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FDA warns of potential mechanical concerns with MAGEC devices
MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.
According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:
- MAGEC Spinal Bracing and Distraction System
- MAGEC 2 Spinal Bracing and Distraction System
- MAGEC System
- MAGEC System Model X Device
- MAGEC System Model X Rod
- MAGEC System Rods
Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.
In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.
The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.
To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.
A version of this article first appeared on Medscape.com.
MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.
According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:
- MAGEC Spinal Bracing and Distraction System
- MAGEC 2 Spinal Bracing and Distraction System
- MAGEC System
- MAGEC System Model X Device
- MAGEC System Model X Rod
- MAGEC System Rods
Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.
In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.
The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.
To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.
A version of this article first appeared on Medscape.com.
MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.
According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:
- MAGEC Spinal Bracing and Distraction System
- MAGEC 2 Spinal Bracing and Distraction System
- MAGEC System
- MAGEC System Model X Device
- MAGEC System Model X Rod
- MAGEC System Rods
Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.
In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.
The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.
To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.
A version of this article first appeared on Medscape.com.
Does early delivery for FGR affect school outcomes?
Iatrogenic delivery for suspected fetal growth restriction (FGR) may be associated with an increased likelihood of poorer school outcomes among infants born severely small for gestational age, a study of children in Australia suggests.
researchers reported in JAMA.
“It raises the question: in our efforts to improve outcomes in babies that are small, are we potentially doing more harm than good?” said Robert M. Silver, MD, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, who was not involved in the study. “I think that is a very important question to ask.”
However, “we can’t make that conclusion based on this one study,” he said in an interview. It could be that, in cases where severely small infants were delivered early, there may have been testing that indicated acute risks, and these infants may have tended to be sicker overall. “It may have been that if those babies weren’t delivered, they would have suffered a stillbirth or major brain injury,” Dr. Silver said. “It is really important that we acknowledge that we shouldn’t change our clinical practice” based on this one study.”
At the same time, the study underscores questions and challenges that surround the definition, identification, and management of suspected FGR, Dr. Silver said.
The study authors described their research as exploratory. In a related editorial Dr. Silver and Nathan R. Blue, MD said the findings should be considered hypothesis generating.
For the study, Roshan John Selvaratnam, BMedSc(Hons), a researcher affiliated with Monash University, Melbourne, and colleagues analyzed data from 181,902 children with developmental outcomes and 425,717 children with educational outcomes in Australia. They included children born at 32 weeks’ or more gestation between 2003 and 2013.
Severely small infants delivered early for suspected FGR had an average gestation of 37.9 weeks, whereas those not suspected of having FGR had an average gestation of 39.4 weeks.
Among infants who were severely small for gestational age, those delivered early for suspected FGR were more likely to be in the bottom 10th percentile on at least two developmental domains when they started school, compared with those not suspected of having FGR (16.2% vs. 12.7%; adjusted odds ratio, 1.36). They also were more likely to have low test scores in subsequent years. In grade 7, for example, the adjusted odds ratio for scoring below the national minimum standard on at least two educational domains was 1.33 (13.4% vs. 10.5%).
The researchers defined severely small for gestational age as birth weight below the third percentile. Among infants with normal growth, defined as birth weight at the 10th percentile or greater, school outcomes did not significantly differ between those with early delivery for suspected FGR and those not suspected of having FGR. Approximately 8% of the infants with normal growth had poor developmental outcomes.
The study authors described the dilemma that clinicians face with suspected FGR: “Either intervene early to prevent a small risk of stillbirth but potentially cause immediate and lifelong harm to the child or accept the increasing risk of stillbirth associated with prolonging the pregnancy to avoid more common neonatal and longer-term morbidities.”
It could be that severely small infants with suspected FGR in the study were “more compromised than those not suspected of having FGR,” which might explain the outcomes, Mr. Selvaratnam and coauthors wrote.
Another more plausible explanation is that “iatrogenic prematurity was harmful,” they said.
The researchers were unable to adjust for many factors that may influence academic success, including smoking and alcohol use during pregnancy, maternal body mass index, and breastfeeding, they noted. They also lacked information about the etiology for FGR and whether children had genetic abnormalities.
The study also does not take into account neonatal, infant, and childhood complications, Dr. Silver and Dr. Blue wrote in their editorial. “Nonetheless, these data are a welcome contribution given the knowledge gaps with regard to the optimal obstetric management of FGR.”
The establishment of a diagnostic standard for FGR is needed to properly investigate ways to improve risk stratification, diagnosis, and management, Dr. Silver and Dr. Blue added.
“What we have to do is get better at predicting which babies are at very high risk for continuing the pregnancy and which babies are at low risk for continuing the pregnancy so that we can better decide which babies would benefit from slightly early delivery,” Dr. Silver said.
Improved detection and management of FGR may be on the horizon. “Our ability to image the placental function has gotten a lot better, and I think that is really going to help us,” Dr. Silver said. Studies that aim to further improve the ability to assess whether babies are getting adequate blood flow during pregnancy are ongoing, which could further help doctors evaluate risks.
The study investigators and Dr. Silver had no conflict of interest disclosures. Dr. Blue disclosed grants from Samsung Medison and personal fees from Elsevier. The study was supported by a grant from the Australian government’s National Health and Medical Research Council Program, and Mr. Selvaratnam is supported by scholarships from an Australian government research training program and the National Centre of Research Excellence in Stillbirth.
Iatrogenic delivery for suspected fetal growth restriction (FGR) may be associated with an increased likelihood of poorer school outcomes among infants born severely small for gestational age, a study of children in Australia suggests.
researchers reported in JAMA.
“It raises the question: in our efforts to improve outcomes in babies that are small, are we potentially doing more harm than good?” said Robert M. Silver, MD, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, who was not involved in the study. “I think that is a very important question to ask.”
However, “we can’t make that conclusion based on this one study,” he said in an interview. It could be that, in cases where severely small infants were delivered early, there may have been testing that indicated acute risks, and these infants may have tended to be sicker overall. “It may have been that if those babies weren’t delivered, they would have suffered a stillbirth or major brain injury,” Dr. Silver said. “It is really important that we acknowledge that we shouldn’t change our clinical practice” based on this one study.”
At the same time, the study underscores questions and challenges that surround the definition, identification, and management of suspected FGR, Dr. Silver said.
The study authors described their research as exploratory. In a related editorial Dr. Silver and Nathan R. Blue, MD said the findings should be considered hypothesis generating.
For the study, Roshan John Selvaratnam, BMedSc(Hons), a researcher affiliated with Monash University, Melbourne, and colleagues analyzed data from 181,902 children with developmental outcomes and 425,717 children with educational outcomes in Australia. They included children born at 32 weeks’ or more gestation between 2003 and 2013.
Severely small infants delivered early for suspected FGR had an average gestation of 37.9 weeks, whereas those not suspected of having FGR had an average gestation of 39.4 weeks.
Among infants who were severely small for gestational age, those delivered early for suspected FGR were more likely to be in the bottom 10th percentile on at least two developmental domains when they started school, compared with those not suspected of having FGR (16.2% vs. 12.7%; adjusted odds ratio, 1.36). They also were more likely to have low test scores in subsequent years. In grade 7, for example, the adjusted odds ratio for scoring below the national minimum standard on at least two educational domains was 1.33 (13.4% vs. 10.5%).
The researchers defined severely small for gestational age as birth weight below the third percentile. Among infants with normal growth, defined as birth weight at the 10th percentile or greater, school outcomes did not significantly differ between those with early delivery for suspected FGR and those not suspected of having FGR. Approximately 8% of the infants with normal growth had poor developmental outcomes.
The study authors described the dilemma that clinicians face with suspected FGR: “Either intervene early to prevent a small risk of stillbirth but potentially cause immediate and lifelong harm to the child or accept the increasing risk of stillbirth associated with prolonging the pregnancy to avoid more common neonatal and longer-term morbidities.”
It could be that severely small infants with suspected FGR in the study were “more compromised than those not suspected of having FGR,” which might explain the outcomes, Mr. Selvaratnam and coauthors wrote.
Another more plausible explanation is that “iatrogenic prematurity was harmful,” they said.
The researchers were unable to adjust for many factors that may influence academic success, including smoking and alcohol use during pregnancy, maternal body mass index, and breastfeeding, they noted. They also lacked information about the etiology for FGR and whether children had genetic abnormalities.
The study also does not take into account neonatal, infant, and childhood complications, Dr. Silver and Dr. Blue wrote in their editorial. “Nonetheless, these data are a welcome contribution given the knowledge gaps with regard to the optimal obstetric management of FGR.”
The establishment of a diagnostic standard for FGR is needed to properly investigate ways to improve risk stratification, diagnosis, and management, Dr. Silver and Dr. Blue added.
“What we have to do is get better at predicting which babies are at very high risk for continuing the pregnancy and which babies are at low risk for continuing the pregnancy so that we can better decide which babies would benefit from slightly early delivery,” Dr. Silver said.
Improved detection and management of FGR may be on the horizon. “Our ability to image the placental function has gotten a lot better, and I think that is really going to help us,” Dr. Silver said. Studies that aim to further improve the ability to assess whether babies are getting adequate blood flow during pregnancy are ongoing, which could further help doctors evaluate risks.
The study investigators and Dr. Silver had no conflict of interest disclosures. Dr. Blue disclosed grants from Samsung Medison and personal fees from Elsevier. The study was supported by a grant from the Australian government’s National Health and Medical Research Council Program, and Mr. Selvaratnam is supported by scholarships from an Australian government research training program and the National Centre of Research Excellence in Stillbirth.
Iatrogenic delivery for suspected fetal growth restriction (FGR) may be associated with an increased likelihood of poorer school outcomes among infants born severely small for gestational age, a study of children in Australia suggests.
researchers reported in JAMA.
“It raises the question: in our efforts to improve outcomes in babies that are small, are we potentially doing more harm than good?” said Robert M. Silver, MD, of the department of obstetrics and gynecology at the University of Utah, Salt Lake City, who was not involved in the study. “I think that is a very important question to ask.”
However, “we can’t make that conclusion based on this one study,” he said in an interview. It could be that, in cases where severely small infants were delivered early, there may have been testing that indicated acute risks, and these infants may have tended to be sicker overall. “It may have been that if those babies weren’t delivered, they would have suffered a stillbirth or major brain injury,” Dr. Silver said. “It is really important that we acknowledge that we shouldn’t change our clinical practice” based on this one study.”
At the same time, the study underscores questions and challenges that surround the definition, identification, and management of suspected FGR, Dr. Silver said.
The study authors described their research as exploratory. In a related editorial Dr. Silver and Nathan R. Blue, MD said the findings should be considered hypothesis generating.
For the study, Roshan John Selvaratnam, BMedSc(Hons), a researcher affiliated with Monash University, Melbourne, and colleagues analyzed data from 181,902 children with developmental outcomes and 425,717 children with educational outcomes in Australia. They included children born at 32 weeks’ or more gestation between 2003 and 2013.
Severely small infants delivered early for suspected FGR had an average gestation of 37.9 weeks, whereas those not suspected of having FGR had an average gestation of 39.4 weeks.
Among infants who were severely small for gestational age, those delivered early for suspected FGR were more likely to be in the bottom 10th percentile on at least two developmental domains when they started school, compared with those not suspected of having FGR (16.2% vs. 12.7%; adjusted odds ratio, 1.36). They also were more likely to have low test scores in subsequent years. In grade 7, for example, the adjusted odds ratio for scoring below the national minimum standard on at least two educational domains was 1.33 (13.4% vs. 10.5%).
