Pediatrics

Exposure to “forever chemicals” widely used in consumer products disrupts important biological processes in children and young adults, a new study says.

One key finding was that per- and polyfluoroalkyl substances, or PFAS, hurt thyroid hormone function, which affects growth and metabolism, said the study published in Environmental Health Perspectives. That could leave children vulnerable to numerous diseases later in life, including diabetes, cardiovascular disease, and cancer, the study said.

Another important finding was that the disruption appeared to be caused by a mixture of PFAS, rather than a single chemical of that type.

PFAS are known as “forever chemicals” because they don’t break down easily over time and persist in water, soil, and the body. They’re used in numerous consumer products, such as nonstick cookware, stain-resistant carpeting, cosmetics, and water-repellent clothing.

PFAS have previously been linked to a host of health issues, including decreased birth weights and immune system problems. To the study authors’ knowledge, this study is the first to evaluate which biological processes are altered by exposure to multiple PFAS, said a news release from the University of Southern California, Los Angeles.

Researchers studied blood samples from 312 children from the Study of Latino Adolescents at Risk and 137 children from the Southern California Children’s Health Study. All the children had a mixture of common PFAS in their blood, including PFOS, PFHxS, PFHpS, PFOA, and PFNA.

“While current interventions have focused on phasing out the use of individual PFAS, such as PFOS and PFOA, this research shows why the focus should be on reducing exposure to all PFAS chemicals,” said Leda Chatzi, MD, a professor of population and public health sciences at the University of Southern California, Los Angeles. Dr. Chatzi is also one of the study authors.

In October 2021, the Biden administration announced a plan to reduce the amount of PFAS released into the air, drinking and ground water, and food supply chain.

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

Exposure to “forever chemicals” widely used in consumer products disrupts important biological processes in children and young adults, a new study says.

One key finding was that per- and polyfluoroalkyl substances, or PFAS, hurt thyroid hormone function, which affects growth and metabolism, said the study published in Environmental Health Perspectives. That could leave children vulnerable to numerous diseases later in life, including diabetes, cardiovascular disease, and cancer, the study said.

Another important finding was that the disruption appeared to be caused by a mixture of PFAS, rather than a single chemical of that type.

PFAS are known as “forever chemicals” because they don’t break down easily over time and persist in water, soil, and the body. They’re used in numerous consumer products, such as nonstick cookware, stain-resistant carpeting, cosmetics, and water-repellent clothing.

PFAS have previously been linked to a host of health issues, including decreased birth weights and immune system problems. To the study authors’ knowledge, this study is the first to evaluate which biological processes are altered by exposure to multiple PFAS, said a news release from the University of Southern California, Los Angeles.

Researchers studied blood samples from 312 children from the Study of Latino Adolescents at Risk and 137 children from the Southern California Children’s Health Study. All the children had a mixture of common PFAS in their blood, including PFOS, PFHxS, PFHpS, PFOA, and PFNA.

“While current interventions have focused on phasing out the use of individual PFAS, such as PFOS and PFOA, this research shows why the focus should be on reducing exposure to all PFAS chemicals,” said Leda Chatzi, MD, a professor of population and public health sciences at the University of Southern California, Los Angeles. Dr. Chatzi is also one of the study authors.

In October 2021, the Biden administration announced a plan to reduce the amount of PFAS released into the air, drinking and ground water, and food supply chain.

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

Exposure to “forever chemicals” widely used in consumer products disrupts important biological processes in children and young adults, a new study says.

One key finding was that per- and polyfluoroalkyl substances, or PFAS, hurt thyroid hormone function, which affects growth and metabolism, said the study published in Environmental Health Perspectives. That could leave children vulnerable to numerous diseases later in life, including diabetes, cardiovascular disease, and cancer, the study said.

Another important finding was that the disruption appeared to be caused by a mixture of PFAS, rather than a single chemical of that type.

PFAS are known as “forever chemicals” because they don’t break down easily over time and persist in water, soil, and the body. They’re used in numerous consumer products, such as nonstick cookware, stain-resistant carpeting, cosmetics, and water-repellent clothing.

PFAS have previously been linked to a host of health issues, including decreased birth weights and immune system problems. To the study authors’ knowledge, this study is the first to evaluate which biological processes are altered by exposure to multiple PFAS, said a news release from the University of Southern California, Los Angeles.

Researchers studied blood samples from 312 children from the Study of Latino Adolescents at Risk and 137 children from the Southern California Children’s Health Study. All the children had a mixture of common PFAS in their blood, including PFOS, PFHxS, PFHpS, PFOA, and PFNA.

“While current interventions have focused on phasing out the use of individual PFAS, such as PFOS and PFOA, this research shows why the focus should be on reducing exposure to all PFAS chemicals,” said Leda Chatzi, MD, a professor of population and public health sciences at the University of Southern California, Los Angeles. Dr. Chatzi is also one of the study authors.

In October 2021, the Biden administration announced a plan to reduce the amount of PFAS released into the air, drinking and ground water, and food supply chain.

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

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

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].

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

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].

Last night I invested an hour and a half watching the first half of the Super Bowl ... because ... well, just because. As exciting as it might have been to watch, investing another 2 hours on the second half would have kept me up well past my bedtime. As I lay in bed with the thwack-thwack-thud of helmets hitting pads still reverberating in my ears, my thoughts drifted to the ever-shifting landscape of concussion management.

More than 2 decades ago, concussions were just beginning to exit the dark ages when loss of consciousness was the defining symptom or sign that most folks (and here I am including physicians) used to separate the run-of-the-mill stinger or bell-ringer from a “real” concussion.

The new era dawned with the appearance of clinics devoted to concussion management and the development of protocols that limited everything from physical exertion to reading and screen time. Schools were coaxed into subjecting their athletes to preparticipation testing sessions with the hope that creating a baseline cognitive assessment would somehow make the diagnosis and management of concussion feel more scientific. Many of the recommended management strategies were based on the intuitive but flawed notion of “brain rest.” If reading or bright lights aggravate patient’s symptoms, they should be avoided but otherwise resting the brain doesn’t seem to make sense.

Fortunately, there were, and hopefully will continue to be, clinicians willing to question hastily developed management protocols. One recent cohort study from Canada has found that, surprisingly, (to some experts), “early return to school was associated with a lower symptom burden” This association held true for both age groups the researches studied (8-12 years and 13-18 years). The authors conclude that delayed return to school “may be detrimental to recovery.” In this study, early return to school was defined as less than 3 days.

In another study, this one in the journal Pediatrics, the authors found that “the association of early screen time with postconcussion symptoms is not linear.” Their conclusion was that the best approach to clinical management of concussion should include a moderate amount of screen time.

After reading both of these studies I am heartened that we are now hearing voices suggesting a return to concussion management based on careful observation of the individual patient and common sense. A concussed brain is not a torn hamstring or a broken clavicle that under most circumstances will heal in a predictable amount of time. It is prudent to exclude the concussed patient from activities that carry a significant risk of reinjury until the symptoms have subsided. However, postconcussion symptoms are often vague and can be mistaken for or aggravated by a host of other conditions including learning disabilities, anxiety, and depression.

I hope that our experience with the COVID pandemic has taught us that removing children from school and their usual activities can have a serious negative effect on their emotional health and academic achievement. This seems to be particularly true for the young people who were already struggling to adjust to being a student. Getting out of the habit of going to school often intensifies the anxieties of an emotionally or academically challenged student. Each day away from the school atmosphere can compound the symptoms that may or may not have been triggered by the concussion.

The message here is clear that, whether we are talking about concussions or appendectomies or mononucleosis, the sooner we can return the child to something close to their old normal the more successful we will be in a helping them adjust to the new normal.

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].

More than 1 in 5 children worldwide are at risk of developing an eating disorder such as bulimia, anorexia, or binge eating, a new analysis suggests.

The study was published in the journal JAMA Pediatrics. Researchers analyzed data for 63,181 adolescents 6-18 years old from 16 countries to look for what is called “disordered eating.” None of the children included in the study had diagnosed physical or mental disorders, and data were not included from the COVID-19 time period.

The researchers examined results from a widely used standardized eating disorder questionnaire called the Sick, Control, One, Fat, Food (SCOFF). When someone answers yes to two or more of the questions, the person is considered to have disordered eating, which “denotes a suspicion of an existing eating disorder,” the researchers write. The five questions are:

• Do you make yourself sick because you feel uncomfortably full?
• Do you worry you have lost control over how much you eat?
• Have you recently lost more than 14 pounds in a 3-month period?
• Do you believe yourself to be fat when others say you are too thin?
• Would you say that food dominates your life?

Overall, 22% of children replied yes to two or more of the questions. The proportion of children with disordered eating is likely even higher, the researchers explain, because children may hide symptoms “due to feelings of shame or stigmatization.”

The findings are a dramatic shift from the estimation that 2.7% of people ages 13-18 have an eating disorder during their adolescent years.

In this latest study, disordered eating was more common among girls, older children, and those with a higher body mass index, or BMI, which is a combined measure of height and weight.

The analysis showed that 30% of girls had disordered eating, compared with 17% of boys. When looking at responses by age, the proportion of kids with disordered eating increased by 20 percentage points between the ages of 10 and 18.

The findings regarding children who already have a high BMI confirms previous research that many of those children are already following disordered eating behaviors while trying to lose weight, the authors write.

“Although most adolescents who develop an eating disorder do not report prior excess weight problems, some adolescents could misinterpret what eating healthy consists of and engage in unhealthy behaviors (for instance, skipping meals to generate a caloric deficit), which could then lead to development of an eating disorder,” the researchers explain.

The study points to the need for parents, caregivers, and health care professionals to be on the lookout for disordered eating symptoms in children because they are linked to the risk of developing a clinical eating disorder. The symptoms to watch for include behaviors such as weight loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics, the researchers write.

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

More than 1 in 5 children worldwide are at risk of developing an eating disorder such as bulimia, anorexia, or binge eating, a new analysis suggests.

The study was published in the journal JAMA Pediatrics. Researchers analyzed data for 63,181 adolescents 6-18 years old from 16 countries to look for what is called “disordered eating.” None of the children included in the study had diagnosed physical or mental disorders, and data were not included from the COVID-19 time period.

The researchers examined results from a widely used standardized eating disorder questionnaire called the Sick, Control, One, Fat, Food (SCOFF). When someone answers yes to two or more of the questions, the person is considered to have disordered eating, which “denotes a suspicion of an existing eating disorder,” the researchers write. The five questions are:

• Do you make yourself sick because you feel uncomfortably full?
• Do you worry you have lost control over how much you eat?
• Have you recently lost more than 14 pounds in a 3-month period?
• Do you believe yourself to be fat when others say you are too thin?
• Would you say that food dominates your life?

Overall, 22% of children replied yes to two or more of the questions. The proportion of children with disordered eating is likely even higher, the researchers explain, because children may hide symptoms “due to feelings of shame or stigmatization.”

The findings are a dramatic shift from the estimation that 2.7% of people ages 13-18 have an eating disorder during their adolescent years.

In this latest study, disordered eating was more common among girls, older children, and those with a higher body mass index, or BMI, which is a combined measure of height and weight.

The analysis showed that 30% of girls had disordered eating, compared with 17% of boys. When looking at responses by age, the proportion of kids with disordered eating increased by 20 percentage points between the ages of 10 and 18.

The findings regarding children who already have a high BMI confirms previous research that many of those children are already following disordered eating behaviors while trying to lose weight, the authors write.

“Although most adolescents who develop an eating disorder do not report prior excess weight problems, some adolescents could misinterpret what eating healthy consists of and engage in unhealthy behaviors (for instance, skipping meals to generate a caloric deficit), which could then lead to development of an eating disorder,” the researchers explain.

The study points to the need for parents, caregivers, and health care professionals to be on the lookout for disordered eating symptoms in children because they are linked to the risk of developing a clinical eating disorder. The symptoms to watch for include behaviors such as weight loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics, the researchers write.

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

More than 1 in 5 children worldwide are at risk of developing an eating disorder such as bulimia, anorexia, or binge eating, a new analysis suggests.

The study was published in the journal JAMA Pediatrics. Researchers analyzed data for 63,181 adolescents 6-18 years old from 16 countries to look for what is called “disordered eating.” None of the children included in the study had diagnosed physical or mental disorders, and data were not included from the COVID-19 time period.

The researchers examined results from a widely used standardized eating disorder questionnaire called the Sick, Control, One, Fat, Food (SCOFF). When someone answers yes to two or more of the questions, the person is considered to have disordered eating, which “denotes a suspicion of an existing eating disorder,” the researchers write. The five questions are:

• Do you make yourself sick because you feel uncomfortably full?
• Do you worry you have lost control over how much you eat?
• Have you recently lost more than 14 pounds in a 3-month period?
• Do you believe yourself to be fat when others say you are too thin?
• Would you say that food dominates your life?

