Pediatric News

Enrollment is opening for four clinical trials that will evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing today. Additional clinical trials to test at least seven more treatments are expected to launch in the coming months, officials said.

The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are in phase 2 and will test safety and effectiveness.

“The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and colead of the RECOVER Initiative. How many people have long COVID is uncertain, he told attendees at the briefing. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta.” Some estimates suggest that 5%-10% of those infected develop long COVID. “I don’t think we have solid numbers, as it’s a moving target,” Dr. Koroshetz said.

Patients with long COVID have grown increasingly frustrated at the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.

The four trials include the following:

• RECOVER-VITAL will focus on a treatment for viral persistence, which can occur if the virus lingers and causes the immune system to not work properly. One treatment will test a longer dose regimen of the antiviral Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID to halt progression to severe COVID.
• RECOVER-NEURO will target treatments for symptoms such as brain fog, memory problems, and attention challenges. Among the potential treatments are a program called BrainHQ, which provides Web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a Web-based program developed by Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to improve brain activity.
• RECOVER-SLEEP will evaluate treatments for sleep problems, which can include daytime sleepiness and other problems. According to Dr. Koroshetz, melatonin, light therapy, and an educational coaching system are among the treatments that will be studied.
• RECOVER-AUTONOMIC will evaluate treatments to address symptoms linked with problems of the autonomic nervous system. The first trial will target postural orthostatic tachycardia syndrome (POTS), which can include irregular heartbeat, fatigue, and dizziness. A treatment for immune disease and a drug currently used to treat chronic heart failure will be tested.

Timelines

The first trial, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance, which is reported by many with long COVID.

Information on how to join long COVID trials is available here.

A version of this article first appeared on Medscape.com.

Enrollment is opening for four clinical trials that will evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing today. Additional clinical trials to test at least seven more treatments are expected to launch in the coming months, officials said.

The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are in phase 2 and will test safety and effectiveness.

“The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and colead of the RECOVER Initiative. How many people have long COVID is uncertain, he told attendees at the briefing. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta.” Some estimates suggest that 5%-10% of those infected develop long COVID. “I don’t think we have solid numbers, as it’s a moving target,” Dr. Koroshetz said.

Patients with long COVID have grown increasingly frustrated at the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.

The four trials include the following:

• RECOVER-VITAL will focus on a treatment for viral persistence, which can occur if the virus lingers and causes the immune system to not work properly. One treatment will test a longer dose regimen of the antiviral Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID to halt progression to severe COVID.
• RECOVER-NEURO will target treatments for symptoms such as brain fog, memory problems, and attention challenges. Among the potential treatments are a program called BrainHQ, which provides Web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a Web-based program developed by Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to improve brain activity.
• RECOVER-SLEEP will evaluate treatments for sleep problems, which can include daytime sleepiness and other problems. According to Dr. Koroshetz, melatonin, light therapy, and an educational coaching system are among the treatments that will be studied.
• RECOVER-AUTONOMIC will evaluate treatments to address symptoms linked with problems of the autonomic nervous system. The first trial will target postural orthostatic tachycardia syndrome (POTS), which can include irregular heartbeat, fatigue, and dizziness. A treatment for immune disease and a drug currently used to treat chronic heart failure will be tested.

Timelines

The first trial, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance, which is reported by many with long COVID.

Information on how to join long COVID trials is available here.

A version of this article first appeared on Medscape.com.

Enrollment is opening for four clinical trials that will evaluate new treatments for long COVID, the National Institutes of Health announced at a media briefing today. Additional clinical trials to test at least seven more treatments are expected to launch in the coming months, officials said.

The trials are part of the NIH’s research effort known as the Researching COVID to Enhance Recovery (RECOVER) Initiative. In December 2020, Congress approved $1.15 billion for the NIH to research and test treatments for long COVID. The new clinical trials are in phase 2 and will test safety and effectiveness.

“The condition affects nearly all body systems and presents with more than 200 symptoms,” said Walter J. Koroshetz, MD, director of the NIH National Institute of Neurological Disorders and Stroke and colead of the RECOVER Initiative. How many people have long COVID is uncertain, he told attendees at the briefing. “The answer kind of depends on how you define the problem and also what variant caused it. The incidence was higher in Delta.” Some estimates suggest that 5%-10% of those infected develop long COVID. “I don’t think we have solid numbers, as it’s a moving target,” Dr. Koroshetz said.

Patients with long COVID have grown increasingly frustrated at the lack of effective treatments. Some doctors have turned to off-label use of some drugs to treat them.

The four trials include the following:

• RECOVER-VITAL will focus on a treatment for viral persistence, which can occur if the virus lingers and causes the immune system to not work properly. One treatment will test a longer dose regimen of the antiviral Paxlovid (nirmatrelvir and ritonavir), which is currently used to treat mild to moderate COVID to halt progression to severe COVID.
• RECOVER-NEURO will target treatments for symptoms such as brain fog, memory problems, and attention challenges. Among the potential treatments are a program called BrainHQ, which provides Web-based training, and PASC-Cognitive Recovery (post-acute sequelae of COVID), a Web-based program developed by Mount Sinai Health System in New York. Also being tested is a direct current stimulation program to improve brain activity.
• RECOVER-SLEEP will evaluate treatments for sleep problems, which can include daytime sleepiness and other problems. According to Dr. Koroshetz, melatonin, light therapy, and an educational coaching system are among the treatments that will be studied.
• RECOVER-AUTONOMIC will evaluate treatments to address symptoms linked with problems of the autonomic nervous system. The first trial will target postural orthostatic tachycardia syndrome (POTS), which can include irregular heartbeat, fatigue, and dizziness. A treatment for immune disease and a drug currently used to treat chronic heart failure will be tested.

Timelines

The first trial, on viral persistence, has launched, said Kanecia Zimmerman, MD, a principal investigator at the Duke Clinical Research Institute, the clinical trials data coordinating center for the trials. “We are actively working to launch the second on cognitive dysfunction.” The sleep and autonomic trials will launch in the coming months, she said. Also planned is a trial to study exercise intolerance, which is reported by many with long COVID.

Information on how to join long COVID trials is available here.

A version of this article first appeared on Medscape.com.

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

A version of this article first appeared on WebMD.com.

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

A version of this article first appeared on WebMD.com.

Most plant-based milks, such as almond or oat milk, have less calcium, vitamin D, and protein than what is found in cow’s milk, a cornerstone beverage for meeting nutritional needs, according to research from the University of Minnesota, Minneapolis. 

To make up for it, many plant-based milks are fortified with calcium and vitamin D, but most still lack the same level of protein found in cow’s milk, researchers found. The analysis included more than 200 plant-based milk alternatives, including those made from almonds, cashews, coconuts, flax, hazelnuts, hemp, oats, pistachios, rice, soy, and walnuts. The findings, which have not been published, were presented at the American Society for Nutrition’s annual conference in Boston.

“About half were fortified with vitamin D, two-thirds were fortified with calcium, and nearly 20% had protein levels similar to cow’s milk,” said lead study author Abigail Johnson, PhD, RD.

Dr. Johnson is the director of the University of Minnesota Nutrition Coordinating Center, which maintains a database of 19,000 foods for dietary research.

“I’m not seriously concerned about this, as it’s easy to get these nutrients from other sources, and cow’s milk certainly isn’t perfect and infallible,” Dr. Johnson said. “But if a consumer thinks plant-based milks are a one-to-one substitution for dairy, many of them are not.”

Consumers should read product labels and choose those that list calcium and vitamin D as ingredients, as well as consider adding other sources of calcium and vitamin D to their diets, Dr. Johnson said in a statement.

The research team plans to study plant-based milk alternatives further, such as how the products contain fiber, which cow’s milk does not. Nutrition experts explained that plant-based products have attractive features such as less fat, lower cholesterol, and higher fiber, in addition to being produced using more environmentally friendly methods, compared with cow’s milk.

Current U.S. dietary guidelines state that most plant-based milks don’t contribute to meeting recommended amounts of dairy nutrients, because their nutritional content is not similar to dairy milk or to fortified soy beverages. As many as 9 in 10 people in the U.S. don’t meet the current recommendations for dairy intake, the USDA says. An estimated 65% of U.S. children drink milk daily, and just 20% of adults drink dairy milk. Many dairy products contain high levels of added sugar, saturated fat, and sodium, the guidelines warn.

