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Mitchel is a reporter for MDedge based in the Philadelphia area. He started with the company in 1992, when it was International Medical News Group (IMNG), and has since covered a range of medical specialties. Mitchel trained as a virologist at Roswell Park Memorial Institute in Buffalo, and then worked briefly as a researcher at Boston Children's Hospital before pivoting to journalism as a AAAS Mass Media Fellow in 1980. His first reporting job was with Science Digest magazine, and from the mid-1980s to early-1990s he was a reporter with Medical World News. @mitchelzoler
Anxiety, depression compromise believability of drug-allergy testing
SAN FRANCISCO – Less than 4% of people who undergo drug-allergy testing are positive and need to avoid the drug in the future, but many patients who undergo drug-allergy testing and have a negative result cling to their allergic status and struggle with letting go.
New findings suggest that preexisting anxiety or depression plays a role in some people who refuse to believe a negative drug-allergy result, which suggests that these people may need a more tailored intervention to drug-allergy testing and its aftermath, including some type of behavioral intervention.
“Underlying anxiety and depression may reduce the effectiveness of negative drug-allergy evaluation and functional delabeling,” Christine Rukasin, MD, said while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “In the future, tailored drug-allergy evaluation, behavioral interventions, targeted follow-up communication, and patient education appear necessary to improve the sustained effectiveness of a negative drug-allergy and functional delabeling,” said Dr. Rukasin, an allergy immunology physician at Vanderbilt University in Nashville, Tenn.
The results showed that some people who undergo drug allergy testing “have a high anxiety state and don’t feel comfortable regardless of their test result,” she said in an interview. “This is not where one size fits all. We usually perform a single, oral drug challenge and then pronounce the person free of allergy if the result was negative. We need to better anticipate how effective a drug evaluation will be for someone; will they believe the result?” Individual patients, especially those with diagnosed anxiety or depression, may need multiple challenge tests, both oral and skin, before they believe a negative result, and they may also need referral to a behavioral health specialist, she said.
Dr. Rukasin and her associates ran their study with 100 people who underwent assessment at the Vanderbilt drug-allergy clinic and completed a set of questionnaires. The range of suspected drug allergies included 40% with a suspected reaction to penicillin, 22% to a sulfa-containing drug, 17% to a cephalosporin, 8% to another antibiotic, 7% to an NSAID, and the remainder to other drugs. The 100 participants included 57 people without diagnosed anxiety or depression, 31 diagnosed with anxiety, and 33 diagnosed with depression; some patients had diagnoses for both anxiety and depression.
The questionnaire results from before and after drug-allergy testing showed an apparent association between anxiety, depression, and a decreased willingness to believe the results of a negative drug-allergy test. For example, when posed with the prospect of finding out they were not allergic to the tested drug, 24% of the people with anxiety and 20% of those with depression said that they still would not take the medication if it were prescribed to them, compared with 7% of those without anxiety or depression who gave this response.
Many patients who come to the drug-allergy clinic are scared and worried. “We want to dig deeper, to better help these patients,” Dr. Rukasin said. This is the first reported study to evaluate anxiety in the setting of drug-allergy testing. Further insight into ways to improve the effectiveness of drug-allergy testing hopefully will come from additional analysis of the findings.
Dr. Rukasin had no relevant financial disclosures.
SOURCE: Rukasin C et al. J Allergy Clin Immunol. 2019 Feb;143(2):AB428.
SAN FRANCISCO – Less than 4% of people who undergo drug-allergy testing are positive and need to avoid the drug in the future, but many patients who undergo drug-allergy testing and have a negative result cling to their allergic status and struggle with letting go.
New findings suggest that preexisting anxiety or depression plays a role in some people who refuse to believe a negative drug-allergy result, which suggests that these people may need a more tailored intervention to drug-allergy testing and its aftermath, including some type of behavioral intervention.
“Underlying anxiety and depression may reduce the effectiveness of negative drug-allergy evaluation and functional delabeling,” Christine Rukasin, MD, said while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “In the future, tailored drug-allergy evaluation, behavioral interventions, targeted follow-up communication, and patient education appear necessary to improve the sustained effectiveness of a negative drug-allergy and functional delabeling,” said Dr. Rukasin, an allergy immunology physician at Vanderbilt University in Nashville, Tenn.
The results showed that some people who undergo drug allergy testing “have a high anxiety state and don’t feel comfortable regardless of their test result,” she said in an interview. “This is not where one size fits all. We usually perform a single, oral drug challenge and then pronounce the person free of allergy if the result was negative. We need to better anticipate how effective a drug evaluation will be for someone; will they believe the result?” Individual patients, especially those with diagnosed anxiety or depression, may need multiple challenge tests, both oral and skin, before they believe a negative result, and they may also need referral to a behavioral health specialist, she said.
Dr. Rukasin and her associates ran their study with 100 people who underwent assessment at the Vanderbilt drug-allergy clinic and completed a set of questionnaires. The range of suspected drug allergies included 40% with a suspected reaction to penicillin, 22% to a sulfa-containing drug, 17% to a cephalosporin, 8% to another antibiotic, 7% to an NSAID, and the remainder to other drugs. The 100 participants included 57 people without diagnosed anxiety or depression, 31 diagnosed with anxiety, and 33 diagnosed with depression; some patients had diagnoses for both anxiety and depression.
The questionnaire results from before and after drug-allergy testing showed an apparent association between anxiety, depression, and a decreased willingness to believe the results of a negative drug-allergy test. For example, when posed with the prospect of finding out they were not allergic to the tested drug, 24% of the people with anxiety and 20% of those with depression said that they still would not take the medication if it were prescribed to them, compared with 7% of those without anxiety or depression who gave this response.
Many patients who come to the drug-allergy clinic are scared and worried. “We want to dig deeper, to better help these patients,” Dr. Rukasin said. This is the first reported study to evaluate anxiety in the setting of drug-allergy testing. Further insight into ways to improve the effectiveness of drug-allergy testing hopefully will come from additional analysis of the findings.
Dr. Rukasin had no relevant financial disclosures.
SOURCE: Rukasin C et al. J Allergy Clin Immunol. 2019 Feb;143(2):AB428.
SAN FRANCISCO – Less than 4% of people who undergo drug-allergy testing are positive and need to avoid the drug in the future, but many patients who undergo drug-allergy testing and have a negative result cling to their allergic status and struggle with letting go.
New findings suggest that preexisting anxiety or depression plays a role in some people who refuse to believe a negative drug-allergy result, which suggests that these people may need a more tailored intervention to drug-allergy testing and its aftermath, including some type of behavioral intervention.
“Underlying anxiety and depression may reduce the effectiveness of negative drug-allergy evaluation and functional delabeling,” Christine Rukasin, MD, said while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. “In the future, tailored drug-allergy evaluation, behavioral interventions, targeted follow-up communication, and patient education appear necessary to improve the sustained effectiveness of a negative drug-allergy and functional delabeling,” said Dr. Rukasin, an allergy immunology physician at Vanderbilt University in Nashville, Tenn.
The results showed that some people who undergo drug allergy testing “have a high anxiety state and don’t feel comfortable regardless of their test result,” she said in an interview. “This is not where one size fits all. We usually perform a single, oral drug challenge and then pronounce the person free of allergy if the result was negative. We need to better anticipate how effective a drug evaluation will be for someone; will they believe the result?” Individual patients, especially those with diagnosed anxiety or depression, may need multiple challenge tests, both oral and skin, before they believe a negative result, and they may also need referral to a behavioral health specialist, she said.
Dr. Rukasin and her associates ran their study with 100 people who underwent assessment at the Vanderbilt drug-allergy clinic and completed a set of questionnaires. The range of suspected drug allergies included 40% with a suspected reaction to penicillin, 22% to a sulfa-containing drug, 17% to a cephalosporin, 8% to another antibiotic, 7% to an NSAID, and the remainder to other drugs. The 100 participants included 57 people without diagnosed anxiety or depression, 31 diagnosed with anxiety, and 33 diagnosed with depression; some patients had diagnoses for both anxiety and depression.
The questionnaire results from before and after drug-allergy testing showed an apparent association between anxiety, depression, and a decreased willingness to believe the results of a negative drug-allergy test. For example, when posed with the prospect of finding out they were not allergic to the tested drug, 24% of the people with anxiety and 20% of those with depression said that they still would not take the medication if it were prescribed to them, compared with 7% of those without anxiety or depression who gave this response.
Many patients who come to the drug-allergy clinic are scared and worried. “We want to dig deeper, to better help these patients,” Dr. Rukasin said. This is the first reported study to evaluate anxiety in the setting of drug-allergy testing. Further insight into ways to improve the effectiveness of drug-allergy testing hopefully will come from additional analysis of the findings.
Dr. Rukasin had no relevant financial disclosures.
SOURCE: Rukasin C et al. J Allergy Clin Immunol. 2019 Feb;143(2):AB428.
REPORTING FROM AAAAI 2019
Epicutaneous milk immunotherapy can resolve pediatric eosinophilic esophagitis
SAN FRANCISCO – Clinicians safely used epicutaneous immunotherapy to resolve eosinophilic esophagitis in children and teens secondary to milk consumption in a placebo-controlled, pilot study that included 20 patients.
Following the randomized phase of the study, all 19 patients who continued to participate began an 11-month open-label phase of epicutaneous immunotherapy to milk. At the end of this open-label phase, nine patients (47%) followed in this phase showed a substantial cut in their eosinophilic esophagitis (EoE) response to milk, with fewer than 15 eosinophils in a high-powered field, said Jonathan M. Spergel, MD, chief of the allergy section and Stuart E. Starr Chair of Pediatrics at the Children’s Hospital of Philadelphia, while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. An immunologic response of this sort would likely correlate with substantial clinical benefit.
“I’m happy with a 47% response,” Dr. Spergel said, adding that the responding patients “tolerate milk without symptoms, and there is really no risk” from this form of immunotherapy, which produced no serious adverse effects and caused 1 of 15 patients to stop treatment because of a treatment-related effect during the randomized phase. The most common adverse reaction was gastrointestinal symptoms, but these were just marginally more common among patients on active treatment than in control patients.
