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Novel oral immunotherapy increased peanut tolerance in children, adults
ORLANDO – compared with those receiving placebo, according to research results.
Stacie M. Jones, MD, of the University of Arkansas and Arkansas Children’s Hospital, Little Rock, presented the late-breaking results from the pivotal PALISADE trial at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization, in which Dr. Jones and her colleagues sought to examine the safety and efficacy of the novel oral immunotherapy AR101 for patients with peanut allergy.
At 12 months, 67% of patients who received AR101 tolerated 600 mg or more of peanut protein, compared with 4% of control patients (P less than .00001). The tolerance benefit for AR101 appeared to continue when the researchers evaluated 1,000 mg of peanut protein. A dose of 1,000 mg or more was tolerated by 50% of patients in the AR101 group, compared with 2.4% of patients in the control group (P less than .00001).
“Tolerance at 600 mg should indicate, not prove, but indicate that this therapy should be able to provide protection for the vast majority of individuals treated,” Dr. Jones said in an interview.
The majority of patients in the study experienced an adverse event; however, those who received AR101 experienced more events, and more events that were considered serious, she said. Patients in the treatment arm also experienced more treatment-related hypersensitivity, compared with patients in the placebo arm (14.5% vs. 3.2%), nearly all of which were mild to moderate.
It is important to note two key safety outcomes regarding AR101, Dr. Jones said. First, that one patient was diagnosed with eosinophilic esophagitis (EoE) during the study. “EoE has been a recurring theme with oral immunotherapy. Previous data showed EoE diagnoses in as many as 2%-5% of patients, and although one is certainly less than that, it is still important.”
Secondly, she pointed out that 6.7% of patients in the treatment group withdrew as a result of gastrointestinal adverse events. “This is a lower percentage than previously published data, but I don’t think you can understate this safety concern,” Dr. Jones said.
The efficacy of AR101 has prompted energy and hope for children with a peanut allergy. In the weeks following her presentation at AAAAI/WAO, Dr. Jones said she has been inundated with emails and calls from allergists asking for these data. However, she called for caution and patience, saying that it is important for the therapy to clear the appropriate steps in the process.
“This should not change clinical care that much in the next 12-18 months,” Dr. Jones said. “But it is very hopeful that this will be a new therapy on the market.”
The PALISADE trial was funded by Aimmune Therapeutics, and Dr. Jones reported holding an advisory board position for Aimmune Therapeutics, as well as having received other forms of support from biotech, pharmaceutical, and governmental organizations.
SOURCE: Jones SM et al. AAAAI/WAO Joint Congress, Abstract L6.
ORLANDO – compared with those receiving placebo, according to research results.
Stacie M. Jones, MD, of the University of Arkansas and Arkansas Children’s Hospital, Little Rock, presented the late-breaking results from the pivotal PALISADE trial at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization, in which Dr. Jones and her colleagues sought to examine the safety and efficacy of the novel oral immunotherapy AR101 for patients with peanut allergy.
At 12 months, 67% of patients who received AR101 tolerated 600 mg or more of peanut protein, compared with 4% of control patients (P less than .00001). The tolerance benefit for AR101 appeared to continue when the researchers evaluated 1,000 mg of peanut protein. A dose of 1,000 mg or more was tolerated by 50% of patients in the AR101 group, compared with 2.4% of patients in the control group (P less than .00001).
“Tolerance at 600 mg should indicate, not prove, but indicate that this therapy should be able to provide protection for the vast majority of individuals treated,” Dr. Jones said in an interview.
The majority of patients in the study experienced an adverse event; however, those who received AR101 experienced more events, and more events that were considered serious, she said. Patients in the treatment arm also experienced more treatment-related hypersensitivity, compared with patients in the placebo arm (14.5% vs. 3.2%), nearly all of which were mild to moderate.
It is important to note two key safety outcomes regarding AR101, Dr. Jones said. First, that one patient was diagnosed with eosinophilic esophagitis (EoE) during the study. “EoE has been a recurring theme with oral immunotherapy. Previous data showed EoE diagnoses in as many as 2%-5% of patients, and although one is certainly less than that, it is still important.”
Secondly, she pointed out that 6.7% of patients in the treatment group withdrew as a result of gastrointestinal adverse events. “This is a lower percentage than previously published data, but I don’t think you can understate this safety concern,” Dr. Jones said.
The efficacy of AR101 has prompted energy and hope for children with a peanut allergy. In the weeks following her presentation at AAAAI/WAO, Dr. Jones said she has been inundated with emails and calls from allergists asking for these data. However, she called for caution and patience, saying that it is important for the therapy to clear the appropriate steps in the process.
“This should not change clinical care that much in the next 12-18 months,” Dr. Jones said. “But it is very hopeful that this will be a new therapy on the market.”
The PALISADE trial was funded by Aimmune Therapeutics, and Dr. Jones reported holding an advisory board position for Aimmune Therapeutics, as well as having received other forms of support from biotech, pharmaceutical, and governmental organizations.
SOURCE: Jones SM et al. AAAAI/WAO Joint Congress, Abstract L6.
ORLANDO – compared with those receiving placebo, according to research results.
Stacie M. Jones, MD, of the University of Arkansas and Arkansas Children’s Hospital, Little Rock, presented the late-breaking results from the pivotal PALISADE trial at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization, in which Dr. Jones and her colleagues sought to examine the safety and efficacy of the novel oral immunotherapy AR101 for patients with peanut allergy.
At 12 months, 67% of patients who received AR101 tolerated 600 mg or more of peanut protein, compared with 4% of control patients (P less than .00001). The tolerance benefit for AR101 appeared to continue when the researchers evaluated 1,000 mg of peanut protein. A dose of 1,000 mg or more was tolerated by 50% of patients in the AR101 group, compared with 2.4% of patients in the control group (P less than .00001).
“Tolerance at 600 mg should indicate, not prove, but indicate that this therapy should be able to provide protection for the vast majority of individuals treated,” Dr. Jones said in an interview.
The majority of patients in the study experienced an adverse event; however, those who received AR101 experienced more events, and more events that were considered serious, she said. Patients in the treatment arm also experienced more treatment-related hypersensitivity, compared with patients in the placebo arm (14.5% vs. 3.2%), nearly all of which were mild to moderate.
It is important to note two key safety outcomes regarding AR101, Dr. Jones said. First, that one patient was diagnosed with eosinophilic esophagitis (EoE) during the study. “EoE has been a recurring theme with oral immunotherapy. Previous data showed EoE diagnoses in as many as 2%-5% of patients, and although one is certainly less than that, it is still important.”
Secondly, she pointed out that 6.7% of patients in the treatment group withdrew as a result of gastrointestinal adverse events. “This is a lower percentage than previously published data, but I don’t think you can understate this safety concern,” Dr. Jones said.
The efficacy of AR101 has prompted energy and hope for children with a peanut allergy. In the weeks following her presentation at AAAAI/WAO, Dr. Jones said she has been inundated with emails and calls from allergists asking for these data. However, she called for caution and patience, saying that it is important for the therapy to clear the appropriate steps in the process.
“This should not change clinical care that much in the next 12-18 months,” Dr. Jones said. “But it is very hopeful that this will be a new therapy on the market.”
The PALISADE trial was funded by Aimmune Therapeutics, and Dr. Jones reported holding an advisory board position for Aimmune Therapeutics, as well as having received other forms of support from biotech, pharmaceutical, and governmental organizations.
SOURCE: Jones SM et al. AAAAI/WAO Joint Congress, Abstract L6.
FROM AAAAI/WAO JOINT CONGRESS 2018
Key clinical point: A novel oral immunotherapy significantly improved peanut tolerance in children and adults with peanut allergy.
Major finding: Two-thirds of patients who received AR101 tolerated 600 mg or more of peanut protein, compared with 4% of patients who did not receive the novel oral immunotherapy.
Data source: The randomized, phase 3, double-blind, placebo-controlled PALISADE trial.
Disclosures: The study was funded by Aimmune Therapeutics. Dr. Jones reported holding an advisory board position with Aimmune Therapeutics.
Source: Jones SM et al. AAAAI/WAO Joint Congress, Abstract L6.
Omalizumab may help with chemotherapy hypersensitivity
ORLANDO – Omalizumab increased reaction-free rapid drug desensitization for patients with hypersensitivity to chemotherapy, according to research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
“In about 99% of patients, a desensitization protocol will be effective enough to allow patients to receive the relevant chemotherapy treatment,” Dr. Hong said in an interview. “However, in a small minority of patents, no matter what we try, we simply cannot desensitize them – those are the patients we looked at in this study.”
Patients received 300 mg of omalizumab every 4 weeks for three treatment sessions. During the 12-week treatment period, patients continued their normal chemotherapy regimens via rapid drug desensitization following protocols previously published by Castelles et al.
The primary outcome was the number of rapid drug desensitizations that were free from hypersensitivity reactions. In a secondary analysis, the researchers compared results of chemotherapy skin tests taken before and after the trial.
Of the five patients included in the study, four were female, received carboplatin, and had a skin tests, while the fifth patient was male, received rituximab, and did not receive a skin test.