“Most individuals would benefit by increasing intake of dairy in fat-free or low-fat forms, whether from milk (including lactose-free milk), yogurt, and cheese, or from fortified soy beverages or soy yogurt,” the guidelines state. “Strategies to increase dairy intake include drinking fat-free or low-fat milk or a fortified soy beverage with meals or incorporating unsweetened fat-free or low-fat yogurt into breakfast or snacks.”

A version of this article first appeared on WebMD.com.

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

A version of this article first appeared on Medscape.com.

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

A version of this article first appeared on Medscape.com.

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

A version of this article first appeared on Medscape.com.

Children’s intelligence quotient scores are not significantly different in the first months after concussion, compared with before concussion, data suggest.

In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.

“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).

The study was published in Pediatrics.
 

A representative sample

The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.

Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.

Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).

The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”

The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”

The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”

Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”

Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
 

Graduated return

Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.

The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.

“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”

The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.

A version of this article appeared on Medscape.com.

Children’s intelligence quotient scores are not significantly different in the first months after concussion, compared with before concussion, data suggest.

In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.

“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).

The study was published in Pediatrics.
 

A representative sample

The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.

Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.

Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).

The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”

The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”

The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”

Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”

Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
 

Graduated return

Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.

The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.

“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”

The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.

A version of this article appeared on Medscape.com.

Children’s intelligence quotient scores are not significantly different in the first months after concussion, compared with before concussion, data suggest.

In a multicenter study of almost 900 children with concussion or orthopedic injury, differences between groups in full-scale IQ (Cohen’s d = 0.13) and matrix reasoning scores (d = 0.16) were small.

“We draw the inference that IQ scores are unchanged, in the sense that they’re not different from [those of] kids with other types of injuries that don’t involve the brain,” said study author Keith Owen Yeates, PhD, Ronald and Irene Ward Chair in Pediatric Brain Injury and a professor of psychology at the University of Calgary (Alta.).

The study was published in Pediatrics.
 

A representative sample

The investigators analyzed data from two prospective cohort studies of children who were treated for concussion or mild orthopedic injury at two hospitals in the United States and five in Canada. Participants were aged 8-17 years and were recruited within 24 hours of the index event. Patients in the United States completed IQ and performance validity testing at 3-18 days after injury. Patients in Canada did so at 3 months after injury. The study used the short-form IQ test. The investigators included 866 children in their analysis.

Using linear modeling, Bayesian analysis, and multigroup factor analysis, the researchers found “very small group differences” in full-scale IQ scores between the two groups. Mean IQ was 104.95 for the concussion group and 106.08 for the orthopedic-injury group. Matrix reasoning scores were 52.28 and 53.81 for the concussion and orthopedic-injury groups, respectively.

Vocabulary scores did not differ between the two groups (53.25 for the concussion group and 53.27 for the orthopedic-injury group).

The study population is “pretty representative” from a demographic perspective, although it was predominantly White, said Dr. Yeates. “On the other hand, we did look at socioeconomic status, and that didn’t seem to alter the findings at all.”

The sample size is one of the study’s strengths, said Dr. Yeates. “Having 866 kids is far larger, I think, than just about any other study out there.” Drawing from seven children’s hospitals in North America is another strength. “Previous studies, in addition to having smaller samples, were from a single site and often recruited from a clinic population, not a representative group for a general population of kids with concussion.”

The findings must be interpreted precisely, however. “We don’t have actual preinjury data, so the more precise way of describing the findings is to say they’re not different from kids who are very similar to them demographically, have the same risk factors for injuries, and had a similar experience of a traumatic injury,” said Dr. Yeates. “The IQ scores for both groups are smack dab in the average range.”

Overall, the results are encouraging. “There’s been a lot of bad news in the media and in the science about concussion that worries patients, so it’s nice to be able to provide a little bit of balance,” said Dr. Yeates. “The message I give parents is that most kids recover within 2-4 weeks, and we’re much better now at predicting who’s going to [recover] and who isn’t, and that helps, too, so that we can focus our intervention on kids who are most at risk.”

Some children will have persisting symptoms, but evidence-based treatments are lacking. “I think that’ll be a really important direction for the future,” said Dr. Yeates.
 

Graduated return

Commenting on the findings, Michael Esser, MD, a pediatric neurologist at Alberta Children’s Hospital, Calgary, and an associate professor in pediatrics at the University of Calgary, said that they can help allay parents’ concerns about concussions. “It can also be of help for clinicians who want to have evidence to reassure families and promote a graduated return to activities. In particular, the study would support the philosophy of a graduated return to school or work, after a brief period of rest, following concussion.” Dr. Esser did not participate in the study.

The research is also noteworthy because it acknowledges that the differences in the design and methodology used in prior studies may explain the apparent disagreement over how concussion may influence cognitive function.

“This is an important message,” said Dr. Esser. “Families struggle with determining the merit of a lot of information due to the myriad of social media comments about concussion and the risk for cognitive impairment. Therefore, it is important that conclusions with a significant implication are evaluated with a variety of approaches.”

The study received funding from the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Yeates disclosed relationships with the American Psychological Association, Guilford Press, and Cambridge University Press. He has received grant funding from the Canadian Institutes of Health Research, the National Institutes of Health, Brain Canada Foundation, and the National Football League Scientific Advisory Board. He also has relationships with the National Institute for Child Health and Human Development, National Institute of Neurologic Disorders and Stroke, National Pediatric Rehabilitation Resource Center, Center for Pediatric Rehabilitation, and Virginia Tech University. Dr. Esser had no relevant relationships to disclose.

A version of this article appeared on Medscape.com.

A defined exercise program significantly improved cardiometabolic health and body composition in children with overweight and obesity, but no effect was seen on mental health, based on data from 92 children.

Childhood obesity is associated with negative health outcomes including type 2 diabetes, cardiovascular disease, and mental health disorders, and exercise is considered essential to treatment, wrote Jairo H. Migueles, PhD, of the University of Granada, Spain, and colleagues. However, the effect on children with obesity and overweight of an exercise program on physical and mental health, including within-individual changes, has not been well studied, they said.

In a study published in JAMA Network Open, the researchers reviewed data from 36 girls and 56 boys with overweight or obesity who were randomized to a 20-week exercise program with aerobic and resistance elements, or waitlisted to serve as controls. The participants ranged in age from 8 to 11 years with a mean age of 10 years. The data were collected between Nov. 1, 2014, and June 30, 2016, as part of a parallel-group randomized clinical trial. The exercise program consisted of three to five 90-minute exercise sessions per week for 20 weeks, and the control children continued their usual routines.

The main cardiometabolic outcomes measured in the study were divided into three categories: body composition, physical fitness, and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure).

A cardiometabolic risk score was defined by z score. The researchers also added cardiorespiratory fitness (CRF) to the cardiometabolic risk score. Mental health was assessed using composite standardized scores for psychological well-being and poor mental health.

After 20 weeks, cardiometabolic risk scores decreased by approximately 0.38 standard deviations in the exercise group compared with the control group. In addition, specific measures of cardiometabolic health improved significantly from baseline in the exercise group compared with control children for low-density lipoprotein (change of –7.00 mg/dL), body mass index (–5.9 kg/m²), fat mass index (−0.67), and visceral adipose tissue (31.44 g).

Cardiorespiratory fitness improved by 2.75 laps in the exercise group compared with control children. In addition, significantly more children in the exercise group showed meaningful changes (defined as individual changes of at least 0.2 SDs) compared with control children in measures of fat mass index (37 vs. 17, P < .001) and CRF performance (30 vs. 17, P = .03).

However, no significant effects appeared on mental health outcomes in exercisers, the researchers noted.

The reduction in cardiometabolic score was attributable mainly to improvements in cardiovascular fitness, blood lipid levels, and total and visceral adiposity, the researchers wrote in their discussion. The lack of changes in mental health measures may be a result of the healthy mental state of the children at the study outset, they said. “The null effect on mental health outcomes needs to be further investigated, including, among other things, whether the instruments are sensitive enough to detect changes and whether there is a ceiling effect in young children who might be mentally healthy overall,” they wrote.