Overall, 22% of children replied yes to two or more of the questions. The proportion of children with disordered eating is likely even higher, the researchers explain, because children may hide symptoms “due to feelings of shame or stigmatization.”

The findings are a dramatic shift from the estimation that 2.7% of people ages 13-18 have an eating disorder during their adolescent years.

In this latest study, disordered eating was more common among girls, older children, and those with a higher body mass index, or BMI, which is a combined measure of height and weight.

The analysis showed that 30% of girls had disordered eating, compared with 17% of boys. When looking at responses by age, the proportion of kids with disordered eating increased by 20 percentage points between the ages of 10 and 18.

The findings regarding children who already have a high BMI confirms previous research that many of those children are already following disordered eating behaviors while trying to lose weight, the authors write.

“Although most adolescents who develop an eating disorder do not report prior excess weight problems, some adolescents could misinterpret what eating healthy consists of and engage in unhealthy behaviors (for instance, skipping meals to generate a caloric deficit), which could then lead to development of an eating disorder,” the researchers explain.

The study points to the need for parents, caregivers, and health care professionals to be on the lookout for disordered eating symptoms in children because they are linked to the risk of developing a clinical eating disorder. The symptoms to watch for include behaviors such as weight loss dieting, binge eating, self-induced vomiting, excessive exercise, and the use of laxatives or diuretics, the researchers write.

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

While most providers think that biosimilars will positively impact care, few feel that the economic benefits of biosimilars to date are enough to motivate switching.

Fuse/Thinkstock

In a new survey of over 350 dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, clinicians shared their opinions on the rapidly evolving landscape of biosimilars, detailing top concerns about prescribing these medications and how they presently use biosimilars in clinical practice. Across all specialties, providers said they would be most likely to prescribe biosimilars to new patients or if a patient’s health plan mandated the switch. Most providers listed concerns about biosimilar efficacy and lack of economic benefit as the main barriers to adoption of biosimilars in clinical practice.

Cardinal Health, a health care services company based in Dublin, Ohio, conducted the surveys from July through October 2022.
 

Rheumatologists want cost-savings for patients

2023 is gearing up to be a big year for biosimilars for inflammatory diseases, with at least eight adalimumab biosimilars entering the market in the United States. Amjevita, manufactured by Amgen, was the first to become commercially available on Jan. 31. Out of 103 surveyed rheumatologists, 62% said they were very comfortable prescribing biosimilars to patients, and 32% said they were somewhat comfortable. Providers said they would be most likely to prescribe a biosimilar to new patients (40%) or if biosimilars were mandated by a patient’s health plan (41%). Nearly one-third (31%) of rheumatologists said that a discount of 21%-30% from a reference product would be necessary to consider switching a patient to a biosimilar.

There are several reasons why a rheumatologist might be wary of switching patients to biosimilars, said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “Rheumatologists will always express concern about changing medications that work well for their patients. It is not ideal to ‘force switch’ to a different product, even if it is almost identical,” he told this news organization in an email. “Also, we must remember that a patient on a biologic has failed traditional medications, which speaks to the struggle a patient must endure to get their disease under control. Fail-first situations can cause a rheumatologist to be initially resistant or hesitant to any changes.”

The top concerns among rheumatologists about prescribing biosimilars were medication efficacy (36%), lack of economic benefit (24%), and evaluating when to prescribe a biosimilar versus a reference product (17%). For adalimumab biosimilars, rheumatologists said that interchangeability – a regulatory designation where a biosimilar can be automatically substituted for its reference product at the pharmacy – and citrate-free formulation were the most important product attributes. Sixty-four percent of providers also noted that patient out-of-pocket cost would be key when deciding to prescribe an adalimumab biosimilar.

“There needs to be a true reduction in price, to change providers’ opinions on the economic benefits of biosimilars – in the system generally and for the patient,” Dr. Snow said. “Things will get there eventually, but it is not there yet, based on the list prices we see for some biosimilars.”
 

Gastroenterologists emphasize patient education

Gastroenterology is another specialty to be affected by the influx of adalimumab biosimilars. Out of 72 surveyed gastroenterologists, 86% said they were very comfortable prescribing biosimilars. About half (49%) said they would be most likely to prescribe a biosimilar to patients with health plans mandating a biosimilar. More than 60% of surveyed gastroenterologists said that biosimilars would positively impact care; providers were divided on the current economic benefits of biosimilars, with 36% saying that the current discounts on biosimilars versus reference products were not favorable enough to motivate switching, and 35% stating that they were. A total of 40% of surveyed providers said that savings of 21%-30%, compared with savings of a reference product, would motivate them to switch patients to a biosimilar, with all other clinical factors being equal.

Gastroenterologists said that, along with the efficacy and cost savings of biosimilars, providing patient education (18%) was a top concern when prescribing biosimilars. Eighty-four percent of respondents said that educating patients about biosimilars as safe and effective treatment options was at least somewhat important. Nearly all participants (99%) cited device ease-of-use as at least somewhat important when considering prescribing adalimumab biosimilars, in addition to interchangeability (97%) and citrate-free formulation (93%).

“Despite general acceptance of biosimilars, there remains some uncertainty regarding their place in the current gastroenterology landscape,” wrote Vivek Kaul, MD, a professor of medicine at the University of Rochester (N.Y.) Medical Center, in the report. “This is likely because only half of the survey respondents believed that biosimilars will positively impact gastroenterology care, further highlighting the ongoing need for real-world data and incorporation of biosimilar use and interchangeability into clinical guidelines.”

Few dermatologists currently prescribe biosimilars

Eight out of ten dermatologists reported being at least somewhat comfortable prescribing biosimilars to patients, though fewer than 20% said they had prescribed a biosimilar in the past year. This indicates limited adoption of infliximab biosimilars, which were the only biosimilars with a dermatologic indication available in 2022, Alex Gross, MD, a dermatologist in Cumming, Ga., noted in his featured commentary in the report. Just 15% of respondents disagreed that biosimilars would have a positive impact on care, and 41% said they were excited about new biosimilars becoming available.

About half (47%) of dermatologists thought the economic benefits of biosimilars were not strong enough to motivate switching patients from reference products. Twenty-nine percent of respondents said that discounts of 21%-30% from a reference product would motivate them to switch patients to a biosimilar, with all other clinical factors being equal, while 20% said they were not likely to prescribe a biosimilar regardless of savings.

Dermatologists may be concerned that these cost savings may not be passed onto patients, said Alison Ehrlich, MD, a dermatologist in Washington, in an email to this news organization. Patient out-of-pocket cost savings would need to be “both significant and transparent” to begin to change providers’ minds, she noted.

Biosimilar efficacy was a top concern for 48% of dermatologists, while 13% said their main concern around prescribing biosimilars was lack of payer adoption. At least 95% of providers said that device ease-of-use and interchangeability were the most important attributes when considering adalimumab biosimilars. Nearly two-thirds (65%) reported that patient out-of-pocket cost would be key when deciding to prescribe an adalimumab biosimilar.

If both patients and providers are informed on biosimilar use and there are cost benefits, dermatologists’ opinions may become more favorable toward biosimilars, but that will take time, Dr. Ehrlich said. “We are very early in the game for biosimilar use in dermatology,” she added.
 

Ophthalmologists remain wary

Biosimilars have been relatively new to ophthalmology, with the first ranibizumab biosimilar becoming commercially available in July 2022. In the survey, 64 retina specialists were asked different questions than participants from other specialties to gauge ophthalmologists› familiarity with the biosimilars approval process and their overall comfort prescribing these medications. The primary concerns with prescribing biosimilars among respondents was payer coverage (52%), being uncomfortable with biosimilars from a clinical standpoint (48%), and administrative barriers (45%), such as prior authorization. Despite this lack of comfort with biosimilars, two-thirds of participants thought the U.S. Food and Drug Administration approval process for these medications was sufficient to evaluate their efficacy and safety. Still, fewer than half (48%) of providers said they do or would prescribe biosimilars.

George Williams, MD, a spokesperson for the American Academy of Ophthalmology, noted that the FDA approval process for biosimilars was not as rigorous as for the respective reference product, and fewer patients are followed over a shorter time period. “Since anti–[vascular endothelial growth factor (VEGF)] therapy for indications such as neovascular age-related macular degeneration continues indefinitely over years, ophthalmologists may have concerns about the long-term efficacy and safety when applied to larger real-world populations. Ophthalmologists are well aware of safety issues with VEGF inhibitors arising after FDA approval,” he told this news organization in an email.

When asked about the likelihood of using either aflibercept or ranibizumab biosimilars in their clinical practice once commercially available, 70% of ophthalmologists said they would be at least somewhat likely to prescribe aflibercept biosimilars, and 64% said they would be at least somewhat likely to prescribe ranibizumab biosimilars. About half of respondents said they would not likely switch a currently stable patient on either aflibercept or ranibizumab to the corresponding biosimilar. More than half of ophthalmologists (56%) said they would prescribe a biosimilar only if it had an interchangeability designation.

Out of all four specialties, ophthalmologists more frequently reported that higher discounts from a reference product would be necessary to consider switching a patient to a biosimilar. Currently, many ophthalmologists are comfortable with the off-label use of bevacizumab (Avastin) for treating wet age-related macular degeneration, which also offers more cost savings than any currently available biosimilar on the market, Dr. Williams said.

While the limited number of respondents makes it difficult to draw concrete conclusions, Dr. Williams emphasized that the AAO supported the use of biosimilars. “We believe that with clinical experience ophthalmic biosimilars will become useful therapeutic agents,” he noted.

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

While most providers think that biosimilars will positively impact care, few feel that the economic benefits of biosimilars to date are enough to motivate switching.

Fuse/Thinkstock

In a new survey of over 350 dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, clinicians shared their opinions on the rapidly evolving landscape of biosimilars, detailing top concerns about prescribing these medications and how they presently use biosimilars in clinical practice. Across all specialties, providers said they would be most likely to prescribe biosimilars to new patients or if a patient’s health plan mandated the switch. Most providers listed concerns about biosimilar efficacy and lack of economic benefit as the main barriers to adoption of biosimilars in clinical practice.

Cardinal Health, a health care services company based in Dublin, Ohio, conducted the surveys from July through October 2022.
 

Rheumatologists want cost-savings for patients

2023 is gearing up to be a big year for biosimilars for inflammatory diseases, with at least eight adalimumab biosimilars entering the market in the United States. Amjevita, manufactured by Amgen, was the first to become commercially available on Jan. 31. Out of 103 surveyed rheumatologists, 62% said they were very comfortable prescribing biosimilars to patients, and 32% said they were somewhat comfortable. Providers said they would be most likely to prescribe a biosimilar to new patients (40%) or if biosimilars were mandated by a patient’s health plan (41%). Nearly one-third (31%) of rheumatologists said that a discount of 21%-30% from a reference product would be necessary to consider switching a patient to a biosimilar.

There are several reasons why a rheumatologist might be wary of switching patients to biosimilars, said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “Rheumatologists will always express concern about changing medications that work well for their patients. It is not ideal to ‘force switch’ to a different product, even if it is almost identical,” he told this news organization in an email. “Also, we must remember that a patient on a biologic has failed traditional medications, which speaks to the struggle a patient must endure to get their disease under control. Fail-first situations can cause a rheumatologist to be initially resistant or hesitant to any changes.”

The top concerns among rheumatologists about prescribing biosimilars were medication efficacy (36%), lack of economic benefit (24%), and evaluating when to prescribe a biosimilar versus a reference product (17%). For adalimumab biosimilars, rheumatologists said that interchangeability – a regulatory designation where a biosimilar can be automatically substituted for its reference product at the pharmacy – and citrate-free formulation were the most important product attributes. Sixty-four percent of providers also noted that patient out-of-pocket cost would be key when deciding to prescribe an adalimumab biosimilar.

“There needs to be a true reduction in price, to change providers’ opinions on the economic benefits of biosimilars – in the system generally and for the patient,” Dr. Snow said. “Things will get there eventually, but it is not there yet, based on the list prices we see for some biosimilars.”
 

Gastroenterologists emphasize patient education

Gastroenterology is another specialty to be affected by the influx of adalimumab biosimilars. Out of 72 surveyed gastroenterologists, 86% said they were very comfortable prescribing biosimilars. About half (49%) said they would be most likely to prescribe a biosimilar to patients with health plans mandating a biosimilar. More than 60% of surveyed gastroenterologists said that biosimilars would positively impact care; providers were divided on the current economic benefits of biosimilars, with 36% saying that the current discounts on biosimilars versus reference products were not favorable enough to motivate switching, and 35% stating that they were. A total of 40% of surveyed providers said that savings of 21%-30%, compared with savings of a reference product, would motivate them to switch patients to a biosimilar, with all other clinical factors being equal.

Gastroenterologists said that, along with the efficacy and cost savings of biosimilars, providing patient education (18%) was a top concern when prescribing biosimilars. Eighty-four percent of respondents said that educating patients about biosimilars as safe and effective treatment options was at least somewhat important. Nearly all participants (99%) cited device ease-of-use as at least somewhat important when considering prescribing adalimumab biosimilars, in addition to interchangeability (97%) and citrate-free formulation (93%).

