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The leading independent newspaper covering news and commentary in pediatrics.
People still want their medical intelligence in human form
Doctors or AI? Lukewarm vote of confidence goes to …
Well, we’ve got some good news for the physicians out there, and we’ve got some bad news. Which do you want first? Okay, we’re mostly hearing good news, so here goes: Most people would choose a human doctor over artificial intelligence for the diagnosis and treatment of their medical conditions.
And the bad news? In the survey we’re talking about, “most” was 53%, so not exactly a huge victory for the carbon-based life forms. Yup, about 47% of the 2,472 respondents said they would prefer an AI-based clinic over a human specialist, and that number went up if individuals were told that their primary care physicians were on board with AI, “or otherwise nudged to consider AI as good,” the research team said in a written statement released by the University of Arizona, Tucson.
They went on to add that “this signaled the significance of the human physician in guiding a patient’s decision.” So patients will still need their doctors in the future to … um … this is a bit awkward … tell them how good the AI is?
And yes, we know that ChatGPT is already doing the same thing to journalists, but could it write a medical-humor column? Not a chance. Probably can’t even tell a joke.
How do ghosts get rid of wrinkles? Boo-tox. There, let’s see ChatGPT do that.
Explaining the joke makes it funnier, right?
Here at LOTME headquarters, we live by one simple rule, passed down directly from the Buddha himself: “Never let a good presurgical assessment of refractory epilepsy go to waste. Also, don’t believe everything you read on the Internet.”
This human-created joke has been brought to you by the leading theory of humor, which states that comedy stems from our brain reacting to an incongruous part of reality in a positive way. These positive emotions light up our neurons in a specific fashion, and boom, comedy is achieved.
Previous studies into the science of comedy have typically used functional MRI to analyze the brain while it was gripped in the throes of a comedic reaction. Unfortunately, fMRI cannot detect the entirety of the electromagnetic spectrum generated by the brain during these moments, so observing scientists have been, quite literally, missing out on some of the joke. And that’s where a new study from France comes in.
In the study, the researchers showed a group of patients with epilepsy who were hooked up to deep brain electrodes and a high-tech neuroimaging machine – part of the aforementioned presurgical assessment – a 3-minute excerpt from a Charlie Chaplin movie and analyzed their brain activity. Why Charlie Chaplin? Simple. Slapstick is perhaps the most accessible form of comedy across cultures. We can all appreciate a man getting hit in the head with a coconut. The world’s oldest bar joke or whatever this is? Not so much.
During the funniest scenes, all study participants showed increased high-frequency gamma waves (indicating high cognitive engagement) and a decrease in low-frequency waves (indicating reduced inattention and introspection). During unfunny scenes, such as transition moments, the opposite occurred. Importantly, this inverse relationship occurred in the temporal lobe but not in other regions, supporting previous research that indicated humor was mainly processed in the temporal lobe.
The investigators suggested future research should focus on longer videos with more complex forms of comedy, such as jokes, irony, sarcasm, or reference humor. So, uh, a guy getting hit in the head with two coconuts? That’s high-brow stuff right there.
Hot take: Humans aren’t that special
We humans have always prided ourselves on being different from “the animals” in an exceptional way. News flash! We aren’t. We may be the apex predator, but new research shows that humans, as part of the animal kingdom, just aren’t special.
Not special? How can they say that? Are gorillas doing open-heart surgery? Do wolverines tell jokes? At a more basic level, though, the way we operate as mammals in societies is not unique or even new. Elephants are known to mourn their deceased and to have funeral-like practices, ants invented agriculture, and we’re certainly not the only species that has figured out how to use tools.
This new research just demonstrates another way we aren’t exceptional, and that’s in our mating practices and outcomes.
“Humans appear to resemble mammals that live in monogamous partnerships and to some extent, those classified as cooperative breeders, where breeding individuals have to rely on the help of others to raise their offspring,” Monique Borgerhoff Mulder, PhD, professor emerita of anthropology at the University of California, Davis, said in a written statement.
The research team, which consisted of over 100 investigators, looked at 90 human populations based on data from over 80,000 people globally and compared the human data with 49 different nonhuman mammal species. In polygynous societies in which men take several wives, they found, women have more access to resources like food, shelter, and parenting help. Monogamy, on the other hand, “can drive significant inequalities among women,” Dr. Borgerhoff Mulder said, by promoting large differences in the number of children couples produce.
Human day-to-day behavior and child-rearing habits – one parent taking a daughter to ballet class and fixing dinner so the other parent can get to exercise class before picking up the son from soccer practice – may have us thinking that we are part of an evolved society, but really we are not much different than other mammals that hunt, forage for food, and rear and teach their children, the researchers suggested.
So, yes, humans can travel to the moon, create a vaccine for smallpox, and hit other humans with coconuts, but when it comes to simply having offspring or raising them, we’re not all that special. Get over it.
Doctors or AI? Lukewarm vote of confidence goes to …
Well, we’ve got some good news for the physicians out there, and we’ve got some bad news. Which do you want first? Okay, we’re mostly hearing good news, so here goes: Most people would choose a human doctor over artificial intelligence for the diagnosis and treatment of their medical conditions.
And the bad news? In the survey we’re talking about, “most” was 53%, so not exactly a huge victory for the carbon-based life forms. Yup, about 47% of the 2,472 respondents said they would prefer an AI-based clinic over a human specialist, and that number went up if individuals were told that their primary care physicians were on board with AI, “or otherwise nudged to consider AI as good,” the research team said in a written statement released by the University of Arizona, Tucson.
They went on to add that “this signaled the significance of the human physician in guiding a patient’s decision.” So patients will still need their doctors in the future to … um … this is a bit awkward … tell them how good the AI is?
And yes, we know that ChatGPT is already doing the same thing to journalists, but could it write a medical-humor column? Not a chance. Probably can’t even tell a joke.
How do ghosts get rid of wrinkles? Boo-tox. There, let’s see ChatGPT do that.
Explaining the joke makes it funnier, right?
Here at LOTME headquarters, we live by one simple rule, passed down directly from the Buddha himself: “Never let a good presurgical assessment of refractory epilepsy go to waste. Also, don’t believe everything you read on the Internet.”
This human-created joke has been brought to you by the leading theory of humor, which states that comedy stems from our brain reacting to an incongruous part of reality in a positive way. These positive emotions light up our neurons in a specific fashion, and boom, comedy is achieved.
Previous studies into the science of comedy have typically used functional MRI to analyze the brain while it was gripped in the throes of a comedic reaction. Unfortunately, fMRI cannot detect the entirety of the electromagnetic spectrum generated by the brain during these moments, so observing scientists have been, quite literally, missing out on some of the joke. And that’s where a new study from France comes in.
In the study, the researchers showed a group of patients with epilepsy who were hooked up to deep brain electrodes and a high-tech neuroimaging machine – part of the aforementioned presurgical assessment – a 3-minute excerpt from a Charlie Chaplin movie and analyzed their brain activity. Why Charlie Chaplin? Simple. Slapstick is perhaps the most accessible form of comedy across cultures. We can all appreciate a man getting hit in the head with a coconut. The world’s oldest bar joke or whatever this is? Not so much.
During the funniest scenes, all study participants showed increased high-frequency gamma waves (indicating high cognitive engagement) and a decrease in low-frequency waves (indicating reduced inattention and introspection). During unfunny scenes, such as transition moments, the opposite occurred. Importantly, this inverse relationship occurred in the temporal lobe but not in other regions, supporting previous research that indicated humor was mainly processed in the temporal lobe.
The investigators suggested future research should focus on longer videos with more complex forms of comedy, such as jokes, irony, sarcasm, or reference humor. So, uh, a guy getting hit in the head with two coconuts? That’s high-brow stuff right there.
Hot take: Humans aren’t that special
We humans have always prided ourselves on being different from “the animals” in an exceptional way. News flash! We aren’t. We may be the apex predator, but new research shows that humans, as part of the animal kingdom, just aren’t special.
Not special? How can they say that? Are gorillas doing open-heart surgery? Do wolverines tell jokes? At a more basic level, though, the way we operate as mammals in societies is not unique or even new. Elephants are known to mourn their deceased and to have funeral-like practices, ants invented agriculture, and we’re certainly not the only species that has figured out how to use tools.
This new research just demonstrates another way we aren’t exceptional, and that’s in our mating practices and outcomes.
“Humans appear to resemble mammals that live in monogamous partnerships and to some extent, those classified as cooperative breeders, where breeding individuals have to rely on the help of others to raise their offspring,” Monique Borgerhoff Mulder, PhD, professor emerita of anthropology at the University of California, Davis, said in a written statement.
The research team, which consisted of over 100 investigators, looked at 90 human populations based on data from over 80,000 people globally and compared the human data with 49 different nonhuman mammal species. In polygynous societies in which men take several wives, they found, women have more access to resources like food, shelter, and parenting help. Monogamy, on the other hand, “can drive significant inequalities among women,” Dr. Borgerhoff Mulder said, by promoting large differences in the number of children couples produce.
Human day-to-day behavior and child-rearing habits – one parent taking a daughter to ballet class and fixing dinner so the other parent can get to exercise class before picking up the son from soccer practice – may have us thinking that we are part of an evolved society, but really we are not much different than other mammals that hunt, forage for food, and rear and teach their children, the researchers suggested.
So, yes, humans can travel to the moon, create a vaccine for smallpox, and hit other humans with coconuts, but when it comes to simply having offspring or raising them, we’re not all that special. Get over it.
Doctors or AI? Lukewarm vote of confidence goes to …
Well, we’ve got some good news for the physicians out there, and we’ve got some bad news. Which do you want first? Okay, we’re mostly hearing good news, so here goes: Most people would choose a human doctor over artificial intelligence for the diagnosis and treatment of their medical conditions.
And the bad news? In the survey we’re talking about, “most” was 53%, so not exactly a huge victory for the carbon-based life forms. Yup, about 47% of the 2,472 respondents said they would prefer an AI-based clinic over a human specialist, and that number went up if individuals were told that their primary care physicians were on board with AI, “or otherwise nudged to consider AI as good,” the research team said in a written statement released by the University of Arizona, Tucson.
They went on to add that “this signaled the significance of the human physician in guiding a patient’s decision.” So patients will still need their doctors in the future to … um … this is a bit awkward … tell them how good the AI is?
And yes, we know that ChatGPT is already doing the same thing to journalists, but could it write a medical-humor column? Not a chance. Probably can’t even tell a joke.
How do ghosts get rid of wrinkles? Boo-tox. There, let’s see ChatGPT do that.
Explaining the joke makes it funnier, right?
Here at LOTME headquarters, we live by one simple rule, passed down directly from the Buddha himself: “Never let a good presurgical assessment of refractory epilepsy go to waste. Also, don’t believe everything you read on the Internet.”
This human-created joke has been brought to you by the leading theory of humor, which states that comedy stems from our brain reacting to an incongruous part of reality in a positive way. These positive emotions light up our neurons in a specific fashion, and boom, comedy is achieved.
Previous studies into the science of comedy have typically used functional MRI to analyze the brain while it was gripped in the throes of a comedic reaction. Unfortunately, fMRI cannot detect the entirety of the electromagnetic spectrum generated by the brain during these moments, so observing scientists have been, quite literally, missing out on some of the joke. And that’s where a new study from France comes in.
In the study, the researchers showed a group of patients with epilepsy who were hooked up to deep brain electrodes and a high-tech neuroimaging machine – part of the aforementioned presurgical assessment – a 3-minute excerpt from a Charlie Chaplin movie and analyzed their brain activity. Why Charlie Chaplin? Simple. Slapstick is perhaps the most accessible form of comedy across cultures. We can all appreciate a man getting hit in the head with a coconut. The world’s oldest bar joke or whatever this is? Not so much.
During the funniest scenes, all study participants showed increased high-frequency gamma waves (indicating high cognitive engagement) and a decrease in low-frequency waves (indicating reduced inattention and introspection). During unfunny scenes, such as transition moments, the opposite occurred. Importantly, this inverse relationship occurred in the temporal lobe but not in other regions, supporting previous research that indicated humor was mainly processed in the temporal lobe.
The investigators suggested future research should focus on longer videos with more complex forms of comedy, such as jokes, irony, sarcasm, or reference humor. So, uh, a guy getting hit in the head with two coconuts? That’s high-brow stuff right there.
Hot take: Humans aren’t that special
We humans have always prided ourselves on being different from “the animals” in an exceptional way. News flash! We aren’t. We may be the apex predator, but new research shows that humans, as part of the animal kingdom, just aren’t special.
Not special? How can they say that? Are gorillas doing open-heart surgery? Do wolverines tell jokes? At a more basic level, though, the way we operate as mammals in societies is not unique or even new. Elephants are known to mourn their deceased and to have funeral-like practices, ants invented agriculture, and we’re certainly not the only species that has figured out how to use tools.
This new research just demonstrates another way we aren’t exceptional, and that’s in our mating practices and outcomes.
“Humans appear to resemble mammals that live in monogamous partnerships and to some extent, those classified as cooperative breeders, where breeding individuals have to rely on the help of others to raise their offspring,” Monique Borgerhoff Mulder, PhD, professor emerita of anthropology at the University of California, Davis, said in a written statement.
The research team, which consisted of over 100 investigators, looked at 90 human populations based on data from over 80,000 people globally and compared the human data with 49 different nonhuman mammal species. In polygynous societies in which men take several wives, they found, women have more access to resources like food, shelter, and parenting help. Monogamy, on the other hand, “can drive significant inequalities among women,” Dr. Borgerhoff Mulder said, by promoting large differences in the number of children couples produce.
Human day-to-day behavior and child-rearing habits – one parent taking a daughter to ballet class and fixing dinner so the other parent can get to exercise class before picking up the son from soccer practice – may have us thinking that we are part of an evolved society, but really we are not much different than other mammals that hunt, forage for food, and rear and teach their children, the researchers suggested.