The findings were limited by several factors, including the relatively small sample size and lack of blinding for some evaluators. However, the results show the potential of exercise programs to affect meaningful change and improve cardiometabolic health in overweight and obese children, although more research is needed to explore the effects of larger-scale and longer-lasting public health interventions combining exercise and other health behaviors such as diet, the researchers concluded.
 

Bottom line: Exercise works

The increasing rates of overweight and obesity in children in the United States have “significant downstream consequences that include increased risk of metabolic disease, including diabetes and hypertension, as well as increased rates of anxiety and depression,” Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, said in an interview.

Therefore, the effect of interventions such as exercise training on outcomes is important, he said. 

The current study findings are “what you would hope for and expect – improvement in cardiometabolic parameters and fitness,” said Dr. Skolnik. “It was encouraging to see the effect of this relatively short duration of intervention has a clear positive effect on weight, BMI, and cardiometabolic parameters,” he said. “The real benefit, of course, comes from sustaining these habits over a long period of time.”

The lack of improvement in mental health is not surprising given the small study population “who did not have a high rate of mental health problems to begin with,” Dr. Skolnik added.

Barriers to promoting exercise programs for obese and overweight children in primary care are many, Dr. Skolnik said, including “having the motivation and funding to create programs like this so they are readily available to youth.”

However, the key message from the current study is simple and straightforward, according to Dr. Skolnik. “Exercise works! It works to improve fitness, cardiometabolic parameters, and weight control,” he said.

“There is always room for more research,” Dr. Skolnik added. The questions now are not about whether exercise benefits health; they are about figuring out how to implement the known benefits of exercise into daily living for all children, athletes and nonathletes alike, he said. “We need to find nonjudgmental ways to encourage exercise as a part of routine daily healthy living, up there with brushing teeth every day,” he emphasized.

The study was supported by grants from the Spanish Ministry of Economy and Competitiveness and El Fondo Europeo de Desarrollo Regional (FEDER) and by the MCIN (Ministerio de Ciencia e Innovación) / AEI (Agencia Estatal de Investigación. The researchers and Dr. Skolnik had no financial conflicts to disclose. Dr. Skolnik serves on the editorial advisory board of Family Practice News.

A defined exercise program significantly improved cardiometabolic health and body composition in children with overweight and obesity, but no effect was seen on mental health, based on data from 92 children.

Childhood obesity is associated with negative health outcomes including type 2 diabetes, cardiovascular disease, and mental health disorders, and exercise is considered essential to treatment, wrote Jairo H. Migueles, PhD, of the University of Granada, Spain, and colleagues. However, the effect on children with obesity and overweight of an exercise program on physical and mental health, including within-individual changes, has not been well studied, they said.

In a study published in JAMA Network Open, the researchers reviewed data from 36 girls and 56 boys with overweight or obesity who were randomized to a 20-week exercise program with aerobic and resistance elements, or waitlisted to serve as controls. The participants ranged in age from 8 to 11 years with a mean age of 10 years. The data were collected between Nov. 1, 2014, and June 30, 2016, as part of a parallel-group randomized clinical trial. The exercise program consisted of three to five 90-minute exercise sessions per week for 20 weeks, and the control children continued their usual routines.

The main cardiometabolic outcomes measured in the study were divided into three categories: body composition, physical fitness, and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure).

A cardiometabolic risk score was defined by z score. The researchers also added cardiorespiratory fitness (CRF) to the cardiometabolic risk score. Mental health was assessed using composite standardized scores for psychological well-being and poor mental health.

After 20 weeks, cardiometabolic risk scores decreased by approximately 0.38 standard deviations in the exercise group compared with the control group. In addition, specific measures of cardiometabolic health improved significantly from baseline in the exercise group compared with control children for low-density lipoprotein (change of –7.00 mg/dL), body mass index (–5.9 kg/m²), fat mass index (−0.67), and visceral adipose tissue (31.44 g).

Cardiorespiratory fitness improved by 2.75 laps in the exercise group compared with control children. In addition, significantly more children in the exercise group showed meaningful changes (defined as individual changes of at least 0.2 SDs) compared with control children in measures of fat mass index (37 vs. 17, P < .001) and CRF performance (30 vs. 17, P = .03).

However, no significant effects appeared on mental health outcomes in exercisers, the researchers noted.

The reduction in cardiometabolic score was attributable mainly to improvements in cardiovascular fitness, blood lipid levels, and total and visceral adiposity, the researchers wrote in their discussion. The lack of changes in mental health measures may be a result of the healthy mental state of the children at the study outset, they said. “The null effect on mental health outcomes needs to be further investigated, including, among other things, whether the instruments are sensitive enough to detect changes and whether there is a ceiling effect in young children who might be mentally healthy overall,” they wrote.

The findings were limited by several factors, including the relatively small sample size and lack of blinding for some evaluators. However, the results show the potential of exercise programs to affect meaningful change and improve cardiometabolic health in overweight and obese children, although more research is needed to explore the effects of larger-scale and longer-lasting public health interventions combining exercise and other health behaviors such as diet, the researchers concluded.
 

Bottom line: Exercise works

The increasing rates of overweight and obesity in children in the United States have “significant downstream consequences that include increased risk of metabolic disease, including diabetes and hypertension, as well as increased rates of anxiety and depression,” Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, said in an interview.

Therefore, the effect of interventions such as exercise training on outcomes is important, he said. 

The current study findings are “what you would hope for and expect – improvement in cardiometabolic parameters and fitness,” said Dr. Skolnik. “It was encouraging to see the effect of this relatively short duration of intervention has a clear positive effect on weight, BMI, and cardiometabolic parameters,” he said. “The real benefit, of course, comes from sustaining these habits over a long period of time.”

The lack of improvement in mental health is not surprising given the small study population “who did not have a high rate of mental health problems to begin with,” Dr. Skolnik added.

Barriers to promoting exercise programs for obese and overweight children in primary care are many, Dr. Skolnik said, including “having the motivation and funding to create programs like this so they are readily available to youth.”

However, the key message from the current study is simple and straightforward, according to Dr. Skolnik. “Exercise works! It works to improve fitness, cardiometabolic parameters, and weight control,” he said.

“There is always room for more research,” Dr. Skolnik added. The questions now are not about whether exercise benefits health; they are about figuring out how to implement the known benefits of exercise into daily living for all children, athletes and nonathletes alike, he said. “We need to find nonjudgmental ways to encourage exercise as a part of routine daily healthy living, up there with brushing teeth every day,” he emphasized.

The study was supported by grants from the Spanish Ministry of Economy and Competitiveness and El Fondo Europeo de Desarrollo Regional (FEDER) and by the MCIN (Ministerio de Ciencia e Innovación) / AEI (Agencia Estatal de Investigación. The researchers and Dr. Skolnik had no financial conflicts to disclose. Dr. Skolnik serves on the editorial advisory board of Family Practice News.

A defined exercise program significantly improved cardiometabolic health and body composition in children with overweight and obesity, but no effect was seen on mental health, based on data from 92 children.

Childhood obesity is associated with negative health outcomes including type 2 diabetes, cardiovascular disease, and mental health disorders, and exercise is considered essential to treatment, wrote Jairo H. Migueles, PhD, of the University of Granada, Spain, and colleagues. However, the effect on children with obesity and overweight of an exercise program on physical and mental health, including within-individual changes, has not been well studied, they said.

In a study published in JAMA Network Open, the researchers reviewed data from 36 girls and 56 boys with overweight or obesity who were randomized to a 20-week exercise program with aerobic and resistance elements, or waitlisted to serve as controls. The participants ranged in age from 8 to 11 years with a mean age of 10 years. The data were collected between Nov. 1, 2014, and June 30, 2016, as part of a parallel-group randomized clinical trial. The exercise program consisted of three to five 90-minute exercise sessions per week for 20 weeks, and the control children continued their usual routines.

The main cardiometabolic outcomes measured in the study were divided into three categories: body composition, physical fitness, and traditional risk factors (waist circumference, blood lipid levels, glucose levels, insulin levels, and blood pressure).