In contrast, oral immunotherapy with milk has been ineffective in children with an EoE milk reaction, and results from subcutaneous or sublingual immunotherapy for this form of milk allergy haven’t been reported, he said. The most common, current approaches to managing EoE from milk in children are either milk avoidance or treatment to reduce inflammation.
The epicutaneous approach “uses substantially lower dosing [micrograms vs. milligrams], avoids oral allergen ingestion, and may have a more advantageous adverse event profile and better adherence than other therapies,” according to a recent report that tested epicutaneous immunotherapy for peanut allergy in a phase 3 trial with 356 children (JAMA. 2019 Feb 22. doi: 10.1001/jama.2019.1113). The Viaskin Milk system tested in the current milk study involves placing a disc coated with 500 mcg of lyophilized milk protein on the skin for a gradually increasing number of hours daily until the disc is worn continuously, with daily changes of the disk. On the skin, the protein on the disk interacts with epidermal Langerhans cells to trigger desensitization.
The Milk Patch for Eosinophilic Esophagitis (SMILEE) study enrolled 20 patients at Children’s Hospital aged 4-17 years old and had milk-induced EoE, and randomized 15 to receive active epicutaneous immunotherapy to milk and 5 to receive placebo treatment. The protocol called for 9 month of epicutaneous immunotherapy without any milk exposure, followed by 2 months of continued treatment coupled with at least 240 mL of milk consumption daily. At the end of 2 months the researchers performed an esophageal biopsy on each patient to determine eosinophil density in the tissue. The study’s primary endpoint was the number of eosinophils in a high-powered field.
During the randomized phase, 8 of the 15 patients assigned to active treatment and 3 of 5 patients assigned to the placebo arm had violations of the treatment protocol, the diet protocol, or both. A per protocol analysis that focused on the seven actively treated and two placebo patients who adhered to the protocol showed a mean eosinophil count of 26 cells in patients on active treatment and 95 cells among the controls, a statistically significant difference. However, for the intention-to-treat analysis, which included all 20 enrolled patients, the primary endpoint showed no significant difference in eosinophil counts between the two study arms.
Although Dr. Spergel said that he was not aware of the developing company’s plans for further study of epicutaneous milk immunotherapy, from a scientific standpoint the next step should be a phase 2 or phase 2/3 trial for safety and efficacy. EoE was historically considered a rare disease, but a 2015 review of the condition called it “one of the most common conditions diagnosed during the assessment of feeding problems in children” (New Engl J Med. 2015 Oct 22;373[17]:1640-8).
The study was funded by DBV Technologies, which is developing the epicutaneous immunotherapy system. Dr. Spergel has been a consultant to and has received research funding from DBV Technologies.
SOURCE: Spergel JM et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB430.
SAN FRANCISCO – Clinicians safely used epicutaneous immunotherapy to resolve eosinophilic esophagitis in children and teens secondary to milk consumption in a placebo-controlled, pilot study that included 20 patients.
Following the randomized phase of the study, all 19 patients who continued to participate began an 11-month open-label phase of epicutaneous immunotherapy to milk. At the end of this open-label phase, nine patients (47%) followed in this phase showed a substantial cut in their eosinophilic esophagitis (EoE) response to milk, with fewer than 15 eosinophils in a high-powered field, said Jonathan M. Spergel, MD, chief of the allergy section and Stuart E. Starr Chair of Pediatrics at the Children’s Hospital of Philadelphia, while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. An immunologic response of this sort would likely correlate with substantial clinical benefit.
“I’m happy with a 47% response,” Dr. Spergel said, adding that the responding patients “tolerate milk without symptoms, and there is really no risk” from this form of immunotherapy, which produced no serious adverse effects and caused 1 of 15 patients to stop treatment because of a treatment-related effect during the randomized phase. The most common adverse reaction was gastrointestinal symptoms, but these were just marginally more common among patients on active treatment than in control patients.
In contrast, oral immunotherapy with milk has been ineffective in children with an EoE milk reaction, and results from subcutaneous or sublingual immunotherapy for this form of milk allergy haven’t been reported, he said. The most common, current approaches to managing EoE from milk in children are either milk avoidance or treatment to reduce inflammation.
The epicutaneous approach “uses substantially lower dosing [micrograms vs. milligrams], avoids oral allergen ingestion, and may have a more advantageous adverse event profile and better adherence than other therapies,” according to a recent report that tested epicutaneous immunotherapy for peanut allergy in a phase 3 trial with 356 children (JAMA. 2019 Feb 22. doi: 10.1001/jama.2019.1113). The Viaskin Milk system tested in the current milk study involves placing a disc coated with 500 mcg of lyophilized milk protein on the skin for a gradually increasing number of hours daily until the disc is worn continuously, with daily changes of the disk. On the skin, the protein on the disk interacts with epidermal Langerhans cells to trigger desensitization.
The Milk Patch for Eosinophilic Esophagitis (SMILEE) study enrolled 20 patients at Children’s Hospital aged 4-17 years old and had milk-induced EoE, and randomized 15 to receive active epicutaneous immunotherapy to milk and 5 to receive placebo treatment. The protocol called for 9 month of epicutaneous immunotherapy without any milk exposure, followed by 2 months of continued treatment coupled with at least 240 mL of milk consumption daily. At the end of 2 months the researchers performed an esophageal biopsy on each patient to determine eosinophil density in the tissue. The study’s primary endpoint was the number of eosinophils in a high-powered field.
During the randomized phase, 8 of the 15 patients assigned to active treatment and 3 of 5 patients assigned to the placebo arm had violations of the treatment protocol, the diet protocol, or both. A per protocol analysis that focused on the seven actively treated and two placebo patients who adhered to the protocol showed a mean eosinophil count of 26 cells in patients on active treatment and 95 cells among the controls, a statistically significant difference. However, for the intention-to-treat analysis, which included all 20 enrolled patients, the primary endpoint showed no significant difference in eosinophil counts between the two study arms.
Although Dr. Spergel said that he was not aware of the developing company’s plans for further study of epicutaneous milk immunotherapy, from a scientific standpoint the next step should be a phase 2 or phase 2/3 trial for safety and efficacy. EoE was historically considered a rare disease, but a 2015 review of the condition called it “one of the most common conditions diagnosed during the assessment of feeding problems in children” (New Engl J Med. 2015 Oct 22;373[17]:1640-8).
The study was funded by DBV Technologies, which is developing the epicutaneous immunotherapy system. Dr. Spergel has been a consultant to and has received research funding from DBV Technologies.
SOURCE: Spergel JM et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB430.
SAN FRANCISCO – Clinicians safely used epicutaneous immunotherapy to resolve eosinophilic esophagitis in children and teens secondary to milk consumption in a placebo-controlled, pilot study that included 20 patients.
Following the randomized phase of the study, all 19 patients who continued to participate began an 11-month open-label phase of epicutaneous immunotherapy to milk. At the end of this open-label phase, nine patients (47%) followed in this phase showed a substantial cut in their eosinophilic esophagitis (EoE) response to milk, with fewer than 15 eosinophils in a high-powered field, said Jonathan M. Spergel, MD, chief of the allergy section and Stuart E. Starr Chair of Pediatrics at the Children’s Hospital of Philadelphia, while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. An immunologic response of this sort would likely correlate with substantial clinical benefit.
“I’m happy with a 47% response,” Dr. Spergel said, adding that the responding patients “tolerate milk without symptoms, and there is really no risk” from this form of immunotherapy, which produced no serious adverse effects and caused 1 of 15 patients to stop treatment because of a treatment-related effect during the randomized phase. The most common adverse reaction was gastrointestinal symptoms, but these were just marginally more common among patients on active treatment than in control patients.
In contrast, oral immunotherapy with milk has been ineffective in children with an EoE milk reaction, and results from subcutaneous or sublingual immunotherapy for this form of milk allergy haven’t been reported, he said. The most common, current approaches to managing EoE from milk in children are either milk avoidance or treatment to reduce inflammation.
The epicutaneous approach “uses substantially lower dosing [micrograms vs. milligrams], avoids oral allergen ingestion, and may have a more advantageous adverse event profile and better adherence than other therapies,” according to a recent report that tested epicutaneous immunotherapy for peanut allergy in a phase 3 trial with 356 children (JAMA. 2019 Feb 22. doi: 10.1001/jama.2019.1113). The Viaskin Milk system tested in the current milk study involves placing a disc coated with 500 mcg of lyophilized milk protein on the skin for a gradually increasing number of hours daily until the disc is worn continuously, with daily changes of the disk. On the skin, the protein on the disk interacts with epidermal Langerhans cells to trigger desensitization.
The Milk Patch for Eosinophilic Esophagitis (SMILEE) study enrolled 20 patients at Children’s Hospital aged 4-17 years old and had milk-induced EoE, and randomized 15 to receive active epicutaneous immunotherapy to milk and 5 to receive placebo treatment. The protocol called for 9 month of epicutaneous immunotherapy without any milk exposure, followed by 2 months of continued treatment coupled with at least 240 mL of milk consumption daily. At the end of 2 months the researchers performed an esophageal biopsy on each patient to determine eosinophil density in the tissue. The study’s primary endpoint was the number of eosinophils in a high-powered field.
During the randomized phase, 8 of the 15 patients assigned to active treatment and 3 of 5 patients assigned to the placebo arm had violations of the treatment protocol, the diet protocol, or both. A per protocol analysis that focused on the seven actively treated and two placebo patients who adhered to the protocol showed a mean eosinophil count of 26 cells in patients on active treatment and 95 cells among the controls, a statistically significant difference. However, for the intention-to-treat analysis, which included all 20 enrolled patients, the primary endpoint showed no significant difference in eosinophil counts between the two study arms.