So, yes, humans can travel to the moon, create a vaccine for smallpox, and hit other humans with coconuts, but when it comes to simply having offspring or raising them, we’re not all that special. Get over it.
FDA approves Yuflyma as ninth adalimumab biosimilar
The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.
The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”
The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.
“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.
The citrate-free formulation is thought to lead to less pain on injection.
Yuflyma will be available in prefilled syringe and autoinjector administration options.
Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.
Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.
If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.
Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.
In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.
In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.
The full prescribing information for Yuflyma is available here.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.
The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”
The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.
“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.
The citrate-free formulation is thought to lead to less pain on injection.
Yuflyma will be available in prefilled syringe and autoinjector administration options.
Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.
Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.
If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.
Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.
In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.
In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.
The full prescribing information for Yuflyma is available here.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients aged 2 years or older, as well as for Crohn’s disease in adults and in pediatric patients aged 6 years or older.
The formulation was approved on the basis of a comprehensive data package of analytic, preclinical, and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics, and immunogenicity up to 24 weeks and 1 year following treatment.”
The company conducted a double-blind, randomized phase 3 trial that compared switching from reference adalimumab to Yuflyma with continuing either reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that trial, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, including after switching from reference adalimumab to Yuflyma.
“Currently, more than 80% of patients treated with Humira in the United States rely on a high-concentration and citrate-free formulation of this medication. The availability of a high-concentration and citrate-free formulation adalimumab biosimilar provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the press release.
The citrate-free formulation is thought to lead to less pain on injection.
Yuflyma will be available in prefilled syringe and autoinjector administration options.
Celltrion USA plans to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, the company plans to launch dose forms of 80 mg/0.8 mL and 20 mg/0.2 mL.
Celltrion USA is also seeking an interchangeability designation from the FDA following the completion of an interchangeability trial of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times in the trial. The interchangeability designation would allow pharmacists to autosubstitute Humira with Yuflyma. In these cases, individual state laws control how and whether physicians will be notified of this switch.
If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be just the third interchangeable biosimilar approved by the FDA overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in October 2021.
Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and pediatric uveitis.
In February 2022, the European Commission granted marketing authorization for Yuflyma across those 10 indications, as well as for nonradiographic axial spondyloarthritis, pediatric plaque psoriasis, and pediatric Crohn’s disease.
In April 2022, Celltrion USA signed a licensing agreement with AbbVie, the manufacturer of Humira. Under that agreement, Celltrion will pay royalties to AbbVie on sales of their individual biosimilars, and AbbVie agreed to drop all patent litigation.
The full prescribing information for Yuflyma is available here.
A version of this article first appeared on Medscape.com.
AI & U
Since the November 2022 release of a much-discussed artificial intelligence (AI)-based chatbot, I have been curious what all the buzz is about. I decided to engage my well-connected software-savvy son-in-law to hear where he thought things were going.
He started by suggesting that I pose a question to the chatbot about something of which I had some current knowledge. I had recently researched the concept of primal beliefs and so we asked the chatbot to write a short essay about when an individual develops his/her primal beliefs.
In a matter of seconds the “machine” spit out a very readable document that included all the information that had taken me several hours to unearth and digest. And ... it included the references that I had determined to be valid and appropriate. It was an impressive performance to say the least.
Obviously, a technological development with this capability is sending tremors through the educational establishment. One can easily think of several human skills that an AI like this might eventually make superfluous. It will also make it increasingly difficult for educators to determine a students’ true abilities – research, synthesis, and writing to name just a few. But, of course, one could question whether we will need to teach and then test for these skills that the chatbot can perform more quickly. I’m going to leave it to the educators to struggle with that question.
In the long term you and I may find that AI is a serious threat to our existence as health care providers. In the meantime
My first thought is that if I were having trouble arriving at a diagnosis, I might appreciate having a chatbot to ask for help. Of course this would require that I had already taken a history, done a good exam, and ordered some obvious lab and imaging studies. It would also mean that I had decent knowledge and understanding of basic pathophysiology and was capable of thinking broadly enough to ask a question that would give me the greatest chance of getting the correct answer.
Knowing how to ask the right question is a skill that can be taught. For example, my wife is a successful and experienced online shopper but she acknowledges that when we have medical questions, I can often find the answer more quickly than she can. My relative success usually hinges on my choice of the key word(s) to begin the search, clearly the result of my medical training.
Once I have received a list of possible diagnoses from the chatbot, I must then be able to evaluate the validity and applicability of the references it has supplied. That too is a skill that can be taught. And, for the moment the critical importance of having these two skills suggests that graduating from medical school will continue to give us some job security in the face of expanding AI.
The same process I could used to coax the chatbot to arrive at a diagnosis could be applied when faced with a therapeutic question. Is surgery better than a pharmacological approach? If I need help with a dosage regimen, I could find this information online now. But, wouldn’t it be quicker and maybe better if I asked the chatbot to do the research for me and print a short essay on the pros and cons of different management approaches?
Once I’ve made the diagnosis, crafted a management plan, and now want to hand the patient a document in his/her primary language and at his/her reading skill level describing the diagnosis and giving detailed instructions to follow, this would seem to be a piece of cake for a chatbot given the appropriate commands. Hopefully I would remember to include the disclaimer that “This document was created with the help of a chatbot.”
Clearly, there is nothing to prevent our patients from asking the chatbot the same questions I have posed. And, no doubt, this will happen. It is already happening in a more cumbersome fashion when patients research their own symptoms. However, in the short term I believe we will retain the upper hand.
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].
Since the November 2022 release of a much-discussed artificial intelligence (AI)-based chatbot, I have been curious what all the buzz is about. I decided to engage my well-connected software-savvy son-in-law to hear where he thought things were going.
He started by suggesting that I pose a question to the chatbot about something of which I had some current knowledge. I had recently researched the concept of primal beliefs and so we asked the chatbot to write a short essay about when an individual develops his/her primal beliefs.
In a matter of seconds the “machine” spit out a very readable document that included all the information that had taken me several hours to unearth and digest. And ... it included the references that I had determined to be valid and appropriate. It was an impressive performance to say the least.
Obviously, a technological development with this capability is sending tremors through the educational establishment. One can easily think of several human skills that an AI like this might eventually make superfluous. It will also make it increasingly difficult for educators to determine a students’ true abilities – research, synthesis, and writing to name just a few. But, of course, one could question whether we will need to teach and then test for these skills that the chatbot can perform more quickly. I’m going to leave it to the educators to struggle with that question.
In the long term you and I may find that AI is a serious threat to our existence as health care providers. In the meantime
My first thought is that if I were having trouble arriving at a diagnosis, I might appreciate having a chatbot to ask for help. Of course this would require that I had already taken a history, done a good exam, and ordered some obvious lab and imaging studies. It would also mean that I had decent knowledge and understanding of basic pathophysiology and was capable of thinking broadly enough to ask a question that would give me the greatest chance of getting the correct answer.
Knowing how to ask the right question is a skill that can be taught. For example, my wife is a successful and experienced online shopper but she acknowledges that when we have medical questions, I can often find the answer more quickly than she can. My relative success usually hinges on my choice of the key word(s) to begin the search, clearly the result of my medical training.
Once I have received a list of possible diagnoses from the chatbot, I must then be able to evaluate the validity and applicability of the references it has supplied. That too is a skill that can be taught. And, for the moment the critical importance of having these two skills suggests that graduating from medical school will continue to give us some job security in the face of expanding AI.
The same process I could used to coax the chatbot to arrive at a diagnosis could be applied when faced with a therapeutic question. Is surgery better than a pharmacological approach? If I need help with a dosage regimen, I could find this information online now. But, wouldn’t it be quicker and maybe better if I asked the chatbot to do the research for me and print a short essay on the pros and cons of different management approaches?
Once I’ve made the diagnosis, crafted a management plan, and now want to hand the patient a document in his/her primary language and at his/her reading skill level describing the diagnosis and giving detailed instructions to follow, this would seem to be a piece of cake for a chatbot given the appropriate commands. Hopefully I would remember to include the disclaimer that “This document was created with the help of a chatbot.”
Clearly, there is nothing to prevent our patients from asking the chatbot the same questions I have posed. And, no doubt, this will happen. It is already happening in a more cumbersome fashion when patients research their own symptoms. However, in the short term I believe we will retain the upper hand.
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].
Since the November 2022 release of a much-discussed artificial intelligence (AI)-based chatbot, I have been curious what all the buzz is about. I decided to engage my well-connected software-savvy son-in-law to hear where he thought things were going.
He started by suggesting that I pose a question to the chatbot about something of which I had some current knowledge. I had recently researched the concept of primal beliefs and so we asked the chatbot to write a short essay about when an individual develops his/her primal beliefs.
In a matter of seconds the “machine” spit out a very readable document that included all the information that had taken me several hours to unearth and digest. And ... it included the references that I had determined to be valid and appropriate. It was an impressive performance to say the least.
Obviously, a technological development with this capability is sending tremors through the educational establishment. One can easily think of several human skills that an AI like this might eventually make superfluous. It will also make it increasingly difficult for educators to determine a students’ true abilities – research, synthesis, and writing to name just a few. But, of course, one could question whether we will need to teach and then test for these skills that the chatbot can perform more quickly. I’m going to leave it to the educators to struggle with that question.
In the long term you and I may find that AI is a serious threat to our existence as health care providers. In the meantime
My first thought is that if I were having trouble arriving at a diagnosis, I might appreciate having a chatbot to ask for help. Of course this would require that I had already taken a history, done a good exam, and ordered some obvious lab and imaging studies. It would also mean that I had decent knowledge and understanding of basic pathophysiology and was capable of thinking broadly enough to ask a question that would give me the greatest chance of getting the correct answer.
Knowing how to ask the right question is a skill that can be taught. For example, my wife is a successful and experienced online shopper but she acknowledges that when we have medical questions, I can often find the answer more quickly than she can. My relative success usually hinges on my choice of the key word(s) to begin the search, clearly the result of my medical training.
Once I have received a list of possible diagnoses from the chatbot, I must then be able to evaluate the validity and applicability of the references it has supplied. That too is a skill that can be taught. And, for the moment the critical importance of having these two skills suggests that graduating from medical school will continue to give us some job security in the face of expanding AI.
The same process I could used to coax the chatbot to arrive at a diagnosis could be applied when faced with a therapeutic question. Is surgery better than a pharmacological approach? If I need help with a dosage regimen, I could find this information online now. But, wouldn’t it be quicker and maybe better if I asked the chatbot to do the research for me and print a short essay on the pros and cons of different management approaches?
Once I’ve made the diagnosis, crafted a management plan, and now want to hand the patient a document in his/her primary language and at his/her reading skill level describing the diagnosis and giving detailed instructions to follow, this would seem to be a piece of cake for a chatbot given the appropriate commands. Hopefully I would remember to include the disclaimer that “This document was created with the help of a chatbot.”
Clearly, there is nothing to prevent our patients from asking the chatbot the same questions I have posed. And, no doubt, this will happen. It is already happening in a more cumbersome fashion when patients research their own symptoms. However, in the short term I believe we will retain the upper hand.
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].
Safety remains top parent concern for HPV vaccine
, according to a study published online in Pediatrics.
“Although HPV vaccination rates in the United States have steadily improved over the past decade, a sizable subset of parents remains highly hesitant about administering the vaccine to their adolescent children,” wrote Eric Adjei Boakye, PhD, of the departments of public health sciences and otolaryngology–head and neck surgery at the Henry Ford Health System, Detroit, and associates. But a silver lining in the study is the downward trend in parents not vaccinating their children against HPV because the child’s provider did not recommend it.
“Provider recommendation has been shown to be the single best predictor of HPV vaccine uptake and vaccine acceptability,” the authors wrote. They noted one previous study finding that provider recommendations for the vaccine had increased from 27% in 2012 to 49.3% in 2018.
Safety concerns increased while other concerns decreased
The findings were not surprising to Robert A. Bednarczyk, PhD, associate professor of global health at Emory University Rollins School of Public Health, Atlanta, who specializes in HPV vaccine research.
“We have seen over the years that vaccine safety concerns have been on the increase, notably recently in the context of the COVID-19 pandemic and vaccination program, but HPV vaccine safety, though well established, continues to be a major concern for parents,” Dr. Bednarczyk said in an interview. But he found it striking that parents’ other reasons for turning down the vaccine had declined. “This shows that the outreach around the need for HPV vaccination and efforts to improve provider recommendation strategies is likely having positive impacts on HPV vaccine attitudes.”
Top five reasons for not vaccinating
The researchers analyzed data from the National Immunization Survey–Teen for the years 2010 through 2020 to track the annual changes in the top five reasons cited for not planning to get the HPV vaccine. The data covered 119,695 teens aged 13-17.
The researchers identified parents’ five most commonly cited reasons for not planning to vaccinate their children against HPV: “not necessary,” “safety concerns,” “lack of recommendation,” “lack of knowledge,” and “not sexually active.”
Parents’ HPV vaccine hesitancy decreased by 5.5% each year from 2010 to 2012, but then it stagnated for the remaining years through 2020. Across most of that time, from 2010 to 2018, parents’ concerns about the vaccine’s safety and side effects increased by 15.6%. A major reason for this increase, the authors suggested, may include the widespread distribution of online misinformation, particularly given the 7.8 million increase in antivaccine social media accounts since 2019.
“Fear tactics are often used by antivaccine campaigners to dissuade parents from vaccinating their children. There have been several myths propagated about vaccines causing adverse reactions,” the authors wrote. “Although these myths have been scientifically debunked, they continue to circulate.”
