Social media makes kids with type 1 diabetes feel less alone

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Changed
Fri, 10/06/2023 - 10:18

After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

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After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

After being diagnosed with type 1 diabetes in 2021, British teenager Johnny Bailey felt isolated. That’s when he turned to social media, where he found others living with type 1 diabetes. He began to share his experience and now has more than 329,000 followers on his TikTok account, where he regularly posts videos.

These include short clips of him demonstrating how he changes his FreeStyle Libre sensor for his flash glucose monitor. In the videos, Johnny appropriately places his sensor on the back of his arm with background music, makes facial expressions, and transforms a dreaded diabetes-related task into an experience that appears fun and entertaining. In the limited videos I was able to review, he follows all the appropriate steps for sensor placement.

Many youths living with type 1 diabetes struggle with living with a chronic medical condition. Because type 1 diabetes is a rare condition, affecting about 1 in 500 children in the United States, many youth may not meet anyone else their age with type 1 diabetes through school, social events, or extracurricular activities.

For adolescents with intensively managed conditions like type 1 diabetes, this can present numerous psychosocial challenges – specifically, many youth experience shame or stigma associated with managing type 1 diabetes.

Diabetes-specific tasks may include wearing an insulin pump, monitoring blood glucose with finger pricks or a continuous glucose monitor (CGM), giving injections of insulin before meals and snacks, adjusting times for meals and snacks based on metabolic needs, waking up in the middle of the night to treat high or low blood glucose – the list goes on and on.

One study estimated that the average time it takes a child with type 1 diabetes to perform diabetes-specific tasks is over 5 hours per day.

Although much of this diabetes management time is spent by parents, as children get older and become teenagers, they are gradually transitioning to taking on more of this responsibility themselves. Wearing diabetes technology (insulin pumps and CGMs) can draw unwanted attention, leading to diabetes-specific body image concerns. Kids may also have to excuse themselves from an activity to treat a low or high blood glucose, creating uncomfortable situations when others inquire about why the activity was interrupted. As a result, many youths will avoid managing their diabetes properly to avoid drawing unwanted attention, consequently put their health at risk.

So, for many youths with type 1 diabetes, watching Johnny Bailey, or others on social media, may help them feel more comfortable. Those who are afraid of placing their glucose sensor owing to fear of pain may be reassured by seeing Johnny placing his sensor with a smile on his face. Some of his content also highlights other stigmatizing situations that teens may face, for example someone with a judgmental look questioning why he needed to give an insulin injection here.

This highlights an important concept – that people with type 1 diabetes may face criticism when dosing insulin in public, but it doesn’t mean they should feel forced to manage diabetes in private unless they choose to. Johnny is an inspirational individual who has bravely taken his type 1 diabetes experiences and used his creative skills to make these seemingly boring health-related tasks fun, interesting, and accessible.

Social media has become an outlet for people with type 1 diabetes to connect with others who can relate to their experiences.

However, there’s another side to consider. Although social media may provide a great source of support for youth, it may also adversely affect mental health. Just as quickly as social media outlets have grown, so has concern over excessive social media use and its impact on adolescents’ mental health. There’s a growing body of literature that describes the negative mental health aspects related to social media use.

Some adolescents struggling to manage type 1 diabetes may feel worse when seeing others thrive on social media, which has the potential to worsen stigma and shame. Youth may wonder how someone else is able to manage their type 1 diabetes so well when they are facing so many challenges.

Short videos on social media provide an incomplete picture of living with type 1 diabetes – just a glimpse into others’ lives, and only the parts that they want others to see. Managing a chronic condition can’t be fully represented in 10-second videos. And if youths choose to post their type 1 diabetes experiences on social media, they also risk receiving backlash or criticism, which can negatively their impact mental health in return.

Furthermore, the content being posted may not always be accurate or educational, leading to the potential for some youth to misunderstand type 1 diabetes.

Although I wouldn’t discourage youth with type 1 diabetes from engaging on social media and viewing diabetes-related content, they need to know that social media is flooded with misinformation. Creating an open space for youth to ask their clinicians questions about type 1 diabetes–related topics they view on social media is vital to ensuring they are viewing accurate information, so they are able to continue to manage their diabetes safely.

As a pediatric endocrinologist, I sometimes share resources on social media with patients if I believe it will help them cope with their type 1 diabetes diagnosis and management. I have had numerous patients – many of whom have struggled to accept their diagnosis – mention with joy and excitement that they were following an organization addressing type 1 diabetes on social media.

When making suggestions, I may refer them to The Diabetes Link, an organization with resources for young adults with type 1 diabetes that creates a space to connect with other young adults with type 1 diabetes. diaTribe is another organization created and led by people with diabetes that has a plethora of resources and provides evidence-based education for patients. I have also shared Project 50-in-50, which highlights two individuals with type 1 diabetes hiking the highest peak in each state in less than 50 days. Being able to see type 1 diabetes in a positive light is a huge step toward a more positive outlook on diabetes management.

Dr. Nally is an assistant professor, department of pediatrics, and a pediatric endocrinologist, division of pediatric endocrinology, at Yale University, New Haven, Conn. She reported conflicts of interest with Medtronic and the National Institutes of Health.

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

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Adolescents’ acute care use for eating disorders has risen

Article Type
Changed
Fri, 10/06/2023 - 10:09

Emergency department visits and hospital admissions for eating disorders have increased significantly among adolescents during the COVID-19 pandemic, according to new research.

In a repeated cross-sectional study that examined population-based data from January 2017 through August 2022, ED visits increased by 121% above expected levels, and hospital admissions increased by 54% above expected among patients aged 10-17 years during the pandemic.

“We are hoping this study continues to heighten awareness of the importance of eating disorders, and also to bolster support for eating disorder programs so that we can adequately care for patients and address the increasing demand for treatment and services,” lead author Alene Toulany, MD, adolescent medicine specialist and researcher at the Hospital for Sick Children in Toronto, told this news organization.

The study was published in the Canadian Medical Association Journal.
 

‘A pressing concern’

The researchers used linked health administrative databases that included all patients in Ontario who were eligible for the Ontario Health Insurance Plan, which is publicly funded. They compared observed and expected rates of ED visits and hospitalizations for eating disorders between a prepandemic period (Jan. 1, 2017, to Feb. 29, 2020) and a pandemic period (Mar. 1, 2020, to Aug. 31, 2022). The researchers examined the following four age categories: adolescents (aged 10-17 years), young adults (aged 18-26 years), adults (aged 27-40 years), and older adults (aged 41-105 years).

Among adolescents, the observed rate of ED visits during the 30 pandemic months studied was 7.38 per 100,000 population, compared with 3.33 per 100,000 before the pandemic (incidence rate ratio [IRR], 2.21).

The rate of ED visits among young adults increased by 13% above the expected rate. It reached 2.79 per 100,000, compared with 2.46 per 100,000 in the prepandemic period (IRR, 1.13).

Among older adults, ED visits increased from 0.11 per 100,000 in the prepandemic period to 0.14 per 100,000 in the pandemic period (IRR, 1.15). The rate of ED visits among adults remained approximately the same.

The rate of hospital admissions among adolescents increased by 54% above the expected rate during the pandemic. The observed rate of hospital admissions before the pandemic was 5.74 per 100,000, vs. 8.82 per 100,000 during the pandemic (IRR, 1.54). Hospital admissions remained stable or decreased for the other age groups.

“Eating disorders have increased globally in children and adolescents during COVID,” said Dr. Toulany. “There are a number of risk factors contributing to this pandemic rise, including isolation, more time on social media, decreased access to care (as many in-person services were not available due to the pandemic), as well as fear of getting infected. All of these could contribute to an increased risk of developing an eating disorder or of making an existing one worse.”

Regardless of the cause, more investment in eating disorders research and eating disorder programs for adolescents and adults is needed, she said.

“The pandemic served as a catalyst, because it started to shed light on the prevalence of eating disorders, especially in young people. But it’s very important that we recognize that this has been a long-standing issue and a pressing concern that has been consistently overlooked and underfunded,” said Dr. Toulany.
 

 

 

Surging eating disorders

Commenting on the findings, Victor Fornari, MD, director of child and adolescent psychiatry at Zucker Hillside Hospital/Northwell Health in Glen Oaks, N.Y., said, “Our experience in the United States parallels what is described in this Canadian paper. This was a surge of eating disorders the likes of which I had not experienced in my career.” Dr. Fornari did not participate in the current study.

“I’ve been here for over 40 years, and the average number of our inpatients in our eating disorder program has been three to five and about a dozen patients in our day clinic at any one time. But in the spring of 2020, we surged to 20 inpatients and over 20 day patients,” Dr. Fornari said.

“We can speculate as to the reasons for this,” he continued. “Kids were isolated. School was closed. They spent more time on social media and the Internet. Their sports activities were curtailed. There was anxiety because the guidance that we were all offered to prevent contagion was increasing people’s anxiety about safety and danger. So, I think we saw dramatic rises in eating disorders in the same way we saw dramatic rises in anxiety and depression in adolescents, as well.”

Dr. Fornari cited social media as an important contributing factor to eating disorders, especially among vulnerable teenagers. “Many of these vulnerable kids are looking at pictures of people who are very thin and comparing themselves, feeling inadequate, feeling sad. Social media is one of the reasons why the rates of psychopathology amongst teens has skyrocketed in the last decade. The surgeon general recently said we should delay access to social media until age 16 because the younger kids are impressionable and vulnerable. I think there is wisdom there, but it is very hard to actually put into practice.”
 

Worsening mental health

“I thought this was very relevant research and an important contribution to our understanding of eating disorders during pandemic times,” said Simon Sherry, PhD, professor of psychology and neuroscience at Dalhousie University in Halifax, Nova Scotia. “It also dovetails with my own experience as a practitioner.” Dr. Sherry was not involved in the research.

The pandemic has been difficult for people with disordered eating for many reasons, Dr. Sherry said. “There was a massive disruption or ‘loss of normal’ around food. Restaurants closed, grocery shopping was disrupted, scarcity of food occurred, hoarding of food occurred. That meant that eating was difficult for all of us, but especially for individuals who were rigid and controlling around the consumption of food. In this COVID era, you would need flexibility and acceptance around eating, but if you had a narrow range of preferred foods and preferred shopping locations, no doubt the pandemic made this a lot worse.”

Certain forms of disordered eating would be much more likely during the pandemic, Dr. Sherry noted. “For example, binge eating is often triggered by psychological, social, and environmental events,” and those triggers were abundant at the beginning of the pandemic. Boredom, anxiety, depression, stress, loneliness, confinement, and isolation are among the triggers. “COVID-19-related stress was and is very fertile ground for the growth of emotional eating, binge eating, or turning to food to cope. Eating disorders tend to fester amid silence and isolation and inactivity, and that was very much our experience during the lockdown phase of the pandemic,” he said.

Dr. Sherry agrees with the need for more funding for eating disorders research. “We know in Canada that eating disorders are a very important and deadly issue that is chronically underfunded. We are not funding disordered eating in proportion to its prevalence or in proportion to the amount of harm and destruction it creates for individuals, their family members, and our society at large. The authors are absolutely correct to advocate for care in proportion to the prevalence and the damage associated with eating disorders,” he said.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health, the Ministry of Long-Term Care, and the Canadian Institutes of Health Research (CIHR). Dr. Toulany, Dr. Fornari, and Dr. Sherry reported no relevant financial relationships. One study author reported receiving personal fees from the BMJ Group’s Archives of Diseases in Childhood and grants from CIHR, the Ontario Ministry of Health, the Centre for Addiction and Mental Health, and the Hospital for Sick Children. A second author reported funding from CIHR.

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

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Emergency department visits and hospital admissions for eating disorders have increased significantly among adolescents during the COVID-19 pandemic, according to new research.

In a repeated cross-sectional study that examined population-based data from January 2017 through August 2022, ED visits increased by 121% above expected levels, and hospital admissions increased by 54% above expected among patients aged 10-17 years during the pandemic.

“We are hoping this study continues to heighten awareness of the importance of eating disorders, and also to bolster support for eating disorder programs so that we can adequately care for patients and address the increasing demand for treatment and services,” lead author Alene Toulany, MD, adolescent medicine specialist and researcher at the Hospital for Sick Children in Toronto, told this news organization.

The study was published in the Canadian Medical Association Journal.
 

‘A pressing concern’

The researchers used linked health administrative databases that included all patients in Ontario who were eligible for the Ontario Health Insurance Plan, which is publicly funded. They compared observed and expected rates of ED visits and hospitalizations for eating disorders between a prepandemic period (Jan. 1, 2017, to Feb. 29, 2020) and a pandemic period (Mar. 1, 2020, to Aug. 31, 2022). The researchers examined the following four age categories: adolescents (aged 10-17 years), young adults (aged 18-26 years), adults (aged 27-40 years), and older adults (aged 41-105 years).

Among adolescents, the observed rate of ED visits during the 30 pandemic months studied was 7.38 per 100,000 population, compared with 3.33 per 100,000 before the pandemic (incidence rate ratio [IRR], 2.21).

The rate of ED visits among young adults increased by 13% above the expected rate. It reached 2.79 per 100,000, compared with 2.46 per 100,000 in the prepandemic period (IRR, 1.13).

Among older adults, ED visits increased from 0.11 per 100,000 in the prepandemic period to 0.14 per 100,000 in the pandemic period (IRR, 1.15). The rate of ED visits among adults remained approximately the same.

The rate of hospital admissions among adolescents increased by 54% above the expected rate during the pandemic. The observed rate of hospital admissions before the pandemic was 5.74 per 100,000, vs. 8.82 per 100,000 during the pandemic (IRR, 1.54). Hospital admissions remained stable or decreased for the other age groups.

“Eating disorders have increased globally in children and adolescents during COVID,” said Dr. Toulany. “There are a number of risk factors contributing to this pandemic rise, including isolation, more time on social media, decreased access to care (as many in-person services were not available due to the pandemic), as well as fear of getting infected. All of these could contribute to an increased risk of developing an eating disorder or of making an existing one worse.”

Regardless of the cause, more investment in eating disorders research and eating disorder programs for adolescents and adults is needed, she said.

“The pandemic served as a catalyst, because it started to shed light on the prevalence of eating disorders, especially in young people. But it’s very important that we recognize that this has been a long-standing issue and a pressing concern that has been consistently overlooked and underfunded,” said Dr. Toulany.
 

 

 

Surging eating disorders

Commenting on the findings, Victor Fornari, MD, director of child and adolescent psychiatry at Zucker Hillside Hospital/Northwell Health in Glen Oaks, N.Y., said, “Our experience in the United States parallels what is described in this Canadian paper. This was a surge of eating disorders the likes of which I had not experienced in my career.” Dr. Fornari did not participate in the current study.

