2011 AAAAI Annual Meeting

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – In a University of Toronto case series, 150-mg injections of omalizumab (Xolair) put seven of nine patients with severe, refractory chronic idiopathic urticaria into remission, sometimes after the first injection.

There have been other reports of the anti-IgE monoclonal antibody successfully treating refractory chronic idiopathic urticaria (CIU), but usually at higher doses.

"Because of the cost, we wanted to see if it would work at 150 mg," the standard dose for asthma, said lead investigator Dr. Gordon Sussman, division director of clinical allergy and immunology at the university.

Cost was an issue because the patients paid for the biologic themselves. Although omalizumab carries an asthma indication, it is not yet indicated for chronic urticaria, and so was not covered by the patients’ insurance. A single 150-mg injection costs from $500-$1,000, Dr. Sussman said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

"The patients paid for it, and would pay for it again because it’s effective," he said.

"The standard dose seemed to work after one treatment. In some people [hives came back] in sometimes 2 months, sometimes 4 months. But when [they] came back and we treated people again, they seemed to be able to respond to the second treatment," Dr. Sussman said.

The five women and four men in the series were aged 27-66 years (mean 47.7) and had suffered from severe, refractory CIU from 1-13 years (mean 5.5). Initial IgE levels ranged up to 750 mcg/L. Initial urticaria activity scores ranged from about 33 to 40.

They were all taking nonsedating antihistamines, 20- to 50-mg prednisone daily, and other drugs to control their hives, without success.

The first patient was dosed at 225 mg based on an IgE of 384 mcg/L but because of the cost issue, subsequent patients were treated with 150-mg doses. They each received from one to five doses spaced from 2-10 weeks apart, depending on symptoms.

The 225-mg patient and four 150-mg patients went into spontaneous remissions within a week of their first injections. Another two patients went into remission after two 150-mg injections and another patient after three.

Dr. Sussman and his colleagues took those patients off their prednisone, but kept them on their antihistamines, the standard treatment for urticaria.

Three patients have remained symptom free for up to 8 months. Other patients have gotten follow-up omalizumab shots as needed.

A ninth patient went into remission after three doses, but symptoms returned after several months. A second course of three injections had little effect, and the woman is currently on 10-mg dose of prednisone daily.

"She responded at first very well, and then she rebounded. At this point she’s refractory. So it doesn’t work for everyone," Dr. Sussman said.

Initial IgE level "is not really a predictor" of response, he noted. "We don’t think [the effect] is related to IgE. My hypothesis is that maybe it’s related to down-regulation of IgE receptors in some way that we don’t really understand."

Even so, "Xolair seems to work quickly after the first treatment. We think it’s a real effect," Dr. Sussman said.

Dr. Sussman said he had no relevant financial disclosures. The case series received no outside funding.

SAN FRANCISCO – Adding long-acting beta-agonists to a regimen consisting of inhaled corticosteroids did not increase the rate of admissions to the pediatric intensive care unit, results from a year-long study showed.

"This supports the guidelines from the National Asthma Education and Prevention Program," Dr. Tammy S. Jacobs said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "When you fail to have adequate control with inhaled corticosteroids alone, long-acting beta-agonists can be a very good medication to add."

While results from the U.K. Serevent Nationwide Surveillance study and the U.S. Salmeterol Multicenter Asthma Research Trial suggested that long-acting beta-agonists (LABAs) increase the risk of asthma-related mortality, neither trial was adequately powered to study the safety of LABAs when used in conjunction with inhaled corticosteroids (ICS), said Dr. Jacobs, a resident at Children’s Hospital of Pittsburgh. In an effort to evaluate the impact of LABA use in conjunction with inhaled corticosteroids on the risk of near-fatal asthma in children, she and her associates reviewed the medical charts of 363 children aged 4-18 years who were admitted for asthma exacerbations to Children’s Hospital of Pittsburgh in 2005.

Cases and controls were determined by pediatric intensive care (PICU) and floor admissions, respectively. Exposure was defined by LABA use in combination with ICS vs. ICS alone.

After excluding patients with non–asthma-indicated admissions, complicated pneumonias, debilitating comorbid disorders, and multiple admissions, 85 PICU admissions and 96 floor admissions were included in the final analysis. The mean age of patients was 9 years, 54% were male, and 51% were white.