“Despite general acceptance of biosimilars, there remains some uncertainty regarding their place in the current gastroenterology landscape,” wrote Vivek Kaul, MD, a professor of medicine at the University of Rochester (N.Y.) Medical Center, in the report. “This is likely because only half of the survey respondents believed that biosimilars will positively impact gastroenterology care, further highlighting the ongoing need for real-world data and incorporation of biosimilar use and interchangeability into clinical guidelines.”

Few dermatologists currently prescribe biosimilars

Eight out of ten dermatologists reported being at least somewhat comfortable prescribing biosimilars to patients, though fewer than 20% said they had prescribed a biosimilar in the past year. This indicates limited adoption of infliximab biosimilars, which were the only biosimilars with a dermatologic indication available in 2022, Alex Gross, MD, a dermatologist in Cumming, Ga., noted in his featured commentary in the report. Just 15% of respondents disagreed that biosimilars would have a positive impact on care, and 41% said they were excited about new biosimilars becoming available.

About half (47%) of dermatologists thought the economic benefits of biosimilars were not strong enough to motivate switching patients from reference products. Twenty-nine percent of respondents said that discounts of 21%-30% from a reference product would motivate them to switch patients to a biosimilar, with all other clinical factors being equal, while 20% said they were not likely to prescribe a biosimilar regardless of savings.

Dermatologists may be concerned that these cost savings may not be passed onto patients, said Alison Ehrlich, MD, a dermatologist in Washington, in an email to this news organization. Patient out-of-pocket cost savings would need to be “both significant and transparent” to begin to change providers’ minds, she noted.

Biosimilar efficacy was a top concern for 48% of dermatologists, while 13% said their main concern around prescribing biosimilars was lack of payer adoption. At least 95% of providers said that device ease-of-use and interchangeability were the most important attributes when considering adalimumab biosimilars. Nearly two-thirds (65%) reported that patient out-of-pocket cost would be key when deciding to prescribe an adalimumab biosimilar.

If both patients and providers are informed on biosimilar use and there are cost benefits, dermatologists’ opinions may become more favorable toward biosimilars, but that will take time, Dr. Ehrlich said. “We are very early in the game for biosimilar use in dermatology,” she added.
 

Ophthalmologists remain wary

Biosimilars have been relatively new to ophthalmology, with the first ranibizumab biosimilar becoming commercially available in July 2022. In the survey, 64 retina specialists were asked different questions than participants from other specialties to gauge ophthalmologists› familiarity with the biosimilars approval process and their overall comfort prescribing these medications. The primary concerns with prescribing biosimilars among respondents was payer coverage (52%), being uncomfortable with biosimilars from a clinical standpoint (48%), and administrative barriers (45%), such as prior authorization. Despite this lack of comfort with biosimilars, two-thirds of participants thought the U.S. Food and Drug Administration approval process for these medications was sufficient to evaluate their efficacy and safety. Still, fewer than half (48%) of providers said they do or would prescribe biosimilars.

George Williams, MD, a spokesperson for the American Academy of Ophthalmology, noted that the FDA approval process for biosimilars was not as rigorous as for the respective reference product, and fewer patients are followed over a shorter time period. “Since anti–[vascular endothelial growth factor (VEGF)] therapy for indications such as neovascular age-related macular degeneration continues indefinitely over years, ophthalmologists may have concerns about the long-term efficacy and safety when applied to larger real-world populations. Ophthalmologists are well aware of safety issues with VEGF inhibitors arising after FDA approval,” he told this news organization in an email.

When asked about the likelihood of using either aflibercept or ranibizumab biosimilars in their clinical practice once commercially available, 70% of ophthalmologists said they would be at least somewhat likely to prescribe aflibercept biosimilars, and 64% said they would be at least somewhat likely to prescribe ranibizumab biosimilars. About half of respondents said they would not likely switch a currently stable patient on either aflibercept or ranibizumab to the corresponding biosimilar. More than half of ophthalmologists (56%) said they would prescribe a biosimilar only if it had an interchangeability designation.

Out of all four specialties, ophthalmologists more frequently reported that higher discounts from a reference product would be necessary to consider switching a patient to a biosimilar. Currently, many ophthalmologists are comfortable with the off-label use of bevacizumab (Avastin) for treating wet age-related macular degeneration, which also offers more cost savings than any currently available biosimilar on the market, Dr. Williams said.

While the limited number of respondents makes it difficult to draw concrete conclusions, Dr. Williams emphasized that the AAO supported the use of biosimilars. “We believe that with clinical experience ophthalmic biosimilars will become useful therapeutic agents,” he noted.

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

While most providers think that biosimilars will positively impact care, few feel that the economic benefits of biosimilars to date are enough to motivate switching.

Fuse/Thinkstock

In a new survey of over 350 dermatologists, gastroenterologists, ophthalmologists, and rheumatologists, clinicians shared their opinions on the rapidly evolving landscape of biosimilars, detailing top concerns about prescribing these medications and how they presently use biosimilars in clinical practice. Across all specialties, providers said they would be most likely to prescribe biosimilars to new patients or if a patient’s health plan mandated the switch. Most providers listed concerns about biosimilar efficacy and lack of economic benefit as the main barriers to adoption of biosimilars in clinical practice.

Cardinal Health, a health care services company based in Dublin, Ohio, conducted the surveys from July through October 2022.
 

Rheumatologists want cost-savings for patients

2023 is gearing up to be a big year for biosimilars for inflammatory diseases, with at least eight adalimumab biosimilars entering the market in the United States. Amjevita, manufactured by Amgen, was the first to become commercially available on Jan. 31. Out of 103 surveyed rheumatologists, 62% said they were very comfortable prescribing biosimilars to patients, and 32% said they were somewhat comfortable. Providers said they would be most likely to prescribe a biosimilar to new patients (40%) or if biosimilars were mandated by a patient’s health plan (41%). Nearly one-third (31%) of rheumatologists said that a discount of 21%-30% from a reference product would be necessary to consider switching a patient to a biosimilar.

There are several reasons why a rheumatologist might be wary of switching patients to biosimilars, said Marcus Snow, MD, chair of the American College of Rheumatology’s Committee on Rheumatologic Care. “Rheumatologists will always express concern about changing medications that work well for their patients. It is not ideal to ‘force switch’ to a different product, even if it is almost identical,” he told this news organization in an email. “Also, we must remember that a patient on a biologic has failed traditional medications, which speaks to the struggle a patient must endure to get their disease under control. Fail-first situations can cause a rheumatologist to be initially resistant or hesitant to any changes.”

The top concerns among rheumatologists about prescribing biosimilars were medication efficacy (36%), lack of economic benefit (24%), and evaluating when to prescribe a biosimilar versus a reference product (17%). For adalimumab biosimilars, rheumatologists said that interchangeability – a regulatory designation where a biosimilar can be automatically substituted for its reference product at the pharmacy – and citrate-free formulation were the most important product attributes. Sixty-four percent of providers also noted that patient out-of-pocket cost would be key when deciding to prescribe an adalimumab biosimilar.

“There needs to be a true reduction in price, to change providers’ opinions on the economic benefits of biosimilars – in the system generally and for the patient,” Dr. Snow said. “Things will get there eventually, but it is not there yet, based on the list prices we see for some biosimilars.”
 

Gastroenterologists emphasize patient education

Gastroenterology is another specialty to be affected by the influx of adalimumab biosimilars. Out of 72 surveyed gastroenterologists, 86% said they were very comfortable prescribing biosimilars. About half (49%) said they would be most likely to prescribe a biosimilar to patients with health plans mandating a biosimilar. More than 60% of surveyed gastroenterologists said that biosimilars would positively impact care; providers were divided on the current economic benefits of biosimilars, with 36% saying that the current discounts on biosimilars versus reference products were not favorable enough to motivate switching, and 35% stating that they were. A total of 40% of surveyed providers said that savings of 21%-30%, compared with savings of a reference product, would motivate them to switch patients to a biosimilar, with all other clinical factors being equal.

Gastroenterologists said that, along with the efficacy and cost savings of biosimilars, providing patient education (18%) was a top concern when prescribing biosimilars. Eighty-four percent of respondents said that educating patients about biosimilars as safe and effective treatment options was at least somewhat important. Nearly all participants (99%) cited device ease-of-use as at least somewhat important when considering prescribing adalimumab biosimilars, in addition to interchangeability (97%) and citrate-free formulation (93%).

“Despite general acceptance of biosimilars, there remains some uncertainty regarding their place in the current gastroenterology landscape,” wrote Vivek Kaul, MD, a professor of medicine at the University of Rochester (N.Y.) Medical Center, in the report. “This is likely because only half of the survey respondents believed that biosimilars will positively impact gastroenterology care, further highlighting the ongoing need for real-world data and incorporation of biosimilar use and interchangeability into clinical guidelines.”

Few dermatologists currently prescribe biosimilars

Eight out of ten dermatologists reported being at least somewhat comfortable prescribing biosimilars to patients, though fewer than 20% said they had prescribed a biosimilar in the past year. This indicates limited adoption of infliximab biosimilars, which were the only biosimilars with a dermatologic indication available in 2022, Alex Gross, MD, a dermatologist in Cumming, Ga., noted in his featured commentary in the report. Just 15% of respondents disagreed that biosimilars would have a positive impact on care, and 41% said they were excited about new biosimilars becoming available.

About half (47%) of dermatologists thought the economic benefits of biosimilars were not strong enough to motivate switching patients from reference products. Twenty-nine percent of respondents said that discounts of 21%-30% from a reference product would motivate them to switch patients to a biosimilar, with all other clinical factors being equal, while 20% said they were not likely to prescribe a biosimilar regardless of savings.

Dermatologists may be concerned that these cost savings may not be passed onto patients, said Alison Ehrlich, MD, a dermatologist in Washington, in an email to this news organization. Patient out-of-pocket cost savings would need to be “both significant and transparent” to begin to change providers’ minds, she noted.

Biosimilar efficacy was a top concern for 48% of dermatologists, while 13% said their main concern around prescribing biosimilars was lack of payer adoption. At least 95% of providers said that device ease-of-use and interchangeability were the most important attributes when considering adalimumab biosimilars. Nearly two-thirds (65%) reported that patient out-of-pocket cost would be key when deciding to prescribe an adalimumab biosimilar.

If both patients and providers are informed on biosimilar use and there are cost benefits, dermatologists’ opinions may become more favorable toward biosimilars, but that will take time, Dr. Ehrlich said. “We are very early in the game for biosimilar use in dermatology,” she added.
 

Ophthalmologists remain wary

Biosimilars have been relatively new to ophthalmology, with the first ranibizumab biosimilar becoming commercially available in July 2022. In the survey, 64 retina specialists were asked different questions than participants from other specialties to gauge ophthalmologists› familiarity with the biosimilars approval process and their overall comfort prescribing these medications. The primary concerns with prescribing biosimilars among respondents was payer coverage (52%), being uncomfortable with biosimilars from a clinical standpoint (48%), and administrative barriers (45%), such as prior authorization. Despite this lack of comfort with biosimilars, two-thirds of participants thought the U.S. Food and Drug Administration approval process for these medications was sufficient to evaluate their efficacy and safety. Still, fewer than half (48%) of providers said they do or would prescribe biosimilars.

George Williams, MD, a spokesperson for the American Academy of Ophthalmology, noted that the FDA approval process for biosimilars was not as rigorous as for the respective reference product, and fewer patients are followed over a shorter time period. “Since anti–[vascular endothelial growth factor (VEGF)] therapy for indications such as neovascular age-related macular degeneration continues indefinitely over years, ophthalmologists may have concerns about the long-term efficacy and safety when applied to larger real-world populations. Ophthalmologists are well aware of safety issues with VEGF inhibitors arising after FDA approval,” he told this news organization in an email.

When asked about the likelihood of using either aflibercept or ranibizumab biosimilars in their clinical practice once commercially available, 70% of ophthalmologists said they would be at least somewhat likely to prescribe aflibercept biosimilars, and 64% said they would be at least somewhat likely to prescribe ranibizumab biosimilars. About half of respondents said they would not likely switch a currently stable patient on either aflibercept or ranibizumab to the corresponding biosimilar. More than half of ophthalmologists (56%) said they would prescribe a biosimilar only if it had an interchangeability designation.

Out of all four specialties, ophthalmologists more frequently reported that higher discounts from a reference product would be necessary to consider switching a patient to a biosimilar. Currently, many ophthalmologists are comfortable with the off-label use of bevacizumab (Avastin) for treating wet age-related macular degeneration, which also offers more cost savings than any currently available biosimilar on the market, Dr. Williams said.

