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Life-threatening paradoxical bronchospasm may escape recognition in patients with COPD or asthma
according to a researcher who reviewed spirometry test results from U.S. military veterans.
Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.
However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.
“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.
“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
Recognizing paradoxical bronchospasm
In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.
“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.
Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.
If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.
Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.
Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
Latest study results
Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.
A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.
Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.
Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.
Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.
A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
Greater awareness needed
Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.
“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.
Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.
Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.
according to a researcher who reviewed spirometry test results from U.S. military veterans.
Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.
However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.
“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.
“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
Recognizing paradoxical bronchospasm
In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.
“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.
Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.
If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.
Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.
Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
Latest study results
Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.
A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.
Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.
Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.
Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.
A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
Greater awareness needed
Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.
“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.
Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.
Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.
according to a researcher who reviewed spirometry test results from U.S. military veterans.
Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol.
However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago.
“Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr. Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr. Kaul.
“We hope in the future, education of clinicians about this phenomena is emphasized,” Dr. Kaul said in her presentation.
Recognizing paradoxical bronchospasm
In an interview, Dr. Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test.
“I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said.
Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr. Kaul.
If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate.
Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr. Kaul.
Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr. Kaul said.
Latest study results
Dr. Kaul described a retrospective analysis of 1,150 pre- and postbronchodilator spirometry tests conducted in patients with COPD or asthma at the Jesse Brown VA Medical Center between 2017 and 2020.
A positive paradoxical bronchodilator response was defined as a decrease of least 12% and 200 mL in forced expiratory volume in 1 second and forced vital capacity from baseline after four puffs of albuterol were inhaled, Dr. Kaul said.
Out of 18 reviewed spirometry results that met the criteria, none of the test results reported or recognized paradoxical bronchospasm, according to Dr. Kaul.
Those meeting the criteria were predominantly COPD patients, according to Dr. Kaul, who said 12 had an underlying diagnosis COPD, 4 had asthma, and 2 had COPD and asthma.
Of the 18 patients, 13 were African American, and all but 1 of the 18 patients had a current or past smoking history, according to reported data.
A history of obstructive sleep apnea was reported in nine patients, and history of gastroesophageal reflux disease was also reported in nine patients. Eleven patients had emphysema.
Greater awareness needed
Results of this study emphasize the need to recognize potential cases paradoxical bronchospasm in clinical practice, as well as a need for more research, according to Allen J. Blaivas, DO, FCCP, chair of the CHEST Airway Disorders NetWork.
“It’s something to be on the alert for, and certainly be aware that, if your patient is telling you that they feel worse, we shouldn’t just pooh-pooh it,” said Dr. Blaivas, who is medical director of the intensive care unit at the East Orange campus of the VA New Jersey Health Care System.
Further research could focus on breaking down whether patients with suspected paradoxical bronchospasm are using metered-dose inhalers or nebulizers, whether or not they are also taking inhaled corticosteroids, and whether prospective testing can confirm paradoxical bronchospasm in patients who report tightness after using a SABA, he said in an interview.
Dr. Kaul and coauthor Israel Rubinstein, MD had no relevant relationships to disclose. Dr. Blaivas had no relevant relationships to disclose.
FROM CHEST 2021
Dupilumab-improved lung function lasts in children with moderate to severe asthma
Add-on treatment with dupilumab may improve lung function in children aged 6-11 years with uncontrolled moderate to severe type 2 inflammatory asthma, results from a randomized, placebo-controlled, phase 3 study show.
Improvements in lung function parameters were observed as early as 2 weeks and persisted over the 52-week treatment period among children in the LIBERTY ASTHMA VOYAGE study, according to investigator Leonard B. Bacharier, MD, of Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn.
“Dupilumab led to clinically meaningful rapid and sustained improvements in lung function parameters,” Dr. Bacharier said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
The improvements in forced expiratory volume in 1 second (FEV1) and other measures reported for children with moderate to severe asthma who have the type 2 phenotype, which is the most common driver of pediatric asthma, according to Dr. Bacharier.
“Many children with moderate to severe asthma have abnormal lung function, and this can be a risk factor for future lung disease in adulthood,” Dr. Bacharier said in his presentation.
The VOYAGE continues
The findings presented at the meeting build on another report earlier this year from the LIBERTY ASTHMA VOYAGE study demonstrating that add-on dupilumab treatment led to a significant improvement versus placebo in FEV1 up to 12 weeks.
“We now have a long term data on this drug as well, showing its efficacy over a period of time,” said Muhammad Adrish, MD, MBA, FCCP, associate professor of pulmonary, critical care and sleep medicine at Baylor College of Medicine, Houston.
“I think that’s pretty exciting, and that’s another step towards precision medicine in treatment of asthma,” Dr. Adrish, who is Vice-Chair of CHEST’s Airways Disorders NetWork Steering Committee and was not involved in the study.
Dupilumab received Food and Drug Administration approval in 2018 as add-on maintenance therapy for the treatment of patients aged 12 years or older with moderate to severe asthma that has an eosinophilic phenotype or that is dependent on oral corticosteroid treatment.
In March 2021, Sanofi and Regeneron announced that the FDA had accepted for review a supplemental Biologics License Application for dupilumab as an add-on treatment in children aged 6-11 years with uncontrolled moderate to severe asthma.
That sBLA is supported by data from the LIBERTY ASTHMA VOYAGE study, Sanofi and Regeneron said.
In results of the phase 3 study that Dr. Bacharier presented in May at the American Thoracic Society International Conference, add-on dupilumab dosed every 2 weeks significant improved percent predicted prebronchodilator FEV1 by an additional 5.21 percentage points versus placebo at week 12.
Dupilumab and the type 2 phenotype
The new data reported at the CHEST meeting come from a prespecified analysis evaluating the impact of dupilumab on lung function over a 52-week treatment period in patients with a T2 inflammatory asthma phenotype.
“Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and -13, key and central drivers of T2 inflammation in multiple diseases,” Dr. Bacharier and coinvestigators reported in their study abstract.
Of 408 patients in the study, 350 met the T2 phenotype criteria, including 236 in the dupilumab arm and 114 in the placebo arm.
Patients met T2 phenotype criteria if they had blood eosinophils of at least 150 cells/mcL or fractional exhaled nitric oxide FeNO of at least 20 parts per billion at baseline, investigators said.
Dr. Bacharier and coinvestigators reported on several different endpoints, including absolute and percent predicted prebronchodilator FEV1, percent predicted postbronchodilator FEV1, prebronchodilator forced expiratory flow at 25%-75% of pulmonary volume (FEF25%-75%), and forced vital capacity (FVC).
Dupilumab, when compared with placebo, significantly improved prebronchodilator FEV1 in pediatric patients with uncontrolled moderate to severe type 2 asthma, according to Dr. Bacharier.
“Patients receiving dupilumab experienced rapid improvements by week 2, and this was sustained for up to 52 weeks,” he said.
The prebronchodilator FEV1 improved from baseline for dupilumab versus placebo, with a least squares mean difference of 0.06 L at week 2, which reached 0.17 L by week 52, according to their data. Similarly, postbronchodilator FEV1 improved from baseline for dupilumab, with a least square mean difference versus placebo of 0.09 L at week 52.
Dupilumab compared to placebo also significantly improved percent predicted FEF25%-75%, and percent predicted FVC over the 52-week treatment period, according to Dr. Bacharier.
“Dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children aged 6-11 years,” Dr. Bacharier added in a CHEST press release that described the findings.
The LIBERTY ASTHMA VOYAGE study was sponsored by Sanofi and Regeneron Pharmaceuticals. Dr. Bacharier provided disclosures related to AstraZeneca, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, CF Foundation, DBV Technologies, NIH, and Vectura.
Add-on treatment with dupilumab may improve lung function in children aged 6-11 years with uncontrolled moderate to severe type 2 inflammatory asthma, results from a randomized, placebo-controlled, phase 3 study show.
Improvements in lung function parameters were observed as early as 2 weeks and persisted over the 52-week treatment period among children in the LIBERTY ASTHMA VOYAGE study, according to investigator Leonard B. Bacharier, MD, of Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn.
“Dupilumab led to clinically meaningful rapid and sustained improvements in lung function parameters,” Dr. Bacharier said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
The improvements in forced expiratory volume in 1 second (FEV1) and other measures reported for children with moderate to severe asthma who have the type 2 phenotype, which is the most common driver of pediatric asthma, according to Dr. Bacharier.
“Many children with moderate to severe asthma have abnormal lung function, and this can be a risk factor for future lung disease in adulthood,” Dr. Bacharier said in his presentation.
The VOYAGE continues
The findings presented at the meeting build on another report earlier this year from the LIBERTY ASTHMA VOYAGE study demonstrating that add-on dupilumab treatment led to a significant improvement versus placebo in FEV1 up to 12 weeks.
“We now have a long term data on this drug as well, showing its efficacy over a period of time,” said Muhammad Adrish, MD, MBA, FCCP, associate professor of pulmonary, critical care and sleep medicine at Baylor College of Medicine, Houston.
“I think that’s pretty exciting, and that’s another step towards precision medicine in treatment of asthma,” Dr. Adrish, who is Vice-Chair of CHEST’s Airways Disorders NetWork Steering Committee and was not involved in the study.
Dupilumab received Food and Drug Administration approval in 2018 as add-on maintenance therapy for the treatment of patients aged 12 years or older with moderate to severe asthma that has an eosinophilic phenotype or that is dependent on oral corticosteroid treatment.
In March 2021, Sanofi and Regeneron announced that the FDA had accepted for review a supplemental Biologics License Application for dupilumab as an add-on treatment in children aged 6-11 years with uncontrolled moderate to severe asthma.
That sBLA is supported by data from the LIBERTY ASTHMA VOYAGE study, Sanofi and Regeneron said.
In results of the phase 3 study that Dr. Bacharier presented in May at the American Thoracic Society International Conference, add-on dupilumab dosed every 2 weeks significant improved percent predicted prebronchodilator FEV1 by an additional 5.21 percentage points versus placebo at week 12.
Dupilumab and the type 2 phenotype
The new data reported at the CHEST meeting come from a prespecified analysis evaluating the impact of dupilumab on lung function over a 52-week treatment period in patients with a T2 inflammatory asthma phenotype.
“Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and -13, key and central drivers of T2 inflammation in multiple diseases,” Dr. Bacharier and coinvestigators reported in their study abstract.
Of 408 patients in the study, 350 met the T2 phenotype criteria, including 236 in the dupilumab arm and 114 in the placebo arm.
Patients met T2 phenotype criteria if they had blood eosinophils of at least 150 cells/mcL or fractional exhaled nitric oxide FeNO of at least 20 parts per billion at baseline, investigators said.
Dr. Bacharier and coinvestigators reported on several different endpoints, including absolute and percent predicted prebronchodilator FEV1, percent predicted postbronchodilator FEV1, prebronchodilator forced expiratory flow at 25%-75% of pulmonary volume (FEF25%-75%), and forced vital capacity (FVC).
Dupilumab, when compared with placebo, significantly improved prebronchodilator FEV1 in pediatric patients with uncontrolled moderate to severe type 2 asthma, according to Dr. Bacharier.
“Patients receiving dupilumab experienced rapid improvements by week 2, and this was sustained for up to 52 weeks,” he said.
The prebronchodilator FEV1 improved from baseline for dupilumab versus placebo, with a least squares mean difference of 0.06 L at week 2, which reached 0.17 L by week 52, according to their data. Similarly, postbronchodilator FEV1 improved from baseline for dupilumab, with a least square mean difference versus placebo of 0.09 L at week 52.
Dupilumab compared to placebo also significantly improved percent predicted FEF25%-75%, and percent predicted FVC over the 52-week treatment period, according to Dr. Bacharier.
“Dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children aged 6-11 years,” Dr. Bacharier added in a CHEST press release that described the findings.
The LIBERTY ASTHMA VOYAGE study was sponsored by Sanofi and Regeneron Pharmaceuticals. Dr. Bacharier provided disclosures related to AstraZeneca, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, CF Foundation, DBV Technologies, NIH, and Vectura.
Add-on treatment with dupilumab may improve lung function in children aged 6-11 years with uncontrolled moderate to severe type 2 inflammatory asthma, results from a randomized, placebo-controlled, phase 3 study show.
Improvements in lung function parameters were observed as early as 2 weeks and persisted over the 52-week treatment period among children in the LIBERTY ASTHMA VOYAGE study, according to investigator Leonard B. Bacharier, MD, of Monroe Carell Jr. Children’s Hospital at Vanderbilt University Medical Center, Nashville, Tenn.
“Dupilumab led to clinically meaningful rapid and sustained improvements in lung function parameters,” Dr. Bacharier said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year.
The improvements in forced expiratory volume in 1 second (FEV1) and other measures reported for children with moderate to severe asthma who have the type 2 phenotype, which is the most common driver of pediatric asthma, according to Dr. Bacharier.
“Many children with moderate to severe asthma have abnormal lung function, and this can be a risk factor for future lung disease in adulthood,” Dr. Bacharier said in his presentation.
