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Gentle Parenting
In one my recent Letters, I concluded with the concern that infant-led weaning, which makes some sense, can be confused with child-led family meals, which make none. I referred to an increasingly popular style of parenting overemphasizing child autonomy that seems to be a major contributor to the mealtime chaos that occurs when pleasing every palate at the table becomes the goal.
In the intervening weeks, I have learned that this parenting style is called “gentle parenting.” Despite its growing popularity, possibly fueled by the pandemic, it has not been well-defined nor its effectiveness investigated. In a recent paper published in PLOS ONE, two professors of developmental psychology have attempted correct this deficit in our understanding of this parenting style, which doesn’t appear to make sense to many of us with experience in child behavior and development.
Gentle Parents
By surveying a group of 100 parents of young children, the investigators were able to sort out a group of parents (n = 49) who self-identified as employing gentle parenting. Their responses emphasized a high level of parental affection and emotional regulation by both their children and themselves.
Investigators found that 40% of the self-defined gentle parents “had negative difference scores indicating misbehavior response descriptions that included more child directed responses. I interpret this to mean that almost half of the time the parents failed to evenly include themselves in a solution to a conflict, which indicates incomplete or unsuccessful emotional regulation on their part. The investigators also observed that, like many other parenting styles, gentle parenting includes an emphasis on boundaries “yet, enactment of those boundaries is not uniform.”
More telling was the authors’ observation that “statements of parenting uncertainty and burnout were present in over one third of the gentle of the gentle parenting sample.” While some parents were pleased with their experience, the downside seems unacceptable to me. When asked to explain this finding, Annie Pezalla, PhD, one of the coauthors, has said “gentle parenting practices work best when a parent is emotionally regulated and unconstrained for time — commodities that parents struggle with the most.”
Abundance Advice on Parenting Styles
I find this to be a very sad story. Parenting can be difficult. Creating and then gently and effectively policing those boundaries is often the hardest part.
It is not surprising to me that of the four books I have written for parents, the one titled How to Say No to Your Toddler is the only one popular enough to be published in four languages.Of course I am troubled, as I suspect you may be, with the label “gentle parenting.” It implies that the rest of us are doing something terrible, “harsh” maybe, “cruel” maybe. We can dispense with the “affectionate” descriptor immediately because gentle parenting can’t claim sole ownership to it. Every, behavior management scheme I am aware of touts being caring and loving at its core.
I completely agree that emotional regulation for both parent and child are worthy goals, but I’m not hearing much on how that is to be achieved other than by trying to avoid the inevitable conflict by failing to even say “No” when poorly crafted boundaries are breached.
There are scores of parenting styles out there. And there should be, because we are all different. Parents have strengths and weaknesses and they have begotten children with different personalities and vulnerabilities. And, families come from different cultures and socioeconomic backgrounds.
Across all of these differences there are two primary roles for every parent. The first is to lead by example. If a parent wants his/her child to be kind and caring and polite, then the parent has no choice but to behave that way. If the parent can’t always be present, the environment where the child spends most of his/her day should model the desired behavior. I’m not talking about teaching because you can’t preach good behavior. It must be modeled.
The second role for the parent is to keep his/her child safe from dangers that exist in every environment. This can mean accepting vaccines and seeking available medical care. But, it also means creating some limits — the current buzzword is “guardrails” — to keep the child from veering into the ditch.
Setting Limits
Limits will, of necessity, vary with the environment. The risks of a child growing on a farm differ from those of child living in the city. And they must be tailored to the personality and developmental stage of the child. A parent may need advice from someone experienced in child behavior to create individualized limits. You may be able to allow your 3-year-old to roam freely in an environment in which I would have to monitor my risk-taking 3-year-old every second. A parent must learn and accept his/her child’s personality and the environment they can provide.
Limits should be inanimate objects whenever possible. Fences, gates, doors with latches, and locked cabinets to keep temptations out of view, etc. Creative environmental manipulations should be employed to keep the annoying verbal warnings, unenforceable threats, and direct child-to-parent confrontations to a minimum.
Consequences
Challenges to even the most carefully crafted limits are inevitable, and this is where we get to the third-rail topic of consequences. Yes, when prevention has failed for whatever reason, I believe that an intelligently and affectionately applied time-out is the most efficient and most effective consequence. This is not the place for me to explore or defend the details, but before you write me off as an octogenarian hard-ass (or hard-liner if you prefer) I urge you to read a few chapters in How to Say No to Your Toddler.
Far more important than which consequence a parent chooses are the steps the family has taken to keep both parent and child in a state of balanced emotional regulation. Is everyone well rested and getting enough sleep? Sleep deprivation is one of the most potent triggers of a tantrum; it also leaves parents vulnerable to saying things and making threats they will regret later. Does the child’s schedule leave him or her enough time to decompress? Does the parent’s schedule sync with a developmentally appropriate schedule for the child? Is he/she getting the right kind of attention when it makes the most sense to him/her?
Intelligent Parenting
If a family has created an environment in which limits are appropriate for the child’s personality and developmental stage, used physical barriers whenever possible, and kept everyone as well rested as possible, both challenges to the limits and consequences can be kept to a minimum.
But achieving this state requires time as free of constraints as possible. For the few families that have the luxury of meeting these conditions, gentle parenting might be the answer. For the rest of us, intelligent parenting that acknowledges the realities and limits of our own abilities and our children’s vulnerabilities is the better answer.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
In one my recent Letters, I concluded with the concern that infant-led weaning, which makes some sense, can be confused with child-led family meals, which make none. I referred to an increasingly popular style of parenting overemphasizing child autonomy that seems to be a major contributor to the mealtime chaos that occurs when pleasing every palate at the table becomes the goal.
In the intervening weeks, I have learned that this parenting style is called “gentle parenting.” Despite its growing popularity, possibly fueled by the pandemic, it has not been well-defined nor its effectiveness investigated. In a recent paper published in PLOS ONE, two professors of developmental psychology have attempted correct this deficit in our understanding of this parenting style, which doesn’t appear to make sense to many of us with experience in child behavior and development.
Gentle Parents
By surveying a group of 100 parents of young children, the investigators were able to sort out a group of parents (n = 49) who self-identified as employing gentle parenting. Their responses emphasized a high level of parental affection and emotional regulation by both their children and themselves.
Investigators found that 40% of the self-defined gentle parents “had negative difference scores indicating misbehavior response descriptions that included more child directed responses. I interpret this to mean that almost half of the time the parents failed to evenly include themselves in a solution to a conflict, which indicates incomplete or unsuccessful emotional regulation on their part. The investigators also observed that, like many other parenting styles, gentle parenting includes an emphasis on boundaries “yet, enactment of those boundaries is not uniform.”
More telling was the authors’ observation that “statements of parenting uncertainty and burnout were present in over one third of the gentle of the gentle parenting sample.” While some parents were pleased with their experience, the downside seems unacceptable to me. When asked to explain this finding, Annie Pezalla, PhD, one of the coauthors, has said “gentle parenting practices work best when a parent is emotionally regulated and unconstrained for time — commodities that parents struggle with the most.”
Abundance Advice on Parenting Styles
I find this to be a very sad story. Parenting can be difficult. Creating and then gently and effectively policing those boundaries is often the hardest part.
It is not surprising to me that of the four books I have written for parents, the one titled How to Say No to Your Toddler is the only one popular enough to be published in four languages.Of course I am troubled, as I suspect you may be, with the label “gentle parenting.” It implies that the rest of us are doing something terrible, “harsh” maybe, “cruel” maybe. We can dispense with the “affectionate” descriptor immediately because gentle parenting can’t claim sole ownership to it. Every, behavior management scheme I am aware of touts being caring and loving at its core.
I completely agree that emotional regulation for both parent and child are worthy goals, but I’m not hearing much on how that is to be achieved other than by trying to avoid the inevitable conflict by failing to even say “No” when poorly crafted boundaries are breached.
There are scores of parenting styles out there. And there should be, because we are all different. Parents have strengths and weaknesses and they have begotten children with different personalities and vulnerabilities. And, families come from different cultures and socioeconomic backgrounds.
Across all of these differences there are two primary roles for every parent. The first is to lead by example. If a parent wants his/her child to be kind and caring and polite, then the parent has no choice but to behave that way. If the parent can’t always be present, the environment where the child spends most of his/her day should model the desired behavior. I’m not talking about teaching because you can’t preach good behavior. It must be modeled.
The second role for the parent is to keep his/her child safe from dangers that exist in every environment. This can mean accepting vaccines and seeking available medical care. But, it also means creating some limits — the current buzzword is “guardrails” — to keep the child from veering into the ditch.
Setting Limits
Limits will, of necessity, vary with the environment. The risks of a child growing on a farm differ from those of child living in the city. And they must be tailored to the personality and developmental stage of the child. A parent may need advice from someone experienced in child behavior to create individualized limits. You may be able to allow your 3-year-old to roam freely in an environment in which I would have to monitor my risk-taking 3-year-old every second. A parent must learn and accept his/her child’s personality and the environment they can provide.
Limits should be inanimate objects whenever possible. Fences, gates, doors with latches, and locked cabinets to keep temptations out of view, etc. Creative environmental manipulations should be employed to keep the annoying verbal warnings, unenforceable threats, and direct child-to-parent confrontations to a minimum.
Consequences
Challenges to even the most carefully crafted limits are inevitable, and this is where we get to the third-rail topic of consequences. Yes, when prevention has failed for whatever reason, I believe that an intelligently and affectionately applied time-out is the most efficient and most effective consequence. This is not the place for me to explore or defend the details, but before you write me off as an octogenarian hard-ass (or hard-liner if you prefer) I urge you to read a few chapters in How to Say No to Your Toddler.
Far more important than which consequence a parent chooses are the steps the family has taken to keep both parent and child in a state of balanced emotional regulation. Is everyone well rested and getting enough sleep? Sleep deprivation is one of the most potent triggers of a tantrum; it also leaves parents vulnerable to saying things and making threats they will regret later. Does the child’s schedule leave him or her enough time to decompress? Does the parent’s schedule sync with a developmentally appropriate schedule for the child? Is he/she getting the right kind of attention when it makes the most sense to him/her?
Intelligent Parenting
If a family has created an environment in which limits are appropriate for the child’s personality and developmental stage, used physical barriers whenever possible, and kept everyone as well rested as possible, both challenges to the limits and consequences can be kept to a minimum.
But achieving this state requires time as free of constraints as possible. For the few families that have the luxury of meeting these conditions, gentle parenting might be the answer. For the rest of us, intelligent parenting that acknowledges the realities and limits of our own abilities and our children’s vulnerabilities is the better answer.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
In one my recent Letters, I concluded with the concern that infant-led weaning, which makes some sense, can be confused with child-led family meals, which make none. I referred to an increasingly popular style of parenting overemphasizing child autonomy that seems to be a major contributor to the mealtime chaos that occurs when pleasing every palate at the table becomes the goal.
In the intervening weeks, I have learned that this parenting style is called “gentle parenting.” Despite its growing popularity, possibly fueled by the pandemic, it has not been well-defined nor its effectiveness investigated. In a recent paper published in PLOS ONE, two professors of developmental psychology have attempted correct this deficit in our understanding of this parenting style, which doesn’t appear to make sense to many of us with experience in child behavior and development.
Gentle Parents
By surveying a group of 100 parents of young children, the investigators were able to sort out a group of parents (n = 49) who self-identified as employing gentle parenting. Their responses emphasized a high level of parental affection and emotional regulation by both their children and themselves.
Investigators found that 40% of the self-defined gentle parents “had negative difference scores indicating misbehavior response descriptions that included more child directed responses. I interpret this to mean that almost half of the time the parents failed to evenly include themselves in a solution to a conflict, which indicates incomplete or unsuccessful emotional regulation on their part. The investigators also observed that, like many other parenting styles, gentle parenting includes an emphasis on boundaries “yet, enactment of those boundaries is not uniform.”