In an intention-to-treat approach, Dr. Hong and his colleagues reported that 33% of all rapid drug desensitizations for omalizumab had no reaction.
In the poster, the researchers noted that these data could be significant because the 95% confidence interval for nonreactivity on omalizumab ranged from 11% to 98%.
“This is a unique situation,” Dr. Hong said in an interview. Because ovarian cancer diagnoses tend to come later in the disease course, patients often can receive extended chemotherapy regimens to treat disease metastases.
He speculated that there could be more uses for omalizumab. “In this study, we looked at the most sensitive patients, but perhaps this drug could have a significant impact on patients with a more mild form of sensitivity,” Dr. Hong said. “Maybe [omalizumab] could take the place of desensitization for patients with a milder sensitivity – we don’t know.”
Dr. Hong reports no relevant financial disclosures. Novartis Pharmaceuticals funded this research and provided omalizumab.
SOURCE: Hong DI et al. AAAAI/WAO Joint Congress, Poster L33.
ORLANDO – Omalizumab increased reaction-free rapid drug desensitization for patients with hypersensitivity to chemotherapy, according to research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
“In about 99% of patients, a desensitization protocol will be effective enough to allow patients to receive the relevant chemotherapy treatment,” Dr. Hong said in an interview. “However, in a small minority of patents, no matter what we try, we simply cannot desensitize them – those are the patients we looked at in this study.”
Patients received 300 mg of omalizumab every 4 weeks for three treatment sessions. During the 12-week treatment period, patients continued their normal chemotherapy regimens via rapid drug desensitization following protocols previously published by Castelles et al.
The primary outcome was the number of rapid drug desensitizations that were free from hypersensitivity reactions. In a secondary analysis, the researchers compared results of chemotherapy skin tests taken before and after the trial.
Of the five patients included in the study, four were female, received carboplatin, and had a skin tests, while the fifth patient was male, received rituximab, and did not receive a skin test.
In an intention-to-treat approach, Dr. Hong and his colleagues reported that 33% of all rapid drug desensitizations for omalizumab had no reaction.
In the poster, the researchers noted that these data could be significant because the 95% confidence interval for nonreactivity on omalizumab ranged from 11% to 98%.
“This is a unique situation,” Dr. Hong said in an interview. Because ovarian cancer diagnoses tend to come later in the disease course, patients often can receive extended chemotherapy regimens to treat disease metastases.
He speculated that there could be more uses for omalizumab. “In this study, we looked at the most sensitive patients, but perhaps this drug could have a significant impact on patients with a more mild form of sensitivity,” Dr. Hong said. “Maybe [omalizumab] could take the place of desensitization for patients with a milder sensitivity – we don’t know.”
Dr. Hong reports no relevant financial disclosures. Novartis Pharmaceuticals funded this research and provided omalizumab.
SOURCE: Hong DI et al. AAAAI/WAO Joint Congress, Poster L33.
ORLANDO – Omalizumab increased reaction-free rapid drug desensitization for patients with hypersensitivity to chemotherapy, according to research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
“In about 99% of patients, a desensitization protocol will be effective enough to allow patients to receive the relevant chemotherapy treatment,” Dr. Hong said in an interview. “However, in a small minority of patents, no matter what we try, we simply cannot desensitize them – those are the patients we looked at in this study.”
Patients received 300 mg of omalizumab every 4 weeks for three treatment sessions. During the 12-week treatment period, patients continued their normal chemotherapy regimens via rapid drug desensitization following protocols previously published by Castelles et al.
The primary outcome was the number of rapid drug desensitizations that were free from hypersensitivity reactions. In a secondary analysis, the researchers compared results of chemotherapy skin tests taken before and after the trial.
Of the five patients included in the study, four were female, received carboplatin, and had a skin tests, while the fifth patient was male, received rituximab, and did not receive a skin test.
In an intention-to-treat approach, Dr. Hong and his colleagues reported that 33% of all rapid drug desensitizations for omalizumab had no reaction.
In the poster, the researchers noted that these data could be significant because the 95% confidence interval for nonreactivity on omalizumab ranged from 11% to 98%.
“This is a unique situation,” Dr. Hong said in an interview. Because ovarian cancer diagnoses tend to come later in the disease course, patients often can receive extended chemotherapy regimens to treat disease metastases.
He speculated that there could be more uses for omalizumab. “In this study, we looked at the most sensitive patients, but perhaps this drug could have a significant impact on patients with a more mild form of sensitivity,” Dr. Hong said. “Maybe [omalizumab] could take the place of desensitization for patients with a milder sensitivity – we don’t know.”
Dr. Hong reports no relevant financial disclosures. Novartis Pharmaceuticals funded this research and provided omalizumab.
SOURCE: Hong DI et al. AAAAI/WAO Joint Congress, Poster L33.
REPORTING FROM AAAAI/WAO JOINT CONGRESS
Key clinical point: Omalizumab increased reaction-free rapid drug desensitization for patients with hypersensitivity to chemotherapy.
Major finding: Despite low enrollment, omalizumab appeared to significantly increase the number of reaction-free rapid drug desensitizations.
Data source: A 12-week, open-label, non-randomized trial of omalizumab.
Disclosures: Dr. Hong reports no relevant financial disclosures. Novartis Pharmaceuticals funded the research and provided omalizumab.
Source: Hong DI et al. AAAAI/WAO Joint Congress, Poster L33.
Switch to mepolizumab safe in eosinophilic asthma
ORLANDO – Switching to mepolizumab resulted in a clinically significant benefit and a reduction in exacerbations for patients with severe eosinophilic asthma, according to late-breaking research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
Frank C. Albers, MD, PhD, of GlaxoSmithKline in Chapel Hill, N.C., and his colleagues examined safety and efficacy outcomes for 145 patients aged 12 years or older with severe eosinophilic asthma (SEA) that was not well-controlled with omalizumab.
“You see similar research in oncology where, if a patient doesn’t respond, you want to try a switch,” Dr. Albers said in an interview. “The key is deciphering which patients would benefit from a switch.”
The researchers discontinued omalizumab at baseline and treated patients with 100 mg of mepolizumab every 4 weeks for 28 weeks and observed patients for 4 more weeks following last treatment. They examined Asthma Control Questionnaire-5 and St. George’s Respiratory Questionnaire results. In a secondary analysis, the researchers also compared their results with placebo-arm data from previously published research.
At 32 weeks, the least squares mean ACQ-5 score changed by -1.45 (+/- 0.107) points and the SGRQ scores changed by -19.0 (+/- 1.64) points.
“But you also see that the improvement seems steady.”
At 4 weeks, 57% of patients experienced a minimum clinically important difference in ACQ-5 score and at 12 weeks, 69% of patients experienced a minimum clinically important difference in SGRQ response. At 32 weeks, minimum clinically important difference ACQ-5 and SGRQ scores were reported for 77% and 79% of patients, respectively.
Dr. Albers and his colleagues also analyzed how these results might look in a randomized phase 3 setting by comparing their results to previously reported data from the MENSA (mepolizumab treatment in patients with severe eosinophilic asthma) and epolizumab for severe eosinophilic asthma) DREAM studies. They reported that compared with the previously reported placebo cohorts, patients who switched to mepolizumab experienced an ACQ-5 score improvement of -0.90 (P less than 0.001).
The researchers presented safety results in an accompanying poster and reported a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations for patients with SAE who switched to mepolizumab. They also reported a 69% (P less than 0.001) reduction in exacerbations that required ED visits and/or hospitalizations.
“This study provides practical reassurance to clinicians considering substituting one biologic for another in the treatment of patients with SEA,” the researchers concluded.
This research was funded by GlaxoSmithKline, the makers of mepolizumab.
SOURCE: Albers FC et al. AAAAI/WAO Joint Congress, Posters L29 and L30.
http://www.jacionline.org/article/S0091-6749(17)32864-6/abstract
ORLANDO – Switching to mepolizumab resulted in a clinically significant benefit and a reduction in exacerbations for patients with severe eosinophilic asthma, according to late-breaking research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
Frank C. Albers, MD, PhD, of GlaxoSmithKline in Chapel Hill, N.C., and his colleagues examined safety and efficacy outcomes for 145 patients aged 12 years or older with severe eosinophilic asthma (SEA) that was not well-controlled with omalizumab.
“You see similar research in oncology where, if a patient doesn’t respond, you want to try a switch,” Dr. Albers said in an interview. “The key is deciphering which patients would benefit from a switch.”
The researchers discontinued omalizumab at baseline and treated patients with 100 mg of mepolizumab every 4 weeks for 28 weeks and observed patients for 4 more weeks following last treatment. They examined Asthma Control Questionnaire-5 and St. George’s Respiratory Questionnaire results. In a secondary analysis, the researchers also compared their results with placebo-arm data from previously published research.
At 32 weeks, the least squares mean ACQ-5 score changed by -1.45 (+/- 0.107) points and the SGRQ scores changed by -19.0 (+/- 1.64) points.
“But you also see that the improvement seems steady.”