The VOYAGE continues
The findings presented at the meeting build on another report earlier this year from the LIBERTY ASTHMA VOYAGE study demonstrating that add-on dupilumab treatment led to a significant improvement versus placebo in FEV1 up to 12 weeks.
“We now have a long term data on this drug as well, showing its efficacy over a period of time,” said Muhammad Adrish, MD, MBA, FCCP, associate professor of pulmonary, critical care and sleep medicine at Baylor College of Medicine, Houston.
“I think that’s pretty exciting, and that’s another step towards precision medicine in treatment of asthma,” Dr. Adrish, who is Vice-Chair of CHEST’s Airways Disorders NetWork Steering Committee and was not involved in the study.
Dupilumab received Food and Drug Administration approval in 2018 as add-on maintenance therapy for the treatment of patients aged 12 years or older with moderate to severe asthma that has an eosinophilic phenotype or that is dependent on oral corticosteroid treatment.
In March 2021, Sanofi and Regeneron announced that the FDA had accepted for review a supplemental Biologics License Application for dupilumab as an add-on treatment in children aged 6-11 years with uncontrolled moderate to severe asthma.
That sBLA is supported by data from the LIBERTY ASTHMA VOYAGE study, Sanofi and Regeneron said.
In results of the phase 3 study that Dr. Bacharier presented in May at the American Thoracic Society International Conference, add-on dupilumab dosed every 2 weeks significant improved percent predicted prebronchodilator FEV1 by an additional 5.21 percentage points versus placebo at week 12.
Dupilumab and the type 2 phenotype
The new data reported at the CHEST meeting come from a prespecified analysis evaluating the impact of dupilumab on lung function over a 52-week treatment period in patients with a T2 inflammatory asthma phenotype.
“Dupilumab, a fully human monoclonal antibody, blocks the shared receptor component for interleukin-4 and -13, key and central drivers of T2 inflammation in multiple diseases,” Dr. Bacharier and coinvestigators reported in their study abstract.
Of 408 patients in the study, 350 met the T2 phenotype criteria, including 236 in the dupilumab arm and 114 in the placebo arm.
Patients met T2 phenotype criteria if they had blood eosinophils of at least 150 cells/mcL or fractional exhaled nitric oxide FeNO of at least 20 parts per billion at baseline, investigators said.
Dr. Bacharier and coinvestigators reported on several different endpoints, including absolute and percent predicted prebronchodilator FEV1, percent predicted postbronchodilator FEV1, prebronchodilator forced expiratory flow at 25%-75% of pulmonary volume (FEF25%-75%), and forced vital capacity (FVC).
Dupilumab, when compared with placebo, significantly improved prebronchodilator FEV1 in pediatric patients with uncontrolled moderate to severe type 2 asthma, according to Dr. Bacharier.
“Patients receiving dupilumab experienced rapid improvements by week 2, and this was sustained for up to 52 weeks,” he said.
The prebronchodilator FEV1 improved from baseline for dupilumab versus placebo, with a least squares mean difference of 0.06 L at week 2, which reached 0.17 L by week 52, according to their data. Similarly, postbronchodilator FEV1 improved from baseline for dupilumab, with a least square mean difference versus placebo of 0.09 L at week 52.
Dupilumab compared to placebo also significantly improved percent predicted FEF25%-75%, and percent predicted FVC over the 52-week treatment period, according to Dr. Bacharier.
“Dupilumab led to significant, rapid, and sustained improvements in multiple aspects of lung function in children aged 6-11 years,” Dr. Bacharier added in a CHEST press release that described the findings.
The LIBERTY ASTHMA VOYAGE study was sponsored by Sanofi and Regeneron Pharmaceuticals. Dr. Bacharier provided disclosures related to AstraZeneca, GlaxoSmithKline, Regeneron Pharmaceuticals, Sanofi, CF Foundation, DBV Technologies, NIH, and Vectura.
FROM CHEST 2021
9-step ladder may kids with allergies return to eggs
For many children in the process of outgrowing egg allergy, the step-wise reintroduction of foods that contain eggs can be achieved at home using a nine-rung laddered approach, according to updated guidelines from the British Society for Allergy and Clinical Immunology (BSACI).
Attempts to reintroduce egg into the child’s diet can start at the age of 12 months or 6 months from the last reaction, as long as past reactions have been mild to moderate and the child does not have asthma, according to guidelines from the BSACI, which represents allergists, pediatricians, and other health care practitioners.
According to the guidelines, the reintroduction needs to be guided by a specialist allergy service for children who have had severe reactions to egg or who have asthma.
Susan C. Leech, MB BChir, DCH, first author of the guidelines and a consultant in pediatric allergy with the Department of Child Health at Kings College Hospital, London, told this news organization that home reintroduction should begin slowly with small amounts of baked egg, starting with a pea-sized piece of cake, and should proceed gradually.
“Parents can be reassured that it’s a relatively safe thing to do as long as it’s done with caution,” said Dr. Leech.
The expanded guidelines include a new nine-step reintroduction ladder. It builds on a three-stage classification of egg-containing foods that was first introduced in BSACI guidelines in 2010.
On the bottom four rungs, children work their way through small but increasing amounts of fairy cakes (cupcakes), biscuits (cookies), and other foods containing baked eggs.
The next three rungs involve hard-boiled eggs, quiche, and other well-cooked egg products.
At the eighth rung, children can have small mouthfuls of runny scrambled eggs, mayonnaise, and other less-cooked or raw egg-containing products. At the top rung, children can have increasing amounts of those products as well as licks of cake batter.
The guidelines were published online September 29 in Clinical and Experimental Allergy along with a supplement that includes a series of examples showing how the guidelines apply to specific patient cases.
“These are examples only,” the guideline authors caution in the appendix. “Clinical judgment of severity is important as risk assessment is not always easy.”
Anna Nowak-Wegrzyn, MD, PhD, a professor of pediatrics at NYU Grossman School of Medicine and chief of pediatric allergy and immunology for Hassenfeld Children’s Hospital at NYU Langone, who was not involved in the BSACI guidelines, described the egg ladder as a “proactive” strategy that deserves further study and consideration.
“I think that this may be a valid approach,” said Dr. Nowak-Wegrzyn in an interview. “Eggs have good nutritional value, and they are present in a lot of foods, so avoidance creates logistical challenges.”
Using the egg ladder for home-based reintroduction may be especially suited in resource-poor areas where access to an allergist may be difficult, she said. It may also be suited for families that can’t visit the office because of pandemic-related restrictions.
“If the child had a severe reaction or if they have asthma, then it’s a no-go,” she added, “but if you have a patient who has a really mild reaction and you think that overall the risk of a significant reaction or bad symptoms is low, then it may be worth doing.”
Dr. Leech and Dr. Nowak-Wegrzyn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For many children in the process of outgrowing egg allergy, the step-wise reintroduction of foods that contain eggs can be achieved at home using a nine-rung laddered approach, according to updated guidelines from the British Society for Allergy and Clinical Immunology (BSACI).
Attempts to reintroduce egg into the child’s diet can start at the age of 12 months or 6 months from the last reaction, as long as past reactions have been mild to moderate and the child does not have asthma, according to guidelines from the BSACI, which represents allergists, pediatricians, and other health care practitioners.
According to the guidelines, the reintroduction needs to be guided by a specialist allergy service for children who have had severe reactions to egg or who have asthma.
Susan C. Leech, MB BChir, DCH, first author of the guidelines and a consultant in pediatric allergy with the Department of Child Health at Kings College Hospital, London, told this news organization that home reintroduction should begin slowly with small amounts of baked egg, starting with a pea-sized piece of cake, and should proceed gradually.
“Parents can be reassured that it’s a relatively safe thing to do as long as it’s done with caution,” said Dr. Leech.
The expanded guidelines include a new nine-step reintroduction ladder. It builds on a three-stage classification of egg-containing foods that was first introduced in BSACI guidelines in 2010.
On the bottom four rungs, children work their way through small but increasing amounts of fairy cakes (cupcakes), biscuits (cookies), and other foods containing baked eggs.
The next three rungs involve hard-boiled eggs, quiche, and other well-cooked egg products.
At the eighth rung, children can have small mouthfuls of runny scrambled eggs, mayonnaise, and other less-cooked or raw egg-containing products. At the top rung, children can have increasing amounts of those products as well as licks of cake batter.
The guidelines were published online September 29 in Clinical and Experimental Allergy along with a supplement that includes a series of examples showing how the guidelines apply to specific patient cases.
“These are examples only,” the guideline authors caution in the appendix. “Clinical judgment of severity is important as risk assessment is not always easy.”
Anna Nowak-Wegrzyn, MD, PhD, a professor of pediatrics at NYU Grossman School of Medicine and chief of pediatric allergy and immunology for Hassenfeld Children’s Hospital at NYU Langone, who was not involved in the BSACI guidelines, described the egg ladder as a “proactive” strategy that deserves further study and consideration.
“I think that this may be a valid approach,” said Dr. Nowak-Wegrzyn in an interview. “Eggs have good nutritional value, and they are present in a lot of foods, so avoidance creates logistical challenges.”
Using the egg ladder for home-based reintroduction may be especially suited in resource-poor areas where access to an allergist may be difficult, she said. It may also be suited for families that can’t visit the office because of pandemic-related restrictions.
“If the child had a severe reaction or if they have asthma, then it’s a no-go,” she added, “but if you have a patient who has a really mild reaction and you think that overall the risk of a significant reaction or bad symptoms is low, then it may be worth doing.”
Dr. Leech and Dr. Nowak-Wegrzyn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
For many children in the process of outgrowing egg allergy, the step-wise reintroduction of foods that contain eggs can be achieved at home using a nine-rung laddered approach, according to updated guidelines from the British Society for Allergy and Clinical Immunology (BSACI).
Attempts to reintroduce egg into the child’s diet can start at the age of 12 months or 6 months from the last reaction, as long as past reactions have been mild to moderate and the child does not have asthma, according to guidelines from the BSACI, which represents allergists, pediatricians, and other health care practitioners.
According to the guidelines, the reintroduction needs to be guided by a specialist allergy service for children who have had severe reactions to egg or who have asthma.
Susan C. Leech, MB BChir, DCH, first author of the guidelines and a consultant in pediatric allergy with the Department of Child Health at Kings College Hospital, London, told this news organization that home reintroduction should begin slowly with small amounts of baked egg, starting with a pea-sized piece of cake, and should proceed gradually.
“Parents can be reassured that it’s a relatively safe thing to do as long as it’s done with caution,” said Dr. Leech.
The expanded guidelines include a new nine-step reintroduction ladder. It builds on a three-stage classification of egg-containing foods that was first introduced in BSACI guidelines in 2010.
On the bottom four rungs, children work their way through small but increasing amounts of fairy cakes (cupcakes), biscuits (cookies), and other foods containing baked eggs.
The next three rungs involve hard-boiled eggs, quiche, and other well-cooked egg products.
At the eighth rung, children can have small mouthfuls of runny scrambled eggs, mayonnaise, and other less-cooked or raw egg-containing products. At the top rung, children can have increasing amounts of those products as well as licks of cake batter.
The guidelines were published online September 29 in Clinical and Experimental Allergy along with a supplement that includes a series of examples showing how the guidelines apply to specific patient cases.
“These are examples only,” the guideline authors caution in the appendix. “Clinical judgment of severity is important as risk assessment is not always easy.”
Anna Nowak-Wegrzyn, MD, PhD, a professor of pediatrics at NYU Grossman School of Medicine and chief of pediatric allergy and immunology for Hassenfeld Children’s Hospital at NYU Langone, who was not involved in the BSACI guidelines, described the egg ladder as a “proactive” strategy that deserves further study and consideration.
“I think that this may be a valid approach,” said Dr. Nowak-Wegrzyn in an interview. “Eggs have good nutritional value, and they are present in a lot of foods, so avoidance creates logistical challenges.”
Using the egg ladder for home-based reintroduction may be especially suited in resource-poor areas where access to an allergist may be difficult, she said. It may also be suited for families that can’t visit the office because of pandemic-related restrictions.
“If the child had a severe reaction or if they have asthma, then it’s a no-go,” she added, “but if you have a patient who has a really mild reaction and you think that overall the risk of a significant reaction or bad symptoms is low, then it may be worth doing.”
Dr. Leech and Dr. Nowak-Wegrzyn have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Polyethylene glycol linked to rare allergic reactions seen with mRNA COVID-19 vaccines
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A common inert ingredient may be the culprit behind the rare allergic reactions reported among individuals who have received mRNA COVID-19 vaccines, according to investigators at a large regional health center that was among the first to administer the shots.
Blood samples from 10 of 11 individuals with suspected allergic reactions reacted to polyethylene glycol (PEG), a component of both the Pfizer and Moderna mRNA vaccines, according to a report in JAMA Network Open.
In total, only 22 individuals had suspected allergic reactions out of nearly 39,000 mRNA COVID-19 vaccine doses administered, the investigators reported, noting that the reactions were generally mild and all fully resolved.
