2011 AAAAI Annual Meeting

ORLANDO – Elevated levels of soluble CD14 in umbilical cord blood appear to be highly predictive of wheeze and cough in the first year of an infant’s life, Taiwanese investigators reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children with elevated cord-blood soluble CD14 (sCD14) had nearly an eightfold risk for wheezing and a sixfold risk for cough in the first year, compared with children with low levels, said Dr. Yu-Lin Huang from the department of pediatrics at the Chang Gung Memorial Hospital and Chang Gung University in Keelung, Taiwan.

The finding lends credence to the hypothesis that prenatal factors play a role in the pathogenesis of asthma.

Soluble CD14 is a pathogen pattern receptor molecule that works with other receptors to recognize bacterial lipopolysaccharides (LPS) and mediate LPS-induced inflammation. Evidence for its utility as a biomarker for allergy and asthma has been decidedly mixed, however, said Dr. Huang.

One study, for example, showed that lower sCD14 levels at birth were associated with increased risk of wheeze at age 1 (Am. J. Respir. Crit. Care Med. 2004;169:70-6), whereas a different study showed that sCD14 levels are higher during acute asthma episodes (Am. J. Respir. Care Crit. Med. 2006;173:617-22).

Because allergic diseases have been steadily rising in Taiwan since the 1970s, the investigators hoped to clarify whether sCD14 level at birth and/or the urine leukotriene E4 to creatinine (LC) ratio at 1 month could be useful predictors of an individual child’s risk for future atopic diseases and asthma.

They recruited newborns delivered at the Chang Chung Memorial Hospital from October 2007 through September 2009, recording sCD14 levels at birth and collecting questionnaires from the mothers asking about parental medical and allergic histories. The questionnaires were repeated at 1, 6, 12, and 18 months.

At 1 month they collected and examined urine for the LC ratio, and followed with child blood and urine samples at 6 and 12 months, and mother’s blood sample at 6 months.

They defined outcomes at age 1 as parental report of wheezing, cough persisting for more than 3 weeks, rhinitis (runny or blocked nose in the absence of a cold or flu), rhinoconjunctivitis, rash (intermittent for at least 3 months), and atopy (positive specific immunoglobulin E to Dermatophagoides pteronyssinus, D.farinae, egg white, milk, Cladosporium herbarum, and wheat).

Of the 206 children available for follow-up at 1 year, wheeze was prevalent in 14%), and sCD14 levels in these children were significantly higher than in the 177 children with no reported wheeze (583 plus or minus 127 vs. 491 plus or minus 162 ng/mL, P = .001).

Similarly, prolonged cough was reported in 7% at 1 year, and these children also had significantly higher sCD14 levels in cord blood (615 plus or minus 170 vs. 496 plus or minus 157, P = .008).

There were no other significant associations with sCD14 and other outcomes. LC ratio at 1 month was not significantly associated with any of the outcomes.

In multiple logistic regression analysis, they found that factors significantly predictive for wheeze at 1 year included sCD14 (P = .002), duration of day care attendance (P = .005), and parental smoking, with each pack per day of cigarettes associated with a doubling of risk (P = .016).

Significant risk factors for prolonged cough include sCD14 (P = .008) and number of older siblings (P = .015).

In a comparison of high vs. low sCD14, the adjusted odds ratio for wheeze with high levels was 7.74 (P less than .001). The adjusted OR for prolonged cough was 5.99 (P = .021).

The study was supported by a Chang Gung Research project grant. Dr. Huang reported that he had no relevant disclosures.

ORLANDO – Elevated levels of soluble CD14 in umbilical cord blood appear to be highly predictive of wheeze and cough in the first year of an infant’s life, Taiwanese investigators reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children with elevated cord-blood soluble CD14 (sCD14) had nearly an eightfold risk for wheezing and a sixfold risk for cough in the first year, compared with children with low levels, said Dr. Yu-Lin Huang from the department of pediatrics at the Chang Gung Memorial Hospital and Chang Gung University in Keelung, Taiwan.

The finding lends credence to the hypothesis that prenatal factors play a role in the pathogenesis of asthma.

Soluble CD14 is a pathogen pattern receptor molecule that works with other receptors to recognize bacterial lipopolysaccharides (LPS) and mediate LPS-induced inflammation. Evidence for its utility as a biomarker for allergy and asthma has been decidedly mixed, however, said Dr. Huang.

One study, for example, showed that lower sCD14 levels at birth were associated with increased risk of wheeze at age 1 (Am. J. Respir. Crit. Care Med. 2004;169:70-6), whereas a different study showed that sCD14 levels are higher during acute asthma episodes (Am. J. Respir. Care Crit. Med. 2006;173:617-22).

Because allergic diseases have been steadily rising in Taiwan since the 1970s, the investigators hoped to clarify whether sCD14 level at birth and/or the urine leukotriene E4 to creatinine (LC) ratio at 1 month could be useful predictors of an individual child’s risk for future atopic diseases and asthma.

They recruited newborns delivered at the Chang Chung Memorial Hospital from October 2007 through September 2009, recording sCD14 levels at birth and collecting questionnaires from the mothers asking about parental medical and allergic histories. The questionnaires were repeated at 1, 6, 12, and 18 months.

At 1 month they collected and examined urine for the LC ratio, and followed with child blood and urine samples at 6 and 12 months, and mother’s blood sample at 6 months.

They defined outcomes at age 1 as parental report of wheezing, cough persisting for more than 3 weeks, rhinitis (runny or blocked nose in the absence of a cold or flu), rhinoconjunctivitis, rash (intermittent for at least 3 months), and atopy (positive specific immunoglobulin E to Dermatophagoides pteronyssinus, D.farinae, egg white, milk, Cladosporium herbarum, and wheat).

Of the 206 children available for follow-up at 1 year, wheeze was prevalent in 14%), and sCD14 levels in these children were significantly higher than in the 177 children with no reported wheeze (583 plus or minus 127 vs. 491 plus or minus 162 ng/mL, P = .001).

Similarly, prolonged cough was reported in 7% at 1 year, and these children also had significantly higher sCD14 levels in cord blood (615 plus or minus 170 vs. 496 plus or minus 157, P = .008).

There were no other significant associations with sCD14 and other outcomes. LC ratio at 1 month was not significantly associated with any of the outcomes.

In multiple logistic regression analysis, they found that factors significantly predictive for wheeze at 1 year included sCD14 (P = .002), duration of day care attendance (P = .005), and parental smoking, with each pack per day of cigarettes associated with a doubling of risk (P = .016).

Significant risk factors for prolonged cough include sCD14 (P = .008) and number of older siblings (P = .015).

In a comparison of high vs. low sCD14, the adjusted odds ratio for wheeze with high levels was 7.74 (P less than .001). The adjusted OR for prolonged cough was 5.99 (P = .021).

The study was supported by a Chang Gung Research project grant. Dr. Huang reported that he had no relevant disclosures.