More telling was the authors’ observation that “statements of parenting uncertainty and burnout were present in over one third of the gentle of the gentle parenting sample.” While some parents were pleased with their experience, the downside seems unacceptable to me. When asked to explain this finding, Annie Pezalla, PhD, one of the coauthors, has said “gentle parenting practices work best when a parent is emotionally regulated and unconstrained for time — commodities that parents struggle with the most.”
Abundance Advice on Parenting Styles
I find this to be a very sad story. Parenting can be difficult. Creating and then gently and effectively policing those boundaries is often the hardest part.
It is not surprising to me that of the four books I have written for parents, the one titled How to Say No to Your Toddler is the only one popular enough to be published in four languages.Of course I am troubled, as I suspect you may be, with the label “gentle parenting.” It implies that the rest of us are doing something terrible, “harsh” maybe, “cruel” maybe. We can dispense with the “affectionate” descriptor immediately because gentle parenting can’t claim sole ownership to it. Every, behavior management scheme I am aware of touts being caring and loving at its core.
I completely agree that emotional regulation for both parent and child are worthy goals, but I’m not hearing much on how that is to be achieved other than by trying to avoid the inevitable conflict by failing to even say “No” when poorly crafted boundaries are breached.
There are scores of parenting styles out there. And there should be, because we are all different. Parents have strengths and weaknesses and they have begotten children with different personalities and vulnerabilities. And, families come from different cultures and socioeconomic backgrounds.
Across all of these differences there are two primary roles for every parent. The first is to lead by example. If a parent wants his/her child to be kind and caring and polite, then the parent has no choice but to behave that way. If the parent can’t always be present, the environment where the child spends most of his/her day should model the desired behavior. I’m not talking about teaching because you can’t preach good behavior. It must be modeled.
The second role for the parent is to keep his/her child safe from dangers that exist in every environment. This can mean accepting vaccines and seeking available medical care. But, it also means creating some limits — the current buzzword is “guardrails” — to keep the child from veering into the ditch.
Setting Limits
Limits will, of necessity, vary with the environment. The risks of a child growing on a farm differ from those of child living in the city. And they must be tailored to the personality and developmental stage of the child. A parent may need advice from someone experienced in child behavior to create individualized limits. You may be able to allow your 3-year-old to roam freely in an environment in which I would have to monitor my risk-taking 3-year-old every second. A parent must learn and accept his/her child’s personality and the environment they can provide.
Limits should be inanimate objects whenever possible. Fences, gates, doors with latches, and locked cabinets to keep temptations out of view, etc. Creative environmental manipulations should be employed to keep the annoying verbal warnings, unenforceable threats, and direct child-to-parent confrontations to a minimum.
Consequences
Challenges to even the most carefully crafted limits are inevitable, and this is where we get to the third-rail topic of consequences. Yes, when prevention has failed for whatever reason, I believe that an intelligently and affectionately applied time-out is the most efficient and most effective consequence. This is not the place for me to explore or defend the details, but before you write me off as an octogenarian hard-ass (or hard-liner if you prefer) I urge you to read a few chapters in How to Say No to Your Toddler.
Far more important than which consequence a parent chooses are the steps the family has taken to keep both parent and child in a state of balanced emotional regulation. Is everyone well rested and getting enough sleep? Sleep deprivation is one of the most potent triggers of a tantrum; it also leaves parents vulnerable to saying things and making threats they will regret later. Does the child’s schedule leave him or her enough time to decompress? Does the parent’s schedule sync with a developmentally appropriate schedule for the child? Is he/she getting the right kind of attention when it makes the most sense to him/her?
Intelligent Parenting
If a family has created an environment in which limits are appropriate for the child’s personality and developmental stage, used physical barriers whenever possible, and kept everyone as well rested as possible, both challenges to the limits and consequences can be kept to a minimum.
But achieving this state requires time as free of constraints as possible. For the few families that have the luxury of meeting these conditions, gentle parenting might be the answer. For the rest of us, intelligent parenting that acknowledges the realities and limits of our own abilities and our children’s vulnerabilities is the better answer.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Fine Particulate Matter Exposure During Pregnancy Linked to Increased Risk for Spontaneous Preterm Birth
TOPLINE:
Exposure to fine particulate matter (PM2.5) during pregnancy is associated with an increased risk for spontaneous preterm birth, with peak vulnerability in the second trimester. Lower socioeconomic status, limited green space exposure, and extreme heat amplify this risk, whereas living around more trees provides protective effects.
METHODOLOGY:
- The researchers conducted a population-based retrospective cohort study to examine the associations of exposures to total PM2.5 and five constituents (black carbon, nitrate, organic matter, and sulfate) during pregnancy with spontaneous preterm birth.
- They included 409,037 singleton live births from the Kaiser Permanente Southern California health care system between 2008 and 2018, with mothers having a mean age of 30.3 years at delivery (51% Hispanic).
- Daily total PM2.5 concentrations and monthly data on the constituents in California were obtained; mean exposures during the entire pregnancy and in each trimester were calculated.
- Spontaneous preterm births were identified through the evaluation of preterm labor visits and were defined as a delivery occurring before 37 weeks following the onset of spontaneous labor, without pregnancy complications, and within 7 days of the last preterm labor visit.
- The analysis also examined the effect of factors such as race and ethnicity, education, median household income, exposure to green spaces, wildfire smoke, and temperature.
TAKEAWAY:
- Each 2.76 µg/m3 increase in total PM2.5 exposure during pregnancy raised the risk for spontaneous preterm birth by 15% (P < .001), with black carbon showing the highest risk (adjusted odds ratio [aOR], 1.15; 95% CI, 1.12-1.18; P < .001).
- Exposure to PM2.5 during the second trimester showed the highest association with spontaneous preterm birth (aOR, 1.10; P < .001), followed by that during the third (aOR, 1.09; P < .001) and first (aOR, 1.07; P < .001) trimesters.
- Individuals with lower education levels showed a higher risk for spontaneous preterm birth than those with more than 4 years of college education (P = .003).
- Exposure to extreme heat (P < .001) and lower exposure to total green space (P = .003) increased the risk for spontaneous preterm abortion.
IN PRACTICE:
“Targeted and preventive public health interventions among these subpopulations with high risk may be critical for minimizing the burden of spontaneous preterm birth,” the authors wrote.
SOURCE:
The study was led by Anqi Jiao of the program in public health at the Department of Environmental and Occupational Health at the University of California, Irvine. It was published online in JAMA Network Open.
LIMITATIONS:
According to the authors, exposure misclassification was inevitable as individual exposure to PM2.5 was estimated according to census tract-level data without considering personal activity patterns. Only five major PM2.5 constituents were measured due to data availability. Additionally, street-view green space data were considered spatial snapshots, which cannot capture temporal variations, possibly leading to exposure misclassification and biased associations in either direction.
DISCLOSURES:
The study was supported by the National Institute of Environmental Health Sciences and the California Air Resources Board. One author reported receiving research funding from pharmaceutical and biopharmaceutical companies, which was paid to the institute. Another author reported receiving grants from a medical technology company outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Exposure to fine particulate matter (PM2.5) during pregnancy is associated with an increased risk for spontaneous preterm birth, with peak vulnerability in the second trimester. Lower socioeconomic status, limited green space exposure, and extreme heat amplify this risk, whereas living around more trees provides protective effects.
METHODOLOGY:
- The researchers conducted a population-based retrospective cohort study to examine the associations of exposures to total PM2.5 and five constituents (black carbon, nitrate, organic matter, and sulfate) during pregnancy with spontaneous preterm birth.
- They included 409,037 singleton live births from the Kaiser Permanente Southern California health care system between 2008 and 2018, with mothers having a mean age of 30.3 years at delivery (51% Hispanic).
- Daily total PM2.5 concentrations and monthly data on the constituents in California were obtained; mean exposures during the entire pregnancy and in each trimester were calculated.
- Spontaneous preterm births were identified through the evaluation of preterm labor visits and were defined as a delivery occurring before 37 weeks following the onset of spontaneous labor, without pregnancy complications, and within 7 days of the last preterm labor visit.
- The analysis also examined the effect of factors such as race and ethnicity, education, median household income, exposure to green spaces, wildfire smoke, and temperature.
TAKEAWAY:
- Each 2.76 µg/m3 increase in total PM2.5 exposure during pregnancy raised the risk for spontaneous preterm birth by 15% (P < .001), with black carbon showing the highest risk (adjusted odds ratio [aOR], 1.15; 95% CI, 1.12-1.18; P < .001).
- Exposure to PM2.5 during the second trimester showed the highest association with spontaneous preterm birth (aOR, 1.10; P < .001), followed by that during the third (aOR, 1.09; P < .001) and first (aOR, 1.07; P < .001) trimesters.
- Individuals with lower education levels showed a higher risk for spontaneous preterm birth than those with more than 4 years of college education (P = .003).
- Exposure to extreme heat (P < .001) and lower exposure to total green space (P = .003) increased the risk for spontaneous preterm abortion.
IN PRACTICE:
“Targeted and preventive public health interventions among these subpopulations with high risk may be critical for minimizing the burden of spontaneous preterm birth,” the authors wrote.
SOURCE:
The study was led by Anqi Jiao of the program in public health at the Department of Environmental and Occupational Health at the University of California, Irvine. It was published online in JAMA Network Open.
LIMITATIONS:
According to the authors, exposure misclassification was inevitable as individual exposure to PM2.5 was estimated according to census tract-level data without considering personal activity patterns. Only five major PM2.5 constituents were measured due to data availability. Additionally, street-view green space data were considered spatial snapshots, which cannot capture temporal variations, possibly leading to exposure misclassification and biased associations in either direction.
DISCLOSURES:
The study was supported by the National Institute of Environmental Health Sciences and the California Air Resources Board. One author reported receiving research funding from pharmaceutical and biopharmaceutical companies, which was paid to the institute. Another author reported receiving grants from a medical technology company outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Exposure to fine particulate matter (PM2.5) during pregnancy is associated with an increased risk for spontaneous preterm birth, with peak vulnerability in the second trimester. Lower socioeconomic status, limited green space exposure, and extreme heat amplify this risk, whereas living around more trees provides protective effects.
METHODOLOGY:
- The researchers conducted a population-based retrospective cohort study to examine the associations of exposures to total PM2.5 and five constituents (black carbon, nitrate, organic matter, and sulfate) during pregnancy with spontaneous preterm birth.
- They included 409,037 singleton live births from the Kaiser Permanente Southern California health care system between 2008 and 2018, with mothers having a mean age of 30.3 years at delivery (51% Hispanic).
- Daily total PM2.5 concentrations and monthly data on the constituents in California were obtained; mean exposures during the entire pregnancy and in each trimester were calculated.
- Spontaneous preterm births were identified through the evaluation of preterm labor visits and were defined as a delivery occurring before 37 weeks following the onset of spontaneous labor, without pregnancy complications, and within 7 days of the last preterm labor visit.
- The analysis also examined the effect of factors such as race and ethnicity, education, median household income, exposure to green spaces, wildfire smoke, and temperature.
TAKEAWAY:
- Each 2.76 µg/m3 increase in total PM2.5 exposure during pregnancy raised the risk for spontaneous preterm birth by 15% (P < .001), with black carbon showing the highest risk (adjusted odds ratio [aOR], 1.15; 95% CI, 1.12-1.18; P < .001).
- Exposure to PM2.5 during the second trimester showed the highest association with spontaneous preterm birth (aOR, 1.10; P < .001), followed by that during the third (aOR, 1.09; P < .001) and first (aOR, 1.07; P < .001) trimesters.
- Individuals with lower education levels showed a higher risk for spontaneous preterm birth than those with more than 4 years of college education (P = .003).