Those findings should be reassuring to individuals who are reticent to sign up for a COVID-19 vaccine because of fear of an allergic reaction, said study senior author Kari Nadeau, MD, PhD, director of the Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.
“We’re hoping that this word will get out and then that the companies could also think about making vaccines that have other products in them that don’t include polyethylene glycol,” Dr. Nadeau said in an interview.
PEG is a compound used in many products, including pharmaceuticals, cosmetics, and food. In the mRNA COVID-19 vaccines, PEG serves to stabilize the lipid nanoparticles that help protect and transport mRNA. However, its use in this setting has been linked to allergic reactions in this and previous studies.
No immunoglobulin E (IgE) antibodies to PEG were detected among the 22 individuals with suspected allergic reactions to mRNA COVID-19 vaccine, but PEG immunoglobulin G (IgG) was present. That suggests non-IgE mediated allergic reactions to PEG may be implicated for the majority of cases, Dr. Nadeau said.
This case series provides interesting new evidence to confirm previous reports that a mechanism other than the classic IgE-mediated allergic response is behind the suspected allergic reactions that are occurring after mRNA COVID-19 vaccine, said Aleena Banerji, MD, associate professor at Harvard Medical School, Boston, and clinical director of the Drug Allergy Program at Massachusetts General Hospital.
“We need to further understand the mechanism of these reactions, but what we know is that IGE mediated allergy to excipients like PEG is probably not the main cause,” Dr. Banerji, who was not involved in the study, said in an interview.
In a recent research letter published in JAMA Internal Medicine, Dr. Banerji and coauthors reported that all individuals with immediate suspected allergic reactions to mRNA COVID-19 vaccine went on to tolerate the second dose, with mild symptoms reported in the minority of patients (32 out of 159, or about 20%).
“Again, that is very consistent with not having an IgE-mediated allergy, so it seems to all be fitting with that picture,” Dr. Banerji said.
The case series by Dr. Nadeau and coauthors was based on review of nearly 39,000 mRNA COVID-19 vaccine doses administered between December 18, 2020 and January 26, 2021. Most mRNA vaccine recipients were Stanford-affiliated health care workers, according to the report.
Among recipients of those doses, they identified 148 individuals who had anaphylaxis-related ICD-10 codes recorded over the same time period. In a review of medical records, investigators pinpointed 22 individuals as having suspected allergy and invited them to participate in follow-up allergy testing.
A total of 11 individuals underwent skin prick testing, but none of them tested positive to PEG or to polysorbate 80, another excipient that has been linked to vaccine-related allergic reactions. One of the patients tested positive to the same mRNA vaccine they had previously received, according to the report.
Those same 11 individuals also underwent basophil activation testing (BAT). In contrast to the skin testing results, BAT results were positive for PEG in 10 of 11 cases (or 91%) and positive for their administered vaccine in all 11 cases, the report shows.
High levels of IgG to PEG were identified in blood samples of individuals with an allergy to the vaccine. Investigators said it’s possible that the BAT results were activated due to IgG via complement activation–related pseudoallergy, or CARPA, as has been hypothesized by some other investigators.
The negative skin prick testing results for PEG, which contrast with the positive BAT results to PEG, suggest that the former may not be appropriate for use as a predictive marker of potential vaccine allergy, according to Dr. Nadeau.
“The take-home message for doctors is to be careful,” she said. “Don’t assume that just because the person skin-tests negative to PEG or to the vaccine itself that you’re out of the woods, because the skin test would be often negative in those scenarios.”
The study was supported by a grants from the Asthma and Allergic Diseases Cooperative Research Centers, a grant from the National Institutes of Health, the National Institute of Allergy and Infectious Disease SARS Vaccine study, the Parker Foundation, the Crown Foundation, and the Sunshine Foundation. Dr. Nadeau reports numerous conflicts with various sources in the industry. Dr. Banerji has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Refined heart rate cutoffs may improve prognostic value of acute PE scoring systems
In patients with acute pulmonary embolism, using cutoff values other than 110 beats per minute might improve the prognostic value of heart rate at admission, a recent observational study suggests.
For identifying low-risk patients, a cutoff of 80 bpm increased the sensitivity of the simplified Pulmonary Embolism Severity Index (sPESI) from about 94% to nearly 99% among nonhypotensive patients with acute symptomatic pulmonary embolism (PE), according to results of the large, registry-based study.
Similarly, using a 140-bpm cutoff increased the specificity of the Bova score for identifying intermediate-high–risk patients from about 93% to 98% in the study, which was recently published in the journal CHEST.
“Although standard dichotomization of HR [i.e., HR less than 110 vs. greater than 110 bpm] may be useful for guideline recommendations, our results will allow for more accuracy regarding clinical decision-making,” wrote lead author Ana Jaureguízar, MD, of the University of Alcalá in Madrid, on behalf of the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) investigators.
Intuitive findings inform future research
These observational findings are intuitive and do at least have the potential to inform the design of future randomized clinical trials, according to Albert J. Polito, MD, chief of the division of pulmonary medicine and medical director for the lung center at Mercy Medical Center in Baltimore.
“In medicine, there is a spectrum of risk,” Dr. Polito said in an interview. “While we love our cutoffs, which in this case has traditionally always been that 110 beats per minute for heart rate, it makes sense that there would be some range of risks of bad outcomes.”
Building on the observations of the present study, subsequent prospective randomized studies could potentially aim to determine, for example, when thrombolytic therapy should be considered in nonhypotensive patients with acute PE and higher heart rates.
“It would not be easy to design, but it’s a straightforward question to ask whether patients with the highest heart rates are the ones who potentially might benefit the most from thrombolytic therapy,” Dr. Polito said.
Value of alternative HR cutoffs
Heart rate is a simple and easily available vital sign that is clearly linked to prognosis in patients with pulmonary embolism, authors of the RIETE registry study say in their report. Accordingly, a heart rate threshold of 110 bpm has made its way into scoring systems that seek to identify low-risk patients, such as the sPESI, and those focused on identifying higher-risk patients, such as the Bova score.
However, it has not been clear whether alternative HR cutoffs would improve upon the 110-bpm threshold, they added. At the low-risk end, more accurate scoring systems could optimize the selection of patients for home treatment, while at the intermediate-high–risk end, they could better select patients for close monitoring or advanced PE treatments.
Better granularity on heart rate risks?
To better define the prognostic value of different heart rate thresholds, investigators analyzed data from RIETE, a large, ongoing, multinational prospective registry including patients with objectively confirmed acute venous thromboembolism.
For 44,331 consecutive nonhypotensive symptomatic PEs, the overall rate of 30-day all-cause mortality was 5.1%, and the 30-day PE-related mortality was 1.9%, the authors report.
Significantly poorer outcomes were seen in patients with higher heart rates as compared to patients in the 80-99 bpm range, they also found. As compared to that reference range, odds ratios for 30-day all-cause death ranged from 1.5 for heart rates of 100-109, up to 2.4 for those with heart rates of 140 bpm or greater.
Likewise, patients with higher heart rates had a 1.7- to 2.4-fold greater risk of 30-day PE-related death as compared to the 80- to 99-bpm reference range, while patients with lower heart rates had lesser risk, the data published in CHEST show.
Toward refinement of prognostic scoring
Next, investigators sought to refine the prognostic scoring systems for low-risk PE (sPESI) and intermediate-high–risk PE (Bova).
For sPESI, they found that dropping the cutoff value from 110 to 100 bpm increased the sensitivity of the score from 93.4% to 95.3%. Going down even further to 80 bpm increased sensitivity to 98.8%, according to the report.
By going down from 110 to 80 bpm, the proportion of patients defined as low-risk dropped from 35% to 12%, according to the investigators.
For the Bova score, increasing the cutoff value from 110 to 120 bpm likewise increased specificity from 93.2% to 95%, while going up even further to 140 bpm increased specificity to 98.0%, the report shows.
In sensitivity analyses, the findings were not impacted by excluding younger patients, those who received reperfusion therapies, or those with atrial fibrillation, according to the study findings.
Potential implications for clinical practice
Taken together, these findings could serve as a resource to inform discussions regarding PE management that include whether home therapy or use of thrombolytic therapy is appropriate, investigators said in their report.
“For instance, among low-risk sPESI patients, those with borderline tachycardia [i.e., a heart rate between 100-109 bpm] might benefit from initial hospital observation for trending,” they wrote.
Dr. Jaureguízar reported no disclosures. One coinvestigator reported funding support from the Institute of Health Carlos III (ISCIII) and the European Development Regional Fund (ERDF). One coinvestigator reported consulting in litigation involving two models of inferior vena cava filters.
Dr. Polito reported no disclosures.
In patients with acute pulmonary embolism, using cutoff values other than 110 beats per minute might improve the prognostic value of heart rate at admission, a recent observational study suggests.
For identifying low-risk patients, a cutoff of 80 bpm increased the sensitivity of the simplified Pulmonary Embolism Severity Index (sPESI) from about 94% to nearly 99% among nonhypotensive patients with acute symptomatic pulmonary embolism (PE), according to results of the large, registry-based study.
Similarly, using a 140-bpm cutoff increased the specificity of the Bova score for identifying intermediate-high–risk patients from about 93% to 98% in the study, which was recently published in the journal CHEST.
“Although standard dichotomization of HR [i.e., HR less than 110 vs. greater than 110 bpm] may be useful for guideline recommendations, our results will allow for more accuracy regarding clinical decision-making,” wrote lead author Ana Jaureguízar, MD, of the University of Alcalá in Madrid, on behalf of the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) investigators.
Intuitive findings inform future research
These observational findings are intuitive and do at least have the potential to inform the design of future randomized clinical trials, according to Albert J. Polito, MD, chief of the division of pulmonary medicine and medical director for the lung center at Mercy Medical Center in Baltimore.
“In medicine, there is a spectrum of risk,” Dr. Polito said in an interview. “While we love our cutoffs, which in this case has traditionally always been that 110 beats per minute for heart rate, it makes sense that there would be some range of risks of bad outcomes.”
Building on the observations of the present study, subsequent prospective randomized studies could potentially aim to determine, for example, when thrombolytic therapy should be considered in nonhypotensive patients with acute PE and higher heart rates.
“It would not be easy to design, but it’s a straightforward question to ask whether patients with the highest heart rates are the ones who potentially might benefit the most from thrombolytic therapy,” Dr. Polito said.
Value of alternative HR cutoffs
Heart rate is a simple and easily available vital sign that is clearly linked to prognosis in patients with pulmonary embolism, authors of the RIETE registry study say in their report. Accordingly, a heart rate threshold of 110 bpm has made its way into scoring systems that seek to identify low-risk patients, such as the sPESI, and those focused on identifying higher-risk patients, such as the Bova score.
However, it has not been clear whether alternative HR cutoffs would improve upon the 110-bpm threshold, they added. At the low-risk end, more accurate scoring systems could optimize the selection of patients for home treatment, while at the intermediate-high–risk end, they could better select patients for close monitoring or advanced PE treatments.
Better granularity on heart rate risks?
To better define the prognostic value of different heart rate thresholds, investigators analyzed data from RIETE, a large, ongoing, multinational prospective registry including patients with objectively confirmed acute venous thromboembolism.
For 44,331 consecutive nonhypotensive symptomatic PEs, the overall rate of 30-day all-cause mortality was 5.1%, and the 30-day PE-related mortality was 1.9%, the authors report.
Significantly poorer outcomes were seen in patients with higher heart rates as compared to patients in the 80-99 bpm range, they also found. As compared to that reference range, odds ratios for 30-day all-cause death ranged from 1.5 for heart rates of 100-109, up to 2.4 for those with heart rates of 140 bpm or greater.
Likewise, patients with higher heart rates had a 1.7- to 2.4-fold greater risk of 30-day PE-related death as compared to the 80- to 99-bpm reference range, while patients with lower heart rates had lesser risk, the data published in CHEST show.
Toward refinement of prognostic scoring
Next, investigators sought to refine the prognostic scoring systems for low-risk PE (sPESI) and intermediate-high–risk PE (Bova).
For sPESI, they found that dropping the cutoff value from 110 to 100 bpm increased the sensitivity of the score from 93.4% to 95.3%. Going down even further to 80 bpm increased sensitivity to 98.8%, according to the report.
By going down from 110 to 80 bpm, the proportion of patients defined as low-risk dropped from 35% to 12%, according to the investigators.
For the Bova score, increasing the cutoff value from 110 to 120 bpm likewise increased specificity from 93.2% to 95%, while going up even further to 140 bpm increased specificity to 98.0%, the report shows.
In sensitivity analyses, the findings were not impacted by excluding younger patients, those who received reperfusion therapies, or those with atrial fibrillation, according to the study findings.
Potential implications for clinical practice
Taken together, these findings could serve as a resource to inform discussions regarding PE management that include whether home therapy or use of thrombolytic therapy is appropriate, investigators said in their report.
