Immunology

The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.

The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.

In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.

The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.

Teva Pharmaceuticals is marketing the drug as Cinqair.

[email protected]

The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.

The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.

In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.

The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.

Teva Pharmaceuticals is marketing the drug as Cinqair.

[email protected]

The U.S. Food and Drug Administration has approved the use of reslizumab with other asthma medication for maintenance treatment in adult patients with a history of severe asthma attacks.

The drug is a humanized monoclonal antibody of the IgG4/K isotype, and reduces blood levels of eosinophils. The intravenously infused biologic must be administered in a clinical setting by a health professional who is prepared to manage anaphylaxis, according to a written statement from the FDA.

In December, the FDA’s Pulmonary-Allergy Drug Advisory Committee had recommended approval of the drug for use in 18- to 75-year-olds with inadequately controlled eosinophilic asthma, based on the results of phase III double-blind randomized, placebo-controlled trials in which the drug was administered every 4 weeks as an add-on asthma treatment. As compared with patients who received a placebo, patients who received the drug had fewer asthma attacks, had a later-onset first attack, and experienced a significant improvement in lung function based on measures of forced expiratory volume in 1 second.

The most common side effects of taking reslizumab experienced by patients in clinical trials included anaphylaxis, cancer, and muscle pain.

Teva Pharmaceuticals is marketing the drug as Cinqair.

[email protected]

LOS ANGELES – The interleukin-5 inhibitor reslizumab showed particularly strong efficacy in patients with severe eosinophilic asthma accompanied by chronic sinusitis and nasal polyps, as well as in patients age 65 and older, in separate analyses presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Both presentations were post hoc, pooled analyses of two published 52-week, double-blind, pivotal phase III randomized trials of IV reslizumab at 3.0 mg/kg or placebo every 4 weeks on top of standard background therapy. The trials included a combined total of close to 1,000 patients aged 12-75 years with baseline blood eosinophil counts of at least 400 cells/mcL and inadequately controlled asthma despite being on at least moderate-dose inhaled corticosteroids. The primary endpoint – frequency of clinical asthma exacerbations – was positive in both trials, with a reduction of 54% with reslizumab compared to placebo (Lancet Respir Med. 2015 May;3[5]:355-66).

Reslizumab is a humanized monoclonal antibody of the IgG4/K isotype. On the basis of the phase III trials and other data, last December the Food and Drug Administration’s Pulmonary-Allergy Drug Advisory Committee voted 11-3 to recommend approval of the biologic in 18- to 75-year-olds with inadequately controlled eosinophilic asthma. A decision by the federal agency is expected imminently.

The two post hoc analyses were conducted to highlight the biologic’s performance in clinically important but previously understudied patient subgroups, according to investigators.

Dr. Steven F. Weinstein compared 52-week outcomes in 250 patients with chronic sinusitis, including 150 who also had nasal polyps, in juxtaposition to the total two-study population of 953 eosinophilic asthma patients. Of note, aspirin sensitivity was present in 37% of those with chronic sinusitis with nasal polyps (CSwNP) compared to 11% of total participants in the two phase III trials. The CSwNP group had higher blood eosinophil levels, too: an average of 884 cells/mcL, compared with 655/mcL in the study population as a whole.

The frequency of clinical asthma exacerbations was 3.22 episodes in 52 weeks in CSwNP patients on placebo and 0.56 in those given reslizumab, for an 83% reduction in the active treatment arm. In the overall study population, the frequency was 1.81 episodes with placebo versus 0.84 with reslizumab, for a less robust but still highly significant 54% reduction. The reduction in exacerbations among all subjects with chronic sinusitis who received reslizumab was intermediate at 70%, going from 2.81 episodes in controls to 0.83 with biologic therapy.

Clinical asthma exacerbations were defined as the use of systemic steroids by patients not already on such medication or at least a twofold increase in doses of inhaled or systemic corticosteroids for at least 3 days.

The placebo-subtracted improvement in lung function from baseline to 52 weeks in reslizumab-treated patients was 326 mL in the CSwNP group, 235 mL in all patients with chronic sinusitis, and 109 mL in the overall study population, according to Dr. Weinstein, an allergist-immunologist practicing in Huntington Beach, Calif.

A 0.5-point improvement on the validated Asthma Quality of Life Questionnaire (AQLQ) is accepted by researchers as the minimum for demonstrating clinically significant benefit. The 52-week placebo-subtracted improvement on this measure was 0.69 points in the reslizumab-treated CSwNP group, 0.47 in the total cohort of asthmatics with chronic sinusitis, and 0.27 points in the overall reslizumab-treated population.