- Exposure to extreme heat (P < .001) and lower exposure to total green space (P = .003) increased the risk for spontaneous preterm abortion.
IN PRACTICE:
“Targeted and preventive public health interventions among these subpopulations with high risk may be critical for minimizing the burden of spontaneous preterm birth,” the authors wrote.
SOURCE:
The study was led by Anqi Jiao of the program in public health at the Department of Environmental and Occupational Health at the University of California, Irvine. It was published online in JAMA Network Open.
LIMITATIONS:
According to the authors, exposure misclassification was inevitable as individual exposure to PM2.5 was estimated according to census tract-level data without considering personal activity patterns. Only five major PM2.5 constituents were measured due to data availability. Additionally, street-view green space data were considered spatial snapshots, which cannot capture temporal variations, possibly leading to exposure misclassification and biased associations in either direction.
DISCLOSURES:
The study was supported by the National Institute of Environmental Health Sciences and the California Air Resources Board. One author reported receiving research funding from pharmaceutical and biopharmaceutical companies, which was paid to the institute. Another author reported receiving grants from a medical technology company outside the submitted work.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Screen Use and Toddler Bedtimes
For decades I have suspected that there is a strong association between sleep deprivation and pediatric attention disorders. More recently I have wondered whether screen time, particularly at bedtime might be a significant contributor to sleep quantity and quality in both children and adults. There is a growing body of research that combines my two observations and suggests that bedtime screen time through its effect on sleep may be linked to pediatric attention problems. However, most of this work is preliminary and needs to be confirmed.
Stumbling across a paper from England titled “Toddler Screen Use Before Bed and Its Effect on Sleep and Attention” renewed my hope that we finally have evidence to close that knowledge gap. My bubble burst quickly however when I jumped ahead and read the conclusion portion of the abstract and learned that authors observed “no clear difference in parent reported attention” in the group of children in which screen time before bedtime had been eliminated. The authors wonder if their small study sample may be to blame.
Disappointed, I persisted and read the paper in its entirety and found that despite their failure to link bedtime screen time with attention disorders, the investigators have made a significant contribution to our understanding of how we can better encourage good pediatric sleep hygiene.
The Study
One hundred and five families with a toddler who was being exposed to a video screen in the hour before bedtime were divided into three groups. One group received guidance and advice from a pediatric team about the potential benefit of eliminating bedtime screen time. They were also given a box of activities that contained “activity cards and age appropriate toys” to replace the screen use. The family also received periodic support and follow-up contacts. A second group received only the “bedtime box.” And the third received no intervention.
It is important to note that the investigators modeled their intervention on one developed in a previous study using older children that was “co-created with caregivers and early years practitioners”(my italics).
The intervention resulted in reductions in parent-reported screen time, sleep efficiency, night awakenings, and daytime sleep. The decrease in nap time was a surprise to the investigators.
These reductions were small. However, the investigators were most impressed (and I share in their sentiment) with the finding that 99% (104/105) of the families stayed with the study until completion, demonstrating that future studies using this format were highly feasible. The authors of the study were pleased also and possibly surprised that 94% (33/35) of the families who received the intervention adhered to the recommendations.
One Suggestion: ‘Just Shut the TV Off’
If you are a cynic, you might be tempted to explain the investigators’ (and my) excitement over the feasibility and adherence numbers as an attempt to pump up the importance of a set of otherwise lackluster numbers regarding sleep and the failure to find any association between the intervention and attention. However, having spent a large part of my career trying to encourage parents to improve their child’s sleep hygiene, often with little success, I am encouraged by this study’s success in getting families to accept and then adhere to the intervention.
I must admit that when presented with a child who appeared to be having some attention difficulties and was watching television as part of his or her bedtime ritual, there’s a good chance I would have simply told the parents, “Just shut the TV off.” This certainly worked with some families, particularly those who had already bought into my preaching about the importance of sleep. However, my acceptance and adherence rates were no where near the 99% and 94% these investigators where achieving.
I did try to make follow-up phone calls, as these investigators did, but generally only to the most seriously effected families or in situations in which felt I was going to have the greatest chance of success. I am sorry to say that I didn’t involve the parents in crafting my overly simplistic intervention. Had I been more open to parental input, I suspect my results would have improved.
An Alternative
I think another reason for these investigators’ success was the clever ploy of offering a replacement (in this case the bedtime box of alternative activities) when they asked the parents to remove the screen time. Getting anyone to break an unhealthy habit, be they parents or patients, it often helps to offer them an alternative. The activity may not be as appealing as their current behavior but it can fill the gap until a new even healthier behavior develops.
Building an efficient and effective bedtime ritual begins in the first months of life. The initial challenge could be separating nursing or a bottle from the settling in process. Later on it could mean helping a parent who is out of the home all day understand that they may have to suppress their natural urge to engage in vigorous play with his/her child at a time that is best devoted to winding down into a healthy bedtime ritual. Although screen time may not be physically stimulating, there is increasing evidence that it shouldn’t be part of a pre-bedtime ritual. The question of if and how it contributes to attention problems will have to wait until another day.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
For decades I have suspected that there is a strong association between sleep deprivation and pediatric attention disorders. More recently I have wondered whether screen time, particularly at bedtime might be a significant contributor to sleep quantity and quality in both children and adults. There is a growing body of research that combines my two observations and suggests that bedtime screen time through its effect on sleep may be linked to pediatric attention problems. However, most of this work is preliminary and needs to be confirmed.
Stumbling across a paper from England titled “Toddler Screen Use Before Bed and Its Effect on Sleep and Attention” renewed my hope that we finally have evidence to close that knowledge gap. My bubble burst quickly however when I jumped ahead and read the conclusion portion of the abstract and learned that authors observed “no clear difference in parent reported attention” in the group of children in which screen time before bedtime had been eliminated. The authors wonder if their small study sample may be to blame.
Disappointed, I persisted and read the paper in its entirety and found that despite their failure to link bedtime screen time with attention disorders, the investigators have made a significant contribution to our understanding of how we can better encourage good pediatric sleep hygiene.
The Study
One hundred and five families with a toddler who was being exposed to a video screen in the hour before bedtime were divided into three groups. One group received guidance and advice from a pediatric team about the potential benefit of eliminating bedtime screen time. They were also given a box of activities that contained “activity cards and age appropriate toys” to replace the screen use. The family also received periodic support and follow-up contacts. A second group received only the “bedtime box.” And the third received no intervention.
It is important to note that the investigators modeled their intervention on one developed in a previous study using older children that was “co-created with caregivers and early years practitioners”(my italics).
The intervention resulted in reductions in parent-reported screen time, sleep efficiency, night awakenings, and daytime sleep. The decrease in nap time was a surprise to the investigators.
These reductions were small. However, the investigators were most impressed (and I share in their sentiment) with the finding that 99% (104/105) of the families stayed with the study until completion, demonstrating that future studies using this format were highly feasible. The authors of the study were pleased also and possibly surprised that 94% (33/35) of the families who received the intervention adhered to the recommendations.
One Suggestion: ‘Just Shut the TV Off’
If you are a cynic, you might be tempted to explain the investigators’ (and my) excitement over the feasibility and adherence numbers as an attempt to pump up the importance of a set of otherwise lackluster numbers regarding sleep and the failure to find any association between the intervention and attention. However, having spent a large part of my career trying to encourage parents to improve their child’s sleep hygiene, often with little success, I am encouraged by this study’s success in getting families to accept and then adhere to the intervention.
I must admit that when presented with a child who appeared to be having some attention difficulties and was watching television as part of his or her bedtime ritual, there’s a good chance I would have simply told the parents, “Just shut the TV off.” This certainly worked with some families, particularly those who had already bought into my preaching about the importance of sleep. However, my acceptance and adherence rates were no where near the 99% and 94% these investigators where achieving.
I did try to make follow-up phone calls, as these investigators did, but generally only to the most seriously effected families or in situations in which felt I was going to have the greatest chance of success. I am sorry to say that I didn’t involve the parents in crafting my overly simplistic intervention. Had I been more open to parental input, I suspect my results would have improved.
An Alternative
I think another reason for these investigators’ success was the clever ploy of offering a replacement (in this case the bedtime box of alternative activities) when they asked the parents to remove the screen time. Getting anyone to break an unhealthy habit, be they parents or patients, it often helps to offer them an alternative. The activity may not be as appealing as their current behavior but it can fill the gap until a new even healthier behavior develops.
Building an efficient and effective bedtime ritual begins in the first months of life. The initial challenge could be separating nursing or a bottle from the settling in process. Later on it could mean helping a parent who is out of the home all day understand that they may have to suppress their natural urge to engage in vigorous play with his/her child at a time that is best devoted to winding down into a healthy bedtime ritual. Although screen time may not be physically stimulating, there is increasing evidence that it shouldn’t be part of a pre-bedtime ritual. The question of if and how it contributes to attention problems will have to wait until another day.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
For decades I have suspected that there is a strong association between sleep deprivation and pediatric attention disorders. More recently I have wondered whether screen time, particularly at bedtime might be a significant contributor to sleep quantity and quality in both children and adults. There is a growing body of research that combines my two observations and suggests that bedtime screen time through its effect on sleep may be linked to pediatric attention problems. However, most of this work is preliminary and needs to be confirmed.
Stumbling across a paper from England titled “Toddler Screen Use Before Bed and Its Effect on Sleep and Attention” renewed my hope that we finally have evidence to close that knowledge gap. My bubble burst quickly however when I jumped ahead and read the conclusion portion of the abstract and learned that authors observed “no clear difference in parent reported attention” in the group of children in which screen time before bedtime had been eliminated. The authors wonder if their small study sample may be to blame.
Disappointed, I persisted and read the paper in its entirety and found that despite their failure to link bedtime screen time with attention disorders, the investigators have made a significant contribution to our understanding of how we can better encourage good pediatric sleep hygiene.
The Study
One hundred and five families with a toddler who was being exposed to a video screen in the hour before bedtime were divided into three groups. One group received guidance and advice from a pediatric team about the potential benefit of eliminating bedtime screen time. They were also given a box of activities that contained “activity cards and age appropriate toys” to replace the screen use. The family also received periodic support and follow-up contacts. A second group received only the “bedtime box.” And the third received no intervention.
It is important to note that the investigators modeled their intervention on one developed in a previous study using older children that was “co-created with caregivers and early years practitioners”(my italics).
The intervention resulted in reductions in parent-reported screen time, sleep efficiency, night awakenings, and daytime sleep. The decrease in nap time was a surprise to the investigators.
These reductions were small. However, the investigators were most impressed (and I share in their sentiment) with the finding that 99% (104/105) of the families stayed with the study until completion, demonstrating that future studies using this format were highly feasible. The authors of the study were pleased also and possibly surprised that 94% (33/35) of the families who received the intervention adhered to the recommendations.
One Suggestion: ‘Just Shut the TV Off’
If you are a cynic, you might be tempted to explain the investigators’ (and my) excitement over the feasibility and adherence numbers as an attempt to pump up the importance of a set of otherwise lackluster numbers regarding sleep and the failure to find any association between the intervention and attention. However, having spent a large part of my career trying to encourage parents to improve their child’s sleep hygiene, often with little success, I am encouraged by this study’s success in getting families to accept and then adhere to the intervention.
I must admit that when presented with a child who appeared to be having some attention difficulties and was watching television as part of his or her bedtime ritual, there’s a good chance I would have simply told the parents, “Just shut the TV off.” This certainly worked with some families, particularly those who had already bought into my preaching about the importance of sleep. However, my acceptance and adherence rates were no where near the 99% and 94% these investigators where achieving.
I did try to make follow-up phone calls, as these investigators did, but generally only to the most seriously effected families or in situations in which felt I was going to have the greatest chance of success. I am sorry to say that I didn’t involve the parents in crafting my overly simplistic intervention. Had I been more open to parental input, I suspect my results would have improved.