Dr. Jacobs reported that the use of LABA in conjunction with ICS did not significantly increase the risk of PICU admissions (odds ratio, 1.07), compared with ICS alone. After the researchers adjusted for demographics, asthma severity, history of PICU admissions, and concurrent infection, they found that the use of LABA in conjunction with ICS may have decreased the risk of PICU admission, compared with ICS alone (OR, 0.85). No deaths occurred during the study period.

"Although this [study] does not directly evaluate increase in mortality (as in previous trials), risk of ICU admission may actually be a more clinically relevant outcome to evaluate LABA safety," the researchers concluded in their poster. "Findings are generalizable to a population of children with relatively higher-risk asthma/poorer asthma control since all subjects were admitted, and no outpatient subjects were included."

Dr. Jacobs acknowledged certain limitations of the study, including the fact that it was a retrospective chart review with the potential for missing data.

She said that she had no relevant financial conflicts to disclose.

SAN FRANCISCO – Adding long-acting beta-agonists to a regimen consisting of inhaled corticosteroids did not increase the rate of admissions to the pediatric intensive care unit, results from a year-long study showed.

"This supports the guidelines from the National Asthma Education and Prevention Program," Dr. Tammy S. Jacobs said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "When you fail to have adequate control with inhaled corticosteroids alone, long-acting beta-agonists can be a very good medication to add."

While results from the U.K. Serevent Nationwide Surveillance study and the U.S. Salmeterol Multicenter Asthma Research Trial suggested that long-acting beta-agonists (LABAs) increase the risk of asthma-related mortality, neither trial was adequately powered to study the safety of LABAs when used in conjunction with inhaled corticosteroids (ICS), said Dr. Jacobs, a resident at Children’s Hospital of Pittsburgh. In an effort to evaluate the impact of LABA use in conjunction with inhaled corticosteroids on the risk of near-fatal asthma in children, she and her associates reviewed the medical charts of 363 children aged 4-18 years who were admitted for asthma exacerbations to Children’s Hospital of Pittsburgh in 2005.

Cases and controls were determined by pediatric intensive care (PICU) and floor admissions, respectively. Exposure was defined by LABA use in combination with ICS vs. ICS alone.

After excluding patients with non–asthma-indicated admissions, complicated pneumonias, debilitating comorbid disorders, and multiple admissions, 85 PICU admissions and 96 floor admissions were included in the final analysis. The mean age of patients was 9 years, 54% were male, and 51% were white.

Dr. Jacobs reported that the use of LABA in conjunction with ICS did not significantly increase the risk of PICU admissions (odds ratio, 1.07), compared with ICS alone. After the researchers adjusted for demographics, asthma severity, history of PICU admissions, and concurrent infection, they found that the use of LABA in conjunction with ICS may have decreased the risk of PICU admission, compared with ICS alone (OR, 0.85). No deaths occurred during the study period.

"Although this [study] does not directly evaluate increase in mortality (as in previous trials), risk of ICU admission may actually be a more clinically relevant outcome to evaluate LABA safety," the researchers concluded in their poster. "Findings are generalizable to a population of children with relatively higher-risk asthma/poorer asthma control since all subjects were admitted, and no outpatient subjects were included."

Dr. Jacobs acknowledged certain limitations of the study, including the fact that it was a retrospective chart review with the potential for missing data.

She said that she had no relevant financial conflicts to disclose.

SAN FRANCISCO – Adding long-acting beta-agonists to a regimen consisting of inhaled corticosteroids did not increase the rate of admissions to the pediatric intensive care unit, results from a year-long study showed.

"This supports the guidelines from the National Asthma Education and Prevention Program," Dr. Tammy S. Jacobs said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "When you fail to have adequate control with inhaled corticosteroids alone, long-acting beta-agonists can be a very good medication to add."

While results from the U.K. Serevent Nationwide Surveillance study and the U.S. Salmeterol Multicenter Asthma Research Trial suggested that long-acting beta-agonists (LABAs) increase the risk of asthma-related mortality, neither trial was adequately powered to study the safety of LABAs when used in conjunction with inhaled corticosteroids (ICS), said Dr. Jacobs, a resident at Children’s Hospital of Pittsburgh. In an effort to evaluate the impact of LABA use in conjunction with inhaled corticosteroids on the risk of near-fatal asthma in children, she and her associates reviewed the medical charts of 363 children aged 4-18 years who were admitted for asthma exacerbations to Children’s Hospital of Pittsburgh in 2005.