While the limited number of respondents makes it difficult to draw concrete conclusions, Dr. Williams emphasized that the AAO supported the use of biosimilars. “We believe that with clinical experience ophthalmic biosimilars will become useful therapeutic agents,” he noted.

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

Youth with type 1 diabetes who use real-time continuous glucose monitoring (rtCGM) and an insulin pump spend more time in target glucose range than do those using intermittently scanned CGM (isCGM) and/or multiple daily insulin injections, new data show.

In the multinational cohort study of more than 4,500 people younger than age 21 with type 1 diabetes, those using rtCGM and pumps also spent less time above and below glucose targets and had fewer severe adverse events – either severe hypoglycemia or diabetic ketoacidosis (DKA) – compared with injections and isCGM.

Daria Nipot/Getty Images

The findings were published online in JAMA Network Open by Klemen Dovc, MD, PhD, assistant professor in the department of pediatric endocrinology, diabetes, and metabolic diseases, University Children’s Hospital, Ljubljana, Slovenia, and colleagues.

“These results underscore the synergistic effect of advanced diabetes technologies that should be more readily available to youths with type 1 diabetes for further improvement of diabetes-related clinical outcomes,” the authors wrote.

Moreover, Dr. Dovc told this news organization: “Clinicians should be aware that there may be differences in effectiveness between different types of devices, and that choosing the right device for each individual may be important for achieving optimal outcomes.”
 

Real-time CGM + insulin pump = highest time in range

The researchers explained that two modalities of CGM are broadly available: rtCGM, which continuously displays glucose concentration in the interstitial fluid (usually at intervals of 1-5 minutes) on a dedicated receiver or other portable device, such as a smartphone, and provides various adjustable alarms, and isCGM, which displays data on demand when the transmitter is scanned using either a dedicated reader or smartphone-based application.

rtCGMs include devices from Dexcom and Medtronic. The isCGM, or “flash,” generally refers to the Abbott FreeStyle Libre.

The study included individuals younger than 21 years from 34 centers in 21 countries in the SWEET registry, a worldwide network of diabetes care centers for youth, between Jan. 1, 2016, and Dec. 31, 2021.

The researchers didn’t report which particular devices were used in the trial, rather they just divided patients into four groups: 850 used isCGM with a pump, 1,231 used isCGM with multiple daily injections, 2,252 used rtCGM with a pump, and 886 used rtCGM with insulin injections.

After adjustments for sex, age, diabetes duration, and body mass index standard deviation score, rtCGM plus insulin pump was the most likely group to achieve the recommended greater than 70% time in target glycemic range (70-180 mg/dL), with 36.2% achieving it, followed by rtCGM plus injections, at 20.9%, and isCGM plus injections, at 12.5%. Those using isCGM with an insulin pump were the least likely to achieve time in range, at just 11.3%.

Similar trends were seen for the recommended goal of less than 4% of time spent below range (< 70 mg/dL) and less than 25% of time spent above range (> 180 mg/dL). Those using rtCGM with a pump had the highest proportions achieving both of those goals, 73.1% and 32.5%, respectively.  

The use of rtCGM, with or without a pump, was associated with lower rates of severe hypoglycemia (2.5% and 2.0%, respectively) than isCGM with or without a pump (5.5% and 5.2%, respectively).

Similarly, the proportion experiencing at least one DKA episode varied from 1.4% for rtCGM plus insulin pump and 0.7% for rtCGM plus injections to 3.0% for isCGM plus pump and 1.5% isCGM plus injections.


 

Study looked at older technology but results still reflect benefit

Among the rtCGM plus insulin pump group were 264 participants (5% of the total study population) recorded in the database as using automated insulin delivery (AID) systems, also known as the artificial pancreas, although this is likely an undercount as the presence of communication between the two devices was not automatically recorded, Dr. Dovc explained.

Those individuals recorded as using AIDs had a higher unadjusted time in range compared with non-AID users (66.3% vs. 59.0%) and lower time above range (30.1% vs. 37.0%) but didn’t differ in time below range (2.9% vs. 3.0%).

Dr. Dovc told this news organization: “While automated systems are becoming more common, there are still many individuals who do not have access to glucose-responsive devices.” Reasons include lack of reimbursement, or decisions not to use them, he said.

But, he added, “Despite the low reported numbers of AID users, results achieved in the pump with real-time CGM [group] are admirable and approaching recommended consensus targets with a clinically meaningful difference towards all other treatment modalities. As our findings may not be directly applicable to all participants using automated systems, they may still provide useful insights into the factors that influence glycemic control.”

Similarly, the intermittently scanned CGMs used by most in the study, and particularly in the earlier period, didn’t have low- or high-glucose alarms as do later versions. And an even more recent version also doesn’t require scanning either, so is essentially also “real-time.”

Dr. Dovc noted, “in the first half of our observational period only first generation of intermittently-scanned CGM was generally available, and we can speculate that only a small proportion started to use second generation towards the end of our observational period. The exact number of second-generation users was not available in this analysis.”

He acknowledged that because the study was observational and not randomized, patient choice of device could have influenced the outcomes.

“For example, participants who choose to use a more expensive device may have more resources or support available to them, which could influence their ability to manage their diabetes effectively. Additionally, individuals who choose to use a particular device may be more motivated or engaged in their diabetes care, which could also impact their outcomes. It would be important for future studies to explore the impact of device selection on device effectiveness and to control for this potential confounding factor in the analysis.”

This study was supported by the international Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) corporate members, including Abbott Laboratories, Boehringer Ingelheim, Dexcom, Insulet, Eli Lilly, Medtronic, Sanofi, and the Slovenian National Research Agency. Dr. Dovc disclosed ties with Abbott Laboratories, Medtronic, Novo Nordisk, Eli Lilly, and Pfizer. He served as a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes.   

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

Youth with type 1 diabetes who use real-time continuous glucose monitoring (rtCGM) and an insulin pump spend more time in target glucose range than do those using intermittently scanned CGM (isCGM) and/or multiple daily insulin injections, new data show.

In the multinational cohort study of more than 4,500 people younger than age 21 with type 1 diabetes, those using rtCGM and pumps also spent less time above and below glucose targets and had fewer severe adverse events – either severe hypoglycemia or diabetic ketoacidosis (DKA) – compared with injections and isCGM.

Daria Nipot/Getty Images

The findings were published online in JAMA Network Open by Klemen Dovc, MD, PhD, assistant professor in the department of pediatric endocrinology, diabetes, and metabolic diseases, University Children’s Hospital, Ljubljana, Slovenia, and colleagues.

“These results underscore the synergistic effect of advanced diabetes technologies that should be more readily available to youths with type 1 diabetes for further improvement of diabetes-related clinical outcomes,” the authors wrote.

Moreover, Dr. Dovc told this news organization: “Clinicians should be aware that there may be differences in effectiveness between different types of devices, and that choosing the right device for each individual may be important for achieving optimal outcomes.”
 

Real-time CGM + insulin pump = highest time in range

The researchers explained that two modalities of CGM are broadly available: rtCGM, which continuously displays glucose concentration in the interstitial fluid (usually at intervals of 1-5 minutes) on a dedicated receiver or other portable device, such as a smartphone, and provides various adjustable alarms, and isCGM, which displays data on demand when the transmitter is scanned using either a dedicated reader or smartphone-based application.

rtCGMs include devices from Dexcom and Medtronic. The isCGM, or “flash,” generally refers to the Abbott FreeStyle Libre.

The study included individuals younger than 21 years from 34 centers in 21 countries in the SWEET registry, a worldwide network of diabetes care centers for youth, between Jan. 1, 2016, and Dec. 31, 2021.

The researchers didn’t report which particular devices were used in the trial, rather they just divided patients into four groups: 850 used isCGM with a pump, 1,231 used isCGM with multiple daily injections, 2,252 used rtCGM with a pump, and 886 used rtCGM with insulin injections.

After adjustments for sex, age, diabetes duration, and body mass index standard deviation score, rtCGM plus insulin pump was the most likely group to achieve the recommended greater than 70% time in target glycemic range (70-180 mg/dL), with 36.2% achieving it, followed by rtCGM plus injections, at 20.9%, and isCGM plus injections, at 12.5%. Those using isCGM with an insulin pump were the least likely to achieve time in range, at just 11.3%.

Similar trends were seen for the recommended goal of less than 4% of time spent below range (< 70 mg/dL) and less than 25% of time spent above range (> 180 mg/dL). Those using rtCGM with a pump had the highest proportions achieving both of those goals, 73.1% and 32.5%, respectively.  

The use of rtCGM, with or without a pump, was associated with lower rates of severe hypoglycemia (2.5% and 2.0%, respectively) than isCGM with or without a pump (5.5% and 5.2%, respectively).

Similarly, the proportion experiencing at least one DKA episode varied from 1.4% for rtCGM plus insulin pump and 0.7% for rtCGM plus injections to 3.0% for isCGM plus pump and 1.5% isCGM plus injections.


 

Study looked at older technology but results still reflect benefit

Among the rtCGM plus insulin pump group were 264 participants (5% of the total study population) recorded in the database as using automated insulin delivery (AID) systems, also known as the artificial pancreas, although this is likely an undercount as the presence of communication between the two devices was not automatically recorded, Dr. Dovc explained.

Those individuals recorded as using AIDs had a higher unadjusted time in range compared with non-AID users (66.3% vs. 59.0%) and lower time above range (30.1% vs. 37.0%) but didn’t differ in time below range (2.9% vs. 3.0%).

Dr. Dovc told this news organization: “While automated systems are becoming more common, there are still many individuals who do not have access to glucose-responsive devices.” Reasons include lack of reimbursement, or decisions not to use them, he said.

But, he added, “Despite the low reported numbers of AID users, results achieved in the pump with real-time CGM [group] are admirable and approaching recommended consensus targets with a clinically meaningful difference towards all other treatment modalities. As our findings may not be directly applicable to all participants using automated systems, they may still provide useful insights into the factors that influence glycemic control.”

Similarly, the intermittently scanned CGMs used by most in the study, and particularly in the earlier period, didn’t have low- or high-glucose alarms as do later versions. And an even more recent version also doesn’t require scanning either, so is essentially also “real-time.”

Dr. Dovc noted, “in the first half of our observational period only first generation of intermittently-scanned CGM was generally available, and we can speculate that only a small proportion started to use second generation towards the end of our observational period. The exact number of second-generation users was not available in this analysis.”

He acknowledged that because the study was observational and not randomized, patient choice of device could have influenced the outcomes.

“For example, participants who choose to use a more expensive device may have more resources or support available to them, which could influence their ability to manage their diabetes effectively. Additionally, individuals who choose to use a particular device may be more motivated or engaged in their diabetes care, which could also impact their outcomes. It would be important for future studies to explore the impact of device selection on device effectiveness and to control for this potential confounding factor in the analysis.”

This study was supported by the international Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) corporate members, including Abbott Laboratories, Boehringer Ingelheim, Dexcom, Insulet, Eli Lilly, Medtronic, Sanofi, and the Slovenian National Research Agency. Dr. Dovc disclosed ties with Abbott Laboratories, Medtronic, Novo Nordisk, Eli Lilly, and Pfizer. He served as a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes.   

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

Youth with type 1 diabetes who use real-time continuous glucose monitoring (rtCGM) and an insulin pump spend more time in target glucose range than do those using intermittently scanned CGM (isCGM) and/or multiple daily insulin injections, new data show.

In the multinational cohort study of more than 4,500 people younger than age 21 with type 1 diabetes, those using rtCGM and pumps also spent less time above and below glucose targets and had fewer severe adverse events – either severe hypoglycemia or diabetic ketoacidosis (DKA) – compared with injections and isCGM.

Daria Nipot/Getty Images

The findings were published online in JAMA Network Open by Klemen Dovc, MD, PhD, assistant professor in the department of pediatric endocrinology, diabetes, and metabolic diseases, University Children’s Hospital, Ljubljana, Slovenia, and colleagues.

“These results underscore the synergistic effect of advanced diabetes technologies that should be more readily available to youths with type 1 diabetes for further improvement of diabetes-related clinical outcomes,” the authors wrote.

Moreover, Dr. Dovc told this news organization: “Clinicians should be aware that there may be differences in effectiveness between different types of devices, and that choosing the right device for each individual may be important for achieving optimal outcomes.”
 

Real-time CGM + insulin pump = highest time in range

The researchers explained that two modalities of CGM are broadly available: rtCGM, which continuously displays glucose concentration in the interstitial fluid (usually at intervals of 1-5 minutes) on a dedicated receiver or other portable device, such as a smartphone, and provides various adjustable alarms, and isCGM, which displays data on demand when the transmitter is scanned using either a dedicated reader or smartphone-based application.

rtCGMs include devices from Dexcom and Medtronic. The isCGM, or “flash,” generally refers to the Abbott FreeStyle Libre.

The study included individuals younger than 21 years from 34 centers in 21 countries in the SWEET registry, a worldwide network of diabetes care centers for youth, between Jan. 1, 2016, and Dec. 31, 2021.