An Alternative
I think another reason for these investigators’ success was the clever ploy of offering a replacement (in this case the bedtime box of alternative activities) when they asked the parents to remove the screen time. Getting anyone to break an unhealthy habit, be they parents or patients, it often helps to offer them an alternative. The activity may not be as appealing as their current behavior but it can fill the gap until a new even healthier behavior develops.
Building an efficient and effective bedtime ritual begins in the first months of life. The initial challenge could be separating nursing or a bottle from the settling in process. Later on it could mean helping a parent who is out of the home all day understand that they may have to suppress their natural urge to engage in vigorous play with his/her child at a time that is best devoted to winding down into a healthy bedtime ritual. Although screen time may not be physically stimulating, there is increasing evidence that it shouldn’t be part of a pre-bedtime ritual. The question of if and how it contributes to attention problems will have to wait until another day.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].
Key Updates in Resuscitation Procedure After Drowning
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
From Pediatrics
Topical Retinoids a Key Component of Acne Treatment Regimens
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
LAS VEGAS —
Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.
“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”
No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.
More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.
Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.
Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”
To improve retinoid tolerability, Baldwin offered the following tips:
- Use a pea-sized amount for the entire affected area and avoid spot treatments.
- Start with every other day application.
- Moisturize regularly, possibly applying moisturizer before the retinoid.
- Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
- Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”
Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).
Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.
A version of this article appeared on Medscape.com.
FROM SDPA 2024
A Child’s Picky Eating: Normal Phase or Health Concern?
PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration.
Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.
In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.
Key Phases and Development
Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.
A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.
Parental Pressure and Nutritional Balance
Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”
Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.
When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.
For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.
Avoidant/Restrictive Food Intake Disorder (ARFID)
ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.
Case Profiles in Eating Issues
Bellaïche outlined three typical cases among children considered “picky eaters”:
- The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods.
- The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention.
- The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage.
Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration.
Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.
In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.
Key Phases and Development
Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.
A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.
Parental Pressure and Nutritional Balance
Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”
Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.
When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.
For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.
Avoidant/Restrictive Food Intake Disorder (ARFID)
ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.
Case Profiles in Eating Issues
Bellaïche outlined three typical cases among children considered “picky eaters”:
- The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods.
- The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention.
- The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage.
Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
PARIS — “My child is a poor eater” is a complaint frequently heard during medical consultations. Such concerns are often unjustified but a source of much parental frustration.
Marc Bellaïche, MD, a pediatrician at Robert-Debré Hospital in Paris, addressed this issue at France’s annual general medicine conference (JNMG 2024). His presentation focused on distinguishing between parental perception, typical childhood behaviors, and feeding issues that require intervention.
In assessing parental worries, tools such as The Montreal Children’s Hospital Feeding Scale for children aged 6 months to 6 years and the Baby Eating Behavior Questionnaire for those under 6 months can help identify and monitor feeding issues. Observing the child eat, when possible, is also valuable.
Key Phases and Development
Bellaïche focused on children under 6 years, as they frequently experience feeding challenges during critical development phases, such as weaning or when the child is able to sit up.
A phase of neophilia (interest in new foods) typically occurs before 12 months, followed by a phase of neophobia (fear of new foods) between ages 1 and 3 years. This neophobia is a normal part of neuropsychological, sensory, and taste development and can persist if a key developmental moment is marked by a choking incident, mealtime stress, or forced feeding. “Challenges differ between a difficult 3-year-old and a 6- or 7-year-old who still refuses new foods,” he explained.
Parental Pressure and Nutritional Balance
Nutritional balance is essential, but “parental pressure is often too high.” Parents worry because they see food as a “nutraceutical.” Bellaïche recommended defusing anxiety by keeping mealtimes calm, allowing the child to eat at their pace, avoiding force-feeding, keeping meals brief, and avoiding snacks. While “it’s important to stay vigilant — as it’s incorrect to assume a child won’t let themselves starve — most cases can be managed in general practice through parental guidance, empathy, and a positive approach.”
Monitoring growth and weight curves is crucial, with the Kanawati index (ratio of arm circumference to head circumference) being a reliable indicator for specialist referral if < 0.31. A varied diet is important for nutritional balance; when this isn’t achieved, continued consumption of toddler formula after age 3 can prevent iron and calcium deficiencies.
When eating difficulties are documented, healthcare providers should investigate for underlying organic, digestive, or extra-digestive diseases (neurologic, cardiac, renal, etc.). “It’s best not to hastily diagnose cow’s milk protein allergy,” Bellaïche advised, as cases are relatively rare and unnecessarily eliminating milk can complicate a child’s relationship with food. Similarly, gastroesophageal reflux disease should be objectively diagnosed to avoid unnecessary proton pump inhibitor treatment and associated side effects.
For children with low birth weight, mild congenital heart disease, or suggestive dysmorphology, consider evaluating for a genetic syndrome.
Avoidant/Restrictive Food Intake Disorder (ARFID)
ARFID is marked by a lack of interest in food and avoidance due to sensory characteristics. Often observed in anxious children, ARFID is diagnosed in approximately 20% of children with autism spectrum disorder, where food selectivity is prevalent. This condition can hinder a child’s development and may necessitate nutritional supplementation.
Case Profiles in Eating Issues
Bellaïche outlined three typical cases among children considered “picky eaters”:
- The small eater: Often near the lower growth curve limits, this child “grazes and doesn’t sit still.” These children are usually active and have a family history of similar eating habits. Parents should encourage psychomotor activities, discourage snacks outside of mealtimes, and consider fun family picnics on the floor, offering a mezze-style variety of foods.
- The child with a history of trauma: Children with trauma (from intubation, nasogastric tubes, severe vomiting, forced feeding, or choking) may develop aversions requiring behavioral intervention.
- The child with high sensory sensitivity: This child dislikes getting the hands dirty, avoids mouthing objects, or resists certain textures, such as grass and sand. Gradual behavioral approaches with sensory play and visually appealing new foods can be beneficial. Guided self-led food exploration (baby-led weaning) may also help, though dairy intake is often needed to prevent deficiencies during this stage.
Finally, gastroesophageal reflux disease or constipation can contribute to appetite loss. Studies have shown that treating these issues can improve appetite in small eaters.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM JNMG 2024
Children With Severe Atopic Dermatitis Catch Up on Growth With Dupilumab
AMSTERDAM — , revealed a post hoc trial analysis.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The trial included a “rigorously selected … well-characterized, well-studied” population of children aged 6-11 years, said presenter Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland.
It showed that “severe atopic dermatitis does cause restriction of growth, as well as a higher weight, and therefore obviously a higher BMI [body mass index].”
He continued, however, that children at the lower percentiles of height receiving prompt treatment with dupilumab (Dupixent) “were able to rapidly move through the centiles over the 16 weeks of the study, and that may be the window for catch-up growth … when children are growing rapidly.”
Anna Yasmine Kirkorian, MD, chief of dermatology, Children’s National Hospital, Washington, DC, who was not involved in the study, said that she was “surprised” at the degree of growth achieved over the study period, as height is not something that jumps up “overnight.”
“On the other hand, it fits with my experience with children who’ve had the brakes on all of their life due to inflammation, whether it be height, going to school, sleeping — everything is sort of put on pause by this terrible inflammatory process,” she said.
“When you take the brakes off, they get to be who they are going to be,” Kirkorian added. “So I was surprised by the speed of it, but not by the fact that height was acquired.”
Her belief is that in the pre-dupilumab era, severe atopic dermatitis was often insufficiently controlled, so children were “smaller than you would predict from parental height,” and the treatment is “allowing them to reach their genetic potential.”
Post Hoc Analysis
In his presentation, Irvine emphasized that it has been clearly demonstrated that adolescents with moderate and severe atopic dermatitis have a significantly higher likelihood of being below the 25th percentile of height on growth reference charts.
Such children are also at a higher risk of having low bone mineral density and low serum alkaline phosphatase (ALP) levels . While data presented at the EADV 2023 Congress showed that dupilumab significantly increased serum levels of bone ALP compared with placebo, the underlying mechanism remains unclear.
For the current analysis, Irvine and colleagues determined that the proportion of children aged 6-11 years with severe atopic dermatitis and lower stature reach a ≥ 5 centile improvement in height following 16 weeks of dupilumab treatment.
They examined data from the LIBERTY AD PEDS trial, in which patients aged 6-11 years with severe atopic dermatitis were randomized to 300 mg dupilumab every 4 weeks or placebo along with a mild or moderately potent topical corticosteroid. The study found that, overall, dupilumab was associated with significant improvements in signs, symptoms, and quality of life compared with placebo.
Height measures at baseline revealed that “more boys and more girls were below the 50th centile than you would predict for a healthy, normal control population,” Irvine said. “If we look at weight, we see the opposite,” he continued, “with a disproportionate number of boys and girls who are above the 50th centile for weight at baseline.”
Consequently, “we’re seeing these children who are shorter and heavier than the predicted healthy weight range and, as a result, obviously have higher BMI,” Irvine noted, with 67% girls and 62% boys found to have a higher BMI than normal for their age.
After 16 weeks of treatment with dupilumab, there was a much greater gain in height than that seen among those on placebo, with the most pronounced effect seen in children who had the lowest height at baseline. Indeed, among children in the lowest 25% height percentile at baseline, 30.6% on dupilumab vs 11.9% on placebo experienced an increase in height of 5 centiles or more(P < .05).
“This reflects what we see in clinical practice,” Irvine said. “Children often grow dramatically on treatment for atopic dermatitis.”
Among patients with a baseline height below the 30th percentile, 31.9% treated with dupilumab vs 11.1% treated with placebo gained at least 5 centiles in height. The figures for children below the 40th height percentile at baseline were 31.3% vs 15.5% (P < .05 for both).
Although there remained a marked difference in the proportion of children below the 50th height percentile at baseline gaining 5 centiles or more in height, at 29.0% with dupilumab versus 15.7% with placebo, it was no longer significant.
“So the effect of catch-up growth, or growth through the centiles, is most marked in those who are in the 40th centile or below,” Irvine said, indicating that the “more growth restricted kids have much more potential to catch up.”
‘Convincing’ Data
Overall, Kirkorian said in the interview, the data are “convincing” and support her view that severe atopic dermatitis is a “terrible chronic disease that we really underappreciate.” Atopic dermatitis, she added, “should get the respect that any severe chronic illness would have, whether that be arthritis, diabetes, or cardiac disease, because it is a systemic disorder that … profoundly affects quality of life, every minute of every day.”
However, “we don’t get all the referrals we should, until the child has suffered for years and years, and the family has suffered,” as there is a bias that it can be outgrown — although not everybody does — and it “doesn’t look as conspicuous as other chronic skin disorders,” such as psoriasis.
“Now with this study,” Kirkorian said, “it gives us a really compelling point to make to parents, to the community, and to insurers that not only are we affecting the quality of life from the itch standpoint [with dupilumab] but we may have long profound effects on growth and bone health.”
The research was sponsored by Sanofi and Regeneron Pharmaceuticals. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAI, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome. Kirkorian declared relationships with Dermavant, Verrica Pharmaceuticals, Pfizer, and Incyte.
A version of this article first appeared on Medscape.com.
AMSTERDAM — , revealed a post hoc trial analysis.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The trial included a “rigorously selected … well-characterized, well-studied” population of children aged 6-11 years, said presenter Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland.
It showed that “severe atopic dermatitis does cause restriction of growth, as well as a higher weight, and therefore obviously a higher BMI [body mass index].”
He continued, however, that children at the lower percentiles of height receiving prompt treatment with dupilumab (Dupixent) “were able to rapidly move through the centiles over the 16 weeks of the study, and that may be the window for catch-up growth … when children are growing rapidly.”