The researchers defined severely small for gestational age as birth weight below the third percentile. Among infants with normal growth, defined as birth weight at the 10th percentile or greater, school outcomes did not significantly differ between those with early delivery for suspected FGR and those not suspected of having FGR. Approximately 8% of the infants with normal growth had poor developmental outcomes.
The study authors described the dilemma that clinicians face with suspected FGR: “Either intervene early to prevent a small risk of stillbirth but potentially cause immediate and lifelong harm to the child or accept the increasing risk of stillbirth associated with prolonging the pregnancy to avoid more common neonatal and longer-term morbidities.”
It could be that severely small infants with suspected FGR in the study were “more compromised than those not suspected of having FGR,” which might explain the outcomes, Mr. Selvaratnam and coauthors wrote.
Another more plausible explanation is that “iatrogenic prematurity was harmful,” they said.
The researchers were unable to adjust for many factors that may influence academic success, including smoking and alcohol use during pregnancy, maternal body mass index, and breastfeeding, they noted. They also lacked information about the etiology for FGR and whether children had genetic abnormalities.
The study also does not take into account neonatal, infant, and childhood complications, Dr. Silver and Dr. Blue wrote in their editorial. “Nonetheless, these data are a welcome contribution given the knowledge gaps with regard to the optimal obstetric management of FGR.”
The establishment of a diagnostic standard for FGR is needed to properly investigate ways to improve risk stratification, diagnosis, and management, Dr. Silver and Dr. Blue added.
“What we have to do is get better at predicting which babies are at very high risk for continuing the pregnancy and which babies are at low risk for continuing the pregnancy so that we can better decide which babies would benefit from slightly early delivery,” Dr. Silver said.
Improved detection and management of FGR may be on the horizon. “Our ability to image the placental function has gotten a lot better, and I think that is really going to help us,” Dr. Silver said. Studies that aim to further improve the ability to assess whether babies are getting adequate blood flow during pregnancy are ongoing, which could further help doctors evaluate risks.
The study investigators and Dr. Silver had no conflict of interest disclosures. Dr. Blue disclosed grants from Samsung Medison and personal fees from Elsevier. The study was supported by a grant from the Australian government’s National Health and Medical Research Council Program, and Mr. Selvaratnam is supported by scholarships from an Australian government research training program and the National Centre of Research Excellence in Stillbirth.
FROM JAMA
Long-term outcome data suggest optimism for MIS-C patients
Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.
In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.
The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.
Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.
Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.
By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.
All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.
“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.
The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.
The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.
“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
Cautious optimism, long-term monitoring
The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.
“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.
The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.
“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.
The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.
Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.
In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.
The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.
Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.
Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.
By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.
All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.
“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.
The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.
The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.
“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
Cautious optimism, long-term monitoring
The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.
“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.
The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.
“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.
The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.
Only 1 child from a cohort of 45 children hospitalized with multisystem inflammatory syndrome following COVID-19 infection had persistent mild cardiac dysfunction after 9 months, according to data from patients younger than 21 years seen at a single center in 2020.
In a study published in Pediatrics, Kanwal M. Farooqi, MD, of Columbia University, New York, and colleagues provided the first report on longitudinal cardiac and immunologic outcomes in North American children hospitalized with multisystem inflammatory syndrome (MIS-C). In response to the COVID-19 pandemic, clinicians at New York–Presbyterian Hospital consolidated pediatric admissions and developed an interdisciplinary inpatient and outpatient MIS-C follow-up program to monitor cardiac and immunologic outcomes in their patients.
The study included all children younger than 21 years admitted to Columbia University Irving Medical Center/New York–Presbyterian Morgan Stanley Children’s Hospital for MIS-C in 2020. The median age of the patients was 9 years, and the median length of hospital stay was 5 days. Follow-up visits occurred at 1-4 weeks (average 2 weeks), 1-4 months (average 2 months), and 4-9 months (average 6 months) after hospital discharge. Follow-up visits included echocardiograms and measures of inflammatory markers.
Most of the children (84%) had no underlying medical conditions, but 24% presented with some level of respiratory distress or oxygen requirement, and 64% had vasodilatory shock. In addition, 80% had at least mild cardiac abnormalities and 66% had significant lymphopenia on admission.
Inflammatory profiles on admission showed elevation of C-reactive protein, ferritin, and D-dimer in 87%-98% of the patients. Consistent with cardiac involvement, 64% of the patients also had elevated troponin levels, and 91% had elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) levels.
“These parameters peaked at or shortly after admission and then gradually normalized,” the researchers said. “By the first follow-up, [C-reactive protein], troponin, and NT-proBNP had normalized in nearly all tested patients (97%-100%),” they noted.
By the first follow-up period at 1-4 weeks, all patients had normal coronary arteries, and 18% (seven patients) had mild echocardiographic findings. However, approximately one-third (32%) of the patients had persistent lymphocytosis at 1-4 weeks, and 23 of the 24 patients assessed had elevated double-negative T cells, which persisted in 96% of the patients at 1-4 months’ follow-up. However, during the last follow-up of 4-9 months, only one patient had persistent mild biventricular dysfunction and a second patient had mild mitral and tricuspid valve regurgitation.
All patients were treated with steroids and immunoglobulins (2 g/kg), as well as enoxaparin prophylaxis or low-dose aspirin and GI prophylaxis. Treatment with methylprednisolone varied based on disease severity; patients with mild presentation received 2 mg/kg per day; those with moderate presentation received a methylprednisolone pulse of 10 mg/kg per day, followed by 2 mg/kg per day; those with severe disease received methylprednisolone at 20-30 mg/kg per day for 1-3 days, followed by 2 mg/kg per day.
“Aggressive use of steroids may also explain the lower incidence of coronary artery abnormalities in our cohort,” the researchers noted.
The study findings were limited by the observational design and inability to make definitive conclusions about treatment and outcomes, as well as the evolving case definitions for MIS-C, the researchers said.
The persistence of double-negative T cells was surprising, and “likely represent a prolonged postinflammatory recovery cell population, but further study is ongoing to better define this observation,” they noted.
“Our study reveals generally encouraging medium-term outcomes, including rapid normalization of inflammatory markers and significant cardiac abnormalities in the majority of patients with MIS-C,” the researchers said. “The exact nature and potential for long-term cardiac fibrosis, exercise intolerance, or other changes remain unknown,” and long-term caution and follow-up are recommended, they concluded.
Cautious optimism, long-term monitoring
The study is important to provide guidance for clinicians on how to manage their patients who have been hospitalized with MIS-C, said Susan Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H.
“It was both surprising and reassuring to see that so many of the patients had positive outcomes in terms of cardiac function and that during the acute stage there were no deaths,” said Dr. Boulter. “Hospitalizations were brief, averaging just 5 days. The patients had many symptoms, but unlike adults, there was not a preponderance of underlying risk factors in this cohort of patients,” she said.
The results suggest optimism for MIS-C patients in that they generally recover, but the take-home message for clinicians is that these patients will require careful monitoring for long-term issues, Dr. Boulter said.
“These patients should be followed for years to assess long-term effects on morbidity and mortality,” Dr. Boulter emphasized.
The study was funded by Genentech. The researchers had no financial conflicts to disclose. Dr. Boulter had no financial conflicts to disclose, but serves on the Pediatric News Editorial Advisory Board.
FROM PEDIATRICS
Mindfulness benefits kids with ADHD, and their families
Meditation, yoga, breathing exercises, and other mindfulness activities can help children with attention-deficit/hyperactivity disorder, but it’s not just the kids who benefit.
When families of children with ADHD complete a mindfulness program together, a new study suggests, children and parents can profit, with potential boosts to self-control, self-compassion, and psychological symptoms.
The findings do not suggest children should ditch medication in favor of focusing on the present moment. Instead, the study adds to growing evidence that mindfulness can be a helpful tool along with other strategies for children and adults with ADHD, said John Mitchell, PhD, a psychologist at Duke University, Durham, N.C., who was not involved with the new study. Mindfulness might help families ease stress and improve quality of life.
“We talk about ADHD because one person has that diagnosis, but we don’t live in bubbles,” he said. “We’re all interconnected and impact one another. And having treatments that acknowledge that and measuring that in the scientific literature is pretty important.”
Mindfulness training, which has its roots in Eastern traditions, generally aims to teach people how to be present in the moment and let go of judgment. Over the last couple of decades, researchers working on depression and other conditions have gathered evidence that practicing mindfulness can help in a variety of ways, including with the self-regulation of attention and emotions. It didn’t take long for those findings to draw interest from researchers who study ADHD, Dr. Mitchell said.
Research on mindfulness for ADHD started with adults, and results have been encouraging, Dr. Mitchell said. People who complete a mindfulness program tend to show some improvement in focus, impulsivity, and hyperactivity, studies show. In one small pilot study, Dr. Mitchell and colleagues reported improvements in symptoms and executive function in adults with ADHD.
Studies with children have lagged behind, but recent work has been promising. When looking at data from a number of studies, researchers have found small reductions in inattentiveness, hyperactivity, and impulsivity in young people with ADHD. Several randomized, controlled trials have also shown a reduction in symptoms as rated by parents and teachers.
Greater understanding, acceptance
In related research, there was a noticed reduction in stress among parents who get mindfulness training that teaches them to listen with their full attention, accept and develop compassion for themselves and their children, and regulate themselves within the relationship with their kids.
Still, first-line treatment for children with ADHD usually includes a combination of medication, cognitive behavioral therapy, and education, even though those strategies don’t always work well for everyone, says Corina Greven, PhD, a psychologist at Radboud (the Netherlands) University Medical Centre and Karakter Child and Adolescent Psychiatry.
Despite suggestive results, the data on mindfulness remains murky, in part because early studies that looked at mindfulness training for children with ADHD have been small. Few trials of mindfulness treatment for ADHD, Dr. Greven said, have included parents.
To fill in some of the gaps, Dr. Greven and colleagues conducted a trial with 103 families who had a child with ADHD between ages 8 and 16. Half of the families were randomly assigned simply to continue care as usual, which included medication for most.
The other half continued their usual care and also took part in a program called MYMind, which used mindfulness-based cognitive therapy for children and mindful parenting training for parents.
Families attended 90-minute group sessions once a week for 8 weeks, with an extra session 2 months later. The mindfulness group also completed homework every day that took about 30-45 minutes for parents and 15 minutes for children. Homework included workbooks and guided meditations.
In the short term, the team reported, children who received the mindfulness intervention showed small improvements in ADHD symptoms, anxiety, autistic symptoms, and problems falling asleep. One-third children who received mindfulness training improved on measures of self-control, Dr. Greven added, compared with just 1 in 10 who got only their usual care.
Benefits were larger and longer-lasting for parents. Compared with parents who didn’t get mindfulness training, those assigned to the mindfulness group improved in self-control, self-compassion, depression, anxiety, stress, well-being, and their own ADHD symptoms. Given a large genetic component to the disorder, it is common for parents of children with ADHD to have a diagnosis or ADHD symptoms as well. In addition, Dr. Greven said, families who completed the mindfulness-based intervention reported improvements in their relationships as well as acceptance of ADHD.
A new therapy?
The findings suggest new potential treatment options for children with ADHD, and for their parents, Dr. Greven said, as well as a need to study the condition more broadly. “Although parents of children with ADHD often have elevated parenting stress, anxiety, or their own ADHD symptoms, usual interventions for children with ADHD do not typically target parental mental health,” she said. “As researchers, we need to go broader than just looking at whether an intervention reduces symptoms and include additional outcomes that families find important.”
It will take more research to find out who is most likely to benefit from mindfulness training and how long those benefits last, but the new study is a useful starting point, experts say.