Cases and controls were determined by pediatric intensive care (PICU) and floor admissions, respectively. Exposure was defined by LABA use in combination with ICS vs. ICS alone.

After excluding patients with non–asthma-indicated admissions, complicated pneumonias, debilitating comorbid disorders, and multiple admissions, 85 PICU admissions and 96 floor admissions were included in the final analysis. The mean age of patients was 9 years, 54% were male, and 51% were white.

Dr. Jacobs reported that the use of LABA in conjunction with ICS did not significantly increase the risk of PICU admissions (odds ratio, 1.07), compared with ICS alone. After the researchers adjusted for demographics, asthma severity, history of PICU admissions, and concurrent infection, they found that the use of LABA in conjunction with ICS may have decreased the risk of PICU admission, compared with ICS alone (OR, 0.85). No deaths occurred during the study period.

"Although this [study] does not directly evaluate increase in mortality (as in previous trials), risk of ICU admission may actually be a more clinically relevant outcome to evaluate LABA safety," the researchers concluded in their poster. "Findings are generalizable to a population of children with relatively higher-risk asthma/poorer asthma control since all subjects were admitted, and no outpatient subjects were included."

Dr. Jacobs acknowledged certain limitations of the study, including the fact that it was a retrospective chart review with the potential for missing data.

She said that she had no relevant financial conflicts to disclose.

SAN FRANCISCO – Adding long-acting beta-agonists to a regimen consisting of inhaled corticosteroids did not increase the rate of admissions to the pediatric intensive care unit, results from a year-long study showed.

"This supports the guidelines from the National Asthma Education and Prevention Program," Dr. Tammy S. Jacobs said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "When you fail to have adequate control with inhaled corticosteroids alone, long-acting beta-agonists can be a very good medication to add."

While results from the U.K. Serevent Nationwide Surveillance study and the U.S. Salmeterol Multicenter Asthma Research Trial suggested that long-acting beta-agonists (LABAs) increase the risk of asthma-related mortality, neither trial was adequately powered to study the safety of LABAs when used in conjunction with inhaled corticosteroids (ICS), said Dr. Jacobs, a resident at Children’s Hospital of Pittsburgh. In an effort to evaluate the impact of LABA use in conjunction with inhaled corticosteroids on the risk of near-fatal asthma in children, she and her associates reviewed the medical charts of 363 children aged 4-18 years who were admitted for asthma exacerbations to Children’s Hospital of Pittsburgh in 2005.

Cases and controls were determined by pediatric intensive care (PICU) and floor admissions, respectively. Exposure was defined by LABA use in combination with ICS vs. ICS alone.

After excluding patients with non–asthma-indicated admissions, complicated pneumonias, debilitating comorbid disorders, and multiple admissions, 85 PICU admissions and 96 floor admissions were included in the final analysis. The mean age of patients was 9 years, 54% were male, and 51% were white.

Dr. Jacobs reported that the use of LABA in conjunction with ICS did not significantly increase the risk of PICU admissions (odds ratio, 1.07), compared with ICS alone. After the researchers adjusted for demographics, asthma severity, history of PICU admissions, and concurrent infection, they found that the use of LABA in conjunction with ICS may have decreased the risk of PICU admission, compared with ICS alone (OR, 0.85). No deaths occurred during the study period.

"Although this [study] does not directly evaluate increase in mortality (as in previous trials), risk of ICU admission may actually be a more clinically relevant outcome to evaluate LABA safety," the researchers concluded in their poster. "Findings are generalizable to a population of children with relatively higher-risk asthma/poorer asthma control since all subjects were admitted, and no outpatient subjects were included."

Dr. Jacobs acknowledged certain limitations of the study, including the fact that it was a retrospective chart review with the potential for missing data.

She said that she had no relevant financial conflicts to disclose.

SAN FRANCISCO – Adding long-acting beta-agonists to a regimen consisting of inhaled corticosteroids did not increase the rate of admissions to the pediatric intensive care unit, results from a year-long study showed.

"This supports the guidelines from the National Asthma Education and Prevention Program," Dr. Tammy S. Jacobs said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "When you fail to have adequate control with inhaled corticosteroids alone, long-acting beta-agonists can be a very good medication to add."