ORLANDO – Elevated levels of soluble CD14 in umbilical cord blood appear to be highly predictive of wheeze and cough in the first year of an infant’s life, Taiwanese investigators reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Children with elevated cord-blood soluble CD14 (sCD14) had nearly an eightfold risk for wheezing and a sixfold risk for cough in the first year, compared with children with low levels, said Dr. Yu-Lin Huang from the department of pediatrics at the Chang Gung Memorial Hospital and Chang Gung University in Keelung, Taiwan.

The finding lends credence to the hypothesis that prenatal factors play a role in the pathogenesis of asthma.

Soluble CD14 is a pathogen pattern receptor molecule that works with other receptors to recognize bacterial lipopolysaccharides (LPS) and mediate LPS-induced inflammation. Evidence for its utility as a biomarker for allergy and asthma has been decidedly mixed, however, said Dr. Huang.

One study, for example, showed that lower sCD14 levels at birth were associated with increased risk of wheeze at age 1 (Am. J. Respir. Crit. Care Med. 2004;169:70-6), whereas a different study showed that sCD14 levels are higher during acute asthma episodes (Am. J. Respir. Care Crit. Med. 2006;173:617-22).

Because allergic diseases have been steadily rising in Taiwan since the 1970s, the investigators hoped to clarify whether sCD14 level at birth and/or the urine leukotriene E4 to creatinine (LC) ratio at 1 month could be useful predictors of an individual child’s risk for future atopic diseases and asthma.

They recruited newborns delivered at the Chang Chung Memorial Hospital from October 2007 through September 2009, recording sCD14 levels at birth and collecting questionnaires from the mothers asking about parental medical and allergic histories. The questionnaires were repeated at 1, 6, 12, and 18 months.

At 1 month they collected and examined urine for the LC ratio, and followed with child blood and urine samples at 6 and 12 months, and mother’s blood sample at 6 months.

They defined outcomes at age 1 as parental report of wheezing, cough persisting for more than 3 weeks, rhinitis (runny or blocked nose in the absence of a cold or flu), rhinoconjunctivitis, rash (intermittent for at least 3 months), and atopy (positive specific immunoglobulin E to Dermatophagoides pteronyssinus, D.farinae, egg white, milk, Cladosporium herbarum, and wheat).

Of the 206 children available for follow-up at 1 year, wheeze was prevalent in 14%), and sCD14 levels in these children were significantly higher than in the 177 children with no reported wheeze (583 plus or minus 127 vs. 491 plus or minus 162 ng/mL, P = .001).

Similarly, prolonged cough was reported in 7% at 1 year, and these children also had significantly higher sCD14 levels in cord blood (615 plus or minus 170 vs. 496 plus or minus 157, P = .008).

There were no other significant associations with sCD14 and other outcomes. LC ratio at 1 month was not significantly associated with any of the outcomes.

In multiple logistic regression analysis, they found that factors significantly predictive for wheeze at 1 year included sCD14 (P = .002), duration of day care attendance (P = .005), and parental smoking, with each pack per day of cigarettes associated with a doubling of risk (P = .016).

Significant risk factors for prolonged cough include sCD14 (P = .008) and number of older siblings (P = .015).

In a comparison of high vs. low sCD14, the adjusted odds ratio for wheeze with high levels was 7.74 (P less than .001). The adjusted OR for prolonged cough was 5.99 (P = .021).

The study was supported by a Chang Gung Research project grant. Dr. Huang reported that he had no relevant disclosures.

SAN FRANCISCO – Some lots of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine may contain milk protein, which puts milk-allergic children at risk for reactions, according to Dr. Hugh A. Sampson, professor of pediatrics, allergy and immunology and dean for translational biomedical sciences at the Mount Sinai School of Medicine, New York.

Seven milk-allergic children in his practice had severe anaphylactic reactions to either primary or booster shots of the Tdap vaccine (Sanofi Pasteur's Adacel) that were given between September 2007 and March 2010.

"We were struck by the fact that just in our practice we had seven patients with milk allergy who reacted. You wouldn't anticipate that kind of number from one single practice. We believe it is due to contamination of milk protein in this vaccine," Dr. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The five boys and two girls (median age, 11 years; range, 5-17 years) had prior allergic reactions to cow's milk, including five severe reactions and four reactions to trace exposures. One was diagnosed with milk allergy based on serologic testing.

Dr. Sampson and his colleagues suspect it was milk protein in the vaccine after testing two vials from two lots by inhibition-ELISA. One vial "clearly had milk protein in it" (30 ng/mL). "The other did not," he said.

Bacterial growth media that are used to produce the vaccine contain casamino acids, according to Adacel labeling. These are derived from the milk protein casein.

As "with any process, there can be some variation, lots that for some reason seem to be higher in milk protein. Apparently, there were enough lots that we had seven children end up with anaphylactic reactions," Dr. Sampson said.

He and his colleagues confirmed that two patients received shots from the same vaccine lot, but the vials used on the children were not available for testing.

Even so, "we certainly have circumstantial evidence that there is the possibility of sufficient milk protein in certain lots" that could potentially – if given to a person who is highly milk allergic – cause a reaction, he said.

The problem must be "uncommon or it would have shown up before," and there are no reports yet in the literature, said Dr. Robert A. Wood, a professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center in Baltimore.

The children all had elevated, milk-specific IgE levels (most over 100 kUA/L) within 2 years of their reactions.

Each had symptoms consistent with anaphylaxis promptly after getting the shot, including wheezing and urticaria in five; sneezing, nasal congestion, and angioedema in three; and repetitive cough in two.

Five were treated with antihistamines, three with epinephrine, three with inhaled beta-agonists, and two with corticosteroids.

Dr. Sampson and his colleagues are continuing to test additional vaccine lots for milk protein.

"There used to be a tremendous variation in the amount of egg protein in flu vaccine, and I think that's why, in egg-allergic children receiving flu shots, some of them had bad reactions [and] some of them did not. It just depended on the content of the egg protein in the lot," he said.

"I think, with the Tdap vaccine, we are seeing basically the same thing. There are lots that for some reason seem to be higher in milk protein," he said.

Dr. Sampson is a consultant for Genentech and holds shares in Herbal Springs LLC. Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Some lots of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine may contain milk protein, which puts milk-allergic children at risk for reactions, according to Dr. Hugh A. Sampson, professor of pediatrics, allergy and immunology and dean for translational biomedical sciences at the Mount Sinai School of Medicine, New York.

Seven milk-allergic children in his practice had severe anaphylactic reactions to either primary or booster shots of the Tdap vaccine (Sanofi Pasteur's Adacel) that were given between September 2007 and March 2010.

"We were struck by the fact that just in our practice we had seven patients with milk allergy who reacted. You wouldn't anticipate that kind of number from one single practice. We believe it is due to contamination of milk protein in this vaccine," Dr. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The five boys and two girls (median age, 11 years; range, 5-17 years) had prior allergic reactions to cow's milk, including five severe reactions and four reactions to trace exposures. One was diagnosed with milk allergy based on serologic testing.

Dr. Sampson and his colleagues suspect it was milk protein in the vaccine after testing two vials from two lots by inhibition-ELISA. One vial "clearly had milk protein in it" (30 ng/mL). "The other did not," he said.

Bacterial growth media that are used to produce the vaccine contain casamino acids, according to Adacel labeling. These are derived from the milk protein casein.