The researchers didn’t report which particular devices were used in the trial, rather they just divided patients into four groups: 850 used isCGM with a pump, 1,231 used isCGM with multiple daily injections, 2,252 used rtCGM with a pump, and 886 used rtCGM with insulin injections.

After adjustments for sex, age, diabetes duration, and body mass index standard deviation score, rtCGM plus insulin pump was the most likely group to achieve the recommended greater than 70% time in target glycemic range (70-180 mg/dL), with 36.2% achieving it, followed by rtCGM plus injections, at 20.9%, and isCGM plus injections, at 12.5%. Those using isCGM with an insulin pump were the least likely to achieve time in range, at just 11.3%.

Similar trends were seen for the recommended goal of less than 4% of time spent below range (< 70 mg/dL) and less than 25% of time spent above range (> 180 mg/dL). Those using rtCGM with a pump had the highest proportions achieving both of those goals, 73.1% and 32.5%, respectively.  

The use of rtCGM, with or without a pump, was associated with lower rates of severe hypoglycemia (2.5% and 2.0%, respectively) than isCGM with or without a pump (5.5% and 5.2%, respectively).

Similarly, the proportion experiencing at least one DKA episode varied from 1.4% for rtCGM plus insulin pump and 0.7% for rtCGM plus injections to 3.0% for isCGM plus pump and 1.5% isCGM plus injections.


 

Study looked at older technology but results still reflect benefit

Among the rtCGM plus insulin pump group were 264 participants (5% of the total study population) recorded in the database as using automated insulin delivery (AID) systems, also known as the artificial pancreas, although this is likely an undercount as the presence of communication between the two devices was not automatically recorded, Dr. Dovc explained.

Those individuals recorded as using AIDs had a higher unadjusted time in range compared with non-AID users (66.3% vs. 59.0%) and lower time above range (30.1% vs. 37.0%) but didn’t differ in time below range (2.9% vs. 3.0%).

Dr. Dovc told this news organization: “While automated systems are becoming more common, there are still many individuals who do not have access to glucose-responsive devices.” Reasons include lack of reimbursement, or decisions not to use them, he said.

But, he added, “Despite the low reported numbers of AID users, results achieved in the pump with real-time CGM [group] are admirable and approaching recommended consensus targets with a clinically meaningful difference towards all other treatment modalities. As our findings may not be directly applicable to all participants using automated systems, they may still provide useful insights into the factors that influence glycemic control.”

Similarly, the intermittently scanned CGMs used by most in the study, and particularly in the earlier period, didn’t have low- or high-glucose alarms as do later versions. And an even more recent version also doesn’t require scanning either, so is essentially also “real-time.”

Dr. Dovc noted, “in the first half of our observational period only first generation of intermittently-scanned CGM was generally available, and we can speculate that only a small proportion started to use second generation towards the end of our observational period. The exact number of second-generation users was not available in this analysis.”

He acknowledged that because the study was observational and not randomized, patient choice of device could have influenced the outcomes.

“For example, participants who choose to use a more expensive device may have more resources or support available to them, which could influence their ability to manage their diabetes effectively. Additionally, individuals who choose to use a particular device may be more motivated or engaged in their diabetes care, which could also impact their outcomes. It would be important for future studies to explore the impact of device selection on device effectiveness and to control for this potential confounding factor in the analysis.”

This study was supported by the international Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) corporate members, including Abbott Laboratories, Boehringer Ingelheim, Dexcom, Insulet, Eli Lilly, Medtronic, Sanofi, and the Slovenian National Research Agency. Dr. Dovc disclosed ties with Abbott Laboratories, Medtronic, Novo Nordisk, Eli Lilly, and Pfizer. He served as a member of the European Commission Expert Panel for Medical Devices for Endocrinology and Diabetes.   

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

A new study shows the Pfizer vaccine is safe and highly effective against COVID-19 in children as young as 6 months old.

A three-dose series of the Pfizer COVID-19 vaccine was 73% effective at preventing symptomatic COVID-19 in children aged 6 months to 4 years, the researchers found. They also found that an examination of reactions and safety results “did not suggest any concerns.”

The study, published in the New England Journal of Medicine, included 1,776 children aged 6 months to 2 years old, and 2,750 children aged 2-4 years. Children were randomly assigned to receive either the three-shot series of the Pfizer vaccine or placebo shots. Participants received the first dose of the vaccine by March 31, 2022, and lived in Brazil, Finland, Poland, Spain, or the United States.

The authors wrote that having safe and effective COVID vaccines for young children is important to protect them from hospitalization or death and because young children play a role in spreading highly transmissible variants of the virus. COVID hospitalizations for children under 5 years old peaked at a rate of 14.5 per 100,000 in January 2022, the authors wrote, noting that the Omicron virus variant appeared to affect young children more severely than the previous variant, Delta.

When the researchers evaluated vaccine effectiveness by age group, they found that it prevented symptomatic COVID in 75.8% of children aged 6 months to 2 years, and in 71.8% of children aged 2-4 years.

Less than 0.5% of participants reported severe reactions to the vaccine. The most common reactions reported were tenderness or pain. Reactions typically appeared within the first couple days following vaccine administration and resolved within 2 days. No cases of inflammation of the heart muscle or its lining were reported among participants.

Uptake of COVID vaccines for young children has been lower than other age groups in the United States. The Centers for Disease Control and Prevention says 10% of children younger than 5 have received at least one dose of a COVID-19 vaccine, and 5% have completed a primary vaccine series.

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

A new study shows the Pfizer vaccine is safe and highly effective against COVID-19 in children as young as 6 months old.

A three-dose series of the Pfizer COVID-19 vaccine was 73% effective at preventing symptomatic COVID-19 in children aged 6 months to 4 years, the researchers found. They also found that an examination of reactions and safety results “did not suggest any concerns.”

The study, published in the New England Journal of Medicine, included 1,776 children aged 6 months to 2 years old, and 2,750 children aged 2-4 years. Children were randomly assigned to receive either the three-shot series of the Pfizer vaccine or placebo shots. Participants received the first dose of the vaccine by March 31, 2022, and lived in Brazil, Finland, Poland, Spain, or the United States.

The authors wrote that having safe and effective COVID vaccines for young children is important to protect them from hospitalization or death and because young children play a role in spreading highly transmissible variants of the virus. COVID hospitalizations for children under 5 years old peaked at a rate of 14.5 per 100,000 in January 2022, the authors wrote, noting that the Omicron virus variant appeared to affect young children more severely than the previous variant, Delta.

When the researchers evaluated vaccine effectiveness by age group, they found that it prevented symptomatic COVID in 75.8% of children aged 6 months to 2 years, and in 71.8% of children aged 2-4 years.

Less than 0.5% of participants reported severe reactions to the vaccine. The most common reactions reported were tenderness or pain. Reactions typically appeared within the first couple days following vaccine administration and resolved within 2 days. No cases of inflammation of the heart muscle or its lining were reported among participants.

Uptake of COVID vaccines for young children has been lower than other age groups in the United States. The Centers for Disease Control and Prevention says 10% of children younger than 5 have received at least one dose of a COVID-19 vaccine, and 5% have completed a primary vaccine series.

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

A new study shows the Pfizer vaccine is safe and highly effective against COVID-19 in children as young as 6 months old.

A three-dose series of the Pfizer COVID-19 vaccine was 73% effective at preventing symptomatic COVID-19 in children aged 6 months to 4 years, the researchers found. They also found that an examination of reactions and safety results “did not suggest any concerns.”

The study, published in the New England Journal of Medicine, included 1,776 children aged 6 months to 2 years old, and 2,750 children aged 2-4 years. Children were randomly assigned to receive either the three-shot series of the Pfizer vaccine or placebo shots. Participants received the first dose of the vaccine by March 31, 2022, and lived in Brazil, Finland, Poland, Spain, or the United States.

The authors wrote that having safe and effective COVID vaccines for young children is important to protect them from hospitalization or death and because young children play a role in spreading highly transmissible variants of the virus. COVID hospitalizations for children under 5 years old peaked at a rate of 14.5 per 100,000 in January 2022, the authors wrote, noting that the Omicron virus variant appeared to affect young children more severely than the previous variant, Delta.

When the researchers evaluated vaccine effectiveness by age group, they found that it prevented symptomatic COVID in 75.8% of children aged 6 months to 2 years, and in 71.8% of children aged 2-4 years.

Less than 0.5% of participants reported severe reactions to the vaccine. The most common reactions reported were tenderness or pain. Reactions typically appeared within the first couple days following vaccine administration and resolved within 2 days. No cases of inflammation of the heart muscle or its lining were reported among participants.

Uptake of COVID vaccines for young children has been lower than other age groups in the United States. The Centers for Disease Control and Prevention says 10% of children younger than 5 have received at least one dose of a COVID-19 vaccine, and 5% have completed a primary vaccine series.

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

Mindi Rosen met Seuli Brill, MD, at just the right time. 

Ms. Rosen’s firstborn son was in the neointensive natal unit at The Ohio State University Wexner Medical Center in Columbus, and she didn’t have a pediatrician picked out yet for the baby. Nor did she have a primary care physician who could help her manage the gestational diabetes she developed during her pregnancy.

Dr. Brill, a clinical associate professor of internal medicine and pediatrics at Ohio State, suggested Ms. Rosen visit her at the new clinic she was piloting in Columbus. There, she provided pediatric care for newborns and primary care for mothers who had developed gestational diabetes.  

“I looked at my husband, my husband looked at me, and I said: ‘Why not?’ “ Ms. Rosen, 38, recalled of that 2019 meeting. “I’m so glad she walked in at that moment.”

The mother of two is still part of the rapidly growing program at the medical facility that provides care for more than 200 mothers and babies.

Launched in 2018, the clinic – called the Multi-Modal Maternal Infant Perinatal Outpatient Delivery System, or “Momi Pods,” started with a focus  on helping women with gestational diabetes, which occurs in up to 10% of pregnancies.

The program allows moms to book regular checkups for their baby, and then a follow-up appointment immediately after for themselves. Women are seen for the first 1,000 days (just under 3 years) after giving birth.

The idea was simple. Dr. Brill wanted to develop a more formalized program for the work she was already doing as a primary care physician and pediatrician. At the time, she was fielding referrals from specialists for young women who didn’t have a physician. She’d often develop a relationship with the patient over the years, go on to help oversee their care during pregnancy, then new mothers would select her as their newborn’s pediatrician.

“I would have a relationship with the mom when they did have the newborn, and then I would see the baby because I’m a pediatrician,” Dr. Brill said.

Dr. Brill was serving on the Ohio Gestational Diabetes Mellitus Collaborative, a state-backed program that aims to raise awareness about the condition and encourage more preventative care for patients. She presented her proposal to launch the program to the Ohio Department of Medicaid, which helped to fund the pilot.

The idea, she hoped, would improve postpartum follow-up care for mothers diagnosed with the condition. 

Follow-up care is especially important for women who develop gestational diabetes because the condition raises their lifetime risk of developing type 2 diabetes up to 10-fold. 

Yet most of those mothers don’t get the appropriate follow-up care during the crucial postpartum period, said Maya Subbalakshmi Venkataramani, MD, MPH, an assistant professor of medicine at Johns Hopkins University in Baltimore, who has researched parental care. 

“Things get very busy after you have a child. There’s just the general logistics of a mom having to take care of a newborn and thinking about themselves,” Dr. Venkataramani, a primary care clinician and pediatrician, said. “A lot of parents in general may not put a lot of emphasis on their own health.”

Seeking care may be especially difficult for low-income mothers who might not have consistent health care coverage, she added.

In fact, only half of women who developed gestational diabetes received primary follow-up care, according to a study published in JAMA Network Open. The study, which examined more than 280,000 insurance claims between 2015 and 2018, found only 36% of women with gestational diabetes received the recommended blood glucose testing in the first 12 weeks of the postpartum period.

In the Momi Pods program, Dr. Brill checked in on Ms. Rosen’s gestational diabetes regularly during pediatric office visits for her newborn’s care. Ms. Rosen said whenever she brought her baby in for a visit during the postpartum period, Dr. Brill measured her blood sugar. 

Dr. Brill and her team also asked how Ms. Rosen was doing physically and mentally during each visit. The screenings helped to catch a bout of postpartum depression Ms. Rosen experienced after the birth of her first son.

“I thought it was great, because honestly as a new mom I wouldn’t have followed up with myself so much,” Ms. Rosen said. “Every time you went into the doctor appointments, they’d ask you how you are doing. As a new mom, it’s so much easier to do it at the same time.”

Those who participate in the program are also more likely to complete postpartum visits with their ob.gyn. (95% vs. 58%, respectively; P < .001) than those who don’t participate, according to research Dr. Brill and colleagues published.