Anna Yasmine Kirkorian, MD, chief of dermatology, Children’s National Hospital, Washington, DC, who was not involved in the study, said that she was “surprised” at the degree of growth achieved over the study period, as height is not something that jumps up “overnight.”
“On the other hand, it fits with my experience with children who’ve had the brakes on all of their life due to inflammation, whether it be height, going to school, sleeping — everything is sort of put on pause by this terrible inflammatory process,” she said.
“When you take the brakes off, they get to be who they are going to be,” Kirkorian added. “So I was surprised by the speed of it, but not by the fact that height was acquired.”
Her belief is that in the pre-dupilumab era, severe atopic dermatitis was often insufficiently controlled, so children were “smaller than you would predict from parental height,” and the treatment is “allowing them to reach their genetic potential.”
Post Hoc Analysis
In his presentation, Irvine emphasized that it has been clearly demonstrated that adolescents with moderate and severe atopic dermatitis have a significantly higher likelihood of being below the 25th percentile of height on growth reference charts.
Such children are also at a higher risk of having low bone mineral density and low serum alkaline phosphatase (ALP) levels . While data presented at the EADV 2023 Congress showed that dupilumab significantly increased serum levels of bone ALP compared with placebo, the underlying mechanism remains unclear.
For the current analysis, Irvine and colleagues determined that the proportion of children aged 6-11 years with severe atopic dermatitis and lower stature reach a ≥ 5 centile improvement in height following 16 weeks of dupilumab treatment.
They examined data from the LIBERTY AD PEDS trial, in which patients aged 6-11 years with severe atopic dermatitis were randomized to 300 mg dupilumab every 4 weeks or placebo along with a mild or moderately potent topical corticosteroid. The study found that, overall, dupilumab was associated with significant improvements in signs, symptoms, and quality of life compared with placebo.
Height measures at baseline revealed that “more boys and more girls were below the 50th centile than you would predict for a healthy, normal control population,” Irvine said. “If we look at weight, we see the opposite,” he continued, “with a disproportionate number of boys and girls who are above the 50th centile for weight at baseline.”
Consequently, “we’re seeing these children who are shorter and heavier than the predicted healthy weight range and, as a result, obviously have higher BMI,” Irvine noted, with 67% girls and 62% boys found to have a higher BMI than normal for their age.
After 16 weeks of treatment with dupilumab, there was a much greater gain in height than that seen among those on placebo, with the most pronounced effect seen in children who had the lowest height at baseline. Indeed, among children in the lowest 25% height percentile at baseline, 30.6% on dupilumab vs 11.9% on placebo experienced an increase in height of 5 centiles or more(P < .05).
“This reflects what we see in clinical practice,” Irvine said. “Children often grow dramatically on treatment for atopic dermatitis.”
Among patients with a baseline height below the 30th percentile, 31.9% treated with dupilumab vs 11.1% treated with placebo gained at least 5 centiles in height. The figures for children below the 40th height percentile at baseline were 31.3% vs 15.5% (P < .05 for both).
Although there remained a marked difference in the proportion of children below the 50th height percentile at baseline gaining 5 centiles or more in height, at 29.0% with dupilumab versus 15.7% with placebo, it was no longer significant.
“So the effect of catch-up growth, or growth through the centiles, is most marked in those who are in the 40th centile or below,” Irvine said, indicating that the “more growth restricted kids have much more potential to catch up.”
‘Convincing’ Data
Overall, Kirkorian said in the interview, the data are “convincing” and support her view that severe atopic dermatitis is a “terrible chronic disease that we really underappreciate.” Atopic dermatitis, she added, “should get the respect that any severe chronic illness would have, whether that be arthritis, diabetes, or cardiac disease, because it is a systemic disorder that … profoundly affects quality of life, every minute of every day.”
However, “we don’t get all the referrals we should, until the child has suffered for years and years, and the family has suffered,” as there is a bias that it can be outgrown — although not everybody does — and it “doesn’t look as conspicuous as other chronic skin disorders,” such as psoriasis.
“Now with this study,” Kirkorian said, “it gives us a really compelling point to make to parents, to the community, and to insurers that not only are we affecting the quality of life from the itch standpoint [with dupilumab] but we may have long profound effects on growth and bone health.”
The research was sponsored by Sanofi and Regeneron Pharmaceuticals. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAI, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome. Kirkorian declared relationships with Dermavant, Verrica Pharmaceuticals, Pfizer, and Incyte.
A version of this article first appeared on Medscape.com.
AMSTERDAM — , revealed a post hoc trial analysis.
The research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The trial included a “rigorously selected … well-characterized, well-studied” population of children aged 6-11 years, said presenter Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin, Ireland.
It showed that “severe atopic dermatitis does cause restriction of growth, as well as a higher weight, and therefore obviously a higher BMI [body mass index].”
He continued, however, that children at the lower percentiles of height receiving prompt treatment with dupilumab (Dupixent) “were able to rapidly move through the centiles over the 16 weeks of the study, and that may be the window for catch-up growth … when children are growing rapidly.”
Anna Yasmine Kirkorian, MD, chief of dermatology, Children’s National Hospital, Washington, DC, who was not involved in the study, said that she was “surprised” at the degree of growth achieved over the study period, as height is not something that jumps up “overnight.”
“On the other hand, it fits with my experience with children who’ve had the brakes on all of their life due to inflammation, whether it be height, going to school, sleeping — everything is sort of put on pause by this terrible inflammatory process,” she said.
“When you take the brakes off, they get to be who they are going to be,” Kirkorian added. “So I was surprised by the speed of it, but not by the fact that height was acquired.”
Her belief is that in the pre-dupilumab era, severe atopic dermatitis was often insufficiently controlled, so children were “smaller than you would predict from parental height,” and the treatment is “allowing them to reach their genetic potential.”
Post Hoc Analysis
In his presentation, Irvine emphasized that it has been clearly demonstrated that adolescents with moderate and severe atopic dermatitis have a significantly higher likelihood of being below the 25th percentile of height on growth reference charts.
Such children are also at a higher risk of having low bone mineral density and low serum alkaline phosphatase (ALP) levels . While data presented at the EADV 2023 Congress showed that dupilumab significantly increased serum levels of bone ALP compared with placebo, the underlying mechanism remains unclear.
For the current analysis, Irvine and colleagues determined that the proportion of children aged 6-11 years with severe atopic dermatitis and lower stature reach a ≥ 5 centile improvement in height following 16 weeks of dupilumab treatment.
They examined data from the LIBERTY AD PEDS trial, in which patients aged 6-11 years with severe atopic dermatitis were randomized to 300 mg dupilumab every 4 weeks or placebo along with a mild or moderately potent topical corticosteroid. The study found that, overall, dupilumab was associated with significant improvements in signs, symptoms, and quality of life compared with placebo.
Height measures at baseline revealed that “more boys and more girls were below the 50th centile than you would predict for a healthy, normal control population,” Irvine said. “If we look at weight, we see the opposite,” he continued, “with a disproportionate number of boys and girls who are above the 50th centile for weight at baseline.”
Consequently, “we’re seeing these children who are shorter and heavier than the predicted healthy weight range and, as a result, obviously have higher BMI,” Irvine noted, with 67% girls and 62% boys found to have a higher BMI than normal for their age.
After 16 weeks of treatment with dupilumab, there was a much greater gain in height than that seen among those on placebo, with the most pronounced effect seen in children who had the lowest height at baseline. Indeed, among children in the lowest 25% height percentile at baseline, 30.6% on dupilumab vs 11.9% on placebo experienced an increase in height of 5 centiles or more(P < .05).
“This reflects what we see in clinical practice,” Irvine said. “Children often grow dramatically on treatment for atopic dermatitis.”
Among patients with a baseline height below the 30th percentile, 31.9% treated with dupilumab vs 11.1% treated with placebo gained at least 5 centiles in height. The figures for children below the 40th height percentile at baseline were 31.3% vs 15.5% (P < .05 for both).
Although there remained a marked difference in the proportion of children below the 50th height percentile at baseline gaining 5 centiles or more in height, at 29.0% with dupilumab versus 15.7% with placebo, it was no longer significant.
“So the effect of catch-up growth, or growth through the centiles, is most marked in those who are in the 40th centile or below,” Irvine said, indicating that the “more growth restricted kids have much more potential to catch up.”
‘Convincing’ Data
Overall, Kirkorian said in the interview, the data are “convincing” and support her view that severe atopic dermatitis is a “terrible chronic disease that we really underappreciate.” Atopic dermatitis, she added, “should get the respect that any severe chronic illness would have, whether that be arthritis, diabetes, or cardiac disease, because it is a systemic disorder that … profoundly affects quality of life, every minute of every day.”
However, “we don’t get all the referrals we should, until the child has suffered for years and years, and the family has suffered,” as there is a bias that it can be outgrown — although not everybody does — and it “doesn’t look as conspicuous as other chronic skin disorders,” such as psoriasis.
“Now with this study,” Kirkorian said, “it gives us a really compelling point to make to parents, to the community, and to insurers that not only are we affecting the quality of life from the itch standpoint [with dupilumab] but we may have long profound effects on growth and bone health.”
The research was sponsored by Sanofi and Regeneron Pharmaceuticals. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAI, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome. Kirkorian declared relationships with Dermavant, Verrica Pharmaceuticals, Pfizer, and Incyte.
A version of this article first appeared on Medscape.com.
FROM EADV 2024
Nemolizumab Benefits for Atopic Dermatitis Maintained in Long-Term Follow-Up Study
ARCADIA open-label extension study.
(AD), revealed an interim analysis of theThe research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The results showed nemolizumab was associated with “ongoing clinically meaningful improvements in itch, skin lesions, and sleep disturbance,” said study presenter Diamant Thaçi, MD, PhD, of the Comprehensive Center for Inflammation Medicine, University of Lü̈beck in Germany.
Moreover, “patient-reported outcomes, including quality of life ... continued to improve over 56 weeks of treatment.” In addition, Thaçi added, the “safety data support the long-term use of nemolizumab for the treatment of adolescent and adult patients with moderate to severe atopic dermatitis.”
He explained that interleukin (IL) 31 is a key neuroimmune cytokine in AD, triggering itch, skin barrier disruption, and exacerbation of inflammation via its receptor. Nemolizumab inhibits IL-31 receptor binding and was shown in the ARCADIA 1 and ARCADIA 2 trials to provide, along with background topical corticosteroids, clinically meaningful improvements in itch, skin lesions, and sleep for up to weeks 48 of follow-up in adolescents and adults with moderate to severe AD.
The current open-label long-term extension study involved patients who were enrolled in both ARCADIA 1 and 2 trials, as well as those from four phase 2 and 2b studies, a phase 3b study, and adolescents who had not been included in a trial but who met the criteria for the extension study. All patients, whether they started on placebo plus background topical corticosteroids in a prior study, were treated with nemolizumab 30 mg subcutaneously every 4 weeks along with topical corticosteroids.
The interim analysis included all efficacy and safety data up to the cutoff of September 30, 2022, on 723 patients who had completed 56 weeks of treatment among the 1751 patients initially enrolled in the extension study.
The results showed that, regardless of whether patients were nemolizumab naive at enrollment or had previously taken the drug, there were increases in the proportion of patients with an Investigator Global Assessment (IGA) score of 0/1 and an Eczema Area and Severity Index (EASI) score of at least 75 (EASI-75) over the 56 weeks of the study.
In those naive to nemolizumab, the increase in the proportion with an IGA score of 0/1 increased from 17.7% at baseline to 49.0% at 56 weeks, while the proportion with an EASI-75 increased from 24.0% to 78.7%.
The increase in the proportion of patients with an IGA score 0/1 among those who had previously received nemolizumab increased from 28.5% at baseline to 47.1% at 56 weeks. The proportion with an EASI-75 was 38.1% at baseline, rising to 73.0% at 56 weeks.