Similarly, the average placebo-subtracted improvement on the Asthma Control Questionnaire–6 was 1.45 points in reslizumab-treated patients with CSwNP, a sixfold greater response than seen in the total study population, Dr. Weinstein noted.

The same pattern of greater-than-average efficacy on both primary and secondary study endpoints was seen with reslizumab in the 77 patients aged 65 years and older included in the two phase III trials compared with those age 18-64, according to Dr. David Bernstein, professor of medicine and environmental health at the University of Cincinnati.

Although older patients made up only a small fraction of total subjects in the two trials, it was important to examine how reslizumab performed in such patients because asthma affects an estimated 7% of Americans age 65 and up, and rates of both asthma hospitalization and mortality are higher than in younger patients, he noted.

Older and younger asthma patients in the two trials had comparable baseline characteristics. Yet in the older cohort the reduction in frequency of asthma exacerbations with reslizumab as compared to placebo was 67%, while in the younger patients it was only 53%.

Improvements in symptoms and quality of life as measured on the AQLQ, the Asthma Control Questionnaire–7, and the Asthma Symptom Utility Index were consistently larger in the reslizumab-treated older as compared to younger patients. On all three measures, only the older reslizumab-treated group successfully hurdled the bar defining minimal clinically significant improvement.

The two post hoc analyses were funded by Teva Pharmaceuticals. Both investigators serve on advisory boards for Teva and multiple other pharmaceutical companies.

[email protected]

LOS ANGELES – The interleukin-5 inhibitor reslizumab showed particularly strong efficacy in patients with severe eosinophilic asthma accompanied by chronic sinusitis and nasal polyps, as well as in patients age 65 and older, in separate analyses presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Both presentations were post hoc, pooled analyses of two published 52-week, double-blind, pivotal phase III randomized trials of IV reslizumab at 3.0 mg/kg or placebo every 4 weeks on top of standard background therapy. The trials included a combined total of close to 1,000 patients aged 12-75 years with baseline blood eosinophil counts of at least 400 cells/mcL and inadequately controlled asthma despite being on at least moderate-dose inhaled corticosteroids. The primary endpoint – frequency of clinical asthma exacerbations – was positive in both trials, with a reduction of 54% with reslizumab compared to placebo (Lancet Respir Med. 2015 May;3[5]:355-66).

Reslizumab is a humanized monoclonal antibody of the IgG4/K isotype. On the basis of the phase III trials and other data, last December the Food and Drug Administration’s Pulmonary-Allergy Drug Advisory Committee voted 11-3 to recommend approval of the biologic in 18- to 75-year-olds with inadequately controlled eosinophilic asthma. A decision by the federal agency is expected imminently.

The two post hoc analyses were conducted to highlight the biologic’s performance in clinically important but previously understudied patient subgroups, according to investigators.

Dr. Steven F. Weinstein compared 52-week outcomes in 250 patients with chronic sinusitis, including 150 who also had nasal polyps, in juxtaposition to the total two-study population of 953 eosinophilic asthma patients. Of note, aspirin sensitivity was present in 37% of those with chronic sinusitis with nasal polyps (CSwNP) compared to 11% of total participants in the two phase III trials. The CSwNP group had higher blood eosinophil levels, too: an average of 884 cells/mcL, compared with 655/mcL in the study population as a whole.

The frequency of clinical asthma exacerbations was 3.22 episodes in 52 weeks in CSwNP patients on placebo and 0.56 in those given reslizumab, for an 83% reduction in the active treatment arm. In the overall study population, the frequency was 1.81 episodes with placebo versus 0.84 with reslizumab, for a less robust but still highly significant 54% reduction. The reduction in exacerbations among all subjects with chronic sinusitis who received reslizumab was intermediate at 70%, going from 2.81 episodes in controls to 0.83 with biologic therapy.

Clinical asthma exacerbations were defined as the use of systemic steroids by patients not already on such medication or at least a twofold increase in doses of inhaled or systemic corticosteroids for at least 3 days.

The placebo-subtracted improvement in lung function from baseline to 52 weeks in reslizumab-treated patients was 326 mL in the CSwNP group, 235 mL in all patients with chronic sinusitis, and 109 mL in the overall study population, according to Dr. Weinstein, an allergist-immunologist practicing in Huntington Beach, Calif.