Although Dr. Spergel said that he was not aware of the developing company’s plans for further study of epicutaneous milk immunotherapy, from a scientific standpoint the next step should be a phase 2 or phase 2/3 trial for safety and efficacy. EoE was historically considered a rare disease, but a 2015 review of the condition called it “one of the most common conditions diagnosed during the assessment of feeding problems in children” (New Engl J Med. 2015 Oct 22;373[17]:1640-8).
The study was funded by DBV Technologies, which is developing the epicutaneous immunotherapy system. Dr. Spergel has been a consultant to and has received research funding from DBV Technologies.
SOURCE: Spergel JM et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB430.
REPORTING FROM AAAAI 2019
Key clinical point:
Major finding: After 11 months of open-label treatment, 9 of 19 patients resolved their eosinophilic esophagitis reaction to milk.
Study details: A 2-year, single-center study of epicutaneous milk immunotherapy in 20 children with milk-induced eosinophilic esophagitis.
Disclosures: The study was funded by DBV Technologies, which is developing the epicutaneous immunotherapy system. Dr. Spergel has been a consultant to and has received research funding from DBV Technologies.
Source: Spergel JM et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB430.
Poor asthma control during pregnancy trims live birth rate
SAN FRANCISCO – and among the live births had a significantly increased rate of both preterm delivery and neonatal intensive care admissions, according to a review of insurance claims data for more than 1 million American women during 2011-2015.
On the other hand, asthma severity, which the researchers inferred based on the type and amount of treatment patients received, showed essentially no link with the live birth rate, Jennifer Yland said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“The findings add to the body of evidence that relate poor asthma control to an increased risk for pregnancy complications.” explained Michael X. Schatz, MD, an allergist at Kaiser Permanente of Southern California, in San Diego, and a coauthor of the study.
Results from several prior studies had shown links between asthma and an increased rate of preterm birth, “but the larger, more generalizable population is a strength of the current findings. Results from prior studies have less frequently shown a link between asthma during pregnancy and neonatal ICU admissions,” he added.“The findings strengthen the case for good asthma control during pregnancy.”
For their review, Ms. Yland and her coauthors used insurance claims data from privately-insured American women aged 12-55 years who were pregnant and had drug prescription records during the study period. The database included 996,861 women without an asthma diagnosis and 29,882 women diagnosed with asthma. The analysis excluded women diagnosed with chronic obstructive pulmonary disease at least twice during pregnancy.
To analyze the pregnancy outcomes by asthma severity Ms. Yland and her associates divided the asthma patients into five subgroups based on the drug regimens they were on during pregnancy as a surrogate marker of disease severity. This analysis showed no relationship between disease severity and live birth rate.
The researchers also ran an analysis that divided patients into the quality of their management during pregnancy – either good or poor – based on either of two markers of poor control: filling five or more prescriptions for a short-acting beta-antagonist, or at least one exacerbation episode defined as an asthma-related emergency department visit, hospitalization, or need for oral corticosteroid treatment. By these criteria 7,135 (24%) of the pregnant women with asthma were poorly controlled. The live birth rate was 74% among women without asthma, 71% among those with well-controlled asthma, and 68% among women with poorly-controlled asthma, reported Ms. Yland, a researcher at the Harvard T.H. Chan School of Public Health in Boston.
In a multivariate analysis that adjusted for demographic differences and comorbidities, women with poorly-controlled asthma had preterm delivery a statistically significant 30% more often than did women with well-controlled asthma, and the rate of neonatal ICU admissions was a significant 24% higher in women with poorly-controlled asthma, compared with women who had well-controlled asthma. However, the rates of small-for-gestational-age infants and infants with congenital malformations was not significantly different between the well-controlled and poorly-controlled subgroups.
The finding that almost a quarter of the pregnant women in the study were poorly controlled wasn’t surprising, Dr. Schatz said in an interview. In some studies as many as half the asthma patients have poor control.
The 24% rate of poor asthma control during pregnancy in the studied women is “most likely an underestimate of poor control in the general population” because the study used data from women with commercial health insurance, noted Sonia Hernandez-Diaz, MD, lead investigator for the study and professor of epidemiology at Harvard T.H. Chan School of Public Health. “More disadvantaged populations, such as pregnant women on Medicaid, tend to have worse control.”
Barriers to good asthma control during pregnancy include smoking, weight gain, undertreatment, poor adherence, and viral infection. The overall approach to managing asthma during pregnancy is the same as when women are not pregnant, although certain asthma medications have a better safety record during pregnancy. “The most reassuring data exist for albuterol and inhaled steroids, particularly budesonide and fluticasone. Reassuring data also exist for the long-acting beta agonists salmeterol and formoterol, which are combined with inhaled steroids, and for montelukast,” Dr. Schatz said.
This is the first study to assess the impact of asthma management on pregnancy outcome in such a large population. The large number of women included provided a lot of statistical power and allowed the analyses to control for several potential confounders, Ms. Yland noted in an interview. She plans to expand the analysis with Medicaid data to try to further increase the generalizability and precision of the findings.
The study was funded by GlaxoSmithKline, and a coauthor of the study is a company employee. Ms. Yland had no disclosures. Dr. Schatz has received research funding from ALK, AstraZeneca, Medimmune, GlaxoSmithKline, and Merck. Dr. Hernandez-Diaz has been a consultant to Boehringer Ingelheim, Roche, and UCB, and has received research funding from GlaxoSmithKline, Lilly, and Pfizer.
SOURCE: Yland J et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB422.
SAN FRANCISCO – and among the live births had a significantly increased rate of both preterm delivery and neonatal intensive care admissions, according to a review of insurance claims data for more than 1 million American women during 2011-2015.
On the other hand, asthma severity, which the researchers inferred based on the type and amount of treatment patients received, showed essentially no link with the live birth rate, Jennifer Yland said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“The findings add to the body of evidence that relate poor asthma control to an increased risk for pregnancy complications.” explained Michael X. Schatz, MD, an allergist at Kaiser Permanente of Southern California, in San Diego, and a coauthor of the study.
Results from several prior studies had shown links between asthma and an increased rate of preterm birth, “but the larger, more generalizable population is a strength of the current findings. Results from prior studies have less frequently shown a link between asthma during pregnancy and neonatal ICU admissions,” he added.“The findings strengthen the case for good asthma control during pregnancy.”
For their review, Ms. Yland and her coauthors used insurance claims data from privately-insured American women aged 12-55 years who were pregnant and had drug prescription records during the study period. The database included 996,861 women without an asthma diagnosis and 29,882 women diagnosed with asthma. The analysis excluded women diagnosed with chronic obstructive pulmonary disease at least twice during pregnancy.
To analyze the pregnancy outcomes by asthma severity Ms. Yland and her associates divided the asthma patients into five subgroups based on the drug regimens they were on during pregnancy as a surrogate marker of disease severity. This analysis showed no relationship between disease severity and live birth rate.
The researchers also ran an analysis that divided patients into the quality of their management during pregnancy – either good or poor – based on either of two markers of poor control: filling five or more prescriptions for a short-acting beta-antagonist, or at least one exacerbation episode defined as an asthma-related emergency department visit, hospitalization, or need for oral corticosteroid treatment. By these criteria 7,135 (24%) of the pregnant women with asthma were poorly controlled. The live birth rate was 74% among women without asthma, 71% among those with well-controlled asthma, and 68% among women with poorly-controlled asthma, reported Ms. Yland, a researcher at the Harvard T.H. Chan School of Public Health in Boston.
In a multivariate analysis that adjusted for demographic differences and comorbidities, women with poorly-controlled asthma had preterm delivery a statistically significant 30% more often than did women with well-controlled asthma, and the rate of neonatal ICU admissions was a significant 24% higher in women with poorly-controlled asthma, compared with women who had well-controlled asthma. However, the rates of small-for-gestational-age infants and infants with congenital malformations was not significantly different between the well-controlled and poorly-controlled subgroups.
The finding that almost a quarter of the pregnant women in the study were poorly controlled wasn’t surprising, Dr. Schatz said in an interview. In some studies as many as half the asthma patients have poor control.
The 24% rate of poor asthma control during pregnancy in the studied women is “most likely an underestimate of poor control in the general population” because the study used data from women with commercial health insurance, noted Sonia Hernandez-Diaz, MD, lead investigator for the study and professor of epidemiology at Harvard T.H. Chan School of Public Health. “More disadvantaged populations, such as pregnant women on Medicaid, tend to have worse control.”
Barriers to good asthma control during pregnancy include smoking, weight gain, undertreatment, poor adherence, and viral infection. The overall approach to managing asthma during pregnancy is the same as when women are not pregnant, although certain asthma medications have a better safety record during pregnancy. “The most reassuring data exist for albuterol and inhaled steroids, particularly budesonide and fluticasone. Reassuring data also exist for the long-acting beta agonists salmeterol and formoterol, which are combined with inhaled steroids, and for montelukast,” Dr. Schatz said.
This is the first study to assess the impact of asthma management on pregnancy outcome in such a large population. The large number of women included provided a lot of statistical power and allowed the analyses to control for several potential confounders, Ms. Yland noted in an interview. She plans to expand the analysis with Medicaid data to try to further increase the generalizability and precision of the findings.
The study was funded by GlaxoSmithKline, and a coauthor of the study is a company employee. Ms. Yland had no disclosures. Dr. Schatz has received research funding from ALK, AstraZeneca, Medimmune, GlaxoSmithKline, and Merck. Dr. Hernandez-Diaz has been a consultant to Boehringer Ingelheim, Roche, and UCB, and has received research funding from GlaxoSmithKline, Lilly, and Pfizer.
SOURCE: Yland J et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB422.
SAN FRANCISCO – and among the live births had a significantly increased rate of both preterm delivery and neonatal intensive care admissions, according to a review of insurance claims data for more than 1 million American women during 2011-2015.
On the other hand, asthma severity, which the researchers inferred based on the type and amount of treatment patients received, showed essentially no link with the live birth rate, Jennifer Yland said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
“The findings add to the body of evidence that relate poor asthma control to an increased risk for pregnancy complications.” explained Michael X. Schatz, MD, an allergist at Kaiser Permanente of Southern California, in San Diego, and a coauthor of the study.