“I’ve been here for over 40 years, and the average number of our inpatients in our eating disorder program has been three to five and about a dozen patients in our day clinic at any one time. But in the spring of 2020, we surged to 20 inpatients and over 20 day patients,” Dr. Fornari said.

“We can speculate as to the reasons for this,” he continued. “Kids were isolated. School was closed. They spent more time on social media and the Internet. Their sports activities were curtailed. There was anxiety because the guidance that we were all offered to prevent contagion was increasing people’s anxiety about safety and danger. So, I think we saw dramatic rises in eating disorders in the same way we saw dramatic rises in anxiety and depression in adolescents, as well.”

Dr. Fornari cited social media as an important contributing factor to eating disorders, especially among vulnerable teenagers. “Many of these vulnerable kids are looking at pictures of people who are very thin and comparing themselves, feeling inadequate, feeling sad. Social media is one of the reasons why the rates of psychopathology amongst teens has skyrocketed in the last decade. The surgeon general recently said we should delay access to social media until age 16 because the younger kids are impressionable and vulnerable. I think there is wisdom there, but it is very hard to actually put into practice.”
 

Worsening mental health

“I thought this was very relevant research and an important contribution to our understanding of eating disorders during pandemic times,” said Simon Sherry, PhD, professor of psychology and neuroscience at Dalhousie University in Halifax, Nova Scotia. “It also dovetails with my own experience as a practitioner.” Dr. Sherry was not involved in the research.

The pandemic has been difficult for people with disordered eating for many reasons, Dr. Sherry said. “There was a massive disruption or ‘loss of normal’ around food. Restaurants closed, grocery shopping was disrupted, scarcity of food occurred, hoarding of food occurred. That meant that eating was difficult for all of us, but especially for individuals who were rigid and controlling around the consumption of food. In this COVID era, you would need flexibility and acceptance around eating, but if you had a narrow range of preferred foods and preferred shopping locations, no doubt the pandemic made this a lot worse.”

Certain forms of disordered eating would be much more likely during the pandemic, Dr. Sherry noted. “For example, binge eating is often triggered by psychological, social, and environmental events,” and those triggers were abundant at the beginning of the pandemic. Boredom, anxiety, depression, stress, loneliness, confinement, and isolation are among the triggers. “COVID-19-related stress was and is very fertile ground for the growth of emotional eating, binge eating, or turning to food to cope. Eating disorders tend to fester amid silence and isolation and inactivity, and that was very much our experience during the lockdown phase of the pandemic,” he said.

Dr. Sherry agrees with the need for more funding for eating disorders research. “We know in Canada that eating disorders are a very important and deadly issue that is chronically underfunded. We are not funding disordered eating in proportion to its prevalence or in proportion to the amount of harm and destruction it creates for individuals, their family members, and our society at large. The authors are absolutely correct to advocate for care in proportion to the prevalence and the damage associated with eating disorders,” he said.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health, the Ministry of Long-Term Care, and the Canadian Institutes of Health Research (CIHR). Dr. Toulany, Dr. Fornari, and Dr. Sherry reported no relevant financial relationships. One study author reported receiving personal fees from the BMJ Group’s Archives of Diseases in Childhood and grants from CIHR, the Ontario Ministry of Health, the Centre for Addiction and Mental Health, and the Hospital for Sick Children. A second author reported funding from CIHR.

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

Emergency department visits and hospital admissions for eating disorders have increased significantly among adolescents during the COVID-19 pandemic, according to new research.

In a repeated cross-sectional study that examined population-based data from January 2017 through August 2022, ED visits increased by 121% above expected levels, and hospital admissions increased by 54% above expected among patients aged 10-17 years during the pandemic.

“We are hoping this study continues to heighten awareness of the importance of eating disorders, and also to bolster support for eating disorder programs so that we can adequately care for patients and address the increasing demand for treatment and services,” lead author Alene Toulany, MD, adolescent medicine specialist and researcher at the Hospital for Sick Children in Toronto, told this news organization.

The study was published in the Canadian Medical Association Journal.
 

‘A pressing concern’

The researchers used linked health administrative databases that included all patients in Ontario who were eligible for the Ontario Health Insurance Plan, which is publicly funded. They compared observed and expected rates of ED visits and hospitalizations for eating disorders between a prepandemic period (Jan. 1, 2017, to Feb. 29, 2020) and a pandemic period (Mar. 1, 2020, to Aug. 31, 2022). The researchers examined the following four age categories: adolescents (aged 10-17 years), young adults (aged 18-26 years), adults (aged 27-40 years), and older adults (aged 41-105 years).

Among adolescents, the observed rate of ED visits during the 30 pandemic months studied was 7.38 per 100,000 population, compared with 3.33 per 100,000 before the pandemic (incidence rate ratio [IRR], 2.21).

The rate of ED visits among young adults increased by 13% above the expected rate. It reached 2.79 per 100,000, compared with 2.46 per 100,000 in the prepandemic period (IRR, 1.13).

Among older adults, ED visits increased from 0.11 per 100,000 in the prepandemic period to 0.14 per 100,000 in the pandemic period (IRR, 1.15). The rate of ED visits among adults remained approximately the same.

The rate of hospital admissions among adolescents increased by 54% above the expected rate during the pandemic. The observed rate of hospital admissions before the pandemic was 5.74 per 100,000, vs. 8.82 per 100,000 during the pandemic (IRR, 1.54). Hospital admissions remained stable or decreased for the other age groups.

“Eating disorders have increased globally in children and adolescents during COVID,” said Dr. Toulany. “There are a number of risk factors contributing to this pandemic rise, including isolation, more time on social media, decreased access to care (as many in-person services were not available due to the pandemic), as well as fear of getting infected. All of these could contribute to an increased risk of developing an eating disorder or of making an existing one worse.”

Regardless of the cause, more investment in eating disorders research and eating disorder programs for adolescents and adults is needed, she said.

“The pandemic served as a catalyst, because it started to shed light on the prevalence of eating disorders, especially in young people. But it’s very important that we recognize that this has been a long-standing issue and a pressing concern that has been consistently overlooked and underfunded,” said Dr. Toulany.
 

 

 

Surging eating disorders

Commenting on the findings, Victor Fornari, MD, director of child and adolescent psychiatry at Zucker Hillside Hospital/Northwell Health in Glen Oaks, N.Y., said, “Our experience in the United States parallels what is described in this Canadian paper. This was a surge of eating disorders the likes of which I had not experienced in my career.” Dr. Fornari did not participate in the current study.

“I’ve been here for over 40 years, and the average number of our inpatients in our eating disorder program has been three to five and about a dozen patients in our day clinic at any one time. But in the spring of 2020, we surged to 20 inpatients and over 20 day patients,” Dr. Fornari said.

“We can speculate as to the reasons for this,” he continued. “Kids were isolated. School was closed. They spent more time on social media and the Internet. Their sports activities were curtailed. There was anxiety because the guidance that we were all offered to prevent contagion was increasing people’s anxiety about safety and danger. So, I think we saw dramatic rises in eating disorders in the same way we saw dramatic rises in anxiety and depression in adolescents, as well.”

Dr. Fornari cited social media as an important contributing factor to eating disorders, especially among vulnerable teenagers. “Many of these vulnerable kids are looking at pictures of people who are very thin and comparing themselves, feeling inadequate, feeling sad. Social media is one of the reasons why the rates of psychopathology amongst teens has skyrocketed in the last decade. The surgeon general recently said we should delay access to social media until age 16 because the younger kids are impressionable and vulnerable. I think there is wisdom there, but it is very hard to actually put into practice.”
 

Worsening mental health

“I thought this was very relevant research and an important contribution to our understanding of eating disorders during pandemic times,” said Simon Sherry, PhD, professor of psychology and neuroscience at Dalhousie University in Halifax, Nova Scotia. “It also dovetails with my own experience as a practitioner.” Dr. Sherry was not involved in the research.

The pandemic has been difficult for people with disordered eating for many reasons, Dr. Sherry said. “There was a massive disruption or ‘loss of normal’ around food. Restaurants closed, grocery shopping was disrupted, scarcity of food occurred, hoarding of food occurred. That meant that eating was difficult for all of us, but especially for individuals who were rigid and controlling around the consumption of food. In this COVID era, you would need flexibility and acceptance around eating, but if you had a narrow range of preferred foods and preferred shopping locations, no doubt the pandemic made this a lot worse.”

Certain forms of disordered eating would be much more likely during the pandemic, Dr. Sherry noted. “For example, binge eating is often triggered by psychological, social, and environmental events,” and those triggers were abundant at the beginning of the pandemic. Boredom, anxiety, depression, stress, loneliness, confinement, and isolation are among the triggers. “COVID-19-related stress was and is very fertile ground for the growth of emotional eating, binge eating, or turning to food to cope. Eating disorders tend to fester amid silence and isolation and inactivity, and that was very much our experience during the lockdown phase of the pandemic,” he said.

Dr. Sherry agrees with the need for more funding for eating disorders research. “We know in Canada that eating disorders are a very important and deadly issue that is chronically underfunded. We are not funding disordered eating in proportion to its prevalence or in proportion to the amount of harm and destruction it creates for individuals, their family members, and our society at large. The authors are absolutely correct to advocate for care in proportion to the prevalence and the damage associated with eating disorders,” he said.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health, the Ministry of Long-Term Care, and the Canadian Institutes of Health Research (CIHR). Dr. Toulany, Dr. Fornari, and Dr. Sherry reported no relevant financial relationships. One study author reported receiving personal fees from the BMJ Group’s Archives of Diseases in Childhood and grants from CIHR, the Ontario Ministry of Health, the Centre for Addiction and Mental Health, and the Hospital for Sick Children. A second author reported funding from CIHR.

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

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Long-Awaited RSV Vaccines Now Available for Older Adults and Pediatric Patients

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Long-Awaited RSV Vaccines Now Available for Older Adults and Pediatric Patients
References
  1. Jha A et al. Respiratory syncytial virus. In: Hui DS, Rossi GA, Johnston SL, eds. Respiratory Syncytial Virus. SARS, MERS and Other Viral Lung Infections. European Respiratory Society; 2016:chap 5. Accessed May 17, 2023.
  2. Ginsburg SA, Srikantiah P. Lancet Glob Health. 2021;9(12):e1644-e6145. doi:10.1016/S2214-109X(21)00455-1
  3. US Food and Drug Administration. FDA approves first respiratory syncytial virus (RSV) vaccine [press release]. Published May 3, 2023. Accessed May 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
  4. US Food and Drug Administration. FDA Approves New Drug to Prevent RSV in Babies and Toddlers [press release]. Published July 17, 2023. Accessed August 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
  5. US Food and Drug Administration. FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants. Published August 21, 2023. Accessed August 22, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
  6. Madhi SA et al. N Engl J Med. 2020;383(5):426-439. doi:10.1056/ NEJMoa1908380
  7. Centers for Disease Control. Advisory Committee on Immunization Practices (ACIP) Meeting recommendations, August 2023. https://www.cdc.gov/vaccines/acip/recommendations.html
  8. Hammit LL et al. N Engl J Med. 2022;386(9):837-846. doi:10.1056/ NEJMoa2110275
  9. Centers for Disease Control and Prevention. RSV in infants and young children. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/ high-risk/infants-young-children.html
  10. Centers for Disease Control and Prevention. RSV in older adults and adults with chronic medical conditions. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/high-risk/older-adults.html
  11. Widmer K et al. J Infect Dis. 2012;206(1):56-62. doi:10.1093/infdis/jis309
  12. Hall CB et al. N Engl J Med. 2009;360(6):588-598. doi:10.1056/NEJMoa0804877
  13. McLaughlin JM et al. Open Forum Infect Dis. 2022;9(7):ofac300. doi:10.1093/ofid/ofac300
  14. Thompson et al. JAMA. 2003;289(2):179-186. doi:10.1001/jama.289.2.179
  15. Hansen CL et al. JAMA Netw Open. 2022;5(2):e220527. doi:10.1001/jamanetworkopen.2022.0527
  16. Walsh EE et al; RENOIR Clinical Trial Group. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836
  17. Martin JA et al. Natl Vital Stat Rep. 2019;68(13):1-47. PMID:32501202
  18. Townsi N et al. Eur Clin Respir J. 2018;5(1):1487214. doi:10.1080/20018525.20 18.1487214
  19. Malek A et al. Am J Reprod Immunol. 1994;32(1):8-14. doi:10.1111/j.1600-0897.1994.tb00873.x
  20. Kampmann B et al; MATISSE Study Group. N Engl J Med. 2023;388(16):1451- 1464. doi:10.1056/NEJMoa2216480
  21. Synagis (palivizumab) injection prescribing information. Published June 2023. Accessed August 2023. https://www.synagis.com/synagis.pdf
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Pediatric Pulmonologist
Children’s Healthcare of Atlanta
Atlanta, GA