A cardiometabolic risk score was defined by z score. The researchers also added cardiorespiratory fitness (CRF) to the cardiometabolic risk score. Mental health was assessed using composite standardized scores for psychological well-being and poor mental health.

After 20 weeks, cardiometabolic risk scores decreased by approximately 0.38 standard deviations in the exercise group compared with the control group. In addition, specific measures of cardiometabolic health improved significantly from baseline in the exercise group compared with control children for low-density lipoprotein (change of –7.00 mg/dL), body mass index (–5.9 kg/m²), fat mass index (−0.67), and visceral adipose tissue (31.44 g).

Cardiorespiratory fitness improved by 2.75 laps in the exercise group compared with control children. In addition, significantly more children in the exercise group showed meaningful changes (defined as individual changes of at least 0.2 SDs) compared with control children in measures of fat mass index (37 vs. 17, P < .001) and CRF performance (30 vs. 17, P = .03).

However, no significant effects appeared on mental health outcomes in exercisers, the researchers noted.

The reduction in cardiometabolic score was attributable mainly to improvements in cardiovascular fitness, blood lipid levels, and total and visceral adiposity, the researchers wrote in their discussion. The lack of changes in mental health measures may be a result of the healthy mental state of the children at the study outset, they said. “The null effect on mental health outcomes needs to be further investigated, including, among other things, whether the instruments are sensitive enough to detect changes and whether there is a ceiling effect in young children who might be mentally healthy overall,” they wrote.

The findings were limited by several factors, including the relatively small sample size and lack of blinding for some evaluators. However, the results show the potential of exercise programs to affect meaningful change and improve cardiometabolic health in overweight and obese children, although more research is needed to explore the effects of larger-scale and longer-lasting public health interventions combining exercise and other health behaviors such as diet, the researchers concluded.
 

Bottom line: Exercise works

The increasing rates of overweight and obesity in children in the United States have “significant downstream consequences that include increased risk of metabolic disease, including diabetes and hypertension, as well as increased rates of anxiety and depression,” Neil Skolnik, MD, professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, said in an interview.

Therefore, the effect of interventions such as exercise training on outcomes is important, he said. 

The current study findings are “what you would hope for and expect – improvement in cardiometabolic parameters and fitness,” said Dr. Skolnik. “It was encouraging to see the effect of this relatively short duration of intervention has a clear positive effect on weight, BMI, and cardiometabolic parameters,” he said. “The real benefit, of course, comes from sustaining these habits over a long period of time.”

The lack of improvement in mental health is not surprising given the small study population “who did not have a high rate of mental health problems to begin with,” Dr. Skolnik added.

Barriers to promoting exercise programs for obese and overweight children in primary care are many, Dr. Skolnik said, including “having the motivation and funding to create programs like this so they are readily available to youth.”

However, the key message from the current study is simple and straightforward, according to Dr. Skolnik. “Exercise works! It works to improve fitness, cardiometabolic parameters, and weight control,” he said.

“There is always room for more research,” Dr. Skolnik added. The questions now are not about whether exercise benefits health; they are about figuring out how to implement the known benefits of exercise into daily living for all children, athletes and nonathletes alike, he said. “We need to find nonjudgmental ways to encourage exercise as a part of routine daily healthy living, up there with brushing teeth every day,” he emphasized.

The study was supported by grants from the Spanish Ministry of Economy and Competitiveness and El Fondo Europeo de Desarrollo Regional (FEDER) and by the MCIN (Ministerio de Ciencia e Innovación) / AEI (Agencia Estatal de Investigación. The researchers and Dr. Skolnik had no financial conflicts to disclose. Dr. Skolnik serves on the editorial advisory board of Family Practice News.

Despite my best efforts to cultivate acquaintances across a broader age group, my social circle still has the somewhat musty odor of septuagenarians. We try to talk about things beyond the weather and grandchildren but pain scenarios surface with unfortunate frequency. Arthritic joints ache, body parts wear out or become diseased and have to be removed or replaced. That stuff can hurt.

There are two pain-related themes that seem to crop up more frequently than you might expect. The first is the unfortunate side effects of opioid medication – most often gastric distress and vomiting, then of course there’s constipation. They seem so common that a good many of my acquaintances just plain refuse to take opioids when they have been prescribed postoperatively because of their vivid memories of the consequences or horror stories friends have told.

The second theme is the general annoyance with the damn “Please rate your pain from one to ten” request issued by every well-intentioned nurse. Do you mean the pain I am having right now, this second, or last night, or the average over the last day and a half? Or should I be comparing it with when I gave birth 70 years ago, or when I stubbed my toe getting out of the shower last week? And then what are you going to do with my guesstimated number?

It may surprise some of you that 40 years ago there wasn’t a pain scale fetish. But a few observant health care professionals realized that many of our patients were suffering because we weren’t adequately managing their pain. In postoperative situations this was slowing recovery and effecting outcomes. Like good pseudoscientists, they realized that we should first quantify the pain and the notion that no pain should go unrated came into being. Nor should pain go untreated, which is too frequently interpreted as meaning unmedicated.

Pain is a complex, multifaceted phenomenon. Distilling a person’s pain experience to a single number doesn’t make sense, nor does reflexly reaching for a prescription.

For example a systematic review of 61 studies of juvenile idiopathic arthritis (JIA) published in the journal Pediatric Rheumatology found that there was positive relationship between pain and a child’s belief that pain causes harm, disability, and lack of control. Not surprisingly, stress was also associated with pain intensity.

It is a long paper and touches on numerous other associations of varying degrees of strength between parental, social, and other external factors. But, in general, they were not as consistent as those related to a child’s beliefs.

Before, or at least at the same time, we treat a patient’s pain, we should learn more about that patient – his or her concerns, beliefs, and stressors. You and I may have exactly the same hernia operation, but if you have a better understanding of why you are going to feel uncomfortable after the surgery, and understand that not every pain is the result of a complication, I suspect you are more likely to complain of less pain.

The recent JIA study doesn’t claim to suggest therapeutic methods. However, one wonders what the result would be if we could somehow alter a patient’s belief system so that he or she no longer sees pain as always harmful, nor does the patient see himself or herself as powerless to do anything about the pain. To do this experiment we must follow up our robotic request to “rate your pain” with a dialogue in which we learn more about the patient. Which means probing believes, fears, and stressors.

You can tell me this exercise would be unrealistic and time consuming. But I bet in the long run it will save time. Even if it doesn’t it is the better way to manage pain.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Despite my best efforts to cultivate acquaintances across a broader age group, my social circle still has the somewhat musty odor of septuagenarians. We try to talk about things beyond the weather and grandchildren but pain scenarios surface with unfortunate frequency. Arthritic joints ache, body parts wear out or become diseased and have to be removed or replaced. That stuff can hurt.

There are two pain-related themes that seem to crop up more frequently than you might expect. The first is the unfortunate side effects of opioid medication – most often gastric distress and vomiting, then of course there’s constipation. They seem so common that a good many of my acquaintances just plain refuse to take opioids when they have been prescribed postoperatively because of their vivid memories of the consequences or horror stories friends have told.

The second theme is the general annoyance with the damn “Please rate your pain from one to ten” request issued by every well-intentioned nurse. Do you mean the pain I am having right now, this second, or last night, or the average over the last day and a half? Or should I be comparing it with when I gave birth 70 years ago, or when I stubbed my toe getting out of the shower last week? And then what are you going to do with my guesstimated number?

It may surprise some of you that 40 years ago there wasn’t a pain scale fetish. But a few observant health care professionals realized that many of our patients were suffering because we weren’t adequately managing their pain. In postoperative situations this was slowing recovery and effecting outcomes. Like good pseudoscientists, they realized that we should first quantify the pain and the notion that no pain should go unrated came into being. Nor should pain go untreated, which is too frequently interpreted as meaning unmedicated.

Pain is a complex, multifaceted phenomenon. Distilling a person’s pain experience to a single number doesn’t make sense, nor does reflexly reaching for a prescription.

For example a systematic review of 61 studies of juvenile idiopathic arthritis (JIA) published in the journal Pediatric Rheumatology found that there was positive relationship between pain and a child’s belief that pain causes harm, disability, and lack of control. Not surprisingly, stress was also associated with pain intensity.