In contrast to parents’ concerns, a study in 2021 found a downward trend in reports of nonserious adverse effects and no change in reports of serious adverse effects from the HPV vaccine between 2015 and 2018. Further, more than 95% of the adverse effect reports to the Vaccine Adverse Event Reporting System after HPV vaccination were nonserious.
Reducing perceived barriers
Meanwhile, however, parents’ other reasons for avoiding the vaccine became less prevalent throughout most of the study period. For each year between 2013 and 2020, the proportion of parents saying they didn’t intend to get their children the HPV vaccine because it was “not recommended” decreased by 6.8%.
Similarly, avoiding the vaccine due to “lack of knowledge” declined 9.9%, and avoidance because the child was “not sexually active” declined 5.9% each year from 2013 to 2020. No difference occurred during that time period regarding how frequently parents cited that the vaccine was “not necessary.”
“Decreases in the percentage of parents/guardians citing lack of provider recommendation, lack of knowledge, and child ‘not sexually active’ as the main reason for HPV vaccine hesitancy ... are encouraging and suggest that interventions have been successful in reducing perceived barriers to HPV vaccination,” the authors wrote.
Dr. Bednarczyk agreed that these findings were encouraging, underscoring that outreach and support for health care providers to give strong recommendations for the vaccine need to continue.
“But additionally, we need to find better ways to communicate about vaccine safety,” Dr. Bednarczyk said. “Seeing that the number of parents citing safety concerns as the primary barrier has not changed much between 2016 and 2020, but that the percent of parents having those concerns increased, likely means there is a stable part of the population with these safety concerns, and as more adolescents are getting vaccinated against HPV, the relative contribution of safety concerns is increasing.” A key way to address those concerns includes “engaging with our trusted community partners and giving them the tools to discuss the safety of HPV vaccination with members of the community,” he said.
Debunking misinformation
Like the authors, Dr. Bednarczyk pointed out several conditions that parents erroneously worry could be caused by the HPV vaccine, but he emphasized that simply telling parents those misconceptions are untrue is insufficient to allay fears.
“It’s important for both clinicians and community partners to recognize we cannot just present a list of facts and figures and statistics to parents to reassure them and hope that this works,” Dr. Bednarczyk said. “Effective communication, strong narratives to illustrate this knowledge, and engagement with not just clinicians but community partners and other trusted sources is needed.” Dr. Bednarczyk continues to support the evidence-based model of presumptive recommendations, which does not remove parental autonomy but simplifies vaccine messaging about what’s recommended, “but clinicians need to be prepared with both the data and effective ways to communicate it to address questions if they come up after the presumptive recommendation is given,” he added.
The researchers pointed out that their study data were collected before the pandemic, so “it is reasonable to expect that HPV vaccine–related safety concerns may continue to rise because of the plethora of misinformation surrounding coronavirus disease 2019 vaccination.”
Dr. Bednarczyk said it will be important to see in future research whether shifts in beliefs about the HPV vaccine have occurred in the midst of the pandemic and afterward.
“As the authors stated, it’s important to remember that HPV vaccination has consistently been shown to be safe and effective,” Dr. Bednarczyk said. “But those research findings are not seeming to resonate with parents, highlighting how we need to improve our outreach and communication work.”
The research did not receive external funding. A coauthor is a scientific adviser to Navigating Cancer. The other authors and Dr. Bednarczyk had no disclosures.
, according to a study published online in Pediatrics.
“Although HPV vaccination rates in the United States have steadily improved over the past decade, a sizable subset of parents remains highly hesitant about administering the vaccine to their adolescent children,” wrote Eric Adjei Boakye, PhD, of the departments of public health sciences and otolaryngology–head and neck surgery at the Henry Ford Health System, Detroit, and associates. But a silver lining in the study is the downward trend in parents not vaccinating their children against HPV because the child’s provider did not recommend it.
“Provider recommendation has been shown to be the single best predictor of HPV vaccine uptake and vaccine acceptability,” the authors wrote. They noted one previous study finding that provider recommendations for the vaccine had increased from 27% in 2012 to 49.3% in 2018.
Safety concerns increased while other concerns decreased
The findings were not surprising to Robert A. Bednarczyk, PhD, associate professor of global health at Emory University Rollins School of Public Health, Atlanta, who specializes in HPV vaccine research.
“We have seen over the years that vaccine safety concerns have been on the increase, notably recently in the context of the COVID-19 pandemic and vaccination program, but HPV vaccine safety, though well established, continues to be a major concern for parents,” Dr. Bednarczyk said in an interview. But he found it striking that parents’ other reasons for turning down the vaccine had declined. “This shows that the outreach around the need for HPV vaccination and efforts to improve provider recommendation strategies is likely having positive impacts on HPV vaccine attitudes.”
Top five reasons for not vaccinating
The researchers analyzed data from the National Immunization Survey–Teen for the years 2010 through 2020 to track the annual changes in the top five reasons cited for not planning to get the HPV vaccine. The data covered 119,695 teens aged 13-17.
The researchers identified parents’ five most commonly cited reasons for not planning to vaccinate their children against HPV: “not necessary,” “safety concerns,” “lack of recommendation,” “lack of knowledge,” and “not sexually active.”
Parents’ HPV vaccine hesitancy decreased by 5.5% each year from 2010 to 2012, but then it stagnated for the remaining years through 2020. Across most of that time, from 2010 to 2018, parents’ concerns about the vaccine’s safety and side effects increased by 15.6%. A major reason for this increase, the authors suggested, may include the widespread distribution of online misinformation, particularly given the 7.8 million increase in antivaccine social media accounts since 2019.
“Fear tactics are often used by antivaccine campaigners to dissuade parents from vaccinating their children. There have been several myths propagated about vaccines causing adverse reactions,” the authors wrote. “Although these myths have been scientifically debunked, they continue to circulate.”
In contrast to parents’ concerns, a study in 2021 found a downward trend in reports of nonserious adverse effects and no change in reports of serious adverse effects from the HPV vaccine between 2015 and 2018. Further, more than 95% of the adverse effect reports to the Vaccine Adverse Event Reporting System after HPV vaccination were nonserious.
Reducing perceived barriers
Meanwhile, however, parents’ other reasons for avoiding the vaccine became less prevalent throughout most of the study period. For each year between 2013 and 2020, the proportion of parents saying they didn’t intend to get their children the HPV vaccine because it was “not recommended” decreased by 6.8%.
Similarly, avoiding the vaccine due to “lack of knowledge” declined 9.9%, and avoidance because the child was “not sexually active” declined 5.9% each year from 2013 to 2020. No difference occurred during that time period regarding how frequently parents cited that the vaccine was “not necessary.”
“Decreases in the percentage of parents/guardians citing lack of provider recommendation, lack of knowledge, and child ‘not sexually active’ as the main reason for HPV vaccine hesitancy ... are encouraging and suggest that interventions have been successful in reducing perceived barriers to HPV vaccination,” the authors wrote.
Dr. Bednarczyk agreed that these findings were encouraging, underscoring that outreach and support for health care providers to give strong recommendations for the vaccine need to continue.
“But additionally, we need to find better ways to communicate about vaccine safety,” Dr. Bednarczyk said. “Seeing that the number of parents citing safety concerns as the primary barrier has not changed much between 2016 and 2020, but that the percent of parents having those concerns increased, likely means there is a stable part of the population with these safety concerns, and as more adolescents are getting vaccinated against HPV, the relative contribution of safety concerns is increasing.” A key way to address those concerns includes “engaging with our trusted community partners and giving them the tools to discuss the safety of HPV vaccination with members of the community,” he said.
Debunking misinformation
Like the authors, Dr. Bednarczyk pointed out several conditions that parents erroneously worry could be caused by the HPV vaccine, but he emphasized that simply telling parents those misconceptions are untrue is insufficient to allay fears.
“It’s important for both clinicians and community partners to recognize we cannot just present a list of facts and figures and statistics to parents to reassure them and hope that this works,” Dr. Bednarczyk said. “Effective communication, strong narratives to illustrate this knowledge, and engagement with not just clinicians but community partners and other trusted sources is needed.” Dr. Bednarczyk continues to support the evidence-based model of presumptive recommendations, which does not remove parental autonomy but simplifies vaccine messaging about what’s recommended, “but clinicians need to be prepared with both the data and effective ways to communicate it to address questions if they come up after the presumptive recommendation is given,” he added.
The researchers pointed out that their study data were collected before the pandemic, so “it is reasonable to expect that HPV vaccine–related safety concerns may continue to rise because of the plethora of misinformation surrounding coronavirus disease 2019 vaccination.”
Dr. Bednarczyk said it will be important to see in future research whether shifts in beliefs about the HPV vaccine have occurred in the midst of the pandemic and afterward.
“As the authors stated, it’s important to remember that HPV vaccination has consistently been shown to be safe and effective,” Dr. Bednarczyk said. “But those research findings are not seeming to resonate with parents, highlighting how we need to improve our outreach and communication work.”
The research did not receive external funding. A coauthor is a scientific adviser to Navigating Cancer. The other authors and Dr. Bednarczyk had no disclosures.
, according to a study published online in Pediatrics.
“Although HPV vaccination rates in the United States have steadily improved over the past decade, a sizable subset of parents remains highly hesitant about administering the vaccine to their adolescent children,” wrote Eric Adjei Boakye, PhD, of the departments of public health sciences and otolaryngology–head and neck surgery at the Henry Ford Health System, Detroit, and associates. But a silver lining in the study is the downward trend in parents not vaccinating their children against HPV because the child’s provider did not recommend it.
“Provider recommendation has been shown to be the single best predictor of HPV vaccine uptake and vaccine acceptability,” the authors wrote. They noted one previous study finding that provider recommendations for the vaccine had increased from 27% in 2012 to 49.3% in 2018.
Safety concerns increased while other concerns decreased
The findings were not surprising to Robert A. Bednarczyk, PhD, associate professor of global health at Emory University Rollins School of Public Health, Atlanta, who specializes in HPV vaccine research.
“We have seen over the years that vaccine safety concerns have been on the increase, notably recently in the context of the COVID-19 pandemic and vaccination program, but HPV vaccine safety, though well established, continues to be a major concern for parents,” Dr. Bednarczyk said in an interview. But he found it striking that parents’ other reasons for turning down the vaccine had declined. “This shows that the outreach around the need for HPV vaccination and efforts to improve provider recommendation strategies is likely having positive impacts on HPV vaccine attitudes.”
Top five reasons for not vaccinating
The researchers analyzed data from the National Immunization Survey–Teen for the years 2010 through 2020 to track the annual changes in the top five reasons cited for not planning to get the HPV vaccine. The data covered 119,695 teens aged 13-17.
The researchers identified parents’ five most commonly cited reasons for not planning to vaccinate their children against HPV: “not necessary,” “safety concerns,” “lack of recommendation,” “lack of knowledge,” and “not sexually active.”
Parents’ HPV vaccine hesitancy decreased by 5.5% each year from 2010 to 2012, but then it stagnated for the remaining years through 2020. Across most of that time, from 2010 to 2018, parents’ concerns about the vaccine’s safety and side effects increased by 15.6%. A major reason for this increase, the authors suggested, may include the widespread distribution of online misinformation, particularly given the 7.8 million increase in antivaccine social media accounts since 2019.
“Fear tactics are often used by antivaccine campaigners to dissuade parents from vaccinating their children. There have been several myths propagated about vaccines causing adverse reactions,” the authors wrote. “Although these myths have been scientifically debunked, they continue to circulate.”
In contrast to parents’ concerns, a study in 2021 found a downward trend in reports of nonserious adverse effects and no change in reports of serious adverse effects from the HPV vaccine between 2015 and 2018. Further, more than 95% of the adverse effect reports to the Vaccine Adverse Event Reporting System after HPV vaccination were nonserious.
Reducing perceived barriers
Meanwhile, however, parents’ other reasons for avoiding the vaccine became less prevalent throughout most of the study period. For each year between 2013 and 2020, the proportion of parents saying they didn’t intend to get their children the HPV vaccine because it was “not recommended” decreased by 6.8%.
Similarly, avoiding the vaccine due to “lack of knowledge” declined 9.9%, and avoidance because the child was “not sexually active” declined 5.9% each year from 2013 to 2020. No difference occurred during that time period regarding how frequently parents cited that the vaccine was “not necessary.”
“Decreases in the percentage of parents/guardians citing lack of provider recommendation, lack of knowledge, and child ‘not sexually active’ as the main reason for HPV vaccine hesitancy ... are encouraging and suggest that interventions have been successful in reducing perceived barriers to HPV vaccination,” the authors wrote.
Dr. Bednarczyk agreed that these findings were encouraging, underscoring that outreach and support for health care providers to give strong recommendations for the vaccine need to continue.
“But additionally, we need to find better ways to communicate about vaccine safety,” Dr. Bednarczyk said. “Seeing that the number of parents citing safety concerns as the primary barrier has not changed much between 2016 and 2020, but that the percent of parents having those concerns increased, likely means there is a stable part of the population with these safety concerns, and as more adolescents are getting vaccinated against HPV, the relative contribution of safety concerns is increasing.” A key way to address those concerns includes “engaging with our trusted community partners and giving them the tools to discuss the safety of HPV vaccination with members of the community,” he said.
Debunking misinformation
Like the authors, Dr. Bednarczyk pointed out several conditions that parents erroneously worry could be caused by the HPV vaccine, but he emphasized that simply telling parents those misconceptions are untrue is insufficient to allay fears.
“It’s important for both clinicians and community partners to recognize we cannot just present a list of facts and figures and statistics to parents to reassure them and hope that this works,” Dr. Bednarczyk said. “Effective communication, strong narratives to illustrate this knowledge, and engagement with not just clinicians but community partners and other trusted sources is needed.” Dr. Bednarczyk continues to support the evidence-based model of presumptive recommendations, which does not remove parental autonomy but simplifies vaccine messaging about what’s recommended, “but clinicians need to be prepared with both the data and effective ways to communicate it to address questions if they come up after the presumptive recommendation is given,” he added.