A 0.5-point improvement on the validated Asthma Quality of Life Questionnaire (AQLQ) is accepted by researchers as the minimum for demonstrating clinically significant benefit. The 52-week placebo-subtracted improvement on this measure was 0.69 points in the reslizumab-treated CSwNP group, 0.47 in the total cohort of asthmatics with chronic sinusitis, and 0.27 points in the overall reslizumab-treated population.

Similarly, the average placebo-subtracted improvement on the Asthma Control Questionnaire–6 was 1.45 points in reslizumab-treated patients with CSwNP, a sixfold greater response than seen in the total study population, Dr. Weinstein noted.

The same pattern of greater-than-average efficacy on both primary and secondary study endpoints was seen with reslizumab in the 77 patients aged 65 years and older included in the two phase III trials compared with those age 18-64, according to Dr. David Bernstein, professor of medicine and environmental health at the University of Cincinnati.

Although older patients made up only a small fraction of total subjects in the two trials, it was important to examine how reslizumab performed in such patients because asthma affects an estimated 7% of Americans age 65 and up, and rates of both asthma hospitalization and mortality are higher than in younger patients, he noted.

Older and younger asthma patients in the two trials had comparable baseline characteristics. Yet in the older cohort the reduction in frequency of asthma exacerbations with reslizumab as compared to placebo was 67%, while in the younger patients it was only 53%.

Improvements in symptoms and quality of life as measured on the AQLQ, the Asthma Control Questionnaire–7, and the Asthma Symptom Utility Index were consistently larger in the reslizumab-treated older as compared to younger patients. On all three measures, only the older reslizumab-treated group successfully hurdled the bar defining minimal clinically significant improvement.

The two post hoc analyses were funded by Teva Pharmaceuticals. Both investigators serve on advisory boards for Teva and multiple other pharmaceutical companies.

[email protected]

LOS ANGELES – The interleukin-5 inhibitor reslizumab showed particularly strong efficacy in patients with severe eosinophilic asthma accompanied by chronic sinusitis and nasal polyps, as well as in patients age 65 and older, in separate analyses presented at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. Both presentations were post hoc, pooled analyses of two published 52-week, double-blind, pivotal phase III randomized trials of IV reslizumab at 3.0 mg/kg or placebo every 4 weeks on top of standard background therapy. The trials included a combined total of close to 1,000 patients aged 12-75 years with baseline blood eosinophil counts of at least 400 cells/mcL and inadequately controlled asthma despite being on at least moderate-dose inhaled corticosteroids. The primary endpoint – frequency of clinical asthma exacerbations – was positive in both trials, with a reduction of 54% with reslizumab compared to placebo (Lancet Respir Med. 2015 May;3[5]:355-66).

Reslizumab is a humanized monoclonal antibody of the IgG4/K isotype. On the basis of the phase III trials and other data, last December the Food and Drug Administration’s Pulmonary-Allergy Drug Advisory Committee voted 11-3 to recommend approval of the biologic in 18- to 75-year-olds with inadequately controlled eosinophilic asthma. A decision by the federal agency is expected imminently.

The two post hoc analyses were conducted to highlight the biologic’s performance in clinically important but previously understudied patient subgroups, according to investigators.

Dr. Steven F. Weinstein compared 52-week outcomes in 250 patients with chronic sinusitis, including 150 who also had nasal polyps, in juxtaposition to the total two-study population of 953 eosinophilic asthma patients. Of note, aspirin sensitivity was present in 37% of those with chronic sinusitis with nasal polyps (CSwNP) compared to 11% of total participants in the two phase III trials. The CSwNP group had higher blood eosinophil levels, too: an average of 884 cells/mcL, compared with 655/mcL in the study population as a whole.

The frequency of clinical asthma exacerbations was 3.22 episodes in 52 weeks in CSwNP patients on placebo and 0.56 in those given reslizumab, for an 83% reduction in the active treatment arm. In the overall study population, the frequency was 1.81 episodes with placebo versus 0.84 with reslizumab, for a less robust but still highly significant 54% reduction. The reduction in exacerbations among all subjects with chronic sinusitis who received reslizumab was intermediate at 70%, going from 2.81 episodes in controls to 0.83 with biologic therapy.

Clinical asthma exacerbations were defined as the use of systemic steroids by patients not already on such medication or at least a twofold increase in doses of inhaled or systemic corticosteroids for at least 3 days.