At 4 weeks, 57% of patients experienced a minimum clinically important difference in ACQ-5 score and at 12 weeks, 69% of patients experienced a minimum clinically important difference in SGRQ response. At 32 weeks, minimum clinically important difference ACQ-5 and SGRQ scores were reported for 77% and 79% of patients, respectively.
Dr. Albers and his colleagues also analyzed how these results might look in a randomized phase 3 setting by comparing their results to previously reported data from the MENSA (mepolizumab treatment in patients with severe eosinophilic asthma) and epolizumab for severe eosinophilic asthma) DREAM studies. They reported that compared with the previously reported placebo cohorts, patients who switched to mepolizumab experienced an ACQ-5 score improvement of -0.90 (P less than 0.001).
The researchers presented safety results in an accompanying poster and reported a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations for patients with SAE who switched to mepolizumab. They also reported a 69% (P less than 0.001) reduction in exacerbations that required ED visits and/or hospitalizations.
“This study provides practical reassurance to clinicians considering substituting one biologic for another in the treatment of patients with SEA,” the researchers concluded.
This research was funded by GlaxoSmithKline, the makers of mepolizumab.
SOURCE: Albers FC et al. AAAAI/WAO Joint Congress, Posters L29 and L30.
http://www.jacionline.org/article/S0091-6749(17)32864-6/abstract
ORLANDO – Switching to mepolizumab resulted in a clinically significant benefit and a reduction in exacerbations for patients with severe eosinophilic asthma, according to late-breaking research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
Frank C. Albers, MD, PhD, of GlaxoSmithKline in Chapel Hill, N.C., and his colleagues examined safety and efficacy outcomes for 145 patients aged 12 years or older with severe eosinophilic asthma (SEA) that was not well-controlled with omalizumab.
“You see similar research in oncology where, if a patient doesn’t respond, you want to try a switch,” Dr. Albers said in an interview. “The key is deciphering which patients would benefit from a switch.”
The researchers discontinued omalizumab at baseline and treated patients with 100 mg of mepolizumab every 4 weeks for 28 weeks and observed patients for 4 more weeks following last treatment. They examined Asthma Control Questionnaire-5 and St. George’s Respiratory Questionnaire results. In a secondary analysis, the researchers also compared their results with placebo-arm data from previously published research.
At 32 weeks, the least squares mean ACQ-5 score changed by -1.45 (+/- 0.107) points and the SGRQ scores changed by -19.0 (+/- 1.64) points.
“But you also see that the improvement seems steady.”
At 4 weeks, 57% of patients experienced a minimum clinically important difference in ACQ-5 score and at 12 weeks, 69% of patients experienced a minimum clinically important difference in SGRQ response. At 32 weeks, minimum clinically important difference ACQ-5 and SGRQ scores were reported for 77% and 79% of patients, respectively.
Dr. Albers and his colleagues also analyzed how these results might look in a randomized phase 3 setting by comparing their results to previously reported data from the MENSA (mepolizumab treatment in patients with severe eosinophilic asthma) and epolizumab for severe eosinophilic asthma) DREAM studies. They reported that compared with the previously reported placebo cohorts, patients who switched to mepolizumab experienced an ACQ-5 score improvement of -0.90 (P less than 0.001).
The researchers presented safety results in an accompanying poster and reported a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations for patients with SAE who switched to mepolizumab. They also reported a 69% (P less than 0.001) reduction in exacerbations that required ED visits and/or hospitalizations.
“This study provides practical reassurance to clinicians considering substituting one biologic for another in the treatment of patients with SEA,” the researchers concluded.
This research was funded by GlaxoSmithKline, the makers of mepolizumab.
SOURCE: Albers FC et al. AAAAI/WAO Joint Congress, Posters L29 and L30.
http://www.jacionline.org/article/S0091-6749(17)32864-6/abstract
REPORTING FROM AAAAI/WAO JOINT CONGRESS
Key clinical point: Switching to mepolizumab was safe and effective for patients with severe eosinophilic asthma not responsive to omalizumab.
Major finding: Switching to mepolizumab was associated with a 65% (P less than 0.001) reduction in the rate of clinically significant exacerbations in patients not responding to omalizumab.
Study details: A multicenter, open-label, single-arm study.
Disclosures: The study was funded by GlaxoSmithKline. Dr. Frank C. Albers is an employee of GlaxoSmithKline.
Source: Albers FC et al. AAAAI/WAO Joint Congress, Poster L29/L30.
Olopatadine/mometasone combo is safe and effective
ORLANDO – Twice-daily treatment with a combination of olopatadine and mometasone showed significant clinical benefit and demonstrated safety for patients with seasonal allergic rhinitis, according to the results of a phase 3 trial.
The combination, known as GSP301, is a fixed-dose nasal spray containing olopatadine, a Food and Drug Adminstration–approved antihistamine, and mometasone, an FDA-approved corticosteroid.
The combination therapy demonstrated statistically significant improvement in scores, compared with those associated with placebo (P less than .001) and olopatadine alone (P = .003). It also showed benefit when compared with mometasone alone (P = .059), Dr. Hampel reported at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Allergy Organization.
“You expect this outcome,” Dr. Hampel said in an interview. “Olopatadine is a good drug, mometasone is a good drug, so you’d expect the combination to be good, and it was.”
Dr. Hampel and his colleagues also analyzed changes in baseline scores for patients in the olopatadine group and the mometasone group and compared those changes with those seen in the placebo group. Patients in the mometasone group experienced statistically significant improvement, compared with those in the placebo group (P = .004), and patients in the olopatadine group also appeared to experienced benefit (P = .076).
Adverse events were similar across all treatment groups, although a slightly higher percentage of patients in the GSP301 group (12.9%) and olopatadine groups (12.5%) experienced adverse events, Dr. Hampel said.
Glenmark Pharmaceuticals sponsored the study. Dr. Hampel reported funding from Glenmark Pharmaceuticals and other pharmaceutical companies
SOURCE: Hampel F et al. AAAAI/WAO Joint Congress, Abstract 546.
ORLANDO – Twice-daily treatment with a combination of olopatadine and mometasone showed significant clinical benefit and demonstrated safety for patients with seasonal allergic rhinitis, according to the results of a phase 3 trial.
The combination, known as GSP301, is a fixed-dose nasal spray containing olopatadine, a Food and Drug Adminstration–approved antihistamine, and mometasone, an FDA-approved corticosteroid.
The combination therapy demonstrated statistically significant improvement in scores, compared with those associated with placebo (P less than .001) and olopatadine alone (P = .003). It also showed benefit when compared with mometasone alone (P = .059), Dr. Hampel reported at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Allergy Organization.
“You expect this outcome,” Dr. Hampel said in an interview. “Olopatadine is a good drug, mometasone is a good drug, so you’d expect the combination to be good, and it was.”
Dr. Hampel and his colleagues also analyzed changes in baseline scores for patients in the olopatadine group and the mometasone group and compared those changes with those seen in the placebo group. Patients in the mometasone group experienced statistically significant improvement, compared with those in the placebo group (P = .004), and patients in the olopatadine group also appeared to experienced benefit (P = .076).
Adverse events were similar across all treatment groups, although a slightly higher percentage of patients in the GSP301 group (12.9%) and olopatadine groups (12.5%) experienced adverse events, Dr. Hampel said.
Glenmark Pharmaceuticals sponsored the study. Dr. Hampel reported funding from Glenmark Pharmaceuticals and other pharmaceutical companies
SOURCE: Hampel F et al. AAAAI/WAO Joint Congress, Abstract 546.
ORLANDO – Twice-daily treatment with a combination of olopatadine and mometasone showed significant clinical benefit and demonstrated safety for patients with seasonal allergic rhinitis, according to the results of a phase 3 trial.
The combination, known as GSP301, is a fixed-dose nasal spray containing olopatadine, a Food and Drug Adminstration–approved antihistamine, and mometasone, an FDA-approved corticosteroid.
The combination therapy demonstrated statistically significant improvement in scores, compared with those associated with placebo (P less than .001) and olopatadine alone (P = .003). It also showed benefit when compared with mometasone alone (P = .059), Dr. Hampel reported at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Allergy Organization.
“You expect this outcome,” Dr. Hampel said in an interview. “Olopatadine is a good drug, mometasone is a good drug, so you’d expect the combination to be good, and it was.”
Dr. Hampel and his colleagues also analyzed changes in baseline scores for patients in the olopatadine group and the mometasone group and compared those changes with those seen in the placebo group. Patients in the mometasone group experienced statistically significant improvement, compared with those in the placebo group (P = .004), and patients in the olopatadine group also appeared to experienced benefit (P = .076).
Adverse events were similar across all treatment groups, although a slightly higher percentage of patients in the GSP301 group (12.9%) and olopatadine groups (12.5%) experienced adverse events, Dr. Hampel said.
Glenmark Pharmaceuticals sponsored the study. Dr. Hampel reported funding from Glenmark Pharmaceuticals and other pharmaceutical companies
SOURCE: Hampel F et al. AAAAI/WAO Joint Congress, Abstract 546.