“For instance, among low-risk sPESI patients, those with borderline tachycardia [i.e., a heart rate between 100-109 bpm] might benefit from initial hospital observation for trending,” they wrote.
Dr. Jaureguízar reported no disclosures. One coinvestigator reported funding support from the Institute of Health Carlos III (ISCIII) and the European Development Regional Fund (ERDF). One coinvestigator reported consulting in litigation involving two models of inferior vena cava filters.
Dr. Polito reported no disclosures.
In patients with acute pulmonary embolism, using cutoff values other than 110 beats per minute might improve the prognostic value of heart rate at admission, a recent observational study suggests.
For identifying low-risk patients, a cutoff of 80 bpm increased the sensitivity of the simplified Pulmonary Embolism Severity Index (sPESI) from about 94% to nearly 99% among nonhypotensive patients with acute symptomatic pulmonary embolism (PE), according to results of the large, registry-based study.
Similarly, using a 140-bpm cutoff increased the specificity of the Bova score for identifying intermediate-high–risk patients from about 93% to 98% in the study, which was recently published in the journal CHEST.
“Although standard dichotomization of HR [i.e., HR less than 110 vs. greater than 110 bpm] may be useful for guideline recommendations, our results will allow for more accuracy regarding clinical decision-making,” wrote lead author Ana Jaureguízar, MD, of the University of Alcalá in Madrid, on behalf of the RIETE (Registro Informatizado de la Enfermedad TromboEmbólica) investigators.
Intuitive findings inform future research
These observational findings are intuitive and do at least have the potential to inform the design of future randomized clinical trials, according to Albert J. Polito, MD, chief of the division of pulmonary medicine and medical director for the lung center at Mercy Medical Center in Baltimore.
“In medicine, there is a spectrum of risk,” Dr. Polito said in an interview. “While we love our cutoffs, which in this case has traditionally always been that 110 beats per minute for heart rate, it makes sense that there would be some range of risks of bad outcomes.”
Building on the observations of the present study, subsequent prospective randomized studies could potentially aim to determine, for example, when thrombolytic therapy should be considered in nonhypotensive patients with acute PE and higher heart rates.
“It would not be easy to design, but it’s a straightforward question to ask whether patients with the highest heart rates are the ones who potentially might benefit the most from thrombolytic therapy,” Dr. Polito said.
Value of alternative HR cutoffs
Heart rate is a simple and easily available vital sign that is clearly linked to prognosis in patients with pulmonary embolism, authors of the RIETE registry study say in their report. Accordingly, a heart rate threshold of 110 bpm has made its way into scoring systems that seek to identify low-risk patients, such as the sPESI, and those focused on identifying higher-risk patients, such as the Bova score.
However, it has not been clear whether alternative HR cutoffs would improve upon the 110-bpm threshold, they added. At the low-risk end, more accurate scoring systems could optimize the selection of patients for home treatment, while at the intermediate-high–risk end, they could better select patients for close monitoring or advanced PE treatments.
Better granularity on heart rate risks?
To better define the prognostic value of different heart rate thresholds, investigators analyzed data from RIETE, a large, ongoing, multinational prospective registry including patients with objectively confirmed acute venous thromboembolism.
For 44,331 consecutive nonhypotensive symptomatic PEs, the overall rate of 30-day all-cause mortality was 5.1%, and the 30-day PE-related mortality was 1.9%, the authors report.
Significantly poorer outcomes were seen in patients with higher heart rates as compared to patients in the 80-99 bpm range, they also found. As compared to that reference range, odds ratios for 30-day all-cause death ranged from 1.5 for heart rates of 100-109, up to 2.4 for those with heart rates of 140 bpm or greater.
Likewise, patients with higher heart rates had a 1.7- to 2.4-fold greater risk of 30-day PE-related death as compared to the 80- to 99-bpm reference range, while patients with lower heart rates had lesser risk, the data published in CHEST show.
Toward refinement of prognostic scoring
Next, investigators sought to refine the prognostic scoring systems for low-risk PE (sPESI) and intermediate-high–risk PE (Bova).
For sPESI, they found that dropping the cutoff value from 110 to 100 bpm increased the sensitivity of the score from 93.4% to 95.3%. Going down even further to 80 bpm increased sensitivity to 98.8%, according to the report.
By going down from 110 to 80 bpm, the proportion of patients defined as low-risk dropped from 35% to 12%, according to the investigators.
For the Bova score, increasing the cutoff value from 110 to 120 bpm likewise increased specificity from 93.2% to 95%, while going up even further to 140 bpm increased specificity to 98.0%, the report shows.
In sensitivity analyses, the findings were not impacted by excluding younger patients, those who received reperfusion therapies, or those with atrial fibrillation, according to the study findings.
Potential implications for clinical practice
Taken together, these findings could serve as a resource to inform discussions regarding PE management that include whether home therapy or use of thrombolytic therapy is appropriate, investigators said in their report.
“For instance, among low-risk sPESI patients, those with borderline tachycardia [i.e., a heart rate between 100-109 bpm] might benefit from initial hospital observation for trending,” they wrote.
Dr. Jaureguízar reported no disclosures. One coinvestigator reported funding support from the Institute of Health Carlos III (ISCIII) and the European Development Regional Fund (ERDF). One coinvestigator reported consulting in litigation involving two models of inferior vena cava filters.
Dr. Polito reported no disclosures.
FROM CHEST
Targeted CLL treatments found effective in managing associated autoimmune cytopenias
Newer targeted drugs for chronic lymphocytic leukemia also appear to have a beneficial impact on underlying autoimmune cytopenias (AICs), results of a large retrospective study suggest.
Many autoimmune cytopenias improved or resolved during treatment with ibrutinib, idelalisib, or venetoclax, according to authors of the study, which appears in the journal Blood.
Treatment-emergent autoimmune cytopenias were seen in a “negligible portion” of patients overall, according to the report. The prevalence was about 1% each for patients treated with ibrutinib or idelalisib, though seen more frequently (at 7%) among patients who received venetoclax.
Nevertheless, treatment-emergent autoimmune cytopenias were “easily manageable” without interventions such as steroids and rituximab, and without need to interrupt the targeted treatment for chronic lymphocytic leukemia (CLL), according to the authors, led by Candida Vitale, MD, PhD, of the department of molecular biotechnology and health sciences at the University of Torino in Italy.
“Ibrutinib, idelalisib, and venetoclax have a beneficial impact on CLL-related preexisting AICs, achieving in most patients, in parallel with the consolidated antitumor efficacy, an effective control of the autoimmune phenomena,” Dr. Vitale and coauthors wrote in their report.
Study results
The retrospective study included 815 patients, of whom 572 were treated with ibrutinib, 143 with idelalisib plus rituximab, and 100 with venetoclax. Nine percent of ibrutinib-treated patients and 12% of venetoclax-treated patients also received an anti-CD20 monoclonal antibody, rituximab or obinutuzumab.
One hundred and four patients (13%) had preexisting autoimmune cytopenias, though the majority were resolved or controlled at the time targeted therapy was started.
Of patients with autoimmune cytopenias that were unresolved at the beginning of targeted therapy, 80% improved or resolved after starting targeted treatment, authors reported.
Most patients who developed autoimmune cytopenias on treatment had high-risk features such as unmutated IGHV, del(17)p, or TP53 mutation, according to the report.
Those treatment-emergent autoimmune cytopenias were seen in 1% of the ibrutinib group, 0.9% of the idelalisib group, and 7% of the venetoclax group. Out of 12 total treatment-emergent autoimmune cytopenias, all but 2 were resolved or controlled with dose reductions or temporary suspensions and use of steroids or rituximab, the report shows.
The higher incidence of autoimmune cytopenias in the venetoclax group held steady even when considering just the patients who had relapsed/refractory disease or had at least two prior lines of therapy, suggesting a “more meaningful” incidence, compared to what was observed for ibrutinib and idelalisib, the investigators said.
“However, the risk of autoimmune cytopenia episodes should not limit the use of venetoclax, considering the strong efficacy of this drug in treating patients with CLL, including those with high-risk features, and the possibility of effectively managing autoimmune complications, mostly without treatment interruption,” they concluded in their report.
Implications for patients with CLL
Findings of this study indicate that targeted therapies are effective for managing both CLL and autoimmune cytopenias, according to Carol Moreno, MD, PhD, of Hospital Sant Pau in Barcelona.
Moreover, the targeted therapies do not appear to change the overall prevalence of autoimmune cytopenias, compared to untreated patients, Dr. Moreno said in a commentary on the findings also published in Blood.
“These results are consistent with the concept that targeted therapies are not associated with a higher risk of autoimmune cytopenias, and that, if present, can be managed with immunosuppressive agents,” she wrote.
Autoimmune cytopenias and CLL
Autoimmune cytopenias are a relatively common complication of CLL, occurring in 5%-9% of CLL patients, Dr. Vitale and coauthors said in their report. The most common presentations include autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).
Evidence from earlier studies suggests that treatment for CLL may trigger autoimmune cytopenias. Results of retrospective studies in the 1990s linked single-agent fludarabine to increased risk of AIHA, Dr. Moreno said in the commentary.
However, subsequent studies showed that fludarabine plus cyclophosphamide (FC) and fludarabine, cyclophosphamide, and rituximab (FCR) were associated with low proportions of AIHA.
“Taken together, these results convincingly suggest that rather than treatment, it is the lack of response to it that conveys a higher risk of AIC,” Dr. Moreno wrote.
Management considerations
There are currently no clinical practice guidelines that advise on how to manage patients who develop AICs during targeted treatment for CLL, Dr. Vitale and colleagues said in their report.
However, this new study data may help inform management of patients with CLL and an autoimmune cytopenia, Dr. Moreno said in the commentary.
If the patient doesn’t immediately require CLL treatment, patients can be managed according to existing guidelines for AIHA and ITP, she said. “Nonresponding patients should be given CLL therapy,” she added.
For CLL patients who do require therapy and have a preexisting or treatment-emergent AIC, a “CLL-oriented” treatment approach could be considered, according to Dr. Moreno.
“A reasonable approach consists of a short course (2 to 4 weeks) of corticosteroids followed by effective CLL therapy (i.e., FCR, bendamustine plus rituximab or ibrutinib), depending on the clinical situation,” she added.
Dr. Vitale reported receiving consultancy fees from Janssen outside the submitted work. Dr. Moreno declared no competing financial interests related to her commentary.
Newer targeted drugs for chronic lymphocytic leukemia also appear to have a beneficial impact on underlying autoimmune cytopenias (AICs), results of a large retrospective study suggest.
Many autoimmune cytopenias improved or resolved during treatment with ibrutinib, idelalisib, or venetoclax, according to authors of the study, which appears in the journal Blood.
Treatment-emergent autoimmune cytopenias were seen in a “negligible portion” of patients overall, according to the report. The prevalence was about 1% each for patients treated with ibrutinib or idelalisib, though seen more frequently (at 7%) among patients who received venetoclax.
Nevertheless, treatment-emergent autoimmune cytopenias were “easily manageable” without interventions such as steroids and rituximab, and without need to interrupt the targeted treatment for chronic lymphocytic leukemia (CLL), according to the authors, led by Candida Vitale, MD, PhD, of the department of molecular biotechnology and health sciences at the University of Torino in Italy.
“Ibrutinib, idelalisib, and venetoclax have a beneficial impact on CLL-related preexisting AICs, achieving in most patients, in parallel with the consolidated antitumor efficacy, an effective control of the autoimmune phenomena,” Dr. Vitale and coauthors wrote in their report.
Study results
The retrospective study included 815 patients, of whom 572 were treated with ibrutinib, 143 with idelalisib plus rituximab, and 100 with venetoclax. Nine percent of ibrutinib-treated patients and 12% of venetoclax-treated patients also received an anti-CD20 monoclonal antibody, rituximab or obinutuzumab.
One hundred and four patients (13%) had preexisting autoimmune cytopenias, though the majority were resolved or controlled at the time targeted therapy was started.
Of patients with autoimmune cytopenias that were unresolved at the beginning of targeted therapy, 80% improved or resolved after starting targeted treatment, authors reported.
Most patients who developed autoimmune cytopenias on treatment had high-risk features such as unmutated IGHV, del(17)p, or TP53 mutation, according to the report.
Those treatment-emergent autoimmune cytopenias were seen in 1% of the ibrutinib group, 0.9% of the idelalisib group, and 7% of the venetoclax group. Out of 12 total treatment-emergent autoimmune cytopenias, all but 2 were resolved or controlled with dose reductions or temporary suspensions and use of steroids or rituximab, the report shows.
The higher incidence of autoimmune cytopenias in the venetoclax group held steady even when considering just the patients who had relapsed/refractory disease or had at least two prior lines of therapy, suggesting a “more meaningful” incidence, compared to what was observed for ibrutinib and idelalisib, the investigators said.
“However, the risk of autoimmune cytopenia episodes should not limit the use of venetoclax, considering the strong efficacy of this drug in treating patients with CLL, including those with high-risk features, and the possibility of effectively managing autoimmune complications, mostly without treatment interruption,” they concluded in their report.