The placebo-subtracted improvement in lung function from baseline to 52 weeks in reslizumab-treated patients was 326 mL in the CSwNP group, 235 mL in all patients with chronic sinusitis, and 109 mL in the overall study population, according to Dr. Weinstein, an allergist-immunologist practicing in Huntington Beach, Calif.

A 0.5-point improvement on the validated Asthma Quality of Life Questionnaire (AQLQ) is accepted by researchers as the minimum for demonstrating clinically significant benefit. The 52-week placebo-subtracted improvement on this measure was 0.69 points in the reslizumab-treated CSwNP group, 0.47 in the total cohort of asthmatics with chronic sinusitis, and 0.27 points in the overall reslizumab-treated population.

Similarly, the average placebo-subtracted improvement on the Asthma Control Questionnaire–6 was 1.45 points in reslizumab-treated patients with CSwNP, a sixfold greater response than seen in the total study population, Dr. Weinstein noted.

The same pattern of greater-than-average efficacy on both primary and secondary study endpoints was seen with reslizumab in the 77 patients aged 65 years and older included in the two phase III trials compared with those age 18-64, according to Dr. David Bernstein, professor of medicine and environmental health at the University of Cincinnati.

Although older patients made up only a small fraction of total subjects in the two trials, it was important to examine how reslizumab performed in such patients because asthma affects an estimated 7% of Americans age 65 and up, and rates of both asthma hospitalization and mortality are higher than in younger patients, he noted.

Older and younger asthma patients in the two trials had comparable baseline characteristics. Yet in the older cohort the reduction in frequency of asthma exacerbations with reslizumab as compared to placebo was 67%, while in the younger patients it was only 53%.

Improvements in symptoms and quality of life as measured on the AQLQ, the Asthma Control Questionnaire–7, and the Asthma Symptom Utility Index were consistently larger in the reslizumab-treated older as compared to younger patients. On all three measures, only the older reslizumab-treated group successfully hurdled the bar defining minimal clinically significant improvement.

The two post hoc analyses were funded by Teva Pharmaceuticals. Both investigators serve on advisory boards for Teva and multiple other pharmaceutical companies.

[email protected]

LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.

“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.

Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.

At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).

About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.

Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.

The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.

Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.

The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.

The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.

The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.

The work was funded by the Australian government, among others. The investigators have no disclosures.

LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.

“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.

Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.

At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).

About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.

Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.

The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.

Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.

The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.

The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.

The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.

The work was funded by the Australian government, among others. The investigators have no disclosures.

LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.

“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.

Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.

At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).

About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.

Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.

The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.

Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.

The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.

The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.

The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.

The work was funded by the Australian government, among others. The investigators have no disclosures.

LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.

“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.

Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.

At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).

About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.

Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.

The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.

Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.

The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.

The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.

The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.

The work was funded by the Australian government, among others. The investigators have no disclosures.

LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.

“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.

Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.

At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).

About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.

Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.

The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.

Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.

The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.

The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.

The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.

The work was funded by the Australian government, among others. The investigators have no disclosures.

LOS ANGELES – Among infants at risk for allergic disease, egg introduction at 4 months cuts the risk of egg sensitization at 12 months by about half, according a randomized, placebo-controlled, double blind trial from Australia.

“This is what we hoped to find.” Introducing egg early “is certainly safe, and it may promote tolerance,” said senior investigator Dr. Dianne Campbell, professor and chair of pediatric allergy and clinical immunology at the Children’s Hospital at Westmead, which is affiliated with the University of Sydney.

Four-month-old children were randomized to 350 mg of pasteurized raw whole egg powder or – as a control – rice powder sprinkled once daily on their weaning food until month 8, at which time parents in both groups were encouraged to add eggs to their children’s diets. At least one of each child’s parents had a history of atopic disease, including asthma, eczema, hay fever, or food allergy. Even so, all of the infants had negative (less than 2 mm) skin prick tests (SPTs) at baseline. Compliance by parent diary was 89% in the rice and 81% in the egg groups.

At 12 months, SPTs were positive (3 mm or more) for whole egg in 25 of 122 (20%) children in the rice group, but only 13 of 122 (11%) in the egg group (odds ratio, 0.46; 95% confidence interval, 0.22-0.95; P = .03). Whole egg IgG4 and IgG4/IgE ratios to egg, ovalbumin, and ovomucoid were also higher in the egg group, indicating developing tolerance (P less than .0001 for each).