It is a long paper and touches on numerous other associations of varying degrees of strength between parental, social, and other external factors. But, in general, they were not as consistent as those related to a child’s beliefs.

Before, or at least at the same time, we treat a patient’s pain, we should learn more about that patient – his or her concerns, beliefs, and stressors. You and I may have exactly the same hernia operation, but if you have a better understanding of why you are going to feel uncomfortable after the surgery, and understand that not every pain is the result of a complication, I suspect you are more likely to complain of less pain.

The recent JIA study doesn’t claim to suggest therapeutic methods. However, one wonders what the result would be if we could somehow alter a patient’s belief system so that he or she no longer sees pain as always harmful, nor does the patient see himself or herself as powerless to do anything about the pain. To do this experiment we must follow up our robotic request to “rate your pain” with a dialogue in which we learn more about the patient. Which means probing believes, fears, and stressors.

You can tell me this exercise would be unrealistic and time consuming. But I bet in the long run it will save time. Even if it doesn’t it is the better way to manage pain.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Despite my best efforts to cultivate acquaintances across a broader age group, my social circle still has the somewhat musty odor of septuagenarians. We try to talk about things beyond the weather and grandchildren but pain scenarios surface with unfortunate frequency. Arthritic joints ache, body parts wear out or become diseased and have to be removed or replaced. That stuff can hurt.

There are two pain-related themes that seem to crop up more frequently than you might expect. The first is the unfortunate side effects of opioid medication – most often gastric distress and vomiting, then of course there’s constipation. They seem so common that a good many of my acquaintances just plain refuse to take opioids when they have been prescribed postoperatively because of their vivid memories of the consequences or horror stories friends have told.

The second theme is the general annoyance with the damn “Please rate your pain from one to ten” request issued by every well-intentioned nurse. Do you mean the pain I am having right now, this second, or last night, or the average over the last day and a half? Or should I be comparing it with when I gave birth 70 years ago, or when I stubbed my toe getting out of the shower last week? And then what are you going to do with my guesstimated number?

It may surprise some of you that 40 years ago there wasn’t a pain scale fetish. But a few observant health care professionals realized that many of our patients were suffering because we weren’t adequately managing their pain. In postoperative situations this was slowing recovery and effecting outcomes. Like good pseudoscientists, they realized that we should first quantify the pain and the notion that no pain should go unrated came into being. Nor should pain go untreated, which is too frequently interpreted as meaning unmedicated.

Pain is a complex, multifaceted phenomenon. Distilling a person’s pain experience to a single number doesn’t make sense, nor does reflexly reaching for a prescription.

For example a systematic review of 61 studies of juvenile idiopathic arthritis (JIA) published in the journal Pediatric Rheumatology found that there was positive relationship between pain and a child’s belief that pain causes harm, disability, and lack of control. Not surprisingly, stress was also associated with pain intensity.

It is a long paper and touches on numerous other associations of varying degrees of strength between parental, social, and other external factors. But, in general, they were not as consistent as those related to a child’s beliefs.

Before, or at least at the same time, we treat a patient’s pain, we should learn more about that patient – his or her concerns, beliefs, and stressors. You and I may have exactly the same hernia operation, but if you have a better understanding of why you are going to feel uncomfortable after the surgery, and understand that not every pain is the result of a complication, I suspect you are more likely to complain of less pain.

The recent JIA study doesn’t claim to suggest therapeutic methods. However, one wonders what the result would be if we could somehow alter a patient’s belief system so that he or she no longer sees pain as always harmful, nor does the patient see himself or herself as powerless to do anything about the pain. To do this experiment we must follow up our robotic request to “rate your pain” with a dialogue in which we learn more about the patient. Which means probing believes, fears, and stressors.

You can tell me this exercise would be unrealistic and time consuming. But I bet in the long run it will save time. Even if it doesn’t it is the better way to manage pain.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

Optimism about new opportunities to treat alopecia areata can be derived not only from a recently approved Janus kinase (JAK) inhibitor in older children but promising results with the monoclonal antibody dupilumab alone or in combination with additional treatments, such as minoxidil or corticosteroids, in children with AA and concomitant atopy.

It was only a little over a year ago that the JAK inhibitor baricitinib became the first systemic therapy approved by the Food and Drug Administration for AA in adults. In June 2023, the JAK inhibitor ritlecitinib was approved for severe AA in patients as young as 12 years of age, but there is accumulating evidence that dupilumab, which binds to the interleukin-4 receptor, might be an option for even younger children with AA.

Of those who have worked with dupilumab for controlling AA in children, Brittany Craiglow, MD, an adjunct associate professor of dermatology at Yale University, New Haven, Conn., updated a case series at the recent MedscapeLive! Annual Women’s and Pediatric Dermatology Seminar in Baltimore. A series of six children with AA treated with dupilumab was published 2 years ago in JAAD Case Reports.

Even in 2021, her case series was not the first report of benefit from dupilumab in children with AA, but instead contributed to a “growing body of literature” supporting the potential benefit in the setting of concomitant atopy, Dr. Craiglow, one of the authors of the series, said in an interview.

Of the six patients in that series, five had improvement and four had complete regrowth with dupilumab, whether as a monotherapy or in combination with other agents. The children ranged in age from 7 to 12 years. The age range at the time of AA onset was 3-11 years. All had atopic dermatitis (AD) and most had additional atopic conditions, such as food allergies or asthma.

Since publication, Dr. Craiglow has successfully treated many more patients with dupilumab, either as monotherapy or in combination with oral minoxidil, corticosteroids, and/or a topical JAK inhibitor. Dupilumab, which is approved for the treatment of AD in children as young as 6 months of age, has been well tolerated.

“Oral minoxidil is often a great adjuvant treatment in patients with AA and should be used unless there are contraindications,” based on the initial and subsequent experience treating AA with dupilumab, said Dr. Craiglow.

“Topical steroids can be used in combination with dupilumab and minoxidil, but in general dupilumab should not be combined with an oral JAK inhibitor,” she added.

Now, with the approval of ritlecitinib, Dr. Craiglow said this JAK inhibitor will become a first-line therapy in children 12 years or older with severe, persistent AA, but she considers a trial of dupilumab reasonable in younger children, given the controlled studies of safety for atopic diseases.

“I would say that dupilumab could be considered in the following clinical scenarios: children under 12 with AA and concomitant atopy, such as atopic dermatitis, asthma, allergies, and/or elevated IgE; and children over the age of 12 with concomitant atopy who either have a contraindication to a JAK inhibitor or whose families have reservations about or are unwilling to take one,” Dr. Craiglow said.

In older children, she believes that dupilumab has “a much lower chance of being effective” than an oral JAK inhibitor like ritlecitinib, but it circumvents the potential safety issues of JAK inhibitors that have been observed in adults.

With ritlecitinib providing an on-label option for AA in older children, Dr. Craiglow suggested it might be easier to obtain third-party coverage for dupilumab as an alternative to a JAK inhibitor for AA in patients younger than 12, particularly when there is an indication for a concomitant atopic condition and a rationale, such as a concern about relative safety.

Two years ago, when Dr. Craiglow and her coinvestigator published their six-patient case series, a second case series was published about the same time by investigators at the University of Pennsylvania, Philadelphia, in the Journal of the American Academy of Dermatology. This series of 16 pediatric patients with AA on dupilumab was more heterogeneous, but four of six patients with active disease and more than 4 months of follow-up had improvement in AA, including total regrowth. The improvement was concentrated in patients with moderate to severe AD at the time of treatment.

Based on this series, the authors, led by Leslie Castelo-Soccio, MD, PhD, who is now an attending physician in the Dermatology Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Bethesda, Md., concluded that dupilumab “may be a therapeutic option for AA” when traditional therapies have failed, “especially in patients with concurrent AD or asthma, for which the benefits of dupilumab are clear.”

When contacted about where this therapy might fit on the basis of her case series and the update on Dr. Craiglow’s experience, Dr. Castelo-Soccio, like Dr. Craiglow, stressed the importance of employing this therapy selectively.