Implications for patients with CLL
Findings of this study indicate that targeted therapies are effective for managing both CLL and autoimmune cytopenias, according to Carol Moreno, MD, PhD, of Hospital Sant Pau in Barcelona.
Moreover, the targeted therapies do not appear to change the overall prevalence of autoimmune cytopenias, compared to untreated patients, Dr. Moreno said in a commentary on the findings also published in Blood.
“These results are consistent with the concept that targeted therapies are not associated with a higher risk of autoimmune cytopenias, and that, if present, can be managed with immunosuppressive agents,” she wrote.
Autoimmune cytopenias and CLL
Autoimmune cytopenias are a relatively common complication of CLL, occurring in 5%-9% of CLL patients, Dr. Vitale and coauthors said in their report. The most common presentations include autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).
Evidence from earlier studies suggests that treatment for CLL may trigger autoimmune cytopenias. Results of retrospective studies in the 1990s linked single-agent fludarabine to increased risk of AIHA, Dr. Moreno said in the commentary.
However, subsequent studies showed that fludarabine plus cyclophosphamide (FC) and fludarabine, cyclophosphamide, and rituximab (FCR) were associated with low proportions of AIHA.
“Taken together, these results convincingly suggest that rather than treatment, it is the lack of response to it that conveys a higher risk of AIC,” Dr. Moreno wrote.
Management considerations
There are currently no clinical practice guidelines that advise on how to manage patients who develop AICs during targeted treatment for CLL, Dr. Vitale and colleagues said in their report.
However, this new study data may help inform management of patients with CLL and an autoimmune cytopenia, Dr. Moreno said in the commentary.
If the patient doesn’t immediately require CLL treatment, patients can be managed according to existing guidelines for AIHA and ITP, she said. “Nonresponding patients should be given CLL therapy,” she added.
For CLL patients who do require therapy and have a preexisting or treatment-emergent AIC, a “CLL-oriented” treatment approach could be considered, according to Dr. Moreno.
“A reasonable approach consists of a short course (2 to 4 weeks) of corticosteroids followed by effective CLL therapy (i.e., FCR, bendamustine plus rituximab or ibrutinib), depending on the clinical situation,” she added.
Dr. Vitale reported receiving consultancy fees from Janssen outside the submitted work. Dr. Moreno declared no competing financial interests related to her commentary.
Newer targeted drugs for chronic lymphocytic leukemia also appear to have a beneficial impact on underlying autoimmune cytopenias (AICs), results of a large retrospective study suggest.
Many autoimmune cytopenias improved or resolved during treatment with ibrutinib, idelalisib, or venetoclax, according to authors of the study, which appears in the journal Blood.
Treatment-emergent autoimmune cytopenias were seen in a “negligible portion” of patients overall, according to the report. The prevalence was about 1% each for patients treated with ibrutinib or idelalisib, though seen more frequently (at 7%) among patients who received venetoclax.
Nevertheless, treatment-emergent autoimmune cytopenias were “easily manageable” without interventions such as steroids and rituximab, and without need to interrupt the targeted treatment for chronic lymphocytic leukemia (CLL), according to the authors, led by Candida Vitale, MD, PhD, of the department of molecular biotechnology and health sciences at the University of Torino in Italy.
“Ibrutinib, idelalisib, and venetoclax have a beneficial impact on CLL-related preexisting AICs, achieving in most patients, in parallel with the consolidated antitumor efficacy, an effective control of the autoimmune phenomena,” Dr. Vitale and coauthors wrote in their report.
Study results
The retrospective study included 815 patients, of whom 572 were treated with ibrutinib, 143 with idelalisib plus rituximab, and 100 with venetoclax. Nine percent of ibrutinib-treated patients and 12% of venetoclax-treated patients also received an anti-CD20 monoclonal antibody, rituximab or obinutuzumab.
One hundred and four patients (13%) had preexisting autoimmune cytopenias, though the majority were resolved or controlled at the time targeted therapy was started.
Of patients with autoimmune cytopenias that were unresolved at the beginning of targeted therapy, 80% improved or resolved after starting targeted treatment, authors reported.
Most patients who developed autoimmune cytopenias on treatment had high-risk features such as unmutated IGHV, del(17)p, or TP53 mutation, according to the report.
Those treatment-emergent autoimmune cytopenias were seen in 1% of the ibrutinib group, 0.9% of the idelalisib group, and 7% of the venetoclax group. Out of 12 total treatment-emergent autoimmune cytopenias, all but 2 were resolved or controlled with dose reductions or temporary suspensions and use of steroids or rituximab, the report shows.
The higher incidence of autoimmune cytopenias in the venetoclax group held steady even when considering just the patients who had relapsed/refractory disease or had at least two prior lines of therapy, suggesting a “more meaningful” incidence, compared to what was observed for ibrutinib and idelalisib, the investigators said.
“However, the risk of autoimmune cytopenia episodes should not limit the use of venetoclax, considering the strong efficacy of this drug in treating patients with CLL, including those with high-risk features, and the possibility of effectively managing autoimmune complications, mostly without treatment interruption,” they concluded in their report.
Implications for patients with CLL
Findings of this study indicate that targeted therapies are effective for managing both CLL and autoimmune cytopenias, according to Carol Moreno, MD, PhD, of Hospital Sant Pau in Barcelona.
Moreover, the targeted therapies do not appear to change the overall prevalence of autoimmune cytopenias, compared to untreated patients, Dr. Moreno said in a commentary on the findings also published in Blood.
“These results are consistent with the concept that targeted therapies are not associated with a higher risk of autoimmune cytopenias, and that, if present, can be managed with immunosuppressive agents,” she wrote.
Autoimmune cytopenias and CLL
Autoimmune cytopenias are a relatively common complication of CLL, occurring in 5%-9% of CLL patients, Dr. Vitale and coauthors said in their report. The most common presentations include autoimmune hemolytic anemia (AIHA) and immune thrombocytopenia (ITP).
Evidence from earlier studies suggests that treatment for CLL may trigger autoimmune cytopenias. Results of retrospective studies in the 1990s linked single-agent fludarabine to increased risk of AIHA, Dr. Moreno said in the commentary.
However, subsequent studies showed that fludarabine plus cyclophosphamide (FC) and fludarabine, cyclophosphamide, and rituximab (FCR) were associated with low proportions of AIHA.
“Taken together, these results convincingly suggest that rather than treatment, it is the lack of response to it that conveys a higher risk of AIC,” Dr. Moreno wrote.
Management considerations
There are currently no clinical practice guidelines that advise on how to manage patients who develop AICs during targeted treatment for CLL, Dr. Vitale and colleagues said in their report.
However, this new study data may help inform management of patients with CLL and an autoimmune cytopenia, Dr. Moreno said in the commentary.
If the patient doesn’t immediately require CLL treatment, patients can be managed according to existing guidelines for AIHA and ITP, she said. “Nonresponding patients should be given CLL therapy,” she added.
For CLL patients who do require therapy and have a preexisting or treatment-emergent AIC, a “CLL-oriented” treatment approach could be considered, according to Dr. Moreno.
“A reasonable approach consists of a short course (2 to 4 weeks) of corticosteroids followed by effective CLL therapy (i.e., FCR, bendamustine plus rituximab or ibrutinib), depending on the clinical situation,” she added.
Dr. Vitale reported receiving consultancy fees from Janssen outside the submitted work. Dr. Moreno declared no competing financial interests related to her commentary.
FROM BLOOD
‘Praise Diabetes’: Support programs in Black churches yield lasting A1c changes
A church-based diabetes self-management support intervention that incorporated parish nurses and peer leaders is feasible and may help improve diabetes-related outcomes in participants.
Sustained reductions in hemoglobin A1c and diabetes distress were seen in the Praise Diabetes Project, a 33-month study that piloted several different approaches to parish nurse and peer leader support at 21 urban churches in Michigan and Ohio, said Gretchen Piatt, MPH, PhD, associate professor in the department of learning health sciences at the University of Michigan, Ann Arbor, reported at the annual scientific sessions of the American Diabetes Association.
“Of the participants who achieved glycemic control following diabetes self-management education, a really large proportion – upward of 77% of participants across all the groups– achieved sustained glycemic control at 33 months,” Dr. Piatt said.
Findings from this study has helped diabetes educators better understand how to design effective support approaches that may have a long-term impact on glycemic control and diabetes distress, Dr. Piatt said.
The Praise Diabetes Project represents a “very smart strategy” of leveraging institutions that already exist in the African American community that are trusted and provide emotional support, said Tracey D. Brown, CEO of the ADA.
“This is about behavior change, really, at its crux,” Ms. Brown said in an interview. “To get there, you’ve got to have trust, and you have to have an emotional connection. If you don’t get either one of those things, then you really are not going to do anything in terms of changing behavior.”
Long-term solutions needed
Many studies show that diabetes self-management education can improve clinical and psychosocial outcomes, and reduce health care utilization and cost, at least in the short term, Dr. Piatt said. However, it’s less clear how those improvements can be sustained over longer periods of time.
“This then presents a critical need to develop and evaluate diabetes self-management support models that are ongoing, patient driven, and embedded within existing community infrastructures,” Dr. Piatt said in her presentation.
Working with churches is one approach to working within existing community infrastructures: “Churches are embedded in the community, they have the personnel oftentimes to facilitate these types of health programs, and most importantly, they have the established relationships with the community that brings about sustained changes,” Dr. Piatt said in her presentation.
Addressing diabetes education needs in urban, low-resource communities
The Praise Diabetes Project was a randomized, 33-month clinical trial conducted in 21 predominantly Black churches in Detroit; Flint, Mich.; and Toledo, Ohio, which are all urban, low-resource communities where diabetes is a significant public health problem, according to Dr. Piatt.
The study was designed to evaluate the relative effectiveness of three different approaches to diabetes self-management support at improving A1c and levels of diabetes distress, according to the investigators.
The churches were randomized to one of the support arms, including parish nurse plus peer leader support, parish nurse support by itself, or peer leader support by itself.
A total of 47 individuals were trained, including 31 peer leaders and 16 parish nurses.
All three interventions included an initial 6-month period of “enhanced usual care” during which biweekly newsletters that were distributed, according to Dr. Piatt. That was followed by 12 months of diabetes self-management support, and an additional 12 months of ongoing support facilitated by parish nurses and peer leaders on their own, without input from the research team or health care providers.
Participants in the program had to be at least 21 years old and under the care of a physician for their diabetes, according to Dr. Piatt. The parish nurses had to be registered nurses in Michigan or Ohio. Peer leaders had to be at least 21 years old, had at least an eighth-grade education, and had to commit to a 30-hour training program.
Peer leaders also had to be individuals living with diabetes: “Prior studies have found that, when peer leaders are actively working on their own self-management goals, they tend to be much more successful in helping others,” Dr. Piatt explained.
In addition to facilitating diabetes self-management education, the parish nurses and peer leaders in these interventions were responsible for recruitment, church announcements, room reservations, follow-up calls to participants, according to Dr. Piatt. Parish nurses also provided clinical content knowledge and supervised the peer leaders in the combined model.
Sustained reductions in A1c and diabetes distress
These diabetes self-management support approaches led to significant changes over time in A1c and diabetes distress, the primary outcomes of the study, Dr. Piatt said.
The peer leader support approach resulted in a statistically significant decline in A1c, from a mean of 8.0% at baseline to 7.7% at 33 months (P = .04), while nonsignificant declines were observed in the parish nurse and combined parish nurse–peer leader approach, according to the researcher.
Reductions in A1c persisted despite the COVID-19 pandemic, which began roughly 21 months into the study, she said.
Glycemic control remained steady over the course of the study, as illustrated by similar proportions of participants with A1c below 7% from baseline to 33 months, she added.
Sustained glycemic control was seen in all three groups, according to Dr. Piatt. For example, 42.7% of individuals in the parish nurse and peer leader support group achieved glycemic control following the intervention, and 88.5% of them sustained it at 33 months.
“I think this is one of the longest diabetes self-management education and diabetes self-management support interventions that’s out there right now, so we were so happy to see that sustained by glycemic control that far into the future,” she said.
Diabetes distress levels decreased steadily over time in all three groups, with declines that were statistically significant from baseline to 33 months in the parish nurse–only and peer leader–only groups, the investigator said.
The proportion of participants reporting moderate levels of diabetes distress dropped over time, especially in the peer leader support group, where there was a 50% reduction, she added.
Despite these findings, the study had limitations, according to Dr. Piatt, including some “burnout” that impacted participants, parish nurses, and peer leaders, especially after the pandemic started.
In addition, this type of intervention may have limited impact in the community at large: “We probably didn’t reach people who did not have good connection to the church,” Dr. Piatt said.
Dr. Piatt reported no conflicts of interest related to the research.
A church-based diabetes self-management support intervention that incorporated parish nurses and peer leaders is feasible and may help improve diabetes-related outcomes in participants.