REPORTING FROM AAAAI/WAO JOINT CONGRESS
Key clinical point: Twice-daily combination therapy improved reflective total nasal symptom scores better than either component alone.
Major finding: Combination therapy significantly improved total nasal symptom scores (P less than .001).
Study details: Phase 3, double-blind, randomized, parallel-group study of 1,180 patients aged 12 years and older with seasonal allergic rhinitis.
Disclosures: Glenmark Pharmaceuticals sponsored the study. Dr. Hampel reported funding from Glenmark Pharmaceuticals and other pharmaceutical companies.
Source: Hampel F et al. AAAAI/WAO Joint Congress, Abstract 546.
Good definitions, research lacking for COPD-asthma overlap
ORLANDO – to give clinicians data they can actually use.
The topic is even more pressing given the growing interest and research into biological treatments for asthma and consideration of their possible use in COPD, experts said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization. Their remarks came in what was ostensibly a “debate” on whether ACOS is a distinct entity requiring special treatment but largely turned into a discussion about gaps in knowledge on the topic.
“The problem here is that it has not been defined in a way that everyone agrees on – that does create a problem because, if there’s no consensus on the diagnostic criteria, then it may be difficult to study this overlap,” said Donald Tashkin, MD, director of the pulmonary function laboratories at the University of California, Los Angeles. “Because there is no agreement on how to diagnose ACOS, it hasn’t been studied with respect to its responsiveness to different treatment options.”R. Stokes Peebles Jr., MD, professor of allergy, pulmonary, and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., said that, although the number of published articles on ACOS has skyrocketed over the last several years, review articles have outnumbered original research articles.
There is disagreement in published definitions: One set of definitions includes a criterion of fractional exhaled nitric oxide not seen in any other definitions, whereas some other definitions require a history of smoking while others don’t, he said.
“How does one manage a disease without a definition and without clinical studies? It’s impossible for me to know,” Dr. Peebles said.
Jeffrey Drazen, MD, the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, Boston, and the editor of the New England Journal of Medicine, also lamented the polar nature of the research.
“We all treat patients in the middle, everybody does, all the time – and we would love more guidance,” he said. “One of the reasons the number of articles has gone up is that there have been lots of case definitions. But we can’t get consensus. So who do we have to bring to the table to get a consensus definition so we can get the funding we need from the drug companies or governmental bodies to do the research that we all want?”
Dr. Tashkin said the way forward could be to draw on the points of consensus that do exist on certain criteria.
Dr. Peebles said an international panel is needed to draw up a consensus guideline, with the panel including both pulmonologists and allergists – “people experienced with clinical trials, who take care of a lot of patients.”
ORLANDO – to give clinicians data they can actually use.
The topic is even more pressing given the growing interest and research into biological treatments for asthma and consideration of their possible use in COPD, experts said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization. Their remarks came in what was ostensibly a “debate” on whether ACOS is a distinct entity requiring special treatment but largely turned into a discussion about gaps in knowledge on the topic.
“The problem here is that it has not been defined in a way that everyone agrees on – that does create a problem because, if there’s no consensus on the diagnostic criteria, then it may be difficult to study this overlap,” said Donald Tashkin, MD, director of the pulmonary function laboratories at the University of California, Los Angeles. “Because there is no agreement on how to diagnose ACOS, it hasn’t been studied with respect to its responsiveness to different treatment options.”R. Stokes Peebles Jr., MD, professor of allergy, pulmonary, and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., said that, although the number of published articles on ACOS has skyrocketed over the last several years, review articles have outnumbered original research articles.
There is disagreement in published definitions: One set of definitions includes a criterion of fractional exhaled nitric oxide not seen in any other definitions, whereas some other definitions require a history of smoking while others don’t, he said.
“How does one manage a disease without a definition and without clinical studies? It’s impossible for me to know,” Dr. Peebles said.
Jeffrey Drazen, MD, the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, Boston, and the editor of the New England Journal of Medicine, also lamented the polar nature of the research.
“We all treat patients in the middle, everybody does, all the time – and we would love more guidance,” he said. “One of the reasons the number of articles has gone up is that there have been lots of case definitions. But we can’t get consensus. So who do we have to bring to the table to get a consensus definition so we can get the funding we need from the drug companies or governmental bodies to do the research that we all want?”
Dr. Tashkin said the way forward could be to draw on the points of consensus that do exist on certain criteria.
Dr. Peebles said an international panel is needed to draw up a consensus guideline, with the panel including both pulmonologists and allergists – “people experienced with clinical trials, who take care of a lot of patients.”
ORLANDO – to give clinicians data they can actually use.
The topic is even more pressing given the growing interest and research into biological treatments for asthma and consideration of their possible use in COPD, experts said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization. Their remarks came in what was ostensibly a “debate” on whether ACOS is a distinct entity requiring special treatment but largely turned into a discussion about gaps in knowledge on the topic.
“The problem here is that it has not been defined in a way that everyone agrees on – that does create a problem because, if there’s no consensus on the diagnostic criteria, then it may be difficult to study this overlap,” said Donald Tashkin, MD, director of the pulmonary function laboratories at the University of California, Los Angeles. “Because there is no agreement on how to diagnose ACOS, it hasn’t been studied with respect to its responsiveness to different treatment options.”R. Stokes Peebles Jr., MD, professor of allergy, pulmonary, and critical care medicine at Vanderbilt University Medical Center, Nashville, Tenn., said that, although the number of published articles on ACOS has skyrocketed over the last several years, review articles have outnumbered original research articles.
There is disagreement in published definitions: One set of definitions includes a criterion of fractional exhaled nitric oxide not seen in any other definitions, whereas some other definitions require a history of smoking while others don’t, he said.
“How does one manage a disease without a definition and without clinical studies? It’s impossible for me to know,” Dr. Peebles said.
Jeffrey Drazen, MD, the Distinguished Parker B. Francis Professor of Medicine at Harvard Medical School, Boston, and the editor of the New England Journal of Medicine, also lamented the polar nature of the research.
“We all treat patients in the middle, everybody does, all the time – and we would love more guidance,” he said. “One of the reasons the number of articles has gone up is that there have been lots of case definitions. But we can’t get consensus. So who do we have to bring to the table to get a consensus definition so we can get the funding we need from the drug companies or governmental bodies to do the research that we all want?”
Dr. Tashkin said the way forward could be to draw on the points of consensus that do exist on certain criteria.
Dr. Peebles said an international panel is needed to draw up a consensus guideline, with the panel including both pulmonologists and allergists – “people experienced with clinical trials, who take care of a lot of patients.”
EXPERT ANALYSIS FROM AAAAI/WAO JOINT CONGRESS
New approaches needed for food allergies in minority children
ORLANDO – compared with their white counterparts, an expert said.
These ethnic groups have higher odds of food sensitization compared with whites, and an analysis of the U.S. National Mortality Database found a higher rate of food-related anaphylaxis that turned fatal more often among African-Americans than among whites, Mahboobeh Mahdavinia, MD, PhD, an allergist and immunologist at Rush University Medical Center, Chicago, said at the joint congress of the American Academy of Asthma, Allergy, and Immunology and the World Asthma Organization.
The “sadder news,” she said, is that the rate of fatal food-related anaphylaxis has been getting worse with time. Rates of fatal food-related anaphylaxis per million significantly increased in African American males from the period of 1999-2001 (.06), compared with 2008-2010 (.21) (P less than .001). Fatal anaphylaxis caused by food was significantly associated with African American race (P less than .001) (J Allergy Clin Immunol. 2014 Dec;134[6]:1318-28.e7).
“There has been a lot of research and increasing awareness about food allergy, but this has certainly not affected minorities, and they’re even dying more from these diseases,” Dr. Mahdavinia said.
Studies also have shown that African-American and Hispanic children have a higher rate of emergency department visits for food allergy, compared with white children. Dr. Mahdavinia said this might be because the severity of their allergies is worse, because they have less access to primary care, they have inferior practices at home to manage the allergies, and that higher asthma rates in these children is likely leading to worse food allergy incidents.
Compared with white children, African American children were significantly more likely to have allergy to wheat, soy, corn, fish, and shellfish (P less than .01). Compared with white children, Hispanic children were significantly more likely to have allergy to corn, fish, and shellfish (P less than .01) (J Allergy Clin Immunol Pract. 2017 Mar-Apr;5[2]:352-7.e1).
Children from low-income backgrounds, she noted, spend less on specialty outpatient care.
The difference in food allergy rates is likely linked, in part, to familial and cultural differences in childrearing, she said. African-American and Hispanic parents tend to introduce solid foods earlier, and breastfeed children at lower rates than those of white families.
Dr. Mahdavinia noted that while more affluent families are able to sidestep allergies by making a simple stop at a high-end grocer to get an allergen-free version of a food, poorer families are less able to buy these more expensive alternatives.
“The higher rate of asthma anaphylaxis observed in these minority children is concerning, especially when it’s considered in the context of the reported higher rate of fatal anaphylaxis associated food allergy in African Americans,” she said. “So there’s a tremendous need for future studies.”
ORLANDO – compared with their white counterparts, an expert said.