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Atlanta, GA

References
  1. Jha A et al. Respiratory syncytial virus. In: Hui DS, Rossi GA, Johnston SL, eds. Respiratory Syncytial Virus. SARS, MERS and Other Viral Lung Infections. European Respiratory Society; 2016:chap 5. Accessed May 17, 2023.
  2. Ginsburg SA, Srikantiah P. Lancet Glob Health. 2021;9(12):e1644-e6145. doi:10.1016/S2214-109X(21)00455-1
  3. US Food and Drug Administration. FDA approves first respiratory syncytial virus (RSV) vaccine [press release]. Published May 3, 2023. Accessed May 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
  4. US Food and Drug Administration. FDA Approves New Drug to Prevent RSV in Babies and Toddlers [press release]. Published July 17, 2023. Accessed August 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
  5. US Food and Drug Administration. FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants. Published August 21, 2023. Accessed August 22, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
  6. Madhi SA et al. N Engl J Med. 2020;383(5):426-439. doi:10.1056/ NEJMoa1908380
  7. Centers for Disease Control. Advisory Committee on Immunization Practices (ACIP) Meeting recommendations, August 2023. https://www.cdc.gov/vaccines/acip/recommendations.html
  8. Hammit LL et al. N Engl J Med. 2022;386(9):837-846. doi:10.1056/ NEJMoa2110275
  9. Centers for Disease Control and Prevention. RSV in infants and young children. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/ high-risk/infants-young-children.html
  10. Centers for Disease Control and Prevention. RSV in older adults and adults with chronic medical conditions. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/high-risk/older-adults.html
  11. Widmer K et al. J Infect Dis. 2012;206(1):56-62. doi:10.1093/infdis/jis309
  12. Hall CB et al. N Engl J Med. 2009;360(6):588-598. doi:10.1056/NEJMoa0804877
  13. McLaughlin JM et al. Open Forum Infect Dis. 2022;9(7):ofac300. doi:10.1093/ofid/ofac300
  14. Thompson et al. JAMA. 2003;289(2):179-186. doi:10.1001/jama.289.2.179
  15. Hansen CL et al. JAMA Netw Open. 2022;5(2):e220527. doi:10.1001/jamanetworkopen.2022.0527
  16. Walsh EE et al; RENOIR Clinical Trial Group. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836
  17. Martin JA et al. Natl Vital Stat Rep. 2019;68(13):1-47. PMID:32501202
  18. Townsi N et al. Eur Clin Respir J. 2018;5(1):1487214. doi:10.1080/20018525.20 18.1487214
  19. Malek A et al. Am J Reprod Immunol. 1994;32(1):8-14. doi:10.1111/j.1600-0897.1994.tb00873.x
  20. Kampmann B et al; MATISSE Study Group. N Engl J Med. 2023;388(16):1451- 1464. doi:10.1056/NEJMoa2216480
  21. Synagis (palivizumab) injection prescribing information. Published June 2023. Accessed August 2023. https://www.synagis.com/synagis.pdf
References
  1. Jha A et al. Respiratory syncytial virus. In: Hui DS, Rossi GA, Johnston SL, eds. Respiratory Syncytial Virus. SARS, MERS and Other Viral Lung Infections. European Respiratory Society; 2016:chap 5. Accessed May 17, 2023.
  2. Ginsburg SA, Srikantiah P. Lancet Glob Health. 2021;9(12):e1644-e6145. doi:10.1016/S2214-109X(21)00455-1
  3. US Food and Drug Administration. FDA approves first respiratory syncytial virus (RSV) vaccine [press release]. Published May 3, 2023. Accessed May 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
  4. US Food and Drug Administration. FDA Approves New Drug to Prevent RSV in Babies and Toddlers [press release]. Published July 17, 2023. Accessed August 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
  5. US Food and Drug Administration. FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants. Published August 21, 2023. Accessed August 22, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
  6. Madhi SA et al. N Engl J Med. 2020;383(5):426-439. doi:10.1056/ NEJMoa1908380
  7. Centers for Disease Control. Advisory Committee on Immunization Practices (ACIP) Meeting recommendations, August 2023. https://www.cdc.gov/vaccines/acip/recommendations.html
  8. Hammit LL et al. N Engl J Med. 2022;386(9):837-846. doi:10.1056/ NEJMoa2110275
  9. Centers for Disease Control and Prevention. RSV in infants and young children. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/ high-risk/infants-young-children.html
  10. Centers for Disease Control and Prevention. RSV in older adults and adults with chronic medical conditions. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/high-risk/older-adults.html
  11. Widmer K et al. J Infect Dis. 2012;206(1):56-62. doi:10.1093/infdis/jis309
  12. Hall CB et al. N Engl J Med. 2009;360(6):588-598. doi:10.1056/NEJMoa0804877
  13. McLaughlin JM et al. Open Forum Infect Dis. 2022;9(7):ofac300. doi:10.1093/ofid/ofac300
  14. Thompson et al. JAMA. 2003;289(2):179-186. doi:10.1001/jama.289.2.179
  15. Hansen CL et al. JAMA Netw Open. 2022;5(2):e220527. doi:10.1001/jamanetworkopen.2022.0527
  16. Walsh EE et al; RENOIR Clinical Trial Group. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836
  17. Martin JA et al. Natl Vital Stat Rep. 2019;68(13):1-47. PMID:32501202
  18. Townsi N et al. Eur Clin Respir J. 2018;5(1):1487214. doi:10.1080/20018525.20 18.1487214
  19. Malek A et al. Am J Reprod Immunol. 1994;32(1):8-14. doi:10.1111/j.1600-0897.1994.tb00873.x
  20. Kampmann B et al; MATISSE Study Group. N Engl J Med. 2023;388(16):1451- 1464. doi:10.1056/NEJMoa2216480
  21. Synagis (palivizumab) injection prescribing information. Published June 2023. Accessed August 2023. https://www.synagis.com/synagis.pdf
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Respiratory syncytial virus (RSV) is highly contagious and transmitted by large aerosol droplets and fomites, either emitted from an infected person or by making surface-to-eye, -nose, or -mouth contact.Severe RSV can increase the risk of bacterial coinfections, pneumonia, and lower respiratory tract infections (LRTI)— particularly in infants and older adults.2

Thankfully, 2023 has been a landmark year for RSV approvals. The FDA approved its first RSV vaccine, called RSV prefusion F protein based (RSVpreF) vaccine, for people aged 60 and over in May 2023.3 In July 2023, the passive monoclonal antibody injection nirsevimab was approved as a preventative option for infants in their first and second winter seasons.4 Finally, the FDA approved the RSVpreF vaccine for pregnant individuals in late August 2023, with the goal of protecting infants.5 However, results from a recent phase 3 trial did not show significance with respect to the primary end point.6

Birth through 6 months is the leading timeframe of RSV-related death because of the low natural defenses and small airways of infants. On August 3, 2023, the CDC Advisory Committee on Immunization Practices unanimously recommended use of nirsevimab for all infants up to 8 months of age at the start of the RSV season and for infants at risk for severe RSV infection until 19 months of age.7 This decision was partly based on the MELODY and MEDLEY trials.8 In an unprecedented move, this monoclonal antibody will be made available through the Vaccines For Children program, the first monoclonal antibody to receive this designation. It is hoped that uptake of this therapy will result in fewer hospitalizations of infants with RSV bronchiolitis.

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Salvage option to replace transplant in r/r Hodgkin lymphoma?

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Children and young adults with low-risk relapsed or refractory classic Hodgkin lymphoma may be able to skip autologous stem cell transplant.

Patients who received second-line chemoimmunotherapy with nivolumab-brentuximab vedotin, with or without bendamustine, and proceeded to involved-site radiation appeared to have similar survival outcomes to those who received the chemoimmunotherapy combination plus the current second-line standard of care, which includes high-dose therapy and autologous stem cell transplant.

Among 28 patients with low-risk relapsed or refractory Hodgkin lymphoma followed for a median of 32 months, 3-year event-free survival without autologous stem cell transplant was 86.9% and 3-year progression-free survival was 95%, reported Brad Hoppe, MD, MPH, from the Mayo Clinic in Jacksonville, Fla. In contrast, 1-year progression-free survival was 91% among the 44 standard-risk patients who received high-dose therapy and autologous stem cell transplant, according to results of a trial the investigators published online in Blood in late 2022.

The latest results from the phase 2 CheckMate 744 trial were reported at the annual meeting of the American Society of Radiation Oncology.

“The findings suggest that children, adolescents, and young adults with low-risk relapsed classic Hodgkin lymphoma can be salvaged with low-toxicity chemoimmunotherapy and may not require high-dose therapy and transplant for a cure,” Dr. Hoppe said in an oral abstract session.

Andrea Ng, MD, MPH, a radiation oncologist who specializes in treating patients with Hodgkin lymphoma and other hematologic malignancies, said that, while the number of patients in the study was small and the follow-up too short, this option is “certainly something that’s very promising for the future.”

“The use of transplant in relapsed patients, which we have been doing for decades, is based on two very old, small, randomized studies,” said Dr. Ng, from the Dana-Farber Cancer Institute in Boston, who moderated the session.

“So, do we really need to transplant everybody? In the back of our minds, we think that we may be overtreating some patients,” she said.

Several small, retrospective studies exploring treatment with conventional chemotherapy with or without radiation therapy and without transplant in patients with relapsed or refractory Hodgkin lymphoma have demonstrated only modest results.

The CheckMate 744 trial, however, was designed to examine a risk-adapted and response-adapted approach to treating children, adolescents, and young adults with relapsed or refractory classic Hodgkin lymphoma within the setting of modern immunotherapy and targeted therapy. This approach was developed jointly by investigators with the Children’s Oncology Group and Euronet.

In the nonrandomized trial, patients were stratified into low-risk or standard-risk disease categories based on an algorithm that included factors at the time of initial diagnosis and relapse.

Patients were considered low-risk for relapse in three scenarios: (1) if they had initial stage IA or IIA disease that relapsed at least 1 year after the end of therapy; (2) if they had initial stage IA or IIA disease that relapsed between 3 and 12 months from the end of therapy but had received no more than three cycles of chemotherapy and no radiation therapy; or (3) if they had initial stage IB, IIB, or IIIA disease that relapsed more than 12 months after the end of first-line therapy.

To be included in the low-risk category, patients also had to be free of B symptoms or extranodal disease, free of relapse in prior radiation therapy fields, and have no more than four sites of lymphoma. 

Low-risk patients were treated with a combination of nivolumab and brentuximab vedotin, which could be followed by additional brentuximab vedotin and bendamustine for those with a suboptimal response. Patients who achieved complete molecular remission after induction went on to consolidation therapy with involved-site radiation at a total dose of 30 Gy.

Patients considered standard-risk for relapse received the same nivolumab-brentuximab vedotin combination, with or without bendamustine, and then went on to high-dose therapy and autologous stem cell transplant.

In other results for the previously mentioned study published in Blood, the 44 standard-risk patients who received high-dose therapy and autologous stem cell transplant had an objective response rate of 95% – 86% of patients achieved complete molecular remission, and 9% achieved partial molecular remission.

At ASTRO, Dr. Hoppe reported results for the 28 patients with low-risk disease. One patient discontinued nivolumab/brentuximab vedotin after two cycles because of skin toxicity and was lost to follow-up. Of the remaining 27 patients, 21 had complete molecular remission after four cycles of the combination, and these patients went on to an additional two cycles of the combination, with 19 of 21 receiving involved-site radiation consolidation. 

Six patients who had either a partial molecular remission or no response were given two additional cycles of brentuximab vedotin plus bendamustine. Of this group, three went on to complete molecular remission and received involved-site radiation consolidation on protocol. The remaining three patients who did not experience complete molecular remission received involved-site radiation off protocol.

The rate of complete molecular remission after four cycles of induction was 82.1%, and the rate of partial molecular remission was 14.3%, for an objective response rate of 96.4%. The respective response rates with the addition of two cycles of brentuximab vedotin and bendamustine were 92.9% and 7.1%, for an objective response rate of 100%, Dr. Hoppe reported.

Overall, at a median follow-up of 32 months, the 3-year event-free survival rate without transplant was 86.9%, and the 3-year progression-free survival rate was 95%.

Treatment-related adverse events of any grade occurred in 22 patients (78.6%) after induction, with 7 of those events (25%) being grade 3 or 4 in severity. Grade 3 or 4 events consisted of skin and subcutaneous tissue disorders in 3 patients, elevated liver function tests in 3 patients, and blood and lymphatic system disorders in 1 patient.

There were no new toxicities detected within 100 days of treatment.

“The results that Dr. Hoppe showed us are really, really good,” Dr. Ng said. And “the volume of treatment is pretty tiny, so I think we can safely say that long-term toxicities are very, very minimal.”

The study was supported by Bristol-Myers Squibb in collaboration with Seagen, Euronet-Paediatric Hodgkin Lymphoma, and the Children’s Oncology Group. Dr. Hoppe reported serving on a scientific advisory committee for Merck. Dr. Ng reported having no relevant conflicts of interest.

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

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Children and young adults with low-risk relapsed or refractory classic Hodgkin lymphoma may be able to skip autologous stem cell transplant.

Patients who received second-line chemoimmunotherapy with nivolumab-brentuximab vedotin, with or without bendamustine, and proceeded to involved-site radiation appeared to have similar survival outcomes to those who received the chemoimmunotherapy combination plus the current second-line standard of care, which includes high-dose therapy and autologous stem cell transplant.

Among 28 patients with low-risk relapsed or refractory Hodgkin lymphoma followed for a median of 32 months, 3-year event-free survival without autologous stem cell transplant was 86.9% and 3-year progression-free survival was 95%, reported Brad Hoppe, MD, MPH, from the Mayo Clinic in Jacksonville, Fla. In contrast, 1-year progression-free survival was 91% among the 44 standard-risk patients who received high-dose therapy and autologous stem cell transplant, according to results of a trial the investigators published online in Blood in late 2022.

The latest results from the phase 2 CheckMate 744 trial were reported at the annual meeting of the American Society of Radiation Oncology.

“The findings suggest that children, adolescents, and young adults with low-risk relapsed classic Hodgkin lymphoma can be salvaged with low-toxicity chemoimmunotherapy and may not require high-dose therapy and transplant for a cure,” Dr. Hoppe said in an oral abstract session.

Andrea Ng, MD, MPH, a radiation oncologist who specializes in treating patients with Hodgkin lymphoma and other hematologic malignancies, said that, while the number of patients in the study was small and the follow-up too short, this option is “certainly something that’s very promising for the future.”

“The use of transplant in relapsed patients, which we have been doing for decades, is based on two very old, small, randomized studies,” said Dr. Ng, from the Dana-Farber Cancer Institute in Boston, who moderated the session.

“So, do we really need to transplant everybody? In the back of our minds, we think that we may be overtreating some patients,” she said.

Several small, retrospective studies exploring treatment with conventional chemotherapy with or without radiation therapy and without transplant in patients with relapsed or refractory Hodgkin lymphoma have demonstrated only modest results.

The CheckMate 744 trial, however, was designed to examine a risk-adapted and response-adapted approach to treating children, adolescents, and young adults with relapsed or refractory classic Hodgkin lymphoma within the setting of modern immunotherapy and targeted therapy. This approach was developed jointly by investigators with the Children’s Oncology Group and Euronet.

In the nonrandomized trial, patients were stratified into low-risk or standard-risk disease categories based on an algorithm that included factors at the time of initial diagnosis and relapse.

Patients were considered low-risk for relapse in three scenarios: (1) if they had initial stage IA or IIA disease that relapsed at least 1 year after the end of therapy; (2) if they had initial stage IA or IIA disease that relapsed between 3 and 12 months from the end of therapy but had received no more than three cycles of chemotherapy and no radiation therapy; or (3) if they had initial stage IB, IIB, or IIIA disease that relapsed more than 12 months after the end of first-line therapy.

To be included in the low-risk category, patients also had to be free of B symptoms or extranodal disease, free of relapse in prior radiation therapy fields, and have no more than four sites of lymphoma. 

Low-risk patients were treated with a combination of nivolumab and brentuximab vedotin, which could be followed by additional brentuximab vedotin and bendamustine for those with a suboptimal response. Patients who achieved complete molecular remission after induction went on to consolidation therapy with involved-site radiation at a total dose of 30 Gy.

Patients considered standard-risk for relapse received the same nivolumab-brentuximab vedotin combination, with or without bendamustine, and then went on to high-dose therapy and autologous stem cell transplant.