“I do think that dupilumab is a reasonable option for AA in children with atopy and IgE levels greater than 200 IU/mL, especially if treatment is for atopic dermatitis or asthma as well,” she said.

Many clinicians, including Dr. Craiglow, have experience with oral JAK inhibitors in children younger than 12. Indeed, a recently published case study associated oral abrocitinib, a JAK inhibitor approved for moderate to severe AD in patients ages 12 and older, with hair regrowth in an 11-year-old child who had persistent AA for more than 6 years despite numerous conventional therapies.

However, the advantage of dupilumab in younger children is the greater evidence of safety, providing a level of reassurance for a treatment that is commonly used for severe atopic diseases but does not have a specific indication for AA, according to Dr. Craiglow.

Dr. Craiglow disclosed being a speaker for AbbVie and a speaker and consultant for Eli Lilly, Incyte, Pfizer, Regeneron, and Sanofi Genzyme. Dr. Castelo-Soccio had no disclosures.

An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 in a room with an infected person within 5 minutes.

The project was a collaboration among researchers from the university’s engineering and medical schools; the results were published in Nature Communications.

One of the challenges the team had to overcome is that detecting the virus in a roomful of air “is like finding a needle in a haystack,” researcher and associate engineering professor Rajan Chakrabarty, PhD, said in a statement.

The team overcame that challenge using a technology called wet cyclone that samples the equivalent of 176 cubic feet of air in 5 minutes. A light on the device turns from green to red when the virus is detected, which the researchers said indicates that increased air circulation is needed. 

The device stands just 10 inches tall and 1 foot wide and is considered a proof of concept. The next step would be to implement the technology into a prototype to see how a commercial or household design could be achieved. The researchers foresee potential for the device to be used in hospitals and schools, as well as to be able to detect other respiratory viruses such as influenza and respiratory syncytial virus.

Current methods used for detecting viruses in the air take between 1 and 24 hours to collect and analyze samples. The existing methods usually require skilled labor, resulting in a process that doesn’t allow for real-time information that could translate into reducing risk or the spread of the virus, the researchers wrote.

The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID positive.

“There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, PhD, said in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real time, or every 5 minutes, if there is a live virus in the air.”

Their goal is to develop a commercially available air quality monitor, the researchers said. 

The study authors reported that they had no conflicts of interest.

A version of this article appeared on WebMD.com.

An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 in a room with an infected person within 5 minutes.

The project was a collaboration among researchers from the university’s engineering and medical schools; the results were published in Nature Communications.

One of the challenges the team had to overcome is that detecting the virus in a roomful of air “is like finding a needle in a haystack,” researcher and associate engineering professor Rajan Chakrabarty, PhD, said in a statement.

The team overcame that challenge using a technology called wet cyclone that samples the equivalent of 176 cubic feet of air in 5 minutes. A light on the device turns from green to red when the virus is detected, which the researchers said indicates that increased air circulation is needed. 

The device stands just 10 inches tall and 1 foot wide and is considered a proof of concept. The next step would be to implement the technology into a prototype to see how a commercial or household design could be achieved. The researchers foresee potential for the device to be used in hospitals and schools, as well as to be able to detect other respiratory viruses such as influenza and respiratory syncytial virus.

Current methods used for detecting viruses in the air take between 1 and 24 hours to collect and analyze samples. The existing methods usually require skilled labor, resulting in a process that doesn’t allow for real-time information that could translate into reducing risk or the spread of the virus, the researchers wrote.

The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID positive.

“There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, PhD, said in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real time, or every 5 minutes, if there is a live virus in the air.”

Their goal is to develop a commercially available air quality monitor, the researchers said. 

The study authors reported that they had no conflicts of interest.

A version of this article appeared on WebMD.com.

An air monitor made by researchers at Washington University in St. Louis can detect COVID-19 in a room with an infected person within 5 minutes.

The project was a collaboration among researchers from the university’s engineering and medical schools; the results were published in Nature Communications.

One of the challenges the team had to overcome is that detecting the virus in a roomful of air “is like finding a needle in a haystack,” researcher and associate engineering professor Rajan Chakrabarty, PhD, said in a statement.

The team overcame that challenge using a technology called wet cyclone that samples the equivalent of 176 cubic feet of air in 5 minutes. A light on the device turns from green to red when the virus is detected, which the researchers said indicates that increased air circulation is needed. 

The device stands just 10 inches tall and 1 foot wide and is considered a proof of concept. The next step would be to implement the technology into a prototype to see how a commercial or household design could be achieved. The researchers foresee potential for the device to be used in hospitals and schools, as well as to be able to detect other respiratory viruses such as influenza and respiratory syncytial virus.

Current methods used for detecting viruses in the air take between 1 and 24 hours to collect and analyze samples. The existing methods usually require skilled labor, resulting in a process that doesn’t allow for real-time information that could translate into reducing risk or the spread of the virus, the researchers wrote.

The team tested their device both in laboratory experiments where they released aerosolized SARS-CoV-2 into a room-sized chamber, as well as in the apartments of two people who were COVID positive.

“There is nothing at the moment that tells us how safe a room is,” Washington University neurology professor John Cirrito, PhD, said in a statement. “If you are in a room with 100 people, you don’t want to find out 5 days later whether you could be sick or not. The idea with this device is that you can know essentially in real time, or every 5 minutes, if there is a live virus in the air.”

Their goal is to develop a commercially available air quality monitor, the researchers said. 

The study authors reported that they had no conflicts of interest.

A version of this article appeared on WebMD.com.

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

A version of this article first appeared on Medscape.com.

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

A version of this article first appeared on Medscape.com.

A new practice guideline is setting a standard for doctors who use lasers to treat cutaneous vascular anomalies.

Poor treatment has been an issue in this field because no uniform guidelines existed to inform practice, according to a press release from the American Society for Laser Medicine and Surgery.

The laser treatment settings can vary based on the type and location of the birthmark and also the patient’s skin type, which has resulted in an inconsistent approach from clinicians, according to the release.

“For decades, I have observed adverse outcomes from the improper laser treatment of vascular birthmarks,” Linda Rozell-Shannon, PhD, president and founder of the Vascular Birthmarks Foundation said in a statement from ASLMS. “As a result of these guidelines, patient outcomes will be improved.”

The guideline, published on the ASLMS website along with supporting videos, was jointly developed by ASLMS, VBF, and an international group of clinicians, marking the first consensus guideline on laser treatments for cutaneous vascular anomalies. It details 32 best practice directives for various scenarios, including advice on safety considerations, additional testing, and when to refer.

“It is important to realize that just because someone is board certified does not mean they are skilled in treating all conditions or using all lasers,” Paul Friedman, MD, a dermatologist in Houston, and former president of ASLMS, said in the ASLMS statement.

Vascular birthmarks are a common condition affecting up to 14% of children, according to VBF. Most are hemangiomas, a buildup of blood vessels that usually appears at birth or within a month after birth. Laser therapy reduces the size and color of the anomalies.

Support for this initiative was provided by Candela Medical.

A version of this article first appeared on Medscape.com.

ASHEVILLE, N.C. – Epidermolysis bullosa (EB), a heterogeneous congenital condition of skin fragility, received its first U.S. Food and Drug Association–approved gene therapy only a few months ago, but accelerated progress across multiple treatment strategies predicts additional important and perhaps dramatic further progress, according to a prominent EB researcher.

Not only are recent developments in EB “exciting,” the progress on multiple fronts for control of disease or its symptoms suggests “we are on the cusp of a new era,” Jemima Mellerio, BSc, MD, a consultant dermatologist, St. John’s Institute of Dermatology, London, said at the annual meeting of the Society for Pediatric Dermatology.

Published clinical studies of cell therapies and gene therapies date back at least 15 years, according to a review by Dr. Mellerio on why developments are starting to move so quickly. The difference now is that many obstacles to routine use of these options are being resolved so that viable strategies have reached or are reaching phase 3 trials.

In addition to cell therapies and gene therapies, Dr. Mellerio discussed progress in three additional areas: gene editing, protein therapy, and drug repurposing.