Dr. Brill began expanding the program’s reach nearly 2 years after its launch, targeting the services for women who are at risk for poor postpartum outcomes, including those with a history of depression, preterm labor, diabetes and congenital heart disease. Ob.gyns. in Ohio State’s network can refer their patients to the program, which now has 43 doctors trained to provide primary and pediatric care through Momi Pods. Soon-to-be moms can be referred to the program as early as the second trimester, Dr. Brill said.

Many of the mothers referred to the program don’t have a primary care clinician when they talk to Paola Beamon, RN, at Ohio State. Ms. Beamon reaches out to each referred patient over voicemail, a MyChart message, and even regular mail in hopes of helping them navigate the postpartum period. She also provides education on what a primary care clinician can offer new moms.

“Really, we’re pursuing these moms and doing everything we can so there’s less of a burden for them,” Ms. Beamon said. “A lot of them don’t even know what a primary care office does.”

One of the biggest perks to the program for new moms is that they don’t have to spend time and money traveling to a different doctor’s office, take time off work, or secure childcare in order to schedule a separate appointment for themselves, she said.

The program, which receives funding from the university and the state, even helps women get bus passes to a doctor’s appointment if needed.

Dyad programs targeting women with substance abuse disorders or mental health conditions have existed for many years. But catering to women with gestational diabetes or other medical conditions appears to be new. In part, Dr. Venkataramani said, because scheduling and space can be big hurdles to launch such a program, as well as finding doctors who can care for both baby and mother.

“There are logistical challenges to even doing this that makes it less common,” she said.

Dr. Brill said she is not aware of any other programs that are structured like the tandem care clinic at Ohio State. She hopes, however, that the program can be a model for other hospital systems to consider, and she is working to expand the program regionally. Her team is collecting data – including on the best way to schedule patients – to help other clinics develop something similar. 

“We really want to leverage that expertise to make it easier for moms to get care with their infants and remove barriers to care,” she said.

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

Mindi Rosen met Seuli Brill, MD, at just the right time. 

Ms. Rosen’s firstborn son was in the neointensive natal unit at The Ohio State University Wexner Medical Center in Columbus, and she didn’t have a pediatrician picked out yet for the baby. Nor did she have a primary care physician who could help her manage the gestational diabetes she developed during her pregnancy.

Dr. Brill, a clinical associate professor of internal medicine and pediatrics at Ohio State, suggested Ms. Rosen visit her at the new clinic she was piloting in Columbus. There, she provided pediatric care for newborns and primary care for mothers who had developed gestational diabetes.  

“I looked at my husband, my husband looked at me, and I said: ‘Why not?’ “ Ms. Rosen, 38, recalled of that 2019 meeting. “I’m so glad she walked in at that moment.”

The mother of two is still part of the rapidly growing program at the medical facility that provides care for more than 200 mothers and babies.

Launched in 2018, the clinic – called the Multi-Modal Maternal Infant Perinatal Outpatient Delivery System, or “Momi Pods,” started with a focus  on helping women with gestational diabetes, which occurs in up to 10% of pregnancies.

The program allows moms to book regular checkups for their baby, and then a follow-up appointment immediately after for themselves. Women are seen for the first 1,000 days (just under 3 years) after giving birth.

The idea was simple. Dr. Brill wanted to develop a more formalized program for the work she was already doing as a primary care physician and pediatrician. At the time, she was fielding referrals from specialists for young women who didn’t have a physician. She’d often develop a relationship with the patient over the years, go on to help oversee their care during pregnancy, then new mothers would select her as their newborn’s pediatrician.

“I would have a relationship with the mom when they did have the newborn, and then I would see the baby because I’m a pediatrician,” Dr. Brill said.

Dr. Brill was serving on the Ohio Gestational Diabetes Mellitus Collaborative, a state-backed program that aims to raise awareness about the condition and encourage more preventative care for patients. She presented her proposal to launch the program to the Ohio Department of Medicaid, which helped to fund the pilot.

The idea, she hoped, would improve postpartum follow-up care for mothers diagnosed with the condition. 

Follow-up care is especially important for women who develop gestational diabetes because the condition raises their lifetime risk of developing type 2 diabetes up to 10-fold. 

Yet most of those mothers don’t get the appropriate follow-up care during the crucial postpartum period, said Maya Subbalakshmi Venkataramani, MD, MPH, an assistant professor of medicine at Johns Hopkins University in Baltimore, who has researched parental care. 

“Things get very busy after you have a child. There’s just the general logistics of a mom having to take care of a newborn and thinking about themselves,” Dr. Venkataramani, a primary care clinician and pediatrician, said. “A lot of parents in general may not put a lot of emphasis on their own health.”

Seeking care may be especially difficult for low-income mothers who might not have consistent health care coverage, she added.

In fact, only half of women who developed gestational diabetes received primary follow-up care, according to a study published in JAMA Network Open. The study, which examined more than 280,000 insurance claims between 2015 and 2018, found only 36% of women with gestational diabetes received the recommended blood glucose testing in the first 12 weeks of the postpartum period.

In the Momi Pods program, Dr. Brill checked in on Ms. Rosen’s gestational diabetes regularly during pediatric office visits for her newborn’s care. Ms. Rosen said whenever she brought her baby in for a visit during the postpartum period, Dr. Brill measured her blood sugar. 

Dr. Brill and her team also asked how Ms. Rosen was doing physically and mentally during each visit. The screenings helped to catch a bout of postpartum depression Ms. Rosen experienced after the birth of her first son.

“I thought it was great, because honestly as a new mom I wouldn’t have followed up with myself so much,” Ms. Rosen said. “Every time you went into the doctor appointments, they’d ask you how you are doing. As a new mom, it’s so much easier to do it at the same time.”

Those who participate in the program are also more likely to complete postpartum visits with their ob.gyn. (95% vs. 58%, respectively; P < .001) than those who don’t participate, according to research Dr. Brill and colleagues published.

Dr. Brill began expanding the program’s reach nearly 2 years after its launch, targeting the services for women who are at risk for poor postpartum outcomes, including those with a history of depression, preterm labor, diabetes and congenital heart disease. Ob.gyns. in Ohio State’s network can refer their patients to the program, which now has 43 doctors trained to provide primary and pediatric care through Momi Pods. Soon-to-be moms can be referred to the program as early as the second trimester, Dr. Brill said.

Many of the mothers referred to the program don’t have a primary care clinician when they talk to Paola Beamon, RN, at Ohio State. Ms. Beamon reaches out to each referred patient over voicemail, a MyChart message, and even regular mail in hopes of helping them navigate the postpartum period. She also provides education on what a primary care clinician can offer new moms.

“Really, we’re pursuing these moms and doing everything we can so there’s less of a burden for them,” Ms. Beamon said. “A lot of them don’t even know what a primary care office does.”

One of the biggest perks to the program for new moms is that they don’t have to spend time and money traveling to a different doctor’s office, take time off work, or secure childcare in order to schedule a separate appointment for themselves, she said.

The program, which receives funding from the university and the state, even helps women get bus passes to a doctor’s appointment if needed.

Dyad programs targeting women with substance abuse disorders or mental health conditions have existed for many years. But catering to women with gestational diabetes or other medical conditions appears to be new. In part, Dr. Venkataramani said, because scheduling and space can be big hurdles to launch such a program, as well as finding doctors who can care for both baby and mother.

“There are logistical challenges to even doing this that makes it less common,” she said.

Dr. Brill said she is not aware of any other programs that are structured like the tandem care clinic at Ohio State. She hopes, however, that the program can be a model for other hospital systems to consider, and she is working to expand the program regionally. Her team is collecting data – including on the best way to schedule patients – to help other clinics develop something similar. 

“We really want to leverage that expertise to make it easier for moms to get care with their infants and remove barriers to care,” she said.

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

Mindi Rosen met Seuli Brill, MD, at just the right time. 

Ms. Rosen’s firstborn son was in the neointensive natal unit at The Ohio State University Wexner Medical Center in Columbus, and she didn’t have a pediatrician picked out yet for the baby. Nor did she have a primary care physician who could help her manage the gestational diabetes she developed during her pregnancy.

Dr. Brill, a clinical associate professor of internal medicine and pediatrics at Ohio State, suggested Ms. Rosen visit her at the new clinic she was piloting in Columbus. There, she provided pediatric care for newborns and primary care for mothers who had developed gestational diabetes.  

“I looked at my husband, my husband looked at me, and I said: ‘Why not?’ “ Ms. Rosen, 38, recalled of that 2019 meeting. “I’m so glad she walked in at that moment.”

The mother of two is still part of the rapidly growing program at the medical facility that provides care for more than 200 mothers and babies.

Launched in 2018, the clinic – called the Multi-Modal Maternal Infant Perinatal Outpatient Delivery System, or “Momi Pods,” started with a focus  on helping women with gestational diabetes, which occurs in up to 10% of pregnancies.

The program allows moms to book regular checkups for their baby, and then a follow-up appointment immediately after for themselves. Women are seen for the first 1,000 days (just under 3 years) after giving birth.

The idea was simple. Dr. Brill wanted to develop a more formalized program for the work she was already doing as a primary care physician and pediatrician. At the time, she was fielding referrals from specialists for young women who didn’t have a physician. She’d often develop a relationship with the patient over the years, go on to help oversee their care during pregnancy, then new mothers would select her as their newborn’s pediatrician.

“I would have a relationship with the mom when they did have the newborn, and then I would see the baby because I’m a pediatrician,” Dr. Brill said.

Dr. Brill was serving on the Ohio Gestational Diabetes Mellitus Collaborative, a state-backed program that aims to raise awareness about the condition and encourage more preventative care for patients. She presented her proposal to launch the program to the Ohio Department of Medicaid, which helped to fund the pilot.

The idea, she hoped, would improve postpartum follow-up care for mothers diagnosed with the condition. 

Follow-up care is especially important for women who develop gestational diabetes because the condition raises their lifetime risk of developing type 2 diabetes up to 10-fold. 

Yet most of those mothers don’t get the appropriate follow-up care during the crucial postpartum period, said Maya Subbalakshmi Venkataramani, MD, MPH, an assistant professor of medicine at Johns Hopkins University in Baltimore, who has researched parental care. 

“Things get very busy after you have a child. There’s just the general logistics of a mom having to take care of a newborn and thinking about themselves,” Dr. Venkataramani, a primary care clinician and pediatrician, said. “A lot of parents in general may not put a lot of emphasis on their own health.”

Seeking care may be especially difficult for low-income mothers who might not have consistent health care coverage, she added.

In fact, only half of women who developed gestational diabetes received primary follow-up care, according to a study published in JAMA Network Open. The study, which examined more than 280,000 insurance claims between 2015 and 2018, found only 36% of women with gestational diabetes received the recommended blood glucose testing in the first 12 weeks of the postpartum period.

In the Momi Pods program, Dr. Brill checked in on Ms. Rosen’s gestational diabetes regularly during pediatric office visits for her newborn’s care. Ms. Rosen said whenever she brought her baby in for a visit during the postpartum period, Dr. Brill measured her blood sugar. 

Dr. Brill and her team also asked how Ms. Rosen was doing physically and mentally during each visit. The screenings helped to catch a bout of postpartum depression Ms. Rosen experienced after the birth of her first son.

“I thought it was great, because honestly as a new mom I wouldn’t have followed up with myself so much,” Ms. Rosen said. “Every time you went into the doctor appointments, they’d ask you how you are doing. As a new mom, it’s so much easier to do it at the same time.”

Those who participate in the program are also more likely to complete postpartum visits with their ob.gyn. (95% vs. 58%, respectively; P < .001) than those who don’t participate, according to research Dr. Brill and colleagues published.

Dr. Brill began expanding the program’s reach nearly 2 years after its launch, targeting the services for women who are at risk for poor postpartum outcomes, including those with a history of depression, preterm labor, diabetes and congenital heart disease. Ob.gyns. in Ohio State’s network can refer their patients to the program, which now has 43 doctors trained to provide primary and pediatric care through Momi Pods. Soon-to-be moms can be referred to the program as early as the second trimester, Dr. Brill said.

Many of the mothers referred to the program don’t have a primary care clinician when they talk to Paola Beamon, RN, at Ohio State. Ms. Beamon reaches out to each referred patient over voicemail, a MyChart message, and even regular mail in hopes of helping them navigate the postpartum period. She also provides education on what a primary care clinician can offer new moms.

“Really, we’re pursuing these moms and doing everything we can so there’s less of a burden for them,” Ms. Beamon said. “A lot of them don’t even know what a primary care office does.”

One of the biggest perks to the program for new moms is that they don’t have to spend time and money traveling to a different doctor’s office, take time off work, or secure childcare in order to schedule a separate appointment for themselves, she said.

The program, which receives funding from the university and the state, even helps women get bus passes to a doctor’s appointment if needed.

Dyad programs targeting women with substance abuse disorders or mental health conditions have existed for many years. But catering to women with gestational diabetes or other medical conditions appears to be new. In part, Dr. Venkataramani said, because scheduling and space can be big hurdles to launch such a program, as well as finding doctors who can care for both baby and mother.