Sustained reductions in hemoglobin A1c and diabetes distress were seen in the Praise Diabetes Project, a 33-month study that piloted several different approaches to parish nurse and peer leader support at 21 urban churches in Michigan and Ohio, said Gretchen Piatt, MPH, PhD, associate professor in the department of learning health sciences at the University of Michigan, Ann Arbor, reported at the annual scientific sessions of the American Diabetes Association.
“Of the participants who achieved glycemic control following diabetes self-management education, a really large proportion – upward of 77% of participants across all the groups– achieved sustained glycemic control at 33 months,” Dr. Piatt said.
Findings from this study has helped diabetes educators better understand how to design effective support approaches that may have a long-term impact on glycemic control and diabetes distress, Dr. Piatt said.
The Praise Diabetes Project represents a “very smart strategy” of leveraging institutions that already exist in the African American community that are trusted and provide emotional support, said Tracey D. Brown, CEO of the ADA.
“This is about behavior change, really, at its crux,” Ms. Brown said in an interview. “To get there, you’ve got to have trust, and you have to have an emotional connection. If you don’t get either one of those things, then you really are not going to do anything in terms of changing behavior.”
Long-term solutions needed
Many studies show that diabetes self-management education can improve clinical and psychosocial outcomes, and reduce health care utilization and cost, at least in the short term, Dr. Piatt said. However, it’s less clear how those improvements can be sustained over longer periods of time.
“This then presents a critical need to develop and evaluate diabetes self-management support models that are ongoing, patient driven, and embedded within existing community infrastructures,” Dr. Piatt said in her presentation.
Working with churches is one approach to working within existing community infrastructures: “Churches are embedded in the community, they have the personnel oftentimes to facilitate these types of health programs, and most importantly, they have the established relationships with the community that brings about sustained changes,” Dr. Piatt said in her presentation.
Addressing diabetes education needs in urban, low-resource communities
The Praise Diabetes Project was a randomized, 33-month clinical trial conducted in 21 predominantly Black churches in Detroit; Flint, Mich.; and Toledo, Ohio, which are all urban, low-resource communities where diabetes is a significant public health problem, according to Dr. Piatt.
The study was designed to evaluate the relative effectiveness of three different approaches to diabetes self-management support at improving A1c and levels of diabetes distress, according to the investigators.
The churches were randomized to one of the support arms, including parish nurse plus peer leader support, parish nurse support by itself, or peer leader support by itself.
A total of 47 individuals were trained, including 31 peer leaders and 16 parish nurses.
All three interventions included an initial 6-month period of “enhanced usual care” during which biweekly newsletters that were distributed, according to Dr. Piatt. That was followed by 12 months of diabetes self-management support, and an additional 12 months of ongoing support facilitated by parish nurses and peer leaders on their own, without input from the research team or health care providers.
Participants in the program had to be at least 21 years old and under the care of a physician for their diabetes, according to Dr. Piatt. The parish nurses had to be registered nurses in Michigan or Ohio. Peer leaders had to be at least 21 years old, had at least an eighth-grade education, and had to commit to a 30-hour training program.
Peer leaders also had to be individuals living with diabetes: “Prior studies have found that, when peer leaders are actively working on their own self-management goals, they tend to be much more successful in helping others,” Dr. Piatt explained.
In addition to facilitating diabetes self-management education, the parish nurses and peer leaders in these interventions were responsible for recruitment, church announcements, room reservations, follow-up calls to participants, according to Dr. Piatt. Parish nurses also provided clinical content knowledge and supervised the peer leaders in the combined model.
Sustained reductions in A1c and diabetes distress
These diabetes self-management support approaches led to significant changes over time in A1c and diabetes distress, the primary outcomes of the study, Dr. Piatt said.
The peer leader support approach resulted in a statistically significant decline in A1c, from a mean of 8.0% at baseline to 7.7% at 33 months (P = .04), while nonsignificant declines were observed in the parish nurse and combined parish nurse–peer leader approach, according to the researcher.
Reductions in A1c persisted despite the COVID-19 pandemic, which began roughly 21 months into the study, she said.
Glycemic control remained steady over the course of the study, as illustrated by similar proportions of participants with A1c below 7% from baseline to 33 months, she added.
Sustained glycemic control was seen in all three groups, according to Dr. Piatt. For example, 42.7% of individuals in the parish nurse and peer leader support group achieved glycemic control following the intervention, and 88.5% of them sustained it at 33 months.
“I think this is one of the longest diabetes self-management education and diabetes self-management support interventions that’s out there right now, so we were so happy to see that sustained by glycemic control that far into the future,” she said.
Diabetes distress levels decreased steadily over time in all three groups, with declines that were statistically significant from baseline to 33 months in the parish nurse–only and peer leader–only groups, the investigator said.
The proportion of participants reporting moderate levels of diabetes distress dropped over time, especially in the peer leader support group, where there was a 50% reduction, she added.
Despite these findings, the study had limitations, according to Dr. Piatt, including some “burnout” that impacted participants, parish nurses, and peer leaders, especially after the pandemic started.
In addition, this type of intervention may have limited impact in the community at large: “We probably didn’t reach people who did not have good connection to the church,” Dr. Piatt said.
Dr. Piatt reported no conflicts of interest related to the research.
A church-based diabetes self-management support intervention that incorporated parish nurses and peer leaders is feasible and may help improve diabetes-related outcomes in participants.
Sustained reductions in hemoglobin A1c and diabetes distress were seen in the Praise Diabetes Project, a 33-month study that piloted several different approaches to parish nurse and peer leader support at 21 urban churches in Michigan and Ohio, said Gretchen Piatt, MPH, PhD, associate professor in the department of learning health sciences at the University of Michigan, Ann Arbor, reported at the annual scientific sessions of the American Diabetes Association.
“Of the participants who achieved glycemic control following diabetes self-management education, a really large proportion – upward of 77% of participants across all the groups– achieved sustained glycemic control at 33 months,” Dr. Piatt said.
Findings from this study has helped diabetes educators better understand how to design effective support approaches that may have a long-term impact on glycemic control and diabetes distress, Dr. Piatt said.
The Praise Diabetes Project represents a “very smart strategy” of leveraging institutions that already exist in the African American community that are trusted and provide emotional support, said Tracey D. Brown, CEO of the ADA.
“This is about behavior change, really, at its crux,” Ms. Brown said in an interview. “To get there, you’ve got to have trust, and you have to have an emotional connection. If you don’t get either one of those things, then you really are not going to do anything in terms of changing behavior.”
Long-term solutions needed
Many studies show that diabetes self-management education can improve clinical and psychosocial outcomes, and reduce health care utilization and cost, at least in the short term, Dr. Piatt said. However, it’s less clear how those improvements can be sustained over longer periods of time.
“This then presents a critical need to develop and evaluate diabetes self-management support models that are ongoing, patient driven, and embedded within existing community infrastructures,” Dr. Piatt said in her presentation.
Working with churches is one approach to working within existing community infrastructures: “Churches are embedded in the community, they have the personnel oftentimes to facilitate these types of health programs, and most importantly, they have the established relationships with the community that brings about sustained changes,” Dr. Piatt said in her presentation.
Addressing diabetes education needs in urban, low-resource communities
The Praise Diabetes Project was a randomized, 33-month clinical trial conducted in 21 predominantly Black churches in Detroit; Flint, Mich.; and Toledo, Ohio, which are all urban, low-resource communities where diabetes is a significant public health problem, according to Dr. Piatt.
The study was designed to evaluate the relative effectiveness of three different approaches to diabetes self-management support at improving A1c and levels of diabetes distress, according to the investigators.
The churches were randomized to one of the support arms, including parish nurse plus peer leader support, parish nurse support by itself, or peer leader support by itself.
A total of 47 individuals were trained, including 31 peer leaders and 16 parish nurses.
All three interventions included an initial 6-month period of “enhanced usual care” during which biweekly newsletters that were distributed, according to Dr. Piatt. That was followed by 12 months of diabetes self-management support, and an additional 12 months of ongoing support facilitated by parish nurses and peer leaders on their own, without input from the research team or health care providers.
Participants in the program had to be at least 21 years old and under the care of a physician for their diabetes, according to Dr. Piatt. The parish nurses had to be registered nurses in Michigan or Ohio. Peer leaders had to be at least 21 years old, had at least an eighth-grade education, and had to commit to a 30-hour training program.
Peer leaders also had to be individuals living with diabetes: “Prior studies have found that, when peer leaders are actively working on their own self-management goals, they tend to be much more successful in helping others,” Dr. Piatt explained.
In addition to facilitating diabetes self-management education, the parish nurses and peer leaders in these interventions were responsible for recruitment, church announcements, room reservations, follow-up calls to participants, according to Dr. Piatt. Parish nurses also provided clinical content knowledge and supervised the peer leaders in the combined model.
Sustained reductions in A1c and diabetes distress
These diabetes self-management support approaches led to significant changes over time in A1c and diabetes distress, the primary outcomes of the study, Dr. Piatt said.
The peer leader support approach resulted in a statistically significant decline in A1c, from a mean of 8.0% at baseline to 7.7% at 33 months (P = .04), while nonsignificant declines were observed in the parish nurse and combined parish nurse–peer leader approach, according to the researcher.
Reductions in A1c persisted despite the COVID-19 pandemic, which began roughly 21 months into the study, she said.
Glycemic control remained steady over the course of the study, as illustrated by similar proportions of participants with A1c below 7% from baseline to 33 months, she added.
Sustained glycemic control was seen in all three groups, according to Dr. Piatt. For example, 42.7% of individuals in the parish nurse and peer leader support group achieved glycemic control following the intervention, and 88.5% of them sustained it at 33 months.
“I think this is one of the longest diabetes self-management education and diabetes self-management support interventions that’s out there right now, so we were so happy to see that sustained by glycemic control that far into the future,” she said.
Diabetes distress levels decreased steadily over time in all three groups, with declines that were statistically significant from baseline to 33 months in the parish nurse–only and peer leader–only groups, the investigator said.
The proportion of participants reporting moderate levels of diabetes distress dropped over time, especially in the peer leader support group, where there was a 50% reduction, she added.
Despite these findings, the study had limitations, according to Dr. Piatt, including some “burnout” that impacted participants, parish nurses, and peer leaders, especially after the pandemic started.
In addition, this type of intervention may have limited impact in the community at large: “We probably didn’t reach people who did not have good connection to the church,” Dr. Piatt said.
Dr. Piatt reported no conflicts of interest related to the research.
FROM ADA 2020
Anti-VEGF injections for diabetic retinopathy linked to mortality risk
The use of anti–vascular endothelial growth factor injections has been linked to an increased risk of mortality in patients with diabetic retinopathy in a new study, sounding a note of caution regarding the cardiovascular safety of these agents in clinical practice, an investigator said.
There was no increased risk of MI or stroke risk associated with intravitreal anti-VEGF injections versus steroid injections or laser photocoagulation in the study, which was based on analysis of health records for more than 60,000 treated individuals.
However, a “signal” was observed for increased risk of death from any cause among patients receiving anti-VEGF injections, and especially so in those with a history of cardiovascular events, said investigator Miin Roh, MD, PhD, a retina surgeon and instructor in ophthalmology at Harvard Medical School, Boston.
“This study suggests that we would have to be very careful in giving anti-VEGF injections in patients for diabetic retinopathy, especially when you’re giving it for a long-term period,” Dr. Roh said in a virtual presentation at the annual scientific sessions of the American Diabetes Association.
Report of a mortality signal
The study by Dr. Roh and colleagues included patients with type 1 or 2 diabetes, identified in health claims databases who started intravitreal anti-VEGF injections, intravitreal steroid injections, or laser photocoagulation between 2009 and 2017.
Their analysis included 30,741 patients who received anti-VEGF injections and 30,741 matched controls who received laser or steroid treatment.
There were no differences in the primary composite outcome of MI or stroke, with 674 events in the anti-VEGF group and 708 events in the laser or steroid group over a 365-day treatment period, Dr. Roh reported.
By contrast, the investigator said she saw a signal for increased risk of all-cause mortality in analyses of secondary outcomes.
Over a 180-day treatment period, there was a “slight numerical increase” in all-cause mortality, with 144 deaths in the anti-VEGF group and 115 in the control group. That translated into a hazard ratio of 1.26 (95% confidence interval, 0.99-1.60).
Looking at a 365-day treatment period, there was an increase in all-cause mortality in the anti-VEGF group that this time was statistically significant, she said, with 311 and 236 events, respectively (HR, 1.32; 95% CI, 1.12-1.57).
The mortality signal was especially strong among individuals who had a prior history of a cardiovascular event, according to Dr. Roh.
In patients with cardiovascular disease history, there were 219 deaths from any cause in the anti-VEGF group and 153 in the laser or steroid group (HR, 1.44, 95% CI, 3.10-11.22) over a 365-day period, the investigator reported. By comparison, in patients with no cardiovascular disease history, there were 95 and 96 deaths (HR, 1.00; 95% CI, 0.75-1.33).