As "with any process, there can be some variation, lots that for some reason seem to be higher in milk protein. Apparently, there were enough lots that we had seven children end up with anaphylactic reactions," Dr. Sampson said.

He and his colleagues confirmed that two patients received shots from the same vaccine lot, but the vials used on the children were not available for testing.

Even so, "we certainly have circumstantial evidence that there is the possibility of sufficient milk protein in certain lots" that could potentially – if given to a person who is highly milk allergic – cause a reaction, he said.

The problem must be "uncommon or it would have shown up before," and there are no reports yet in the literature, said Dr. Robert A. Wood, a professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center in Baltimore.

The children all had elevated, milk-specific IgE levels (most over 100 kUA/L) within 2 years of their reactions.

Each had symptoms consistent with anaphylaxis promptly after getting the shot, including wheezing and urticaria in five; sneezing, nasal congestion, and angioedema in three; and repetitive cough in two.

Five were treated with antihistamines, three with epinephrine, three with inhaled beta-agonists, and two with corticosteroids.

Dr. Sampson and his colleagues are continuing to test additional vaccine lots for milk protein.

"There used to be a tremendous variation in the amount of egg protein in flu vaccine, and I think that's why, in egg-allergic children receiving flu shots, some of them had bad reactions [and] some of them did not. It just depended on the content of the egg protein in the lot," he said.

"I think, with the Tdap vaccine, we are seeing basically the same thing. There are lots that for some reason seem to be higher in milk protein," he said.

Dr. Sampson is a consultant for Genentech and holds shares in Herbal Springs LLC. Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Some lots of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine may contain milk protein, which puts milk-allergic children at risk for reactions, according to Dr. Hugh A. Sampson, professor of pediatrics, allergy and immunology and dean for translational biomedical sciences at the Mount Sinai School of Medicine, New York.

Seven milk-allergic children in his practice had severe anaphylactic reactions to either primary or booster shots of the Tdap vaccine (Sanofi Pasteur's Adacel) that were given between September 2007 and March 2010.

"We were struck by the fact that just in our practice we had seven patients with milk allergy who reacted. You wouldn't anticipate that kind of number from one single practice. We believe it is due to contamination of milk protein in this vaccine," Dr. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The five boys and two girls (median age, 11 years; range, 5-17 years) had prior allergic reactions to cow's milk, including five severe reactions and four reactions to trace exposures. One was diagnosed with milk allergy based on serologic testing.

Dr. Sampson and his colleagues suspect it was milk protein in the vaccine after testing two vials from two lots by inhibition-ELISA. One vial "clearly had milk protein in it" (30 ng/mL). "The other did not," he said.

Bacterial growth media that are used to produce the vaccine contain casamino acids, according to Adacel labeling. These are derived from the milk protein casein.

As "with any process, there can be some variation, lots that for some reason seem to be higher in milk protein. Apparently, there were enough lots that we had seven children end up with anaphylactic reactions," Dr. Sampson said.

He and his colleagues confirmed that two patients received shots from the same vaccine lot, but the vials used on the children were not available for testing.

Even so, "we certainly have circumstantial evidence that there is the possibility of sufficient milk protein in certain lots" that could potentially – if given to a person who is highly milk allergic – cause a reaction, he said.

The problem must be "uncommon or it would have shown up before," and there are no reports yet in the literature, said Dr. Robert A. Wood, a professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center in Baltimore.

The children all had elevated, milk-specific IgE levels (most over 100 kUA/L) within 2 years of their reactions.

Each had symptoms consistent with anaphylaxis promptly after getting the shot, including wheezing and urticaria in five; sneezing, nasal congestion, and angioedema in three; and repetitive cough in two.

Five were treated with antihistamines, three with epinephrine, three with inhaled beta-agonists, and two with corticosteroids.

Dr. Sampson and his colleagues are continuing to test additional vaccine lots for milk protein.

"There used to be a tremendous variation in the amount of egg protein in flu vaccine, and I think that's why, in egg-allergic children receiving flu shots, some of them had bad reactions [and] some of them did not. It just depended on the content of the egg protein in the lot," he said.

"I think, with the Tdap vaccine, we are seeing basically the same thing. There are lots that for some reason seem to be higher in milk protein," he said.

Dr. Sampson is a consultant for Genentech and holds shares in Herbal Springs LLC. Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Some lots of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine may contain milk protein, which puts milk-allergic children at risk for allergic reactions, according to Dr. Hugh A. Sampson, professor of pediatrics, allergy and immunology and dean for translational biomedical sciences at the Mount Sinai School of Medicine, New York.

Seven milk-allergic children in his practice had severe anaphylactic reactions to either primary or booster shots of the Tdap vaccine (Sanofi Pasteur’s Adacel) that were given between September 2007 and March 2010.

"We were struck by the fact that just in our practice we had seven patients with milk allergy who reacted. You wouldn’t anticipate that kind of number from one single practice. We believe it is due to contamination of milk protein in this vaccine," Dr. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The five boys and two girls (median age, 11 years; range, 5-17 years) had prior allergic reactions to cow’s milk, including five severe reactions and four reactions to trace exposures. One was diagnosed with milk allergy based on serologic testing.

Dr. Sampson and his colleagues suspect it was milk protein in the vaccine after testing two vials from two lots by inhibition-ELISA. One vial "clearly had milk protein in it" (30 ng/mL). "The other did not," he said.

Bacterial growth media that are used to produce the vaccine contain casamino acids, according to Adacel labeling. These are derived from the milk protein casein.

As "with any process, there can be some variation, lots that for some reason seem to be higher in milk protein. Apparently, there were enough lots that we had seven children end up with anaphylactic reactions," Dr. Sampson said.

He and his colleagues confirmed that two patients received shots from the same vaccine lot, but the vials used on the children were not available for testing.

Even so, "we certainly have circumstantial evidence that there is the possibility of sufficient milk protein in certain lots" that could potentially – if given to a person who is highly milk allergic – cause a reaction, he said.

The problem must be "uncommon or it would have shown up before," and there are no reports yet in the literature, said Dr. Robert A. Wood, a professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center in Baltimore.

The children all had elevated, milk-specific IgE levels (most over 100 kUA/L) within 2 years of their reactions.

Each had symptoms consistent with anaphylaxis promptly after getting the shot, including wheezing and urticaria in five; sneezing, nasal congestion, and angioedema in three; and repetitive cough in two.

Five were treated with antihistamines, three with epinephrine, three with inhaled beta-agonists, and two with corticosteroids.

Dr. Sampson and his colleagues are continuing to test additional vaccine lots for milk protein.

"There used to be a tremendous variation in the amount of egg protein in flu vaccine, and I think that’s why, in egg-allergic children receiving flu shots, some of them had bad reactions [and] some of them did not. It just depended on the content of the egg protein in the lot," he said.

"I think, with the Tdap vaccine, we are seeing basically the same thing. There are lots that for some reason seem to be higher in milk protein," he said.

Dr. Sampson is a consultant for Genentech and holds shares in Herbal Springs LLC. Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Some lots of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine may contain milk protein, which puts milk-allergic children at risk for allergic reactions, according to Dr. Hugh A. Sampson, professor of pediatrics, allergy and immunology and dean for translational biomedical sciences at the Mount Sinai School of Medicine, New York.