While results from the U.K. Serevent Nationwide Surveillance study and the U.S. Salmeterol Multicenter Asthma Research Trial suggested that long-acting beta-agonists (LABAs) increase the risk of asthma-related mortality, neither trial was adequately powered to study the safety of LABAs when used in conjunction with inhaled corticosteroids (ICS), said Dr. Jacobs, a resident at Children’s Hospital of Pittsburgh. In an effort to evaluate the impact of LABA use in conjunction with inhaled corticosteroids on the risk of near-fatal asthma in children, she and her associates reviewed the medical charts of 363 children aged 4-18 years who were admitted for asthma exacerbations to Children’s Hospital of Pittsburgh in 2005.

Cases and controls were determined by pediatric intensive care (PICU) and floor admissions, respectively. Exposure was defined by LABA use in combination with ICS vs. ICS alone.

After excluding patients with non–asthma-indicated admissions, complicated pneumonias, debilitating comorbid disorders, and multiple admissions, 85 PICU admissions and 96 floor admissions were included in the final analysis. The mean age of patients was 9 years, 54% were male, and 51% were white.

Dr. Jacobs reported that the use of LABA in conjunction with ICS did not significantly increase the risk of PICU admissions (odds ratio, 1.07), compared with ICS alone. After the researchers adjusted for demographics, asthma severity, history of PICU admissions, and concurrent infection, they found that the use of LABA in conjunction with ICS may have decreased the risk of PICU admission, compared with ICS alone (OR, 0.85). No deaths occurred during the study period.

"Although this [study] does not directly evaluate increase in mortality (as in previous trials), risk of ICU admission may actually be a more clinically relevant outcome to evaluate LABA safety," the researchers concluded in their poster. "Findings are generalizable to a population of children with relatively higher-risk asthma/poorer asthma control since all subjects were admitted, and no outpatient subjects were included."

Dr. Jacobs acknowledged certain limitations of the study, including the fact that it was a retrospective chart review with the potential for missing data.

She said that she had no relevant financial conflicts to disclose.

SAN FRANCISCO – Adding long-acting beta-agonists to a regimen consisting of inhaled corticosteroids did not increase the rate of admissions to the pediatric intensive care unit, results from a year-long study showed.

"This supports the guidelines from the National Asthma Education and Prevention Program," Dr. Tammy S. Jacobs said in an interview during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. "When you fail to have adequate control with inhaled corticosteroids alone, long-acting beta-agonists can be a very good medication to add."

While results from the U.K. Serevent Nationwide Surveillance study and the U.S. Salmeterol Multicenter Asthma Research Trial suggested that long-acting beta-agonists (LABAs) increase the risk of asthma-related mortality, neither trial was adequately powered to study the safety of LABAs when used in conjunction with inhaled corticosteroids (ICS), said Dr. Jacobs, a resident at Children’s Hospital of Pittsburgh. In an effort to evaluate the impact of LABA use in conjunction with inhaled corticosteroids on the risk of near-fatal asthma in children, she and her associates reviewed the medical charts of 363 children aged 4-18 years who were admitted for asthma exacerbations to Children’s Hospital of Pittsburgh in 2005.

Cases and controls were determined by pediatric intensive care (PICU) and floor admissions, respectively. Exposure was defined by LABA use in combination with ICS vs. ICS alone.

After excluding patients with non–asthma-indicated admissions, complicated pneumonias, debilitating comorbid disorders, and multiple admissions, 85 PICU admissions and 96 floor admissions were included in the final analysis. The mean age of patients was 9 years, 54% were male, and 51% were white.

Dr. Jacobs reported that the use of LABA in conjunction with ICS did not significantly increase the risk of PICU admissions (odds ratio, 1.07), compared with ICS alone. After the researchers adjusted for demographics, asthma severity, history of PICU admissions, and concurrent infection, they found that the use of LABA in conjunction with ICS may have decreased the risk of PICU admission, compared with ICS alone (OR, 0.85). No deaths occurred during the study period.

"Although this [study] does not directly evaluate increase in mortality (as in previous trials), risk of ICU admission may actually be a more clinically relevant outcome to evaluate LABA safety," the researchers concluded in their poster. "Findings are generalizable to a population of children with relatively higher-risk asthma/poorer asthma control since all subjects were admitted, and no outpatient subjects were included."