Increases in the proportion of patients with an EASI score of at least 50 and at least 90 were also seen with nemolizumab, as were increases in the proportion of patients with an improvement of at least four points on the SCORing Atopic Dermatitis Pruritus visual analogue scale and Sleep loss scores.
Similarly, the proportion of patients with a reduction in Dermatology Life Quality Index of at least four points increased over the study period.
Regarding safety, Thaçi said, there appeared to be fewer adverse events than had been previously reported with nemolizumab. “We don’t see any signs of conjunctivitis,” he continued, or significant risk of infection apart from for COVID-19, but he pointed out that the study was conducted during the pandemic, which was “a very difficult time.”
The most common treatment-related adverse events were, aside from COVID-19, nasopharyngitis in about 10%-11% of patients, upper respiratory tract infection in about 6% to almost 7%, and headache in about 5%.
Among the adverse events of special interest, newly diagnosed asthma or worsening of asthma occurred in 4.7%-4.8% of patients, while peripheral edema was seen in 0.8%-1.7%.
“Besides this, the study results are really looking very good,” he said, adding: “It means, in a long-term study, we can say today that nemolizumab has revealed the [same] safety profile that was shown in the ARCADIA 1 and 2 trials.”
Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin in Ireland, who was not involved in the study, underlined that the current interim assessment does not represent the complete dataset and is based on observed cases rather than a more rigorous methodology, such as net reclassification improvement analysis.
“So it makes it a little harder to interpret when you don’t know how many people are dropping out and why they’re dropping out,” he told this news organization. “That said, those who remain on drug out to 56 weeks do experience ongoing improvement in disease control.”
Consequently, “the most reliable message you can take from this interim analysis of long-term data is that there were no new safety signals,” and nemolizumab looks “safe and well-tolerated.”
Where nemolizumab would fit into the treatment pathway for moderate to severe AD remains an open question, Irvine said, although he believes that IL-13 pathway inhibitors such as dupilumab, tralokinumab, and lebrikizumab “will remain the treatment of choice for the immediate future due to prescriber familiarity and good efficacy data.”
However, for patients who are unsuitable for IL-13 inhibitors and/or Janus kinase inhibitors such as abrocitinib and upadacitinib, nemolizumab “could be an interesting alternative.”
“That’s probably where it is going to start,” Irvine said, “and then obviously that will change over time and as the data mature and prescribers become more familiar with the drug in the real world.”
Nemolizumab (Nemluvio) is approved for treating prurigo nodularis (PN) in the United States and in Japan and is under Food and Drug Administration review for treating AD. It is also under review for PN and AD in Europe, Canada, the United Kingdom, and several other countries, according to Galderma. It is also approved for treating pruritus associated with AD in pediatric, adolescent, and adult patients in Japan.
The study was funded by Galderma. Thaçi declared relationships with AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, Target RWE, and UCB. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAl, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome.
A version of this article first appeared on Medscape.com.
ARCADIA open-label extension study.
(AD), revealed an interim analysis of theThe research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The results showed nemolizumab was associated with “ongoing clinically meaningful improvements in itch, skin lesions, and sleep disturbance,” said study presenter Diamant Thaçi, MD, PhD, of the Comprehensive Center for Inflammation Medicine, University of Lü̈beck in Germany.
Moreover, “patient-reported outcomes, including quality of life ... continued to improve over 56 weeks of treatment.” In addition, Thaçi added, the “safety data support the long-term use of nemolizumab for the treatment of adolescent and adult patients with moderate to severe atopic dermatitis.”
He explained that interleukin (IL) 31 is a key neuroimmune cytokine in AD, triggering itch, skin barrier disruption, and exacerbation of inflammation via its receptor. Nemolizumab inhibits IL-31 receptor binding and was shown in the ARCADIA 1 and ARCADIA 2 trials to provide, along with background topical corticosteroids, clinically meaningful improvements in itch, skin lesions, and sleep for up to weeks 48 of follow-up in adolescents and adults with moderate to severe AD.
The current open-label long-term extension study involved patients who were enrolled in both ARCADIA 1 and 2 trials, as well as those from four phase 2 and 2b studies, a phase 3b study, and adolescents who had not been included in a trial but who met the criteria for the extension study. All patients, whether they started on placebo plus background topical corticosteroids in a prior study, were treated with nemolizumab 30 mg subcutaneously every 4 weeks along with topical corticosteroids.
The interim analysis included all efficacy and safety data up to the cutoff of September 30, 2022, on 723 patients who had completed 56 weeks of treatment among the 1751 patients initially enrolled in the extension study.
The results showed that, regardless of whether patients were nemolizumab naive at enrollment or had previously taken the drug, there were increases in the proportion of patients with an Investigator Global Assessment (IGA) score of 0/1 and an Eczema Area and Severity Index (EASI) score of at least 75 (EASI-75) over the 56 weeks of the study.
In those naive to nemolizumab, the increase in the proportion with an IGA score of 0/1 increased from 17.7% at baseline to 49.0% at 56 weeks, while the proportion with an EASI-75 increased from 24.0% to 78.7%.
The increase in the proportion of patients with an IGA score 0/1 among those who had previously received nemolizumab increased from 28.5% at baseline to 47.1% at 56 weeks. The proportion with an EASI-75 was 38.1% at baseline, rising to 73.0% at 56 weeks.
Increases in the proportion of patients with an EASI score of at least 50 and at least 90 were also seen with nemolizumab, as were increases in the proportion of patients with an improvement of at least four points on the SCORing Atopic Dermatitis Pruritus visual analogue scale and Sleep loss scores.
Similarly, the proportion of patients with a reduction in Dermatology Life Quality Index of at least four points increased over the study period.
Regarding safety, Thaçi said, there appeared to be fewer adverse events than had been previously reported with nemolizumab. “We don’t see any signs of conjunctivitis,” he continued, or significant risk of infection apart from for COVID-19, but he pointed out that the study was conducted during the pandemic, which was “a very difficult time.”
The most common treatment-related adverse events were, aside from COVID-19, nasopharyngitis in about 10%-11% of patients, upper respiratory tract infection in about 6% to almost 7%, and headache in about 5%.
Among the adverse events of special interest, newly diagnosed asthma or worsening of asthma occurred in 4.7%-4.8% of patients, while peripheral edema was seen in 0.8%-1.7%.
“Besides this, the study results are really looking very good,” he said, adding: “It means, in a long-term study, we can say today that nemolizumab has revealed the [same] safety profile that was shown in the ARCADIA 1 and 2 trials.”
Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin in Ireland, who was not involved in the study, underlined that the current interim assessment does not represent the complete dataset and is based on observed cases rather than a more rigorous methodology, such as net reclassification improvement analysis.
“So it makes it a little harder to interpret when you don’t know how many people are dropping out and why they’re dropping out,” he told this news organization. “That said, those who remain on drug out to 56 weeks do experience ongoing improvement in disease control.”
Consequently, “the most reliable message you can take from this interim analysis of long-term data is that there were no new safety signals,” and nemolizumab looks “safe and well-tolerated.”
Where nemolizumab would fit into the treatment pathway for moderate to severe AD remains an open question, Irvine said, although he believes that IL-13 pathway inhibitors such as dupilumab, tralokinumab, and lebrikizumab “will remain the treatment of choice for the immediate future due to prescriber familiarity and good efficacy data.”
However, for patients who are unsuitable for IL-13 inhibitors and/or Janus kinase inhibitors such as abrocitinib and upadacitinib, nemolizumab “could be an interesting alternative.”
“That’s probably where it is going to start,” Irvine said, “and then obviously that will change over time and as the data mature and prescribers become more familiar with the drug in the real world.”
Nemolizumab (Nemluvio) is approved for treating prurigo nodularis (PN) in the United States and in Japan and is under Food and Drug Administration review for treating AD. It is also under review for PN and AD in Europe, Canada, the United Kingdom, and several other countries, according to Galderma. It is also approved for treating pruritus associated with AD in pediatric, adolescent, and adult patients in Japan.
The study was funded by Galderma. Thaçi declared relationships with AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, Target RWE, and UCB. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAl, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome.
A version of this article first appeared on Medscape.com.
ARCADIA open-label extension study.
(AD), revealed an interim analysis of theThe research was presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress.
The results showed nemolizumab was associated with “ongoing clinically meaningful improvements in itch, skin lesions, and sleep disturbance,” said study presenter Diamant Thaçi, MD, PhD, of the Comprehensive Center for Inflammation Medicine, University of Lü̈beck in Germany.
Moreover, “patient-reported outcomes, including quality of life ... continued to improve over 56 weeks of treatment.” In addition, Thaçi added, the “safety data support the long-term use of nemolizumab for the treatment of adolescent and adult patients with moderate to severe atopic dermatitis.”
He explained that interleukin (IL) 31 is a key neuroimmune cytokine in AD, triggering itch, skin barrier disruption, and exacerbation of inflammation via its receptor. Nemolizumab inhibits IL-31 receptor binding and was shown in the ARCADIA 1 and ARCADIA 2 trials to provide, along with background topical corticosteroids, clinically meaningful improvements in itch, skin lesions, and sleep for up to weeks 48 of follow-up in adolescents and adults with moderate to severe AD.
The current open-label long-term extension study involved patients who were enrolled in both ARCADIA 1 and 2 trials, as well as those from four phase 2 and 2b studies, a phase 3b study, and adolescents who had not been included in a trial but who met the criteria for the extension study. All patients, whether they started on placebo plus background topical corticosteroids in a prior study, were treated with nemolizumab 30 mg subcutaneously every 4 weeks along with topical corticosteroids.
The interim analysis included all efficacy and safety data up to the cutoff of September 30, 2022, on 723 patients who had completed 56 weeks of treatment among the 1751 patients initially enrolled in the extension study.
The results showed that, regardless of whether patients were nemolizumab naive at enrollment or had previously taken the drug, there were increases in the proportion of patients with an Investigator Global Assessment (IGA) score of 0/1 and an Eczema Area and Severity Index (EASI) score of at least 75 (EASI-75) over the 56 weeks of the study.
In those naive to nemolizumab, the increase in the proportion with an IGA score of 0/1 increased from 17.7% at baseline to 49.0% at 56 weeks, while the proportion with an EASI-75 increased from 24.0% to 78.7%.
The increase in the proportion of patients with an IGA score 0/1 among those who had previously received nemolizumab increased from 28.5% at baseline to 47.1% at 56 weeks. The proportion with an EASI-75 was 38.1% at baseline, rising to 73.0% at 56 weeks.
Increases in the proportion of patients with an EASI score of at least 50 and at least 90 were also seen with nemolizumab, as were increases in the proportion of patients with an improvement of at least four points on the SCORing Atopic Dermatitis Pruritus visual analogue scale and Sleep loss scores.
Similarly, the proportion of patients with a reduction in Dermatology Life Quality Index of at least four points increased over the study period.
Regarding safety, Thaçi said, there appeared to be fewer adverse events than had been previously reported with nemolizumab. “We don’t see any signs of conjunctivitis,” he continued, or significant risk of infection apart from for COVID-19, but he pointed out that the study was conducted during the pandemic, which was “a very difficult time.”
The most common treatment-related adverse events were, aside from COVID-19, nasopharyngitis in about 10%-11% of patients, upper respiratory tract infection in about 6% to almost 7%, and headache in about 5%.
Among the adverse events of special interest, newly diagnosed asthma or worsening of asthma occurred in 4.7%-4.8% of patients, while peripheral edema was seen in 0.8%-1.7%.
“Besides this, the study results are really looking very good,” he said, adding: “It means, in a long-term study, we can say today that nemolizumab has revealed the [same] safety profile that was shown in the ARCADIA 1 and 2 trials.”