Results from several prior studies had shown links between asthma and an increased rate of preterm birth, “but the larger, more generalizable population is a strength of the current findings. Results from prior studies have less frequently shown a link between asthma during pregnancy and neonatal ICU admissions,” he added.“The findings strengthen the case for good asthma control during pregnancy.”
For their review, Ms. Yland and her coauthors used insurance claims data from privately-insured American women aged 12-55 years who were pregnant and had drug prescription records during the study period. The database included 996,861 women without an asthma diagnosis and 29,882 women diagnosed with asthma. The analysis excluded women diagnosed with chronic obstructive pulmonary disease at least twice during pregnancy.
To analyze the pregnancy outcomes by asthma severity Ms. Yland and her associates divided the asthma patients into five subgroups based on the drug regimens they were on during pregnancy as a surrogate marker of disease severity. This analysis showed no relationship between disease severity and live birth rate.
The researchers also ran an analysis that divided patients into the quality of their management during pregnancy – either good or poor – based on either of two markers of poor control: filling five or more prescriptions for a short-acting beta-antagonist, or at least one exacerbation episode defined as an asthma-related emergency department visit, hospitalization, or need for oral corticosteroid treatment. By these criteria 7,135 (24%) of the pregnant women with asthma were poorly controlled. The live birth rate was 74% among women without asthma, 71% among those with well-controlled asthma, and 68% among women with poorly-controlled asthma, reported Ms. Yland, a researcher at the Harvard T.H. Chan School of Public Health in Boston.
In a multivariate analysis that adjusted for demographic differences and comorbidities, women with poorly-controlled asthma had preterm delivery a statistically significant 30% more often than did women with well-controlled asthma, and the rate of neonatal ICU admissions was a significant 24% higher in women with poorly-controlled asthma, compared with women who had well-controlled asthma. However, the rates of small-for-gestational-age infants and infants with congenital malformations was not significantly different between the well-controlled and poorly-controlled subgroups.
The finding that almost a quarter of the pregnant women in the study were poorly controlled wasn’t surprising, Dr. Schatz said in an interview. In some studies as many as half the asthma patients have poor control.
The 24% rate of poor asthma control during pregnancy in the studied women is “most likely an underestimate of poor control in the general population” because the study used data from women with commercial health insurance, noted Sonia Hernandez-Diaz, MD, lead investigator for the study and professor of epidemiology at Harvard T.H. Chan School of Public Health. “More disadvantaged populations, such as pregnant women on Medicaid, tend to have worse control.”
Barriers to good asthma control during pregnancy include smoking, weight gain, undertreatment, poor adherence, and viral infection. The overall approach to managing asthma during pregnancy is the same as when women are not pregnant, although certain asthma medications have a better safety record during pregnancy. “The most reassuring data exist for albuterol and inhaled steroids, particularly budesonide and fluticasone. Reassuring data also exist for the long-acting beta agonists salmeterol and formoterol, which are combined with inhaled steroids, and for montelukast,” Dr. Schatz said.
This is the first study to assess the impact of asthma management on pregnancy outcome in such a large population. The large number of women included provided a lot of statistical power and allowed the analyses to control for several potential confounders, Ms. Yland noted in an interview. She plans to expand the analysis with Medicaid data to try to further increase the generalizability and precision of the findings.
The study was funded by GlaxoSmithKline, and a coauthor of the study is a company employee. Ms. Yland had no disclosures. Dr. Schatz has received research funding from ALK, AstraZeneca, Medimmune, GlaxoSmithKline, and Merck. Dr. Hernandez-Diaz has been a consultant to Boehringer Ingelheim, Roche, and UCB, and has received research funding from GlaxoSmithKline, Lilly, and Pfizer.
SOURCE: Yland J et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB422.
REPORTING FROM AAAAI 2019
Atopic dermatitis at 1 year links with persistent food allergies
SAN FRANCISCO – Children diagnosed with atopic dermatitis when they were 1 year old were significantly more likely to have active food allergies and to have those allergies persist throughout childhood to age 18 years, based on findings from a prospective, longitudinal study of 287 Wisconsin children.
The link between atopic dermatitis (AD) and food allergy was especially strong in children who displayed early and recurrent AD; the link was weaker or essentially nonexistent for children with early transient AD or AD that first appeared later in childhood, Anne Marie Singh, MD, said while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The results also showed that even mild AD linked with an increased prevalence of food allergy when it appeared early and persisted, but more severe AD with this onset and recurrence pattern led to an even greater prevalence of food allergy, said Dr. Singh, a pediatric allergist and asthma specialist at the University of Wisconsin–Madison.
“The data suggest that something about early, recurrent AD increases the risk for food allergy throughout childhood,” Dr. Singh said in an interview. The findings suggest that surveillance for food allergies need to be intensified in infants who present with AD by the time they’re 1 year old and that food allergy surveillance should continue as these children age as long as their AD recurs.
The results also hint that these children might potentially benefit from steps aimed at desensitizing the allergy, although this must be proven in a future intervention study, she said.
The results suggest that a food allergy prevention regimen like the one used in the Learning Early About Peanut Allergy (LEAP) trial (New Engl J Med. 2015 Feb 26;372[9]:803-13) to prevent peanut allergy may be appropriate for selected, high-risk children with early AD, but this hypothesis needs testing, Dr. Singh said. She noted that some important differences exist between the patients enrolled in LEAP and the children studied in the current report: In LEAP, all enrolled children had severe eczema, an established egg allergy, or both. The findings reported by Dr. Singh came from children with AD, but only about 30% had moderate or severe eczema, and her analysis did not subdivide the observed food allergies by the type of food that caused a reaction.
She and her associates used data collected in the Childhood Origins of Asthma (COAST) study, begun in 1998, which enrolled 287 infants prior to birth who had at least one parent who was allergic, asthmatic, or both (Pediatr Allergy Immunol. 2002 Dec;13[s15]:38-43). The data showed that 62% of the infants had either no AD or transient AD, 14% had late onset AD, and 24% had early, recurrent AD. Although the data showed a statistically significant link between AD at 1 year old and food allergies throughout childhood, further analysis that broke the population into three different patterns of AD showed that the link with food allergy primarily existed among children with the early, recurrent form. Children with early, recurrent atopic dermatitis had a food allergy prevalence of 12%-27% annually through the age of 18 years.
“The data suggest that immunologic changes early in life are critical to food allergy development and that these changes have long-lasting effects throughout childhood,” Dr. Singh concluded. “The immunologic mechanisms by which early AD affects food allergy development and disease expression require further investigation.”
COAST received no commercial funding. Dr. Singh reported no relevant financial disclosures.
SOURCE: Singh AM et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB125.
SAN FRANCISCO – Children diagnosed with atopic dermatitis when they were 1 year old were significantly more likely to have active food allergies and to have those allergies persist throughout childhood to age 18 years, based on findings from a prospective, longitudinal study of 287 Wisconsin children.
The link between atopic dermatitis (AD) and food allergy was especially strong in children who displayed early and recurrent AD; the link was weaker or essentially nonexistent for children with early transient AD or AD that first appeared later in childhood, Anne Marie Singh, MD, said while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The results also showed that even mild AD linked with an increased prevalence of food allergy when it appeared early and persisted, but more severe AD with this onset and recurrence pattern led to an even greater prevalence of food allergy, said Dr. Singh, a pediatric allergist and asthma specialist at the University of Wisconsin–Madison.
“The data suggest that something about early, recurrent AD increases the risk for food allergy throughout childhood,” Dr. Singh said in an interview. The findings suggest that surveillance for food allergies need to be intensified in infants who present with AD by the time they’re 1 year old and that food allergy surveillance should continue as these children age as long as their AD recurs.
The results also hint that these children might potentially benefit from steps aimed at desensitizing the allergy, although this must be proven in a future intervention study, she said.
The results suggest that a food allergy prevention regimen like the one used in the Learning Early About Peanut Allergy (LEAP) trial (New Engl J Med. 2015 Feb 26;372[9]:803-13) to prevent peanut allergy may be appropriate for selected, high-risk children with early AD, but this hypothesis needs testing, Dr. Singh said. She noted that some important differences exist between the patients enrolled in LEAP and the children studied in the current report: In LEAP, all enrolled children had severe eczema, an established egg allergy, or both. The findings reported by Dr. Singh came from children with AD, but only about 30% had moderate or severe eczema, and her analysis did not subdivide the observed food allergies by the type of food that caused a reaction.
She and her associates used data collected in the Childhood Origins of Asthma (COAST) study, begun in 1998, which enrolled 287 infants prior to birth who had at least one parent who was allergic, asthmatic, or both (Pediatr Allergy Immunol. 2002 Dec;13[s15]:38-43). The data showed that 62% of the infants had either no AD or transient AD, 14% had late onset AD, and 24% had early, recurrent AD. Although the data showed a statistically significant link between AD at 1 year old and food allergies throughout childhood, further analysis that broke the population into three different patterns of AD showed that the link with food allergy primarily existed among children with the early, recurrent form. Children with early, recurrent atopic dermatitis had a food allergy prevalence of 12%-27% annually through the age of 18 years.
“The data suggest that immunologic changes early in life are critical to food allergy development and that these changes have long-lasting effects throughout childhood,” Dr. Singh concluded. “The immunologic mechanisms by which early AD affects food allergy development and disease expression require further investigation.”
COAST received no commercial funding. Dr. Singh reported no relevant financial disclosures.
SOURCE: Singh AM et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB125.
SAN FRANCISCO – Children diagnosed with atopic dermatitis when they were 1 year old were significantly more likely to have active food allergies and to have those allergies persist throughout childhood to age 18 years, based on findings from a prospective, longitudinal study of 287 Wisconsin children.
The link between atopic dermatitis (AD) and food allergy was especially strong in children who displayed early and recurrent AD; the link was weaker or essentially nonexistent for children with early transient AD or AD that first appeared later in childhood, Anne Marie Singh, MD, said while presenting a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
The results also showed that even mild AD linked with an increased prevalence of food allergy when it appeared early and persisted, but more severe AD with this onset and recurrence pattern led to an even greater prevalence of food allergy, said Dr. Singh, a pediatric allergist and asthma specialist at the University of Wisconsin–Madison.