“There are logistical challenges to even doing this that makes it less common,” she said.

Dr. Brill said she is not aware of any other programs that are structured like the tandem care clinic at Ohio State. She hopes, however, that the program can be a model for other hospital systems to consider, and she is working to expand the program regionally. Her team is collecting data – including on the best way to schedule patients – to help other clinics develop something similar. 

“We really want to leverage that expertise to make it easier for moms to get care with their infants and remove barriers to care,” she said.

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

Children born to mothers who had urinary or genital tract infections during pregnancy appear to have an increased risk for childhood leukemia, said researchers reporting a Danish registry analysis that may point to preventive strategies for the disease.

The research was published online in JAMA Network Open.

The team studied more than 2.2 million children born in Denmark over more than 3 decades, linking their records across multiple national registries to examine both later cancer risk and maternal infection rates.

They found that, overall, at least one maternal infection during pregnancy was associated with a 35% increased risk for leukemia in the children, rising to 65% for urinary tract infections, and 142% for genital infections.

“The findings of this large population-based cohort study suggest that maternal urinary and genital tract infections during pregnancy are associated with a higher risk of childhood leukemia in offspring,” said lead author Jian-Rong He, DPhil, division of birth cohort study, Guangzhou (China) Women and Children’s Medical Center.

However, he added, “the associated absolute risk remained small given the rarity” of the disease. In absolute terms, the risk difference between exposed and unexposed children was 1.8 cases per 100,000 person-years for any infection, 3.4 cases per 100,000 person-years for urinary traction infection, and 7.1 cases per 100,000 person-years for genital tract infection.

Maternal infections during pregnancy may be associated with chromosomal and immunologic alterations in the fetus, the authors speculated.

“Given that little is known about the etiology of childhood leukemia,” these results “suggest an important direction for research on the etiology of childhood leukemia as well as development of potential preventive measures,” they wrote.

In many countries, pregnant women are tested for urinary tract infection and bacterial vaginosis, and treated with antibiotics in antenatal care, as these infections are linked to adverse perinatal outcomes, they pointed out.
 

Study details

The team conducted a large population-based study that included all live births in Denmark between 1978 and 2015.

After exclusions, they gathered information on 2,222,797 children, linking data from several national registries, including the Danish Medical Birth Register, the Danish National Patient Registry, and the Danish National Cancer Registry, to identify cases of childhood cancers and maternal infection during pregnancy.

The results were then validated by comparing them with those in 2.6 million live births in Sweden between 1988 and 2014, for whom similar data were available through linkage with several Swedish registries.

The Danish cohort was followed up for a mean of 12 years per person, yielding a total of 27 million person-years. Just over half (51.3%) were boys.

Cancer was diagnosed in 4,362 children before 15 years of age, of whom 1,307 had leukemia (1,050 had acute lymphocytic leukemia), 1,267 had a brain tumor, 224 had lymphoma, and 1,564 had other cancers.

At least one infection during pregnancy was diagnosed in 81,717 mothers (3.7%). Urinary tract infections were the most common (in 1.7% of women), followed by genital tract infection (in 0.7%), digestive system infection (in 0.5%), and respiratory tract infection (in 0.3%).

Women with any infection during pregnancy were more likely to be younger and primiparous than were women who did not have infections, and they were also more likely to have fewer years of education, higher prepregnancy BMI, diabetes, and to smoke during early pregnancy.

Preterm delivery and low-birth-weight infants were also more common in women with infections during pregnancy.

Cox proportional hazards regression models revealed that, after adjustment for confounders, any maternal infection was associated with a hazard ratio of childhood leukemia of 1.35.

Further analysis revealed that the association was driven by genital tract infection, at a hazard ratio for childhood leukemia of 2.42, and urinary tract infection, at a hazard ratio 1.65.

Moreover, children born to women who had a sexually transmitted infection during pregnancy had a hazard ratio for developing leukemia of 3.13 compared with unexposed children.

There were no associations between other maternal infections and childhood leukemia.

The patterns of association between maternal infections and childhood leukemia were similar when looking at disease subtypes, as well as in the Swedish validation cohort, they added.

When interpreting the results, the researchers caution that, as data on maternal infection were drawn from hospital data, “milder infections and those not diagnosed or treated in specialized health care facilities were not captured.”

“Also, some infections could be captured because the mother sought care for other, more serious conditions, which might bias the association of maternal infections and childhood leukemia.”

The study was supported by grants from the China Scholarship Council–University of Oxford; National Natural Science Foundation of China; Danish Council for Independent Research; Nordic Cancer Union; Novo Nordisk Fonden; and the Swedish Council for Working Life and Social Research. Dr He reported receiving a PhD scholarship from the China Scholarship Council during the conduct of the study. Several other coauthors have disclosures; the full list can be found with the original article.

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

Children born to mothers who had urinary or genital tract infections during pregnancy appear to have an increased risk for childhood leukemia, said researchers reporting a Danish registry analysis that may point to preventive strategies for the disease.

The research was published online in JAMA Network Open.

The team studied more than 2.2 million children born in Denmark over more than 3 decades, linking their records across multiple national registries to examine both later cancer risk and maternal infection rates.

They found that, overall, at least one maternal infection during pregnancy was associated with a 35% increased risk for leukemia in the children, rising to 65% for urinary tract infections, and 142% for genital infections.

“The findings of this large population-based cohort study suggest that maternal urinary and genital tract infections during pregnancy are associated with a higher risk of childhood leukemia in offspring,” said lead author Jian-Rong He, DPhil, division of birth cohort study, Guangzhou (China) Women and Children’s Medical Center.

However, he added, “the associated absolute risk remained small given the rarity” of the disease. In absolute terms, the risk difference between exposed and unexposed children was 1.8 cases per 100,000 person-years for any infection, 3.4 cases per 100,000 person-years for urinary traction infection, and 7.1 cases per 100,000 person-years for genital tract infection.

Maternal infections during pregnancy may be associated with chromosomal and immunologic alterations in the fetus, the authors speculated.

“Given that little is known about the etiology of childhood leukemia,” these results “suggest an important direction for research on the etiology of childhood leukemia as well as development of potential preventive measures,” they wrote.

In many countries, pregnant women are tested for urinary tract infection and bacterial vaginosis, and treated with antibiotics in antenatal care, as these infections are linked to adverse perinatal outcomes, they pointed out.
 

Study details

The team conducted a large population-based study that included all live births in Denmark between 1978 and 2015.

After exclusions, they gathered information on 2,222,797 children, linking data from several national registries, including the Danish Medical Birth Register, the Danish National Patient Registry, and the Danish National Cancer Registry, to identify cases of childhood cancers and maternal infection during pregnancy.

The results were then validated by comparing them with those in 2.6 million live births in Sweden between 1988 and 2014, for whom similar data were available through linkage with several Swedish registries.

The Danish cohort was followed up for a mean of 12 years per person, yielding a total of 27 million person-years. Just over half (51.3%) were boys.

Cancer was diagnosed in 4,362 children before 15 years of age, of whom 1,307 had leukemia (1,050 had acute lymphocytic leukemia), 1,267 had a brain tumor, 224 had lymphoma, and 1,564 had other cancers.

At least one infection during pregnancy was diagnosed in 81,717 mothers (3.7%). Urinary tract infections were the most common (in 1.7% of women), followed by genital tract infection (in 0.7%), digestive system infection (in 0.5%), and respiratory tract infection (in 0.3%).

Women with any infection during pregnancy were more likely to be younger and primiparous than were women who did not have infections, and they were also more likely to have fewer years of education, higher prepregnancy BMI, diabetes, and to smoke during early pregnancy.

Preterm delivery and low-birth-weight infants were also more common in women with infections during pregnancy.

Cox proportional hazards regression models revealed that, after adjustment for confounders, any maternal infection was associated with a hazard ratio of childhood leukemia of 1.35.

Further analysis revealed that the association was driven by genital tract infection, at a hazard ratio for childhood leukemia of 2.42, and urinary tract infection, at a hazard ratio 1.65.

Moreover, children born to women who had a sexually transmitted infection during pregnancy had a hazard ratio for developing leukemia of 3.13 compared with unexposed children.

There were no associations between other maternal infections and childhood leukemia.

The patterns of association between maternal infections and childhood leukemia were similar when looking at disease subtypes, as well as in the Swedish validation cohort, they added.

When interpreting the results, the researchers caution that, as data on maternal infection were drawn from hospital data, “milder infections and those not diagnosed or treated in specialized health care facilities were not captured.”

“Also, some infections could be captured because the mother sought care for other, more serious conditions, which might bias the association of maternal infections and childhood leukemia.”

The study was supported by grants from the China Scholarship Council–University of Oxford; National Natural Science Foundation of China; Danish Council for Independent Research; Nordic Cancer Union; Novo Nordisk Fonden; and the Swedish Council for Working Life and Social Research. Dr He reported receiving a PhD scholarship from the China Scholarship Council during the conduct of the study. Several other coauthors have disclosures; the full list can be found with the original article.

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

Children born to mothers who had urinary or genital tract infections during pregnancy appear to have an increased risk for childhood leukemia, said researchers reporting a Danish registry analysis that may point to preventive strategies for the disease.

The research was published online in JAMA Network Open.

The team studied more than 2.2 million children born in Denmark over more than 3 decades, linking their records across multiple national registries to examine both later cancer risk and maternal infection rates.

They found that, overall, at least one maternal infection during pregnancy was associated with a 35% increased risk for leukemia in the children, rising to 65% for urinary tract infections, and 142% for genital infections.

“The findings of this large population-based cohort study suggest that maternal urinary and genital tract infections during pregnancy are associated with a higher risk of childhood leukemia in offspring,” said lead author Jian-Rong He, DPhil, division of birth cohort study, Guangzhou (China) Women and Children’s Medical Center.

However, he added, “the associated absolute risk remained small given the rarity” of the disease. In absolute terms, the risk difference between exposed and unexposed children was 1.8 cases per 100,000 person-years for any infection, 3.4 cases per 100,000 person-years for urinary traction infection, and 7.1 cases per 100,000 person-years for genital tract infection.

Maternal infections during pregnancy may be associated with chromosomal and immunologic alterations in the fetus, the authors speculated.

“Given that little is known about the etiology of childhood leukemia,” these results “suggest an important direction for research on the etiology of childhood leukemia as well as development of potential preventive measures,” they wrote.

In many countries, pregnant women are tested for urinary tract infection and bacterial vaginosis, and treated with antibiotics in antenatal care, as these infections are linked to adverse perinatal outcomes, they pointed out.
 

Study details

The team conducted a large population-based study that included all live births in Denmark between 1978 and 2015.

After exclusions, they gathered information on 2,222,797 children, linking data from several national registries, including the Danish Medical Birth Register, the Danish National Patient Registry, and the Danish National Cancer Registry, to identify cases of childhood cancers and maternal infection during pregnancy.

The results were then validated by comparing them with those in 2.6 million live births in Sweden between 1988 and 2014, for whom similar data were available through linkage with several Swedish registries.

The Danish cohort was followed up for a mean of 12 years per person, yielding a total of 27 million person-years. Just over half (51.3%) were boys.

Cancer was diagnosed in 4,362 children before 15 years of age, of whom 1,307 had leukemia (1,050 had acute lymphocytic leukemia), 1,267 had a brain tumor, 224 had lymphoma, and 1,564 had other cancers.

At least one infection during pregnancy was diagnosed in 81,717 mothers (3.7%). Urinary tract infections were the most common (in 1.7% of women), followed by genital tract infection (in 0.7%), digestive system infection (in 0.5%), and respiratory tract infection (in 0.3%).

Women with any infection during pregnancy were more likely to be younger and primiparous than were women who did not have infections, and they were also more likely to have fewer years of education, higher prepregnancy BMI, diabetes, and to smoke during early pregnancy.

Preterm delivery and low-birth-weight infants were also more common in women with infections during pregnancy.

Cox proportional hazards regression models revealed that, after adjustment for confounders, any maternal infection was associated with a hazard ratio of childhood leukemia of 1.35.

Further analysis revealed that the association was driven by genital tract infection, at a hazard ratio for childhood leukemia of 2.42, and urinary tract infection, at a hazard ratio 1.65.

Moreover, children born to women who had a sexually transmitted infection during pregnancy had a hazard ratio for developing leukemia of 3.13 compared with unexposed children.

There were no associations between other maternal infections and childhood leukemia.

The patterns of association between maternal infections and childhood leukemia were similar when looking at disease subtypes, as well as in the Swedish validation cohort, they added.

When interpreting the results, the researchers caution that, as data on maternal infection were drawn from hospital data, “milder infections and those not diagnosed or treated in specialized health care facilities were not captured.”

“Also, some infections could be captured because the mother sought care for other, more serious conditions, which might bias the association of maternal infections and childhood leukemia.”