In other results for the previously mentioned study published in Blood, the 44 standard-risk patients who received high-dose therapy and autologous stem cell transplant had an objective response rate of 95% – 86% of patients achieved complete molecular remission, and 9% achieved partial molecular remission.

At ASTRO, Dr. Hoppe reported results for the 28 patients with low-risk disease. One patient discontinued nivolumab/brentuximab vedotin after two cycles because of skin toxicity and was lost to follow-up. Of the remaining 27 patients, 21 had complete molecular remission after four cycles of the combination, and these patients went on to an additional two cycles of the combination, with 19 of 21 receiving involved-site radiation consolidation. 

Six patients who had either a partial molecular remission or no response were given two additional cycles of brentuximab vedotin plus bendamustine. Of this group, three went on to complete molecular remission and received involved-site radiation consolidation on protocol. The remaining three patients who did not experience complete molecular remission received involved-site radiation off protocol.

The rate of complete molecular remission after four cycles of induction was 82.1%, and the rate of partial molecular remission was 14.3%, for an objective response rate of 96.4%. The respective response rates with the addition of two cycles of brentuximab vedotin and bendamustine were 92.9% and 7.1%, for an objective response rate of 100%, Dr. Hoppe reported.

Overall, at a median follow-up of 32 months, the 3-year event-free survival rate without transplant was 86.9%, and the 3-year progression-free survival rate was 95%.

Treatment-related adverse events of any grade occurred in 22 patients (78.6%) after induction, with 7 of those events (25%) being grade 3 or 4 in severity. Grade 3 or 4 events consisted of skin and subcutaneous tissue disorders in 3 patients, elevated liver function tests in 3 patients, and blood and lymphatic system disorders in 1 patient.

There were no new toxicities detected within 100 days of treatment.

“The results that Dr. Hoppe showed us are really, really good,” Dr. Ng said. And “the volume of treatment is pretty tiny, so I think we can safely say that long-term toxicities are very, very minimal.”

The study was supported by Bristol-Myers Squibb in collaboration with Seagen, Euronet-Paediatric Hodgkin Lymphoma, and the Children’s Oncology Group. Dr. Hoppe reported serving on a scientific advisory committee for Merck. Dr. Ng reported having no relevant conflicts of interest.

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

Children and young adults with low-risk relapsed or refractory classic Hodgkin lymphoma may be able to skip autologous stem cell transplant.

Patients who received second-line chemoimmunotherapy with nivolumab-brentuximab vedotin, with or without bendamustine, and proceeded to involved-site radiation appeared to have similar survival outcomes to those who received the chemoimmunotherapy combination plus the current second-line standard of care, which includes high-dose therapy and autologous stem cell transplant.

Among 28 patients with low-risk relapsed or refractory Hodgkin lymphoma followed for a median of 32 months, 3-year event-free survival without autologous stem cell transplant was 86.9% and 3-year progression-free survival was 95%, reported Brad Hoppe, MD, MPH, from the Mayo Clinic in Jacksonville, Fla. In contrast, 1-year progression-free survival was 91% among the 44 standard-risk patients who received high-dose therapy and autologous stem cell transplant, according to results of a trial the investigators published online in Blood in late 2022.

The latest results from the phase 2 CheckMate 744 trial were reported at the annual meeting of the American Society of Radiation Oncology.

“The findings suggest that children, adolescents, and young adults with low-risk relapsed classic Hodgkin lymphoma can be salvaged with low-toxicity chemoimmunotherapy and may not require high-dose therapy and transplant for a cure,” Dr. Hoppe said in an oral abstract session.

Andrea Ng, MD, MPH, a radiation oncologist who specializes in treating patients with Hodgkin lymphoma and other hematologic malignancies, said that, while the number of patients in the study was small and the follow-up too short, this option is “certainly something that’s very promising for the future.”

“The use of transplant in relapsed patients, which we have been doing for decades, is based on two very old, small, randomized studies,” said Dr. Ng, from the Dana-Farber Cancer Institute in Boston, who moderated the session.

“So, do we really need to transplant everybody? In the back of our minds, we think that we may be overtreating some patients,” she said.

Several small, retrospective studies exploring treatment with conventional chemotherapy with or without radiation therapy and without transplant in patients with relapsed or refractory Hodgkin lymphoma have demonstrated only modest results.

The CheckMate 744 trial, however, was designed to examine a risk-adapted and response-adapted approach to treating children, adolescents, and young adults with relapsed or refractory classic Hodgkin lymphoma within the setting of modern immunotherapy and targeted therapy. This approach was developed jointly by investigators with the Children’s Oncology Group and Euronet.

In the nonrandomized trial, patients were stratified into low-risk or standard-risk disease categories based on an algorithm that included factors at the time of initial diagnosis and relapse.

Patients were considered low-risk for relapse in three scenarios: (1) if they had initial stage IA or IIA disease that relapsed at least 1 year after the end of therapy; (2) if they had initial stage IA or IIA disease that relapsed between 3 and 12 months from the end of therapy but had received no more than three cycles of chemotherapy and no radiation therapy; or (3) if they had initial stage IB, IIB, or IIIA disease that relapsed more than 12 months after the end of first-line therapy.

To be included in the low-risk category, patients also had to be free of B symptoms or extranodal disease, free of relapse in prior radiation therapy fields, and have no more than four sites of lymphoma. 

Low-risk patients were treated with a combination of nivolumab and brentuximab vedotin, which could be followed by additional brentuximab vedotin and bendamustine for those with a suboptimal response. Patients who achieved complete molecular remission after induction went on to consolidation therapy with involved-site radiation at a total dose of 30 Gy.

Patients considered standard-risk for relapse received the same nivolumab-brentuximab vedotin combination, with or without bendamustine, and then went on to high-dose therapy and autologous stem cell transplant.

In other results for the previously mentioned study published in Blood, the 44 standard-risk patients who received high-dose therapy and autologous stem cell transplant had an objective response rate of 95% – 86% of patients achieved complete molecular remission, and 9% achieved partial molecular remission.

At ASTRO, Dr. Hoppe reported results for the 28 patients with low-risk disease. One patient discontinued nivolumab/brentuximab vedotin after two cycles because of skin toxicity and was lost to follow-up. Of the remaining 27 patients, 21 had complete molecular remission after four cycles of the combination, and these patients went on to an additional two cycles of the combination, with 19 of 21 receiving involved-site radiation consolidation. 

Six patients who had either a partial molecular remission or no response were given two additional cycles of brentuximab vedotin plus bendamustine. Of this group, three went on to complete molecular remission and received involved-site radiation consolidation on protocol. The remaining three patients who did not experience complete molecular remission received involved-site radiation off protocol.

The rate of complete molecular remission after four cycles of induction was 82.1%, and the rate of partial molecular remission was 14.3%, for an objective response rate of 96.4%. The respective response rates with the addition of two cycles of brentuximab vedotin and bendamustine were 92.9% and 7.1%, for an objective response rate of 100%, Dr. Hoppe reported.

Overall, at a median follow-up of 32 months, the 3-year event-free survival rate without transplant was 86.9%, and the 3-year progression-free survival rate was 95%.

Treatment-related adverse events of any grade occurred in 22 patients (78.6%) after induction, with 7 of those events (25%) being grade 3 or 4 in severity. Grade 3 or 4 events consisted of skin and subcutaneous tissue disorders in 3 patients, elevated liver function tests in 3 patients, and blood and lymphatic system disorders in 1 patient.

There were no new toxicities detected within 100 days of treatment.

“The results that Dr. Hoppe showed us are really, really good,” Dr. Ng said. And “the volume of treatment is pretty tiny, so I think we can safely say that long-term toxicities are very, very minimal.”

The study was supported by Bristol-Myers Squibb in collaboration with Seagen, Euronet-Paediatric Hodgkin Lymphoma, and the Children’s Oncology Group. Dr. Hoppe reported serving on a scientific advisory committee for Merck. Dr. Ng reported having no relevant conflicts of interest.

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

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Preparing for the viral trifecta: RSV, influenza, and COVID-19

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Wed, 10/18/2023 - 22:54

New armamentaria available to fight an old disease.

In July 2023, nirsevimab (Beyfortus), a monoclonal antibody, was approved by the Food and Drug Administration for the prevention of respiratory syncytial virus (RSV) disease in infants and children younger than 2 years of age. On Aug. 3, 2023, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine use of it for all infants younger than 8 months of age born during or entering their first RSV season. Its use is also recommended for certain children 8-19 months of age who are at increased risk for severe RSV disease at the start of their second RSV season. Hearing the approval, I immediately had a flashback to residency, recalling the multiple infants admitted each fall and winter exhibiting classic symptoms including cough, rhinorrhea, nasal flaring, retractions, and wheezing with many having oxygen requirements and others needing intubation. Only supportive care was available.

RSV is the leading cause of infant hospitalizations. Annually, the CDC estimates there are 50,000-80,000 RSV hospitalizations and 100-300 RSV-related deaths in the United States in persons younger than 5 years of age. While premature infants have the highest rates of hospitalization (three times a term infant) about 79% of hospitalized children younger than 2 years have no underlying medical risks.1 The majority of children will experience RSV as an upper respiratory infection within the first 2 years of life. However, severe disease requiring hospitalization is more likely to occur in premature infants and children younger than 6 months; children younger than 2 with congenital heart disease and/or chronic lung disease; children with severe cystic fibrosis; as well as the immunocompromised child and individuals with neuromuscular disorders that preclude clearing mucous secretions or have difficulty swallowing.

Dr. Bonnie M. Word

Palivizumab (Synagis), the first monoclonal antibody to prevent RSV in infants was licensed in 1998. Its use was limited to infants meeting specific criteria developed by the American Academy of Pediatrics. Only 5% of infants had access to it. It was a short-acting agent requiring monthly injections, which were very costly ($1,661-$2,584 per dose). Eligible infants could receive up to five injections per season. Several studies proved its use was not cost beneficial.

What are the advantages of nirsevimab? It’s a long-acting monoclonal antibody. Only one dose is required per season. Costs will significantly diminish. It is recommended for all infants younger than 8 months of age born during RSV season. Those children 8-19 months at risk for severe RSV disease can receive it prior to the start of their second RSV season. During RSV season (October 1 to March 31), the initial dose should be administered to newborns just prior to hospital discharge. Older infants and newborns who did not receive it prior to hospital discharge can receive it at their medical home. Newborns should receive it within the first week of life. It is covered by the Vaccine for Children Program. Simultaneous administration with routine childhood immunizations is recommended. Finally, RSV season may vary in tropical areas (Southern Florida, Puerto Rico. etc.) and Alaska. The timing of nirsevimab administration should be based on local RSV activity provided by state and local authorities.

In addition, the FDA approved an RSV vaccine (Abrysvo) for use in adults at least 60 years of age and in pregnant women at 32-36 weeks’ gestation. The latter is administered to prevent lower respiratory tract infection in infants from birth to 6 months. Recommendations have been published for administration in nonpregnant adults. Specific information is forthcoming in terms timing of administration of nirsevimab in infants whose mothers receive Abrysvo.

RSV season is quickly approaching. Detailed recommendations for administration and FAQ questions related to nirsevimab and palivizumab can be found at https://www.aap.org or https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.
 

 

 

Influenza

So, what about influenza? Vaccine composition has been tweaked to match the circulating viruses but the recommended age for annual routine administration remains unchanged. All persons at least 6 months of age should be vaccinated. Children between 6 months and 8 years need two doses at least 4 weeks apart when receiving vaccine for the first time. Immunizing everyone in the household is encouraged especially if there are household contacts at risk for developing severe disease, including infants too young to be vaccinated. Keep in mind children may be coinfected with multiple viruses. Adams and colleagues reviewed the prevalence of coinfection of influenza and Sars-CoV-2 in persons younger than 18 years reported to three CDC surveillance platforms during the 2021-2022 season.2 Thirty-two of 575 hospitalized (6%) coinfections were analyzed and 7 of 44 (16%) deaths. Compared with patients without coinfections, the coinfected patients were more likely to require mechanical ventilation (13% vs. 4%) or CPAP (16% vs. 6%). Only 4 of 23 who were influenza vaccine eligible were vaccinated. Of seven coinfected children who died, none had received influenza vaccine and only one received an antiviral. Only 5 of 31 (16%) infected only with influenza were vaccinated.3

Influenza activity was lower than usual during the 2021-2022 season. However, this report revealed underuse of both influenza vaccine and antiviral therapy, both of which are routinely recommended.
 

COVID-19

What’s new with COVID-19? On Sept. 12, 2023, ACIP recommended that everyone at least 6 months of age receive the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines. Children at least 5 years of age need one dose and those younger need one or two doses depending on the number of doses previously received. Why the change? Circulating variants continue to change. There is a current uptick in cases including hospitalizations (7.7%) and deaths (4.5%) and it’s just the beginning of the season.4 Symptoms, risk groups and complications have not changed. The primary goal is to prevent infection, hospitalization, long term complications, and death.

We are now armed with the most up-to-date interventions to help prevent the acquisition of these three viruses. Our next step is recommending and delivering them to our patients.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She reported no relevant financial disclosures.

References

1.Suh M et al. J Infect Dis. 2022;226(Suppl 2):S154-36. doi: 10.1093/infdis/jiac120.

2. Adams K et al. MMWR Morb Mortal Wkly Rep. 2022;71:1589-96. doi: http://dx.doi.org/10.15585/mmwr.mm7150a4.

3. Pingali C et al. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72:912-9. doi: http://dx.doi.org/10.15585/mmwr.mm7234a3.

4. CDC Covid Data Tracker.

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New armamentaria available to fight an old disease.

New armamentaria available to fight an old disease.

In July 2023, nirsevimab (Beyfortus), a monoclonal antibody, was approved by the Food and Drug Administration for the prevention of respiratory syncytial virus (RSV) disease in infants and children younger than 2 years of age. On Aug. 3, 2023, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine use of it for all infants younger than 8 months of age born during or entering their first RSV season. Its use is also recommended for certain children 8-19 months of age who are at increased risk for severe RSV disease at the start of their second RSV season. Hearing the approval, I immediately had a flashback to residency, recalling the multiple infants admitted each fall and winter exhibiting classic symptoms including cough, rhinorrhea, nasal flaring, retractions, and wheezing with many having oxygen requirements and others needing intubation. Only supportive care was available.