These ethnic groups have higher odds of food sensitization compared with whites, and an analysis of the U.S. National Mortality Database found a higher rate of food-related anaphylaxis that turned fatal more often among African-Americans than among whites, Mahboobeh Mahdavinia, MD, PhD, an allergist and immunologist at Rush University Medical Center, Chicago, said at the joint congress of the American Academy of Asthma, Allergy, and Immunology and the World Asthma Organization.
The “sadder news,” she said, is that the rate of fatal food-related anaphylaxis has been getting worse with time. Rates of fatal food-related anaphylaxis per million significantly increased in African American males from the period of 1999-2001 (.06), compared with 2008-2010 (.21) (P less than .001). Fatal anaphylaxis caused by food was significantly associated with African American race (P less than .001) (J Allergy Clin Immunol. 2014 Dec;134[6]:1318-28.e7).
“There has been a lot of research and increasing awareness about food allergy, but this has certainly not affected minorities, and they’re even dying more from these diseases,” Dr. Mahdavinia said.
Studies also have shown that African-American and Hispanic children have a higher rate of emergency department visits for food allergy, compared with white children. Dr. Mahdavinia said this might be because the severity of their allergies is worse, because they have less access to primary care, they have inferior practices at home to manage the allergies, and that higher asthma rates in these children is likely leading to worse food allergy incidents.
Compared with white children, African American children were significantly more likely to have allergy to wheat, soy, corn, fish, and shellfish (P less than .01). Compared with white children, Hispanic children were significantly more likely to have allergy to corn, fish, and shellfish (P less than .01) (J Allergy Clin Immunol Pract. 2017 Mar-Apr;5[2]:352-7.e1).
Children from low-income backgrounds, she noted, spend less on specialty outpatient care.
The difference in food allergy rates is likely linked, in part, to familial and cultural differences in childrearing, she said. African-American and Hispanic parents tend to introduce solid foods earlier, and breastfeed children at lower rates than those of white families.
Dr. Mahdavinia noted that while more affluent families are able to sidestep allergies by making a simple stop at a high-end grocer to get an allergen-free version of a food, poorer families are less able to buy these more expensive alternatives.
“The higher rate of asthma anaphylaxis observed in these minority children is concerning, especially when it’s considered in the context of the reported higher rate of fatal anaphylaxis associated food allergy in African Americans,” she said. “So there’s a tremendous need for future studies.”
ORLANDO – compared with their white counterparts, an expert said.
These ethnic groups have higher odds of food sensitization compared with whites, and an analysis of the U.S. National Mortality Database found a higher rate of food-related anaphylaxis that turned fatal more often among African-Americans than among whites, Mahboobeh Mahdavinia, MD, PhD, an allergist and immunologist at Rush University Medical Center, Chicago, said at the joint congress of the American Academy of Asthma, Allergy, and Immunology and the World Asthma Organization.
The “sadder news,” she said, is that the rate of fatal food-related anaphylaxis has been getting worse with time. Rates of fatal food-related anaphylaxis per million significantly increased in African American males from the period of 1999-2001 (.06), compared with 2008-2010 (.21) (P less than .001). Fatal anaphylaxis caused by food was significantly associated with African American race (P less than .001) (J Allergy Clin Immunol. 2014 Dec;134[6]:1318-28.e7).
“There has been a lot of research and increasing awareness about food allergy, but this has certainly not affected minorities, and they’re even dying more from these diseases,” Dr. Mahdavinia said.
Studies also have shown that African-American and Hispanic children have a higher rate of emergency department visits for food allergy, compared with white children. Dr. Mahdavinia said this might be because the severity of their allergies is worse, because they have less access to primary care, they have inferior practices at home to manage the allergies, and that higher asthma rates in these children is likely leading to worse food allergy incidents.
Compared with white children, African American children were significantly more likely to have allergy to wheat, soy, corn, fish, and shellfish (P less than .01). Compared with white children, Hispanic children were significantly more likely to have allergy to corn, fish, and shellfish (P less than .01) (J Allergy Clin Immunol Pract. 2017 Mar-Apr;5[2]:352-7.e1).
Children from low-income backgrounds, she noted, spend less on specialty outpatient care.
The difference in food allergy rates is likely linked, in part, to familial and cultural differences in childrearing, she said. African-American and Hispanic parents tend to introduce solid foods earlier, and breastfeed children at lower rates than those of white families.
Dr. Mahdavinia noted that while more affluent families are able to sidestep allergies by making a simple stop at a high-end grocer to get an allergen-free version of a food, poorer families are less able to buy these more expensive alternatives.
“The higher rate of asthma anaphylaxis observed in these minority children is concerning, especially when it’s considered in the context of the reported higher rate of fatal anaphylaxis associated food allergy in African Americans,” she said. “So there’s a tremendous need for future studies.”
EXPERT ANALYSIS FROM AAAAI/WAO JOINT CONGRESS
Swamp coolers not linked to dust mite sensitization in atopic children
ORLANDO – Swamp coolers – a low-cost alternative to air-conditioning in dry regions – weren’t found to increase sensitization to house dust mites or mold in atopic pediatric patients, researchers reported.
Neema Izadi, MD, and his associates say the findings, seen in a pediatric Colorado population in a study evaluating data over 10 years, could mean that not everyone at risk of dust mite and mold sensitization needs to avoid these cooling systems.
“Evaporative coolers have been shown to raise relative humidity by about 10%,” said Dr. Izadi, a pediatric allergy and immunology fellow at National Jewish Health, Denver, presenting at the joint congress of the American Academy of Asthma, Allergy and Immunology and the World Asthma Organization. “They work best in environments where the air is very warm and dry.”
House dust mites and mold thrive in higher humidity. Small studies performed in Colorado, Utah, and other locations have shown that the swamp coolers increase house dust mite allergen content, but there have been very few studies that have looked at actual sensitization. One smaller study in Nevada did find that the coolers increased sensitization to dust mites and mold.
In this study – thought to be the largest ever to look at this question – Dr. Izadi and his colleagues assessed data on patients aged 21 years and younger who were seen at National Jewish Health during 2008-2017 and who had at least one positive environmental skin-prick test. The average age was about 9 years. The cohort included 8,503 patients with sensitization to house dust mites and 9,286 with sensitization to mold. Researchers examined data on swamp coolers in their homes.
The researchers found that 29% of those with swamp coolers were dust-mite positive on skin testing, and 28% of those without one were positive. This was not a significant difference (P = .85). They found that 45% of those with the coolers were positive for sensitization to any mold, compared with 44% without one – also not a significant difference (P = .43).
They also found no difference according to age group, sex, or individually for atopic dermatitis, asthma, or allergic rhinitis.
He acknowledged that the study had no way to reliably account for patients who were transplants to Colorado, having moved there from somewhere else. The study also didn’t examine the age of homes, whether it had carpeting, or other factors.
He noted that the amount of time the coolers were run in the home was not examined and that “it might matter how much it is on.” This, he said, might account for differences in these results, compared with the Nevada study that did find a sensitization increase cause by the coolers.
“Evaporative coolers or swamp coolers are a great low-cost alternative in semiarid and arid environments – they can cut costs from 15%-35%,” Dr. Izadi said. “These data may indicate that it may be unnecessary to recommend that patients remove their swamp cooler, at least from a dust-mite and mold-sensitization standpoint.”
Dr. Izadi had no relevant financial disclosures.
SOURCE: Izadi N et al. AAAAI/WAO Joint Congress, Abstract 586
Susan Millard, MD, FCCP, comments: Swamp coolers are used in semi-arid and arid climates like Arizona, where I did my fellowship training but they didn't work well to keep apartments and homes cool enough if over about 100°F outside! The system is cheaper than air conditioning. So it is great to know that this type of cooling system does not cause more mold and dust mite allergies.
Susan Millard, MD, FCCP, comments: Swamp coolers are used in semi-arid and arid climates like Arizona, where I did my fellowship training but they didn't work well to keep apartments and homes cool enough if over about 100°F outside! The system is cheaper than air conditioning. So it is great to know that this type of cooling system does not cause more mold and dust mite allergies.
Susan Millard, MD, FCCP, comments: Swamp coolers are used in semi-arid and arid climates like Arizona, where I did my fellowship training but they didn't work well to keep apartments and homes cool enough if over about 100°F outside! The system is cheaper than air conditioning. So it is great to know that this type of cooling system does not cause more mold and dust mite allergies.
ORLANDO – Swamp coolers – a low-cost alternative to air-conditioning in dry regions – weren’t found to increase sensitization to house dust mites or mold in atopic pediatric patients, researchers reported.
Neema Izadi, MD, and his associates say the findings, seen in a pediatric Colorado population in a study evaluating data over 10 years, could mean that not everyone at risk of dust mite and mold sensitization needs to avoid these cooling systems.
“Evaporative coolers have been shown to raise relative humidity by about 10%,” said Dr. Izadi, a pediatric allergy and immunology fellow at National Jewish Health, Denver, presenting at the joint congress of the American Academy of Asthma, Allergy and Immunology and the World Asthma Organization. “They work best in environments where the air is very warm and dry.”