More research needed
Although these findings are “hypothesis generating,” exploration of other datasets would be warranted to measure mortality risk among patients receiving treatment for diabetic neuropathy, said Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA.
“It’s something that we need now to study more rigorously,” Dr. Gabbay said in an interview. “It doesn’t prove that there’s a connection, but it tells us that this is worth studying.”
The current study is not a randomized comparison, which means that the people chosen to receive anti-VEGF therapy, as opposed to steroid injections or laser treatment, may differ in other ways that are associated with mortality, he said.
“It’s always good to monitor these patients,” Dr. Gabbay added. “The good news is that these individuals typically are coming in, oftentimes monthly for repeated injections, and so there’s an opportunity to monitor any changes.”
Dr. Roh reported that she is a coinvestigator in a Boehringer Ingelheim–initiated study that is not directly related to the topic of this research.
The use of anti–vascular endothelial growth factor injections has been linked to an increased risk of mortality in patients with diabetic retinopathy in a new study, sounding a note of caution regarding the cardiovascular safety of these agents in clinical practice, an investigator said.
There was no increased risk of MI or stroke risk associated with intravitreal anti-VEGF injections versus steroid injections or laser photocoagulation in the study, which was based on analysis of health records for more than 60,000 treated individuals.
However, a “signal” was observed for increased risk of death from any cause among patients receiving anti-VEGF injections, and especially so in those with a history of cardiovascular events, said investigator Miin Roh, MD, PhD, a retina surgeon and instructor in ophthalmology at Harvard Medical School, Boston.
“This study suggests that we would have to be very careful in giving anti-VEGF injections in patients for diabetic retinopathy, especially when you’re giving it for a long-term period,” Dr. Roh said in a virtual presentation at the annual scientific sessions of the American Diabetes Association.
Report of a mortality signal
The study by Dr. Roh and colleagues included patients with type 1 or 2 diabetes, identified in health claims databases who started intravitreal anti-VEGF injections, intravitreal steroid injections, or laser photocoagulation between 2009 and 2017.
Their analysis included 30,741 patients who received anti-VEGF injections and 30,741 matched controls who received laser or steroid treatment.
There were no differences in the primary composite outcome of MI or stroke, with 674 events in the anti-VEGF group and 708 events in the laser or steroid group over a 365-day treatment period, Dr. Roh reported.
By contrast, the investigator said she saw a signal for increased risk of all-cause mortality in analyses of secondary outcomes.
Over a 180-day treatment period, there was a “slight numerical increase” in all-cause mortality, with 144 deaths in the anti-VEGF group and 115 in the control group. That translated into a hazard ratio of 1.26 (95% confidence interval, 0.99-1.60).
Looking at a 365-day treatment period, there was an increase in all-cause mortality in the anti-VEGF group that this time was statistically significant, she said, with 311 and 236 events, respectively (HR, 1.32; 95% CI, 1.12-1.57).
The mortality signal was especially strong among individuals who had a prior history of a cardiovascular event, according to Dr. Roh.
In patients with cardiovascular disease history, there were 219 deaths from any cause in the anti-VEGF group and 153 in the laser or steroid group (HR, 1.44, 95% CI, 3.10-11.22) over a 365-day period, the investigator reported. By comparison, in patients with no cardiovascular disease history, there were 95 and 96 deaths (HR, 1.00; 95% CI, 0.75-1.33).
More research needed
Although these findings are “hypothesis generating,” exploration of other datasets would be warranted to measure mortality risk among patients receiving treatment for diabetic neuropathy, said Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA.
“It’s something that we need now to study more rigorously,” Dr. Gabbay said in an interview. “It doesn’t prove that there’s a connection, but it tells us that this is worth studying.”
The current study is not a randomized comparison, which means that the people chosen to receive anti-VEGF therapy, as opposed to steroid injections or laser treatment, may differ in other ways that are associated with mortality, he said.
“It’s always good to monitor these patients,” Dr. Gabbay added. “The good news is that these individuals typically are coming in, oftentimes monthly for repeated injections, and so there’s an opportunity to monitor any changes.”
Dr. Roh reported that she is a coinvestigator in a Boehringer Ingelheim–initiated study that is not directly related to the topic of this research.
The use of anti–vascular endothelial growth factor injections has been linked to an increased risk of mortality in patients with diabetic retinopathy in a new study, sounding a note of caution regarding the cardiovascular safety of these agents in clinical practice, an investigator said.
There was no increased risk of MI or stroke risk associated with intravitreal anti-VEGF injections versus steroid injections or laser photocoagulation in the study, which was based on analysis of health records for more than 60,000 treated individuals.
However, a “signal” was observed for increased risk of death from any cause among patients receiving anti-VEGF injections, and especially so in those with a history of cardiovascular events, said investigator Miin Roh, MD, PhD, a retina surgeon and instructor in ophthalmology at Harvard Medical School, Boston.
“This study suggests that we would have to be very careful in giving anti-VEGF injections in patients for diabetic retinopathy, especially when you’re giving it for a long-term period,” Dr. Roh said in a virtual presentation at the annual scientific sessions of the American Diabetes Association.
Report of a mortality signal
The study by Dr. Roh and colleagues included patients with type 1 or 2 diabetes, identified in health claims databases who started intravitreal anti-VEGF injections, intravitreal steroid injections, or laser photocoagulation between 2009 and 2017.
Their analysis included 30,741 patients who received anti-VEGF injections and 30,741 matched controls who received laser or steroid treatment.
There were no differences in the primary composite outcome of MI or stroke, with 674 events in the anti-VEGF group and 708 events in the laser or steroid group over a 365-day treatment period, Dr. Roh reported.
By contrast, the investigator said she saw a signal for increased risk of all-cause mortality in analyses of secondary outcomes.
Over a 180-day treatment period, there was a “slight numerical increase” in all-cause mortality, with 144 deaths in the anti-VEGF group and 115 in the control group. That translated into a hazard ratio of 1.26 (95% confidence interval, 0.99-1.60).
Looking at a 365-day treatment period, there was an increase in all-cause mortality in the anti-VEGF group that this time was statistically significant, she said, with 311 and 236 events, respectively (HR, 1.32; 95% CI, 1.12-1.57).
The mortality signal was especially strong among individuals who had a prior history of a cardiovascular event, according to Dr. Roh.
In patients with cardiovascular disease history, there were 219 deaths from any cause in the anti-VEGF group and 153 in the laser or steroid group (HR, 1.44, 95% CI, 3.10-11.22) over a 365-day period, the investigator reported. By comparison, in patients with no cardiovascular disease history, there were 95 and 96 deaths (HR, 1.00; 95% CI, 0.75-1.33).
More research needed
Although these findings are “hypothesis generating,” exploration of other datasets would be warranted to measure mortality risk among patients receiving treatment for diabetic neuropathy, said Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA.
“It’s something that we need now to study more rigorously,” Dr. Gabbay said in an interview. “It doesn’t prove that there’s a connection, but it tells us that this is worth studying.”
The current study is not a randomized comparison, which means that the people chosen to receive anti-VEGF therapy, as opposed to steroid injections or laser treatment, may differ in other ways that are associated with mortality, he said.
“It’s always good to monitor these patients,” Dr. Gabbay added. “The good news is that these individuals typically are coming in, oftentimes monthly for repeated injections, and so there’s an opportunity to monitor any changes.”
Dr. Roh reported that she is a coinvestigator in a Boehringer Ingelheim–initiated study that is not directly related to the topic of this research.
FROM ADA 2021
'Full throttle': 'Diabetes Garage' workshops boost Mexican American men's self-management
Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.
The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.
After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.
Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.
”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
Meeting Mexican American men where they’re at
Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.
“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.
“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
Unmet needs for diabetes education
The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.
The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.
Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
Infusing diabetes self-management with car culture
The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.
This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.
The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:
In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.
The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).
The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).
Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
Rubber hits the road
Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.
In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.
The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.
The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.
By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.
Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.
Dr. Concha and coauthors reported no conflicts of interest related to the study.
Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.
The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.
After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.
Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.
”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
Meeting Mexican American men where they’re at
Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.
“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.
“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
Unmet needs for diabetes education
The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.
The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.
Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
Infusing diabetes self-management with car culture
The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.
This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.
The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:
In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.
The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).
The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).
Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
Rubber hits the road
Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.
In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.
The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.
The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.
By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.
Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.
Dr. Concha and coauthors reported no conflicts of interest related to the study.
Automotive-themed workshops that refer to doctor visits as “tune-ups” and nutritious food as “high-performance fuel” are showing promise as a strategy to better explain diabetes self-management to Mexican American men, an investigator has reported.
The workshops, which started out in person and transitioned online because of the COVID-19 pandemic, have improved self-care behaviors among Mexican American men with diabetes, said Jeannie Belinda Concha, PhD, MPH, of the University of Texas, El Paso.
After participating in the workshops, known as The Diabetes Garage, men more often measured food portions and counted carbohydrates, and had improved confidence in their ability to self-manage their diabetes, Dr. Concha said in a virtual presentation on the study.
Although those improvements in self-care behaviors didn’t translate into significant improvements in blood pressure or hemoglobin A1c, she said, they could be predecessors to improved physical health outcomes with longer follow-up.
”We know it takes some time to move those numbers, but they are going in the right direction,” Dr. Concha said in her presentation, which took place during the annual scientific sessions of the American Diabetes Association.
Meeting Mexican American men where they’re at
Robert Gabbay, MD, PhD, chief scientific and medical officer of the ADA, said The Diabetes Garage is an “innovative” approach to tailoring diabetes self-care message for a specific of individuals.
“It’s such a wonderful example of something that we believe so strongly, which is that you’ve got to meet people where they’re at,” Dr. Gabbay said in an interview.
“We know that people learn in different ways, and people and with different backgrounds have different things that resonate with them,” he continued. “For better or worse, one size doesn’t fit all, and that in a sense is one of the challenges around diabetes, because we’re really trying to help everybody.”
Unmet needs for diabetes education
The prevalence of diabetes in the United States is high among Hispanics, higher among Mexican Americans, and even higher still among Mexican-American men, according to Dr. Concha.
The age-adjusted prevalence of diabetes is 16.2% among Mexican-American men, as compared with 12.8% for Mexican American women, and 8.6% for White non-Hispanic men, according to 2018 data from the Centers for Disease Control and Prevention that Dr. Concha highlighted in her presentation.
Moreover, only 25% of participants in diabetes education are men, highlighting another disparity that needs to be addressed, she said.
Infusing diabetes self-management with car culture
The Diabetes Garage leverages a positive “car culture” that is prevalent in Mexican American communities in general, and cities like El Paso in particular, Dr. Concha said.
This culture brings Mexican American people together at numerous car shows, and is viewed as a form of family identification for enthusiasts, who will illustrate their own pride by customizing their cars with cultural symbols, according to Dr. Concha.
The diabetes education intervention consists of four workshops delivered as 2-hour weekly sessions that include a diabetes educator and an automotive instructor:
In the first session, men learn about “starting and operating” their body with diabetes, and checking their “gauges” when it comes to blood pressure, cholesterol, and other measures, according to Dr. Concha.
The second session stresses the importance of physical activity (“using all your gears”) and of managing stress (“full throttle”).
The third session highlights medication as a tool (“to keep your battery charged”) and the importance of diabetes complications (“catastrophic failure”) as well as visiting the doctor (“tune ups and inspections”).
Finally, men learn about nutrition (high-performance fuel) in a workshop on eating well with diabetes. “We ask them to invite their family and friends, and they do,” said Dr. Concha.
Rubber hits the road
Since 2018, 16 workshops have been completed in El Paso, San Antonio, and Harlingen, Tex., of which 9 were in English, 5 were in Spanish, and 2 were bilingual. Due to the COVID-19 pandemic, 10 of the workshops were completed online, Dr. Concha said.
In total, 97 men engaged in the workshops, of whom 91% were Hispanic/Latino; 71% were employed, 71% were married, and 84% had health insurance. Eighty-six percent completed all four workshops, while 89% completed at least three workshops.
The number of days men measured food portions increased significantly from pre- to postworkshop assessment, from a mean of 2.1 days to 2.74 days, Dr. Concha reported. Similarly, the mean number of days counting carbohydrate portions increased significantly, from 1.92 to 2.64 days.
The proportion of men agreeing or strongly agreeing they were confident they could manage diabetes increased from 74% before the intervention to 93% afterward, according to Dr. Concha’s presentation.
By contrast, there were no statistically significant increases in physical outcomes including physical activity, weight, waist circumference, A1c, or blood pressure from before the workshop to after, though outcomes trended in an improved direction, according to Dr. Concha.
Postactivity satisfaction survey results showed that 86%of men said the automotive analogies in the program helped them understand the importance of diabetes management. “I am looking forward to better managing my human-mobile for a long, long time with a good quality of life,” one of the men wrote in survey feedback.
Dr. Concha and coauthors reported no conflicts of interest related to the study.