RSV is the leading cause of infant hospitalizations. Annually, the CDC estimates there are 50,000-80,000 RSV hospitalizations and 100-300 RSV-related deaths in the United States in persons younger than 5 years of age. While premature infants have the highest rates of hospitalization (three times a term infant) about 79% of hospitalized children younger than 2 years have no underlying medical risks.1 The majority of children will experience RSV as an upper respiratory infection within the first 2 years of life. However, severe disease requiring hospitalization is more likely to occur in premature infants and children younger than 6 months; children younger than 2 with congenital heart disease and/or chronic lung disease; children with severe cystic fibrosis; as well as the immunocompromised child and individuals with neuromuscular disorders that preclude clearing mucous secretions or have difficulty swallowing.

Dr. Bonnie M. Word

Palivizumab (Synagis), the first monoclonal antibody to prevent RSV in infants was licensed in 1998. Its use was limited to infants meeting specific criteria developed by the American Academy of Pediatrics. Only 5% of infants had access to it. It was a short-acting agent requiring monthly injections, which were very costly ($1,661-$2,584 per dose). Eligible infants could receive up to five injections per season. Several studies proved its use was not cost beneficial.

What are the advantages of nirsevimab? It’s a long-acting monoclonal antibody. Only one dose is required per season. Costs will significantly diminish. It is recommended for all infants younger than 8 months of age born during RSV season. Those children 8-19 months at risk for severe RSV disease can receive it prior to the start of their second RSV season. During RSV season (October 1 to March 31), the initial dose should be administered to newborns just prior to hospital discharge. Older infants and newborns who did not receive it prior to hospital discharge can receive it at their medical home. Newborns should receive it within the first week of life. It is covered by the Vaccine for Children Program. Simultaneous administration with routine childhood immunizations is recommended. Finally, RSV season may vary in tropical areas (Southern Florida, Puerto Rico. etc.) and Alaska. The timing of nirsevimab administration should be based on local RSV activity provided by state and local authorities.

In addition, the FDA approved an RSV vaccine (Abrysvo) for use in adults at least 60 years of age and in pregnant women at 32-36 weeks’ gestation. The latter is administered to prevent lower respiratory tract infection in infants from birth to 6 months. Recommendations have been published for administration in nonpregnant adults. Specific information is forthcoming in terms timing of administration of nirsevimab in infants whose mothers receive Abrysvo.

RSV season is quickly approaching. Detailed recommendations for administration and FAQ questions related to nirsevimab and palivizumab can be found at https://www.aap.org or https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.
 

 

 

Influenza

So, what about influenza? Vaccine composition has been tweaked to match the circulating viruses but the recommended age for annual routine administration remains unchanged. All persons at least 6 months of age should be vaccinated. Children between 6 months and 8 years need two doses at least 4 weeks apart when receiving vaccine for the first time. Immunizing everyone in the household is encouraged especially if there are household contacts at risk for developing severe disease, including infants too young to be vaccinated. Keep in mind children may be coinfected with multiple viruses. Adams and colleagues reviewed the prevalence of coinfection of influenza and Sars-CoV-2 in persons younger than 18 years reported to three CDC surveillance platforms during the 2021-2022 season.2 Thirty-two of 575 hospitalized (6%) coinfections were analyzed and 7 of 44 (16%) deaths. Compared with patients without coinfections, the coinfected patients were more likely to require mechanical ventilation (13% vs. 4%) or CPAP (16% vs. 6%). Only 4 of 23 who were influenza vaccine eligible were vaccinated. Of seven coinfected children who died, none had received influenza vaccine and only one received an antiviral. Only 5 of 31 (16%) infected only with influenza were vaccinated.3

Influenza activity was lower than usual during the 2021-2022 season. However, this report revealed underuse of both influenza vaccine and antiviral therapy, both of which are routinely recommended.
 

COVID-19

What’s new with COVID-19? On Sept. 12, 2023, ACIP recommended that everyone at least 6 months of age receive the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines. Children at least 5 years of age need one dose and those younger need one or two doses depending on the number of doses previously received. Why the change? Circulating variants continue to change. There is a current uptick in cases including hospitalizations (7.7%) and deaths (4.5%) and it’s just the beginning of the season.4 Symptoms, risk groups and complications have not changed. The primary goal is to prevent infection, hospitalization, long term complications, and death.

We are now armed with the most up-to-date interventions to help prevent the acquisition of these three viruses. Our next step is recommending and delivering them to our patients.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She reported no relevant financial disclosures.

References

1.Suh M et al. J Infect Dis. 2022;226(Suppl 2):S154-36. doi: 10.1093/infdis/jiac120.

2. Adams K et al. MMWR Morb Mortal Wkly Rep. 2022;71:1589-96. doi: http://dx.doi.org/10.15585/mmwr.mm7150a4.

3. Pingali C et al. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72:912-9. doi: http://dx.doi.org/10.15585/mmwr.mm7234a3.

4. CDC Covid Data Tracker.

In July 2023, nirsevimab (Beyfortus), a monoclonal antibody, was approved by the Food and Drug Administration for the prevention of respiratory syncytial virus (RSV) disease in infants and children younger than 2 years of age. On Aug. 3, 2023, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention recommended routine use of it for all infants younger than 8 months of age born during or entering their first RSV season. Its use is also recommended for certain children 8-19 months of age who are at increased risk for severe RSV disease at the start of their second RSV season. Hearing the approval, I immediately had a flashback to residency, recalling the multiple infants admitted each fall and winter exhibiting classic symptoms including cough, rhinorrhea, nasal flaring, retractions, and wheezing with many having oxygen requirements and others needing intubation. Only supportive care was available.

RSV is the leading cause of infant hospitalizations. Annually, the CDC estimates there are 50,000-80,000 RSV hospitalizations and 100-300 RSV-related deaths in the United States in persons younger than 5 years of age. While premature infants have the highest rates of hospitalization (three times a term infant) about 79% of hospitalized children younger than 2 years have no underlying medical risks.1 The majority of children will experience RSV as an upper respiratory infection within the first 2 years of life. However, severe disease requiring hospitalization is more likely to occur in premature infants and children younger than 6 months; children younger than 2 with congenital heart disease and/or chronic lung disease; children with severe cystic fibrosis; as well as the immunocompromised child and individuals with neuromuscular disorders that preclude clearing mucous secretions or have difficulty swallowing.

Dr. Bonnie M. Word

Palivizumab (Synagis), the first monoclonal antibody to prevent RSV in infants was licensed in 1998. Its use was limited to infants meeting specific criteria developed by the American Academy of Pediatrics. Only 5% of infants had access to it. It was a short-acting agent requiring monthly injections, which were very costly ($1,661-$2,584 per dose). Eligible infants could receive up to five injections per season. Several studies proved its use was not cost beneficial.

What are the advantages of nirsevimab? It’s a long-acting monoclonal antibody. Only one dose is required per season. Costs will significantly diminish. It is recommended for all infants younger than 8 months of age born during RSV season. Those children 8-19 months at risk for severe RSV disease can receive it prior to the start of their second RSV season. During RSV season (October 1 to March 31), the initial dose should be administered to newborns just prior to hospital discharge. Older infants and newborns who did not receive it prior to hospital discharge can receive it at their medical home. Newborns should receive it within the first week of life. It is covered by the Vaccine for Children Program. Simultaneous administration with routine childhood immunizations is recommended. Finally, RSV season may vary in tropical areas (Southern Florida, Puerto Rico. etc.) and Alaska. The timing of nirsevimab administration should be based on local RSV activity provided by state and local authorities.

In addition, the FDA approved an RSV vaccine (Abrysvo) for use in adults at least 60 years of age and in pregnant women at 32-36 weeks’ gestation. The latter is administered to prevent lower respiratory tract infection in infants from birth to 6 months. Recommendations have been published for administration in nonpregnant adults. Specific information is forthcoming in terms timing of administration of nirsevimab in infants whose mothers receive Abrysvo.

RSV season is quickly approaching. Detailed recommendations for administration and FAQ questions related to nirsevimab and palivizumab can be found at https://www.aap.org or https://www.cdc.gov/vaccines/hcp/acip-recs/index.html.
 

 

 

Influenza

So, what about influenza? Vaccine composition has been tweaked to match the circulating viruses but the recommended age for annual routine administration remains unchanged. All persons at least 6 months of age should be vaccinated. Children between 6 months and 8 years need two doses at least 4 weeks apart when receiving vaccine for the first time. Immunizing everyone in the household is encouraged especially if there are household contacts at risk for developing severe disease, including infants too young to be vaccinated. Keep in mind children may be coinfected with multiple viruses. Adams and colleagues reviewed the prevalence of coinfection of influenza and Sars-CoV-2 in persons younger than 18 years reported to three CDC surveillance platforms during the 2021-2022 season.2 Thirty-two of 575 hospitalized (6%) coinfections were analyzed and 7 of 44 (16%) deaths. Compared with patients without coinfections, the coinfected patients were more likely to require mechanical ventilation (13% vs. 4%) or CPAP (16% vs. 6%). Only 4 of 23 who were influenza vaccine eligible were vaccinated. Of seven coinfected children who died, none had received influenza vaccine and only one received an antiviral. Only 5 of 31 (16%) infected only with influenza were vaccinated.3

Influenza activity was lower than usual during the 2021-2022 season. However, this report revealed underuse of both influenza vaccine and antiviral therapy, both of which are routinely recommended.
 

COVID-19

What’s new with COVID-19? On Sept. 12, 2023, ACIP recommended that everyone at least 6 months of age receive the 2023-2024 (monovalent, XBB containing) COVID-19 vaccines. Children at least 5 years of age need one dose and those younger need one or two doses depending on the number of doses previously received. Why the change? Circulating variants continue to change. There is a current uptick in cases including hospitalizations (7.7%) and deaths (4.5%) and it’s just the beginning of the season.4 Symptoms, risk groups and complications have not changed. The primary goal is to prevent infection, hospitalization, long term complications, and death.

We are now armed with the most up-to-date interventions to help prevent the acquisition of these three viruses. Our next step is recommending and delivering them to our patients.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She reported no relevant financial disclosures.

References

1.Suh M et al. J Infect Dis. 2022;226(Suppl 2):S154-36. doi: 10.1093/infdis/jiac120.

2. Adams K et al. MMWR Morb Mortal Wkly Rep. 2022;71:1589-96. doi: http://dx.doi.org/10.15585/mmwr.mm7150a4.

3. Pingali C et al. MMWR Morb Mortal Wkly Rep. 2023 Aug 25;72:912-9. doi: http://dx.doi.org/10.15585/mmwr.mm7234a3.

4. CDC Covid Data Tracker.

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FDA approves first tocilizumab biosimilar

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Thu, 10/05/2023 - 20:33

The Food and Drug Administration has approved the biosimilar tocilizumab-bavi (Tofidence), Biogen, the drug’s manufacturer, announced on Sept. 29.

It is the first tocilizumab biosimilar approved by the FDA. The reference product, Actemra (Genentech), was first approved by the agency in 2010.

“The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” Ian Henshaw, global head of biosimilars at Biogen, said in a statement. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for health care systems and an increase in physician choice and patient access to biologics.”

Biogen’s pricing for tocilizumab-bavi will be available closer to the product’s launch date, which has yet to be determined, a company spokesman said. The U.S. average monthly cost of Actemra for rheumatoid arthritis, administered intravenously, is $2,134-$4,268 depending on dosage, according to a Genentech spokesperson.

Tocilizumab-bavi is an intravenous formulation (20 mg/mL) indicated for treatment of moderately to severely active RA, polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). The medication is administered every 4 weeks in RA and PJIA and every 8 weeks in SJIA as a single intravenous drip infusion over 1 hour.

The European Commission approved its first tocilizumab biosimilar, Tyenne (Fresenius Kabi), earlier in 2023 in both subcutaneous and intravenous formulations. Biogen did not comment on whether the company is working on a subcutaneous formulation for tocilizumab-bavi.

A version of this article appeared on Medscape.com.

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The Food and Drug Administration has approved the biosimilar tocilizumab-bavi (Tofidence), Biogen, the drug’s manufacturer, announced on Sept. 29.

It is the first tocilizumab biosimilar approved by the FDA. The reference product, Actemra (Genentech), was first approved by the agency in 2010.

“The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” Ian Henshaw, global head of biosimilars at Biogen, said in a statement. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for health care systems and an increase in physician choice and patient access to biologics.”

Biogen’s pricing for tocilizumab-bavi will be available closer to the product’s launch date, which has yet to be determined, a company spokesman said. The U.S. average monthly cost of Actemra for rheumatoid arthritis, administered intravenously, is $2,134-$4,268 depending on dosage, according to a Genentech spokesperson.

Tocilizumab-bavi is an intravenous formulation (20 mg/mL) indicated for treatment of moderately to severely active RA, polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). The medication is administered every 4 weeks in RA and PJIA and every 8 weeks in SJIA as a single intravenous drip infusion over 1 hour.

The European Commission approved its first tocilizumab biosimilar, Tyenne (Fresenius Kabi), earlier in 2023 in both subcutaneous and intravenous formulations. Biogen did not comment on whether the company is working on a subcutaneous formulation for tocilizumab-bavi.

A version of this article appeared on Medscape.com.

The Food and Drug Administration has approved the biosimilar tocilizumab-bavi (Tofidence), Biogen, the drug’s manufacturer, announced on Sept. 29.

It is the first tocilizumab biosimilar approved by the FDA. The reference product, Actemra (Genentech), was first approved by the agency in 2010.

“The approval of Tofidence in the U.S. marks another positive step toward helping more people with chronic autoimmune conditions gain access to leading therapies,” Ian Henshaw, global head of biosimilars at Biogen, said in a statement. “With the increasing numbers of approved biosimilars, we expect increased savings and sustainability for health care systems and an increase in physician choice and patient access to biologics.”

Biogen’s pricing for tocilizumab-bavi will be available closer to the product’s launch date, which has yet to be determined, a company spokesman said. The U.S. average monthly cost of Actemra for rheumatoid arthritis, administered intravenously, is $2,134-$4,268 depending on dosage, according to a Genentech spokesperson.

Tocilizumab-bavi is an intravenous formulation (20 mg/mL) indicated for treatment of moderately to severely active RA, polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). The medication is administered every 4 weeks in RA and PJIA and every 8 weeks in SJIA as a single intravenous drip infusion over 1 hour.

The European Commission approved its first tocilizumab biosimilar, Tyenne (Fresenius Kabi), earlier in 2023 in both subcutaneous and intravenous formulations. Biogen did not comment on whether the company is working on a subcutaneous formulation for tocilizumab-bavi.

A version of this article appeared on Medscape.com.

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AHA updates CPR guidelines on cardiac arrest after poisoning

Article Type
Changed
Tue, 10/03/2023 - 09:35

The American Heart Association has released a focused update on managing patients with cardiac arrest or life-threatening toxicity due to poisoning.

The update reflects treatment advances and new knowledge, including the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for patients whose condition is refractory to poison antidotes and other therapies.