House dust mites and mold thrive in higher humidity. Small studies performed in Colorado, Utah, and other locations have shown that the swamp coolers increase house dust mite allergen content, but there have been very few studies that have looked at actual sensitization. One smaller study in Nevada did find that the coolers increased sensitization to dust mites and mold.
In this study – thought to be the largest ever to look at this question – Dr. Izadi and his colleagues assessed data on patients aged 21 years and younger who were seen at National Jewish Health during 2008-2017 and who had at least one positive environmental skin-prick test. The average age was about 9 years. The cohort included 8,503 patients with sensitization to house dust mites and 9,286 with sensitization to mold. Researchers examined data on swamp coolers in their homes.
The researchers found that 29% of those with swamp coolers were dust-mite positive on skin testing, and 28% of those without one were positive. This was not a significant difference (P = .85). They found that 45% of those with the coolers were positive for sensitization to any mold, compared with 44% without one – also not a significant difference (P = .43).
They also found no difference according to age group, sex, or individually for atopic dermatitis, asthma, or allergic rhinitis.
He acknowledged that the study had no way to reliably account for patients who were transplants to Colorado, having moved there from somewhere else. The study also didn’t examine the age of homes, whether it had carpeting, or other factors.
He noted that the amount of time the coolers were run in the home was not examined and that “it might matter how much it is on.” This, he said, might account for differences in these results, compared with the Nevada study that did find a sensitization increase cause by the coolers.
“Evaporative coolers or swamp coolers are a great low-cost alternative in semiarid and arid environments – they can cut costs from 15%-35%,” Dr. Izadi said. “These data may indicate that it may be unnecessary to recommend that patients remove their swamp cooler, at least from a dust-mite and mold-sensitization standpoint.”
Dr. Izadi had no relevant financial disclosures.
SOURCE: Izadi N et al. AAAAI/WAO Joint Congress, Abstract 586
ORLANDO – Swamp coolers – a low-cost alternative to air-conditioning in dry regions – weren’t found to increase sensitization to house dust mites or mold in atopic pediatric patients, researchers reported.
Neema Izadi, MD, and his associates say the findings, seen in a pediatric Colorado population in a study evaluating data over 10 years, could mean that not everyone at risk of dust mite and mold sensitization needs to avoid these cooling systems.
“Evaporative coolers have been shown to raise relative humidity by about 10%,” said Dr. Izadi, a pediatric allergy and immunology fellow at National Jewish Health, Denver, presenting at the joint congress of the American Academy of Asthma, Allergy and Immunology and the World Asthma Organization. “They work best in environments where the air is very warm and dry.”
House dust mites and mold thrive in higher humidity. Small studies performed in Colorado, Utah, and other locations have shown that the swamp coolers increase house dust mite allergen content, but there have been very few studies that have looked at actual sensitization. One smaller study in Nevada did find that the coolers increased sensitization to dust mites and mold.
In this study – thought to be the largest ever to look at this question – Dr. Izadi and his colleagues assessed data on patients aged 21 years and younger who were seen at National Jewish Health during 2008-2017 and who had at least one positive environmental skin-prick test. The average age was about 9 years. The cohort included 8,503 patients with sensitization to house dust mites and 9,286 with sensitization to mold. Researchers examined data on swamp coolers in their homes.
The researchers found that 29% of those with swamp coolers were dust-mite positive on skin testing, and 28% of those without one were positive. This was not a significant difference (P = .85). They found that 45% of those with the coolers were positive for sensitization to any mold, compared with 44% without one – also not a significant difference (P = .43).
They also found no difference according to age group, sex, or individually for atopic dermatitis, asthma, or allergic rhinitis.
He acknowledged that the study had no way to reliably account for patients who were transplants to Colorado, having moved there from somewhere else. The study also didn’t examine the age of homes, whether it had carpeting, or other factors.
He noted that the amount of time the coolers were run in the home was not examined and that “it might matter how much it is on.” This, he said, might account for differences in these results, compared with the Nevada study that did find a sensitization increase cause by the coolers.
“Evaporative coolers or swamp coolers are a great low-cost alternative in semiarid and arid environments – they can cut costs from 15%-35%,” Dr. Izadi said. “These data may indicate that it may be unnecessary to recommend that patients remove their swamp cooler, at least from a dust-mite and mold-sensitization standpoint.”
Dr. Izadi had no relevant financial disclosures.
SOURCE: Izadi N et al. AAAAI/WAO Joint Congress, Abstract 586
REPORTING FROM AAAAI/WAO JOINT CONGRESS
Key clinical point:
Major finding: Researchers found that 29% of those with swamp coolers were dust-mite positive on skin testing, and 28% of those without one were as well. This was not a significant difference (P = .85).
Study details: A retrospective review of more than 17,000 cases of atopic children aged 21 years and younger who were seen at National Jewish Health and had a positive environmental skin prick test.
Disclosures: Dr. Izadi had no relevant financial disclosures.
Source: Izadi N et al. AAAAI/WAO Joint Congress, Abstract 586
Teleconference is effective in assessing penicillin allergy
ORLANDO – and resulted in almost every patient having their allergy label removed, researchers reported.
In what the researchers said was the first study showing the utility of telemedicine in evaluating patient-reported penicillin allergies, allergy and immunology physicians did a secure telemedicine consultation with patients after they underwent penicillin skin testing with a physician assistant; an approach which, on average, took 123 minutes fewer each time than if the physician had done the consultation face-to-face. The teleconference can be done on a laptop or smartphone.
She said the approach is sensible and effective, and it is a good alternative to the traditional way of doing these tests. “What this takes out of that is the travel part. Someone else is doing the travel and the technique of testing,” added that people often are labeled in childhood after getting a rash that was thought to be related to penicillin, but actually was just a coincidence that was unrelated. Then the false allergy label is attached to them for life.
“This is so overlabeled,” Dr. Ramsey said. “Ten percent of the population thinks they’re allergic to penicillin, and 90% of them are not.”
A stark difference was found in the types of medicines administered before and after the evaluations, with aminopenicillin therapy jumping from 0 days of use to 188 days, and vancomycin – a more potent, but more costly alternative – dropping from 130 days of use to 16 days (P less than .05 for both).
Dr. Ramsey noted that, in part because of the time-consuming nature of the penicillin skin tests, they often are simply not done, so the false allergy labels are not caught, leading to pointless costs and exposure to more potent and potentially harmful forms of antibiotic therapy.
“Some hospitals don’t have allergists who will come in to do testing,” she said. “Sometimes patients are on medications that may interfere. And then a lot of times it’s just underrecognized – the implications of a penicillin allergy label. That is a very hot topic in our field and also in infectious disease.”
She hopes the telemedicine approach catches on more widely, which would help minimize the multitude of problems linked to penicillin allergy labels.
“Patients that avoid penicillin, they’re on more costly second-line antibiotics that are, in general, less effective, depending on which infection you’re talking about,” Dr. Ramsey said. “The [second-line antibiotics] have more side effects. And there’s data to show that patients with [a] penicillin allergy label have longer hospital stays, more costly hospital stays, are at risk for more resistant infections. And it breeds antimicrobial resistance in the long-term.”
Dr. Ramsey had no relevant financial disclosures.
SOURCE: Ramsey AC et al. AAAAI/WAO Joint Congress, Abstract 104.
ORLANDO – and resulted in almost every patient having their allergy label removed, researchers reported.
In what the researchers said was the first study showing the utility of telemedicine in evaluating patient-reported penicillin allergies, allergy and immunology physicians did a secure telemedicine consultation with patients after they underwent penicillin skin testing with a physician assistant; an approach which, on average, took 123 minutes fewer each time than if the physician had done the consultation face-to-face. The teleconference can be done on a laptop or smartphone.
She said the approach is sensible and effective, and it is a good alternative to the traditional way of doing these tests. “What this takes out of that is the travel part. Someone else is doing the travel and the technique of testing,” added that people often are labeled in childhood after getting a rash that was thought to be related to penicillin, but actually was just a coincidence that was unrelated. Then the false allergy label is attached to them for life.
“This is so overlabeled,” Dr. Ramsey said. “Ten percent of the population thinks they’re allergic to penicillin, and 90% of them are not.”
A stark difference was found in the types of medicines administered before and after the evaluations, with aminopenicillin therapy jumping from 0 days of use to 188 days, and vancomycin – a more potent, but more costly alternative – dropping from 130 days of use to 16 days (P less than .05 for both).
Dr. Ramsey noted that, in part because of the time-consuming nature of the penicillin skin tests, they often are simply not done, so the false allergy labels are not caught, leading to pointless costs and exposure to more potent and potentially harmful forms of antibiotic therapy.
“Some hospitals don’t have allergists who will come in to do testing,” she said. “Sometimes patients are on medications that may interfere. And then a lot of times it’s just underrecognized – the implications of a penicillin allergy label. That is a very hot topic in our field and also in infectious disease.”
She hopes the telemedicine approach catches on more widely, which would help minimize the multitude of problems linked to penicillin allergy labels.