About 10% of the children originally in the egg group broke out in hives after their first few doses, and were withdrawn from the study. “This intervention may not be for everybody. There will be individuals who react” and it’s impossible, at this point, to predict who they will be. “We cannot prevent allergy in everyone,” said lead investigator Dr. John Tan, a pediatric immunologist at the hospital.

Overall, however, early introduction was safe. There was no anaphylaxis in the trial, and no cardiovascular or respiratory complications. Rates of eczema and peanut allergy were similar at 12 months between the two groups, meaning that early egg introduction did not increase the risk of atopy.

The findings echo results from several recent pediatric egg allergy studies, as well as findings from recent peanut trials. Slowly, it’s becoming clear that delaying the introduction of at least some allergenic foods – a common practice for years – doesn’t prevent allergies and may, in fact, promote them.

Despite those findings, there remains “a big disconnect between the [new] research and what we [still] recommend” in Australia, the United States, and elsewhere. Delaying food introductions was medical “dogma for 20 years, from highly esteemed societies,” and it corresponded with a marked increase in food allergies, but “it’s very hard to turn these things around,” Dr. Campbell said at the American Academy of Allergy, Asthma, and Immunology annual meeting.

The Australian government is reworking its infant feeding guidelines to incorporate the new evidence. “Our revised guidelines will say that there’s strong evidence for peanut and moderate evidence for egg” in favor of early introduction in children who are not sensitized by 4 or so months old, she said.

The trial was powered to detect differences in SPT, not actual egg allergies, which were diagnosed in 13 children (11%) in the rice group and eight (7%) in the egg group; the difference was not statistically significant. “Not all kids who are sensitized will be allergic,” she noted.

The study groups were well matched; there were about equal numbers of boys and girls in each, and, in both groups, about 15% of children were exposed to second hand smoke at home and almost all were breastfed.

The work was funded by the Australian government, among others. The investigators have no disclosures.

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

LOS ANGELES – Young asthmatic children on bronchodilator therapy may soon gain access to a novel albuterol multidose dry powder inhaler that’s already proved popular with teen and adult patients with reversible obstructive airway disease because of its ease of use.

A phase III randomized, double-blind multicenter trial of the albuterol multidose dry powder inhaler (MDPI) versus placebo in 184 asthmatic children aged 4-11 years not on systemic corticosteroids met its primary and secondary lung function endpoints, with safety and tolerability similar to placebo, Dr. Tushar P. Shah reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

jancin

The albuterol MDPI is already marketed by Teva Pharmaceuticals as the ProAir RespiClick in patients aged 12 and older. The purpose of this phase III clinical trial was to obtain an expanded indication in 4- to 11-year-olds. The company has submitted its request to the Food and Drug Administration and anticipates smooth sailing based upon the new data, according to Dr. Shah, senior vice president for global respiratory research and development at Teva in Frazer, Pa.

The albuterol MDPI fills an unmet need for a simplified approach to rescue medication, the allergist said in an interview.

“This is a breath-actuated inhaler. Many patients – especially kids – have a hard time coordinating a conventional multidose inhaler actuation with inhalation. They have trouble getting the timing right, so the drug doesn’t get to the distal lung. That’s why this albuterol MDPI has been very well received in adults. For kids, I think it’s going to be even better because this is a very simple and intuitive device. All they do is open the cap, inhale, [and] close the cap,” he explained.

tupungato/©Thinkstock

The young study participants used the albuterol MDPI at two inhalations four times daily, with a total daily albuterol dose of 720 mcg.

The primary study endpoint was the short-term improvement in lung function seen during testing performed after the very first study dose and again after the final dose of medication 3 weeks later. This was expressed as the area under the baseline-adjusted percent-predicted forced expiratory volume in 1 second effect-time curve from predose to 6 hours post dose. On both occasions, a sharp jump in opening of the airways was demonstrated within 5 minutes of dosing, with the effect remaining significantly better than with placebo for more than 2 hours.

Moreover, the maximum change from baseline in peak expiratory flow rate seen within 2 hours after dosing was a 26% increase with the albuterol MDPI, a significantly better result than the 14% increase with placebo.

No adverse events attributable to the study drug were seen.

The study was sponsored by Teva Pharmaceuticals. The presenter is a senior company employee.

LOS ANGELES – A sublingual immunotherapy tablet for house dust mite–induced allergic rhinitis achieved clinically meaningful improvement in symptoms along with less use of rescue medications and a favorable safety profile in a pivotal phase III trial, Dr. Hendrik Nolte reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The double-blind, 52-week randomized trial included 1,482 North American adults and adolescents.