Dr. Jacobs acknowledged certain limitations of the study, including the fact that it was a retrospective chart review with the potential for missing data.

She said that she had no relevant financial conflicts to disclose.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

"This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma," Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers’ poster, which was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, prebronchodilator forced expiratory volume in 0.5- and 1-second (FEV_0.5 and FEV₁) measures obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral corticosteroids, compared with each of the other groups, after the investigators controlled for factors including asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral corticosteroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral corticosteroid treatment, and 1.38 L in children who had wheezing with one oral corticosteroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. "Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known," they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

The study was supported by grants from the National Institutes of Health. Dr. Jackson said he had no relevant financial disclosures.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

"This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma," Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers’ poster, which was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, prebronchodilator forced expiratory volume in 0.5- and 1-second (FEV_0.5 and FEV₁) measures obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral corticosteroids, compared with each of the other groups, after the investigators controlled for factors including asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral corticosteroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral corticosteroid treatment, and 1.38 L in children who had wheezing with one oral corticosteroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. "Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known," they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

The study was supported by grants from the National Institutes of Health. Dr. Jackson said he had no relevant financial disclosures.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

"This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma," Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers’ poster, which was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, prebronchodilator forced expiratory volume in 0.5- and 1-second (FEV_0.5 and FEV₁) measures obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral corticosteroids, compared with each of the other groups, after the investigators controlled for factors including asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral corticosteroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral corticosteroid treatment, and 1.38 L in children who had wheezing with one oral corticosteroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. "Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known," they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

The study was supported by grants from the National Institutes of Health. Dr. Jackson said he had no relevant financial disclosures.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

"This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma," Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers’ poster, which was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, prebronchodilator forced expiratory volume in 0.5- and 1-second (FEV_0.5 and FEV₁) measures obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral corticosteroids, compared with each of the other groups, after the investigators controlled for factors including asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral corticosteroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral corticosteroid treatment, and 1.38 L in children who had wheezing with one oral corticosteroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. "Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known," they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

The study was supported by grants from the National Institutes of Health. Dr. Jackson said he had no relevant financial disclosures.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

"This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma," Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers’ poster, which was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, prebronchodilator forced expiratory volume in 0.5- and 1-second (FEV_0.5 and FEV₁) measures obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral corticosteroids, compared with each of the other groups, after the investigators controlled for factors including asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral corticosteroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral corticosteroid treatment, and 1.38 L in children who had wheezing with one oral corticosteroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. "Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known," they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

The study was supported by grants from the National Institutes of Health. Dr. Jackson said he had no relevant financial disclosures.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

"This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma," Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers’ poster, which was presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Overall, prebronchodilator forced expiratory volume in 0.5- and 1-second (FEV_0.5 and FEV₁) measures obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral corticosteroids, compared with each of the other groups, after the investigators controlled for factors including asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral corticosteroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral corticosteroid treatment, and 1.38 L in children who had wheezing with one oral corticosteroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. "Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known," they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

The study was supported by grants from the National Institutes of Health. Dr. Jackson said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

SAN FRANCISCO – Baseline milk-IgE level and skin-prick wheal size do a good job of predicting if a child will outgrow a milk allergy, but variation in eczema severity does not, two studies have shown.

"If you have a low milk-specific IgE, less than 2 on the ImmunoCAP test, about [65%] of babies outgrow their allergy" by 30 months. "If you look at those with higher numbers, greater than 10, only 7% of those babies outgrow their allergy," said lead investigator Dr. Robert A. Wood, professor of pediatrics and chief of the division of allergy and immunology at Johns Hopkins Children’s Center, Baltimore.

In the eczema study, "what we found was that the more severe the eczema you had when you came into the study, the less chance of outgrowing your milk allergy," but reduction in eczema severity did not correlate with milk allergy resolution, said Dr. Wood, also an investigator on the second trial.

Being able to predict resolution is important not only to reassure parents and guide treatment, but also because immunotherapy desensitization techniques being developed by Dr. Wood and others may be widely available in 5 or 10 years.

"If we have a marker that says this child can do it on their own by the time they are 2½, that’s great. If we have a marker that says this child will have a lifetime milk allergy, and maybe [immunotherapy] will be most effective if we initiate it early, that will be an incredibly important piece of information," he said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Populations for both studies were drawn from the Consortium of Food Allergy Research (CoFAR) cohort, a National Institutes of Health–funded project with more than 500 children.