“The data suggest that something about early, recurrent AD increases the risk for food allergy throughout childhood,” Dr. Singh said in an interview. The findings suggest that surveillance for food allergies need to be intensified in infants who present with AD by the time they’re 1 year old and that food allergy surveillance should continue as these children age as long as their AD recurs.
The results also hint that these children might potentially benefit from steps aimed at desensitizing the allergy, although this must be proven in a future intervention study, she said.
The results suggest that a food allergy prevention regimen like the one used in the Learning Early About Peanut Allergy (LEAP) trial (New Engl J Med. 2015 Feb 26;372[9]:803-13) to prevent peanut allergy may be appropriate for selected, high-risk children with early AD, but this hypothesis needs testing, Dr. Singh said. She noted that some important differences exist between the patients enrolled in LEAP and the children studied in the current report: In LEAP, all enrolled children had severe eczema, an established egg allergy, or both. The findings reported by Dr. Singh came from children with AD, but only about 30% had moderate or severe eczema, and her analysis did not subdivide the observed food allergies by the type of food that caused a reaction.
She and her associates used data collected in the Childhood Origins of Asthma (COAST) study, begun in 1998, which enrolled 287 infants prior to birth who had at least one parent who was allergic, asthmatic, or both (Pediatr Allergy Immunol. 2002 Dec;13[s15]:38-43). The data showed that 62% of the infants had either no AD or transient AD, 14% had late onset AD, and 24% had early, recurrent AD. Although the data showed a statistically significant link between AD at 1 year old and food allergies throughout childhood, further analysis that broke the population into three different patterns of AD showed that the link with food allergy primarily existed among children with the early, recurrent form. Children with early, recurrent atopic dermatitis had a food allergy prevalence of 12%-27% annually through the age of 18 years.
“The data suggest that immunologic changes early in life are critical to food allergy development and that these changes have long-lasting effects throughout childhood,” Dr. Singh concluded. “The immunologic mechanisms by which early AD affects food allergy development and disease expression require further investigation.”
COAST received no commercial funding. Dr. Singh reported no relevant financial disclosures.
SOURCE: Singh AM et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB125.
REPORTING FROM AAAAI 2019
Age 1 food allergies often disappear by age 6
SAN FRANCISCO –
Among 131 infants diagnosed with a peanut allergy when they were 1 year old and then followed with repeat testing 5 years later, 41 (31%) had complete resolution of their peanut allergy, while the allergy persisted in the other 90 children, Rachel L. Peters, PhD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. The study also followed 404 infants diagnosed with an egg allergy at 1 year of age and found that by age 6 the allergy had resolved in 368 (91%), while persisting in 36 children, said Dr. Peters, an epidemiologist at Murdoch Children’s Research Institute in Parkville, Australia.
The analysis also identified risk factors that linked with an increased rate of allergy persistence. For peanut allergy persistence beyond the first year, the correlating factors were early-onset eczema, tree nut allergy, and a stronger peanut allergy identified by a greater than 4-mm reaction to a peanut skin-prick test. Factors that linked with an increased rate of persistent egg allergy were eczema, peanut allergy, gastrointestinal or respiratory reaction symptoms to milk, and reaction on an oral food challenge elicited by a low dose (less than 0.5 mL) of milk.
A consequence of the frequent resolution of these food allergies was that a positive skin-prick test reaction to either peanut or egg at 1 year old was poorly predictive of allergy status at age 6, while skin-prick tests at age 6 worked well for identifying a persistent food allergy at that age.
The analyses that Dr. Peters and her associates ran used data collected in the HealthNuts study, a comprehensive, prospective, population-based study of food allergies in children that enrolled 5,276 infants at 1 year old. The HealthNuts researchers enrolled infants at immunization clinics in the Melbourne area, with enrollment stratified to represent the people who live in that region (Clin Exp Allergy. 2010 Oct;40[10]:1516-22).
[email protected]
On Twitter @mitchelzoler
SOURCE: Peters R et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB421.
SAN FRANCISCO –
Among 131 infants diagnosed with a peanut allergy when they were 1 year old and then followed with repeat testing 5 years later, 41 (31%) had complete resolution of their peanut allergy, while the allergy persisted in the other 90 children, Rachel L. Peters, PhD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. The study also followed 404 infants diagnosed with an egg allergy at 1 year of age and found that by age 6 the allergy had resolved in 368 (91%), while persisting in 36 children, said Dr. Peters, an epidemiologist at Murdoch Children’s Research Institute in Parkville, Australia.
The analysis also identified risk factors that linked with an increased rate of allergy persistence. For peanut allergy persistence beyond the first year, the correlating factors were early-onset eczema, tree nut allergy, and a stronger peanut allergy identified by a greater than 4-mm reaction to a peanut skin-prick test. Factors that linked with an increased rate of persistent egg allergy were eczema, peanut allergy, gastrointestinal or respiratory reaction symptoms to milk, and reaction on an oral food challenge elicited by a low dose (less than 0.5 mL) of milk.
A consequence of the frequent resolution of these food allergies was that a positive skin-prick test reaction to either peanut or egg at 1 year old was poorly predictive of allergy status at age 6, while skin-prick tests at age 6 worked well for identifying a persistent food allergy at that age.
The analyses that Dr. Peters and her associates ran used data collected in the HealthNuts study, a comprehensive, prospective, population-based study of food allergies in children that enrolled 5,276 infants at 1 year old. The HealthNuts researchers enrolled infants at immunization clinics in the Melbourne area, with enrollment stratified to represent the people who live in that region (Clin Exp Allergy. 2010 Oct;40[10]:1516-22).
[email protected]
On Twitter @mitchelzoler
SOURCE: Peters R et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB421.
SAN FRANCISCO –
Among 131 infants diagnosed with a peanut allergy when they were 1 year old and then followed with repeat testing 5 years later, 41 (31%) had complete resolution of their peanut allergy, while the allergy persisted in the other 90 children, Rachel L. Peters, PhD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. The study also followed 404 infants diagnosed with an egg allergy at 1 year of age and found that by age 6 the allergy had resolved in 368 (91%), while persisting in 36 children, said Dr. Peters, an epidemiologist at Murdoch Children’s Research Institute in Parkville, Australia.
The analysis also identified risk factors that linked with an increased rate of allergy persistence. For peanut allergy persistence beyond the first year, the correlating factors were early-onset eczema, tree nut allergy, and a stronger peanut allergy identified by a greater than 4-mm reaction to a peanut skin-prick test. Factors that linked with an increased rate of persistent egg allergy were eczema, peanut allergy, gastrointestinal or respiratory reaction symptoms to milk, and reaction on an oral food challenge elicited by a low dose (less than 0.5 mL) of milk.
A consequence of the frequent resolution of these food allergies was that a positive skin-prick test reaction to either peanut or egg at 1 year old was poorly predictive of allergy status at age 6, while skin-prick tests at age 6 worked well for identifying a persistent food allergy at that age.
The analyses that Dr. Peters and her associates ran used data collected in the HealthNuts study, a comprehensive, prospective, population-based study of food allergies in children that enrolled 5,276 infants at 1 year old. The HealthNuts researchers enrolled infants at immunization clinics in the Melbourne area, with enrollment stratified to represent the people who live in that region (Clin Exp Allergy. 2010 Oct;40[10]:1516-22).
[email protected]
On Twitter @mitchelzoler
SOURCE: Peters R et al. J Allergy Clin Immunol. 2019 Feb;143[2]:AB421.
REPORTING FROM AAAAI
Stroke thrombolysis looks safe 31+ days after prior stroke
HONOLULU – , based on a review of more than 40,000 U.S. stroke patients.
Current U.S. stroke management guidelines say that thrombolytic therapy with tissue plasminogen activator (tPA; alteplase; Activase) is contraindicated for index stroke patients who had a prior stroke within the previous 3 months (Stroke. 2018 Mar;49[3]:e46-99). But analysis of 293 U.S. patients who received thrombolytic treatment for an index acute ischemic stroke despite having had a recent, prior stroke showed no increased risk for adverse outcomes when the prior stroke occurred more than 30 days before, Shreyansh Shah, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“The risk of symptomatic intracranial hemorrhage [ICH] after thrombolysis was highest among those with a history of prior ischemic stroke within the past 14 days,” said Dr. Shah, a neurologist at Duke University in Durham, N.C.
“Even after many adjustments we still saw a high risk of symptomatic ICH within the first 2 weeks, suggesting that these patients are at especially high risk” from treatment with tissue plasminogen activator for the index stroke. These findings “are very important because I don’t see a randomized trial happening to test the hypothesis,” Dr. Shah said in an interview.
He also suggested that prior treatment with tPA was not an important factor, just the occurrence of a recent, prior ischemic stoke that left blood vessels in the affected brain region “friable and at high risk for hemorrhage,” he said.
His study used data from 40,396 patients with an acute ischemic stroke who presented at and received treatment with tPA at any of 1,522 hospitals that participated in the Get With the Guidelines-Stroke program during 2009-2015. The analysis focused on 30,655 of these patients with no prior stroke history who served as the controls, and 293 who had a prior ischemic stroke within the preceding 90 days. These 293 patients further broke into 43 who received thrombolysis within 14 days of their prior stroke, 47 who had the treatment 15-30 days after their prior stroke, and 203 who underwent thrombolysis 31-90 days after their prior stroke. Patients ages’ in both the no-stroke history and recent-stroke subgroups each averaged 80 years.
A comparison between all 293 patients who had a prior stroke within 90 days and the controls showed no statistically significant difference in the rate of symptomatic ICH: 5% among those with no stroke history and 8% in those with a recent stroke. There was also no significant difference in the rate of in-hospital mortality, occurring in 9% of those without a prior stroke, compared with 13% of those with a recent prior stroke. But the patients with no stroke history fared better by other measures, with a significantly lower rate of in-hospital death or discharge to a hospice, and also a significantly higher rate of 0-1 scores on the modified Rankin Scale, compared with patients with a history of prior stroke.