The new guidelines are designed primarily for North American health care professionals who treat adults and children who are critically ill because of poisoning, including intentional and unintentional drug overdose, chemical exposure, and drug-drug interactions, the authors note.

Published online in Circulation, the update was endorsed by the American Academy of Pediatrics.
 

‘Nearly miraculous’

“It’s been 13 years since the poisoning treatment guidelines had a comprehensive update,” lead author Eric J. Lavonas, MD, professor of emergency medicine at Denver Health and the Rocky Mountain Poison and Drug Center, Colo., told this news organization. “In that time, we’ve learned a lot about how to best use antidotes and other treatments to save the most critically poisoned patients.”

Highlighting a few key points from the update, he said, “For those rare situations when antidotes aren’t enough, the new guidelines include the use of heart-lung machines (VA-ECMO) for patients with beta-blocker, calcium channel blocker, or sodium channel blocker poisoning causing cardiogenic shock.”

Furthermore, he said, “High-dose insulin treatment for patients with beta-blocker and calcium channel blocker poisoning [also recommended in the update] has really become mainstream. The doses are up to 10 times higher than the amount used to treat diabetic emergencies.

“Some excellent science has shown that giving IV lipid emulsion can save the life of someone with an accidental overdose of local anesthetic medications, particularly bupivacaine,” he added. “The result is sometimes nearly miraculous.

“But when this treatment is extended to poisoning from other medications, it often doesn’t work as well, and in some situations may make things worse,” he said. “The issue may be that giving lipids increases absorption of drug from the stomach and intestines, which can be dangerous when the patient took an overdose of pills.”
 

Low level of evidence

The guidelines were compiled by the Critical Poisoning Writing Group, which includes experts from emergency medicine, pediatrics, medical toxicology, pharmacology, critical care, emergency medical services, education, research, and nursing. Group members were appointed by the AHA Emergency Cardiovascular Care Science Subcommittee and were approved by the AHA Manuscript Oversight Committee.

First and foremost, the group recommends timely consultation with a medical toxicologist, a clinical toxicologist, or a regional poison center to facilitate rapid, effective therapy, because treatment of cardiac arrest and toxicity from poisoning often requires treatments that most clinicians don’t use frequently.

Other key points include the following:

  • Naloxone administration may reverse respiratory arrest due to opioid overdose, preventing progression to cardiac arrest.
  • Give high-dose insulin therapy early in the treatment of patients with beta-blocker and calcium channel blocker poisoning, Dr. Lavonas noted.
  • Standard advanced life support plus sodium bicarbonate is appropriate for life-threatening dysrhythmias caused by cocaine or other sodium channel blockers.
  • If cyanide poisoning is suspected, clinicians should not wait for confirmatory testing; treatment should begin immediately with hydroxocobalamin (preferred) or sodium nitrite plus sodium thiosulfate.
  • Digoxin-specific immune antibody fragments can reverse life-threatening dysrhythmias from digoxin poisoning.
  • Use of 20% intravenous lipid emulsion can be efficacious in the resuscitation of life-threatening local anesthetic toxicity, especially from bupivacaine, Dr. Lavonas indicated.
  • Sedation is recommended for patients with severe agitation from sympathomimetic poisoning to manage hyperthermia and acidosis, prevent rhabdomyolysis and injury, and allow evaluation for other life-threatening conditions.
  • Although flumazenil reverses central nervous system and respiratory depression from benzodiazepine poisoning, risks and contraindications, provided in the guidelines, limit its use.
  • VA-ECMO can be lifesaving for patients with cardiogenic shock or dysrhythmias that are refractory to other treatments.
 

 

“Unfortunately, despite improvements in the design and funding support for resuscitation research, the overall certainty of the evidence base for resuscitation science and management of critical poisoning is low,” the group acknowledges.

Of the 73 guideline recommendations, only 2 are supported by level A evidence; 3 are supported by level B-randomized evidence, 12 by level B-nonrandomized evidence, and the rest by level C evidence.

“Accordingly, the strength of recommendations is weaker than optimal,” they write. “Clinical trials in resuscitation and the management of critical poisoning are sorely needed.”
 

‘Don’t go it alone!’

“Most critical poisonings are pretty uncommon, and each patient is different,” Dr. Lavonas said. “Even in the emergency department or ICU, most physicians will treat a patient who is critically ill with any given poison less than once a year. The antidotes and medication doses needed to effectively treat these patients are often very different than everyday medical practice.

“Don’t try to go it alone!” he urges. “Poisoning cases are complex, and the treatments work best when they are implemented quickly and assertively. A toxicologist can help sort through complex situations and get effective treatment started without delay.”

Every certified poison center has a medical toxicologist or clinical toxicologist on call 24/7 to give advice to physicians and hospitals about patients who are critically ill after being poisoned, he added. “Everyone in the U.S. has access to a poison center by calling one number: 1-800-222-1222.”

Dr. Lavonas has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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The American Heart Association has released a focused update on managing patients with cardiac arrest or life-threatening toxicity due to poisoning.

The update reflects treatment advances and new knowledge, including the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for patients whose condition is refractory to poison antidotes and other therapies.

The new guidelines are designed primarily for North American health care professionals who treat adults and children who are critically ill because of poisoning, including intentional and unintentional drug overdose, chemical exposure, and drug-drug interactions, the authors note.

Published online in Circulation, the update was endorsed by the American Academy of Pediatrics.
 

‘Nearly miraculous’

“It’s been 13 years since the poisoning treatment guidelines had a comprehensive update,” lead author Eric J. Lavonas, MD, professor of emergency medicine at Denver Health and the Rocky Mountain Poison and Drug Center, Colo., told this news organization. “In that time, we’ve learned a lot about how to best use antidotes and other treatments to save the most critically poisoned patients.”

Highlighting a few key points from the update, he said, “For those rare situations when antidotes aren’t enough, the new guidelines include the use of heart-lung machines (VA-ECMO) for patients with beta-blocker, calcium channel blocker, or sodium channel blocker poisoning causing cardiogenic shock.”

Furthermore, he said, “High-dose insulin treatment for patients with beta-blocker and calcium channel blocker poisoning [also recommended in the update] has really become mainstream. The doses are up to 10 times higher than the amount used to treat diabetic emergencies.

“Some excellent science has shown that giving IV lipid emulsion can save the life of someone with an accidental overdose of local anesthetic medications, particularly bupivacaine,” he added. “The result is sometimes nearly miraculous.

“But when this treatment is extended to poisoning from other medications, it often doesn’t work as well, and in some situations may make things worse,” he said. “The issue may be that giving lipids increases absorption of drug from the stomach and intestines, which can be dangerous when the patient took an overdose of pills.”
 

Low level of evidence

The guidelines were compiled by the Critical Poisoning Writing Group, which includes experts from emergency medicine, pediatrics, medical toxicology, pharmacology, critical care, emergency medical services, education, research, and nursing. Group members were appointed by the AHA Emergency Cardiovascular Care Science Subcommittee and were approved by the AHA Manuscript Oversight Committee.

First and foremost, the group recommends timely consultation with a medical toxicologist, a clinical toxicologist, or a regional poison center to facilitate rapid, effective therapy, because treatment of cardiac arrest and toxicity from poisoning often requires treatments that most clinicians don’t use frequently.

Other key points include the following:

  • Naloxone administration may reverse respiratory arrest due to opioid overdose, preventing progression to cardiac arrest.
  • Give high-dose insulin therapy early in the treatment of patients with beta-blocker and calcium channel blocker poisoning, Dr. Lavonas noted.
  • Standard advanced life support plus sodium bicarbonate is appropriate for life-threatening dysrhythmias caused by cocaine or other sodium channel blockers.
  • If cyanide poisoning is suspected, clinicians should not wait for confirmatory testing; treatment should begin immediately with hydroxocobalamin (preferred) or sodium nitrite plus sodium thiosulfate.
  • Digoxin-specific immune antibody fragments can reverse life-threatening dysrhythmias from digoxin poisoning.
  • Use of 20% intravenous lipid emulsion can be efficacious in the resuscitation of life-threatening local anesthetic toxicity, especially from bupivacaine, Dr. Lavonas indicated.
  • Sedation is recommended for patients with severe agitation from sympathomimetic poisoning to manage hyperthermia and acidosis, prevent rhabdomyolysis and injury, and allow evaluation for other life-threatening conditions.
  • Although flumazenil reverses central nervous system and respiratory depression from benzodiazepine poisoning, risks and contraindications, provided in the guidelines, limit its use.
  • VA-ECMO can be lifesaving for patients with cardiogenic shock or dysrhythmias that are refractory to other treatments.
 

 

“Unfortunately, despite improvements in the design and funding support for resuscitation research, the overall certainty of the evidence base for resuscitation science and management of critical poisoning is low,” the group acknowledges.

Of the 73 guideline recommendations, only 2 are supported by level A evidence; 3 are supported by level B-randomized evidence, 12 by level B-nonrandomized evidence, and the rest by level C evidence.

“Accordingly, the strength of recommendations is weaker than optimal,” they write. “Clinical trials in resuscitation and the management of critical poisoning are sorely needed.”
 

‘Don’t go it alone!’

“Most critical poisonings are pretty uncommon, and each patient is different,” Dr. Lavonas said. “Even in the emergency department or ICU, most physicians will treat a patient who is critically ill with any given poison less than once a year. The antidotes and medication doses needed to effectively treat these patients are often very different than everyday medical practice.

“Don’t try to go it alone!” he urges. “Poisoning cases are complex, and the treatments work best when they are implemented quickly and assertively. A toxicologist can help sort through complex situations and get effective treatment started without delay.”

Every certified poison center has a medical toxicologist or clinical toxicologist on call 24/7 to give advice to physicians and hospitals about patients who are critically ill after being poisoned, he added. “Everyone in the U.S. has access to a poison center by calling one number: 1-800-222-1222.”

Dr. Lavonas has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The American Heart Association has released a focused update on managing patients with cardiac arrest or life-threatening toxicity due to poisoning.

The update reflects treatment advances and new knowledge, including the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) for patients whose condition is refractory to poison antidotes and other therapies.

The new guidelines are designed primarily for North American health care professionals who treat adults and children who are critically ill because of poisoning, including intentional and unintentional drug overdose, chemical exposure, and drug-drug interactions, the authors note.

Published online in Circulation, the update was endorsed by the American Academy of Pediatrics.
 

‘Nearly miraculous’

“It’s been 13 years since the poisoning treatment guidelines had a comprehensive update,” lead author Eric J. Lavonas, MD, professor of emergency medicine at Denver Health and the Rocky Mountain Poison and Drug Center, Colo., told this news organization. “In that time, we’ve learned a lot about how to best use antidotes and other treatments to save the most critically poisoned patients.”

Highlighting a few key points from the update, he said, “For those rare situations when antidotes aren’t enough, the new guidelines include the use of heart-lung machines (VA-ECMO) for patients with beta-blocker, calcium channel blocker, or sodium channel blocker poisoning causing cardiogenic shock.”

Furthermore, he said, “High-dose insulin treatment for patients with beta-blocker and calcium channel blocker poisoning [also recommended in the update] has really become mainstream. The doses are up to 10 times higher than the amount used to treat diabetic emergencies.

“Some excellent science has shown that giving IV lipid emulsion can save the life of someone with an accidental overdose of local anesthetic medications, particularly bupivacaine,” he added. “The result is sometimes nearly miraculous.

“But when this treatment is extended to poisoning from other medications, it often doesn’t work as well, and in some situations may make things worse,” he said. “The issue may be that giving lipids increases absorption of drug from the stomach and intestines, which can be dangerous when the patient took an overdose of pills.”
 

Low level of evidence

The guidelines were compiled by the Critical Poisoning Writing Group, which includes experts from emergency medicine, pediatrics, medical toxicology, pharmacology, critical care, emergency medical services, education, research, and nursing. Group members were appointed by the AHA Emergency Cardiovascular Care Science Subcommittee and were approved by the AHA Manuscript Oversight Committee.

First and foremost, the group recommends timely consultation with a medical toxicologist, a clinical toxicologist, or a regional poison center to facilitate rapid, effective therapy, because treatment of cardiac arrest and toxicity from poisoning often requires treatments that most clinicians don’t use frequently.

Other key points include the following:

  • Naloxone administration may reverse respiratory arrest due to opioid overdose, preventing progression to cardiac arrest.
  • Give high-dose insulin therapy early in the treatment of patients with beta-blocker and calcium channel blocker poisoning, Dr. Lavonas noted.
  • Standard advanced life support plus sodium bicarbonate is appropriate for life-threatening dysrhythmias caused by cocaine or other sodium channel blockers.
  • If cyanide poisoning is suspected, clinicians should not wait for confirmatory testing; treatment should begin immediately with hydroxocobalamin (preferred) or sodium nitrite plus sodium thiosulfate.
  • Digoxin-specific immune antibody fragments can reverse life-threatening dysrhythmias from digoxin poisoning.
  • Use of 20% intravenous lipid emulsion can be efficacious in the resuscitation of life-threatening local anesthetic toxicity, especially from bupivacaine, Dr. Lavonas indicated.
  • Sedation is recommended for patients with severe agitation from sympathomimetic poisoning to manage hyperthermia and acidosis, prevent rhabdomyolysis and injury, and allow evaluation for other life-threatening conditions.
  • Although flumazenil reverses central nervous system and respiratory depression from benzodiazepine poisoning, risks and contraindications, provided in the guidelines, limit its use.
  • VA-ECMO can be lifesaving for patients with cardiogenic shock or dysrhythmias that are refractory to other treatments.
 

 

“Unfortunately, despite improvements in the design and funding support for resuscitation research, the overall certainty of the evidence base for resuscitation science and management of critical poisoning is low,” the group acknowledges.

Of the 73 guideline recommendations, only 2 are supported by level A evidence; 3 are supported by level B-randomized evidence, 12 by level B-nonrandomized evidence, and the rest by level C evidence.

“Accordingly, the strength of recommendations is weaker than optimal,” they write. “Clinical trials in resuscitation and the management of critical poisoning are sorely needed.”
 

‘Don’t go it alone!’

“Most critical poisonings are pretty uncommon, and each patient is different,” Dr. Lavonas said. “Even in the emergency department or ICU, most physicians will treat a patient who is critically ill with any given poison less than once a year. The antidotes and medication doses needed to effectively treat these patients are often very different than everyday medical practice.

“Don’t try to go it alone!” he urges. “Poisoning cases are complex, and the treatments work best when they are implemented quickly and assertively. A toxicologist can help sort through complex situations and get effective treatment started without delay.”