The researchers pointed out that their study data were collected before the pandemic, so “it is reasonable to expect that HPV vaccine–related safety concerns may continue to rise because of the plethora of misinformation surrounding coronavirus disease 2019 vaccination.”
Dr. Bednarczyk said it will be important to see in future research whether shifts in beliefs about the HPV vaccine have occurred in the midst of the pandemic and afterward.
“As the authors stated, it’s important to remember that HPV vaccination has consistently been shown to be safe and effective,” Dr. Bednarczyk said. “But those research findings are not seeming to resonate with parents, highlighting how we need to improve our outreach and communication work.”
The research did not receive external funding. A coauthor is a scientific adviser to Navigating Cancer. The other authors and Dr. Bednarczyk had no disclosures.
FROM PEDIATRICS
FDA approves autoinjector pen for Humira biosimilar, Cyltezo
The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.
Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.
“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.
Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.
“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration on May 22 approved a new autoinjection option for adalimumab-adbm (Cyltezo), a biosimilar to AbbVie’s adalimumab (Humira), ahead of Cyltezo’s commercial launch on July 1, 2023.
Cyltezo was approved by the FDA in 2017 as a prefilled syringe and was the first biosimilar deemed to be interchangeable with Humira in 2021. It is indicated to treat multiple chronic inflammatory conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and hidradenitis suppurativa. This new design, which features one-button, three-step activation, has been certified as an “Ease of Use” product by the Arthritis Foundation, Boehringer Ingelheim said in a press release. The 40-mg, prefilled Cyltezo Pen will be available in two-, four-, and six-pack options.
“The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector,” said Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim in a statement; “we’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”
A version of this article first appeared on Medscape.com.
The family firearm often used in youth suicide
SAN FRANCISCO – , according to results of a novel “psychological autopsy study” of loved ones of youth who died by gun-related suicide.
Yet, families don’t always recognize the danger firearms pose to a young person with suicide risk factors, even when there is a young person in the house with a mental health condition, the data show.
Perhaps most importantly, many parents indicated that they would have removed firearms from the home if it had been suggested by their health care professionals.
The study was presented at the American Psychiatric Association annual meeting.
The message is very clear: Clinicians need to ask about guns and gun safety with patients and families, said study investigator Paul Nestadt, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore.
“It’s never illegal to ask about gun access and it’s medically relevant. Just do it,” he said during a briefing with reporters.
Grim statistics
Suicide rates have been climbing in the United States for the majority of the past 20 years. Suicide is the second most common cause of death among youth.
Dr. Nestadt noted that overall about 8% of suicide attempts result in death, but when an attempt involves a firearm the percentage jumps astronomically to 90%.
Research has shown that for every 10% increase in household firearms in a given community there is a 27% increase in youth suicide deaths.
“In the world of public health and mental health, we think about having access to firearms as an important risk factor for completed suicide. But in the United States, guns have become an important part of how many Americans see themselves,” Dr. Nestadt told reporters.
Research has shown that half of gun owners say owning a gun is central to their identity and three quarters say it’s essential to their freedom, he noted.
To explore these attitudes further, Dr. Nestadt and colleagues did 11 “psychological autopsy interviews” with the loved ones of nine young people aged 17-21 who died by gun-related suicide. They interviewed six mothers, three fathers, one sibling, and one close friend.
Most of the families had some level of “familial engagement” with firearms, Dr. Nestadt reported.
In more than two-thirds of the families, the youth used a family-owned firearm to commit suicide.
Notably, more than three-quarters of the youth had received mental health care before taking their lives, with many receiving care in the weeks prior to their suicide; 44% had made a prior suicide attempt.
In many cases, parents shared that they had not considered their family-owned firearms to be sources of danger and indicated that had their clinicians expressed concern about the gun in the home, they may have acted to reduce the risk by removing it.
Several also shared that they would have considered using Maryland’s Extreme Risk Protective Order Law if it had existed at the time and they had been made aware of it.
Extreme risk protection order (ERPO) laws, or “red flag laws,” prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm.
Dr. Nestadt said youth suicide interventions “must acknowledge culturally embedded roots of identity formation while rescripting firearms from expressions of family cohesion to instruments that may undermine that cohesion.”
‘Courageous study’
Dr. Nestadt noted that while this study was challenging on many fronts, it took no convincing to get these grieving families to participate.
“They wanted to talk to us, especially because they were hopeful that our work could help prevent future suicides, but also they wanted to talk about their loved ones,” he said.
“When you lose someone to cancer, people give you hugs and flowers. When you lose someone to suicide, people don’t discuss it. Suicide has a stigma to it.”
Briefing moderator Howard Liu, MD, MBA, chair of the department of psychiatry, University of Nebraska Medical Center, Omaha, praised the study team for a “courageous study that really required a tremendous amount of vulnerability from the research team and clearly from the survivors as well.”
This is an “important and timely public health discussion,” said Dr. Liu, chair of the APA Council on Communications.
“We’re all facing this challenge of how do we reduce suicide across all ages, from youth to adults as well. This is a really vital discussion and such an important clue about access and trying to reduce access in a moment of impulsivity,” he added.
The study had no commercial funding. Dr. Nestadt and Dr. Liu report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – , according to results of a novel “psychological autopsy study” of loved ones of youth who died by gun-related suicide.
Yet, families don’t always recognize the danger firearms pose to a young person with suicide risk factors, even when there is a young person in the house with a mental health condition, the data show.
Perhaps most importantly, many parents indicated that they would have removed firearms from the home if it had been suggested by their health care professionals.
The study was presented at the American Psychiatric Association annual meeting.
The message is very clear: Clinicians need to ask about guns and gun safety with patients and families, said study investigator Paul Nestadt, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore.
“It’s never illegal to ask about gun access and it’s medically relevant. Just do it,” he said during a briefing with reporters.
Grim statistics
Suicide rates have been climbing in the United States for the majority of the past 20 years. Suicide is the second most common cause of death among youth.
Dr. Nestadt noted that overall about 8% of suicide attempts result in death, but when an attempt involves a firearm the percentage jumps astronomically to 90%.
Research has shown that for every 10% increase in household firearms in a given community there is a 27% increase in youth suicide deaths.
“In the world of public health and mental health, we think about having access to firearms as an important risk factor for completed suicide. But in the United States, guns have become an important part of how many Americans see themselves,” Dr. Nestadt told reporters.
Research has shown that half of gun owners say owning a gun is central to their identity and three quarters say it’s essential to their freedom, he noted.
To explore these attitudes further, Dr. Nestadt and colleagues did 11 “psychological autopsy interviews” with the loved ones of nine young people aged 17-21 who died by gun-related suicide. They interviewed six mothers, three fathers, one sibling, and one close friend.
Most of the families had some level of “familial engagement” with firearms, Dr. Nestadt reported.
In more than two-thirds of the families, the youth used a family-owned firearm to commit suicide.
Notably, more than three-quarters of the youth had received mental health care before taking their lives, with many receiving care in the weeks prior to their suicide; 44% had made a prior suicide attempt.
In many cases, parents shared that they had not considered their family-owned firearms to be sources of danger and indicated that had their clinicians expressed concern about the gun in the home, they may have acted to reduce the risk by removing it.
Several also shared that they would have considered using Maryland’s Extreme Risk Protective Order Law if it had existed at the time and they had been made aware of it.
Extreme risk protection order (ERPO) laws, or “red flag laws,” prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm.
Dr. Nestadt said youth suicide interventions “must acknowledge culturally embedded roots of identity formation while rescripting firearms from expressions of family cohesion to instruments that may undermine that cohesion.”
‘Courageous study’
Dr. Nestadt noted that while this study was challenging on many fronts, it took no convincing to get these grieving families to participate.
“They wanted to talk to us, especially because they were hopeful that our work could help prevent future suicides, but also they wanted to talk about their loved ones,” he said.
“When you lose someone to cancer, people give you hugs and flowers. When you lose someone to suicide, people don’t discuss it. Suicide has a stigma to it.”
Briefing moderator Howard Liu, MD, MBA, chair of the department of psychiatry, University of Nebraska Medical Center, Omaha, praised the study team for a “courageous study that really required a tremendous amount of vulnerability from the research team and clearly from the survivors as well.”
This is an “important and timely public health discussion,” said Dr. Liu, chair of the APA Council on Communications.
“We’re all facing this challenge of how do we reduce suicide across all ages, from youth to adults as well. This is a really vital discussion and such an important clue about access and trying to reduce access in a moment of impulsivity,” he added.
The study had no commercial funding. Dr. Nestadt and Dr. Liu report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
SAN FRANCISCO – , according to results of a novel “psychological autopsy study” of loved ones of youth who died by gun-related suicide.
Yet, families don’t always recognize the danger firearms pose to a young person with suicide risk factors, even when there is a young person in the house with a mental health condition, the data show.
Perhaps most importantly, many parents indicated that they would have removed firearms from the home if it had been suggested by their health care professionals.
The study was presented at the American Psychiatric Association annual meeting.
The message is very clear: Clinicians need to ask about guns and gun safety with patients and families, said study investigator Paul Nestadt, MD, of Johns Hopkins Bloomberg School of Public Health in Baltimore.
“It’s never illegal to ask about gun access and it’s medically relevant. Just do it,” he said during a briefing with reporters.
Grim statistics
Suicide rates have been climbing in the United States for the majority of the past 20 years. Suicide is the second most common cause of death among youth.
Dr. Nestadt noted that overall about 8% of suicide attempts result in death, but when an attempt involves a firearm the percentage jumps astronomically to 90%.
Research has shown that for every 10% increase in household firearms in a given community there is a 27% increase in youth suicide deaths.
“In the world of public health and mental health, we think about having access to firearms as an important risk factor for completed suicide. But in the United States, guns have become an important part of how many Americans see themselves,” Dr. Nestadt told reporters.
Research has shown that half of gun owners say owning a gun is central to their identity and three quarters say it’s essential to their freedom, he noted.
To explore these attitudes further, Dr. Nestadt and colleagues did 11 “psychological autopsy interviews” with the loved ones of nine young people aged 17-21 who died by gun-related suicide. They interviewed six mothers, three fathers, one sibling, and one close friend.
Most of the families had some level of “familial engagement” with firearms, Dr. Nestadt reported.
In more than two-thirds of the families, the youth used a family-owned firearm to commit suicide.
Notably, more than three-quarters of the youth had received mental health care before taking their lives, with many receiving care in the weeks prior to their suicide; 44% had made a prior suicide attempt.
In many cases, parents shared that they had not considered their family-owned firearms to be sources of danger and indicated that had their clinicians expressed concern about the gun in the home, they may have acted to reduce the risk by removing it.
Several also shared that they would have considered using Maryland’s Extreme Risk Protective Order Law if it had existed at the time and they had been made aware of it.
Extreme risk protection order (ERPO) laws, or “red flag laws,” prohibit individuals at risk for harming themselves or others from purchasing or owning a firearm.
Dr. Nestadt said youth suicide interventions “must acknowledge culturally embedded roots of identity formation while rescripting firearms from expressions of family cohesion to instruments that may undermine that cohesion.”
‘Courageous study’
Dr. Nestadt noted that while this study was challenging on many fronts, it took no convincing to get these grieving families to participate.
“They wanted to talk to us, especially because they were hopeful that our work could help prevent future suicides, but also they wanted to talk about their loved ones,” he said.
“When you lose someone to cancer, people give you hugs and flowers. When you lose someone to suicide, people don’t discuss it. Suicide has a stigma to it.”
Briefing moderator Howard Liu, MD, MBA, chair of the department of psychiatry, University of Nebraska Medical Center, Omaha, praised the study team for a “courageous study that really required a tremendous amount of vulnerability from the research team and clearly from the survivors as well.”
This is an “important and timely public health discussion,” said Dr. Liu, chair of the APA Council on Communications.
“We’re all facing this challenge of how do we reduce suicide across all ages, from youth to adults as well. This is a really vital discussion and such an important clue about access and trying to reduce access in a moment of impulsivity,” he added.
The study had no commercial funding. Dr. Nestadt and Dr. Liu report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT APA 2023
Eating disorders in children is a global public health emergency
The high figures are concerning from a public health perspective and highlight the need to implement strategies for preventing eating disorders.
These disorders include anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorder–not otherwise specified. The prevalence of these disorders in young people has markedly increased globally over the past 50 years. Eating disorders are among the most life-threatening mental disorders; they were responsible for 318 deaths worldwide in 2019.
Because some individuals with eating disorders conceal core symptoms and avoid or delay seeking specialist care because of feelings of embarrassment, stigma, or ambivalence toward treatment, most cases of eating disorders remain undetected and untreated.
Brazilian researchers conducted studies to assess risky behaviors and predisposing factors among young people. The researchers observed that the probability of experiencing eating disorders was higher among young people who had an intense fear of gaining weight, who experienced thin-ideal internalization, who were excessively concerned about food, who experienced compulsive eating episodes, or who used laxatives. As previously reported, most participants in these studies had never sought professional help.
A study conducted in 2020 concluded that the media greatly influences the construction of one’s body image and the creation of aesthetic standards, particularly for adolescents. Adolescents then change their eating patterns and become more vulnerable to mental disorders related to eating.
A group of researchers from several countries, including Brazilians connected to the State University of Londrina, conducted the Global Proportion of Disordered Eating in Children and Adolescents – A Systematic Review and Meta-analysis. The study was coordinated by José Francisco López-Gil, PhD, of the University of Castilla–La Mancha (Spain). The investigators determined the rate of disordered eating among children and adolescents using the SCOFF (Sick, Control, One, Fat, Food) questionnaire, which is the most widely used screening measure for eating disorders.
