. Rico is employed by Astellas, the maker of Protopic and sponsor of the study.

MIAMI — A substituted trans-stilbene derivative known as WBI-1001, which showed promise for the topical treatment of atopic dermatitis in preclinical studies, was safe and effective for mild to moderate disease in a small double-blind, randomized, vehicle-controlled study.

A total of 36 patients aged 18-65 years with chronic mild to moderate atopic dermatitis were randomized to apply either 0.5% WBI-1001 cream, 1.0% cream, or vehicle cream twice daily for 4 weeks.

At 1-week follow-up, the two treatment groups had significant reductions in Eczema Area and Severity Index (EASI) scores, compared with the vehicle group, with score reductions of 59.3% and 54.9% in the 0.5% and 1.0% groups, respectively, versus a 7.1% reduction in the vehicle group, Dr. Youwen Zhou reported during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Similar improvements were seen in Severity Scoring of Atopic Dermatitis Severity Index (SCORAD) scores, Investigator Global Assessment (IGA) scores, body surface area (BSA) affected, and pruritis; in the 0.5% and 1.0% treatment groups vs. the vehicle group, respectively, SCORAD scores decreased 56.2% and 50.1% vs. 18.4%; IGA scores decreased by 38.9% and 45.8% vs. 5.6%; body surface area affected decreased by 64.4% and 57.7% vs. 1.08%; and pruritis scores decreased by 74% and 56% vs. 25%.

At 4-week follow-up, half of the patients in the treatment groups were clear or almost clear, compared with only 16.7% of those in the vehicle group, said Dr. Zhou of the University of British Columbia, Vancouver.

No treatment-related adverse events were seen in this study, no drug accumulation was reported, and no detectable drug was found in 76% of plasma samples, indicating that there was only minimal absorption into the blood system, Dr. Zhou said.

This is an early-stage clinical trial, but the findings suggest that the novel nonsteroidal anti-inflammatory WBI-1001 compound has promise for the treatment of mild to moderate atopic dermatitis, he concluded.

He noted that, except for pruritis, which occurred less often in the 0.5% treatment group, the 0.5% and 1.0% doses had similar outcomes that were significantly better than those seen in the vehicle arm.

The study was supported by Welichem Biotech Inc. Dr. Zhou is a paid consultant for Welichem Biotech.

MIAMI — A substituted trans-stilbene derivative known as WBI-1001, which showed promise for the topical treatment of atopic dermatitis in preclinical studies, was safe and effective for mild to moderate disease in a small double-blind, randomized, vehicle-controlled study.

A total of 36 patients aged 18-65 years with chronic mild to moderate atopic dermatitis were randomized to apply either 0.5% WBI-1001 cream, 1.0% cream, or vehicle cream twice daily for 4 weeks.

At 1-week follow-up, the two treatment groups had significant reductions in Eczema Area and Severity Index (EASI) scores, compared with the vehicle group, with score reductions of 59.3% and 54.9% in the 0.5% and 1.0% groups, respectively, versus a 7.1% reduction in the vehicle group, Dr. Youwen Zhou reported during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Similar improvements were seen in Severity Scoring of Atopic Dermatitis Severity Index (SCORAD) scores, Investigator Global Assessment (IGA) scores, body surface area (BSA) affected, and pruritis; in the 0.5% and 1.0% treatment groups vs. the vehicle group, respectively, SCORAD scores decreased 56.2% and 50.1% vs. 18.4%; IGA scores decreased by 38.9% and 45.8% vs. 5.6%; body surface area affected decreased by 64.4% and 57.7% vs. 1.08%; and pruritis scores decreased by 74% and 56% vs. 25%.

At 4-week follow-up, half of the patients in the treatment groups were clear or almost clear, compared with only 16.7% of those in the vehicle group, said Dr. Zhou of the University of British Columbia, Vancouver.

No treatment-related adverse events were seen in this study, no drug accumulation was reported, and no detectable drug was found in 76% of plasma samples, indicating that there was only minimal absorption into the blood system, Dr. Zhou said.

This is an early-stage clinical trial, but the findings suggest that the novel nonsteroidal anti-inflammatory WBI-1001 compound has promise for the treatment of mild to moderate atopic dermatitis, he concluded.

He noted that, except for pruritis, which occurred less often in the 0.5% treatment group, the 0.5% and 1.0% doses had similar outcomes that were significantly better than those seen in the vehicle arm.

The study was supported by Welichem Biotech Inc. Dr. Zhou is a paid consultant for Welichem Biotech.

MIAMI — A substituted trans-stilbene derivative known as WBI-1001, which showed promise for the topical treatment of atopic dermatitis in preclinical studies, was safe and effective for mild to moderate disease in a small double-blind, randomized, vehicle-controlled study.

A total of 36 patients aged 18-65 years with chronic mild to moderate atopic dermatitis were randomized to apply either 0.5% WBI-1001 cream, 1.0% cream, or vehicle cream twice daily for 4 weeks.

At 1-week follow-up, the two treatment groups had significant reductions in Eczema Area and Severity Index (EASI) scores, compared with the vehicle group, with score reductions of 59.3% and 54.9% in the 0.5% and 1.0% groups, respectively, versus a 7.1% reduction in the vehicle group, Dr. Youwen Zhou reported during a poster discussion session at the annual meeting of the American Academy of Dermatology.

Similar improvements were seen in Severity Scoring of Atopic Dermatitis Severity Index (SCORAD) scores, Investigator Global Assessment (IGA) scores, body surface area (BSA) affected, and pruritis; in the 0.5% and 1.0% treatment groups vs. the vehicle group, respectively, SCORAD scores decreased 56.2% and 50.1% vs. 18.4%; IGA scores decreased by 38.9% and 45.8% vs. 5.6%; body surface area affected decreased by 64.4% and 57.7% vs. 1.08%; and pruritis scores decreased by 74% and 56% vs. 25%.

At 4-week follow-up, half of the patients in the treatment groups were clear or almost clear, compared with only 16.7% of those in the vehicle group, said Dr. Zhou of the University of British Columbia, Vancouver.

No treatment-related adverse events were seen in this study, no drug accumulation was reported, and no detectable drug was found in 76% of plasma samples, indicating that there was only minimal absorption into the blood system, Dr. Zhou said.

This is an early-stage clinical trial, but the findings suggest that the novel nonsteroidal anti-inflammatory WBI-1001 compound has promise for the treatment of mild to moderate atopic dermatitis, he concluded.

He noted that, except for pruritis, which occurred less often in the 0.5% treatment group, the 0.5% and 1.0% doses had similar outcomes that were significantly better than those seen in the vehicle arm.

The study was supported by Welichem Biotech Inc. Dr. Zhou is a paid consultant for Welichem Biotech.