In the first study, 89 (36.5%) of 244 milk-allergic infants aged 3-15 months tolerated milk by month 30. The median age of resolution was 2 years.

Those who outgrew their allergy started the trial with a median baseline milk-IgE of 0.72 kU/L; those who did not started with a median of 6.99 kU/L. Only 14.2% of infants who entered the trial with IgE values at or above 5 kU/L resolved their allergy by month 30.

Also associated with resolution was a median baseline milk skin-prick wheal size of 5.0 mm. The median size of those who remained allergic was 9.25 mm (P = less than .001).

"You could really tell a mother with [a] 9-month old baby based on IgE and skin test that [there is a] possibility of outgrowing" the allergy within 30 months. Both are "very useful predictors," Dr. Wood said.

In the eczema study, 27 (46%) of 59 infants aged 3-15 months with mild eczema resolved their milk allergies within 2 years, while only 41 (25%) of 165 with moderate to severe eczema outgrew their allergy (P = .004).

However, in a finding that may surprise some allergists, just 12 (19%) of 62 children enrolled with moderate to severe eczema outgrew their allergy even though their eczema improved to none or mild; among 66 children whose eczema didn’t improve, 21 (32%) outgrew their allergy (P = .11).

"We saw kids whose eczema got a lot better who stayed allergic, and other kids whose eczema stayed severe who managed to outgrow their allergies," Dr. Wood said.

That’s surprising because "there’s just sort of an assumption that many allergists [have] that as atopic dermatitis [gets better, children] are more likely to outgrow their food allergy. What this study showed was there wasn’t that direct line," he said.

Dr. Wood and his colleagues also looked at egg allergy; 13 (39%) of 33 children with no or mild eczema at enrollment outgrew their egg allergy within 2 years, compared with 19 (21%) of 89 enrolled with moderate to severe eczema (P = .047).

About a quarter resolved their egg allergies whether their eczema improved or not, but the finding wasn’t statistically significant.

Dr. Wood said he had no relevant financial disclosures.

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 – Increase in sputum hyaluronan may serve as a noninvasive biomarker of airway remodeling in patients with severe asthma, results from a small novel study demonstrated.

While previous studies have shown that hyaluronan and versican are increased in the extracellular matrix of patients with obstructive lung disease, researchers led by Dr. Andrew G. Ayars, a fellow in allergy and immunology at the University of Washington, Seattle, set out to evaluate levels of hyaluronan and versican in sputum supernatants of 17 prednisone-dependent asthmatics who were randomized to either an anti-interleukin-5 antibody (mepolizumab) or placebo for 16 weeks.

In their abstract, which was unveiled during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, the researchers stated that hyaluronan is a glycosaminoglycan, which "acts as a vital structural component in connective tissues and is important in cell migration, immune cell adhesion, activation, and intracellular signaling." They described versican as "a large extracellular matrix proteoglycan that is present in a variety of human tissues," noting that it binds to hyaluronan.

Seven patients were treated with mepolizumab (at a dose of 750 mg) and 10 were treated with placebo administered intravenously over a 30-minute period at weeks 2, 6, 10, 14, and 18. Patients underwent a predefined prednisone tapering schedule if they remained exacerbation free at follow-up visits. The researchers performed spirometry and used enzyme-linked immunosorbent assay (ELISA) to measure levels of sputum hyaluronan and versican before and after treatment.

Study participants had a mean age of 56 years in the mepolizumab group and 58 years in the placebo group, and men made up 44% of the mepolizumab group and 73% of the placebo group.

Dr. Ayars and his associates observed a significant increase in sputum hyaluronan in the placebo group following prednisone taper (P = .003). They also observed a significantly lower level of sputum hyaluronan after treatment with mepolizumab vs. treatment with placebo (P = .01).

A numerical, nonsignificant increase in sputum versican was seen in the placebo group, while a numerical, nonsignificant decrease was seen in the mepolizumab group.

Dr. Ayars acknowledged that the findings are preliminary, and said that a current study is underway to test the association in patients with mild asthma treated with 2-4 weeks of inhaled corticosteroids.

Dr. Ayars said that he had no relevant financial conflicts to disclose.