Methods and results
Four databases were systematically searched (PubMed, Scopus, Web of Science, and the Cochrane Library); date limits were from January 1999 to November 2022. Studies were required to meet the following criteria: participants – studies of community samples of children and adolescents aged 6-18 years – and outcome – disordered eating assessed by the SCOFF questionnaire. The exclusion criteria were studies conducted with young people who had been diagnosed with physical or mental disorders; studies that were published before 1999, because the SCOFF questionnaire was designed in that year; studies in which data were collected during the COVID-19 pandemic, because of the possibility of selection bias; studies that employed data from the same surveys/studies, to avoid duplication; and systematic reviews and/or meta-analyses and qualitative and case studies.
In all, 32 studies, which involved a total of 63,181 participants from 16 countries, were included in the systematic review and meta-analysis, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The overall proportion of children and adolescents with disordered eating was 22.36% (95% confidence interval, 18.84%-26.09%; P < .001; n = 63,181). According to the researchers, girls were significantly more likely to report disordered eating (30.03%; 95% CI, 25.61%-34.65%; n = 27,548) than boys (16.98%; 95% CI, 13.46%-20.81%; n = 26,170; P < .001). It was also observed that disordered eating became more elevated with increasing age (B, 0.03; 95% CI, 0-0.06; P = .049) and BMI (B, 0.03; 95% CI, 0.01-0.05; P < .001).
Translation of outcomes
According to the authors, this was the first meta-analysis that comprehensively examined the overall proportion of children and adolescents with disordered eating in terms of gender, mean age, and BMI. They identified 14,856 (22.36%) children and adolescents with disordered eating in the population analyzed (n = 63,181). A relevant consideration made by the researchers is that, in general, disordered eating and eating disorders are not similar. “Not all children and adolescents who reported disordered eating behaviors (for example, selective eating) will necessarily be diagnosed with an eating disorder.” However, disordered eating in childhood or adolescence may predict outcomes associated with eating disorders in early adulthood. “For this reason, this high proportion found is worrisome and calls for urgent action to try to address this situation.”
The study also found that the proportion of children and adolescents with disordered eating was higher among girls than boys. The reasons for the difference in the prevalence with respect to the sex of the participants are not well understood. Boys are presumed to underreport the problem because of the societal perception that these disorders mostly affect girls and because disordered eating has usually been thought by the general population to be exclusive to girls and women. In addition, it has been noted that the current diagnostic criteria for eating disorders fail to detect disordered eating behaviors more commonly observed in boys than girls, such as intensely engaging in muscle mass gain and weight gain with the goal of improving body image satisfaction. On the other hand, the proportion of young people with disordered eating increased with increasing age and BMI. This finding is in line with the scientific literature worldwide.
The study has certain limitations. First, only studies that analyzed disordered eating using the SCOFF questionnaire were included. Second, because of the cross-sectional nature of most of the included studies, a causal relationship cannot be established. Third, owing to the inclusion of binge eating disorder and other eating disorders specified in the DSM-5, there is not enough evidence to support the use of SCOFF in primary care and community-based settings for screening for the range of eating disorders. Fourth, the meta-analysis included studies in which self-report questionnaires were used to assess disordered eating, and consequently, social desirability and recall bias could have influenced the findings.
Quick measures required
Identifying the magnitude of disordered eating and its distribution in at-risk populations is crucial for planning and executing actions aimed at preventing, detecting, and treating them. Eating disorders are a global public health problem that health care professionals, families, and other community members involved in caring for children and adolescents must not ignore, the researchers said. In addition to diagnosed eating disorders, parents, guardians, and health care professionals should be aware of symptoms of disordered eating, which include behaviors such as weight-loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics without medical prescription.
This article was translated from the Medscape Portuguese Edition. A version of this article appeared on Medscape.com.
The high figures are concerning from a public health perspective and highlight the need to implement strategies for preventing eating disorders.
These disorders include anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorder–not otherwise specified. The prevalence of these disorders in young people has markedly increased globally over the past 50 years. Eating disorders are among the most life-threatening mental disorders; they were responsible for 318 deaths worldwide in 2019.
Because some individuals with eating disorders conceal core symptoms and avoid or delay seeking specialist care because of feelings of embarrassment, stigma, or ambivalence toward treatment, most cases of eating disorders remain undetected and untreated.
Brazilian researchers conducted studies to assess risky behaviors and predisposing factors among young people. The researchers observed that the probability of experiencing eating disorders was higher among young people who had an intense fear of gaining weight, who experienced thin-ideal internalization, who were excessively concerned about food, who experienced compulsive eating episodes, or who used laxatives. As previously reported, most participants in these studies had never sought professional help.
A study conducted in 2020 concluded that the media greatly influences the construction of one’s body image and the creation of aesthetic standards, particularly for adolescents. Adolescents then change their eating patterns and become more vulnerable to mental disorders related to eating.
A group of researchers from several countries, including Brazilians connected to the State University of Londrina, conducted the Global Proportion of Disordered Eating in Children and Adolescents – A Systematic Review and Meta-analysis. The study was coordinated by José Francisco López-Gil, PhD, of the University of Castilla–La Mancha (Spain). The investigators determined the rate of disordered eating among children and adolescents using the SCOFF (Sick, Control, One, Fat, Food) questionnaire, which is the most widely used screening measure for eating disorders.
Methods and results
Four databases were systematically searched (PubMed, Scopus, Web of Science, and the Cochrane Library); date limits were from January 1999 to November 2022. Studies were required to meet the following criteria: participants – studies of community samples of children and adolescents aged 6-18 years – and outcome – disordered eating assessed by the SCOFF questionnaire. The exclusion criteria were studies conducted with young people who had been diagnosed with physical or mental disorders; studies that were published before 1999, because the SCOFF questionnaire was designed in that year; studies in which data were collected during the COVID-19 pandemic, because of the possibility of selection bias; studies that employed data from the same surveys/studies, to avoid duplication; and systematic reviews and/or meta-analyses and qualitative and case studies.
In all, 32 studies, which involved a total of 63,181 participants from 16 countries, were included in the systematic review and meta-analysis, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The overall proportion of children and adolescents with disordered eating was 22.36% (95% confidence interval, 18.84%-26.09%; P < .001; n = 63,181). According to the researchers, girls were significantly more likely to report disordered eating (30.03%; 95% CI, 25.61%-34.65%; n = 27,548) than boys (16.98%; 95% CI, 13.46%-20.81%; n = 26,170; P < .001). It was also observed that disordered eating became more elevated with increasing age (B, 0.03; 95% CI, 0-0.06; P = .049) and BMI (B, 0.03; 95% CI, 0.01-0.05; P < .001).
Translation of outcomes
According to the authors, this was the first meta-analysis that comprehensively examined the overall proportion of children and adolescents with disordered eating in terms of gender, mean age, and BMI. They identified 14,856 (22.36%) children and adolescents with disordered eating in the population analyzed (n = 63,181). A relevant consideration made by the researchers is that, in general, disordered eating and eating disorders are not similar. “Not all children and adolescents who reported disordered eating behaviors (for example, selective eating) will necessarily be diagnosed with an eating disorder.” However, disordered eating in childhood or adolescence may predict outcomes associated with eating disorders in early adulthood. “For this reason, this high proportion found is worrisome and calls for urgent action to try to address this situation.”
The study also found that the proportion of children and adolescents with disordered eating was higher among girls than boys. The reasons for the difference in the prevalence with respect to the sex of the participants are not well understood. Boys are presumed to underreport the problem because of the societal perception that these disorders mostly affect girls and because disordered eating has usually been thought by the general population to be exclusive to girls and women. In addition, it has been noted that the current diagnostic criteria for eating disorders fail to detect disordered eating behaviors more commonly observed in boys than girls, such as intensely engaging in muscle mass gain and weight gain with the goal of improving body image satisfaction. On the other hand, the proportion of young people with disordered eating increased with increasing age and BMI. This finding is in line with the scientific literature worldwide.
The study has certain limitations. First, only studies that analyzed disordered eating using the SCOFF questionnaire were included. Second, because of the cross-sectional nature of most of the included studies, a causal relationship cannot be established. Third, owing to the inclusion of binge eating disorder and other eating disorders specified in the DSM-5, there is not enough evidence to support the use of SCOFF in primary care and community-based settings for screening for the range of eating disorders. Fourth, the meta-analysis included studies in which self-report questionnaires were used to assess disordered eating, and consequently, social desirability and recall bias could have influenced the findings.
Quick measures required
Identifying the magnitude of disordered eating and its distribution in at-risk populations is crucial for planning and executing actions aimed at preventing, detecting, and treating them. Eating disorders are a global public health problem that health care professionals, families, and other community members involved in caring for children and adolescents must not ignore, the researchers said. In addition to diagnosed eating disorders, parents, guardians, and health care professionals should be aware of symptoms of disordered eating, which include behaviors such as weight-loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics without medical prescription.
This article was translated from the Medscape Portuguese Edition. A version of this article appeared on Medscape.com.
The high figures are concerning from a public health perspective and highlight the need to implement strategies for preventing eating disorders.
These disorders include anorexia nervosa, bulimia nervosa, binge eating disorder, and eating disorder–not otherwise specified. The prevalence of these disorders in young people has markedly increased globally over the past 50 years. Eating disorders are among the most life-threatening mental disorders; they were responsible for 318 deaths worldwide in 2019.
Because some individuals with eating disorders conceal core symptoms and avoid or delay seeking specialist care because of feelings of embarrassment, stigma, or ambivalence toward treatment, most cases of eating disorders remain undetected and untreated.
Brazilian researchers conducted studies to assess risky behaviors and predisposing factors among young people. The researchers observed that the probability of experiencing eating disorders was higher among young people who had an intense fear of gaining weight, who experienced thin-ideal internalization, who were excessively concerned about food, who experienced compulsive eating episodes, or who used laxatives. As previously reported, most participants in these studies had never sought professional help.
A study conducted in 2020 concluded that the media greatly influences the construction of one’s body image and the creation of aesthetic standards, particularly for adolescents. Adolescents then change their eating patterns and become more vulnerable to mental disorders related to eating.
A group of researchers from several countries, including Brazilians connected to the State University of Londrina, conducted the Global Proportion of Disordered Eating in Children and Adolescents – A Systematic Review and Meta-analysis. The study was coordinated by José Francisco López-Gil, PhD, of the University of Castilla–La Mancha (Spain). The investigators determined the rate of disordered eating among children and adolescents using the SCOFF (Sick, Control, One, Fat, Food) questionnaire, which is the most widely used screening measure for eating disorders.
Methods and results
Four databases were systematically searched (PubMed, Scopus, Web of Science, and the Cochrane Library); date limits were from January 1999 to November 2022. Studies were required to meet the following criteria: participants – studies of community samples of children and adolescents aged 6-18 years – and outcome – disordered eating assessed by the SCOFF questionnaire. The exclusion criteria were studies conducted with young people who had been diagnosed with physical or mental disorders; studies that were published before 1999, because the SCOFF questionnaire was designed in that year; studies in which data were collected during the COVID-19 pandemic, because of the possibility of selection bias; studies that employed data from the same surveys/studies, to avoid duplication; and systematic reviews and/or meta-analyses and qualitative and case studies.
In all, 32 studies, which involved a total of 63,181 participants from 16 countries, were included in the systematic review and meta-analysis, according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The overall proportion of children and adolescents with disordered eating was 22.36% (95% confidence interval, 18.84%-26.09%; P < .001; n = 63,181). According to the researchers, girls were significantly more likely to report disordered eating (30.03%; 95% CI, 25.61%-34.65%; n = 27,548) than boys (16.98%; 95% CI, 13.46%-20.81%; n = 26,170; P < .001). It was also observed that disordered eating became more elevated with increasing age (B, 0.03; 95% CI, 0-0.06; P = .049) and BMI (B, 0.03; 95% CI, 0.01-0.05; P < .001).
Translation of outcomes
According to the authors, this was the first meta-analysis that comprehensively examined the overall proportion of children and adolescents with disordered eating in terms of gender, mean age, and BMI. They identified 14,856 (22.36%) children and adolescents with disordered eating in the population analyzed (n = 63,181). A relevant consideration made by the researchers is that, in general, disordered eating and eating disorders are not similar. “Not all children and adolescents who reported disordered eating behaviors (for example, selective eating) will necessarily be diagnosed with an eating disorder.” However, disordered eating in childhood or adolescence may predict outcomes associated with eating disorders in early adulthood. “For this reason, this high proportion found is worrisome and calls for urgent action to try to address this situation.”
The study also found that the proportion of children and adolescents with disordered eating was higher among girls than boys. The reasons for the difference in the prevalence with respect to the sex of the participants are not well understood. Boys are presumed to underreport the problem because of the societal perception that these disorders mostly affect girls and because disordered eating has usually been thought by the general population to be exclusive to girls and women. In addition, it has been noted that the current diagnostic criteria for eating disorders fail to detect disordered eating behaviors more commonly observed in boys than girls, such as intensely engaging in muscle mass gain and weight gain with the goal of improving body image satisfaction. On the other hand, the proportion of young people with disordered eating increased with increasing age and BMI. This finding is in line with the scientific literature worldwide.
The study has certain limitations. First, only studies that analyzed disordered eating using the SCOFF questionnaire were included. Second, because of the cross-sectional nature of most of the included studies, a causal relationship cannot be established. Third, owing to the inclusion of binge eating disorder and other eating disorders specified in the DSM-5, there is not enough evidence to support the use of SCOFF in primary care and community-based settings for screening for the range of eating disorders. Fourth, the meta-analysis included studies in which self-report questionnaires were used to assess disordered eating, and consequently, social desirability and recall bias could have influenced the findings.