A more granular analysis of the timing of the prior stroke showed that most of risk from thrombolysis clustered in patients with a very recent prior stroke. The 43 patients with a prior stroke within the preceding 14 days had a symptomatic ICH rate of 16% after thrombolysis, 3.7-fold higher than the control patients in an adjusted analysis. Once the patients with a prior stroke within the past 14 days were pulled out, the remaining patients with prior strokes 15-30 days before as well as those with a prior stroke 31-90 days previously had symptomatic ICH rates that were not significantly different from the controls, Dr. Shah reported.
The results also showed an increased rate of in-hospital mortality or discharge to a hospice clustered in patients treated either within 14 days or during 15-30 days after a prior stroke. In both subgroups, the rate of this outcome was about triple the control rate. In the subgroup treated with thrombolysis 31-90 days after a prior stroke, the rate of in-hospital mortality or discharge to a hospice was about the same as the controls.
“It appears that some patients could benefit from tPA; there is a potential safety signal. It allows for some discretion when using thrombolytic treatment” in patients with a recent, prior stroke, Dr. Shah suggested. “This is by far the largest analysis ever reported” for thrombolytic treatment of patients following a recent, prior stroke, noted Ying Xian, MD, PhD, a Duke neurologist and study coauthor.
But Gregg C. Fonarow, MD, another coauthor, cautioned against immediately applying this finding to practice. “The findings of Dr. Shah’s study suggest that selected patients with prior stroke within a 14- to 90-day window may be considered for tPA treatment. However, further study is warranted given the relatively small number of patients,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.
Dr. Shah and Dr. Xian had no disclosures. Dr. Fonarow had no relevant disclosures.
SOURCE: Shah S et al. Stroke. 2019 Feb;50(Suppl_1): Abstract 35.
HONOLULU – , based on a review of more than 40,000 U.S. stroke patients.
Current U.S. stroke management guidelines say that thrombolytic therapy with tissue plasminogen activator (tPA; alteplase; Activase) is contraindicated for index stroke patients who had a prior stroke within the previous 3 months (Stroke. 2018 Mar;49[3]:e46-99). But analysis of 293 U.S. patients who received thrombolytic treatment for an index acute ischemic stroke despite having had a recent, prior stroke showed no increased risk for adverse outcomes when the prior stroke occurred more than 30 days before, Shreyansh Shah, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“The risk of symptomatic intracranial hemorrhage [ICH] after thrombolysis was highest among those with a history of prior ischemic stroke within the past 14 days,” said Dr. Shah, a neurologist at Duke University in Durham, N.C.
“Even after many adjustments we still saw a high risk of symptomatic ICH within the first 2 weeks, suggesting that these patients are at especially high risk” from treatment with tissue plasminogen activator for the index stroke. These findings “are very important because I don’t see a randomized trial happening to test the hypothesis,” Dr. Shah said in an interview.
He also suggested that prior treatment with tPA was not an important factor, just the occurrence of a recent, prior ischemic stoke that left blood vessels in the affected brain region “friable and at high risk for hemorrhage,” he said.
His study used data from 40,396 patients with an acute ischemic stroke who presented at and received treatment with tPA at any of 1,522 hospitals that participated in the Get With the Guidelines-Stroke program during 2009-2015. The analysis focused on 30,655 of these patients with no prior stroke history who served as the controls, and 293 who had a prior ischemic stroke within the preceding 90 days. These 293 patients further broke into 43 who received thrombolysis within 14 days of their prior stroke, 47 who had the treatment 15-30 days after their prior stroke, and 203 who underwent thrombolysis 31-90 days after their prior stroke. Patients ages’ in both the no-stroke history and recent-stroke subgroups each averaged 80 years.
A comparison between all 293 patients who had a prior stroke within 90 days and the controls showed no statistically significant difference in the rate of symptomatic ICH: 5% among those with no stroke history and 8% in those with a recent stroke. There was also no significant difference in the rate of in-hospital mortality, occurring in 9% of those without a prior stroke, compared with 13% of those with a recent prior stroke. But the patients with no stroke history fared better by other measures, with a significantly lower rate of in-hospital death or discharge to a hospice, and also a significantly higher rate of 0-1 scores on the modified Rankin Scale, compared with patients with a history of prior stroke.
A more granular analysis of the timing of the prior stroke showed that most of risk from thrombolysis clustered in patients with a very recent prior stroke. The 43 patients with a prior stroke within the preceding 14 days had a symptomatic ICH rate of 16% after thrombolysis, 3.7-fold higher than the control patients in an adjusted analysis. Once the patients with a prior stroke within the past 14 days were pulled out, the remaining patients with prior strokes 15-30 days before as well as those with a prior stroke 31-90 days previously had symptomatic ICH rates that were not significantly different from the controls, Dr. Shah reported.
The results also showed an increased rate of in-hospital mortality or discharge to a hospice clustered in patients treated either within 14 days or during 15-30 days after a prior stroke. In both subgroups, the rate of this outcome was about triple the control rate. In the subgroup treated with thrombolysis 31-90 days after a prior stroke, the rate of in-hospital mortality or discharge to a hospice was about the same as the controls.
“It appears that some patients could benefit from tPA; there is a potential safety signal. It allows for some discretion when using thrombolytic treatment” in patients with a recent, prior stroke, Dr. Shah suggested. “This is by far the largest analysis ever reported” for thrombolytic treatment of patients following a recent, prior stroke, noted Ying Xian, MD, PhD, a Duke neurologist and study coauthor.
But Gregg C. Fonarow, MD, another coauthor, cautioned against immediately applying this finding to practice. “The findings of Dr. Shah’s study suggest that selected patients with prior stroke within a 14- to 90-day window may be considered for tPA treatment. However, further study is warranted given the relatively small number of patients,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.
Dr. Shah and Dr. Xian had no disclosures. Dr. Fonarow had no relevant disclosures.
SOURCE: Shah S et al. Stroke. 2019 Feb;50(Suppl_1): Abstract 35.
HONOLULU – , based on a review of more than 40,000 U.S. stroke patients.
Current U.S. stroke management guidelines say that thrombolytic therapy with tissue plasminogen activator (tPA; alteplase; Activase) is contraindicated for index stroke patients who had a prior stroke within the previous 3 months (Stroke. 2018 Mar;49[3]:e46-99). But analysis of 293 U.S. patients who received thrombolytic treatment for an index acute ischemic stroke despite having had a recent, prior stroke showed no increased risk for adverse outcomes when the prior stroke occurred more than 30 days before, Shreyansh Shah, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“The risk of symptomatic intracranial hemorrhage [ICH] after thrombolysis was highest among those with a history of prior ischemic stroke within the past 14 days,” said Dr. Shah, a neurologist at Duke University in Durham, N.C.
“Even after many adjustments we still saw a high risk of symptomatic ICH within the first 2 weeks, suggesting that these patients are at especially high risk” from treatment with tissue plasminogen activator for the index stroke. These findings “are very important because I don’t see a randomized trial happening to test the hypothesis,” Dr. Shah said in an interview.
He also suggested that prior treatment with tPA was not an important factor, just the occurrence of a recent, prior ischemic stoke that left blood vessels in the affected brain region “friable and at high risk for hemorrhage,” he said.
His study used data from 40,396 patients with an acute ischemic stroke who presented at and received treatment with tPA at any of 1,522 hospitals that participated in the Get With the Guidelines-Stroke program during 2009-2015. The analysis focused on 30,655 of these patients with no prior stroke history who served as the controls, and 293 who had a prior ischemic stroke within the preceding 90 days. These 293 patients further broke into 43 who received thrombolysis within 14 days of their prior stroke, 47 who had the treatment 15-30 days after their prior stroke, and 203 who underwent thrombolysis 31-90 days after their prior stroke. Patients ages’ in both the no-stroke history and recent-stroke subgroups each averaged 80 years.
A comparison between all 293 patients who had a prior stroke within 90 days and the controls showed no statistically significant difference in the rate of symptomatic ICH: 5% among those with no stroke history and 8% in those with a recent stroke. There was also no significant difference in the rate of in-hospital mortality, occurring in 9% of those without a prior stroke, compared with 13% of those with a recent prior stroke. But the patients with no stroke history fared better by other measures, with a significantly lower rate of in-hospital death or discharge to a hospice, and also a significantly higher rate of 0-1 scores on the modified Rankin Scale, compared with patients with a history of prior stroke.
A more granular analysis of the timing of the prior stroke showed that most of risk from thrombolysis clustered in patients with a very recent prior stroke. The 43 patients with a prior stroke within the preceding 14 days had a symptomatic ICH rate of 16% after thrombolysis, 3.7-fold higher than the control patients in an adjusted analysis. Once the patients with a prior stroke within the past 14 days were pulled out, the remaining patients with prior strokes 15-30 days before as well as those with a prior stroke 31-90 days previously had symptomatic ICH rates that were not significantly different from the controls, Dr. Shah reported.
The results also showed an increased rate of in-hospital mortality or discharge to a hospice clustered in patients treated either within 14 days or during 15-30 days after a prior stroke. In both subgroups, the rate of this outcome was about triple the control rate. In the subgroup treated with thrombolysis 31-90 days after a prior stroke, the rate of in-hospital mortality or discharge to a hospice was about the same as the controls.
“It appears that some patients could benefit from tPA; there is a potential safety signal. It allows for some discretion when using thrombolytic treatment” in patients with a recent, prior stroke, Dr. Shah suggested. “This is by far the largest analysis ever reported” for thrombolytic treatment of patients following a recent, prior stroke, noted Ying Xian, MD, PhD, a Duke neurologist and study coauthor.
But Gregg C. Fonarow, MD, another coauthor, cautioned against immediately applying this finding to practice. “The findings of Dr. Shah’s study suggest that selected patients with prior stroke within a 14- to 90-day window may be considered for tPA treatment. However, further study is warranted given the relatively small number of patients,” said Dr. Fonarow, professor of medicine and cochief of cardiology at the University of California, Los Angeles.