Seven milk-allergic children in his practice had severe anaphylactic reactions to either primary or booster shots of the Tdap vaccine (Sanofi Pasteur’s Adacel) that were given between September 2007 and March 2010.

"We were struck by the fact that just in our practice we had seven patients with milk allergy who reacted. You wouldn’t anticipate that kind of number from one single practice. We believe it is due to contamination of milk protein in this vaccine," Dr. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The five boys and two girls (median age, 11 years; range, 5-17 years) had prior allergic reactions to cow’s milk, including five severe reactions and four reactions to trace exposures. One was diagnosed with milk allergy based on serologic testing.

Dr. Sampson and his colleagues suspect it was milk protein in the vaccine after testing two vials from two lots by inhibition-ELISA. One vial "clearly had milk protein in it" (30 ng/mL). "The other did not," he said.

Bacterial growth media that are used to produce the vaccine contain casamino acids, according to Adacel labeling. These are derived from the milk protein casein.

As "with any process, there can be some variation, lots that for some reason seem to be higher in milk protein. Apparently, there were enough lots that we had seven children end up with anaphylactic reactions," Dr. Sampson said.

He and his colleagues confirmed that two patients received shots from the same vaccine lot, but the vials used on the children were not available for testing.

Even so, "we certainly have circumstantial evidence that there is the possibility of sufficient milk protein in certain lots" that could potentially – if given to a person who is highly milk allergic – cause a reaction, he said.

The problem must be "uncommon or it would have shown up before," and there are no reports yet in the literature, said Dr. Robert A. Wood, a professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center in Baltimore.

The children all had elevated, milk-specific IgE levels (most over 100 kUA/L) within 2 years of their reactions.

Each had symptoms consistent with anaphylaxis promptly after getting the shot, including wheezing and urticaria in five; sneezing, nasal congestion, and angioedema in three; and repetitive cough in two.

Five were treated with antihistamines, three with epinephrine, three with inhaled beta-agonists, and two with corticosteroids.

Dr. Sampson and his colleagues are continuing to test additional vaccine lots for milk protein.

"There used to be a tremendous variation in the amount of egg protein in flu vaccine, and I think that’s why, in egg-allergic children receiving flu shots, some of them had bad reactions [and] some of them did not. It just depended on the content of the egg protein in the lot," he said.

"I think, with the Tdap vaccine, we are seeing basically the same thing. There are lots that for some reason seem to be higher in milk protein," he said.

Dr. Sampson is a consultant for Genentech and holds shares in Herbal Springs LLC. Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Some lots of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine may contain milk protein, which puts milk-allergic children at risk for allergic reactions, according to Dr. Hugh A. Sampson, professor of pediatrics, allergy and immunology and dean for translational biomedical sciences at the Mount Sinai School of Medicine, New York.

Seven milk-allergic children in his practice had severe anaphylactic reactions to either primary or booster shots of the Tdap vaccine (Sanofi Pasteur’s Adacel) that were given between September 2007 and March 2010.

"We were struck by the fact that just in our practice we had seven patients with milk allergy who reacted. You wouldn’t anticipate that kind of number from one single practice. We believe it is due to contamination of milk protein in this vaccine," Dr. Sampson said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The five boys and two girls (median age, 11 years; range, 5-17 years) had prior allergic reactions to cow’s milk, including five severe reactions and four reactions to trace exposures. One was diagnosed with milk allergy based on serologic testing.

Dr. Sampson and his colleagues suspect it was milk protein in the vaccine after testing two vials from two lots by inhibition-ELISA. One vial "clearly had milk protein in it" (30 ng/mL). "The other did not," he said.

Bacterial growth media that are used to produce the vaccine contain casamino acids, according to Adacel labeling. These are derived from the milk protein casein.

As "with any process, there can be some variation, lots that for some reason seem to be higher in milk protein. Apparently, there were enough lots that we had seven children end up with anaphylactic reactions," Dr. Sampson said.

He and his colleagues confirmed that two patients received shots from the same vaccine lot, but the vials used on the children were not available for testing.

Even so, "we certainly have circumstantial evidence that there is the possibility of sufficient milk protein in certain lots" that could potentially – if given to a person who is highly milk allergic – cause a reaction, he said.

The problem must be "uncommon or it would have shown up before," and there are no reports yet in the literature, said Dr. Robert A. Wood, a professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center in Baltimore.

The children all had elevated, milk-specific IgE levels (most over 100 kUA/L) within 2 years of their reactions.

Each had symptoms consistent with anaphylaxis promptly after getting the shot, including wheezing and urticaria in five; sneezing, nasal congestion, and angioedema in three; and repetitive cough in two.

Five were treated with antihistamines, three with epinephrine, three with inhaled beta-agonists, and two with corticosteroids.

Dr. Sampson and his colleagues are continuing to test additional vaccine lots for milk protein.

"There used to be a tremendous variation in the amount of egg protein in flu vaccine, and I think that’s why, in egg-allergic children receiving flu shots, some of them had bad reactions [and] some of them did not. It just depended on the content of the egg protein in the lot," he said.

"I think, with the Tdap vaccine, we are seeing basically the same thing. There are lots that for some reason seem to be higher in milk protein," he said.

Dr. Sampson is a consultant for Genentech and holds shares in Herbal Springs LLC. Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – A small, retrospective study suggests that patients with aspirin-exacerbated respiratory disease may be safely desensitized to aspirin in an office setting rather than in a hospital.

Each of 15 patients who underwent a 1-day aspirin desensitization protocol in a clinic completed the protocol and ingested a cumulative total of 568 mg of aspirin on average by the end of the day. Each was then able to tolerate taking aspirin up to 650 mg b.i.d., Richard S. Dunn and Dr. Richard W. Hendershot reported in a poster presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In-hospital aspirin desensitization for patients with aspirin-exacerbated respiratory disease typically takes 2-3 days, and some clinicians recommend doing it in an ICU, said Mr. Dunn, a fourth-year medical student at the University of Utah, Salt Lake City. Dr. Hendershot is an allergy and immunology specialist with Intermountain Healthcare in Salt Lake City.

The outpatient protocol took 8-9 hours. The cost to desensitize a patient averaged $2,678 in the outpatient clinic, compared with an average daily cost for ICU care of $13,347 reported in the literature.

Desensitization started with application of intranasal ketorolac three times over half-hour intervals. Patients then ingested 81 mg of aspirin and increased the dose by 81 mg every 2 hours to a final dose of 325 mg.

They were closely monitored during the desensitization. No complications were seen in 56% of patients. FEV₁ (forced expiratory volume in 1 second) decreased by more than 20% in 19% of patients; 13% of patients developed flushing, and dyspnea or urticaria was each seen in 6% of patients.

Approximately 21% of people with asthma and 40% of patients with asthma who are dependent on glucocorticoids have aspirin-exacerbated respiratory disease. These patients often present with asthma, chronic rhinosinusitis, and nasal polyps. If they ingest a cyclooxygenase-1 inhibitor, they develop asthma symptoms, rhinorrhea, periorbital edema, urticaria, pruritus, angioedema, anaphylaxis, or other symptoms.