Quick measures required
Identifying the magnitude of disordered eating and its distribution in at-risk populations is crucial for planning and executing actions aimed at preventing, detecting, and treating them. Eating disorders are a global public health problem that health care professionals, families, and other community members involved in caring for children and adolescents must not ignore, the researchers said. In addition to diagnosed eating disorders, parents, guardians, and health care professionals should be aware of symptoms of disordered eating, which include behaviors such as weight-loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics without medical prescription.
This article was translated from the Medscape Portuguese Edition. A version of this article appeared on Medscape.com.
FROM JAMA PEDIATRICS
AD in infancy: Diagnostic advice and treatment tips
WASHINGTON – mean it is often “woefully undertreated,” Robert Sidbury, MD, MPH, said at the annual Revolutionizing Atopic Dermatitis conference.
Identifying and mitigating triggers – such as irritation, contact allergy, and infection – is a cornerstone of treatment in infants, but tailored therapy with topical corticosteroids, topical calcineurin inhibitors (TCIs), and topical phosphodiesterase 4 (PDE4) inhibitors also have roles to play, said Dr. Sidbury, chief of dermatology at Seattle Children’s Hospital and professor in the department of pediatrics at the University of Washington, Seattle.
Views on the use of dupilumab as a systemic agent for severe infantile AD, meanwhile, have shifted significantly in the past year with the Food and Drug Administration approval of the biologic for children aged 6 months to 5 years and with extended experience with the biologic in all ages, including children, Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said at the meeting.
The pediatric dermatologists spoke during a session devoted to AD in infants, during which the diagnosis of AD and the role – and risks – of food allergy testing were also discussed. Diagnosis, said Elaine C. Siegfried, MD, who also spoke during the session, requires careful consideration of mimicking conditions and a broader list of differential diagnoses in those infants with poor growth or frequent infections.
Here are some of the experts’ pearls for practice.
Diagnosing AD in infants
Among infants who are growing well and otherwise healthy, the infantile eczema phenotype encompasses AD, seborrheic dermatitis, contact dermatitis, psoriasis – and overlap of more than one of these conditions. “Overlap is common,” said Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and director of the division of pediatric dermatology at Cardinal Glennon Children’s Hospital.
(Initial topical treatment for all these conditions is similar, but optimal treatment may differ for young children with moderate to severe disease that requires systemic treatment, she said in an interview after the meeting.)
Sparing of the diaper area that reflects skin barrier integrity is a classic feature of AD in infants and can be a useful diagnostic sign. In addition, “hypopigmentation is more characteristic of psoriasis” than AD, whereas AD tends to be hyperpigmented, which is most obvious in skin-of-color patients, Dr. Siegfried said.
Disease-specific pigment changes may be related to microbial colonization – such as Malassezia-associated hypopigmentation – or cell turnover, which is faster in psoriasis and slower in AD – with corresponding differences in pigment retention, and may be more obvious in children than adults, she said.
A less common scenario is dermatitis in infants who are not growing well. For these patients, she noted, the differential diagnosis includes metabolic or immune deficiency dermatitis as well as a variety of genodermatoses.
Generalized redness and scaling present on the first day of life is suggestive of non-atopic dermatitis. “If you’re born with red scaly skin, that’s very different than if you develop red skin in the first month or two of life,” Dr. Siegfried said.
When there is diaper area involvement with AD, contact dermatitis, impetigo, and Candida may be complicating factors. And in infants with other morbidities – especially those who are not growing well – diaper area involvement suggests a broader differential diagnosis. “I implore you, if you see children, make sure you weigh and measure them at every appointment,” she said.
Dr. Siegfried has seen infants with Netherton syndrome, and those with cystic fibrosis with zinc deficiency, for instance, presenting with “an eczematous-like picture,” diaper-area involvement, and other morbidities.
For infants with AD, she maintains a high index of suspicion for secondary infections such as molluscum, herpes simplex virus (HSV) with or without streptococci, scabies, tinea, and group A streptococci. “Secondary infections ... may be incognito,” she said. “Look for subtle signs. Even molluscum can be very subtle.”
Secondary allergic contact dermatitis is also common although it’s “technically difficult to confirm the diagnosis,” she said. Patch testing in infants is technically challenging, sensitivity is low, and monosensitization is uncommon. “So I do initial empiric topical allergen avoidance,” she said, keeping in mind ubiquitous and avoidable topical allergens such as Kathon, cocamidopropyl betaine, propylene glycol, disperse blue, and adhesives.
Treating AD in infancy
Irritation “is probably one of the biggest triggers” of AD in infants, and the often “pristine” diaper area compared with inflamed eczema elsewhere can demonstrate the importance of moisturization for healthy skin in atopic infants, Dr. Sidbury said.
Among treatments that “punch above their weight” for AD in infants is an ointment-based barrier applied around the mouth, chin, and chest – where the wet/dry impact of drooling is maximal – before and after meals, he said.
Another is hydrocortisone 2.5% mixed 1:1 with mupirocin for those infants who have secondary infections and “that exudative, weepy-looking appearance on the face,” he said. The topical antibiotic in the combination cream “lessens the potency of the steroid and oftentimes by synergy, makes it more effective” by simultaneously treating inflammation, he said. He cautions against products containing neomycin, which can be an allergen.
A combination antibiotic-steroid-emollient cream (the Aron Regimen) can also “sometimes punch above its weight,” Dr. Sidbury said.
Infections typically involve Staphylococcus aureus, but in up to 16% of cases Streptococcus is involved. And notably, lurking underneath the honey-colored crusting of S. aureus infections may be the grouped vesicles that characterize eczema herpeticum, Dr. Sidbury said.
“Counsel [parents] preemptively to treat cold sores immediately [in order to] decrease HSV shedding and minimize risk to their baby,” Dr. Sidbury said.
For treating AD-associated inflammation in skin not affected by secondary infections, over-the-counter 1% hydrocortisone cream is often sufficient, and “for very young babies and preemies in particular, I generally don’t use anything stronger because their skin barrier isn’t fully complete yet, so they absorb more than an older child does,” he said, referring to ages 2 months corrected as a marker for considering a stronger formulation if needed.
Many parents are “very concerned” about topical corticosteroid (TCS) use and pediatricians are also “often concerned,” Dr. Sidbury said. Addressing this concern, he tries to provide context and promote adherence by pointing out that infants have an easily visible vein at the temple area where the skin is naturally thin. If parents were to see this appearance for the first time in other areas while using topical steroids, he tells them, it may be the first sign of skin thinning, but “it’s entirely reversible at that stage.”
He also stressed the cost of not treating. It’s unknown whether “treating aggressively early on prevents any future development or manifestation of eczema, or future comorbidities, but we don’t know that it doesn’t,” Dr. Sidbury said. “And we certainly know how miserable that baby with eczema can be in the short term. So we need to use these medicines.”
Dr. Sidbury utilizes tacrolimus 0.03% ointment, a topical calcineurin inhibitor (TCI), only if he is worried about overuse of steroids, and uses a regimen that alternates the TCI (used in infants off-label because it is approved for ages 2 years and older) with TCS in periods of similar duration (for example, treatment with TCS for 1 week and TCI for 1 week, or rotations of 2 weeks each or 3 days each). “And these rotations may be dynamic depending on severity of the flare at any given time,” he said after the meeting.
Preapproval data from the pivotal trials of tacrolimus are reassuring and can be shared with parents. “Two-year-olds had 90% of BSA [body surface area] treated for 12 weeks” with no signs of systemic risks, Dr. Sidbury said at the meeting.
Crisaborole, a topical phosphodiesterase 4 (PDE4) inhibitor approved for AD down to age 3 months, does not, like tacrolimus, have a boxed warning about a possible risk for cancer, and may also be alternated with TCSs. It will cause stinging in some children, but TCSs and TCIs can also sting in some children, he said, noting that samples can be helpful to predict what will or won’t sting each infant.
Systemic treatment in infants
The Liberty AD PRESCHOOL phase 3 trial that supported the FDA’s approval of dupilumab down to 6 months of age, published in 2022 in The Lancet, covered ages 6 months to 5 years but included only six children under the age of 2, “leaving us with a very limited dataset in this age group,” Dr. Eichenfield said at the meeting.
Other data and analyses that have provided reassurance, such as a laboratory safety analysis published online in 2022 showing no meaningful changes in laboratory safety parameters in children as young as 6 months, and pediatric data (not including infants) presented at a RAD meeting in 2022 showing that dupilumab, an interleukin-4 receptor alpha antagonist, may have positive effects on bone mineral density.
Data from the Liberty AD PRESCHOOL open-label extension study presented at the American Academy of Dermatology meeting in 2023, meanwhile, show that “the adverse event profile is not looking much different than what we see in older children,” Dr. Eichenfield said. “There are low rates of severe adverse events and a very low rate of discontinuations.”
At Rady Children’s Hospital, where Dr. Eichenfield is chief of pediatric and adolescent dermatology, dupilumab has become a first-line systemic agent for severe infantile AD, supplanting prior traditional but little used systemic agents such as oral corticosteroids, cyclosporine, methotrexate, azathioprine, or mycophenolate, he said after the meeting.
The decision to use systemics in the first 2 years of life is “a comprehensive one,” requiring knowledge of the child’s history, disease course, and assessment of response to prior therapies, comorbidities and severity, he said.
Food allergy in infants with AD
Food allergy is common in children with moderate to severe AD, but true food-triggered AD, with AD being the only symptom of food allergy, is rare, said Anne Marie Singh, MD, associate professor in the division of allergy and immunology and rheumatology at the University of Wisconsin, Madison, who focuses on pediatrics.
Over the years, studies of double-blind placebo-controlled food challenge tests in children with AD have tended to conflate immediate IgE hypersensitivity (and skin symptoms like urticaria) with AD, said Dr. Singh, who directs the university’s Food Allergy Research and Education Center of Excellence. In a recently published study she led involving 374 children with AD referred to allergy and/or dermatology subspecialty clinics at the University of Wisconsin, Madison, 55% had a food allergy but only 2% had food-triggered AD “where eczema is the only symptom and removal of the food cleared up the eczema and its return brought it back,” Dr. Singh said at the meeting. Another 4% had combined IgE-mediated food allergy and food-triggered AD. Almost half of the children with food-triggered AD were under 1 year of age, and egg was the most common trigger, she noted.
Food should be implicated largely by history, Dr. Singh emphasized.
Food allergy testing in the context of AD can be done but is challenging, with the clinical relevance of skin prick testing and food-specific immunoglobulin E (sIgE) difficult to predict. Predictive values of sIgE levels are established for immediate IgE mediated food allergy, but “cut-offs” for food-triggered AD are not established, she explained, noting that “cut-offs are likely higher for our children with AD.”
Elimination diets, moreover, pose significant risks of future oral tolerance and risks of nutritional deficiencies and poor growth, Dr. Singh said. New and immediate reactions to foods that are reintroduced after an elimination diet are common, and research has shown that 20% or more of such reactions involve anaphylaxis. “If an elimination diet is undertaken, you need emergency action plans, injectable epinephrine, and nutrition counseling,” she said.
A recent systematic review and meta-analysis conditionally recommended against elimination diets for the treatment of AD, Dr. Singh noted.
Asked by Dr. Sidbury whether there “is a sweet spot where you can eliminate [foods] without going all the way,” Dr. Singh said she will sometimes do a “diagnostic elimination trial” with food elimination for 2-4 weeks only – a time period after which “I’ll feel really comfortable reintroducing the food.”
Dr. Singh urged dermatologists to “know your allergist” because “patients respond best with a consistent message.”
Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, Lilly, and Beiersdorf. Dr. Siegfried reported ties with Pfizer, Regeneron, Sanofi Genzyme, Pfizer, UCB, Novan and Leo Pharma. Dr. Singh reported ties with Incyte and Siolta Therapeutics. Dr. Eichenfield reported ties with Pfizer, Regeneron, Sanofi Genzyme, Incyte, and Pfizer.
WASHINGTON – mean it is often “woefully undertreated,” Robert Sidbury, MD, MPH, said at the annual Revolutionizing Atopic Dermatitis conference.
Identifying and mitigating triggers – such as irritation, contact allergy, and infection – is a cornerstone of treatment in infants, but tailored therapy with topical corticosteroids, topical calcineurin inhibitors (TCIs), and topical phosphodiesterase 4 (PDE4) inhibitors also have roles to play, said Dr. Sidbury, chief of dermatology at Seattle Children’s Hospital and professor in the department of pediatrics at the University of Washington, Seattle.
Views on the use of dupilumab as a systemic agent for severe infantile AD, meanwhile, have shifted significantly in the past year with the Food and Drug Administration approval of the biologic for children aged 6 months to 5 years and with extended experience with the biologic in all ages, including children, Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said at the meeting.
The pediatric dermatologists spoke during a session devoted to AD in infants, during which the diagnosis of AD and the role – and risks – of food allergy testing were also discussed. Diagnosis, said Elaine C. Siegfried, MD, who also spoke during the session, requires careful consideration of mimicking conditions and a broader list of differential diagnoses in those infants with poor growth or frequent infections.
Here are some of the experts’ pearls for practice.
Diagnosing AD in infants
Among infants who are growing well and otherwise healthy, the infantile eczema phenotype encompasses AD, seborrheic dermatitis, contact dermatitis, psoriasis – and overlap of more than one of these conditions. “Overlap is common,” said Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and director of the division of pediatric dermatology at Cardinal Glennon Children’s Hospital.
(Initial topical treatment for all these conditions is similar, but optimal treatment may differ for young children with moderate to severe disease that requires systemic treatment, she said in an interview after the meeting.)
Sparing of the diaper area that reflects skin barrier integrity is a classic feature of AD in infants and can be a useful diagnostic sign. In addition, “hypopigmentation is more characteristic of psoriasis” than AD, whereas AD tends to be hyperpigmented, which is most obvious in skin-of-color patients, Dr. Siegfried said.