“Mindfulness training had potentially short-term and long-term beneficial effects to children with ADHD and their parents,” says Samuel Wong, MD, director of the JC School of Public Health and Primary Care at the Chinese University of Hong Kong. He says mindfulness is more likely to become an add-on than a replacement for other kinds of therapies.
“Clinicians may consider combining or adding family-based mindfulness training with current practice for children with ADHD who have residual symptoms with their current treatment,” he said.
Mindfulness training may help with issues beyond the classic symptoms that come with ADHD, Dr. Mitchell said, helping make family life better overall, even when some features of the disorder don’t budge much.
“With this study in particular, we see that we have some pretty promising effects that there may be something that will be beneficial above and beyond the core 18 DSM symptoms,” he said. “This is an important study, because it’s going to be a basis for the continuing evolution of the scientific research on this topic. It’s something to feel excited about.”
A version of this article first appeared on WebMD.com.
Meditation, yoga, breathing exercises, and other mindfulness activities can help children with attention-deficit/hyperactivity disorder, but it’s not just the kids who benefit.
When families of children with ADHD complete a mindfulness program together, a new study suggests, children and parents can profit, with potential boosts to self-control, self-compassion, and psychological symptoms.
The findings do not suggest children should ditch medication in favor of focusing on the present moment. Instead, the study adds to growing evidence that mindfulness can be a helpful tool along with other strategies for children and adults with ADHD, said John Mitchell, PhD, a psychologist at Duke University, Durham, N.C., who was not involved with the new study. Mindfulness might help families ease stress and improve quality of life.
“We talk about ADHD because one person has that diagnosis, but we don’t live in bubbles,” he said. “We’re all interconnected and impact one another. And having treatments that acknowledge that and measuring that in the scientific literature is pretty important.”
Mindfulness training, which has its roots in Eastern traditions, generally aims to teach people how to be present in the moment and let go of judgment. Over the last couple of decades, researchers working on depression and other conditions have gathered evidence that practicing mindfulness can help in a variety of ways, including with the self-regulation of attention and emotions. It didn’t take long for those findings to draw interest from researchers who study ADHD, Dr. Mitchell said.
Research on mindfulness for ADHD started with adults, and results have been encouraging, Dr. Mitchell said. People who complete a mindfulness program tend to show some improvement in focus, impulsivity, and hyperactivity, studies show. In one small pilot study, Dr. Mitchell and colleagues reported improvements in symptoms and executive function in adults with ADHD.
Studies with children have lagged behind, but recent work has been promising. When looking at data from a number of studies, researchers have found small reductions in inattentiveness, hyperactivity, and impulsivity in young people with ADHD. Several randomized, controlled trials have also shown a reduction in symptoms as rated by parents and teachers.
Greater understanding, acceptance
In related research, there was a noticed reduction in stress among parents who get mindfulness training that teaches them to listen with their full attention, accept and develop compassion for themselves and their children, and regulate themselves within the relationship with their kids.
Still, first-line treatment for children with ADHD usually includes a combination of medication, cognitive behavioral therapy, and education, even though those strategies don’t always work well for everyone, says Corina Greven, PhD, a psychologist at Radboud (the Netherlands) University Medical Centre and Karakter Child and Adolescent Psychiatry.
Despite suggestive results, the data on mindfulness remains murky, in part because early studies that looked at mindfulness training for children with ADHD have been small. Few trials of mindfulness treatment for ADHD, Dr. Greven said, have included parents.
To fill in some of the gaps, Dr. Greven and colleagues conducted a trial with 103 families who had a child with ADHD between ages 8 and 16. Half of the families were randomly assigned simply to continue care as usual, which included medication for most.
The other half continued their usual care and also took part in a program called MYMind, which used mindfulness-based cognitive therapy for children and mindful parenting training for parents.
Families attended 90-minute group sessions once a week for 8 weeks, with an extra session 2 months later. The mindfulness group also completed homework every day that took about 30-45 minutes for parents and 15 minutes for children. Homework included workbooks and guided meditations.
In the short term, the team reported, children who received the mindfulness intervention showed small improvements in ADHD symptoms, anxiety, autistic symptoms, and problems falling asleep. One-third children who received mindfulness training improved on measures of self-control, Dr. Greven added, compared with just 1 in 10 who got only their usual care.
Benefits were larger and longer-lasting for parents. Compared with parents who didn’t get mindfulness training, those assigned to the mindfulness group improved in self-control, self-compassion, depression, anxiety, stress, well-being, and their own ADHD symptoms. Given a large genetic component to the disorder, it is common for parents of children with ADHD to have a diagnosis or ADHD symptoms as well. In addition, Dr. Greven said, families who completed the mindfulness-based intervention reported improvements in their relationships as well as acceptance of ADHD.
A new therapy?
The findings suggest new potential treatment options for children with ADHD, and for their parents, Dr. Greven said, as well as a need to study the condition more broadly. “Although parents of children with ADHD often have elevated parenting stress, anxiety, or their own ADHD symptoms, usual interventions for children with ADHD do not typically target parental mental health,” she said. “As researchers, we need to go broader than just looking at whether an intervention reduces symptoms and include additional outcomes that families find important.”
It will take more research to find out who is most likely to benefit from mindfulness training and how long those benefits last, but the new study is a useful starting point, experts say.
“Mindfulness training had potentially short-term and long-term beneficial effects to children with ADHD and their parents,” says Samuel Wong, MD, director of the JC School of Public Health and Primary Care at the Chinese University of Hong Kong. He says mindfulness is more likely to become an add-on than a replacement for other kinds of therapies.
“Clinicians may consider combining or adding family-based mindfulness training with current practice for children with ADHD who have residual symptoms with their current treatment,” he said.
Mindfulness training may help with issues beyond the classic symptoms that come with ADHD, Dr. Mitchell said, helping make family life better overall, even when some features of the disorder don’t budge much.
“With this study in particular, we see that we have some pretty promising effects that there may be something that will be beneficial above and beyond the core 18 DSM symptoms,” he said. “This is an important study, because it’s going to be a basis for the continuing evolution of the scientific research on this topic. It’s something to feel excited about.”
A version of this article first appeared on WebMD.com.
Meditation, yoga, breathing exercises, and other mindfulness activities can help children with attention-deficit/hyperactivity disorder, but it’s not just the kids who benefit.
When families of children with ADHD complete a mindfulness program together, a new study suggests, children and parents can profit, with potential boosts to self-control, self-compassion, and psychological symptoms.
The findings do not suggest children should ditch medication in favor of focusing on the present moment. Instead, the study adds to growing evidence that mindfulness can be a helpful tool along with other strategies for children and adults with ADHD, said John Mitchell, PhD, a psychologist at Duke University, Durham, N.C., who was not involved with the new study. Mindfulness might help families ease stress and improve quality of life.
“We talk about ADHD because one person has that diagnosis, but we don’t live in bubbles,” he said. “We’re all interconnected and impact one another. And having treatments that acknowledge that and measuring that in the scientific literature is pretty important.”
Mindfulness training, which has its roots in Eastern traditions, generally aims to teach people how to be present in the moment and let go of judgment. Over the last couple of decades, researchers working on depression and other conditions have gathered evidence that practicing mindfulness can help in a variety of ways, including with the self-regulation of attention and emotions. It didn’t take long for those findings to draw interest from researchers who study ADHD, Dr. Mitchell said.
Research on mindfulness for ADHD started with adults, and results have been encouraging, Dr. Mitchell said. People who complete a mindfulness program tend to show some improvement in focus, impulsivity, and hyperactivity, studies show. In one small pilot study, Dr. Mitchell and colleagues reported improvements in symptoms and executive function in adults with ADHD.
Studies with children have lagged behind, but recent work has been promising. When looking at data from a number of studies, researchers have found small reductions in inattentiveness, hyperactivity, and impulsivity in young people with ADHD. Several randomized, controlled trials have also shown a reduction in symptoms as rated by parents and teachers.
Greater understanding, acceptance
In related research, there was a noticed reduction in stress among parents who get mindfulness training that teaches them to listen with their full attention, accept and develop compassion for themselves and their children, and regulate themselves within the relationship with their kids.
Still, first-line treatment for children with ADHD usually includes a combination of medication, cognitive behavioral therapy, and education, even though those strategies don’t always work well for everyone, says Corina Greven, PhD, a psychologist at Radboud (the Netherlands) University Medical Centre and Karakter Child and Adolescent Psychiatry.
Despite suggestive results, the data on mindfulness remains murky, in part because early studies that looked at mindfulness training for children with ADHD have been small. Few trials of mindfulness treatment for ADHD, Dr. Greven said, have included parents.
To fill in some of the gaps, Dr. Greven and colleagues conducted a trial with 103 families who had a child with ADHD between ages 8 and 16. Half of the families were randomly assigned simply to continue care as usual, which included medication for most.
The other half continued their usual care and also took part in a program called MYMind, which used mindfulness-based cognitive therapy for children and mindful parenting training for parents.
Families attended 90-minute group sessions once a week for 8 weeks, with an extra session 2 months later. The mindfulness group also completed homework every day that took about 30-45 minutes for parents and 15 minutes for children. Homework included workbooks and guided meditations.
In the short term, the team reported, children who received the mindfulness intervention showed small improvements in ADHD symptoms, anxiety, autistic symptoms, and problems falling asleep. One-third children who received mindfulness training improved on measures of self-control, Dr. Greven added, compared with just 1 in 10 who got only their usual care.
Benefits were larger and longer-lasting for parents. Compared with parents who didn’t get mindfulness training, those assigned to the mindfulness group improved in self-control, self-compassion, depression, anxiety, stress, well-being, and their own ADHD symptoms. Given a large genetic component to the disorder, it is common for parents of children with ADHD to have a diagnosis or ADHD symptoms as well. In addition, Dr. Greven said, families who completed the mindfulness-based intervention reported improvements in their relationships as well as acceptance of ADHD.
A new therapy?
The findings suggest new potential treatment options for children with ADHD, and for their parents, Dr. Greven said, as well as a need to study the condition more broadly. “Although parents of children with ADHD often have elevated parenting stress, anxiety, or their own ADHD symptoms, usual interventions for children with ADHD do not typically target parental mental health,” she said. “As researchers, we need to go broader than just looking at whether an intervention reduces symptoms and include additional outcomes that families find important.”
It will take more research to find out who is most likely to benefit from mindfulness training and how long those benefits last, but the new study is a useful starting point, experts say.
“Mindfulness training had potentially short-term and long-term beneficial effects to children with ADHD and their parents,” says Samuel Wong, MD, director of the JC School of Public Health and Primary Care at the Chinese University of Hong Kong. He says mindfulness is more likely to become an add-on than a replacement for other kinds of therapies.
“Clinicians may consider combining or adding family-based mindfulness training with current practice for children with ADHD who have residual symptoms with their current treatment,” he said.
Mindfulness training may help with issues beyond the classic symptoms that come with ADHD, Dr. Mitchell said, helping make family life better overall, even when some features of the disorder don’t budge much.
“With this study in particular, we see that we have some pretty promising effects that there may be something that will be beneficial above and beyond the core 18 DSM symptoms,” he said. “This is an important study, because it’s going to be a basis for the continuing evolution of the scientific research on this topic. It’s something to feel excited about.”
A version of this article first appeared on WebMD.com.
Admissions for eating disorders double in pandemic
Medical admissions for adolescents with restrictive eating disorders more than doubled at one hospital during the first 12 months of the COVID-19 pandemic, relative to the average number of admissions in prior years, a new study shows.
Doctors are seeing similar increases across the United States and in other countries.
Providers and health care systems “may need to rapidly adapt in response to increasing demands for care during the COVID-19 pandemic,” the researchers said in their study, which was published online in Pediatrics.