The design of the desensitization protocol was borrowed from a similar protocol that was tested in a controlled study of 100 patients (Ann. Allergy Asthma Immunol. 2010;105:130-5).

A patient who could not afford desensitization in the hospital inspired the development of the outpatient protocol that was used in the study.

The results suggest that aspirin desensitization for the treatment of aspirin-exacerbated respiratory disease can be done safely and efficaciously in the outpatient setting in less time and with less cost, compared with inpatient treatment protocols, the investigators concluded.

The investigators reported having no conflicts of interest.

SAN FRANCISCO – Compared with placebo, a single dose of montelukast attenuated exercise-induced bronchoconstriction in children within 2 hours and lasted through 24 hours post dose, results from a small study found.

Although this treatment effect of montelukast has been observed in previously published studies of adults with exercise-induced bronchoconstriction, this is the first analysis of its kind in children with the condition.

"The ability to take a single tablet and have it last for 24 hours is probably more meaningful for children than for adults, because children often engage in unplanned physical activities more than adults do," Dr. George Philip said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a multicenter study, Dr. Philip, senior director of clinical research at Merck Research Laboratories, North Wales, Pa., and his associates enrolled 66 children aged 6-14 years with pre-exercise forced expiratory volume in 1 second (FEV₁) of 70% predicted or greater and a maximum fall in FEV₁ of 20% or greater at two screening exercise challenges performed on a treadmill. Study participants were randomized to receive single-dose montelukast (4 or 5 mg) or placebo before the exercise challenges were performed at 2 and 24 hours post dose.

The primary end point was maximum percent fall in FEV₁ after exercise challenge 2 hours post dose. Secondary end points included maximum percent fall in FEV₁ after the 24-hour postdose challenge and each of the following end points at 2 and 24 hours post dose: maximum percent fall in FEV₁ categorized as less than 10%, 10%-20%, and greater than 20%; area under the curve during the 60 minutes post challenge; and time to recovery to within 5% of pre-exercise baseline.

The mean age of patients was 11 years, and 56% were male. About three-quarters (74.2%) were white, 16.7% were black, and 9.1% were from other ethnic groups.

Dr. Philip reported that the mean percent fall in FEV₁ was significantly better after the 2-hour postdose exercise challenge in the montelukast treatment group, compared with the placebo group (15.3% vs. 20%, respectively). Patients in the montelukast group also fared significantly better, compared with their counterparts in the placebo group, in maximum percent fall in FEV₁ after the 24-hour postdose exercise challenge (12.92% vs. 17.25%, respectively); the categorized maximum percent fall at 2 hours (P = .034) though not at 24 hours (P = .061); and area under the curve at 2 hours (P = .022) and 24 hours (P = .013).

There were few clinical adverse events and no serious drug-related adverse events.

Dr. Philip acknowledged that the controlled laboratory setting in which the exercise challenge took place is a limitation of the study. "Natural exercise may be different from what we did in the laboratory, where all the kids had to run on a treadmill and reach a certain heart rate so we could define a clear and reproducible exercise-induced response," he explained. "Based on that response to challenge, we showed a benefit. But the kind of exercise that’s done in a laboratory may or may not match what’s done in other settings. Also, because the use of a single dose of montelukast to prevent exercise-induced bronchoconstriction in children less than age 15 years is not currently approved by the FDA, this use is considered investigational."

Merck funded the study. Dr. Philip is a full-time employee of the company.

SAN FRANCISCO – Compared with placebo, a single dose of montelukast attenuated exercise-induced bronchoconstriction in children within 2 hours and lasted through 24 hours post dose, results from a small study found.

Although this treatment effect of montelukast has been observed in previously published studies of adults with exercise-induced bronchoconstriction, this is the first analysis of its kind in children with the condition.

"The ability to take a single tablet and have it last for 24 hours is probably more meaningful for children than for adults, because children often engage in unplanned physical activities more than adults do," Dr. George Philip said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a multicenter study, Dr. Philip, senior director of clinical research at Merck Research Laboratories, North Wales, Pa., and his associates enrolled 66 children aged 6-14 years with pre-exercise forced expiratory volume in 1 second (FEV₁) of 70% predicted or greater and a maximum fall in FEV₁ of 20% or greater at two screening exercise challenges performed on a treadmill. Study participants were randomized to receive single-dose montelukast (4 or 5 mg) or placebo before the exercise challenges were performed at 2 and 24 hours post dose.

The primary end point was maximum percent fall in FEV₁ after exercise challenge 2 hours post dose. Secondary end points included maximum percent fall in FEV₁ after the 24-hour postdose challenge and each of the following end points at 2 and 24 hours post dose: maximum percent fall in FEV₁ categorized as less than 10%, 10%-20%, and greater than 20%; area under the curve during the 60 minutes post challenge; and time to recovery to within 5% of pre-exercise baseline.

The mean age of patients was 11 years, and 56% were male. About three-quarters (74.2%) were white, 16.7% were black, and 9.1% were from other ethnic groups.

Dr. Philip reported that the mean percent fall in FEV₁ was significantly better after the 2-hour postdose exercise challenge in the montelukast treatment group, compared with the placebo group (15.3% vs. 20%, respectively). Patients in the montelukast group also fared significantly better, compared with their counterparts in the placebo group, in maximum percent fall in FEV₁ after the 24-hour postdose exercise challenge (12.92% vs. 17.25%, respectively); the categorized maximum percent fall at 2 hours (P = .034) though not at 24 hours (P = .061); and area under the curve at 2 hours (P = .022) and 24 hours (P = .013).

There were few clinical adverse events and no serious drug-related adverse events.

Dr. Philip acknowledged that the controlled laboratory setting in which the exercise challenge took place is a limitation of the study. "Natural exercise may be different from what we did in the laboratory, where all the kids had to run on a treadmill and reach a certain heart rate so we could define a clear and reproducible exercise-induced response," he explained. "Based on that response to challenge, we showed a benefit. But the kind of exercise that’s done in a laboratory may or may not match what’s done in other settings. Also, because the use of a single dose of montelukast to prevent exercise-induced bronchoconstriction in children less than age 15 years is not currently approved by the FDA, this use is considered investigational."

Merck funded the study. Dr. Philip is a full-time employee of the company.

SAN FRANCISCO – Compared with placebo, a single dose of montelukast attenuated exercise-induced bronchoconstriction in children within 2 hours and lasted through 24 hours post dose, results from a small study found.

Although this treatment effect of montelukast has been observed in previously published studies of adults with exercise-induced bronchoconstriction, this is the first analysis of its kind in children with the condition.

"The ability to take a single tablet and have it last for 24 hours is probably more meaningful for children than for adults, because children often engage in unplanned physical activities more than adults do," Dr. George Philip said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a multicenter study, Dr. Philip, senior director of clinical research at Merck Research Laboratories, North Wales, Pa., and his associates enrolled 66 children aged 6-14 years with pre-exercise forced expiratory volume in 1 second (FEV₁) of 70% predicted or greater and a maximum fall in FEV₁ of 20% or greater at two screening exercise challenges performed on a treadmill. Study participants were randomized to receive single-dose montelukast (4 or 5 mg) or placebo before the exercise challenges were performed at 2 and 24 hours post dose.