“Patients that avoid penicillin, they’re on more costly second-line antibiotics that are, in general, less effective, depending on which infection you’re talking about,” Dr. Ramsey said. “The [second-line antibiotics] have more side effects. And there’s data to show that patients with [a] penicillin allergy label have longer hospital stays, more costly hospital stays, are at risk for more resistant infections. And it breeds antimicrobial resistance in the long-term.”
Dr. Ramsey had no relevant financial disclosures.
SOURCE: Ramsey AC et al. AAAAI/WAO Joint Congress, Abstract 104.
ORLANDO – and resulted in almost every patient having their allergy label removed, researchers reported.
In what the researchers said was the first study showing the utility of telemedicine in evaluating patient-reported penicillin allergies, allergy and immunology physicians did a secure telemedicine consultation with patients after they underwent penicillin skin testing with a physician assistant; an approach which, on average, took 123 minutes fewer each time than if the physician had done the consultation face-to-face. The teleconference can be done on a laptop or smartphone.
She said the approach is sensible and effective, and it is a good alternative to the traditional way of doing these tests. “What this takes out of that is the travel part. Someone else is doing the travel and the technique of testing,” added that people often are labeled in childhood after getting a rash that was thought to be related to penicillin, but actually was just a coincidence that was unrelated. Then the false allergy label is attached to them for life.
“This is so overlabeled,” Dr. Ramsey said. “Ten percent of the population thinks they’re allergic to penicillin, and 90% of them are not.”
A stark difference was found in the types of medicines administered before and after the evaluations, with aminopenicillin therapy jumping from 0 days of use to 188 days, and vancomycin – a more potent, but more costly alternative – dropping from 130 days of use to 16 days (P less than .05 for both).
Dr. Ramsey noted that, in part because of the time-consuming nature of the penicillin skin tests, they often are simply not done, so the false allergy labels are not caught, leading to pointless costs and exposure to more potent and potentially harmful forms of antibiotic therapy.
“Some hospitals don’t have allergists who will come in to do testing,” she said. “Sometimes patients are on medications that may interfere. And then a lot of times it’s just underrecognized – the implications of a penicillin allergy label. That is a very hot topic in our field and also in infectious disease.”
She hopes the telemedicine approach catches on more widely, which would help minimize the multitude of problems linked to penicillin allergy labels.
“Patients that avoid penicillin, they’re on more costly second-line antibiotics that are, in general, less effective, depending on which infection you’re talking about,” Dr. Ramsey said. “The [second-line antibiotics] have more side effects. And there’s data to show that patients with [a] penicillin allergy label have longer hospital stays, more costly hospital stays, are at risk for more resistant infections. And it breeds antimicrobial resistance in the long-term.”
Dr. Ramsey had no relevant financial disclosures.
SOURCE: Ramsey AC et al. AAAAI/WAO Joint Congress, Abstract 104.
REPORTING FROM AAAAI/WAO JOINT CONGRESS
Key clinical point: Teleconferencing to assess patient-reported penicillin allergies saves time and results in 9 out of 10 patients being delabeled.
Major finding: Of 50 patients prospectively assessed with this approach over a 4-month period last year, 46 were delabeled, with $23,000 in direct antibiotic cost savings, or $360 per patient.
Study details: A prospective study conducted over 4 months in 2017.
Disclosures: Dr. Ramsey had no relevant financial disclosures.
Source: Ramsey AC et al. AAAAI/WAO Joint Congress, Abstract 104.
Artificial intelligence hastens review for asthma risk
ORLANDO – Reviewing patient charts for asthma risk factors using natural language processing can be done 8 times faster than reviewing the charts by hand, and with high levels of accuracy, researchers reported here.
Natural language processing (NLP) is a kind of artificial intelligence in which computers are “trained” through a reiterative process to understand human language.
Researchers at Mayo Clinic previously have shown that a program created in-house can successfully and quickly determine patients’ asthma status. In this study, they turned to assessment of asthma risk factors, Chung-Il Wi, MD, assistant professor of pediatrics at Mayo said in a presentation at the joint congress of the American Academy of Allergy, Asthma and Immunology and the World Asthma Organization.
They used a convenience sample of 177 patient charts to train the NLP system. The system extracted – from key terms and sentences in the electronic health record (EHR) – data such as breastfeeding history and history of atopic conditions such as allergic rhinitis, eczema, and food allergy. From parent charts, the system extracted terms related to family history of asthma and other atopic conditions. The performance of the NLP algorithm was assessed by comparison with results of a manual chart review in a test cohort of 220 patient charts.
Researchers found a high level of agreement between the NLP analysis and the manual review. For breastfeeding, the positive predictive value (PPV) of the NLP was 98% and the negative predictive value (NPV) was 86%. For history of atopic conditions the PPV was at or near 100%, with a NPV of 97% to 99%, depending on the condition.
For family history of atopic conditions, the PPV was 91% to 100%, depending on the condition, and the NPV was 96% to 99%.
“Childhood asthma risk factors identified (an) NLP algorithm using EHR has excellent concordance with chart review,” researchers wrote.
Using an average time per chart, researchers found that it would take 7 hours to complete a manual review for the information presented in the study, compared to 50 minutes for the NLP.
The findings, thought to be the first demonstrating NLP’s value for this purpose, suggest “the huge potential of leveraging NLP for asthma care and research,” researchers said.
Dr. Wi said the system can be applied to any EHR system. He said it only makes sense to put an algorithm to use in this way – it saves both clinical time and time in doing research projects.
“Whenever we do asthma research we need to collect asthma risk factors anyway, but we don’t want to do manual chart review anymore in this EMR era,” he said. “Now, the computer can do it.”
SOURCE: Wi C AAAAI/WAO Joint Congress 2018 abstract 637.
Susan Millard, MD, FCCP, comments: This article brings mixed emotions. On one hand, using artificial intelligence brings a more thorough evaluation regarding asthma risk. On the other hand, our pediatric pulmonary subspecialty has gotten diluted over the last 3 decades. We used to regularly do arterial puncture, thoracentesis, and chest tube placement procedures. Now a computer might replace another aspect of our job, too? The practice of medicine is an art and that art should not be lost.
Susan Millard, MD, FCCP, comments: This article brings mixed emotions. On one hand, using artificial intelligence brings a more thorough evaluation regarding asthma risk. On the other hand, our pediatric pulmonary subspecialty has gotten diluted over the last 3 decades. We used to regularly do arterial puncture, thoracentesis, and chest tube placement procedures. Now a computer might replace another aspect of our job, too? The practice of medicine is an art and that art should not be lost.
Susan Millard, MD, FCCP, comments: This article brings mixed emotions. On one hand, using artificial intelligence brings a more thorough evaluation regarding asthma risk. On the other hand, our pediatric pulmonary subspecialty has gotten diluted over the last 3 decades. We used to regularly do arterial puncture, thoracentesis, and chest tube placement procedures. Now a computer might replace another aspect of our job, too? The practice of medicine is an art and that art should not be lost.
ORLANDO – Reviewing patient charts for asthma risk factors using natural language processing can be done 8 times faster than reviewing the charts by hand, and with high levels of accuracy, researchers reported here.
Natural language processing (NLP) is a kind of artificial intelligence in which computers are “trained” through a reiterative process to understand human language.
Researchers at Mayo Clinic previously have shown that a program created in-house can successfully and quickly determine patients’ asthma status. In this study, they turned to assessment of asthma risk factors, Chung-Il Wi, MD, assistant professor of pediatrics at Mayo said in a presentation at the joint congress of the American Academy of Allergy, Asthma and Immunology and the World Asthma Organization.
They used a convenience sample of 177 patient charts to train the NLP system. The system extracted – from key terms and sentences in the electronic health record (EHR) – data such as breastfeeding history and history of atopic conditions such as allergic rhinitis, eczema, and food allergy. From parent charts, the system extracted terms related to family history of asthma and other atopic conditions. The performance of the NLP algorithm was assessed by comparison with results of a manual chart review in a test cohort of 220 patient charts.
Researchers found a high level of agreement between the NLP analysis and the manual review. For breastfeeding, the positive predictive value (PPV) of the NLP was 98% and the negative predictive value (NPV) was 86%. For history of atopic conditions the PPV was at or near 100%, with a NPV of 97% to 99%, depending on the condition.
For family history of atopic conditions, the PPV was 91% to 100%, depending on the condition, and the NPV was 96% to 99%.
“Childhood asthma risk factors identified (an) NLP algorithm using EHR has excellent concordance with chart review,” researchers wrote.
Using an average time per chart, researchers found that it would take 7 hours to complete a manual review for the information presented in the study, compared to 50 minutes for the NLP.
The findings, thought to be the first demonstrating NLP’s value for this purpose, suggest “the huge potential of leveraging NLP for asthma care and research,” researchers said.
Dr. Wi said the system can be applied to any EHR system. He said it only makes sense to put an algorithm to use in this way – it saves both clinical time and time in doing research projects.
“Whenever we do asthma research we need to collect asthma risk factors anyway, but we don’t want to do manual chart review anymore in this EMR era,” he said. “Now, the computer can do it.”