“This was the largest clinical trial ever conducted with sublingual therapy in North America, and the first successful North American trial of a house dust mite sublingual immunotherapy tablet. It confirms results from previous large European trials,” noted Dr. Nolte of Merck, which is collaborating with the Danish company ALK in developing this therapy.

The sublingual immunotherapy (SLIT) tablet, known for now as the 12 SQ HDM SLIT-tablet, has been approved by European regulatory authorities for treatment of adults with house dust mite (HDM) allergic rhinitis or HDM allergic asthma. Based upon the positive findings in the phase III U.S. trial, Merck applied in February 2016 to the U.S. Food and Drug Administration for approval of the tablet as a biologic agent in patients aged 12 years or older.

HDM is the most common indoor allergen in the world. Unlike pollen and ragweed allergies, it’s not a seasonal problem. Moreover, HDM-induced allergic rhinitis is associated with increased risk of asthma. Although HDM allergic rhinitis can be treated symptomatically with oral antihistamines and nasal steroids, allergy immunotherapy has the appeal of addressing the underlying disease mechanism and potentially altering the long-term course. SLIT using a highly standardized HDM allergen extract offers a major advantage over traditional allergy immunotherapy via a lengthy program of subcutaneous injections – namely, the convenience of home self-administration.

The primary endpoint in the U.S. pivotal trial was the total combined rhinitis score (TCRS), which is the sum of the daily rhinitis symptom score and the daily rescue medication usage score averaged over the last 8 weeks of the year-long study. The FDA has set the bar for establishing clinically meaningful improvement: it requires demonstration of a reduction in the TCRS of at least 15%, compared with placebo. The 12 SQ HDM SLIT-tablet trial exceeded this standard, achieving a 17% reduction. The study also met its key prespecified secondary endpoints, including a 16% reduction in the daily rhinosinusitis symptom score and an 18% decrease in the daily medication score, compared with placebo.

©Eraxion/Thinkstock

Participants in the trial had a mean 18-year history of allergic rhinitis with or without conjunctivitis. Seventy-five percent of them were sensitized to other common allergens in addition to HDM, and 31% of subjects had comorbid asthma. The HDM SLIT therapy was equally effective in asthmatics and nonasthmatics, in patients allergic only to HDM and those who were polysensitized, and in subjects with and without conjunctivitis, according to Dr. Nolte.

There were no serious adverse events related to the 12 SQ HDM SLIT-tablet. A total of 9.8% of patients discontinued SLIT because of treatment-emergent adverse events, chiefly mild-to-moderate throat irritation, mouth swelling, or itchiness of the mouth or ears.

“Importantly, these events were very transient. They occurred typically within the first 8 days and lasted 14-67 hours, with a median 1-day duration of rescue medication,” he said.

Symptomatic improvement was typically seen beginning at 8-12 weeks. Adults were free to take the once-daily tablet anytime during the day. The pediatric patients were advised not to do so in the morning because they wouldn’t be under observation while on a school bus.

The tablet is based upon a formulation of allergen extracts from the two major species of HDM: Dermatophagoides pterornyssinus and D. farinae. More than 90% of HDM-sensitized patients are sensitized to both. A highly standardized manufacturing process ensures that the tablet contains 50 mcg of the four major HDM allergens in equal ratio – Der f1, Der p2, Der p1, and Der f 2 – plus other components.

In response to audience questions, Dr. Nolte said the company had tried incorporating an antihistamine into the tablet to block adverse reactions but it didn’t work. Adverse events typically occur within a couple of minutes after taking the tablet, and antihistamines are far too slow-acting to help.

“You can premedicate with antihistamines. We know European investigators and clinicians who are doing it. But I would not recommend it personally, because these tablets are taken at home after the first administration in the office, and I think it’s important that the patient has a good feel for what happens over the following days. There is a potential risk of masking side effects with premedication, which could be a concern,” Dr. Nolte said.

Merck already has two FDA-approved SLIT tablets developed with ALK on the U.S. market: Grastek, for treatment of grass pollen–induced allergic rhinitis in children and adults, and Ragwitek, for ragweed-induced allergic disease in adults.

The trial was sponsored by Merck and presented by a full-time company employee.