Every certified poison center has a medical toxicologist or clinical toxicologist on call 24/7 to give advice to physicians and hospitals about patients who are critically ill after being poisoned, he added. “Everyone in the U.S. has access to a poison center by calling one number: 1-800-222-1222.”

Dr. Lavonas has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

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Study finds inflammatory bowel disease risk higher in children, adults with atopic dermatitis

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Changed
Tue, 10/03/2023 - 11:50

The risk for inflammatory bowel disease (IBD) was increased among children and adults with atopic dermatitis (AD), with the risk increasing with AD severity, according to data from a large cohort study published recently in JAMA Dermatology.

The study also found an increased risk for Crohn’s disease (CD) in adults and children with AD, as well as an increased risk for ulcerative colitis (UC) in adults with AD and in children with severe AD, researchers reported.

“It is imperative for clinicians to understand atopic dermatitis and the trajectory of our patients with it in order to provide the best standard of care,” senior author Joel M. Gelfand, MD, MSCE, professor in clinical investigation with the department of dermatology at the University of Pennsylvania, Philadelphia, said in a news release.

Courtesy Dr. Gelfand
Dr. Joel M. Gelfand

“There are new and better treatments for AD today, and there will likely continue to be more,” continued Dr. Gelfand. “But providers have to understand how those treatments could impact other autoimmune diseases. For patients with AD and another autoimmune disease, some currently available medications can exacerbate symptoms of their other disease or can help treat two immune diseases at the same time.”

The study results support the idea that AD and IBD may have some common underlying causes, said Sheilagh Maguiness, MD, pediatric dermatologist and associate professor in the department of dermatology at the University of Minnesota, Minneapolis, who was asked to comment on the findings.

“As the pathogenesis of AD is becoming better understood, we are recognizing that, rather than simply a cutaneous disease, the underlying inflammation and immune dysregulation that leads to AD best categorizes it as a systemic inflammatory disease with significant comorbidities,” she told this news organization. “I will be more likely to ask patients and families about GI symptoms, and if positive, may plan to refer to GI more readily than in the past,” added Dr. Maguiness, who was not involved in the study.

Dr. Sheilagh Maguiness

 

UK general practice cohort

AD has been associated with an increasing number of comorbidities, including IBD, but studies linking AD with IBD, including UC, have had mixed results, the authors wrote. And few studies have separately examined how AD or AD severity may be linked with UC or CD risk.

To examine the risk for new-onset IBD, UC, and CD in children and adults with atopic dermatitis, the researchers conducted a population-based cohort study using the THIN (The Health Improvement Network) electronic medical record database of patients registered with United Kingdom general practices. They used 21 years of data collected from January 1994 to February 2015.

The researchers matched each patient who had AD with up to five controls based on age, practice, and index date. Because THIN does not capture AD severity, they used treatment exposure assessed by dermatologic referrals and treatments patients received as proxy for severity. The authors used logistic regression to examine the risks for IBD, UC, and CD in children (aged 1-10) with AD, and in adults (aged 30-68) with AD, and they compared their outcomes with the outcomes for controls.

In the pediatric cohort, the team compared 409,431 children who had AD with 1.8 million children without AD. Slightly more than half were boys. In the adult cohort, they compared 625,083 people who had AD with 2.68 million controls, and slightly more than half were women. Data on race or ethnicity were not available, the authors wrote, but the THIN database is considered to be representative of the UK population.
 

 

 

AD severity linked with IBD risk

The risk for new-onset inflammatory bowel disease appears to be higher in children and adults with AD, and the risk varies based on age, AD severity, and subtype of inflammatory bowel disease, the authors reported.

Overall, AD in children was associated with a 44% increased risk for IBD (adjusted hazard ratio (HR), 1.44; 95% confidence interval [CI], 1.31-1.58) compared with controls, the authors reported. They found a 74% increased risk for CD in children with AD compared with controls (HR, 1.74; 95% CI, 1.54-1.97). More severe AD was linked with increased risk for both IBD and CD.



AD did not appear to increase risk for UC in children, except those with severe AD (HR, 1.65; 95% CI, 1.02-2.67).

Overall, adults with AD had a 34% (HR, 1.34; 95% CI, 1.27-1.40) increased risk for IBD, a 36% (HR, 1.36; 95% CI, 1.26-1.47) increased risk for CD, and a 32% (HR, 1.32; 95% CI, 1.24-1.41) increased risk for UC, with risk increasing with increased AD severity.

Robust data with cautionary note

“This study provides the most robust data to date on the association between IBD and AD. It provides clear evidence for an association that most dermatologists or primary care providers are not typically taught in training,” Kelly Scarberry, MD, assistant professor of dermatology at Case Western Reserve University in Cleveland, told this news organization. “I will be much more likely to pursue diagnostic workup in my AD patients who have GI complaints.”

Case Western Reserve University
Dr. Kelly Scarberry

However, AD severity was measured by proxy, added Dr. Scarberry, who was not involved in the study, and the study lacked important racial and ethnic data.

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., also not involved in the study, said in an interview that she found the size of the cohort and the longitudinal data to be strengths of the study.

Wake Forest University
Dr. Lindsay C. Strowd

But, she added, the “lack of family IBD history, race and ethnicity, and comorbidities, are limitations, as is treatment exposure used as a proxy for disease severity, given that physician treatment practices differ.”

For Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest, “the most important conclusion, and it is a definitive finding, [is] that IBD is uncommon, even in patients with AD.

“The findings could be misinterpreted,” cautioned Dr. Feldman, who was not involved in the study. “While there is an increased relative risk, the absolute risk is small.” The study found that “the highest relative risk group is children with severe AD, who have a roughly fivefold increased risk for CD.” However, he added, the incidence rates of CD were 0.68 per 1,000 person-years in children with severe AD and 0.08 per 1,000 person-years in controls.

Wake Forest University
Dr. Steven R. Feldman

“Basically, because Crohn’s disease and IBD don’t happen very often, the modest increase in relative risk the investigators found doesn’t amount to much we’d have to worry about,” he said. “The findings do not show any need to screen patients with atopic dermatitis for IBD any more than we’d need to screen patients without atopic dermatitis.”

The increased relative risk “could be a clue to possible genetic connections between diseases,” he added. “But when we’re making clinical decisions, those decisions should be based on the absolute risk that some event may occur.”

Susan Massick, MD, dermatologist and associate professor at The Ohio State University in Columbus, who was not involved with the study, said in an interview, “We are still scratching the surface of the complexity of the immune and inflammatory pathways in AD and IBD.

The Ohio State Wexner Medical Center
Dr. Susan Massick

“It is important to remember that correlation does not mean causation,” Dr. Massick said. “It would be premature to draw direct conclusions based on this study alone.”

The authors recommend future related studies in more diverse populations.

Dr. Gelfand and two coauthors reported ties with Pfizer, which supported the study. Dr. Gelfand and three coauthors reported ties with other pharmaceutical companies. Dr. Maguiness, Dr. Scarberry, Dr. Strowd, and Dr. Massick reported having no relevant disclosures. Dr. Feldman reported ties with Pfizer and other pharmaceutical companies.

A version of this article appeared on Medscape.com.

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The risk for inflammatory bowel disease (IBD) was increased among children and adults with atopic dermatitis (AD), with the risk increasing with AD severity, according to data from a large cohort study published recently in JAMA Dermatology.

The study also found an increased risk for Crohn’s disease (CD) in adults and children with AD, as well as an increased risk for ulcerative colitis (UC) in adults with AD and in children with severe AD, researchers reported.

“It is imperative for clinicians to understand atopic dermatitis and the trajectory of our patients with it in order to provide the best standard of care,” senior author Joel M. Gelfand, MD, MSCE, professor in clinical investigation with the department of dermatology at the University of Pennsylvania, Philadelphia, said in a news release.

Courtesy Dr. Gelfand
Dr. Joel M. Gelfand

“There are new and better treatments for AD today, and there will likely continue to be more,” continued Dr. Gelfand. “But providers have to understand how those treatments could impact other autoimmune diseases. For patients with AD and another autoimmune disease, some currently available medications can exacerbate symptoms of their other disease or can help treat two immune diseases at the same time.”

The study results support the idea that AD and IBD may have some common underlying causes, said Sheilagh Maguiness, MD, pediatric dermatologist and associate professor in the department of dermatology at the University of Minnesota, Minneapolis, who was asked to comment on the findings.

“As the pathogenesis of AD is becoming better understood, we are recognizing that, rather than simply a cutaneous disease, the underlying inflammation and immune dysregulation that leads to AD best categorizes it as a systemic inflammatory disease with significant comorbidities,” she told this news organization. “I will be more likely to ask patients and families about GI symptoms, and if positive, may plan to refer to GI more readily than in the past,” added Dr. Maguiness, who was not involved in the study.

Dr. Sheilagh Maguiness

 

UK general practice cohort

AD has been associated with an increasing number of comorbidities, including IBD, but studies linking AD with IBD, including UC, have had mixed results, the authors wrote. And few studies have separately examined how AD or AD severity may be linked with UC or CD risk.

To examine the risk for new-onset IBD, UC, and CD in children and adults with atopic dermatitis, the researchers conducted a population-based cohort study using the THIN (The Health Improvement Network) electronic medical record database of patients registered with United Kingdom general practices. They used 21 years of data collected from January 1994 to February 2015.

The researchers matched each patient who had AD with up to five controls based on age, practice, and index date. Because THIN does not capture AD severity, they used treatment exposure assessed by dermatologic referrals and treatments patients received as proxy for severity. The authors used logistic regression to examine the risks for IBD, UC, and CD in children (aged 1-10) with AD, and in adults (aged 30-68) with AD, and they compared their outcomes with the outcomes for controls.

In the pediatric cohort, the team compared 409,431 children who had AD with 1.8 million children without AD. Slightly more than half were boys. In the adult cohort, they compared 625,083 people who had AD with 2.68 million controls, and slightly more than half were women. Data on race or ethnicity were not available, the authors wrote, but the THIN database is considered to be representative of the UK population.
 

 

 

AD severity linked with IBD risk

The risk for new-onset inflammatory bowel disease appears to be higher in children and adults with AD, and the risk varies based on age, AD severity, and subtype of inflammatory bowel disease, the authors reported.

Overall, AD in children was associated with a 44% increased risk for IBD (adjusted hazard ratio (HR), 1.44; 95% confidence interval [CI], 1.31-1.58) compared with controls, the authors reported. They found a 74% increased risk for CD in children with AD compared with controls (HR, 1.74; 95% CI, 1.54-1.97). More severe AD was linked with increased risk for both IBD and CD.



AD did not appear to increase risk for UC in children, except those with severe AD (HR, 1.65; 95% CI, 1.02-2.67).

Overall, adults with AD had a 34% (HR, 1.34; 95% CI, 1.27-1.40) increased risk for IBD, a 36% (HR, 1.36; 95% CI, 1.26-1.47) increased risk for CD, and a 32% (HR, 1.32; 95% CI, 1.24-1.41) increased risk for UC, with risk increasing with increased AD severity.

Robust data with cautionary note

“This study provides the most robust data to date on the association between IBD and AD. It provides clear evidence for an association that most dermatologists or primary care providers are not typically taught in training,” Kelly Scarberry, MD, assistant professor of dermatology at Case Western Reserve University in Cleveland, told this news organization. “I will be much more likely to pursue diagnostic workup in my AD patients who have GI complaints.”

Case Western Reserve University
Dr. Kelly Scarberry

However, AD severity was measured by proxy, added Dr. Scarberry, who was not involved in the study, and the study lacked important racial and ethnic data.

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., also not involved in the study, said in an interview that she found the size of the cohort and the longitudinal data to be strengths of the study.

Wake Forest University
Dr. Lindsay C. Strowd

But, she added, the “lack of family IBD history, race and ethnicity, and comorbidities, are limitations, as is treatment exposure used as a proxy for disease severity, given that physician treatment practices differ.”

For Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest, “the most important conclusion, and it is a definitive finding, [is] that IBD is uncommon, even in patients with AD.

“The findings could be misinterpreted,” cautioned Dr. Feldman, who was not involved in the study. “While there is an increased relative risk, the absolute risk is small.” The study found that “the highest relative risk group is children with severe AD, who have a roughly fivefold increased risk for CD.” However, he added, the incidence rates of CD were 0.68 per 1,000 person-years in children with severe AD and 0.08 per 1,000 person-years in controls.

Wake Forest University
Dr. Steven R. Feldman

“Basically, because Crohn’s disease and IBD don’t happen very often, the modest increase in relative risk the investigators found doesn’t amount to much we’d have to worry about,” he said. “The findings do not show any need to screen patients with atopic dermatitis for IBD any more than we’d need to screen patients without atopic dermatitis.”

The increased relative risk “could be a clue to possible genetic connections between diseases,” he added. “But when we’re making clinical decisions, those decisions should be based on the absolute risk that some event may occur.”

Susan Massick, MD, dermatologist and associate professor at The Ohio State University in Columbus, who was not involved with the study, said in an interview, “We are still scratching the surface of the complexity of the immune and inflammatory pathways in AD and IBD.

The Ohio State Wexner Medical Center
Dr. Susan Massick

“It is important to remember that correlation does not mean causation,” Dr. Massick said. “It would be premature to draw direct conclusions based on this study alone.”

The authors recommend future related studies in more diverse populations.

Dr. Gelfand and two coauthors reported ties with Pfizer, which supported the study. Dr. Gelfand and three coauthors reported ties with other pharmaceutical companies. Dr. Maguiness, Dr. Scarberry, Dr. Strowd, and Dr. Massick reported having no relevant disclosures. Dr. Feldman reported ties with Pfizer and other pharmaceutical companies.

A version of this article appeared on Medscape.com.

The risk for inflammatory bowel disease (IBD) was increased among children and adults with atopic dermatitis (AD), with the risk increasing with AD severity, according to data from a large cohort study published recently in JAMA Dermatology.

The study also found an increased risk for Crohn’s disease (CD) in adults and children with AD, as well as an increased risk for ulcerative colitis (UC) in adults with AD and in children with severe AD, researchers reported.

“It is imperative for clinicians to understand atopic dermatitis and the trajectory of our patients with it in order to provide the best standard of care,” senior author Joel M. Gelfand, MD, MSCE, professor in clinical investigation with the department of dermatology at the University of Pennsylvania, Philadelphia, said in a news release.

Courtesy Dr. Gelfand
Dr. Joel M. Gelfand

“There are new and better treatments for AD today, and there will likely continue to be more,” continued Dr. Gelfand. “But providers have to understand how those treatments could impact other autoimmune diseases. For patients with AD and another autoimmune disease, some currently available medications can exacerbate symptoms of their other disease or can help treat two immune diseases at the same time.”