To assess whether admission patterns among adolescents with restrictive eating disorders changed during the pandemic, Alana K. Otto, MD, MPH, with the division of adolescent medicine at the University of Michigan, Ann Arbor, and colleagues reviewed the charts of patients admitted to C.S. Mott Children’s Hospital, also in Ann Arbor.
Their analysis included 297 admissions among 248 patients aged 10-23 years between March 1, 2017, and March 31, 2021. Patients had an average age of about 15 years. Approximately 90% were female, and most had a diagnosis of anorexia nervosa or atypical anorexia nervosa.
Indications for medical admission included physiological instability (for example, heart rate less than 50 beats per minute while awake or blood pressure less than 90/40 mm Hg), electrolyte derangements, and acute medical complications of malnutrition such as syncope. Other possible indications included uncontrolled purging, body mass index less than 75% of the median for age and sex, acute food refusal, and failure of outpatient treatment.
Eating disorder–related admissions per month were stable prior to the pandemic. Admissions then decreased in April 2020, but subsequently increased significantly throughout the study period. In all, there were 125 admissions between April 1, 2020, and March 31, 2021. During the previous 3 years, the average number of admissions per year was 56.
Patients’ insurance status was one factor that differed before and during the pandemic. Prepandemic, about 20% of admissions were for adolescents with public insurance. During the pandemic, however, the proportion with public insurance was approximately 9%, the researchers noted. Other characteristics were generally similar.
The study was retrospective and relatively small and only looked at patients with restrictive eating disorders who were severely ill and admitted for medical stabilization. It does not reflect adolescents with eating disorders in different settings, the authors noted.
Primary care pediatricians should be familiar with indications for medical admission, such as severe bradycardia, as outlined by the Society for Adolescent Health and Medicine, they said.
Consistent trends
Unfortunately, the trend seems consistent across the nation, said Michaela M. Voss, MD, director of the the Eating Disorders Center at Children’s Mercy in Kansas City, Mo. “Our outpatient setting went from availability to get in immediately to a 6-month wait list.”
As in Michigan, Dr. Voss noted a drop in admissions as lockdowns started, followed by a spike in treatment demand that has not let up.
Dr. Voss described two of the more common presentations. In one, parents might note that their child had been getting into healthy eating and exercise before the pandemic and seemed fine. “But then COVID came, the lockdown happened, and they became overly obsessed with those things,” Dr. Voss said.
In the other presentation, kids with anxiety, depression, or OCD who lost access to their usual coping strategies and outlets developed eating disorders during the pandemic. “They focused on one of the few things they could during the lockdown, which was their own body, and then their anxiety, depression, [obsessive-compulsive disorder], and other mental health comorbidities presented as an eating disorder,” Dr. Voss said.
The increasing need for treatment over the course of the pandemic may reflect the time that it has taken for the disorders to develop, as well as the time that it takes parents to recognize the problem.
Not only are doctors seeing more cases, but patients are arriving sicker than usual, Dr. Voss said.
Major medical concerns for patients in starvation mode center on the heart, brain, and bones. In addition, refeeding syndrome poses an extreme risk, Dr. Voss noted.
The Academy for Eating Disorders has created a guide to help doctors recognize and manage risks for patients with eating disorders, which may be useful for primary care providers while they are trying to get a patient into more intensive treatment, Dr. Voss suggested. The American Academy of Pediatrics recently published a clinical report on the identification and management of eating disorders in children and adolescents.
At Johns Hopkins Hospital Children’s Center in Baltimore, “we have seen a pretty remarkable increase in the number of eating disorders in the child and adolescent space since COVID,” said Jennifer Leah Goetz, MD, a psychiatrist and medical director of the child and adolescent inpatient unit. “We have seen increasing numbers of kids presenting for acute medical stabilization and refeeding and for specific treatment for the eating disorder.”
It could be that, for people with a genetic predisposition to eating disorders, a confluence of factors related to the pandemic unmasked it. For example, children may have spent more time looking at themselves on virtual meeting platforms, which could stir lingering body image and appearance-related concerns in those who are vulnerable. And some teens who were not able to participate in athletics as usual started to watch what they eat more closely, Dr. Goetz said.
A treatment bottleneck
Patients with eating disorders “can be quite ill from a psychiatric and general medical perspective,” Dr. Goetz said. “Most psychiatrists are not particularly comfortable with the medical complications, and most internists or pediatricians are not particularly comfortable with the psychiatric complications. You end up with a patient population that can only see a really highly specialized group of individuals for care. And it is a problem. It was a problem before the pandemic, and it has been really exacerbated by what we have been going through with COVID.”
Natalie Muth, MD, MPH, RDN, a pediatrician at Children’s Primary Care Medical Group La Costa in Carlsbad, Calif., has also noticed the increase in eating disorders since COVID.
In-patient colleagues “have longer wait lists and more severe cases than they have ever seen previously,” said Dr. Muth, who chairs the American Academy of Pediatrics Section on Obesity and is an adjunct assistant professor at the University of California, Los Angeles. “In primary care, we are all having to better educate and prepare ourselves for identifying and managing patients with eating disorders.”
That could mean connecting with mental health professionals, registered dietitians, and higher levels of care. But that may be a challenge. “Accessing these resources has been more difficult due to the increasing incidence of eating disorders recently,” Dr. Muth said.
Dr. Voss acknowledged that childhood obesity is another concern for pediatricians. “However, there are appropriate and healthy and safe ways to address that,” she said. A patient with overweight or obesity who loses weight may not be doing so in a healthy way.
Clinicians should wonder if a patient’s weight is decreasing too fast. And they should ask patients questions that could help identify a problem, such as: What are they doing to cause the weight loss? Why do they want to lose the weight?
Dr. Voss added that eating disorders “do not discriminate.” While there may be a perception that all patients with eating disorders are White, upper middle–class females who are thin, “that is not the case,” Dr. Voss said. They “come in all genders, all races, all weight classes, and all ages,” she said, “and we see that variety.”
In general, there may be a need to shift how weight is discussed in clinics and society more broadly, Dr. Goetz said. Weight is an incredibly personal thing, and everyone’s genetics, metabolism, and life circumstances vary. At the same time, body mass index is not necessarily the best measure of a person’s health.
Asking a child, teen, or even an adult to go on a diet is not a benign intervention, Dr. Goetz noted. In addition, dieting is unlikely to help in the long term.
Emerging from lockdown, pressure to lose “COVID pounds” is a dangerous message for people with eating disorders, Dr. Goetz said. It also could be a dangerous message for people without eating disorders. “There are so many more interesting things about each one of us than our weight,” she added.
The study authors, Dr. Voss, Dr. Goetz, and Dr. Muth had no relevant disclosures.
Medical admissions for adolescents with restrictive eating disorders more than doubled at one hospital during the first 12 months of the COVID-19 pandemic, relative to the average number of admissions in prior years, a new study shows.
Doctors are seeing similar increases across the United States and in other countries.
Providers and health care systems “may need to rapidly adapt in response to increasing demands for care during the COVID-19 pandemic,” the researchers said in their study, which was published online in Pediatrics.
To assess whether admission patterns among adolescents with restrictive eating disorders changed during the pandemic, Alana K. Otto, MD, MPH, with the division of adolescent medicine at the University of Michigan, Ann Arbor, and colleagues reviewed the charts of patients admitted to C.S. Mott Children’s Hospital, also in Ann Arbor.
Their analysis included 297 admissions among 248 patients aged 10-23 years between March 1, 2017, and March 31, 2021. Patients had an average age of about 15 years. Approximately 90% were female, and most had a diagnosis of anorexia nervosa or atypical anorexia nervosa.
Indications for medical admission included physiological instability (for example, heart rate less than 50 beats per minute while awake or blood pressure less than 90/40 mm Hg), electrolyte derangements, and acute medical complications of malnutrition such as syncope. Other possible indications included uncontrolled purging, body mass index less than 75% of the median for age and sex, acute food refusal, and failure of outpatient treatment.
Eating disorder–related admissions per month were stable prior to the pandemic. Admissions then decreased in April 2020, but subsequently increased significantly throughout the study period. In all, there were 125 admissions between April 1, 2020, and March 31, 2021. During the previous 3 years, the average number of admissions per year was 56.
Patients’ insurance status was one factor that differed before and during the pandemic. Prepandemic, about 20% of admissions were for adolescents with public insurance. During the pandemic, however, the proportion with public insurance was approximately 9%, the researchers noted. Other characteristics were generally similar.
The study was retrospective and relatively small and only looked at patients with restrictive eating disorders who were severely ill and admitted for medical stabilization. It does not reflect adolescents with eating disorders in different settings, the authors noted.
Primary care pediatricians should be familiar with indications for medical admission, such as severe bradycardia, as outlined by the Society for Adolescent Health and Medicine, they said.
Consistent trends
Unfortunately, the trend seems consistent across the nation, said Michaela M. Voss, MD, director of the the Eating Disorders Center at Children’s Mercy in Kansas City, Mo. “Our outpatient setting went from availability to get in immediately to a 6-month wait list.”
As in Michigan, Dr. Voss noted a drop in admissions as lockdowns started, followed by a spike in treatment demand that has not let up.
Dr. Voss described two of the more common presentations. In one, parents might note that their child had been getting into healthy eating and exercise before the pandemic and seemed fine. “But then COVID came, the lockdown happened, and they became overly obsessed with those things,” Dr. Voss said.
In the other presentation, kids with anxiety, depression, or OCD who lost access to their usual coping strategies and outlets developed eating disorders during the pandemic. “They focused on one of the few things they could during the lockdown, which was their own body, and then their anxiety, depression, [obsessive-compulsive disorder], and other mental health comorbidities presented as an eating disorder,” Dr. Voss said.
The increasing need for treatment over the course of the pandemic may reflect the time that it has taken for the disorders to develop, as well as the time that it takes parents to recognize the problem.
Not only are doctors seeing more cases, but patients are arriving sicker than usual, Dr. Voss said.
Major medical concerns for patients in starvation mode center on the heart, brain, and bones. In addition, refeeding syndrome poses an extreme risk, Dr. Voss noted.
The Academy for Eating Disorders has created a guide to help doctors recognize and manage risks for patients with eating disorders, which may be useful for primary care providers while they are trying to get a patient into more intensive treatment, Dr. Voss suggested. The American Academy of Pediatrics recently published a clinical report on the identification and management of eating disorders in children and adolescents.
At Johns Hopkins Hospital Children’s Center in Baltimore, “we have seen a pretty remarkable increase in the number of eating disorders in the child and adolescent space since COVID,” said Jennifer Leah Goetz, MD, a psychiatrist and medical director of the child and adolescent inpatient unit. “We have seen increasing numbers of kids presenting for acute medical stabilization and refeeding and for specific treatment for the eating disorder.”
It could be that, for people with a genetic predisposition to eating disorders, a confluence of factors related to the pandemic unmasked it. For example, children may have spent more time looking at themselves on virtual meeting platforms, which could stir lingering body image and appearance-related concerns in those who are vulnerable. And some teens who were not able to participate in athletics as usual started to watch what they eat more closely, Dr. Goetz said.
A treatment bottleneck
Patients with eating disorders “can be quite ill from a psychiatric and general medical perspective,” Dr. Goetz said. “Most psychiatrists are not particularly comfortable with the medical complications, and most internists or pediatricians are not particularly comfortable with the psychiatric complications. You end up with a patient population that can only see a really highly specialized group of individuals for care. And it is a problem. It was a problem before the pandemic, and it has been really exacerbated by what we have been going through with COVID.”
Natalie Muth, MD, MPH, RDN, a pediatrician at Children’s Primary Care Medical Group La Costa in Carlsbad, Calif., has also noticed the increase in eating disorders since COVID.