Alan D. Irvine, MD, DSc, professor of dermatology, Trinity College Dublin in Ireland, who was not involved in the study, underlined that the current interim assessment does not represent the complete dataset and is based on observed cases rather than a more rigorous methodology, such as net reclassification improvement analysis.
“So it makes it a little harder to interpret when you don’t know how many people are dropping out and why they’re dropping out,” he told this news organization. “That said, those who remain on drug out to 56 weeks do experience ongoing improvement in disease control.”
Consequently, “the most reliable message you can take from this interim analysis of long-term data is that there were no new safety signals,” and nemolizumab looks “safe and well-tolerated.”
Where nemolizumab would fit into the treatment pathway for moderate to severe AD remains an open question, Irvine said, although he believes that IL-13 pathway inhibitors such as dupilumab, tralokinumab, and lebrikizumab “will remain the treatment of choice for the immediate future due to prescriber familiarity and good efficacy data.”
However, for patients who are unsuitable for IL-13 inhibitors and/or Janus kinase inhibitors such as abrocitinib and upadacitinib, nemolizumab “could be an interesting alternative.”
“That’s probably where it is going to start,” Irvine said, “and then obviously that will change over time and as the data mature and prescribers become more familiar with the drug in the real world.”
Nemolizumab (Nemluvio) is approved for treating prurigo nodularis (PN) in the United States and in Japan and is under Food and Drug Administration review for treating AD. It is also under review for PN and AD in Europe, Canada, the United Kingdom, and several other countries, according to Galderma. It is also approved for treating pruritus associated with AD in pediatric, adolescent, and adult patients in Japan.
The study was funded by Galderma. Thaçi declared relationships with AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Galderma, Janssen-Cilag, Kyowa Kirin, LEO Pharma, L’Oréal, Eli Lilly, Novartis, Pfizer, Regeneron, Sanofi, Target RWE, and UCB. Irvine declared relationships with AbbVie, Arena Pharmaceuticals, BenevolentAl, Chugai Pharmaceutical, Dermavant, Eli Lily, Genentech, LEO Pharma, Menlo Therapeutics, Novartis, Pfizer, Regeneron, Sanofi, UCB, DS Biopharma, and Inflazome.
A version of this article first appeared on Medscape.com.
FROM EADV 2024
Triple P
Podcasts, websites, and large “Parenting” sections in bookstores testify to the large demand for parent guidance and support, but also to the fact that there is no one universally accepted guidebook, such as Benjamin Spock provided for parents almost 80 years ago with Baby and Child Care.
We will describe the basic components of this curriculum so that you may determine whether it might be useful to the families in your practice. Then we will expand upon the domains that have proven essential for parents to nurture healthy development in their children. Even if you do not have the time or resources to provide the full Triple P curriculum, you can offer these principles directly to parents and decide when to refer them to access more formal parent training and coaching.
Triple P was developed by psychologist Matthew Sanders, to “promote positive, caring relationships between parents and their children and to help parents develop effective management strategies for dealing with a variety of childhood behavior problems and common developmental issues” as his doctoral project in Australia in the 1980s. Research in the 1990s suggested substantial efficacy, and it was packaged for broader adoption in the early 2000s. It is a tiered approach, meaning there is content for universal education (level 1), up through more intensive, specialized, and individualized content to be delivered in group or individual settings focused on building specific skills or addressing select problems. It was originally developed for the parents of 0- to 11-year-old children, with additional curricula for parents of teenagers created later. It always is delivered to parents only, through a mix of video and reading, or in-person groups or individual coaching. While the universal education resources are available for free to families of children under 12 in Australia, resources and training are available for a fee in the United states (triplep.net). Research has demonstrated considerable efficacy at reducing some of the common behavioral problems of childhood, improving parental confidence and family harmony, and decreasing rates of parental depression. It has even demonstrated efficacy in reducing the incidence of child maltreatment.
Triple P focuses on what Sanders calls the five key principles of positive parenting:
- 1. Creating a safe and engaging environment for children
- 2. Providing a positive learning environment for children
- 3. Assertive discipline
- 4. Having realistic expectations
- 5. Parental self-care.
The educational materials and more intensive parent trainings are all focused on developing knowledge and skills in the parents that will promote a positive relationship with their children, teach the children new skills while encouraging desirable behaviors, and managing problematic behaviors. The training happens with written or video scenarios, up through individualized skill coaching with homework and direct feedback from trained clinicians. While information about the universally helpful knowledge and skills can be found online or accessed through some local programs in the United States, the higher levels of intervention are less consistently available. You should explore what is available in your community, but even if you don’t have the resources for your own training, you are already offering parent guidance at every visit.
Practical Strategies
Below are practical strategies to offer parents the knowledge and support that are essential to “positive parenting,” so they may nurture their children’s healthiest development.
Attunement: Attunement is simply a parent’s ability to know who their child is and where their child is at any given time. This covers an appreciation of the child’s temperament, style, interests, strengths, and vulnerabilities. Where their child is at includes being able to read that particular child’s cues: Are they hungry? Sleepy? Sick? Frustrated? Parents are the experts on their children, but their children are also always changing. You can help the parents in your practice be intentional about being attuned to their children, so they can always be deepening their understanding of who their children are (becoming) and where they are at in any given moment. This requires protecting regular, unstructured time when they can give their children their full attention: reading, doing an art project, practicing music, or basketball. Schedules are often packed with work and school, driving between many structured activities. Reassure the parents in your practice that time spent in play is just as important. When a parent is present, attentive, and curious, asking questions, learning about the child’s thoughts, feelings and ideas, they are doing some of the most essential (and delightful) work of raising children.
Positive Environment: A “positive environment” is child-centered, with access to age-appropriate activities of a wide range. Offering first-time parents written resources about child development and age-appropriate games, books, and activities is an easy way to support positive parenting. A positive environment also has structure and routines, so children can play and explore with the comfort of knowing what to expect and what is expected of them. Do they have a regular bedtime and bedtime routines? Do they consistently eat dinner together and clean up as a family? Do they have reliable unstructured time together, maybe playing board games or kickball after dinner? These varying but predictable routines provide opportunities for children to practice helping, following through, sharing, and tolerating frustration or failure, and they give parents low-stakes opportunities to offer praise for their effort, compassion when they struggle, and affection for no reason at all. They lower the chances of parent-child interactions being predominantly reactive, demanding, pleading, or angry.
Effective Discipline: A positive environment includes reasonable and consistent consequences for rule breaking and poor behavior, and an essential part of predictability includes clear ground rules for what is expected of children at home, around chores, getting ready for school and bedtime, and their behavior. Parents need to agree on and children should understand what the consequences will be for breaking rules. Parents should also have a clear strategy for consistently and calmly enforcing rules. This is not easy, but is just as important as affection and play. If parents are struggling with discipline, it is worth asking for a specific example to learn about where the trouble lies. Are parents not on the same page? Are they worried about their children’s distress? Do they lose their temper and the matter escalates? Clear ground rules and a game plan can help them to stay calm instead of resorting to pleading and yelling. Speaking with them about the value of planning and communicating about these expectations and rules during a quiet time, not in the midst of conflict, might be enough to help them with effective discipline. Others may need more support. Books like 123 Magic with more detail on how to manage time outs can be helpful. For those parents who are managing greater difficulty, a referral to parent coaching (with a modality such as Triple P, Parent-Child Interaction Training or Collaborative Problem Solving) may be needed.
Parental Well-Being: Being aligned with one’s spouse (or other caregiver) in how to manage challenging child behaviors is essential to a healthy relationship, and overall well-being is an essential ingredient in creating a nurturing, positive environment at home. How is the parents’ communication with each other overall? Do they have time together that is not focused on the children? Does each parent have time for outside interests or hobbies? How about other important relationships? Do they prioritize their own sleep, regular exercise, and good nutrition? It can be powerful if they plan family activities that are centered on their own passions and interests as well as their children’s. It is powerful for parents to hear from you that when they protect some of their time and energy to simply care for their own health and well-being, they are building a positive environment for their children, both in how they will show up for their family and in what they model.
Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Suggested Reading
Sanders MR et al. The Development and Dissemination of the Triple P – Positive Parenting Program: A Multilevel Evidence-Based System of Parenting and Family Support. Prev Sci. 2002 Sep;3(3):173-89. doi: 10.1023/a:1019942516231.
Sanders MR. The Triple P System of Evidence-Based Parenting Support: Past, Present, and Future Directions. Clin Child Fam Psychol Rev. 2023 Dec;26(4):880-903. doi: 10.1007/s10567-023-00441-8.
Podcasts, websites, and large “Parenting” sections in bookstores testify to the large demand for parent guidance and support, but also to the fact that there is no one universally accepted guidebook, such as Benjamin Spock provided for parents almost 80 years ago with Baby and Child Care.
We will describe the basic components of this curriculum so that you may determine whether it might be useful to the families in your practice. Then we will expand upon the domains that have proven essential for parents to nurture healthy development in their children. Even if you do not have the time or resources to provide the full Triple P curriculum, you can offer these principles directly to parents and decide when to refer them to access more formal parent training and coaching.
Triple P was developed by psychologist Matthew Sanders, to “promote positive, caring relationships between parents and their children and to help parents develop effective management strategies for dealing with a variety of childhood behavior problems and common developmental issues” as his doctoral project in Australia in the 1980s. Research in the 1990s suggested substantial efficacy, and it was packaged for broader adoption in the early 2000s. It is a tiered approach, meaning there is content for universal education (level 1), up through more intensive, specialized, and individualized content to be delivered in group or individual settings focused on building specific skills or addressing select problems. It was originally developed for the parents of 0- to 11-year-old children, with additional curricula for parents of teenagers created later. It always is delivered to parents only, through a mix of video and reading, or in-person groups or individual coaching. While the universal education resources are available for free to families of children under 12 in Australia, resources and training are available for a fee in the United states (triplep.net). Research has demonstrated considerable efficacy at reducing some of the common behavioral problems of childhood, improving parental confidence and family harmony, and decreasing rates of parental depression. It has even demonstrated efficacy in reducing the incidence of child maltreatment.
Triple P focuses on what Sanders calls the five key principles of positive parenting:
- 1. Creating a safe and engaging environment for children
- 2. Providing a positive learning environment for children
- 3. Assertive discipline
- 4. Having realistic expectations
- 5. Parental self-care.
The educational materials and more intensive parent trainings are all focused on developing knowledge and skills in the parents that will promote a positive relationship with their children, teach the children new skills while encouraging desirable behaviors, and managing problematic behaviors. The training happens with written or video scenarios, up through individualized skill coaching with homework and direct feedback from trained clinicians. While information about the universally helpful knowledge and skills can be found online or accessed through some local programs in the United States, the higher levels of intervention are less consistently available. You should explore what is available in your community, but even if you don’t have the resources for your own training, you are already offering parent guidance at every visit.
Practical Strategies
Below are practical strategies to offer parents the knowledge and support that are essential to “positive parenting,” so they may nurture their children’s healthiest development.
Attunement: Attunement is simply a parent’s ability to know who their child is and where their child is at any given time. This covers an appreciation of the child’s temperament, style, interests, strengths, and vulnerabilities. Where their child is at includes being able to read that particular child’s cues: Are they hungry? Sleepy? Sick? Frustrated? Parents are the experts on their children, but their children are also always changing. You can help the parents in your practice be intentional about being attuned to their children, so they can always be deepening their understanding of who their children are (becoming) and where they are at in any given moment. This requires protecting regular, unstructured time when they can give their children their full attention: reading, doing an art project, practicing music, or basketball. Schedules are often packed with work and school, driving between many structured activities. Reassure the parents in your practice that time spent in play is just as important. When a parent is present, attentive, and curious, asking questions, learning about the child’s thoughts, feelings and ideas, they are doing some of the most essential (and delightful) work of raising children.