The primary end point was maximum percent fall in FEV₁ after exercise challenge 2 hours post dose. Secondary end points included maximum percent fall in FEV₁ after the 24-hour postdose challenge and each of the following end points at 2 and 24 hours post dose: maximum percent fall in FEV₁ categorized as less than 10%, 10%-20%, and greater than 20%; area under the curve during the 60 minutes post challenge; and time to recovery to within 5% of pre-exercise baseline.

The mean age of patients was 11 years, and 56% were male. About three-quarters (74.2%) were white, 16.7% were black, and 9.1% were from other ethnic groups.

Dr. Philip reported that the mean percent fall in FEV₁ was significantly better after the 2-hour postdose exercise challenge in the montelukast treatment group, compared with the placebo group (15.3% vs. 20%, respectively). Patients in the montelukast group also fared significantly better, compared with their counterparts in the placebo group, in maximum percent fall in FEV₁ after the 24-hour postdose exercise challenge (12.92% vs. 17.25%, respectively); the categorized maximum percent fall at 2 hours (P = .034) though not at 24 hours (P = .061); and area under the curve at 2 hours (P = .022) and 24 hours (P = .013).

There were few clinical adverse events and no serious drug-related adverse events.

Dr. Philip acknowledged that the controlled laboratory setting in which the exercise challenge took place is a limitation of the study. "Natural exercise may be different from what we did in the laboratory, where all the kids had to run on a treadmill and reach a certain heart rate so we could define a clear and reproducible exercise-induced response," he explained. "Based on that response to challenge, we showed a benefit. But the kind of exercise that’s done in a laboratory may or may not match what’s done in other settings. Also, because the use of a single dose of montelukast to prevent exercise-induced bronchoconstriction in children less than age 15 years is not currently approved by the FDA, this use is considered investigational."

Merck funded the study. Dr. Philip is a full-time employee of the company.

SAN FRANCISCO – Compared with placebo, a single dose of montelukast attenuated exercise-induced bronchoconstriction in children within 2 hours and lasted through 24 hours post dose, results from a small study found.

Although this treatment effect of montelukast has been observed in previously published studies of adults with exercise-induced bronchoconstriction, this is the first analysis of its kind in children with the condition.

"The ability to take a single tablet and have it last for 24 hours is probably more meaningful for children than for adults, because children often engage in unplanned physical activities more than adults do," Dr. George Philip said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a multicenter study, Dr. Philip, senior director of clinical research at Merck Research Laboratories, North Wales, Pa., and his associates enrolled 66 children aged 6-14 years with pre-exercise forced expiratory volume in 1 second (FEV₁) of 70% predicted or greater and a maximum fall in FEV₁ of 20% or greater at two screening exercise challenges performed on a treadmill. Study participants were randomized to receive single-dose montelukast (4 or 5 mg) or placebo before the exercise challenges were performed at 2 and 24 hours post dose.

The primary end point was maximum percent fall in FEV₁ after exercise challenge 2 hours post dose. Secondary end points included maximum percent fall in FEV₁ after the 24-hour postdose challenge and each of the following end points at 2 and 24 hours post dose: maximum percent fall in FEV₁ categorized as less than 10%, 10%-20%, and greater than 20%; area under the curve during the 60 minutes post challenge; and time to recovery to within 5% of pre-exercise baseline.

The mean age of patients was 11 years, and 56% were male. About three-quarters (74.2%) were white, 16.7% were black, and 9.1% were from other ethnic groups.

Dr. Philip reported that the mean percent fall in FEV₁ was significantly better after the 2-hour postdose exercise challenge in the montelukast treatment group, compared with the placebo group (15.3% vs. 20%, respectively). Patients in the montelukast group also fared significantly better, compared with their counterparts in the placebo group, in maximum percent fall in FEV₁ after the 24-hour postdose exercise challenge (12.92% vs. 17.25%, respectively); the categorized maximum percent fall at 2 hours (P = .034) though not at 24 hours (P = .061); and area under the curve at 2 hours (P = .022) and 24 hours (P = .013).

There were few clinical adverse events and no serious drug-related adverse events.

Dr. Philip acknowledged that the controlled laboratory setting in which the exercise challenge took place is a limitation of the study. "Natural exercise may be different from what we did in the laboratory, where all the kids had to run on a treadmill and reach a certain heart rate so we could define a clear and reproducible exercise-induced response," he explained. "Based on that response to challenge, we showed a benefit. But the kind of exercise that’s done in a laboratory may or may not match what’s done in other settings. Also, because the use of a single dose of montelukast to prevent exercise-induced bronchoconstriction in children less than age 15 years is not currently approved by the FDA, this use is considered investigational."

Merck funded the study. Dr. Philip is a full-time employee of the company.

SAN FRANCISCO – Compared with placebo, a single dose of montelukast attenuated exercise-induced bronchoconstriction in children within 2 hours and lasted through 24 hours post dose, results from a small study found.

Although this treatment effect of montelukast has been observed in previously published studies of adults with exercise-induced bronchoconstriction, this is the first analysis of its kind in children with the condition.

"The ability to take a single tablet and have it last for 24 hours is probably more meaningful for children than for adults, because children often engage in unplanned physical activities more than adults do," Dr. George Philip said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a multicenter study, Dr. Philip, senior director of clinical research at Merck Research Laboratories, North Wales, Pa., and his associates enrolled 66 children aged 6-14 years with pre-exercise forced expiratory volume in 1 second (FEV₁) of 70% predicted or greater and a maximum fall in FEV₁ of 20% or greater at two screening exercise challenges performed on a treadmill. Study participants were randomized to receive single-dose montelukast (4 or 5 mg) or placebo before the exercise challenges were performed at 2 and 24 hours post dose.

The primary end point was maximum percent fall in FEV₁ after exercise challenge 2 hours post dose. Secondary end points included maximum percent fall in FEV₁ after the 24-hour postdose challenge and each of the following end points at 2 and 24 hours post dose: maximum percent fall in FEV₁ categorized as less than 10%, 10%-20%, and greater than 20%; area under the curve during the 60 minutes post challenge; and time to recovery to within 5% of pre-exercise baseline.

The mean age of patients was 11 years, and 56% were male. About three-quarters (74.2%) were white, 16.7% were black, and 9.1% were from other ethnic groups.

Dr. Philip reported that the mean percent fall in FEV₁ was significantly better after the 2-hour postdose exercise challenge in the montelukast treatment group, compared with the placebo group (15.3% vs. 20%, respectively). Patients in the montelukast group also fared significantly better, compared with their counterparts in the placebo group, in maximum percent fall in FEV₁ after the 24-hour postdose exercise challenge (12.92% vs. 17.25%, respectively); the categorized maximum percent fall at 2 hours (P = .034) though not at 24 hours (P = .061); and area under the curve at 2 hours (P = .022) and 24 hours (P = .013).

There were few clinical adverse events and no serious drug-related adverse events.