In-patient colleagues “have longer wait lists and more severe cases than they have ever seen previously,” said Dr. Muth, who chairs the American Academy of Pediatrics Section on Obesity and is an adjunct assistant professor at the University of California, Los Angeles. “In primary care, we are all having to better educate and prepare ourselves for identifying and managing patients with eating disorders.”
That could mean connecting with mental health professionals, registered dietitians, and higher levels of care. But that may be a challenge. “Accessing these resources has been more difficult due to the increasing incidence of eating disorders recently,” Dr. Muth said.
Dr. Voss acknowledged that childhood obesity is another concern for pediatricians. “However, there are appropriate and healthy and safe ways to address that,” she said. A patient with overweight or obesity who loses weight may not be doing so in a healthy way.
Clinicians should wonder if a patient’s weight is decreasing too fast. And they should ask patients questions that could help identify a problem, such as: What are they doing to cause the weight loss? Why do they want to lose the weight?
Dr. Voss added that eating disorders “do not discriminate.” While there may be a perception that all patients with eating disorders are White, upper middle–class females who are thin, “that is not the case,” Dr. Voss said. They “come in all genders, all races, all weight classes, and all ages,” she said, “and we see that variety.”
In general, there may be a need to shift how weight is discussed in clinics and society more broadly, Dr. Goetz said. Weight is an incredibly personal thing, and everyone’s genetics, metabolism, and life circumstances vary. At the same time, body mass index is not necessarily the best measure of a person’s health.
Asking a child, teen, or even an adult to go on a diet is not a benign intervention, Dr. Goetz noted. In addition, dieting is unlikely to help in the long term.
Emerging from lockdown, pressure to lose “COVID pounds” is a dangerous message for people with eating disorders, Dr. Goetz said. It also could be a dangerous message for people without eating disorders. “There are so many more interesting things about each one of us than our weight,” she added.
The study authors, Dr. Voss, Dr. Goetz, and Dr. Muth had no relevant disclosures.
Medical admissions for adolescents with restrictive eating disorders more than doubled at one hospital during the first 12 months of the COVID-19 pandemic, relative to the average number of admissions in prior years, a new study shows.
Doctors are seeing similar increases across the United States and in other countries.
Providers and health care systems “may need to rapidly adapt in response to increasing demands for care during the COVID-19 pandemic,” the researchers said in their study, which was published online in Pediatrics.
To assess whether admission patterns among adolescents with restrictive eating disorders changed during the pandemic, Alana K. Otto, MD, MPH, with the division of adolescent medicine at the University of Michigan, Ann Arbor, and colleagues reviewed the charts of patients admitted to C.S. Mott Children’s Hospital, also in Ann Arbor.
Their analysis included 297 admissions among 248 patients aged 10-23 years between March 1, 2017, and March 31, 2021. Patients had an average age of about 15 years. Approximately 90% were female, and most had a diagnosis of anorexia nervosa or atypical anorexia nervosa.
Indications for medical admission included physiological instability (for example, heart rate less than 50 beats per minute while awake or blood pressure less than 90/40 mm Hg), electrolyte derangements, and acute medical complications of malnutrition such as syncope. Other possible indications included uncontrolled purging, body mass index less than 75% of the median for age and sex, acute food refusal, and failure of outpatient treatment.
Eating disorder–related admissions per month were stable prior to the pandemic. Admissions then decreased in April 2020, but subsequently increased significantly throughout the study period. In all, there were 125 admissions between April 1, 2020, and March 31, 2021. During the previous 3 years, the average number of admissions per year was 56.
Patients’ insurance status was one factor that differed before and during the pandemic. Prepandemic, about 20% of admissions were for adolescents with public insurance. During the pandemic, however, the proportion with public insurance was approximately 9%, the researchers noted. Other characteristics were generally similar.
The study was retrospective and relatively small and only looked at patients with restrictive eating disorders who were severely ill and admitted for medical stabilization. It does not reflect adolescents with eating disorders in different settings, the authors noted.
Primary care pediatricians should be familiar with indications for medical admission, such as severe bradycardia, as outlined by the Society for Adolescent Health and Medicine, they said.
Consistent trends
Unfortunately, the trend seems consistent across the nation, said Michaela M. Voss, MD, director of the the Eating Disorders Center at Children’s Mercy in Kansas City, Mo. “Our outpatient setting went from availability to get in immediately to a 6-month wait list.”
As in Michigan, Dr. Voss noted a drop in admissions as lockdowns started, followed by a spike in treatment demand that has not let up.
Dr. Voss described two of the more common presentations. In one, parents might note that their child had been getting into healthy eating and exercise before the pandemic and seemed fine. “But then COVID came, the lockdown happened, and they became overly obsessed with those things,” Dr. Voss said.
In the other presentation, kids with anxiety, depression, or OCD who lost access to their usual coping strategies and outlets developed eating disorders during the pandemic. “They focused on one of the few things they could during the lockdown, which was their own body, and then their anxiety, depression, [obsessive-compulsive disorder], and other mental health comorbidities presented as an eating disorder,” Dr. Voss said.
The increasing need for treatment over the course of the pandemic may reflect the time that it has taken for the disorders to develop, as well as the time that it takes parents to recognize the problem.
Not only are doctors seeing more cases, but patients are arriving sicker than usual, Dr. Voss said.
Major medical concerns for patients in starvation mode center on the heart, brain, and bones. In addition, refeeding syndrome poses an extreme risk, Dr. Voss noted.
The Academy for Eating Disorders has created a guide to help doctors recognize and manage risks for patients with eating disorders, which may be useful for primary care providers while they are trying to get a patient into more intensive treatment, Dr. Voss suggested. The American Academy of Pediatrics recently published a clinical report on the identification and management of eating disorders in children and adolescents.
At Johns Hopkins Hospital Children’s Center in Baltimore, “we have seen a pretty remarkable increase in the number of eating disorders in the child and adolescent space since COVID,” said Jennifer Leah Goetz, MD, a psychiatrist and medical director of the child and adolescent inpatient unit. “We have seen increasing numbers of kids presenting for acute medical stabilization and refeeding and for specific treatment for the eating disorder.”
It could be that, for people with a genetic predisposition to eating disorders, a confluence of factors related to the pandemic unmasked it. For example, children may have spent more time looking at themselves on virtual meeting platforms, which could stir lingering body image and appearance-related concerns in those who are vulnerable. And some teens who were not able to participate in athletics as usual started to watch what they eat more closely, Dr. Goetz said.
A treatment bottleneck
Patients with eating disorders “can be quite ill from a psychiatric and general medical perspective,” Dr. Goetz said. “Most psychiatrists are not particularly comfortable with the medical complications, and most internists or pediatricians are not particularly comfortable with the psychiatric complications. You end up with a patient population that can only see a really highly specialized group of individuals for care. And it is a problem. It was a problem before the pandemic, and it has been really exacerbated by what we have been going through with COVID.”
Natalie Muth, MD, MPH, RDN, a pediatrician at Children’s Primary Care Medical Group La Costa in Carlsbad, Calif., has also noticed the increase in eating disorders since COVID.
In-patient colleagues “have longer wait lists and more severe cases than they have ever seen previously,” said Dr. Muth, who chairs the American Academy of Pediatrics Section on Obesity and is an adjunct assistant professor at the University of California, Los Angeles. “In primary care, we are all having to better educate and prepare ourselves for identifying and managing patients with eating disorders.”
That could mean connecting with mental health professionals, registered dietitians, and higher levels of care. But that may be a challenge. “Accessing these resources has been more difficult due to the increasing incidence of eating disorders recently,” Dr. Muth said.
Dr. Voss acknowledged that childhood obesity is another concern for pediatricians. “However, there are appropriate and healthy and safe ways to address that,” she said. A patient with overweight or obesity who loses weight may not be doing so in a healthy way.
Clinicians should wonder if a patient’s weight is decreasing too fast. And they should ask patients questions that could help identify a problem, such as: What are they doing to cause the weight loss? Why do they want to lose the weight?
Dr. Voss added that eating disorders “do not discriminate.” While there may be a perception that all patients with eating disorders are White, upper middle–class females who are thin, “that is not the case,” Dr. Voss said. They “come in all genders, all races, all weight classes, and all ages,” she said, “and we see that variety.”
In general, there may be a need to shift how weight is discussed in clinics and society more broadly, Dr. Goetz said. Weight is an incredibly personal thing, and everyone’s genetics, metabolism, and life circumstances vary. At the same time, body mass index is not necessarily the best measure of a person’s health.
Asking a child, teen, or even an adult to go on a diet is not a benign intervention, Dr. Goetz noted. In addition, dieting is unlikely to help in the long term.
Emerging from lockdown, pressure to lose “COVID pounds” is a dangerous message for people with eating disorders, Dr. Goetz said. It also could be a dangerous message for people without eating disorders. “There are so many more interesting things about each one of us than our weight,” she added.
The study authors, Dr. Voss, Dr. Goetz, and Dr. Muth had no relevant disclosures.
FROM PEDIATRICS
Stop using Neutrogena and Aveeno spray sunscreen, J&J warns
Benzene is not an ingredient of sunscreen, and should not be present in these products. The levels detected were low and would not be expected to have an adverse effect on health, but the company says it is recalling the products anyway “out of an abundance of caution.”
The sunscreen products that have been recalled are:
- NEUTROGENA® Beach Defense® aerosol sunscreen.
- NEUTROGENA® Cool Dry Sport aerosol sunscreen.
- NEUTROGENA® Invisible Daily™ defense aerosol sunscreen.
- NEUTROGENA® Ultra Sheer® aerosol sunscreen.
- AVEENO® Protect + Refresh aerosol sunscreen.
These products were distributed nationwide through a variety of retail stores. Consumers should stop using these products and throw them away, the company said.
At the same time, it emphasized the importance of using alternative sunscreen products to protect the skin from excessive sun exposure, which can lead to skin cancer including melanoma.
Johnson & Johnson has launched an investigation into how benzene got into these products.
One of the company’s other spray sunscreen products, Neutrogena Wet Skin, was not included in the recall.
Recently, benzene was found in 78 widely-used sunscreen products in tests conducted by the online pharmacy and laboratory Valisure. Most of the products were aerosol sprays, and the company called on the Food and Drug Administration to recall them all.
That petition suggested that the finding of benzene was the result of contamination somewhere in the manufacturing process.
“This isn’t a sunscreen issue, it’s a manufacturing issue,” said Adam Friedman, MD, professor and chief of dermatology at George Washington University. “We don’t want those things to be blurred.”
There is a risk that people take away the wrong message from these findings.
“People already have ambivalence about sunscreen, and this is just going to make that worse,” Dr. Friedman said in an interview.
He pointed out that benzene is present in car exhaust, second-hand smoke, and elsewhere. Inhalation exposure has been the primary focus of toxicology investigations, as has exposure from things such as contaminated drinking water – not via topical application. “We don’t know how effectively [benzene] gets through the skin, if it gets absorbed systemically, and how that then behaves downstream,” he noted.
On the other hand, ultraviolet radiation is a well-established carcinogen. Avoiding an effective preventive measure such as sunscreen could prove more harmful than exposure to trace amounts of benzene, he said.
A version of this article first appeared on WebMD.com.
Benzene is not an ingredient of sunscreen, and should not be present in these products. The levels detected were low and would not be expected to have an adverse effect on health, but the company says it is recalling the products anyway “out of an abundance of caution.”
The sunscreen products that have been recalled are:
- NEUTROGENA® Beach Defense® aerosol sunscreen.
- NEUTROGENA® Cool Dry Sport aerosol sunscreen.