LOS ANGELES – A sublingual immunotherapy tablet for house dust mite–induced allergic rhinitis achieved clinically meaningful improvement in symptoms along with less use of rescue medications and a favorable safety profile in a pivotal phase III trial, Dr. Hendrik Nolte reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The double-blind, 52-week randomized trial included 1,482 North American adults and adolescents.

“This was the largest clinical trial ever conducted with sublingual therapy in North America, and the first successful North American trial of a house dust mite sublingual immunotherapy tablet. It confirms results from previous large European trials,” noted Dr. Nolte of Merck, which is collaborating with the Danish company ALK in developing this therapy.

The sublingual immunotherapy (SLIT) tablet, known for now as the 12 SQ HDM SLIT-tablet, has been approved by European regulatory authorities for treatment of adults with house dust mite (HDM) allergic rhinitis or HDM allergic asthma. Based upon the positive findings in the phase III U.S. trial, Merck applied in February 2016 to the U.S. Food and Drug Administration for approval of the tablet as a biologic agent in patients aged 12 years or older.

HDM is the most common indoor allergen in the world. Unlike pollen and ragweed allergies, it’s not a seasonal problem. Moreover, HDM-induced allergic rhinitis is associated with increased risk of asthma. Although HDM allergic rhinitis can be treated symptomatically with oral antihistamines and nasal steroids, allergy immunotherapy has the appeal of addressing the underlying disease mechanism and potentially altering the long-term course. SLIT using a highly standardized HDM allergen extract offers a major advantage over traditional allergy immunotherapy via a lengthy program of subcutaneous injections – namely, the convenience of home self-administration.

The primary endpoint in the U.S. pivotal trial was the total combined rhinitis score (TCRS), which is the sum of the daily rhinitis symptom score and the daily rescue medication usage score averaged over the last 8 weeks of the year-long study. The FDA has set the bar for establishing clinically meaningful improvement: it requires demonstration of a reduction in the TCRS of at least 15%, compared with placebo. The 12 SQ HDM SLIT-tablet trial exceeded this standard, achieving a 17% reduction. The study also met its key prespecified secondary endpoints, including a 16% reduction in the daily rhinosinusitis symptom score and an 18% decrease in the daily medication score, compared with placebo.

©Eraxion/Thinkstock

Participants in the trial had a mean 18-year history of allergic rhinitis with or without conjunctivitis. Seventy-five percent of them were sensitized to other common allergens in addition to HDM, and 31% of subjects had comorbid asthma. The HDM SLIT therapy was equally effective in asthmatics and nonasthmatics, in patients allergic only to HDM and those who were polysensitized, and in subjects with and without conjunctivitis, according to Dr. Nolte.

There were no serious adverse events related to the 12 SQ HDM SLIT-tablet. A total of 9.8% of patients discontinued SLIT because of treatment-emergent adverse events, chiefly mild-to-moderate throat irritation, mouth swelling, or itchiness of the mouth or ears.

“Importantly, these events were very transient. They occurred typically within the first 8 days and lasted 14-67 hours, with a median 1-day duration of rescue medication,” he said.

Symptomatic improvement was typically seen beginning at 8-12 weeks. Adults were free to take the once-daily tablet anytime during the day. The pediatric patients were advised not to do so in the morning because they wouldn’t be under observation while on a school bus.

The tablet is based upon a formulation of allergen extracts from the two major species of HDM: Dermatophagoides pterornyssinus and D. farinae. More than 90% of HDM-sensitized patients are sensitized to both. A highly standardized manufacturing process ensures that the tablet contains 50 mcg of the four major HDM allergens in equal ratio – Der f1, Der p2, Der p1, and Der f 2 – plus other components.

In response to audience questions, Dr. Nolte said the company had tried incorporating an antihistamine into the tablet to block adverse reactions but it didn’t work. Adverse events typically occur within a couple of minutes after taking the tablet, and antihistamines are far too slow-acting to help.

“You can premedicate with antihistamines. We know European investigators and clinicians who are doing it. But I would not recommend it personally, because these tablets are taken at home after the first administration in the office, and I think it’s important that the patient has a good feel for what happens over the following days. There is a potential risk of masking side effects with premedication, which could be a concern,” Dr. Nolte said.

Merck already has two FDA-approved SLIT tablets developed with ALK on the U.S. market: Grastek, for treatment of grass pollen–induced allergic rhinitis in children and adults, and Ragwitek, for ragweed-induced allergic disease in adults.

The trial was sponsored by Merck and presented by a full-time company employee.