FROM ADA 2021
Intervention opens access to care for minority youths with type 1 diabetes
For racial or ethnic minority youths with type 1 diabetes, participating in an interventional program improves access to care, new research shows.
Youth categorized as Black, Indigenous, and other people of color (BIPOC) had significantly improved outpatient attendance during and after participating in Novel Interventions in Children’s Healthcare (NICH), a systems intervention for children with chronic health conditions and their families.
By comparison, no improvements in care access were observed among BIPOC children who were not able to access the program because of insurance or other reasons, David V. Wagner, PhD, Associate Professor and NICH research director at Oregon Health & Science University, Portland, reported at the annual scientific sessions of the American Diabetes Association.
The findings demonstrate a need for intensive, home-based services that aim to correct health inequities, said Dr. Wagner, who presented the findings along with Winniebhelle Cadiz, a scholar in the BUILD EXITO undergraduate research training program at Portland (Ore.) State University.
The NICH program hinges on trained interventionists who visit families at home, attend clinic visits, and work with schools and other contacts to help solve problems that keep children from following medical instructions, according to a program description.
“Families report having somebody by their side to help them navigate the system, address the transportation difficulties experienced, and help them and build that relationship with their health care provider seems to be hugely influential in terms of helping them navigate and access care,” Dr. Wagner said in a presentation of the study.
A NICH for youths with chronic health conditions
The NICH program differs from some other programs that have been developed in an attempt to improve health outcomes among youths in the community, according to Dr. Wagner.
“Many of the programs that exist out there are often piloted on, and seemingly built for, those who have more resources,” he said in his presentation. “Those who are in greatest need often have difficulty accessing and responding to the services.”
NICH doesn’t take the place of existing services, but is “an addition to the continuum of care” for youths and families who are struggling because of lack of resources or marginalization in the health care system, Dr. Wagner said.
While NICH is not specific to any one chronic health condition, several previous investigations have specifically looked at the impact of the NICH program on access to care in youths with type 1 diabetes.
Youths participating in the program for a year had fewer ED visits, including fewer visits with diabetic ketoacidosis (DKA), as well as fewer and shorter admissions as compared with the year prior to participating in the program, Dr. Wagner said.
In another study, youths had fewer admissions for diabetes or DKA and less frequent pediatric ICU contact during the NICH program, as compared with before the program.
Another study showed that, while NICH had no impact overall on access to care among youths with type 1 diabetes, BIPOC youths had an improvement in the mean number of outpatient visits as compared with preprogram levels. However, because none of those studies included a control group, Dr. Wagner said, it remained unclear whether this systems intervention might improve outpatient access among youths with type 1 diabetes as compared with those who did not participate.
Intervention linked to increased BIPOC care access
The latest study includes 144 youths with type 1 diabetes referred for the program. The mean age was 13.7 years, 58% were female, and 81% were non-Hispanic White. While 51 youths were able to participate in NICH, the remaining 93 were not served by the program because of insurance denial or nonresponse, according to investigators.
While participation in the program made no difference in access to care overall, results of this study suggest NICH reduced access disparities among BIPOC youths, the investigators said.
Those BIPOC youth, 28 in total, had significantly worse access to care prior to referral. However, BIPOC youth participation in NICH was associated with improved attendance at endocrinology appointments and outpatient attendance overall.
A mean change of 1.9 more appointments per year was seen among BIPOC youth who participated in NICH, compared with a mean decrease of 0.5 appointments per year among BIPOC youth not served by the program (P = .03), according to the study abstract.
Prior to NICH participation, outpatient attendance among BIPOC youths was about 2.5 visits per year, data presented by the investigators show.
Systemic changes needed
This study is representative of systemic changes that are needed to improve access to quality care for BIPOC youth, according Cynthia E. Muñoz, PhD, MPH, ADA’s president of health care and education.
“We know that there are increased risks for poor health outcomes for these children and youths, and we know that there is a risk for mental health and psychosocial challenges for youth from these communities,” said Dr. Muñoz, a bilingual licensed psychologist and assistant professor of clinical pediatrics at the University of Southern California, Los Angeles.
In his presentation, Dr. Wagner said lumping racial and ethnic minority participants under a single BIPOC header probably wasn’t ideal because of the diversity and differences among racial and ethnic minorities. However, it was necessary in this particular study because of limited sample size.
Dr. Wagner and coauthors disclosed no conflicts of interest related to the research, which was supported by the Leona M. and Harry B. Helmsley Charitable Trust.
For racial or ethnic minority youths with type 1 diabetes, participating in an interventional program improves access to care, new research shows.
Youth categorized as Black, Indigenous, and other people of color (BIPOC) had significantly improved outpatient attendance during and after participating in Novel Interventions in Children’s Healthcare (NICH), a systems intervention for children with chronic health conditions and their families.
By comparison, no improvements in care access were observed among BIPOC children who were not able to access the program because of insurance or other reasons, David V. Wagner, PhD, Associate Professor and NICH research director at Oregon Health & Science University, Portland, reported at the annual scientific sessions of the American Diabetes Association.
The findings demonstrate a need for intensive, home-based services that aim to correct health inequities, said Dr. Wagner, who presented the findings along with Winniebhelle Cadiz, a scholar in the BUILD EXITO undergraduate research training program at Portland (Ore.) State University.
The NICH program hinges on trained interventionists who visit families at home, attend clinic visits, and work with schools and other contacts to help solve problems that keep children from following medical instructions, according to a program description.
“Families report having somebody by their side to help them navigate the system, address the transportation difficulties experienced, and help them and build that relationship with their health care provider seems to be hugely influential in terms of helping them navigate and access care,” Dr. Wagner said in a presentation of the study.
A NICH for youths with chronic health conditions
The NICH program differs from some other programs that have been developed in an attempt to improve health outcomes among youths in the community, according to Dr. Wagner.
“Many of the programs that exist out there are often piloted on, and seemingly built for, those who have more resources,” he said in his presentation. “Those who are in greatest need often have difficulty accessing and responding to the services.”
NICH doesn’t take the place of existing services, but is “an addition to the continuum of care” for youths and families who are struggling because of lack of resources or marginalization in the health care system, Dr. Wagner said.
While NICH is not specific to any one chronic health condition, several previous investigations have specifically looked at the impact of the NICH program on access to care in youths with type 1 diabetes.
Youths participating in the program for a year had fewer ED visits, including fewer visits with diabetic ketoacidosis (DKA), as well as fewer and shorter admissions as compared with the year prior to participating in the program, Dr. Wagner said.
In another study, youths had fewer admissions for diabetes or DKA and less frequent pediatric ICU contact during the NICH program, as compared with before the program.
Another study showed that, while NICH had no impact overall on access to care among youths with type 1 diabetes, BIPOC youths had an improvement in the mean number of outpatient visits as compared with preprogram levels. However, because none of those studies included a control group, Dr. Wagner said, it remained unclear whether this systems intervention might improve outpatient access among youths with type 1 diabetes as compared with those who did not participate.
Intervention linked to increased BIPOC care access
The latest study includes 144 youths with type 1 diabetes referred for the program. The mean age was 13.7 years, 58% were female, and 81% were non-Hispanic White. While 51 youths were able to participate in NICH, the remaining 93 were not served by the program because of insurance denial or nonresponse, according to investigators.
While participation in the program made no difference in access to care overall, results of this study suggest NICH reduced access disparities among BIPOC youths, the investigators said.
Those BIPOC youth, 28 in total, had significantly worse access to care prior to referral. However, BIPOC youth participation in NICH was associated with improved attendance at endocrinology appointments and outpatient attendance overall.
A mean change of 1.9 more appointments per year was seen among BIPOC youth who participated in NICH, compared with a mean decrease of 0.5 appointments per year among BIPOC youth not served by the program (P = .03), according to the study abstract.
Prior to NICH participation, outpatient attendance among BIPOC youths was about 2.5 visits per year, data presented by the investigators show.
Systemic changes needed
This study is representative of systemic changes that are needed to improve access to quality care for BIPOC youth, according Cynthia E. Muñoz, PhD, MPH, ADA’s president of health care and education.
“We know that there are increased risks for poor health outcomes for these children and youths, and we know that there is a risk for mental health and psychosocial challenges for youth from these communities,” said Dr. Muñoz, a bilingual licensed psychologist and assistant professor of clinical pediatrics at the University of Southern California, Los Angeles.
In his presentation, Dr. Wagner said lumping racial and ethnic minority participants under a single BIPOC header probably wasn’t ideal because of the diversity and differences among racial and ethnic minorities. However, it was necessary in this particular study because of limited sample size.
Dr. Wagner and coauthors disclosed no conflicts of interest related to the research, which was supported by the Leona M. and Harry B. Helmsley Charitable Trust.
For racial or ethnic minority youths with type 1 diabetes, participating in an interventional program improves access to care, new research shows.
Youth categorized as Black, Indigenous, and other people of color (BIPOC) had significantly improved outpatient attendance during and after participating in Novel Interventions in Children’s Healthcare (NICH), a systems intervention for children with chronic health conditions and their families.
By comparison, no improvements in care access were observed among BIPOC children who were not able to access the program because of insurance or other reasons, David V. Wagner, PhD, Associate Professor and NICH research director at Oregon Health & Science University, Portland, reported at the annual scientific sessions of the American Diabetes Association.
The findings demonstrate a need for intensive, home-based services that aim to correct health inequities, said Dr. Wagner, who presented the findings along with Winniebhelle Cadiz, a scholar in the BUILD EXITO undergraduate research training program at Portland (Ore.) State University.
The NICH program hinges on trained interventionists who visit families at home, attend clinic visits, and work with schools and other contacts to help solve problems that keep children from following medical instructions, according to a program description.
“Families report having somebody by their side to help them navigate the system, address the transportation difficulties experienced, and help them and build that relationship with their health care provider seems to be hugely influential in terms of helping them navigate and access care,” Dr. Wagner said in a presentation of the study.
A NICH for youths with chronic health conditions
The NICH program differs from some other programs that have been developed in an attempt to improve health outcomes among youths in the community, according to Dr. Wagner.
“Many of the programs that exist out there are often piloted on, and seemingly built for, those who have more resources,” he said in his presentation. “Those who are in greatest need often have difficulty accessing and responding to the services.”
NICH doesn’t take the place of existing services, but is “an addition to the continuum of care” for youths and families who are struggling because of lack of resources or marginalization in the health care system, Dr. Wagner said.
While NICH is not specific to any one chronic health condition, several previous investigations have specifically looked at the impact of the NICH program on access to care in youths with type 1 diabetes.
Youths participating in the program for a year had fewer ED visits, including fewer visits with diabetic ketoacidosis (DKA), as well as fewer and shorter admissions as compared with the year prior to participating in the program, Dr. Wagner said.
In another study, youths had fewer admissions for diabetes or DKA and less frequent pediatric ICU contact during the NICH program, as compared with before the program.
Another study showed that, while NICH had no impact overall on access to care among youths with type 1 diabetes, BIPOC youths had an improvement in the mean number of outpatient visits as compared with preprogram levels. However, because none of those studies included a control group, Dr. Wagner said, it remained unclear whether this systems intervention might improve outpatient access among youths with type 1 diabetes as compared with those who did not participate.
Intervention linked to increased BIPOC care access
The latest study includes 144 youths with type 1 diabetes referred for the program. The mean age was 13.7 years, 58% were female, and 81% were non-Hispanic White. While 51 youths were able to participate in NICH, the remaining 93 were not served by the program because of insurance denial or nonresponse, according to investigators.
While participation in the program made no difference in access to care overall, results of this study suggest NICH reduced access disparities among BIPOC youths, the investigators said.
Those BIPOC youth, 28 in total, had significantly worse access to care prior to referral. However, BIPOC youth participation in NICH was associated with improved attendance at endocrinology appointments and outpatient attendance overall.
A mean change of 1.9 more appointments per year was seen among BIPOC youth who participated in NICH, compared with a mean decrease of 0.5 appointments per year among BIPOC youth not served by the program (P = .03), according to the study abstract.
Prior to NICH participation, outpatient attendance among BIPOC youths was about 2.5 visits per year, data presented by the investigators show.
Systemic changes needed
This study is representative of systemic changes that are needed to improve access to quality care for BIPOC youth, according Cynthia E. Muñoz, PhD, MPH, ADA’s president of health care and education.
“We know that there are increased risks for poor health outcomes for these children and youths, and we know that there is a risk for mental health and psychosocial challenges for youth from these communities,” said Dr. Muñoz, a bilingual licensed psychologist and assistant professor of clinical pediatrics at the University of Southern California, Los Angeles.
In his presentation, Dr. Wagner said lumping racial and ethnic minority participants under a single BIPOC header probably wasn’t ideal because of the diversity and differences among racial and ethnic minorities. However, it was necessary in this particular study because of limited sample size.
Dr. Wagner and coauthors disclosed no conflicts of interest related to the research, which was supported by the Leona M. and Harry B. Helmsley Charitable Trust.
FROM ADA 2021