Summarizing progress in each, she described improvement in levels of collagen VII, an important deficit in most types of EB, that were achieved with fibroblast injections that improved levels of collagen VII and anchoring fibrils in a study published in the Journal of Investigative Dermatology. Injection of mesenchymal stromal cells (MSC) have been associated with reduced pain and itch in a series of studies, one of the earliest of which was published in the New England Journal of Medicine.

Since that time, there have been several approaches using MSC.

Of these approaches, intravenous injection of ABCB5+ MSCs might be the first to gain regulatory approval. According to Dr. Mellerio, there is an ongoing phase 3 crossover trial evaluating this approach, which followed several earlier phase studies that demonstrated adequate safety and tolerability while reducing severity scores, relieving pain and itch, and improving wound closure in patients with EB.

In 2006, correction of junctional EB (JEB) was achieved by transplantation of genetically modified epidermal cells to replace the LAMB3 gene, thereby restoring production of laminin 332, which is an essential component of the dermal-epidermal junction, according to Dr. Mellerio, citing a study in Nature Medicine.

The next attempt with this approach did not take place until 2015, resurrected to save the life of a 7-year-old Syrian boy – to generate epidermal sheets that eventually covered 80% of his body. The success is supporting further work on this approach but has also been an inspiration to other gene therapies, including a topical gene therapy recently approved in the United States.

Topically applied beremagene geperpavec (Vyjuvek, formerly known as B-VEC) was approved by the FDA in May for treating wounds in patients 6 months of age and older, with recessive or dominant dystrophic EB, on the basis of a phase 3 trial published in the New England Journal of Medicine, but others are coming. Dr. Mellerio also described a recently completed phase 3 trial with introduction of ex vivo gene-corrected keratinocytes, which has been associated with long-term improvements among patients with recessive dystrophic EB (RDEB). The responses in early phase studies included wound healing and reduction in pain and itch.

Perhaps less advanced but still promising, protein therapy, gene editing, and repurposing of existing therapies are all approaches that are moving forward. Many are supported by at least some clinical data, according to Dr. Mellerio.

As an example of protein therapy, a completed phase I/II trial associated recombinant human collagen with wound healing and pain reduction in RDEB. This study provided proof of principle for a therapy that could be applied topically or intravenously. Further development is anticipated.

Multiple platforms for gene editing have been described with the goal of simply excising pathogenic mutations or antisense oligonucleotides for sustained or permanent control of EB expression. Clinical evidence is limited, but Dr. Mellerio suggested that the theoretical potential for eliminating the source of abnormal transcription is the restoration of functional proteins essential for reversing skin fragility.

In some cases, existing drugs have the same potential. Dr. Mellerio described efforts to use an aminoglycoside to circumvent nonsense mutations that produce messenger RNA decay and impaired production of the proteins that prevent EB. In a pilot study evaluating topical gentamicin in RDEB, there were substantial improvements at 1 month and 3 months in several measures of skin fragility and encouraged studies that are now ongoing in both RDEB and JEB.

More than promising, a multinational randomized phase 3 study with birch bark extract recently published in the British Journal of Dermatology, associated treatment with this topical gel, known as Oleogel-S10, with higher rates of complete wound closure at 45 days (41.3% vs. 28.9% in the control vehicle arm) and a low risk of adverse events.

“This therapy is now approved in Europe and the United Kingdom, although, unfortunately, it is not yet available in the United States,” Dr. Mellerio noted.

Importantly, none of these therapies are necessarily effective across subtypes of EB, which often have different underlying pathogenic mechanisms, she said. However, the growing sophistication with which the pathophysiology of these subtypes is understood makes the numerous treatments in the pipeline “exciting.”

“We are at a point where we can really start to think of personalized medicine in EB,” Dr. Mellerio said. With the clinical advances already available and those expected, she suggested the recently approved treatment options are just the beginning. She expects the treatment landscape to evolve quickly over the next few years.

This does not appear to be a personal opinion. Another prominent researcher in EB, M. Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics at Stanford (Calif.) University, is seeing the same real-world promise of therapies that have been in gestation for a decade or more.

“Dr. Mellerio is right. This is an exciting time for EB patients,” Dr. Marinkovich said in an interview. While the approval of B-VEC, the first gene therapy for EB, is the proof, Dr. Marinkovich, the lead author of the NEJM paper on B-VEC, noted that “many other potential EB therapies are being studied right now.” Based on promise in earlier clinical studies with many of these agents, he, like Dr. Mellerio, expects progress in real-world treatments for EB to accelerate.

Dr. Mellerio reported financial relationships with Amryt Pharma and Krystal Biotech. Dr. Marinkovich receives research support from Abeona Therapeutics, Castle Creek Pharmaceuticals, Krystal Biotech, Phoenix Tissue Repair, and WINGS Therapeutics.

A version of this article first appeared on Medscape.com.

ASHEVILLE, N.C. – Epidermolysis bullosa (EB), a heterogeneous congenital condition of skin fragility, received its first U.S. Food and Drug Association–approved gene therapy only a few months ago, but accelerated progress across multiple treatment strategies predicts additional important and perhaps dramatic further progress, according to a prominent EB researcher.

Not only are recent developments in EB “exciting,” the progress on multiple fronts for control of disease or its symptoms suggests “we are on the cusp of a new era,” Jemima Mellerio, BSc, MD, a consultant dermatologist, St. John’s Institute of Dermatology, London, said at the annual meeting of the Society for Pediatric Dermatology.

Published clinical studies of cell therapies and gene therapies date back at least 15 years, according to a review by Dr. Mellerio on why developments are starting to move so quickly. The difference now is that many obstacles to routine use of these options are being resolved so that viable strategies have reached or are reaching phase 3 trials.

In addition to cell therapies and gene therapies, Dr. Mellerio discussed progress in three additional areas: gene editing, protein therapy, and drug repurposing.

Summarizing progress in each, she described improvement in levels of collagen VII, an important deficit in most types of EB, that were achieved with fibroblast injections that improved levels of collagen VII and anchoring fibrils in a study published in the Journal of Investigative Dermatology. Injection of mesenchymal stromal cells (MSC) have been associated with reduced pain and itch in a series of studies, one of the earliest of which was published in the New England Journal of Medicine.

Since that time, there have been several approaches using MSC.

Of these approaches, intravenous injection of ABCB5+ MSCs might be the first to gain regulatory approval. According to Dr. Mellerio, there is an ongoing phase 3 crossover trial evaluating this approach, which followed several earlier phase studies that demonstrated adequate safety and tolerability while reducing severity scores, relieving pain and itch, and improving wound closure in patients with EB.

In 2006, correction of junctional EB (JEB) was achieved by transplantation of genetically modified epidermal cells to replace the LAMB3 gene, thereby restoring production of laminin 332, which is an essential component of the dermal-epidermal junction, according to Dr. Mellerio, citing a study in Nature Medicine.

The next attempt with this approach did not take place until 2015, resurrected to save the life of a 7-year-old Syrian boy – to generate epidermal sheets that eventually covered 80% of his body. The success is supporting further work on this approach but has also been an inspiration to other gene therapies, including a topical gene therapy recently approved in the United States.

Topically applied beremagene geperpavec (Vyjuvek, formerly known as B-VEC) was approved by the FDA in May for treating wounds in patients 6 months of age and older, with recessive or dominant dystrophic EB, on the basis of a phase 3 trial published in the New England Journal of Medicine, but others are coming. Dr. Mellerio also described a recently completed phase 3 trial with introduction of ex vivo gene-corrected keratinocytes, which has been associated with long-term improvements among patients with recessive dystrophic EB (RDEB). The responses in early phase studies included wound healing and reduction in pain and itch.

Perhaps less advanced but still promising, protein therapy, gene editing, and repurposing of existing therapies are all approaches that are moving forward. Many are supported by at least some clinical data, according to Dr. Mellerio.

As an example of protein therapy, a completed phase I/II trial associated recombinant human collagen with wound healing and pain reduction in RDEB. This study provided proof of principle for a therapy that could be applied topically or intravenously. Further development is anticipated.

Multiple platforms for gene editing have been described with the goal of simply excising pathogenic mutations or antisense oligonucleotides for sustained or permanent control of EB expression. Clinical evidence is limited, but Dr. Mellerio suggested that the theoretical potential for eliminating the source of abnormal transcription is the restoration of functional proteins essential for reversing skin fragility.