Dr. Philip acknowledged that the controlled laboratory setting in which the exercise challenge took place is a limitation of the study. "Natural exercise may be different from what we did in the laboratory, where all the kids had to run on a treadmill and reach a certain heart rate so we could define a clear and reproducible exercise-induced response," he explained. "Based on that response to challenge, we showed a benefit. But the kind of exercise that’s done in a laboratory may or may not match what’s done in other settings. Also, because the use of a single dose of montelukast to prevent exercise-induced bronchoconstriction in children less than age 15 years is not currently approved by the FDA, this use is considered investigational."

Merck funded the study. Dr. Philip is a full-time employee of the company.

SAN FRANCISCO – Compared with placebo, a single dose of montelukast attenuated exercise-induced bronchoconstriction in children within 2 hours and lasted through 24 hours post dose, results from a small study found.

Although this treatment effect of montelukast has been observed in previously published studies of adults with exercise-induced bronchoconstriction, this is the first analysis of its kind in children with the condition.

"The ability to take a single tablet and have it last for 24 hours is probably more meaningful for children than for adults, because children often engage in unplanned physical activities more than adults do," Dr. George Philip said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

In a multicenter study, Dr. Philip, senior director of clinical research at Merck Research Laboratories, North Wales, Pa., and his associates enrolled 66 children aged 6-14 years with pre-exercise forced expiratory volume in 1 second (FEV₁) of 70% predicted or greater and a maximum fall in FEV₁ of 20% or greater at two screening exercise challenges performed on a treadmill. Study participants were randomized to receive single-dose montelukast (4 or 5 mg) or placebo before the exercise challenges were performed at 2 and 24 hours post dose.

The primary end point was maximum percent fall in FEV₁ after exercise challenge 2 hours post dose. Secondary end points included maximum percent fall in FEV₁ after the 24-hour postdose challenge and each of the following end points at 2 and 24 hours post dose: maximum percent fall in FEV₁ categorized as less than 10%, 10%-20%, and greater than 20%; area under the curve during the 60 minutes post challenge; and time to recovery to within 5% of pre-exercise baseline.

The mean age of patients was 11 years, and 56% were male. About three-quarters (74.2%) were white, 16.7% were black, and 9.1% were from other ethnic groups.

Dr. Philip reported that the mean percent fall in FEV₁ was significantly better after the 2-hour postdose exercise challenge in the montelukast treatment group, compared with the placebo group (15.3% vs. 20%, respectively). Patients in the montelukast group also fared significantly better, compared with their counterparts in the placebo group, in maximum percent fall in FEV₁ after the 24-hour postdose exercise challenge (12.92% vs. 17.25%, respectively); the categorized maximum percent fall at 2 hours (P = .034) though not at 24 hours (P = .061); and area under the curve at 2 hours (P = .022) and 24 hours (P = .013).

There were few clinical adverse events and no serious drug-related adverse events.

Dr. Philip acknowledged that the controlled laboratory setting in which the exercise challenge took place is a limitation of the study. "Natural exercise may be different from what we did in the laboratory, where all the kids had to run on a treadmill and reach a certain heart rate so we could define a clear and reproducible exercise-induced response," he explained. "Based on that response to challenge, we showed a benefit. But the kind of exercise that’s done in a laboratory may or may not match what’s done in other settings. Also, because the use of a single dose of montelukast to prevent exercise-induced bronchoconstriction in children less than age 15 years is not currently approved by the FDA, this use is considered investigational."

Merck funded the study. Dr. Philip is a full-time employee of the company.

SAN FRANCISCO – Oral immunotherapy bested sublingual immunotherapy for pediatric milk allergies in the first head-to-head comparison of the two desensitization techniques.

"The results are quite striking in that we found that both groups had significant increases in the amount of milk they could tolerate, but the oral immunotherapy group had a far greater increase," said senior investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore, Md.

However, oral therapy – in which powdered milk extract is put in food and taken as a daily treatment – had more frequent adverse events.

Twelve girls and eighteen boys aged 6-17 years participated in the trial. At baseline, they reacted to less than half a teaspoon of milk and had a median baseline milk-IgE of 37.8 kUa/L, with a range 1.1-572 kUa/L.

Ten randomized to sublingual therapy were gradually escalated to maintenance doses of 7 mg of milk extract per day placed under their tongues, held for a few minutes, then swallowed.

Ten children in the oral group were gradually escalated to daily maintenance doses of 1,000 mg, ten others to 2,000 mg.

One girl dropped out because she had a severe eczema flair, but the others reached the maintenance dose and completed milk challenges.

After 3 months of maintenance, children in the sublingual group tolerated a median of 940 mg of milk – a little less than an ounce – with a range of 40-8,140 mg.

Children in the 1,000 mg oral group tolerated a median of 6,140 mg with a range of 2,540-8,140 mg. Those in the 2,000 mg group tolerated 8,140 mg of milk with a range of 4,140-8,140 mg. The findings were statistically significant.

Six children in the sublingual group repeated the challenge at 14 months; one tolerated 8,000 mg, but the rest tolerated less than 1,000 mg and were switched to oral therapy, Dr. Wood said.

Skin prick tests decreased and milk-IgG4 increased in all the groups. Milk-IgE decreased only after oral immunotherapy. Milk-IgE or milk-IgG4 did not predict food challenge outcomes.

Side effects were similar between the sublingual and oral groups, but more severe in the oral groups. Antihistamines were needed with only about 1% of the sublingual doses, but with 18% of the oral doses. Epinephrine was used twice during sublingual therapy but four times during oral therapy.

Oral therapy’s greater side effects didn’t surprise coinvestigator Dr. Wesley Burks, chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

"In general, oral has more side effects." In immunotherapy trials, "about 15% of children cannot tolerate the procedure at all. They have too many [gastrointestinal] symptoms," he said.

Although promising, Dr. Wood noted the results are preliminary.

His study, as well as immunotherapy trials for peanuts and other allergens, have "very small numbers where we are trying to figure out the right doses and right way to do it. We are hopeful in the next few years we will be comfortable enough with the approach to be able to do some larger studies," he said.

Dr. Wood said he had no relevant financial disclosures. Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals Inc. 

SAN FRANCISCO – Oral immunotherapy bested sublingual immunotherapy for pediatric milk allergies in the first head-to-head comparison of the two desensitization techniques.

"The results are quite striking in that we found that both groups had significant increases in the amount of milk they could tolerate, but the oral immunotherapy group had a far greater increase," said senior investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore, Md.

However, oral therapy – in which powdered milk extract is put in food and taken as a daily treatment – had more frequent adverse events.

Twelve girls and eighteen boys aged 6-17 years participated in the trial. At baseline, they reacted to less than half a teaspoon of milk and had a median baseline milk-IgE of 37.8 kUa/L, with a range 1.1-572 kUa/L.

Ten randomized to sublingual therapy were gradually escalated to maintenance doses of 7 mg of milk extract per day placed under their tongues, held for a few minutes, then swallowed.

Ten children in the oral group were gradually escalated to daily maintenance doses of 1,000 mg, ten others to 2,000 mg.

One girl dropped out because she had a severe eczema flair, but the others reached the maintenance dose and completed milk challenges.