Dr. Shah and Dr. Xian had no disclosures. Dr. Fonarow had no relevant disclosures.
SOURCE: Shah S et al. Stroke. 2019 Feb;50(Suppl_1): Abstract 35.
REPORTING FROM ISC 2019
U.S. sesame allergy prevalence estimated at 750,000
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
SAN FRANCISCO – The estimated roughly about 750,000 people, according to a recent, representative survey of more than 78,000 Americans, which shows sesame allergy apparently is common enough to prompt the Food and Drug Administration to require food labels that identify sesame as an ingredient or possible contaminant.
The sesame-allergy data also showed that sesame reactions were rated as having been severe by about a third of respondents, they caused about two-thirds of people who responded to sesame to go to an emergency department at least once (the highest rate for this outcome among all food allergies), and reactions had led to use of an epinephrine automated injector by about a quarter of people who responded to it, Christopher M. Warren said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
These findings document the public health importance of sesame allergy, which seems widespread and often severe enough to warrant making sesame the ninth allergen to require specific food labeling, said Ruchi S. Gupta, MD, senior author of the study and a professor of pediatrics and medicine at Northwestern University in Chicago.
“It seems to rank up with other food allergens regarding reaction severity,” Dr. Gupta said in a video interview. In October 2018, the FDA requested information on sesame allergy so that its staff could consider adding sesame to its list of major food allergens. The eight current major food allergens that require specific labeling are: peanut, tree nuts, eggs, milk, fish, shellfish, wheat, and soy. The 0.23% prevalence of sesame among U.S. residents makes it more common than certain tree nuts, and so the prevalence numbers also seem to justify adding sesame to the FDA’s labeling list because 750,000 is “a lot of people,” she noted.
An established surveying group based at the University of Chicago ran the data collection, which received responses from 53,575 U.S. household including 40,443 adults and 38,408 children. Dr. Gupta and her associates recently published information on the methods of the survey and other findings it made about U.S. food allergy rates (JAMA Network Open. 2019 Jan 4. doi: 10.1001/jamanetworkopen.2018.5630). The descriptions people provided about their food allergy diagnoses, and the effects these allergies had, underwent detailed review by a panel of experts who decide whether or not the evidence for an allergy was “convincing.” The 0.23% prevalence rate reported for sesame represented people for whom this allergy was convincingly demonstrated, reflected a confirmed physician diagnosis, or both, and hence it was a conservative estimate, Dr. Gupta said.
Mr. Warren had no disclosures. Dr. Gupta has been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she has received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
SOURCE: Chadha AS et al. AAAAI 2019, Abstract 615.
REPORTING FROM AAAAI 2019
Key clinical point: The U.S. prevalence of allergy to sesame is roughly similar to other foods that require food labeling.
Major finding: The prevalence of sesame allergy was 0.23% of U.S. adults and children.
Study details: A detailed survey of food allergies completed for 53,575 U.S. households that included 78,851 people.
Disclosures: Mr. Warren had no disclosures. Dr. Gupta had been a consultant to Aimmune, Before Brands, DBV Technologies, Kaleo, Mylan, and Pfizer, and she had received research funding from Aimmune, Mylan, the National Confectioners Association, Rho, and Thermo Fisher.
Source: Chadha AS et al. AAAAI 2019, Abstract 615.
Dupilumab relieves severe sinusitis with polyposis
SAN FRANCISCO – Dupilumab, an anti-inflammatory drug already approved for use in the United States, met its efficacy endpoints for treating chronic rhinosinusitis with nasal polyps in a pivotal trial with 276 patients.
The results make it likely that dupilumab (Dupixent) will receive a new indication from the Food and Drug Administration, pending similar results in a second pivotal trial for nasal polyps that researchers will report soon. Dupilumab, which works by blocking a receptor for both interleukin 4 and interleukin 13 and thereby shutting down type 2 inflammation, is already approved in the United States for treating atopic dermatitis and asthma.
Type 2 inflammation drives polyp formation in patients with chronic rhinosinusitis that can produce severe nasal congestion, breathing difficulty, and substantially reduced quality of life.
In the new trial, the drug showed efficacy by significantly improving both the nasal congestion score reported by patients and the nasal polyp score measured by sinus endoscopy after 24 weeks on treatment, when compared with control patients on placebo, Joseph K. Han, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Patients enrolled in the study had chronic, severe sinusitis and nasal polyps that remained uncontrolled despite prior surgery, for 75% of enrolled patients, or treatment with systemic corticosteroids, used on about 90% of the patients within the prior 2 years.
During the 24 weeks of treatment, 23% of patients in the control arm had to restart systemic corticosteroid treatment or have surgery, compared with 7% of patients on dupilumab treatment, a statistically significant difference.
The new drug is a “game changer,” for these patients, Dr. Han said in a video interview.
In some patients, treatment produced complete polyp resolution. He and his colleagues in the otolaryngology field are now trying to decide exactly which patients with polyps secondary to sinusitis will be good candidates for dupilumab after it receives an expected indication for shrinking nasal polyps.
Roughly 4% of the adult population has chronic rhinosinusitis that generates polyps. How many of these patients are affected severely enough to warrant dupilumab treatment is not clear, but will likely include several hundreds of thousands of U.S. adults, said Dr. Han, professor of otolaryngology and chief of the division of allergy at Eastern Virginia Medical School in Norfolk.
The SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps) trial enrolled patients at 76 sites in the United States and in several European countries. The study randomized 143 patients who received standard treatment plus a 300-mg dupilumab subcutaneous injection every 2 weeks, and 133 patients who received standard treatment plus placebo injections. Standard treatment included a nasal corticosteroid spray.
After 24 weeks of treatment, the endoscopically-measured nasal polyp score, which averaged about 6 at baseline on a scale of 0-8, fell by an average of 2.06 points, compared with controls, which was a statistically significant and clinically meaningful change, said Dr. Han.
The second primary endpoint, patient self-assessment of nasal congestion on a scale of 0-3, showed an average 0.89 improvement, compared with controls, which was also a statistically significant and meaningful change from the average baseline score of about 2.4.
Other efficacy measures also showed benefits from treatment, including a substantial improvement compared with controls in a quality-of-life measure. The safety profile was benign compared with placebo, and consistent with existing safety data for the drug.SINUS-24 was funded by Regeneron and Sanofi, the companies that market dupilumab. Dr. Han has been an adviser to Regeneron and Sanofi.
SOURCE: Han JK et al. AAAAI 2019, Abstract L4.
SAN FRANCISCO – Dupilumab, an anti-inflammatory drug already approved for use in the United States, met its efficacy endpoints for treating chronic rhinosinusitis with nasal polyps in a pivotal trial with 276 patients.
The results make it likely that dupilumab (Dupixent) will receive a new indication from the Food and Drug Administration, pending similar results in a second pivotal trial for nasal polyps that researchers will report soon. Dupilumab, which works by blocking a receptor for both interleukin 4 and interleukin 13 and thereby shutting down type 2 inflammation, is already approved in the United States for treating atopic dermatitis and asthma.
Type 2 inflammation drives polyp formation in patients with chronic rhinosinusitis that can produce severe nasal congestion, breathing difficulty, and substantially reduced quality of life.
In the new trial, the drug showed efficacy by significantly improving both the nasal congestion score reported by patients and the nasal polyp score measured by sinus endoscopy after 24 weeks on treatment, when compared with control patients on placebo, Joseph K. Han, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Patients enrolled in the study had chronic, severe sinusitis and nasal polyps that remained uncontrolled despite prior surgery, for 75% of enrolled patients, or treatment with systemic corticosteroids, used on about 90% of the patients within the prior 2 years.
During the 24 weeks of treatment, 23% of patients in the control arm had to restart systemic corticosteroid treatment or have surgery, compared with 7% of patients on dupilumab treatment, a statistically significant difference.
The new drug is a “game changer,” for these patients, Dr. Han said in a video interview.
In some patients, treatment produced complete polyp resolution. He and his colleagues in the otolaryngology field are now trying to decide exactly which patients with polyps secondary to sinusitis will be good candidates for dupilumab after it receives an expected indication for shrinking nasal polyps.
Roughly 4% of the adult population has chronic rhinosinusitis that generates polyps. How many of these patients are affected severely enough to warrant dupilumab treatment is not clear, but will likely include several hundreds of thousands of U.S. adults, said Dr. Han, professor of otolaryngology and chief of the division of allergy at Eastern Virginia Medical School in Norfolk.
The SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps) trial enrolled patients at 76 sites in the United States and in several European countries. The study randomized 143 patients who received standard treatment plus a 300-mg dupilumab subcutaneous injection every 2 weeks, and 133 patients who received standard treatment plus placebo injections. Standard treatment included a nasal corticosteroid spray.
After 24 weeks of treatment, the endoscopically-measured nasal polyp score, which averaged about 6 at baseline on a scale of 0-8, fell by an average of 2.06 points, compared with controls, which was a statistically significant and clinically meaningful change, said Dr. Han.
The second primary endpoint, patient self-assessment of nasal congestion on a scale of 0-3, showed an average 0.89 improvement, compared with controls, which was also a statistically significant and meaningful change from the average baseline score of about 2.4.
Other efficacy measures also showed benefits from treatment, including a substantial improvement compared with controls in a quality-of-life measure. The safety profile was benign compared with placebo, and consistent with existing safety data for the drug.SINUS-24 was funded by Regeneron and Sanofi, the companies that market dupilumab. Dr. Han has been an adviser to Regeneron and Sanofi.
SOURCE: Han JK et al. AAAAI 2019, Abstract L4.
SAN FRANCISCO – Dupilumab, an anti-inflammatory drug already approved for use in the United States, met its efficacy endpoints for treating chronic rhinosinusitis with nasal polyps in a pivotal trial with 276 patients.