In some cases, existing drugs have the same potential. Dr. Mellerio described efforts to use an aminoglycoside to circumvent nonsense mutations that produce messenger RNA decay and impaired production of the proteins that prevent EB. In a pilot study evaluating topical gentamicin in RDEB, there were substantial improvements at 1 month and 3 months in several measures of skin fragility and encouraged studies that are now ongoing in both RDEB and JEB.

More than promising, a multinational randomized phase 3 study with birch bark extract recently published in the British Journal of Dermatology, associated treatment with this topical gel, known as Oleogel-S10, with higher rates of complete wound closure at 45 days (41.3% vs. 28.9% in the control vehicle arm) and a low risk of adverse events.

“This therapy is now approved in Europe and the United Kingdom, although, unfortunately, it is not yet available in the United States,” Dr. Mellerio noted.

Importantly, none of these therapies are necessarily effective across subtypes of EB, which often have different underlying pathogenic mechanisms, she said. However, the growing sophistication with which the pathophysiology of these subtypes is understood makes the numerous treatments in the pipeline “exciting.”

“We are at a point where we can really start to think of personalized medicine in EB,” Dr. Mellerio said. With the clinical advances already available and those expected, she suggested the recently approved treatment options are just the beginning. She expects the treatment landscape to evolve quickly over the next few years.

This does not appear to be a personal opinion. Another prominent researcher in EB, M. Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics at Stanford (Calif.) University, is seeing the same real-world promise of therapies that have been in gestation for a decade or more.

“Dr. Mellerio is right. This is an exciting time for EB patients,” Dr. Marinkovich said in an interview. While the approval of B-VEC, the first gene therapy for EB, is the proof, Dr. Marinkovich, the lead author of the NEJM paper on B-VEC, noted that “many other potential EB therapies are being studied right now.” Based on promise in earlier clinical studies with many of these agents, he, like Dr. Mellerio, expects progress in real-world treatments for EB to accelerate.

Dr. Mellerio reported financial relationships with Amryt Pharma and Krystal Biotech. Dr. Marinkovich receives research support from Abeona Therapeutics, Castle Creek Pharmaceuticals, Krystal Biotech, Phoenix Tissue Repair, and WINGS Therapeutics.

A version of this article first appeared on Medscape.com.

ASHEVILLE, N.C. – Epidermolysis bullosa (EB), a heterogeneous congenital condition of skin fragility, received its first U.S. Food and Drug Association–approved gene therapy only a few months ago, but accelerated progress across multiple treatment strategies predicts additional important and perhaps dramatic further progress, according to a prominent EB researcher.

Not only are recent developments in EB “exciting,” the progress on multiple fronts for control of disease or its symptoms suggests “we are on the cusp of a new era,” Jemima Mellerio, BSc, MD, a consultant dermatologist, St. John’s Institute of Dermatology, London, said at the annual meeting of the Society for Pediatric Dermatology.

Published clinical studies of cell therapies and gene therapies date back at least 15 years, according to a review by Dr. Mellerio on why developments are starting to move so quickly. The difference now is that many obstacles to routine use of these options are being resolved so that viable strategies have reached or are reaching phase 3 trials.

In addition to cell therapies and gene therapies, Dr. Mellerio discussed progress in three additional areas: gene editing, protein therapy, and drug repurposing.

Summarizing progress in each, she described improvement in levels of collagen VII, an important deficit in most types of EB, that were achieved with fibroblast injections that improved levels of collagen VII and anchoring fibrils in a study published in the Journal of Investigative Dermatology. Injection of mesenchymal stromal cells (MSC) have been associated with reduced pain and itch in a series of studies, one of the earliest of which was published in the New England Journal of Medicine.

Since that time, there have been several approaches using MSC.

Of these approaches, intravenous injection of ABCB5+ MSCs might be the first to gain regulatory approval. According to Dr. Mellerio, there is an ongoing phase 3 crossover trial evaluating this approach, which followed several earlier phase studies that demonstrated adequate safety and tolerability while reducing severity scores, relieving pain and itch, and improving wound closure in patients with EB.

In 2006, correction of junctional EB (JEB) was achieved by transplantation of genetically modified epidermal cells to replace the LAMB3 gene, thereby restoring production of laminin 332, which is an essential component of the dermal-epidermal junction, according to Dr. Mellerio, citing a study in Nature Medicine.

The next attempt with this approach did not take place until 2015, resurrected to save the life of a 7-year-old Syrian boy – to generate epidermal sheets that eventually covered 80% of his body. The success is supporting further work on this approach but has also been an inspiration to other gene therapies, including a topical gene therapy recently approved in the United States.

Topically applied beremagene geperpavec (Vyjuvek, formerly known as B-VEC) was approved by the FDA in May for treating wounds in patients 6 months of age and older, with recessive or dominant dystrophic EB, on the basis of a phase 3 trial published in the New England Journal of Medicine, but others are coming. Dr. Mellerio also described a recently completed phase 3 trial with introduction of ex vivo gene-corrected keratinocytes, which has been associated with long-term improvements among patients with recessive dystrophic EB (RDEB). The responses in early phase studies included wound healing and reduction in pain and itch.

Perhaps less advanced but still promising, protein therapy, gene editing, and repurposing of existing therapies are all approaches that are moving forward. Many are supported by at least some clinical data, according to Dr. Mellerio.

As an example of protein therapy, a completed phase I/II trial associated recombinant human collagen with wound healing and pain reduction in RDEB. This study provided proof of principle for a therapy that could be applied topically or intravenously. Further development is anticipated.

Multiple platforms for gene editing have been described with the goal of simply excising pathogenic mutations or antisense oligonucleotides for sustained or permanent control of EB expression. Clinical evidence is limited, but Dr. Mellerio suggested that the theoretical potential for eliminating the source of abnormal transcription is the restoration of functional proteins essential for reversing skin fragility.

In some cases, existing drugs have the same potential. Dr. Mellerio described efforts to use an aminoglycoside to circumvent nonsense mutations that produce messenger RNA decay and impaired production of the proteins that prevent EB. In a pilot study evaluating topical gentamicin in RDEB, there were substantial improvements at 1 month and 3 months in several measures of skin fragility and encouraged studies that are now ongoing in both RDEB and JEB.

More than promising, a multinational randomized phase 3 study with birch bark extract recently published in the British Journal of Dermatology, associated treatment with this topical gel, known as Oleogel-S10, with higher rates of complete wound closure at 45 days (41.3% vs. 28.9% in the control vehicle arm) and a low risk of adverse events.

“This therapy is now approved in Europe and the United Kingdom, although, unfortunately, it is not yet available in the United States,” Dr. Mellerio noted.

Importantly, none of these therapies are necessarily effective across subtypes of EB, which often have different underlying pathogenic mechanisms, she said. However, the growing sophistication with which the pathophysiology of these subtypes is understood makes the numerous treatments in the pipeline “exciting.”

“We are at a point where we can really start to think of personalized medicine in EB,” Dr. Mellerio said. With the clinical advances already available and those expected, she suggested the recently approved treatment options are just the beginning. She expects the treatment landscape to evolve quickly over the next few years.

This does not appear to be a personal opinion. Another prominent researcher in EB, M. Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics at Stanford (Calif.) University, is seeing the same real-world promise of therapies that have been in gestation for a decade or more.

“Dr. Mellerio is right. This is an exciting time for EB patients,” Dr. Marinkovich said in an interview. While the approval of B-VEC, the first gene therapy for EB, is the proof, Dr. Marinkovich, the lead author of the NEJM paper on B-VEC, noted that “many other potential EB therapies are being studied right now.” Based on promise in earlier clinical studies with many of these agents, he, like Dr. Mellerio, expects progress in real-world treatments for EB to accelerate.

Dr. Mellerio reported financial relationships with Amryt Pharma and Krystal Biotech. Dr. Marinkovich receives research support from Abeona Therapeutics, Castle Creek Pharmaceuticals, Krystal Biotech, Phoenix Tissue Repair, and WINGS Therapeutics.

A version of this article first appeared on Medscape.com.