SAN FRANCISCO – Increase in sputum hyaluronan may serve as a noninvasive biomarker of airway remodeling in patients with severe asthma, results from a small novel study demonstrated.

While previous studies have shown that hyaluronan and versican are increased in the extracellular matrix of patients with obstructive lung disease, researchers led by Dr. Andrew G. Ayars, a fellow in allergy and immunology at the University of Washington, Seattle, set out to evaluate levels of hyaluronan and versican in sputum supernatants of 17 prednisone-dependent asthmatics who were randomized to either an anti-interleukin-5 antibody (mepolizumab) or placebo for 16 weeks.

In their abstract, which was unveiled during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, the researchers stated that hyaluronan is a glycosaminoglycan, which "acts as a vital structural component in connective tissues and is important in cell migration, immune cell adhesion, activation, and intracellular signaling." They described versican as "a large extracellular matrix proteoglycan that is present in a variety of human tissues," noting that it binds to hyaluronan.

Seven patients were treated with mepolizumab (at a dose of 750 mg) and 10 were treated with placebo administered intravenously over a 30-minute period at weeks 2, 6, 10, 14, and 18. Patients underwent a predefined prednisone tapering schedule if they remained exacerbation free at follow-up visits. The researchers performed spirometry and used enzyme-linked immunosorbent assay (ELISA) to measure levels of sputum hyaluronan and versican before and after treatment.

Study participants had a mean age of 56 years in the mepolizumab group and 58 years in the placebo group, and men made up 44% of the mepolizumab group and 73% of the placebo group.

Dr. Ayars and his associates observed a significant increase in sputum hyaluronan in the placebo group following prednisone taper (P = .003). They also observed a significantly lower level of sputum hyaluronan after treatment with mepolizumab vs. treatment with placebo (P = .01).

A numerical, nonsignificant increase in sputum versican was seen in the placebo group, while a numerical, nonsignificant decrease was seen in the mepolizumab group.

Dr. Ayars acknowledged that the findings are preliminary, and said that a current study is underway to test the association in patients with mild asthma treated with 2-4 weeks of inhaled corticosteroids.

Dr. Ayars said that he had no relevant financial conflicts to disclose.

SAN FRANCISCO – Increase in sputum hyaluronan may serve as a noninvasive biomarker of airway remodeling in patients with severe asthma, results from a small novel study demonstrated.

While previous studies have shown that hyaluronan and versican are increased in the extracellular matrix of patients with obstructive lung disease, researchers led by Dr. Andrew G. Ayars, a fellow in allergy and immunology at the University of Washington, Seattle, set out to evaluate levels of hyaluronan and versican in sputum supernatants of 17 prednisone-dependent asthmatics who were randomized to either an anti-interleukin-5 antibody (mepolizumab) or placebo for 16 weeks.

In their abstract, which was unveiled during a poster session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, the researchers stated that hyaluronan is a glycosaminoglycan, which "acts as a vital structural component in connective tissues and is important in cell migration, immune cell adhesion, activation, and intracellular signaling." They described versican as "a large extracellular matrix proteoglycan that is present in a variety of human tissues," noting that it binds to hyaluronan.

Seven patients were treated with mepolizumab (at a dose of 750 mg) and 10 were treated with placebo administered intravenously over a 30-minute period at weeks 2, 6, 10, 14, and 18. Patients underwent a predefined prednisone tapering schedule if they remained exacerbation free at follow-up visits. The researchers performed spirometry and used enzyme-linked immunosorbent assay (ELISA) to measure levels of sputum hyaluronan and versican before and after treatment.

Study participants had a mean age of 56 years in the mepolizumab group and 58 years in the placebo group, and men made up 44% of the mepolizumab group and 73% of the placebo group.

Dr. Ayars and his associates observed a significant increase in sputum hyaluronan in the placebo group following prednisone taper (P = .003). They also observed a significantly lower level of sputum hyaluronan after treatment with mepolizumab vs. treatment with placebo (P = .01).

A numerical, nonsignificant increase in sputum versican was seen in the placebo group, while a numerical, nonsignificant decrease was seen in the mepolizumab group.

Dr. Ayars acknowledged that the findings are preliminary, and said that a current study is underway to test the association in patients with mild asthma treated with 2-4 weeks of inhaled corticosteroids.

Dr. Ayars said that he had no relevant financial conflicts to disclose.