The results make it likely that dupilumab (Dupixent) will receive a new indication from the Food and Drug Administration, pending similar results in a second pivotal trial for nasal polyps that researchers will report soon. Dupilumab, which works by blocking a receptor for both interleukin 4 and interleukin 13 and thereby shutting down type 2 inflammation, is already approved in the United States for treating atopic dermatitis and asthma.
Type 2 inflammation drives polyp formation in patients with chronic rhinosinusitis that can produce severe nasal congestion, breathing difficulty, and substantially reduced quality of life.
In the new trial, the drug showed efficacy by significantly improving both the nasal congestion score reported by patients and the nasal polyp score measured by sinus endoscopy after 24 weeks on treatment, when compared with control patients on placebo, Joseph K. Han, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
Patients enrolled in the study had chronic, severe sinusitis and nasal polyps that remained uncontrolled despite prior surgery, for 75% of enrolled patients, or treatment with systemic corticosteroids, used on about 90% of the patients within the prior 2 years.
During the 24 weeks of treatment, 23% of patients in the control arm had to restart systemic corticosteroid treatment or have surgery, compared with 7% of patients on dupilumab treatment, a statistically significant difference.
The new drug is a “game changer,” for these patients, Dr. Han said in a video interview.
In some patients, treatment produced complete polyp resolution. He and his colleagues in the otolaryngology field are now trying to decide exactly which patients with polyps secondary to sinusitis will be good candidates for dupilumab after it receives an expected indication for shrinking nasal polyps.
Roughly 4% of the adult population has chronic rhinosinusitis that generates polyps. How many of these patients are affected severely enough to warrant dupilumab treatment is not clear, but will likely include several hundreds of thousands of U.S. adults, said Dr. Han, professor of otolaryngology and chief of the division of allergy at Eastern Virginia Medical School in Norfolk.
The SINUS-24 (A Controlled Clinical Study of Dupilumab in Patients With Nasal Polyps) trial enrolled patients at 76 sites in the United States and in several European countries. The study randomized 143 patients who received standard treatment plus a 300-mg dupilumab subcutaneous injection every 2 weeks, and 133 patients who received standard treatment plus placebo injections. Standard treatment included a nasal corticosteroid spray.
After 24 weeks of treatment, the endoscopically-measured nasal polyp score, which averaged about 6 at baseline on a scale of 0-8, fell by an average of 2.06 points, compared with controls, which was a statistically significant and clinically meaningful change, said Dr. Han.
The second primary endpoint, patient self-assessment of nasal congestion on a scale of 0-3, showed an average 0.89 improvement, compared with controls, which was also a statistically significant and meaningful change from the average baseline score of about 2.4.
Other efficacy measures also showed benefits from treatment, including a substantial improvement compared with controls in a quality-of-life measure. The safety profile was benign compared with placebo, and consistent with existing safety data for the drug.SINUS-24 was funded by Regeneron and Sanofi, the companies that market dupilumab. Dr. Han has been an adviser to Regeneron and Sanofi.
SOURCE: Han JK et al. AAAAI 2019, Abstract L4.
REPORTING FROM AAAAI
Severe, uncontrolled asthma patients must avoid subcutaneous immunotherapy
SAN FRANCISCO – appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.
The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.
Other factors affecting SCIT safety based on the survey results included:
- Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
- Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
- Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
- Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
- Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.
Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).
Dr. Bernstein had no relevant disclosures.
SAN FRANCISCO – appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.
The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.
Other factors affecting SCIT safety based on the survey results included:
- Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
- Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
- Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
- Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
- Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.
Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).
Dr. Bernstein had no relevant disclosures.
SAN FRANCISCO – appears to be the “major factor” causing higher-grade systemic reactions or death from this treatment, David I. Bernstein, MD, said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.
While that was Dr. Bernstein’s top take-home message on how to optimize tolerability of subcutaneous immunotherapy (SCIT), a few other empiric rules have also emerged from his ongoing analysis of survey results from the AAAAI/American College of Allergy, Asthma, and Immunology SCIT surveillance study. The study began tracking the safety of SCIT in 2008 through annual surveys sent to members of either of these two allergy societies. By early 2019, the surveys had gathered data from more than 55 million office visits for SCIT, with responses from roughly 200-500 allergy practices annually, said Dr. Bernstein, professor of medicine at the University of Cincinnati.
The survey results identified seven SCIT-related fatalities over about a decade of surveillance. The most common risk factor among these cases was severe, uncontrolled asthma, prompting Dr. Bernstein to conclude that these patients should not receive SCIT. “If the asthma is well controlled, then SCIT is fine,” even if it had been severe before treatment, he said in an interview.
Other factors affecting SCIT safety based on the survey results included:
- Screening patients with an asthma history for current asthma symptoms and lung function before each injection. Survey results showed that while 86% of respondents screened for symptoms, only a third also checked lung function.
- Modifying the dose or stopping SCIT injections after a severe systemic reaction. Survey results showed that more than a quarter of all systemic reactions and more than a third of grade 3 systemic reactions (severe anaphylaxis) happened following a prior systemic reaction. Dr. Bernstein called this “an important, modifiable risk factor.”
- Administering SCIT only in a setting staffed to manage a possible anaphylaxis episode, and adhere to at least a 30-minute observation period. “A key step is observing for at least 30 minutes, and giving epinephrine promptly when needed; the sooner the better,” Dr. Bernstein said. Although the percentage of practices that observe patients for at least 30 minutes has steadily improved during the decade that the survey has run, in 2016 a quarter of responding practices continued to not observe patients for at least 30 minutes.
- Modifying the SCIT dose in high-risk patients during the peak season for aeroallergens like pollen. Survey results showed that practices that did not adjust their SCIT dosages during peak pollen seasons had about double the rate of grade 3 or 4 systemic reactions, compared with practices that dialed down their dosages.
- Reducing SCIT dosages during an accelerated cluster buildup, a treatment approach that in general increases the risk for systemic reactions.
Survey results also showed that sublingual immunotherapy, available in U.S. practice since 2014, has been very safe, with no reported associated deaths and only rare reports of anaphylactic episodes, Dr. Bernstein said. The most recent published report from the surveillance study appeared online a few days before Dr. Bernstein spoke (J Allergy Clin Immunol Pract. 2019 Feb 15. doi: 10.1016/j.jaip.2019.01.058).
Dr. Bernstein had no relevant disclosures.
REPORTING FROM AAAAI
Stroke endovascular therapy: The more you do, the better you do
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
in analysis of data from two different U.S. sources: the National Inpatient Sample (NIS) and the state of Florida, Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
The idea that when centers perform more of a procedure, such as endovascular thrombectomy for acute ischemic stroke, they more often do it better is intuitively plausible, which helps makes these findings believable. It’s also a relationship we’ve already seen for other types of endovascular therapies. What this study did not address were other factors beyond case volume also might also make important contributions to outcome, such as the speed of treatment delivery.
Volume thresholds for endovascular stroke programs will come eventually, but for the time being our focus should be on insuring wide access to endovascular treatment.
Bruce Ovbiagele, MD, a neurologist and chief of staff for the San Francisco Veteran Affairs Health Care System, made these comments in an interview. He reported no disclosures.
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
in analysis of data from two different U.S. sources: the National Inpatient Sample (NIS) and the state of Florida, Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
HONOLULU – The well-documented link between higher procedure volumes and better procedure efficacy also applies to endovascular thrombectomy for acute ischemic stroke.
in analysis of data from two different U.S. sources: the National Inpatient Sample (NIS) and the state of Florida, Sunil A. Sheth, MD, said at the International Stroke Conference sponsored by the American Heart Association.
The finding raises questions about how to best triage patients with an acute ischemic stroke, suggesting that, in at least some situations, patients might be better served being taken to a higher-volume center even if it’s not the closest, noted Dr. Sheth, The results also suggest that the findings in the trials proving the value of EST run primarily at large, tertiary care, referral centers might not be generalizable to all centers that start an endovascular program.
The study looked at data collected during 2006-2016 in Florida and during 2012-2016 in the NIS, and found that in both databases the rate of EST procedures performed showed steadily increasing use over time, with a sharp increase in the number of centers performing EST in 2015. Each of the two data sets also showed that better discharge outcomes occurred in patients treated at centers with the highest procedural volumes.
In the nationwide NIS data, for every 10 additional patients a center treated with EST annually, the incidence of a “good” hospital-discharge outcome (defined as either discharge home or to an acute rehabilitation hospital) rose by 30%, compared with lower-volume centers in a multivariate regression analysis, a statistically significant relationship, said Dr. Sheth, a neurologist at the University of Texas, Houston. This volume-outcome relationship held fairly constant through volumes up to about 50 EST cases annually. “The more the better,” he observed.
“The data suggest that EST outcomes are not always the same,” but right now most emergency medical service systems do not take EST case volume into account when deciding where to take an acute stroke patient, Dr. Sheth said in an interview. But he cautioned against an oversimplified focus on just EST case volume.
A link between volume and better outcomes “is easy to understand and not surprising. We see this relationship for a variety of procedures. The data suggest we need to consider procedure volumes. But volume is only part of makes for good outcomes; it’s not the only factor,” he stressed.
Dr. Sheth and his associates used data collected by the Florida Agency for Health Care Administration on 3,890 acute ischemic stroke patients treated with EST at 56 Florida hospitals and on 42,505 such patients in the NIS database treated at 2,260 U.S. hospitals. During the 11-year period for Florida data collection, the number of centers performing EST in the state rose steadily at an average rate of about four new centers per year. Although the number of EST procedures done also rose sharply, in general over time a higher percentage of patients underwent treatment at lower-volume centers. Similar patterns existed in the national data. The Florida data showed a statistically significant 10% improvement in good discharge outcomes for every 10 additional EST patients a center treated a year, consistent with the NIS data.
Concurrently with Dr. Sheth’s report, the results also appeared in an article published online (Stroke. 2019 Feb 6. doi: 10.1161/STROKEAHA.118.023967).
Dr. Sheth reported no disclosures.
SOURCE: Sheth SA et al. ISC 2019, Abstract 002.
REPORTING FROM ISC 2019