- NEUTROGENA® Invisible Daily™ defense aerosol sunscreen.
- NEUTROGENA® Ultra Sheer® aerosol sunscreen.
- AVEENO® Protect + Refresh aerosol sunscreen.
These products were distributed nationwide through a variety of retail stores. Consumers should stop using these products and throw them away, the company said.
At the same time, it emphasized the importance of using alternative sunscreen products to protect the skin from excessive sun exposure, which can lead to skin cancer including melanoma.
Johnson & Johnson has launched an investigation into how benzene got into these products.
One of the company’s other spray sunscreen products, Neutrogena Wet Skin, was not included in the recall.
Recently, benzene was found in 78 widely-used sunscreen products in tests conducted by the online pharmacy and laboratory Valisure. Most of the products were aerosol sprays, and the company called on the Food and Drug Administration to recall them all.
That petition suggested that the finding of benzene was the result of contamination somewhere in the manufacturing process.
“This isn’t a sunscreen issue, it’s a manufacturing issue,” said Adam Friedman, MD, professor and chief of dermatology at George Washington University. “We don’t want those things to be blurred.”
There is a risk that people take away the wrong message from these findings.
“People already have ambivalence about sunscreen, and this is just going to make that worse,” Dr. Friedman said in an interview.
He pointed out that benzene is present in car exhaust, second-hand smoke, and elsewhere. Inhalation exposure has been the primary focus of toxicology investigations, as has exposure from things such as contaminated drinking water – not via topical application. “We don’t know how effectively [benzene] gets through the skin, if it gets absorbed systemically, and how that then behaves downstream,” he noted.
On the other hand, ultraviolet radiation is a well-established carcinogen. Avoiding an effective preventive measure such as sunscreen could prove more harmful than exposure to trace amounts of benzene, he said.
A version of this article first appeared on WebMD.com.
Benzene is not an ingredient of sunscreen, and should not be present in these products. The levels detected were low and would not be expected to have an adverse effect on health, but the company says it is recalling the products anyway “out of an abundance of caution.”
The sunscreen products that have been recalled are:
- NEUTROGENA® Beach Defense® aerosol sunscreen.
- NEUTROGENA® Cool Dry Sport aerosol sunscreen.
- NEUTROGENA® Invisible Daily™ defense aerosol sunscreen.
- NEUTROGENA® Ultra Sheer® aerosol sunscreen.
- AVEENO® Protect + Refresh aerosol sunscreen.
These products were distributed nationwide through a variety of retail stores. Consumers should stop using these products and throw them away, the company said.
At the same time, it emphasized the importance of using alternative sunscreen products to protect the skin from excessive sun exposure, which can lead to skin cancer including melanoma.
Johnson & Johnson has launched an investigation into how benzene got into these products.
One of the company’s other spray sunscreen products, Neutrogena Wet Skin, was not included in the recall.
Recently, benzene was found in 78 widely-used sunscreen products in tests conducted by the online pharmacy and laboratory Valisure. Most of the products were aerosol sprays, and the company called on the Food and Drug Administration to recall them all.
That petition suggested that the finding of benzene was the result of contamination somewhere in the manufacturing process.
“This isn’t a sunscreen issue, it’s a manufacturing issue,” said Adam Friedman, MD, professor and chief of dermatology at George Washington University. “We don’t want those things to be blurred.”
There is a risk that people take away the wrong message from these findings.
“People already have ambivalence about sunscreen, and this is just going to make that worse,” Dr. Friedman said in an interview.
He pointed out that benzene is present in car exhaust, second-hand smoke, and elsewhere. Inhalation exposure has been the primary focus of toxicology investigations, as has exposure from things such as contaminated drinking water – not via topical application. “We don’t know how effectively [benzene] gets through the skin, if it gets absorbed systemically, and how that then behaves downstream,” he noted.
On the other hand, ultraviolet radiation is a well-established carcinogen. Avoiding an effective preventive measure such as sunscreen could prove more harmful than exposure to trace amounts of benzene, he said.
A version of this article first appeared on WebMD.com.
Dupilumab safe, effective in kids 6-11 with moderate-to-severe asthma
Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.
A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.
Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.
Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.
Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.
Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.
Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.
“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”
At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.
Results also indicate a favorable safety profile for dupilumab.
James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”
Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.
“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.
More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.
Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”
Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.
“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.
Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.
A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.
Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.
Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.
Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.
Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.
Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.
“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”
At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.
Results also indicate a favorable safety profile for dupilumab.
James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”
Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.
“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.
More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.
Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”
Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.
“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.
Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Dupilumab (Dupixent, Sanofi and Regeneron) significantly reduced exacerbations compared with placebo in children ages 6-11 years who had moderate-to-severe asthma in a phase 3 trial.
A fully human monoclonal antibody, dupilumab also improved lung function versus placebo by week 12, an improvement that lasted the length of the 52-week trial.
Dupilumab previously had been shown to be safe and effective in adolescents and adults with moderate-to-severe asthma, patients 6 years and older with moderate-to-severe atopic dermatitis, and adults with chronic rhinosinusitis with nasal polyposis, but its safety and effectiveness for moderate-to-severe asthma in the 6-11 years age group was not known.
Results from the randomized, double-blind VOYAGE study conducted across several countries were presented Saturday, July 10, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021.
Leonard B. Bacharier, MD, professor of pediatrics, allergy/immunology/pulmonary medicine at Vanderbilt University Medical Center in Nashville, Tennessee, presented the results from the trial, which was funded by Sanofi/Regeneron.
Researchers enrolled 408 children ages 6-11 years with uncontrolled moderate-to-severe asthma. Children on high-dose inhaled corticosteroids (ICS) alone or medium-to-high–dose ICS with a second controller were randomly assigned either to add-on subcutaneous dupilumab 100 mg or 200 mg, based on body weight at study start, or to placebo every 2 weeks for 52 weeks.
Analyses were done in two populations: 350 patients with markers of type 2 inflammation (baseline blood eosinophils ≥150 cells/μl or fractional exhaled nitric oxide [FeNO] ≥20 ppb) and 259 patients with baseline blood eosinophils ≥300 cells/µl.
“The primary endpoint was the annualized rate of severe asthma exacerbations,” Dr. Bacharier said. “The key secondary endpoint was change in percent predicted prebronchodilator FEV1 [forced expiratory volume at 1 second] from baseline to week 12.”
At week 12, the annualized severe asthma exacerbation rate was reduced by 59% (P < .0001) in children with blood eosinophils ≥300 cells/µL and results were similar in those with the type 2 inflammatory phenotype compared with placebo.
Results also indicate a favorable safety profile for dupilumab.
James M. Tracy, DO, an expert with the American College of Allergy, Asthma, and Immunology, told this news organization that adding the dupilumab option for children in the 6-11 age group is “huge.”
Dr. Tracy, who was not involved with the study, said although omalizumab (Xolair, Genentech) is also available for these children, dupilumab stands out because of the range of comorbidities it can treat.
“[Children] don’t have the same rhinosinusitis and polyposis that adults would have, but a lot of them have eczema, and this drug with multiple prongs is incredibly useful and addresses a broad array of allergic conditions,” Dr. Tracy said.
More than 90% of children in the study had at least one concurrent type 2 inflammatory condition, including atopic dermatitis and eosinophilic esophagitis. Dupilumab blocks the shared receptor for interleukin (IL)-4/IL-13, which are key drivers of type 2 inflammation in multiple diseases.
Dr. Tracy said that while dupilumab is not the only drug available to treat children 6-11 years with moderate-to-severe asthma, it is “a significant and unique addition to the armamentarium of the individual practitioner taking care of these very severe asthmatics in the 6-11 age group.”
Dupilumab also led to rapid and sustained improvement in lung function. At 12 weeks, children assigned dupilumab improved their lung function as measured by FEV1 by 5.21% (P = .0009), and that continued through the 52-week study period.
“What we know is the [improved lung function] effect is sustained. What we don’t know is how long you have to keep on the drug for a more permanent effect, which is an issue for all these biologics,” Tracy said.
Dr. Bacharier reported speaker fees and research support from Sanofi/Regeneron. Dr. Tracy has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pediatric alopecia areata in the U.S. has increased twofold since 2009, study finds
according to results from the largest study to date on the topic.
“Alopecia areata is a relatively common cause of nonscarring hair loss in children,” Paige McKenzie said during the annual meeting of the Society for Pediatric Dermatology. “The only two epidemiologic studies that have been performed in children have been based on registry or survey data which is inherently at risk for bias,” she added, referring to studies published in 2017 and 2018. “Additionally, epidemiologic descriptions of alopecia areata in adults are limited and overall estimates have varied from 0.2% to 2%. Current understanding is also largely based on population studies in Olmsted County, Minnesota, an area with mostly White racial demographics, so it’s not representative of the U.S. population as a whole.”
To identify the incidence and prevalence of pediatric AA over time, and across age, race/ethnicity, and sex, Ms. McKenzie and colleagues conducted a retrospective cohort study from 2009 to 2020 using PEDSnet, a network of seven U.S. pediatric health institutions with a database of more than 6.5 million children. “PEDSnet is unique because it uses a common data model to standardize EHR data across different health systems and uses SNOMED [Systematized Nomenclature of Medicine]–Clinical Terms to identify specific patient populations,” said Ms. McKenzie, who was a clinical research fellow in the section of dermatology at the Children’s Hospital of Philadelphia during the 2020-2021 academic year.
She and her coauthors limited their analysis to children younger than age 18 who were assigned a SNOMED code for AA during at least one dermatology physician visit or at least two nondermatology physician visits. They also identified an incidence cohort that was a subset of the study cohort who had at least 12 months of follow-up. “To determine the accuracy of AA patient identification, we also reviewed 100 cases at random from one institution with a threshold of greater than 95% accuracy,” said Ms. McKenzie, who is now a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas.
Of 5,409,919 children included in the study, 5,801 had AA, for an overall prevalence of 0.11%. The prevalence doubled from 0.04% in 2009 to 0.08% in 2019. “It fell in 2020, which we believe is a result of the COVID-19 pandemic’s effects on health care utilization,” she said. AA prevalence peaked at 9 years of age and was higher among females, compared with males (0.12% vs. 0.09%, respectively). The prevalence was highest among Hispanic children (0.23%), followed by Asian children (0.17%), Black children (0.12%), and White children (0.08%).
The incidence cohort consisted of 2,896,241 children. Of these, 2,398 had AA between 2009-2020, for an overall incidence of 13.6 cases per 100,000 patient-years. The incidence rate of AA by age was normally distributed and peaked at 6 years of age. Rates were 22.8% higher in female patients than in male patients. In addition, incidence rates were highest among Hispanics (31.5/100,000 person-years), followed by Asians (23.1/100,000 person-years), Blacks (17.0/100,000 person-years), and Whites (8.8/100,000).
Logistic regression analysis showed general agreement with the unadjusted incidence data. Males were less likely to be diagnosed with AA, compared with females (adjusted odds ratio, 0.80; P < .001). Analysis across race/ethnicity revealed significantly increased rates among children from minority backgrounds when compared with white children. Hispanic children had the greatest risk of developing AA (aOR, 3.07), followed by Asian children (aOR, 2.02), and Black children (aOR, 1.73) (P < .001 for all associations). Patients with atopic dermatitis, thyroid disease, psoriasis, vitiligo, and trisomy 21 prior to AA diagnosis all had a significantly higher risk of developing AA, compared with those without those diagnoses.
“This is the largest description of pediatric AA to date,” Ms. McKenzie said. “The prevalence has increased steadily, with a twofold increase over the last 10 years, which mirrors other autoimmune disorders. Children who identify as Hispanic, Asian, and Black have significantly higher incidence rates of alopecia areata compared to those who identify as White.”