The study results support the idea that AD and IBD may have some common underlying causes, said Sheilagh Maguiness, MD, pediatric dermatologist and associate professor in the department of dermatology at the University of Minnesota, Minneapolis, who was asked to comment on the findings.

“As the pathogenesis of AD is becoming better understood, we are recognizing that, rather than simply a cutaneous disease, the underlying inflammation and immune dysregulation that leads to AD best categorizes it as a systemic inflammatory disease with significant comorbidities,” she told this news organization. “I will be more likely to ask patients and families about GI symptoms, and if positive, may plan to refer to GI more readily than in the past,” added Dr. Maguiness, who was not involved in the study.

Dr. Sheilagh Maguiness

 

UK general practice cohort

AD has been associated with an increasing number of comorbidities, including IBD, but studies linking AD with IBD, including UC, have had mixed results, the authors wrote. And few studies have separately examined how AD or AD severity may be linked with UC or CD risk.

To examine the risk for new-onset IBD, UC, and CD in children and adults with atopic dermatitis, the researchers conducted a population-based cohort study using the THIN (The Health Improvement Network) electronic medical record database of patients registered with United Kingdom general practices. They used 21 years of data collected from January 1994 to February 2015.

The researchers matched each patient who had AD with up to five controls based on age, practice, and index date. Because THIN does not capture AD severity, they used treatment exposure assessed by dermatologic referrals and treatments patients received as proxy for severity. The authors used logistic regression to examine the risks for IBD, UC, and CD in children (aged 1-10) with AD, and in adults (aged 30-68) with AD, and they compared their outcomes with the outcomes for controls.

In the pediatric cohort, the team compared 409,431 children who had AD with 1.8 million children without AD. Slightly more than half were boys. In the adult cohort, they compared 625,083 people who had AD with 2.68 million controls, and slightly more than half were women. Data on race or ethnicity were not available, the authors wrote, but the THIN database is considered to be representative of the UK population.
 

 

 

AD severity linked with IBD risk

The risk for new-onset inflammatory bowel disease appears to be higher in children and adults with AD, and the risk varies based on age, AD severity, and subtype of inflammatory bowel disease, the authors reported.

Overall, AD in children was associated with a 44% increased risk for IBD (adjusted hazard ratio (HR), 1.44; 95% confidence interval [CI], 1.31-1.58) compared with controls, the authors reported. They found a 74% increased risk for CD in children with AD compared with controls (HR, 1.74; 95% CI, 1.54-1.97). More severe AD was linked with increased risk for both IBD and CD.



AD did not appear to increase risk for UC in children, except those with severe AD (HR, 1.65; 95% CI, 1.02-2.67).

Overall, adults with AD had a 34% (HR, 1.34; 95% CI, 1.27-1.40) increased risk for IBD, a 36% (HR, 1.36; 95% CI, 1.26-1.47) increased risk for CD, and a 32% (HR, 1.32; 95% CI, 1.24-1.41) increased risk for UC, with risk increasing with increased AD severity.

Robust data with cautionary note

“This study provides the most robust data to date on the association between IBD and AD. It provides clear evidence for an association that most dermatologists or primary care providers are not typically taught in training,” Kelly Scarberry, MD, assistant professor of dermatology at Case Western Reserve University in Cleveland, told this news organization. “I will be much more likely to pursue diagnostic workup in my AD patients who have GI complaints.”

Case Western Reserve University
Dr. Kelly Scarberry

However, AD severity was measured by proxy, added Dr. Scarberry, who was not involved in the study, and the study lacked important racial and ethnic data.

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., also not involved in the study, said in an interview that she found the size of the cohort and the longitudinal data to be strengths of the study.

Wake Forest University
Dr. Lindsay C. Strowd

But, she added, the “lack of family IBD history, race and ethnicity, and comorbidities, are limitations, as is treatment exposure used as a proxy for disease severity, given that physician treatment practices differ.”

For Steven R. Feldman, MD, PhD, professor of dermatology at Wake Forest, “the most important conclusion, and it is a definitive finding, [is] that IBD is uncommon, even in patients with AD.

“The findings could be misinterpreted,” cautioned Dr. Feldman, who was not involved in the study. “While there is an increased relative risk, the absolute risk is small.” The study found that “the highest relative risk group is children with severe AD, who have a roughly fivefold increased risk for CD.” However, he added, the incidence rates of CD were 0.68 per 1,000 person-years in children with severe AD and 0.08 per 1,000 person-years in controls.

Wake Forest University
Dr. Steven R. Feldman

“Basically, because Crohn’s disease and IBD don’t happen very often, the modest increase in relative risk the investigators found doesn’t amount to much we’d have to worry about,” he said. “The findings do not show any need to screen patients with atopic dermatitis for IBD any more than we’d need to screen patients without atopic dermatitis.”

The increased relative risk “could be a clue to possible genetic connections between diseases,” he added. “But when we’re making clinical decisions, those decisions should be based on the absolute risk that some event may occur.”

Susan Massick, MD, dermatologist and associate professor at The Ohio State University in Columbus, who was not involved with the study, said in an interview, “We are still scratching the surface of the complexity of the immune and inflammatory pathways in AD and IBD.

The Ohio State Wexner Medical Center
Dr. Susan Massick

“It is important to remember that correlation does not mean causation,” Dr. Massick said. “It would be premature to draw direct conclusions based on this study alone.”

The authors recommend future related studies in more diverse populations.

Dr. Gelfand and two coauthors reported ties with Pfizer, which supported the study. Dr. Gelfand and three coauthors reported ties with other pharmaceutical companies. Dr. Maguiness, Dr. Scarberry, Dr. Strowd, and Dr. Massick reported having no relevant disclosures. Dr. Feldman reported ties with Pfizer and other pharmaceutical companies.

A version of this article appeared on Medscape.com.

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FDA approves bosutinib for children with CML

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Fri, 09/29/2023 - 11:24

The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m2 once daily with food. For resistant/intolerant disease, the dose is 400 mg/m2 once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m2, the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m2, the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

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

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The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m2 once daily with food. For resistant/intolerant disease, the dose is 400 mg/m2 once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m2, the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m2, the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

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

The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m2 once daily with food. For resistant/intolerant disease, the dose is 400 mg/m2 once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m2, the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m2, the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

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

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Diagnosing pediatric forearm fractures: Radiograph or ultrasound?

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Thu, 09/28/2023 - 09:09

 

TOPLINE:

Ultrasonography may serve as an alternative to radiography for diagnosing pediatric forearm fractures, thus reducing the number of children undergoing radiography at initial emergency department presentation, as well as their waiting time in ED.

METHODOLOGY:

  • After the World Health Organization reported a lack of access to any diagnostic imaging in approximately two-thirds of the world population in 2010, ultrasonography has gained popularity in low- and middle-income countries.
  • The initial use of ultrasonography is in accordance with the principle of maintaining radiation levels as low as reasonably achievable.
  • The BUCKLED trial was conducted, including 270 pediatric patients (age, 5-15 years) who presented to the ED with isolated, acute, clinically nondeformed distal forearm fractures.
  • The participants were randomly assigned to receive initial point-of-care ultrasonography (n = 135) or radiography (n = 135) in the ED.
  • The primary outcome was the physical function of the affected arm at 4 weeks evaluated using the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool.

TAKEAWAY:

  • At 4 weeks, mean PROMIS scores were 36.4 and 36.3 points in ultrasonography and radiography groups, respectively (mean difference, 0.1 point; 95% confidence interval, − 1.3 to 1.4), indicating noninferiority of ultrasonography over radiography.
  • Ultrasonography and radiography groups showed similar efficacy in terms of PROMIS scores at 1 week (MD, 0.7 points; 95% CI, − 1.4 to 2.8) and 8 weeks (MD, 0.1 points; 95% CI, − 0.5 to 0.7).
  • Participants in the ultrasonography group had a shorter length of stay in the ED (median difference, 15 minutes; 95% CI, 1-29) and a shorter treatment time (median difference, 28 minutes; 95% CI, 17-40) than those in the radiography group.
  • No important fractures were missed with ultrasonography, and no significant difference was observed in the frequency of adverse events or unplanned returns to the ED between the two groups.

IN PRACTICE:

Noting the benefit-risk profile of an ultrasound-first approach in an ED setting, the lead author, Peter J. Snelling, MB, BS, MPH&TM, from Menzies Health Institute Queensland, Gold Coast, Australia, said: “It is highly unlikely that any important fractures would be missed using the protocol that we trained clinicians. The risk is low and the benefit is moderate, such as reducing length of stay and increased level of patient satisfaction.”

He further added that, “with an ultrasound-first approach, clinicians can scan the patient at time of review and may even be able to discharge them immediately (two-thirds of instances in our NEJM trial). This places the patient at the center of care being provided.”
 

SOURCE: 

Authors from the BUCKLED Trial Group published their study in the New England Journal of Medicine.

LIMITATIONS:

PROMIS scores may have been affected by variations in subsequent therapeutic interventions rather than the initial diagnostic method. PROMIS tool was not validated in children younger than 5 years of age.

DISCLOSURES:

The study was funded by the Emergency Medicine Foundation and others. The authors have declared no relevant interests to disclose.

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

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TOPLINE:

Ultrasonography may serve as an alternative to radiography for diagnosing pediatric forearm fractures, thus reducing the number of children undergoing radiography at initial emergency department presentation, as well as their waiting time in ED.

METHODOLOGY:

  • After the World Health Organization reported a lack of access to any diagnostic imaging in approximately two-thirds of the world population in 2010, ultrasonography has gained popularity in low- and middle-income countries.
  • The initial use of ultrasonography is in accordance with the principle of maintaining radiation levels as low as reasonably achievable.
  • The BUCKLED trial was conducted, including 270 pediatric patients (age, 5-15 years) who presented to the ED with isolated, acute, clinically nondeformed distal forearm fractures.
  • The participants were randomly assigned to receive initial point-of-care ultrasonography (n = 135) or radiography (n = 135) in the ED.
  • The primary outcome was the physical function of the affected arm at 4 weeks evaluated using the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool.

TAKEAWAY:

  • At 4 weeks, mean PROMIS scores were 36.4 and 36.3 points in ultrasonography and radiography groups, respectively (mean difference, 0.1 point; 95% confidence interval, − 1.3 to 1.4), indicating noninferiority of ultrasonography over radiography.
  • Ultrasonography and radiography groups showed similar efficacy in terms of PROMIS scores at 1 week (MD, 0.7 points; 95% CI, − 1.4 to 2.8) and 8 weeks (MD, 0.1 points; 95% CI, − 0.5 to 0.7).
  • Participants in the ultrasonography group had a shorter length of stay in the ED (median difference, 15 minutes; 95% CI, 1-29) and a shorter treatment time (median difference, 28 minutes; 95% CI, 17-40) than those in the radiography group.
  • No important fractures were missed with ultrasonography, and no significant difference was observed in the frequency of adverse events or unplanned returns to the ED between the two groups.

IN PRACTICE:

Noting the benefit-risk profile of an ultrasound-first approach in an ED setting, the lead author, Peter J. Snelling, MB, BS, MPH&TM, from Menzies Health Institute Queensland, Gold Coast, Australia, said: “It is highly unlikely that any important fractures would be missed using the protocol that we trained clinicians. The risk is low and the benefit is moderate, such as reducing length of stay and increased level of patient satisfaction.”

He further added that, “with an ultrasound-first approach, clinicians can scan the patient at time of review and may even be able to discharge them immediately (two-thirds of instances in our NEJM trial). This places the patient at the center of care being provided.”
 

SOURCE: 

Authors from the BUCKLED Trial Group published their study in the New England Journal of Medicine.

LIMITATIONS:

PROMIS scores may have been affected by variations in subsequent therapeutic interventions rather than the initial diagnostic method. PROMIS tool was not validated in children younger than 5 years of age.

DISCLOSURES:

The study was funded by the Emergency Medicine Foundation and others. The authors have declared no relevant interests to disclose.

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

 

TOPLINE:

Ultrasonography may serve as an alternative to radiography for diagnosing pediatric forearm fractures, thus reducing the number of children undergoing radiography at initial emergency department presentation, as well as their waiting time in ED.

METHODOLOGY:

  • After the World Health Organization reported a lack of access to any diagnostic imaging in approximately two-thirds of the world population in 2010, ultrasonography has gained popularity in low- and middle-income countries.
  • The initial use of ultrasonography is in accordance with the principle of maintaining radiation levels as low as reasonably achievable.
  • The BUCKLED trial was conducted, including 270 pediatric patients (age, 5-15 years) who presented to the ED with isolated, acute, clinically nondeformed distal forearm fractures.
  • The participants were randomly assigned to receive initial point-of-care ultrasonography (n = 135) or radiography (n = 135) in the ED.
  • The primary outcome was the physical function of the affected arm at 4 weeks evaluated using the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool.

TAKEAWAY:

  • At 4 weeks, mean PROMIS scores were 36.4 and 36.3 points in ultrasonography and radiography groups, respectively (mean difference, 0.1 point; 95% confidence interval, − 1.3 to 1.4), indicating noninferiority of ultrasonography over radiography.
  • Ultrasonography and radiography groups showed similar efficacy in terms of PROMIS scores at 1 week (MD, 0.7 points; 95% CI, − 1.4 to 2.8) and 8 weeks (MD, 0.1 points; 95% CI, − 0.5 to 0.7).
  • Participants in the ultrasonography group had a shorter length of stay in the ED (median difference, 15 minutes; 95% CI, 1-29) and a shorter treatment time (median difference, 28 minutes; 95% CI, 17-40) than those in the radiography group.
  • No important fractures were missed with ultrasonography, and no significant difference was observed in the frequency of adverse events or unplanned returns to the ED between the two groups.

IN PRACTICE:

Noting the benefit-risk profile of an ultrasound-first approach in an ED setting, the lead author, Peter J. Snelling, MB, BS, MPH&TM, from Menzies Health Institute Queensland, Gold Coast, Australia, said: “It is highly unlikely that any important fractures would be missed using the protocol that we trained clinicians. The risk is low and the benefit is moderate, such as reducing length of stay and increased level of patient satisfaction.”

He further added that, “with an ultrasound-first approach, clinicians can scan the patient at time of review and may even be able to discharge them immediately (two-thirds of instances in our NEJM trial). This places the patient at the center of care being provided.”
 

SOURCE: 

Authors from the BUCKLED Trial Group published their study in the New England Journal of Medicine.

LIMITATIONS:

PROMIS scores may have been affected by variations in subsequent therapeutic interventions rather than the initial diagnostic method. PROMIS tool was not validated in children younger than 5 years of age.

DISCLOSURES:

The study was funded by the Emergency Medicine Foundation and others. The authors have declared no relevant interests to disclose.

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

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