LOS ANGELES – A sublingual immunotherapy tablet for house dust mite–induced allergic rhinitis achieved clinically meaningful improvement in symptoms along with less use of rescue medications and a favorable safety profile in a pivotal phase III trial, Dr. Hendrik Nolte reported at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

The double-blind, 52-week randomized trial included 1,482 North American adults and adolescents.

“This was the largest clinical trial ever conducted with sublingual therapy in North America, and the first successful North American trial of a house dust mite sublingual immunotherapy tablet. It confirms results from previous large European trials,” noted Dr. Nolte of Merck, which is collaborating with the Danish company ALK in developing this therapy.

The sublingual immunotherapy (SLIT) tablet, known for now as the 12 SQ HDM SLIT-tablet, has been approved by European regulatory authorities for treatment of adults with house dust mite (HDM) allergic rhinitis or HDM allergic asthma. Based upon the positive findings in the phase III U.S. trial, Merck applied in February 2016 to the U.S. Food and Drug Administration for approval of the tablet as a biologic agent in patients aged 12 years or older.

HDM is the most common indoor allergen in the world. Unlike pollen and ragweed allergies, it’s not a seasonal problem. Moreover, HDM-induced allergic rhinitis is associated with increased risk of asthma. Although HDM allergic rhinitis can be treated symptomatically with oral antihistamines and nasal steroids, allergy immunotherapy has the appeal of addressing the underlying disease mechanism and potentially altering the long-term course. SLIT using a highly standardized HDM allergen extract offers a major advantage over traditional allergy immunotherapy via a lengthy program of subcutaneous injections – namely, the convenience of home self-administration.

The primary endpoint in the U.S. pivotal trial was the total combined rhinitis score (TCRS), which is the sum of the daily rhinitis symptom score and the daily rescue medication usage score averaged over the last 8 weeks of the year-long study. The FDA has set the bar for establishing clinically meaningful improvement: it requires demonstration of a reduction in the TCRS of at least 15%, compared with placebo. The 12 SQ HDM SLIT-tablet trial exceeded this standard, achieving a 17% reduction. The study also met its key prespecified secondary endpoints, including a 16% reduction in the daily rhinosinusitis symptom score and an 18% decrease in the daily medication score, compared with placebo.

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Participants in the trial had a mean 18-year history of allergic rhinitis with or without conjunctivitis. Seventy-five percent of them were sensitized to other common allergens in addition to HDM, and 31% of subjects had comorbid asthma. The HDM SLIT therapy was equally effective in asthmatics and nonasthmatics, in patients allergic only to HDM and those who were polysensitized, and in subjects with and without conjunctivitis, according to Dr. Nolte.

There were no serious adverse events related to the 12 SQ HDM SLIT-tablet. A total of 9.8% of patients discontinued SLIT because of treatment-emergent adverse events, chiefly mild-to-moderate throat irritation, mouth swelling, or itchiness of the mouth or ears.

“Importantly, these events were very transient. They occurred typically within the first 8 days and lasted 14-67 hours, with a median 1-day duration of rescue medication,” he said.

Symptomatic improvement was typically seen beginning at 8-12 weeks. Adults were free to take the once-daily tablet anytime during the day. The pediatric patients were advised not to do so in the morning because they wouldn’t be under observation while on a school bus.

The tablet is based upon a formulation of allergen extracts from the two major species of HDM: Dermatophagoides pterornyssinus and D. farinae. More than 90% of HDM-sensitized patients are sensitized to both. A highly standardized manufacturing process ensures that the tablet contains 50 mcg of the four major HDM allergens in equal ratio – Der f1, Der p2, Der p1, and Der f 2 – plus other components.

In response to audience questions, Dr. Nolte said the company had tried incorporating an antihistamine into the tablet to block adverse reactions but it didn’t work. Adverse events typically occur within a couple of minutes after taking the tablet, and antihistamines are far too slow-acting to help.

“You can premedicate with antihistamines. We know European investigators and clinicians who are doing it. But I would not recommend it personally, because these tablets are taken at home after the first administration in the office, and I think it’s important that the patient has a good feel for what happens over the following days. There is a potential risk of masking side effects with premedication, which could be a concern,” Dr. Nolte said.

Merck already has two FDA-approved SLIT tablets developed with ALK on the U.S. market: Grastek, for treatment of grass pollen–induced allergic rhinitis in children and adults, and Ragwitek, for ragweed-induced allergic disease in adults.

The trial was sponsored by Merck and presented by a full-time company employee.