Moving forward, she added, “efforts should focus on increasing education and awareness of AA in diverse communities and in community pediatricians so that patients can be diagnosed correctly early on. We can also use this data to ensure that representative populations are included in clinical trials for patients with AA.”
Asked to comment on the results Maria Hordinsky, MD, professor and chair of the department of dermatology at the University of Minnesota, Minneapolis, said that the study “is a great contribution to our understanding of the epidemiology of pediatric alopecia areata and also highlights how common alopecia areata is in children.” In an interview, she said that it would be interesting to see if this is a worldwide phenomenon or unique to the United States.
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized the work as being “very informative. Looking at a large cohort of pediatric patients with alopecia areata diagnosed by a dermatologist or two or more nondermatologists, the authors found a higher incidence and prevalence in nonwhite children here in the United States. I am worried in fact, the true incidence could be even higher than noted in the searched database because nonwhite children can often come from underserved and undercared for areas.”
The other authors were Christopher B. Forrest, MD, PhD, Mitchell Maltenfort, PhD, and Leslie Castelo-Soccio, MD, PhD, of Children’s Hospital of Philadelphia. Dr. Castelo-Soccio is a consultant for Pfizer; the other authors reported having no financial disclosures. Dr. Hordinsky disclosed receiving grant support for clinical research work on hair diseases from Pfizer, Eli Lilly, Concert Pharmaceuticals, and Target Derm and grant support from the National Alopecia Areata Foundation; and is on an advisory panel for Cassiopea. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
*This story was updated on 7/19/21.
according to results from the largest study to date on the topic.
“Alopecia areata is a relatively common cause of nonscarring hair loss in children,” Paige McKenzie said during the annual meeting of the Society for Pediatric Dermatology. “The only two epidemiologic studies that have been performed in children have been based on registry or survey data which is inherently at risk for bias,” she added, referring to studies published in 2017 and 2018. “Additionally, epidemiologic descriptions of alopecia areata in adults are limited and overall estimates have varied from 0.2% to 2%. Current understanding is also largely based on population studies in Olmsted County, Minnesota, an area with mostly White racial demographics, so it’s not representative of the U.S. population as a whole.”
To identify the incidence and prevalence of pediatric AA over time, and across age, race/ethnicity, and sex, Ms. McKenzie and colleagues conducted a retrospective cohort study from 2009 to 2020 using PEDSnet, a network of seven U.S. pediatric health institutions with a database of more than 6.5 million children. “PEDSnet is unique because it uses a common data model to standardize EHR data across different health systems and uses SNOMED [Systematized Nomenclature of Medicine]–Clinical Terms to identify specific patient populations,” said Ms. McKenzie, who was a clinical research fellow in the section of dermatology at the Children’s Hospital of Philadelphia during the 2020-2021 academic year.
She and her coauthors limited their analysis to children younger than age 18 who were assigned a SNOMED code for AA during at least one dermatology physician visit or at least two nondermatology physician visits. They also identified an incidence cohort that was a subset of the study cohort who had at least 12 months of follow-up. “To determine the accuracy of AA patient identification, we also reviewed 100 cases at random from one institution with a threshold of greater than 95% accuracy,” said Ms. McKenzie, who is now a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas.
Of 5,409,919 children included in the study, 5,801 had AA, for an overall prevalence of 0.11%. The prevalence doubled from 0.04% in 2009 to 0.08% in 2019. “It fell in 2020, which we believe is a result of the COVID-19 pandemic’s effects on health care utilization,” she said. AA prevalence peaked at 9 years of age and was higher among females, compared with males (0.12% vs. 0.09%, respectively). The prevalence was highest among Hispanic children (0.23%), followed by Asian children (0.17%), Black children (0.12%), and White children (0.08%).
The incidence cohort consisted of 2,896,241 children. Of these, 2,398 had AA between 2009-2020, for an overall incidence of 13.6 cases per 100,000 patient-years. The incidence rate of AA by age was normally distributed and peaked at 6 years of age. Rates were 22.8% higher in female patients than in male patients. In addition, incidence rates were highest among Hispanics (31.5/100,000 person-years), followed by Asians (23.1/100,000 person-years), Blacks (17.0/100,000 person-years), and Whites (8.8/100,000).
Logistic regression analysis showed general agreement with the unadjusted incidence data. Males were less likely to be diagnosed with AA, compared with females (adjusted odds ratio, 0.80; P < .001). Analysis across race/ethnicity revealed significantly increased rates among children from minority backgrounds when compared with white children. Hispanic children had the greatest risk of developing AA (aOR, 3.07), followed by Asian children (aOR, 2.02), and Black children (aOR, 1.73) (P < .001 for all associations). Patients with atopic dermatitis, thyroid disease, psoriasis, vitiligo, and trisomy 21 prior to AA diagnosis all had a significantly higher risk of developing AA, compared with those without those diagnoses.
“This is the largest description of pediatric AA to date,” Ms. McKenzie said. “The prevalence has increased steadily, with a twofold increase over the last 10 years, which mirrors other autoimmune disorders. Children who identify as Hispanic, Asian, and Black have significantly higher incidence rates of alopecia areata compared to those who identify as White.”
Moving forward, she added, “efforts should focus on increasing education and awareness of AA in diverse communities and in community pediatricians so that patients can be diagnosed correctly early on. We can also use this data to ensure that representative populations are included in clinical trials for patients with AA.”
Asked to comment on the results Maria Hordinsky, MD, professor and chair of the department of dermatology at the University of Minnesota, Minneapolis, said that the study “is a great contribution to our understanding of the epidemiology of pediatric alopecia areata and also highlights how common alopecia areata is in children.” In an interview, she said that it would be interesting to see if this is a worldwide phenomenon or unique to the United States.
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized the work as being “very informative. Looking at a large cohort of pediatric patients with alopecia areata diagnosed by a dermatologist or two or more nondermatologists, the authors found a higher incidence and prevalence in nonwhite children here in the United States. I am worried in fact, the true incidence could be even higher than noted in the searched database because nonwhite children can often come from underserved and undercared for areas.”
The other authors were Christopher B. Forrest, MD, PhD, Mitchell Maltenfort, PhD, and Leslie Castelo-Soccio, MD, PhD, of Children’s Hospital of Philadelphia. Dr. Castelo-Soccio is a consultant for Pfizer; the other authors reported having no financial disclosures. Dr. Hordinsky disclosed receiving grant support for clinical research work on hair diseases from Pfizer, Eli Lilly, Concert Pharmaceuticals, and Target Derm and grant support from the National Alopecia Areata Foundation; and is on an advisory panel for Cassiopea. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
*This story was updated on 7/19/21.
according to results from the largest study to date on the topic.
“Alopecia areata is a relatively common cause of nonscarring hair loss in children,” Paige McKenzie said during the annual meeting of the Society for Pediatric Dermatology. “The only two epidemiologic studies that have been performed in children have been based on registry or survey data which is inherently at risk for bias,” she added, referring to studies published in 2017 and 2018. “Additionally, epidemiologic descriptions of alopecia areata in adults are limited and overall estimates have varied from 0.2% to 2%. Current understanding is also largely based on population studies in Olmsted County, Minnesota, an area with mostly White racial demographics, so it’s not representative of the U.S. population as a whole.”
To identify the incidence and prevalence of pediatric AA over time, and across age, race/ethnicity, and sex, Ms. McKenzie and colleagues conducted a retrospective cohort study from 2009 to 2020 using PEDSnet, a network of seven U.S. pediatric health institutions with a database of more than 6.5 million children. “PEDSnet is unique because it uses a common data model to standardize EHR data across different health systems and uses SNOMED [Systematized Nomenclature of Medicine]–Clinical Terms to identify specific patient populations,” said Ms. McKenzie, who was a clinical research fellow in the section of dermatology at the Children’s Hospital of Philadelphia during the 2020-2021 academic year.
She and her coauthors limited their analysis to children younger than age 18 who were assigned a SNOMED code for AA during at least one dermatology physician visit or at least two nondermatology physician visits. They also identified an incidence cohort that was a subset of the study cohort who had at least 12 months of follow-up. “To determine the accuracy of AA patient identification, we also reviewed 100 cases at random from one institution with a threshold of greater than 95% accuracy,” said Ms. McKenzie, who is now a fourth-year medical student at the University of Texas Southwestern Medical Center, Dallas.
Of 5,409,919 children included in the study, 5,801 had AA, for an overall prevalence of 0.11%. The prevalence doubled from 0.04% in 2009 to 0.08% in 2019. “It fell in 2020, which we believe is a result of the COVID-19 pandemic’s effects on health care utilization,” she said. AA prevalence peaked at 9 years of age and was higher among females, compared with males (0.12% vs. 0.09%, respectively). The prevalence was highest among Hispanic children (0.23%), followed by Asian children (0.17%), Black children (0.12%), and White children (0.08%).
The incidence cohort consisted of 2,896,241 children. Of these, 2,398 had AA between 2009-2020, for an overall incidence of 13.6 cases per 100,000 patient-years. The incidence rate of AA by age was normally distributed and peaked at 6 years of age. Rates were 22.8% higher in female patients than in male patients. In addition, incidence rates were highest among Hispanics (31.5/100,000 person-years), followed by Asians (23.1/100,000 person-years), Blacks (17.0/100,000 person-years), and Whites (8.8/100,000).
Logistic regression analysis showed general agreement with the unadjusted incidence data. Males were less likely to be diagnosed with AA, compared with females (adjusted odds ratio, 0.80; P < .001). Analysis across race/ethnicity revealed significantly increased rates among children from minority backgrounds when compared with white children. Hispanic children had the greatest risk of developing AA (aOR, 3.07), followed by Asian children (aOR, 2.02), and Black children (aOR, 1.73) (P < .001 for all associations). Patients with atopic dermatitis, thyroid disease, psoriasis, vitiligo, and trisomy 21 prior to AA diagnosis all had a significantly higher risk of developing AA, compared with those without those diagnoses.
“This is the largest description of pediatric AA to date,” Ms. McKenzie said. “The prevalence has increased steadily, with a twofold increase over the last 10 years, which mirrors other autoimmune disorders. Children who identify as Hispanic, Asian, and Black have significantly higher incidence rates of alopecia areata compared to those who identify as White.”
Moving forward, she added, “efforts should focus on increasing education and awareness of AA in diverse communities and in community pediatricians so that patients can be diagnosed correctly early on. We can also use this data to ensure that representative populations are included in clinical trials for patients with AA.”
Asked to comment on the results Maria Hordinsky, MD, professor and chair of the department of dermatology at the University of Minnesota, Minneapolis, said that the study “is a great contribution to our understanding of the epidemiology of pediatric alopecia areata and also highlights how common alopecia areata is in children.” In an interview, she said that it would be interesting to see if this is a worldwide phenomenon or unique to the United States.
Lawrence J. Green, MD, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study, characterized the work as being “very informative. Looking at a large cohort of pediatric patients with alopecia areata diagnosed by a dermatologist or two or more nondermatologists, the authors found a higher incidence and prevalence in nonwhite children here in the United States. I am worried in fact, the true incidence could be even higher than noted in the searched database because nonwhite children can often come from underserved and undercared for areas.”
The other authors were Christopher B. Forrest, MD, PhD, Mitchell Maltenfort, PhD, and Leslie Castelo-Soccio, MD, PhD, of Children’s Hospital of Philadelphia. Dr. Castelo-Soccio is a consultant for Pfizer; the other authors reported having no financial disclosures. Dr. Hordinsky disclosed receiving grant support for clinical research work on hair diseases from Pfizer, Eli Lilly, Concert Pharmaceuticals, and Target Derm and grant support from the National Alopecia Areata Foundation; and is on an advisory panel for Cassiopea. Dr. Green disclosed that he is a speaker, consultant, or investigator for numerous pharmaceutical companies.