SOURCE: Wi C AAAAI/WAO Joint Congress 2018 abstract 637.
ORLANDO – Reviewing patient charts for asthma risk factors using natural language processing can be done 8 times faster than reviewing the charts by hand, and with high levels of accuracy, researchers reported here.
Natural language processing (NLP) is a kind of artificial intelligence in which computers are “trained” through a reiterative process to understand human language.
Researchers at Mayo Clinic previously have shown that a program created in-house can successfully and quickly determine patients’ asthma status. In this study, they turned to assessment of asthma risk factors, Chung-Il Wi, MD, assistant professor of pediatrics at Mayo said in a presentation at the joint congress of the American Academy of Allergy, Asthma and Immunology and the World Asthma Organization.
They used a convenience sample of 177 patient charts to train the NLP system. The system extracted – from key terms and sentences in the electronic health record (EHR) – data such as breastfeeding history and history of atopic conditions such as allergic rhinitis, eczema, and food allergy. From parent charts, the system extracted terms related to family history of asthma and other atopic conditions. The performance of the NLP algorithm was assessed by comparison with results of a manual chart review in a test cohort of 220 patient charts.
Researchers found a high level of agreement between the NLP analysis and the manual review. For breastfeeding, the positive predictive value (PPV) of the NLP was 98% and the negative predictive value (NPV) was 86%. For history of atopic conditions the PPV was at or near 100%, with a NPV of 97% to 99%, depending on the condition.
For family history of atopic conditions, the PPV was 91% to 100%, depending on the condition, and the NPV was 96% to 99%.
“Childhood asthma risk factors identified (an) NLP algorithm using EHR has excellent concordance with chart review,” researchers wrote.
Using an average time per chart, researchers found that it would take 7 hours to complete a manual review for the information presented in the study, compared to 50 minutes for the NLP.
The findings, thought to be the first demonstrating NLP’s value for this purpose, suggest “the huge potential of leveraging NLP for asthma care and research,” researchers said.
Dr. Wi said the system can be applied to any EHR system. He said it only makes sense to put an algorithm to use in this way – it saves both clinical time and time in doing research projects.
“Whenever we do asthma research we need to collect asthma risk factors anyway, but we don’t want to do manual chart review anymore in this EMR era,” he said. “Now, the computer can do it.”
SOURCE: Wi C AAAAI/WAO Joint Congress 2018 abstract 637.
REPORTING FROM AAAAI/WAO JOINT CONGRESS 2018
Key clinical point: Using natural language processing, a form of artificial intelligence that trains computers to discern natural human language, accurately and quickly identified asthma risk factors.
Major finding: In 50 minutes, a computer program performed the risk review that took 7 hours for manual chart review, with positive and negative predictive values for most risk factors in the 90% to 100% range.
Study details: A sample of charts for patients in the Olmsted County Birth Cohort, some analyzed with natural language processing and some reviewed manually.
Disclosures: No disclosures.
Source: Wi C AAAAI/WAO Joint Congress 2018 abstract 637.
Unassigned school epinephrine used more than assigned injectors
ORLANDO –
In the 2015-2016 and 2016-2017 school years, epinephrine was administered to students 31 times at schools in the Austin Independent School District, which began to stock unassigned epinephrine in its schools after state legislators approved a law in 2015 allowing, but not requiring, school districts to do so. In 21 of those cases, or 68% of the time, it was the unassigned stockpile that was used, Kathryn Neupert, MD, said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
She drew attention to the finding that 22% of the time in the study, the epinephrine use involved the unassigned stock for children with no history of anaphylaxis or allergy.
“It kind of argues that, for those people that we don’t know have anaphylaxis to anything, it’s definitely important to have it available to them,” reported Dr. Neupert, a resident at the University of Texas, Austin.
In 45% of the cases, epinephrine was administered to children who had a known history of allergic reactions but, for whatever reason, did not have an epinephrine injector assigned to them.
Food was the most common trigger for use of epinephrine, accounting for 48% of the injections, with fragrance at 16%, insect stings at 10%, and exercise and overheating at 7%.
Dr. Neupert and her associates said the frequency with which epinephrine was administered after exposure to a fragrance – seen in about the same amount for unassigned and assigned epinephrine – might signal a need for greater education.
She emphasized the importance of follow-up after the use of unassigned injectors. If children get epinephrine that was unassigned and they have known allergies, “be sure that they subsequently get back in with their pediatrician or their allergist [and] that they’re getting their up-to-date epinephrine pens renewed,” she noted.
Carla Davis, MD, a pediatrician at Baylor College of Medicine, Houston, said she hopes more school districts adopt the stock epinephrine policy, despite barriers of cost and education. “I do think that it’s important for these schools to have these, because 20% of children will have their first episode of food allergic reaction – and in some of those cases it will be anaphylaxis – in schools.”
Dr. Neupert had no relevant financial disclosures.
SOURCE: AAAAI/WAO Joint Congress Abstract 465.
ORLANDO –
In the 2015-2016 and 2016-2017 school years, epinephrine was administered to students 31 times at schools in the Austin Independent School District, which began to stock unassigned epinephrine in its schools after state legislators approved a law in 2015 allowing, but not requiring, school districts to do so. In 21 of those cases, or 68% of the time, it was the unassigned stockpile that was used, Kathryn Neupert, MD, said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
She drew attention to the finding that 22% of the time in the study, the epinephrine use involved the unassigned stock for children with no history of anaphylaxis or allergy.
“It kind of argues that, for those people that we don’t know have anaphylaxis to anything, it’s definitely important to have it available to them,” reported Dr. Neupert, a resident at the University of Texas, Austin.
In 45% of the cases, epinephrine was administered to children who had a known history of allergic reactions but, for whatever reason, did not have an epinephrine injector assigned to them.
Food was the most common trigger for use of epinephrine, accounting for 48% of the injections, with fragrance at 16%, insect stings at 10%, and exercise and overheating at 7%.
Dr. Neupert and her associates said the frequency with which epinephrine was administered after exposure to a fragrance – seen in about the same amount for unassigned and assigned epinephrine – might signal a need for greater education.
She emphasized the importance of follow-up after the use of unassigned injectors. If children get epinephrine that was unassigned and they have known allergies, “be sure that they subsequently get back in with their pediatrician or their allergist [and] that they’re getting their up-to-date epinephrine pens renewed,” she noted.
Carla Davis, MD, a pediatrician at Baylor College of Medicine, Houston, said she hopes more school districts adopt the stock epinephrine policy, despite barriers of cost and education. “I do think that it’s important for these schools to have these, because 20% of children will have their first episode of food allergic reaction – and in some of those cases it will be anaphylaxis – in schools.”
Dr. Neupert had no relevant financial disclosures.
SOURCE: AAAAI/WAO Joint Congress Abstract 465.
ORLANDO –
In the 2015-2016 and 2016-2017 school years, epinephrine was administered to students 31 times at schools in the Austin Independent School District, which began to stock unassigned epinephrine in its schools after state legislators approved a law in 2015 allowing, but not requiring, school districts to do so. In 21 of those cases, or 68% of the time, it was the unassigned stockpile that was used, Kathryn Neupert, MD, said at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.
She drew attention to the finding that 22% of the time in the study, the epinephrine use involved the unassigned stock for children with no history of anaphylaxis or allergy.
“It kind of argues that, for those people that we don’t know have anaphylaxis to anything, it’s definitely important to have it available to them,” reported Dr. Neupert, a resident at the University of Texas, Austin.
In 45% of the cases, epinephrine was administered to children who had a known history of allergic reactions but, for whatever reason, did not have an epinephrine injector assigned to them.
Food was the most common trigger for use of epinephrine, accounting for 48% of the injections, with fragrance at 16%, insect stings at 10%, and exercise and overheating at 7%.
Dr. Neupert and her associates said the frequency with which epinephrine was administered after exposure to a fragrance – seen in about the same amount for unassigned and assigned epinephrine – might signal a need for greater education.
She emphasized the importance of follow-up after the use of unassigned injectors. If children get epinephrine that was unassigned and they have known allergies, “be sure that they subsequently get back in with their pediatrician or their allergist [and] that they’re getting their up-to-date epinephrine pens renewed,” she noted.
Carla Davis, MD, a pediatrician at Baylor College of Medicine, Houston, said she hopes more school districts adopt the stock epinephrine policy, despite barriers of cost and education. “I do think that it’s important for these schools to have these, because 20% of children will have their first episode of food allergic reaction – and in some of those cases it will be anaphylaxis – in schools.”
Dr. Neupert had no relevant financial disclosures.
SOURCE: AAAAI/WAO Joint Congress Abstract 465.
REPORTING FROM AAAAI/WAO JOINT CONGRESS
Key clinical point: Unassigned epinephrine was used more often in a Texas school district than assigned epinephrine.
Major finding: Over 2 years, 31 epinephrine injections were administered, and in 68% of the cases, it was the unassigned stock that was used.
Study details: A review of nursing records for the Austin Independent School District.
Disclosures: Dr. Kathryn Neupert had no relevant financial disclosures.
Source: Neupert K et al. Abstract 465.