After 3 months of maintenance, children in the sublingual group tolerated a median of 940 mg of milk – a little less than an ounce – with a range of 40-8,140 mg.

Children in the 1,000 mg oral group tolerated a median of 6,140 mg with a range of 2,540-8,140 mg. Those in the 2,000 mg group tolerated 8,140 mg of milk with a range of 4,140-8,140 mg. The findings were statistically significant.

Six children in the sublingual group repeated the challenge at 14 months; one tolerated 8,000 mg, but the rest tolerated less than 1,000 mg and were switched to oral therapy, Dr. Wood said.

Skin prick tests decreased and milk-IgG4 increased in all the groups. Milk-IgE decreased only after oral immunotherapy. Milk-IgE or milk-IgG4 did not predict food challenge outcomes.

Side effects were similar between the sublingual and oral groups, but more severe in the oral groups. Antihistamines were needed with only about 1% of the sublingual doses, but with 18% of the oral doses. Epinephrine was used twice during sublingual therapy but four times during oral therapy.

Oral therapy’s greater side effects didn’t surprise coinvestigator Dr. Wesley Burks, chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

"In general, oral has more side effects." In immunotherapy trials, "about 15% of children cannot tolerate the procedure at all. They have too many [gastrointestinal] symptoms," he said.

Although promising, Dr. Wood noted the results are preliminary.

His study, as well as immunotherapy trials for peanuts and other allergens, have "very small numbers where we are trying to figure out the right doses and right way to do it. We are hopeful in the next few years we will be comfortable enough with the approach to be able to do some larger studies," he said.

Dr. Wood said he had no relevant financial disclosures. Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals Inc. 

SAN FRANCISCO – Oral immunotherapy bested sublingual immunotherapy for pediatric milk allergies in the first head-to-head comparison of the two desensitization techniques.

"The results are quite striking in that we found that both groups had significant increases in the amount of milk they could tolerate, but the oral immunotherapy group had a far greater increase," said senior investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore, Md.

However, oral therapy – in which powdered milk extract is put in food and taken as a daily treatment – had more frequent adverse events.

Twelve girls and eighteen boys aged 6-17 years participated in the trial. At baseline, they reacted to less than half a teaspoon of milk and had a median baseline milk-IgE of 37.8 kUa/L, with a range 1.1-572 kUa/L.

Ten randomized to sublingual therapy were gradually escalated to maintenance doses of 7 mg of milk extract per day placed under their tongues, held for a few minutes, then swallowed.

Ten children in the oral group were gradually escalated to daily maintenance doses of 1,000 mg, ten others to 2,000 mg.

One girl dropped out because she had a severe eczema flair, but the others reached the maintenance dose and completed milk challenges.

After 3 months of maintenance, children in the sublingual group tolerated a median of 940 mg of milk – a little less than an ounce – with a range of 40-8,140 mg.

Children in the 1,000 mg oral group tolerated a median of 6,140 mg with a range of 2,540-8,140 mg. Those in the 2,000 mg group tolerated 8,140 mg of milk with a range of 4,140-8,140 mg. The findings were statistically significant.

Six children in the sublingual group repeated the challenge at 14 months; one tolerated 8,000 mg, but the rest tolerated less than 1,000 mg and were switched to oral therapy, Dr. Wood said.

Skin prick tests decreased and milk-IgG4 increased in all the groups. Milk-IgE decreased only after oral immunotherapy. Milk-IgE or milk-IgG4 did not predict food challenge outcomes.

Side effects were similar between the sublingual and oral groups, but more severe in the oral groups. Antihistamines were needed with only about 1% of the sublingual doses, but with 18% of the oral doses. Epinephrine was used twice during sublingual therapy but four times during oral therapy.

Oral therapy’s greater side effects didn’t surprise coinvestigator Dr. Wesley Burks, chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

"In general, oral has more side effects." In immunotherapy trials, "about 15% of children cannot tolerate the procedure at all. They have too many [gastrointestinal] symptoms," he said.

Although promising, Dr. Wood noted the results are preliminary.

His study, as well as immunotherapy trials for peanuts and other allergens, have "very small numbers where we are trying to figure out the right doses and right way to do it. We are hopeful in the next few years we will be comfortable enough with the approach to be able to do some larger studies," he said.

Dr. Wood said he had no relevant financial disclosures. Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals Inc. 

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can't tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can't tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can't tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can’t tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can’t tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.

SAN FRANCISCO – Sublingual immunotherapy desensitized 11 children to peanut allergies in a double-blind, placebo-controlled trial.

When challenged with peanut after a year of treatment, they tolerated a median of 1,710 mg (about seven peanuts), while 7 children in the placebo arm tolerated a median of 85 mg (about one-fifth of a peanut), a 20-fold difference (P = .011).

Photo credit: © mates/Fotolia.com

The results were so impressive that the interim analysis was cut short to switch placebo children to active therapy, said senior investigator Dr. Wesley Burks, professor of pediatrics and chief of the division of pediatric allergy and immunology at Duke University Medical Center, Durham, N.C.

But however promising these results, and those of other immunotherapy trials, Dr. Burks cautioned that additional efficacy and safety verification are needed.

In some immunotherapy trials, children who seemed to tolerate gradual exposure and desensitization to their particular allergens had unexpected anaphylactic reactions, especially if they came down with a viral illness. A significant proportion of children also can’t tolerate oral immunotherapy, he said.

Those points are often missed in news reports that suggest immunotherapy cures food allergies. Until more is known, immunotherapy "is not the right thing to do right now. We don’t put people on immunotherapy unless it’s in a study," he said.

Children in the trial were aged 1- to 11-years-old and had histories of peanut reactions plus elevated peanut IgE levels.

Treated children were dose escalated over a period of 6 months to a total of 2,000 mcg of peanut protein daily, then maintenance dosed for the next 6 months. The peanut extract was placed under their tongues, held for a couple minutes, then swallowed; 2,500-mg peanut challenges came at the 1-year mark.

Although the median was 1,710 mg, "there was a pretty wide range in how much [treated children] tolerated," Dr. Burks said, with some able to handle the entire 2,500 mg, others only 200 mg.

Peanut-specific IgE increased over the first 4 months of treatment (P = .002), then steadily decreased over the remaining 8 months (P = .003). Peanut-specific IgG4 increased over the entire year of therapy (P = .014).

"Their skin-prick tests [also] went down in the first 6 months [of treatment] and stayed down" versus placebo, Dr. Burks said. Treated children had wheal sizes significantly smaller than children in the placebo group (P = .020).

The findings "suggest a significant change in the allergic response," Dr. Burks concluded.

Dosing side effects were mostly oropharyngeal and seldom required treatment.

Children in the placebo group were switched to sublingual therapy following the peanut challenges. After a year of treatment, five of the seven now tolerate 2,500 mg of peanut, with the other two tolerating between 1,500 and 2,000 mg, Dr. Burks said.

Dr. Burks disclosed that he is a consultant for Actogenix, Dannon, Intelliject, McNeil Nutritionals, Novartis, Schering-Plough (now a part of Merck), and Nutricia. He is a minority stockholder in Allertein Therapeutics and Mast Cell Pharmaceuticals.