*This story was updated on 7/19/21.
FROM SPD 2021
UV light linked to prevention of allergic disease in infants
Higher direct ultraviolet light exposure in the first 3 months of life was linked to lower incidence of proinflammatory immune markers and lower incidence of eczema in an early-stage double-blind, randomized controlled trial.
Kristina Rueter, MD, with the University of Western Australia, Perth, who presented her team’s findings on Sunday at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021, said their study is the first to demonstrate the association.
“There has been a significant rise in allergic diseases, particularly within the last 20-30 years,” Dr. Rueter noted.
“Changes to the genetic pool take thousands of years to have an impact,” she said, “so the question is why do we have the significant, very recent rise of allergic diseases?”
Suboptimal vitamin D levels during infancy, lifestyle changes, nutritional changes, and living at higher latitudes have emerged as explanations.
In this study, 195 high-risk newborns were randomized to receive oral vitamin D supplements (400 IU/day) or placebo until 6 months of age.
Researchers found that UV light exposure appears more beneficial than vitamin D supplements as an allergy prevention strategy in the critical early years of immune system development.
The researchers used a novel approach of attaching a personal UV dosimeter to the infants’ clothing to measure direct UV light exposure (290-380 nm). Vitamin D levels were measured at 3, 6, 12, and 30 months of age. Immune function was assessed at 6 months of age, and food allergy, eczema, and wheeze were assessed at 6, 12, and 30 months of age.
At 3 (P < .01) and 6 (P = .02) months of age, vitamin D levels were greater in the children who received vitamin D supplements than those who received placebo, but there was no difference in eczema incidence between groups. The finding matched those of previous studies that compared the supplements with placebo, Dr. Rueter said.
However, infants with eczema were found to have had less UV light exposure compared to those without eczema (median interquartile range [IQR], 555 J/m2 vs. 998 J/m2; P = .023).
“We also found an inverse correlation between total UV light exposure and toll-like receptor cytokine production,” Dr. Rueter said.
“The more direct UV light exposure a child got, the less the chance to develop eczema,” she said.
Researchers then extended their analysis to see whether the effect of direct UV light exposure on reduced eczema would be maintained in the first 2.5 years of life, “and we could see again a significant difference, that the children who received higher UV light exposure had less eczema,” Dr. Rueter said.
Barbara Rogala, MD, PhD, professor at the Medical University of Silesia, Katowice, Poland, told this news organization that, just as in studies on vitamin D in adult populations, there must be a balance in infant studies between potential benefit of a therapeutic strategy of vitamin D and sunlight and risk of side effects. (Dr. Rogala was not involved in Dr. Rueter’s study.)
Although vitamin D supplements are a standard part of infant care, exposure to sunlight can come with cancer risk, she noted.
Dr. Rueter agreed caution is necessary.
“You have to follow the cancer guidelines,” she said. “Sunlight may play a role in causing skin cancer, and lots of research needs to be done to find the right balance between what is a good amount which may influence the immune system in a positive way and what, on the other hand, might be too much.”
As for vitamin D supplements, Dr. Rueter said, toxic levels require “extremely high doses,” so with 400 IU/day used in the study, children are likely not being overtreated by combining sunlight and vitamin D supplements.
The study was supported by grants from Telethon–New Children’s Hospital Research Fund, Australia; Asthma Foundation of Western Australia; and the Princess Margaret Hospital Foundation, Australia. Dr. Rueter and Dr. Rogala have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Higher direct ultraviolet light exposure in the first 3 months of life was linked to lower incidence of proinflammatory immune markers and lower incidence of eczema in an early-stage double-blind, randomized controlled trial.
Kristina Rueter, MD, with the University of Western Australia, Perth, who presented her team’s findings on Sunday at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021, said their study is the first to demonstrate the association.
“There has been a significant rise in allergic diseases, particularly within the last 20-30 years,” Dr. Rueter noted.
“Changes to the genetic pool take thousands of years to have an impact,” she said, “so the question is why do we have the significant, very recent rise of allergic diseases?”
Suboptimal vitamin D levels during infancy, lifestyle changes, nutritional changes, and living at higher latitudes have emerged as explanations.
In this study, 195 high-risk newborns were randomized to receive oral vitamin D supplements (400 IU/day) or placebo until 6 months of age.
Researchers found that UV light exposure appears more beneficial than vitamin D supplements as an allergy prevention strategy in the critical early years of immune system development.
The researchers used a novel approach of attaching a personal UV dosimeter to the infants’ clothing to measure direct UV light exposure (290-380 nm). Vitamin D levels were measured at 3, 6, 12, and 30 months of age. Immune function was assessed at 6 months of age, and food allergy, eczema, and wheeze were assessed at 6, 12, and 30 months of age.
At 3 (P < .01) and 6 (P = .02) months of age, vitamin D levels were greater in the children who received vitamin D supplements than those who received placebo, but there was no difference in eczema incidence between groups. The finding matched those of previous studies that compared the supplements with placebo, Dr. Rueter said.
However, infants with eczema were found to have had less UV light exposure compared to those without eczema (median interquartile range [IQR], 555 J/m2 vs. 998 J/m2; P = .023).
“We also found an inverse correlation between total UV light exposure and toll-like receptor cytokine production,” Dr. Rueter said.
“The more direct UV light exposure a child got, the less the chance to develop eczema,” she said.
Researchers then extended their analysis to see whether the effect of direct UV light exposure on reduced eczema would be maintained in the first 2.5 years of life, “and we could see again a significant difference, that the children who received higher UV light exposure had less eczema,” Dr. Rueter said.
Barbara Rogala, MD, PhD, professor at the Medical University of Silesia, Katowice, Poland, told this news organization that, just as in studies on vitamin D in adult populations, there must be a balance in infant studies between potential benefit of a therapeutic strategy of vitamin D and sunlight and risk of side effects. (Dr. Rogala was not involved in Dr. Rueter’s study.)
Although vitamin D supplements are a standard part of infant care, exposure to sunlight can come with cancer risk, she noted.
Dr. Rueter agreed caution is necessary.
“You have to follow the cancer guidelines,” she said. “Sunlight may play a role in causing skin cancer, and lots of research needs to be done to find the right balance between what is a good amount which may influence the immune system in a positive way and what, on the other hand, might be too much.”
As for vitamin D supplements, Dr. Rueter said, toxic levels require “extremely high doses,” so with 400 IU/day used in the study, children are likely not being overtreated by combining sunlight and vitamin D supplements.
The study was supported by grants from Telethon–New Children’s Hospital Research Fund, Australia; Asthma Foundation of Western Australia; and the Princess Margaret Hospital Foundation, Australia. Dr. Rueter and Dr. Rogala have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Higher direct ultraviolet light exposure in the first 3 months of life was linked to lower incidence of proinflammatory immune markers and lower incidence of eczema in an early-stage double-blind, randomized controlled trial.
Kristina Rueter, MD, with the University of Western Australia, Perth, who presented her team’s findings on Sunday at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021, said their study is the first to demonstrate the association.
“There has been a significant rise in allergic diseases, particularly within the last 20-30 years,” Dr. Rueter noted.
“Changes to the genetic pool take thousands of years to have an impact,” she said, “so the question is why do we have the significant, very recent rise of allergic diseases?”
Suboptimal vitamin D levels during infancy, lifestyle changes, nutritional changes, and living at higher latitudes have emerged as explanations.
In this study, 195 high-risk newborns were randomized to receive oral vitamin D supplements (400 IU/day) or placebo until 6 months of age.
Researchers found that UV light exposure appears more beneficial than vitamin D supplements as an allergy prevention strategy in the critical early years of immune system development.
The researchers used a novel approach of attaching a personal UV dosimeter to the infants’ clothing to measure direct UV light exposure (290-380 nm). Vitamin D levels were measured at 3, 6, 12, and 30 months of age. Immune function was assessed at 6 months of age, and food allergy, eczema, and wheeze were assessed at 6, 12, and 30 months of age.
At 3 (P < .01) and 6 (P = .02) months of age, vitamin D levels were greater in the children who received vitamin D supplements than those who received placebo, but there was no difference in eczema incidence between groups. The finding matched those of previous studies that compared the supplements with placebo, Dr. Rueter said.
However, infants with eczema were found to have had less UV light exposure compared to those without eczema (median interquartile range [IQR], 555 J/m2 vs. 998 J/m2; P = .023).
“We also found an inverse correlation between total UV light exposure and toll-like receptor cytokine production,” Dr. Rueter said.
“The more direct UV light exposure a child got, the less the chance to develop eczema,” she said.
Researchers then extended their analysis to see whether the effect of direct UV light exposure on reduced eczema would be maintained in the first 2.5 years of life, “and we could see again a significant difference, that the children who received higher UV light exposure had less eczema,” Dr. Rueter said.
Barbara Rogala, MD, PhD, professor at the Medical University of Silesia, Katowice, Poland, told this news organization that, just as in studies on vitamin D in adult populations, there must be a balance in infant studies between potential benefit of a therapeutic strategy of vitamin D and sunlight and risk of side effects. (Dr. Rogala was not involved in Dr. Rueter’s study.)
Although vitamin D supplements are a standard part of infant care, exposure to sunlight can come with cancer risk, she noted.
Dr. Rueter agreed caution is necessary.
“You have to follow the cancer guidelines,” she said. “Sunlight may play a role in causing skin cancer, and lots of research needs to be done to find the right balance between what is a good amount which may influence the immune system in a positive way and what, on the other hand, might be too much.”
As for vitamin D supplements, Dr. Rueter said, toxic levels require “extremely high doses,” so with 400 IU/day used in the study, children are likely not being overtreated by combining sunlight and vitamin D supplements.
The study was supported by grants from Telethon–New Children’s Hospital Research Fund, Australia; Asthma Foundation of Western Australia; and the Princess Margaret Hospital Foundation, Australia. Dr. Rueter and Dr. Rogala have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Trans youth in sports
Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.1 One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.
The majority of the population, and thus the majority of athletes, are cisgender.2 According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.
While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.2 In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”5 Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.6
In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.7 The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.2,5
In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.
More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”
Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.
References
1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.
2. Turban J. Scientific American. 2021 May 21.
3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.
4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.
5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.
6. Strangio C et al. ACLU News. 2020 Apr 30.
7. Strauss L. USA Today. 2021 Apr 9.
8. Darling N et al. J Leisure Res. 2005;37(1):51-76.
9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.
10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.
11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.
12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.
Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.1 One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.
The majority of the population, and thus the majority of athletes, are cisgender.2 According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.
While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.2 In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”5 Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.6
In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.7 The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.2,5
In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.
More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”
Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.
References
1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.
2. Turban J. Scientific American. 2021 May 21.
3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.
4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.
5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.
6. Strangio C et al. ACLU News. 2020 Apr 30.
7. Strauss L. USA Today. 2021 Apr 9.
8. Darling N et al. J Leisure Res. 2005;37(1):51-76.
9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.
10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.
11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.
12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.
Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.1 One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.
The majority of the population, and thus the majority of athletes, are cisgender.2 According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.
While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.2 In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”5 Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.6
In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.7 The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.2,5
In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.
More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”
Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.
Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.
References
1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.
2. Turban J. Scientific American. 2021 May 21.
3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.
4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.
5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.
6. Strangio C et al. ACLU News. 2020 Apr 30.
7. Strauss L. USA Today. 2021 Apr 9.
8. Darling N et al. J Leisure Res. 2005;37(1):51-76.
9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.
10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.
11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.
12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.