Disease-specific pigment changes may be related to microbial colonization – such as Malassezia-associated hypopigmentation – or cell turnover, which is faster in psoriasis and slower in AD – with corresponding differences in pigment retention, and may be more obvious in children than adults, she said.
A less common scenario is dermatitis in infants who are not growing well. For these patients, she noted, the differential diagnosis includes metabolic or immune deficiency dermatitis as well as a variety of genodermatoses.
Generalized redness and scaling present on the first day of life is suggestive of non-atopic dermatitis. “If you’re born with red scaly skin, that’s very different than if you develop red skin in the first month or two of life,” Dr. Siegfried said.
When there is diaper area involvement with AD, contact dermatitis, impetigo, and Candida may be complicating factors. And in infants with other morbidities – especially those who are not growing well – diaper area involvement suggests a broader differential diagnosis. “I implore you, if you see children, make sure you weigh and measure them at every appointment,” she said.
Dr. Siegfried has seen infants with Netherton syndrome, and those with cystic fibrosis with zinc deficiency, for instance, presenting with “an eczematous-like picture,” diaper-area involvement, and other morbidities.
For infants with AD, she maintains a high index of suspicion for secondary infections such as molluscum, herpes simplex virus (HSV) with or without streptococci, scabies, tinea, and group A streptococci. “Secondary infections ... may be incognito,” she said. “Look for subtle signs. Even molluscum can be very subtle.”
Secondary allergic contact dermatitis is also common although it’s “technically difficult to confirm the diagnosis,” she said. Patch testing in infants is technically challenging, sensitivity is low, and monosensitization is uncommon. “So I do initial empiric topical allergen avoidance,” she said, keeping in mind ubiquitous and avoidable topical allergens such as Kathon, cocamidopropyl betaine, propylene glycol, disperse blue, and adhesives.
Treating AD in infancy
Irritation “is probably one of the biggest triggers” of AD in infants, and the often “pristine” diaper area compared with inflamed eczema elsewhere can demonstrate the importance of moisturization for healthy skin in atopic infants, Dr. Sidbury said.
Among treatments that “punch above their weight” for AD in infants is an ointment-based barrier applied around the mouth, chin, and chest – where the wet/dry impact of drooling is maximal – before and after meals, he said.
Another is hydrocortisone 2.5% mixed 1:1 with mupirocin for those infants who have secondary infections and “that exudative, weepy-looking appearance on the face,” he said. The topical antibiotic in the combination cream “lessens the potency of the steroid and oftentimes by synergy, makes it more effective” by simultaneously treating inflammation, he said. He cautions against products containing neomycin, which can be an allergen.
A combination antibiotic-steroid-emollient cream (the Aron Regimen) can also “sometimes punch above its weight,” Dr. Sidbury said.
Infections typically involve Staphylococcus aureus, but in up to 16% of cases Streptococcus is involved. And notably, lurking underneath the honey-colored crusting of S. aureus infections may be the grouped vesicles that characterize eczema herpeticum, Dr. Sidbury said.
“Counsel [parents] preemptively to treat cold sores immediately [in order to] decrease HSV shedding and minimize risk to their baby,” Dr. Sidbury said.
For treating AD-associated inflammation in skin not affected by secondary infections, over-the-counter 1% hydrocortisone cream is often sufficient, and “for very young babies and preemies in particular, I generally don’t use anything stronger because their skin barrier isn’t fully complete yet, so they absorb more than an older child does,” he said, referring to ages 2 months corrected as a marker for considering a stronger formulation if needed.
Many parents are “very concerned” about topical corticosteroid (TCS) use and pediatricians are also “often concerned,” Dr. Sidbury said. Addressing this concern, he tries to provide context and promote adherence by pointing out that infants have an easily visible vein at the temple area where the skin is naturally thin. If parents were to see this appearance for the first time in other areas while using topical steroids, he tells them, it may be the first sign of skin thinning, but “it’s entirely reversible at that stage.”
He also stressed the cost of not treating. It’s unknown whether “treating aggressively early on prevents any future development or manifestation of eczema, or future comorbidities, but we don’t know that it doesn’t,” Dr. Sidbury said. “And we certainly know how miserable that baby with eczema can be in the short term. So we need to use these medicines.”
Dr. Sidbury utilizes tacrolimus 0.03% ointment, a topical calcineurin inhibitor (TCI), only if he is worried about overuse of steroids, and uses a regimen that alternates the TCI (used in infants off-label because it is approved for ages 2 years and older) with TCS in periods of similar duration (for example, treatment with TCS for 1 week and TCI for 1 week, or rotations of 2 weeks each or 3 days each). “And these rotations may be dynamic depending on severity of the flare at any given time,” he said after the meeting.
Preapproval data from the pivotal trials of tacrolimus are reassuring and can be shared with parents. “Two-year-olds had 90% of BSA [body surface area] treated for 12 weeks” with no signs of systemic risks, Dr. Sidbury said at the meeting.
Crisaborole, a topical phosphodiesterase 4 (PDE4) inhibitor approved for AD down to age 3 months, does not, like tacrolimus, have a boxed warning about a possible risk for cancer, and may also be alternated with TCSs. It will cause stinging in some children, but TCSs and TCIs can also sting in some children, he said, noting that samples can be helpful to predict what will or won’t sting each infant.
Systemic treatment in infants
The Liberty AD PRESCHOOL phase 3 trial that supported the FDA’s approval of dupilumab down to 6 months of age, published in 2022 in The Lancet, covered ages 6 months to 5 years but included only six children under the age of 2, “leaving us with a very limited dataset in this age group,” Dr. Eichenfield said at the meeting.
Other data and analyses that have provided reassurance, such as a laboratory safety analysis published online in 2022 showing no meaningful changes in laboratory safety parameters in children as young as 6 months, and pediatric data (not including infants) presented at a RAD meeting in 2022 showing that dupilumab, an interleukin-4 receptor alpha antagonist, may have positive effects on bone mineral density.
Data from the Liberty AD PRESCHOOL open-label extension study presented at the American Academy of Dermatology meeting in 2023, meanwhile, show that “the adverse event profile is not looking much different than what we see in older children,” Dr. Eichenfield said. “There are low rates of severe adverse events and a very low rate of discontinuations.”
At Rady Children’s Hospital, where Dr. Eichenfield is chief of pediatric and adolescent dermatology, dupilumab has become a first-line systemic agent for severe infantile AD, supplanting prior traditional but little used systemic agents such as oral corticosteroids, cyclosporine, methotrexate, azathioprine, or mycophenolate, he said after the meeting.
The decision to use systemics in the first 2 years of life is “a comprehensive one,” requiring knowledge of the child’s history, disease course, and assessment of response to prior therapies, comorbidities and severity, he said.
Food allergy in infants with AD
Food allergy is common in children with moderate to severe AD, but true food-triggered AD, with AD being the only symptom of food allergy, is rare, said Anne Marie Singh, MD, associate professor in the division of allergy and immunology and rheumatology at the University of Wisconsin, Madison, who focuses on pediatrics.
Over the years, studies of double-blind placebo-controlled food challenge tests in children with AD have tended to conflate immediate IgE hypersensitivity (and skin symptoms like urticaria) with AD, said Dr. Singh, who directs the university’s Food Allergy Research and Education Center of Excellence. In a recently published study she led involving 374 children with AD referred to allergy and/or dermatology subspecialty clinics at the University of Wisconsin, Madison, 55% had a food allergy but only 2% had food-triggered AD “where eczema is the only symptom and removal of the food cleared up the eczema and its return brought it back,” Dr. Singh said at the meeting. Another 4% had combined IgE-mediated food allergy and food-triggered AD. Almost half of the children with food-triggered AD were under 1 year of age, and egg was the most common trigger, she noted.
Food should be implicated largely by history, Dr. Singh emphasized.
Food allergy testing in the context of AD can be done but is challenging, with the clinical relevance of skin prick testing and food-specific immunoglobulin E (sIgE) difficult to predict. Predictive values of sIgE levels are established for immediate IgE mediated food allergy, but “cut-offs” for food-triggered AD are not established, she explained, noting that “cut-offs are likely higher for our children with AD.”
Elimination diets, moreover, pose significant risks of future oral tolerance and risks of nutritional deficiencies and poor growth, Dr. Singh said. New and immediate reactions to foods that are reintroduced after an elimination diet are common, and research has shown that 20% or more of such reactions involve anaphylaxis. “If an elimination diet is undertaken, you need emergency action plans, injectable epinephrine, and nutrition counseling,” she said.
A recent systematic review and meta-analysis conditionally recommended against elimination diets for the treatment of AD, Dr. Singh noted.
Asked by Dr. Sidbury whether there “is a sweet spot where you can eliminate [foods] without going all the way,” Dr. Singh said she will sometimes do a “diagnostic elimination trial” with food elimination for 2-4 weeks only – a time period after which “I’ll feel really comfortable reintroducing the food.”
Dr. Singh urged dermatologists to “know your allergist” because “patients respond best with a consistent message.”
Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, Lilly, and Beiersdorf. Dr. Siegfried reported ties with Pfizer, Regeneron, Sanofi Genzyme, Pfizer, UCB, Novan and Leo Pharma. Dr. Singh reported ties with Incyte and Siolta Therapeutics. Dr. Eichenfield reported ties with Pfizer, Regeneron, Sanofi Genzyme, Incyte, and Pfizer.
WASHINGTON – mean it is often “woefully undertreated,” Robert Sidbury, MD, MPH, said at the annual Revolutionizing Atopic Dermatitis conference.
Identifying and mitigating triggers – such as irritation, contact allergy, and infection – is a cornerstone of treatment in infants, but tailored therapy with topical corticosteroids, topical calcineurin inhibitors (TCIs), and topical phosphodiesterase 4 (PDE4) inhibitors also have roles to play, said Dr. Sidbury, chief of dermatology at Seattle Children’s Hospital and professor in the department of pediatrics at the University of Washington, Seattle.
Views on the use of dupilumab as a systemic agent for severe infantile AD, meanwhile, have shifted significantly in the past year with the Food and Drug Administration approval of the biologic for children aged 6 months to 5 years and with extended experience with the biologic in all ages, including children, Lawrence F. Eichenfield, MD, professor of dermatology and pediatrics at the University of California, San Diego, said at the meeting.
The pediatric dermatologists spoke during a session devoted to AD in infants, during which the diagnosis of AD and the role – and risks – of food allergy testing were also discussed. Diagnosis, said Elaine C. Siegfried, MD, who also spoke during the session, requires careful consideration of mimicking conditions and a broader list of differential diagnoses in those infants with poor growth or frequent infections.
Here are some of the experts’ pearls for practice.
Diagnosing AD in infants
Among infants who are growing well and otherwise healthy, the infantile eczema phenotype encompasses AD, seborrheic dermatitis, contact dermatitis, psoriasis – and overlap of more than one of these conditions. “Overlap is common,” said Dr. Siegfried, professor of pediatrics and dermatology at Saint Louis University, and director of the division of pediatric dermatology at Cardinal Glennon Children’s Hospital.
(Initial topical treatment for all these conditions is similar, but optimal treatment may differ for young children with moderate to severe disease that requires systemic treatment, she said in an interview after the meeting.)
Sparing of the diaper area that reflects skin barrier integrity is a classic feature of AD in infants and can be a useful diagnostic sign. In addition, “hypopigmentation is more characteristic of psoriasis” than AD, whereas AD tends to be hyperpigmented, which is most obvious in skin-of-color patients, Dr. Siegfried said.
Disease-specific pigment changes may be related to microbial colonization – such as Malassezia-associated hypopigmentation – or cell turnover, which is faster in psoriasis and slower in AD – with corresponding differences in pigment retention, and may be more obvious in children than adults, she said.
A less common scenario is dermatitis in infants who are not growing well. For these patients, she noted, the differential diagnosis includes metabolic or immune deficiency dermatitis as well as a variety of genodermatoses.
Generalized redness and scaling present on the first day of life is suggestive of non-atopic dermatitis. “If you’re born with red scaly skin, that’s very different than if you develop red skin in the first month or two of life,” Dr. Siegfried said.
When there is diaper area involvement with AD, contact dermatitis, impetigo, and Candida may be complicating factors. And in infants with other morbidities – especially those who are not growing well – diaper area involvement suggests a broader differential diagnosis. “I implore you, if you see children, make sure you weigh and measure them at every appointment,” she said.
Dr. Siegfried has seen infants with Netherton syndrome, and those with cystic fibrosis with zinc deficiency, for instance, presenting with “an eczematous-like picture,” diaper-area involvement, and other morbidities.
For infants with AD, she maintains a high index of suspicion for secondary infections such as molluscum, herpes simplex virus (HSV) with or without streptococci, scabies, tinea, and group A streptococci. “Secondary infections ... may be incognito,” she said. “Look for subtle signs. Even molluscum can be very subtle.”
Secondary allergic contact dermatitis is also common although it’s “technically difficult to confirm the diagnosis,” she said. Patch testing in infants is technically challenging, sensitivity is low, and monosensitization is uncommon. “So I do initial empiric topical allergen avoidance,” she said, keeping in mind ubiquitous and avoidable topical allergens such as Kathon, cocamidopropyl betaine, propylene glycol, disperse blue, and adhesives.
Treating AD in infancy
Irritation “is probably one of the biggest triggers” of AD in infants, and the often “pristine” diaper area compared with inflamed eczema elsewhere can demonstrate the importance of moisturization for healthy skin in atopic infants, Dr. Sidbury said.
Among treatments that “punch above their weight” for AD in infants is an ointment-based barrier applied around the mouth, chin, and chest – where the wet/dry impact of drooling is maximal – before and after meals, he said.