Positive Environment: A “positive environment” is child-centered, with access to age-appropriate activities of a wide range. Offering first-time parents written resources about child development and age-appropriate games, books, and activities is an easy way to support positive parenting. A positive environment also has structure and routines, so children can play and explore with the comfort of knowing what to expect and what is expected of them. Do they have a regular bedtime and bedtime routines? Do they consistently eat dinner together and clean up as a family? Do they have reliable unstructured time together, maybe playing board games or kickball after dinner? These varying but predictable routines provide opportunities for children to practice helping, following through, sharing, and tolerating frustration or failure, and they give parents low-stakes opportunities to offer praise for their effort, compassion when they struggle, and affection for no reason at all. They lower the chances of parent-child interactions being predominantly reactive, demanding, pleading, or angry.
Effective Discipline: A positive environment includes reasonable and consistent consequences for rule breaking and poor behavior, and an essential part of predictability includes clear ground rules for what is expected of children at home, around chores, getting ready for school and bedtime, and their behavior. Parents need to agree on and children should understand what the consequences will be for breaking rules. Parents should also have a clear strategy for consistently and calmly enforcing rules. This is not easy, but is just as important as affection and play. If parents are struggling with discipline, it is worth asking for a specific example to learn about where the trouble lies. Are parents not on the same page? Are they worried about their children’s distress? Do they lose their temper and the matter escalates? Clear ground rules and a game plan can help them to stay calm instead of resorting to pleading and yelling. Speaking with them about the value of planning and communicating about these expectations and rules during a quiet time, not in the midst of conflict, might be enough to help them with effective discipline. Others may need more support. Books like 123 Magic with more detail on how to manage time outs can be helpful. For those parents who are managing greater difficulty, a referral to parent coaching (with a modality such as Triple P, Parent-Child Interaction Training or Collaborative Problem Solving) may be needed.
Parental Well-Being: Being aligned with one’s spouse (or other caregiver) in how to manage challenging child behaviors is essential to a healthy relationship, and overall well-being is an essential ingredient in creating a nurturing, positive environment at home. How is the parents’ communication with each other overall? Do they have time together that is not focused on the children? Does each parent have time for outside interests or hobbies? How about other important relationships? Do they prioritize their own sleep, regular exercise, and good nutrition? It can be powerful if they plan family activities that are centered on their own passions and interests as well as their children’s. It is powerful for parents to hear from you that when they protect some of their time and energy to simply care for their own health and well-being, they are building a positive environment for their children, both in how they will show up for their family and in what they model.
Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Suggested Reading
Sanders MR et al. The Development and Dissemination of the Triple P – Positive Parenting Program: A Multilevel Evidence-Based System of Parenting and Family Support. Prev Sci. 2002 Sep;3(3):173-89. doi: 10.1023/a:1019942516231.
Sanders MR. The Triple P System of Evidence-Based Parenting Support: Past, Present, and Future Directions. Clin Child Fam Psychol Rev. 2023 Dec;26(4):880-903. doi: 10.1007/s10567-023-00441-8.
Podcasts, websites, and large “Parenting” sections in bookstores testify to the large demand for parent guidance and support, but also to the fact that there is no one universally accepted guidebook, such as Benjamin Spock provided for parents almost 80 years ago with Baby and Child Care.
We will describe the basic components of this curriculum so that you may determine whether it might be useful to the families in your practice. Then we will expand upon the domains that have proven essential for parents to nurture healthy development in their children. Even if you do not have the time or resources to provide the full Triple P curriculum, you can offer these principles directly to parents and decide when to refer them to access more formal parent training and coaching.
Triple P was developed by psychologist Matthew Sanders, to “promote positive, caring relationships between parents and their children and to help parents develop effective management strategies for dealing with a variety of childhood behavior problems and common developmental issues” as his doctoral project in Australia in the 1980s. Research in the 1990s suggested substantial efficacy, and it was packaged for broader adoption in the early 2000s. It is a tiered approach, meaning there is content for universal education (level 1), up through more intensive, specialized, and individualized content to be delivered in group or individual settings focused on building specific skills or addressing select problems. It was originally developed for the parents of 0- to 11-year-old children, with additional curricula for parents of teenagers created later. It always is delivered to parents only, through a mix of video and reading, or in-person groups or individual coaching. While the universal education resources are available for free to families of children under 12 in Australia, resources and training are available for a fee in the United states (triplep.net). Research has demonstrated considerable efficacy at reducing some of the common behavioral problems of childhood, improving parental confidence and family harmony, and decreasing rates of parental depression. It has even demonstrated efficacy in reducing the incidence of child maltreatment.
Triple P focuses on what Sanders calls the five key principles of positive parenting:
- 1. Creating a safe and engaging environment for children
- 2. Providing a positive learning environment for children
- 3. Assertive discipline
- 4. Having realistic expectations
- 5. Parental self-care.
The educational materials and more intensive parent trainings are all focused on developing knowledge and skills in the parents that will promote a positive relationship with their children, teach the children new skills while encouraging desirable behaviors, and managing problematic behaviors. The training happens with written or video scenarios, up through individualized skill coaching with homework and direct feedback from trained clinicians. While information about the universally helpful knowledge and skills can be found online or accessed through some local programs in the United States, the higher levels of intervention are less consistently available. You should explore what is available in your community, but even if you don’t have the resources for your own training, you are already offering parent guidance at every visit.
Practical Strategies
Below are practical strategies to offer parents the knowledge and support that are essential to “positive parenting,” so they may nurture their children’s healthiest development.
Attunement: Attunement is simply a parent’s ability to know who their child is and where their child is at any given time. This covers an appreciation of the child’s temperament, style, interests, strengths, and vulnerabilities. Where their child is at includes being able to read that particular child’s cues: Are they hungry? Sleepy? Sick? Frustrated? Parents are the experts on their children, but their children are also always changing. You can help the parents in your practice be intentional about being attuned to their children, so they can always be deepening their understanding of who their children are (becoming) and where they are at in any given moment. This requires protecting regular, unstructured time when they can give their children their full attention: reading, doing an art project, practicing music, or basketball. Schedules are often packed with work and school, driving between many structured activities. Reassure the parents in your practice that time spent in play is just as important. When a parent is present, attentive, and curious, asking questions, learning about the child’s thoughts, feelings and ideas, they are doing some of the most essential (and delightful) work of raising children.
Positive Environment: A “positive environment” is child-centered, with access to age-appropriate activities of a wide range. Offering first-time parents written resources about child development and age-appropriate games, books, and activities is an easy way to support positive parenting. A positive environment also has structure and routines, so children can play and explore with the comfort of knowing what to expect and what is expected of them. Do they have a regular bedtime and bedtime routines? Do they consistently eat dinner together and clean up as a family? Do they have reliable unstructured time together, maybe playing board games or kickball after dinner? These varying but predictable routines provide opportunities for children to practice helping, following through, sharing, and tolerating frustration or failure, and they give parents low-stakes opportunities to offer praise for their effort, compassion when they struggle, and affection for no reason at all. They lower the chances of parent-child interactions being predominantly reactive, demanding, pleading, or angry.
Effective Discipline: A positive environment includes reasonable and consistent consequences for rule breaking and poor behavior, and an essential part of predictability includes clear ground rules for what is expected of children at home, around chores, getting ready for school and bedtime, and their behavior. Parents need to agree on and children should understand what the consequences will be for breaking rules. Parents should also have a clear strategy for consistently and calmly enforcing rules. This is not easy, but is just as important as affection and play. If parents are struggling with discipline, it is worth asking for a specific example to learn about where the trouble lies. Are parents not on the same page? Are they worried about their children’s distress? Do they lose their temper and the matter escalates? Clear ground rules and a game plan can help them to stay calm instead of resorting to pleading and yelling. Speaking with them about the value of planning and communicating about these expectations and rules during a quiet time, not in the midst of conflict, might be enough to help them with effective discipline. Others may need more support. Books like 123 Magic with more detail on how to manage time outs can be helpful. For those parents who are managing greater difficulty, a referral to parent coaching (with a modality such as Triple P, Parent-Child Interaction Training or Collaborative Problem Solving) may be needed.
Parental Well-Being: Being aligned with one’s spouse (or other caregiver) in how to manage challenging child behaviors is essential to a healthy relationship, and overall well-being is an essential ingredient in creating a nurturing, positive environment at home. How is the parents’ communication with each other overall? Do they have time together that is not focused on the children? Does each parent have time for outside interests or hobbies? How about other important relationships? Do they prioritize their own sleep, regular exercise, and good nutrition? It can be powerful if they plan family activities that are centered on their own passions and interests as well as their children’s. It is powerful for parents to hear from you that when they protect some of their time and energy to simply care for their own health and well-being, they are building a positive environment for their children, both in how they will show up for their family and in what they model.
Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Suggested Reading
Sanders MR et al. The Development and Dissemination of the Triple P – Positive Parenting Program: A Multilevel Evidence-Based System of Parenting and Family Support. Prev Sci. 2002 Sep;3(3):173-89. doi: 10.1023/a:1019942516231.
Sanders MR. The Triple P System of Evidence-Based Parenting Support: Past, Present, and Future Directions. Clin Child Fam Psychol Rev. 2023 Dec;26(4):880-903. doi: 10.1007/s10567-023-00441-8.
Rituximab Not Inferior to Cyclophosphamide in Pediatric Vasculitis
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
and those who received rituximab required a significantly lower steroid dose than those who received cyclophosphamide or a combination therapy.
METHODOLOGY:
- Researchers evaluated the efficacy of rituximab, cyclophosphamide, or a combination of both in pediatric patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis.
- A total of 104 patients (median age at diagnosis, 14 years; 67% girls) were included from A Registry of Childhood Vasculitis; the majority had a diagnosis of GPA (81%) and renal involvement (87%). Overall, induction therapy involved rituximab for 43%, cyclophosphamide for 46%, and a combination of both for 11% patients.
- The primary endpoint was the rate of achieving remission (Pediatric Vasculitis Activity Score [PVAS] of 0) or low disease activity (PVAS ≤ 2) at the post-induction visit (4-6 months after diagnosis).
- The secondary endpoints were the degree of disease-related damage at 12- and 24-month visits and rates of drug-related hospitalization occurring between the diagnosis and post-induction visits.
TAKEAWAY:
- At the post-induction visit, 63% patients achieved remission or low disease activity, with the rates being similar between patients who received rituximab and those who received cyclophosphamide (64% vs 62%).
- Patients treated with rituximab required a significantly lower median steroid dose (0.13 mg/kg per day) than those treated with cyclophosphamide (0.3 mg/kg per day) or the combination therapy (0.3 mg/kg per day; P < .001) at the post-induction visit.
- Overall, 61% and 56% patients receiving rituximab and cyclophosphamide, respectively, had disease-related damage measure on the Pediatric Vasculitis Damage Index at the 12-month visit; however, the degree of damage was low.
- The percentage of patients requiring hospitalization was higher in the rituximab group than in the cyclophosphamide group (22% vs 10%), primarily stemming from drug- or infection-related causes (11% vs 2%).
IN PRACTICE:
“The results of this study may assist with current clinical decision-making with regard to the choice of induction medications in childhood-onset AAV and will complement the ongoing [Childhood Arthritis and Rheumatology Research Alliance] prospective [consensus treatment plans] study,” the authors wrote.
SOURCE:
This study was led by Samuel J. Gagne, MD, Children’s Hospital of Pittsburgh, University of Pittsburgh Medical Center in Pennsylvania, and was published online in Arthritis Care & Research.
LIMITATIONS:
Study limitations included the inconsistencies in glucocorticoid dosing, which may have affected remission rates. Moreover, data on the adverse events not requiring hospitalization and long-term adverse events were not captured.
DISCLOSURES:
This study received funding through a Nationwide Children’s Hospital intramural grant award. The authors reported no potential conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.