Another is hydrocortisone 2.5% mixed 1:1 with mupirocin for those infants who have secondary infections and “that exudative, weepy-looking appearance on the face,” he said. The topical antibiotic in the combination cream “lessens the potency of the steroid and oftentimes by synergy, makes it more effective” by simultaneously treating inflammation, he said. He cautions against products containing neomycin, which can be an allergen.
A combination antibiotic-steroid-emollient cream (the Aron Regimen) can also “sometimes punch above its weight,” Dr. Sidbury said.
Infections typically involve Staphylococcus aureus, but in up to 16% of cases Streptococcus is involved. And notably, lurking underneath the honey-colored crusting of S. aureus infections may be the grouped vesicles that characterize eczema herpeticum, Dr. Sidbury said.
“Counsel [parents] preemptively to treat cold sores immediately [in order to] decrease HSV shedding and minimize risk to their baby,” Dr. Sidbury said.
For treating AD-associated inflammation in skin not affected by secondary infections, over-the-counter 1% hydrocortisone cream is often sufficient, and “for very young babies and preemies in particular, I generally don’t use anything stronger because their skin barrier isn’t fully complete yet, so they absorb more than an older child does,” he said, referring to ages 2 months corrected as a marker for considering a stronger formulation if needed.
Many parents are “very concerned” about topical corticosteroid (TCS) use and pediatricians are also “often concerned,” Dr. Sidbury said. Addressing this concern, he tries to provide context and promote adherence by pointing out that infants have an easily visible vein at the temple area where the skin is naturally thin. If parents were to see this appearance for the first time in other areas while using topical steroids, he tells them, it may be the first sign of skin thinning, but “it’s entirely reversible at that stage.”
He also stressed the cost of not treating. It’s unknown whether “treating aggressively early on prevents any future development or manifestation of eczema, or future comorbidities, but we don’t know that it doesn’t,” Dr. Sidbury said. “And we certainly know how miserable that baby with eczema can be in the short term. So we need to use these medicines.”
Dr. Sidbury utilizes tacrolimus 0.03% ointment, a topical calcineurin inhibitor (TCI), only if he is worried about overuse of steroids, and uses a regimen that alternates the TCI (used in infants off-label because it is approved for ages 2 years and older) with TCS in periods of similar duration (for example, treatment with TCS for 1 week and TCI for 1 week, or rotations of 2 weeks each or 3 days each). “And these rotations may be dynamic depending on severity of the flare at any given time,” he said after the meeting.
Preapproval data from the pivotal trials of tacrolimus are reassuring and can be shared with parents. “Two-year-olds had 90% of BSA [body surface area] treated for 12 weeks” with no signs of systemic risks, Dr. Sidbury said at the meeting.
Crisaborole, a topical phosphodiesterase 4 (PDE4) inhibitor approved for AD down to age 3 months, does not, like tacrolimus, have a boxed warning about a possible risk for cancer, and may also be alternated with TCSs. It will cause stinging in some children, but TCSs and TCIs can also sting in some children, he said, noting that samples can be helpful to predict what will or won’t sting each infant.
Systemic treatment in infants
The Liberty AD PRESCHOOL phase 3 trial that supported the FDA’s approval of dupilumab down to 6 months of age, published in 2022 in The Lancet, covered ages 6 months to 5 years but included only six children under the age of 2, “leaving us with a very limited dataset in this age group,” Dr. Eichenfield said at the meeting.
Other data and analyses that have provided reassurance, such as a laboratory safety analysis published online in 2022 showing no meaningful changes in laboratory safety parameters in children as young as 6 months, and pediatric data (not including infants) presented at a RAD meeting in 2022 showing that dupilumab, an interleukin-4 receptor alpha antagonist, may have positive effects on bone mineral density.
Data from the Liberty AD PRESCHOOL open-label extension study presented at the American Academy of Dermatology meeting in 2023, meanwhile, show that “the adverse event profile is not looking much different than what we see in older children,” Dr. Eichenfield said. “There are low rates of severe adverse events and a very low rate of discontinuations.”
At Rady Children’s Hospital, where Dr. Eichenfield is chief of pediatric and adolescent dermatology, dupilumab has become a first-line systemic agent for severe infantile AD, supplanting prior traditional but little used systemic agents such as oral corticosteroids, cyclosporine, methotrexate, azathioprine, or mycophenolate, he said after the meeting.
The decision to use systemics in the first 2 years of life is “a comprehensive one,” requiring knowledge of the child’s history, disease course, and assessment of response to prior therapies, comorbidities and severity, he said.
Food allergy in infants with AD
Food allergy is common in children with moderate to severe AD, but true food-triggered AD, with AD being the only symptom of food allergy, is rare, said Anne Marie Singh, MD, associate professor in the division of allergy and immunology and rheumatology at the University of Wisconsin, Madison, who focuses on pediatrics.
Over the years, studies of double-blind placebo-controlled food challenge tests in children with AD have tended to conflate immediate IgE hypersensitivity (and skin symptoms like urticaria) with AD, said Dr. Singh, who directs the university’s Food Allergy Research and Education Center of Excellence. In a recently published study she led involving 374 children with AD referred to allergy and/or dermatology subspecialty clinics at the University of Wisconsin, Madison, 55% had a food allergy but only 2% had food-triggered AD “where eczema is the only symptom and removal of the food cleared up the eczema and its return brought it back,” Dr. Singh said at the meeting. Another 4% had combined IgE-mediated food allergy and food-triggered AD. Almost half of the children with food-triggered AD were under 1 year of age, and egg was the most common trigger, she noted.
Food should be implicated largely by history, Dr. Singh emphasized.
Food allergy testing in the context of AD can be done but is challenging, with the clinical relevance of skin prick testing and food-specific immunoglobulin E (sIgE) difficult to predict. Predictive values of sIgE levels are established for immediate IgE mediated food allergy, but “cut-offs” for food-triggered AD are not established, she explained, noting that “cut-offs are likely higher for our children with AD.”
Elimination diets, moreover, pose significant risks of future oral tolerance and risks of nutritional deficiencies and poor growth, Dr. Singh said. New and immediate reactions to foods that are reintroduced after an elimination diet are common, and research has shown that 20% or more of such reactions involve anaphylaxis. “If an elimination diet is undertaken, you need emergency action plans, injectable epinephrine, and nutrition counseling,” she said.
A recent systematic review and meta-analysis conditionally recommended against elimination diets for the treatment of AD, Dr. Singh noted.
Asked by Dr. Sidbury whether there “is a sweet spot where you can eliminate [foods] without going all the way,” Dr. Singh said she will sometimes do a “diagnostic elimination trial” with food elimination for 2-4 weeks only – a time period after which “I’ll feel really comfortable reintroducing the food.”
Dr. Singh urged dermatologists to “know your allergist” because “patients respond best with a consistent message.”
Dr. Sidbury reported ties with Regeneron, UCB, Pfizer, Leo Pharma, Lilly, and Beiersdorf. Dr. Siegfried reported ties with Pfizer, Regeneron, Sanofi Genzyme, Pfizer, UCB, Novan and Leo Pharma. Dr. Singh reported ties with Incyte and Siolta Therapeutics. Dr. Eichenfield reported ties with Pfizer, Regeneron, Sanofi Genzyme, Incyte, and Pfizer.
AT RAD 2023
Study says casual pot use harmful to teens
Teenagers who use cannabis recreationally are two to three times more likely to have depression and suicidal thoughts than those who don’t use it. And teens who have cannabis use disorder – which means they can’t stop using it despite health and social problems – are four times more likely to have those same thoughts and feelings.
The study was published in JAMA. It looked at information from 68,000 teens in the National Survey on Drug Use and Health.
Marijuana use was also linked to other issues including not doing well in school, skipping school, and getting in trouble with the police. 
“Kids, year by year, have been moving towards a view that marijuana is safe and benign – that’s factually incorrect,” lead author of the study, Ryan Sultan, MD, an assistant professor of clinical psychiatry at Columbia University, New York, told Yahoo Life.
Dr. Sultan said he was surprised that recreational users had a much higher risk of mental health issues. “We typically think of recreational use as not being a concerning behavior.”
The study did not seek to explain the link between mental health problems and cannabis use.
“The more you use it, the more it negatively affects your thinking. That’s increasing the likelihood of depression and more suicidal thoughts,” Dr. Sultan said. “It’s feedback that spirals downward and gets to a place that really concerns us as child psychiatrists.”
Dr. Sultan said parents should talk to their children about marijuana use, depression, and anxiety.
NIDA and American Academy of Child and Adolescent Psychiatry provided funding for the study. One coauthor reported receiving grants and personal fees from several medical and sports organizations. The other authors reported no conflicts of interest.
A version of this article first appeared on WebMD.com.
Teenagers who use cannabis recreationally are two to three times more likely to have depression and suicidal thoughts than those who don’t use it. And teens who have cannabis use disorder – which means they can’t stop using it despite health and social problems – are four times more likely to have those same thoughts and feelings.
The study was published in JAMA. It looked at information from 68,000 teens in the National Survey on Drug Use and Health.
Marijuana use was also linked to other issues including not doing well in school, skipping school, and getting in trouble with the police.
“Kids, year by year, have been moving towards a view that marijuana is safe and benign – that’s factually incorrect,” lead author of the study, Ryan Sultan, MD, an assistant professor of clinical psychiatry at Columbia University, New York, told Yahoo Life.
Dr. Sultan said he was surprised that recreational users had a much higher risk of mental health issues. “We typically think of recreational use as not being a concerning behavior.”
The study did not seek to explain the link between mental health problems and cannabis use.
“The more you use it, the more it negatively affects your thinking. That’s increasing the likelihood of depression and more suicidal thoughts,” Dr. Sultan said. “It’s feedback that spirals downward and gets to a place that really concerns us as child psychiatrists.”
Dr. Sultan said parents should talk to their children about marijuana use, depression, and anxiety.
NIDA and American Academy of Child and Adolescent Psychiatry provided funding for the study. One coauthor reported receiving grants and personal fees from several medical and sports organizations. The other authors reported no conflicts of interest.
A version of this article first appeared on WebMD.com.
Teenagers who use cannabis recreationally are two to three times more likely to have depression and suicidal thoughts than those who don’t use it. And teens who have cannabis use disorder – which means they can’t stop using it despite health and social problems – are four times more likely to have those same thoughts and feelings.
The study was published in JAMA. It looked at information from 68,000 teens in the National Survey on Drug Use and Health.
Marijuana use was also linked to other issues including not doing well in school, skipping school, and getting in trouble with the police.
“Kids, year by year, have been moving towards a view that marijuana is safe and benign – that’s factually incorrect,” lead author of the study, Ryan Sultan, MD, an assistant professor of clinical psychiatry at Columbia University, New York, told Yahoo Life.
Dr. Sultan said he was surprised that recreational users had a much higher risk of mental health issues. “We typically think of recreational use as not being a concerning behavior.”
The study did not seek to explain the link between mental health problems and cannabis use.
“The more you use it, the more it negatively affects your thinking. That’s increasing the likelihood of depression and more suicidal thoughts,” Dr. Sultan said. “It’s feedback that spirals downward and gets to a place that really concerns us as child psychiatrists.”
Dr. Sultan said parents should talk to their children about marijuana use, depression, and anxiety.
NIDA and American Academy of Child and Adolescent Psychiatry provided funding for the study. One coauthor reported receiving grants and personal fees from several medical and sports organizations. The other authors reported no conflicts of interest.
A version of this article first appeared on WebMD.com.
FROM JAMA
FDA clears iLet bionic pancreas insulin delivery system
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.
Working together with a previously cleared integrated continuous glucose monitor (CGM), the entire new system is called the iLet Bionic Pancreas. It differs from current automated insulin delivery (AID) systems in its increased level of automation. The adaptive algorithm is initialized using only the patient’s body weight, without other insulin dosing parameters. Rather than entering specific carbohydrate counts, users only input whether the carbohydrate amount in the meal is “small,” “medium,” or “large.” The algorithm adapts over time to users’ individual 24/7 insulin needs.
Pivotal data for the system were presented in June 2022 at the annual scientific sessions of the American Diabetes Association.
In the 16-center trial involving 440 adults and children 6 years and older with type 1 diabetes, the system reduced hemoglobin A1c by 0.5 percentage points by 13 weeks, without increased hypoglycemia. They spent an average of 2.6 hours more time in range, compared with standard of care (either currently available AIDs, stand-alone pump and CGM devices, or multiple daily injections plus CGM).
The FDA had granted the iLet a breakthrough device designation in December 2019.
Anne L. Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes program, commented on the pivotal study and the system in June 2022. She called the study “cool” because it enrolled more than 25% minority individuals “who aren’t routinely studied in these insulin device trials” and also that it included people with a range of baseline A1c levels, with more than 30% greater than 8%.
Regarding the system’s algorithm, she pointed out that it “doesn’t allow for the individual using the pump to fidget with it. They can’t override the system and they can’t put in other insulin doses. The system is just there to take care of their diabetes.”
That might represent a limitation for some with type 1 diabetes, study coprincipal investigator Roy W. Beck, MD, PhD, said in an interview during the ADA meeting. “The iLet could dramatically reduce type 1 diabetes management burden for many patients, but it might not suit everyone. For example, somebody who’s very compulsive and has an A1c of 6.5% and is used to manipulating what they do, this is probably not a good system for them because the system is kind of taking over.”
On the other hand, Dr. Peters said, “I think what’s important about this system is that it may allow for greater use of automated insulin delivery systems. It may allow primary care providers to use these systems without needing all sorts of support, and patients may be able to use these devices more simply than a device where they have to do carb counting and adjusting in ways that I think tend to be pretty complicated and require higher numeracy and literacy skills.”
The “bionic pancreas” was originally conceived as a dual-hormone system including glucagon delivery as well as insulin. Beta Bionics is continuing to work with the FDA on that front.
A version of this article first appeared on Medscape.com.