The study was supported by grants from the China Scholarship Council–University of Oxford; National Natural Science Foundation of China; Danish Council for Independent Research; Nordic Cancer Union; Novo Nordisk Fonden; and the Swedish Council for Working Life and Social Research. Dr He reported receiving a PhD scholarship from the China Scholarship Council during the conduct of the study. Several other coauthors have disclosures; the full list can be found with the original article.

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

HONOLULU – In the clinical experience of John S. Barbieri, MD, MBA, cheilitis occurs in nearly all patients taking any dose of isotretinoin.

“If they don’t have dry lips, you have to wonder if they’re even absorbing isotretinoin,” Dr. Barbieri, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “Everyone is going to get dry lips.”

According to a retrospective review of 1,743 patients started on isotretinoin, other common mucocutaneous side effects include eczema, nose bleeds, and eye problems. Emerging research suggests that there may be a role for oral omega-3 in decreasing such side effects of the drug. In a case control study, 118 patients were randomized to isotretinoin alone or isotretinoin plus 1 g/day of oral omega-3 for 16 weeks. At week 16, the rate of dry lips was 26% in the isoretinoin only group compared with 14% in the combination group; similar trends were seen with dry nose (11% vs. 0 %, respectively) and dry skin (11% vs. 2%).

“Omega-3 is a simple thing that we can think about recommending for patients,” Dr. Barbieri said. “It’s very safe, inexpensive, and it may help us manage these common sides effect we run into.”

Another potential side effect of isotretinoin that he characterized as underappreciated is chronic dry eye and other ocular changes. One retrospective cohort study of 14,682 adolescents and young adults in Israel found that use of the drug resulted in reduced tear production and reduced tear quality. In another study, a review and meta-analysis of 21 publications involving 1,105 eyes of 842 patients, isotretinoin use was associated with increased conjunctival fluorescein staining, decreased corneal thickness, and worse patient-reported ocular surface disease index scores.

“These changes may be mediated by meibomian gland dysfunction and atrophy,” Dr. Barbieri said. “Fortunately, many of these tear film changes appear to resolve after treatment. Those changes in corneal thickness do seem to get better. That’s reassuring.”

In a study of 54 patients treated with isotretinoin, tear production and quality returned to baseline within 6 months of treatment completion. “But some changes in the meibomian gland may be persistent,” Dr. Barbieri said. “At 6 and 12 months after the end of treatment, you can still see changes in the meibomian glands of patients who were treated with a standard course of 120 to 150 mg/kg isotretinoin,” he said, referring to the results of a study of 88 patients .

One study investigated the effects of omega-3 fatty acids and punctal plugs on tear film and ocular surface parameters in 90 patients receiving systemic isotretinoin therapy. They were divided into three groups: Those who received a soft preloaded silicone plug that was inserted in the inferior punctum of both eyes and received oral omega-3 fatty acid capsules twice daily for a total dose of 1,040 mg/day for 6 months; those who received a soft preloaded silicone plug and oral placebo, and those who received isotretinoin alone. At 6 months’ follow-up, those who were treated with omega-3 combined with the preloaded silicone plug had better meibomian gland function than did those who received isotretinoin alone or isotretinoin with the preloaded silicone plug.

Dr. Barbieri also noted that antihistamines may play a role in enhancing the effect of isotretinoin. In one study, 20 patients were treated with isotretinoin 0.4 mg/kg per day and 20 patients were also treated with an antihistamine, desloratadine 5 mg/day for 12 weeks. At week 12, patients in the group treated with isotretinoin and the antihistamine showed a more statistically significant decrease in acne lesion counts, compared with the isotretinoin-only group (reductions of 44.8% vs. 17.8%, respectively, in noninflammatory lesions; 55.8% vs. 22.9% in inflammatory lesions, and 45.6% vs. 18.7% in total lesions (P < .05 for all associations).

A subsequent larger study yielded similar findings. There were also lower rates of initial flaring and higher rates of patient satisfaction in the antihistamine groups in both studies.

In an interview at the meeting, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, described Dr. Barbieri as “a leader in taking a comprehensive view on what the history and latest information is on isotretinoin. His fresh approach is something everyone should consider and figure out what they can use in their practice.”

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Galderma, and Ortho Dermatologics. Medscape and this news organization are owned by the same parent company.

HONOLULU – In the clinical experience of John S. Barbieri, MD, MBA, cheilitis occurs in nearly all patients taking any dose of isotretinoin.

“If they don’t have dry lips, you have to wonder if they’re even absorbing isotretinoin,” Dr. Barbieri, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “Everyone is going to get dry lips.”

According to a retrospective review of 1,743 patients started on isotretinoin, other common mucocutaneous side effects include eczema, nose bleeds, and eye problems. Emerging research suggests that there may be a role for oral omega-3 in decreasing such side effects of the drug. In a case control study, 118 patients were randomized to isotretinoin alone or isotretinoin plus 1 g/day of oral omega-3 for 16 weeks. At week 16, the rate of dry lips was 26% in the isoretinoin only group compared with 14% in the combination group; similar trends were seen with dry nose (11% vs. 0 %, respectively) and dry skin (11% vs. 2%).

“Omega-3 is a simple thing that we can think about recommending for patients,” Dr. Barbieri said. “It’s very safe, inexpensive, and it may help us manage these common sides effect we run into.”

Another potential side effect of isotretinoin that he characterized as underappreciated is chronic dry eye and other ocular changes. One retrospective cohort study of 14,682 adolescents and young adults in Israel found that use of the drug resulted in reduced tear production and reduced tear quality. In another study, a review and meta-analysis of 21 publications involving 1,105 eyes of 842 patients, isotretinoin use was associated with increased conjunctival fluorescein staining, decreased corneal thickness, and worse patient-reported ocular surface disease index scores.

“These changes may be mediated by meibomian gland dysfunction and atrophy,” Dr. Barbieri said. “Fortunately, many of these tear film changes appear to resolve after treatment. Those changes in corneal thickness do seem to get better. That’s reassuring.”

In a study of 54 patients treated with isotretinoin, tear production and quality returned to baseline within 6 months of treatment completion. “But some changes in the meibomian gland may be persistent,” Dr. Barbieri said. “At 6 and 12 months after the end of treatment, you can still see changes in the meibomian glands of patients who were treated with a standard course of 120 to 150 mg/kg isotretinoin,” he said, referring to the results of a study of 88 patients .

One study investigated the effects of omega-3 fatty acids and punctal plugs on tear film and ocular surface parameters in 90 patients receiving systemic isotretinoin therapy. They were divided into three groups: Those who received a soft preloaded silicone plug that was inserted in the inferior punctum of both eyes and received oral omega-3 fatty acid capsules twice daily for a total dose of 1,040 mg/day for 6 months; those who received a soft preloaded silicone plug and oral placebo, and those who received isotretinoin alone. At 6 months’ follow-up, those who were treated with omega-3 combined with the preloaded silicone plug had better meibomian gland function than did those who received isotretinoin alone or isotretinoin with the preloaded silicone plug.

Dr. Barbieri also noted that antihistamines may play a role in enhancing the effect of isotretinoin. In one study, 20 patients were treated with isotretinoin 0.4 mg/kg per day and 20 patients were also treated with an antihistamine, desloratadine 5 mg/day for 12 weeks. At week 12, patients in the group treated with isotretinoin and the antihistamine showed a more statistically significant decrease in acne lesion counts, compared with the isotretinoin-only group (reductions of 44.8% vs. 17.8%, respectively, in noninflammatory lesions; 55.8% vs. 22.9% in inflammatory lesions, and 45.6% vs. 18.7% in total lesions (P < .05 for all associations).

A subsequent larger study yielded similar findings. There were also lower rates of initial flaring and higher rates of patient satisfaction in the antihistamine groups in both studies.

In an interview at the meeting, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, described Dr. Barbieri as “a leader in taking a comprehensive view on what the history and latest information is on isotretinoin. His fresh approach is something everyone should consider and figure out what they can use in their practice.”

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Galderma, and Ortho Dermatologics. Medscape and this news organization are owned by the same parent company.

HONOLULU – In the clinical experience of John S. Barbieri, MD, MBA, cheilitis occurs in nearly all patients taking any dose of isotretinoin.

“If they don’t have dry lips, you have to wonder if they’re even absorbing isotretinoin,” Dr. Barbieri, director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “Everyone is going to get dry lips.”

According to a retrospective review of 1,743 patients started on isotretinoin, other common mucocutaneous side effects include eczema, nose bleeds, and eye problems. Emerging research suggests that there may be a role for oral omega-3 in decreasing such side effects of the drug. In a case control study, 118 patients were randomized to isotretinoin alone or isotretinoin plus 1 g/day of oral omega-3 for 16 weeks. At week 16, the rate of dry lips was 26% in the isoretinoin only group compared with 14% in the combination group; similar trends were seen with dry nose (11% vs. 0 %, respectively) and dry skin (11% vs. 2%).

“Omega-3 is a simple thing that we can think about recommending for patients,” Dr. Barbieri said. “It’s very safe, inexpensive, and it may help us manage these common sides effect we run into.”

Another potential side effect of isotretinoin that he characterized as underappreciated is chronic dry eye and other ocular changes. One retrospective cohort study of 14,682 adolescents and young adults in Israel found that use of the drug resulted in reduced tear production and reduced tear quality. In another study, a review and meta-analysis of 21 publications involving 1,105 eyes of 842 patients, isotretinoin use was associated with increased conjunctival fluorescein staining, decreased corneal thickness, and worse patient-reported ocular surface disease index scores.

“These changes may be mediated by meibomian gland dysfunction and atrophy,” Dr. Barbieri said. “Fortunately, many of these tear film changes appear to resolve after treatment. Those changes in corneal thickness do seem to get better. That’s reassuring.”

In a study of 54 patients treated with isotretinoin, tear production and quality returned to baseline within 6 months of treatment completion. “But some changes in the meibomian gland may be persistent,” Dr. Barbieri said. “At 6 and 12 months after the end of treatment, you can still see changes in the meibomian glands of patients who were treated with a standard course of 120 to 150 mg/kg isotretinoin,” he said, referring to the results of a study of 88 patients .

One study investigated the effects of omega-3 fatty acids and punctal plugs on tear film and ocular surface parameters in 90 patients receiving systemic isotretinoin therapy. They were divided into three groups: Those who received a soft preloaded silicone plug that was inserted in the inferior punctum of both eyes and received oral omega-3 fatty acid capsules twice daily for a total dose of 1,040 mg/day for 6 months; those who received a soft preloaded silicone plug and oral placebo, and those who received isotretinoin alone. At 6 months’ follow-up, those who were treated with omega-3 combined with the preloaded silicone plug had better meibomian gland function than did those who received isotretinoin alone or isotretinoin with the preloaded silicone plug.

Dr. Barbieri also noted that antihistamines may play a role in enhancing the effect of isotretinoin. In one study, 20 patients were treated with isotretinoin 0.4 mg/kg per day and 20 patients were also treated with an antihistamine, desloratadine 5 mg/day for 12 weeks. At week 12, patients in the group treated with isotretinoin and the antihistamine showed a more statistically significant decrease in acne lesion counts, compared with the isotretinoin-only group (reductions of 44.8% vs. 17.8%, respectively, in noninflammatory lesions; 55.8% vs. 22.9% in inflammatory lesions, and 45.6% vs. 18.7% in total lesions (P < .05 for all associations).

A subsequent larger study yielded similar findings. There were also lower rates of initial flaring and higher rates of patient satisfaction in the antihistamine groups in both studies.

In an interview at the meeting, Lawrence F. Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego, described Dr. Barbieri as “a leader in taking a comprehensive view on what the history and latest information is on isotretinoin. His fresh approach is something everyone should consider and figure out what they can use in their practice.”

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Galderma, and Ortho Dermatologics. Medscape and this news organization are owned by the same parent company.

Modifiable chronic health conditions and socioeconomic factors may raise the risk for death in adult survivors of childhood cancer, according to new data from the St. Jude Lifetime Cohort.

Survivors with a greater number and severity of modifiable chronic health conditions as well as those living in the most versus least resource-deprived areas had a significantly higher risk of all-cause and health-related late death.

Finding ways to mitigate these factors “will be important to improving health outcomes and developing risk-stratification strategies to optimize care delivery to survivors at varying risk of adverse health events,” the researchers wrote.

The study indicates that treating chronic health conditions alone may not be enough to increase a cancer survivor’s lifespan; improving local environments matters too.

“It is important for clinicians to ask patients about their specific situation,” first author Matthew J. Ehrhardt, MD, department of oncology, St. Jude Children’s Research Hospital, Memphis, said in a news release. “It’s easy to prescribe medications or to tell people to exercise. It takes more time and more thoughtfulness to sit and understand environments in which they are residing.”

“As clinicians, we may have limited ability to modify some of those factors. But we can work closely with the rest of the health care team, such as social workers, for example, to help survivors to identify and access local resources,” Dr. Ehrhardt added.

The study was published online in JAMA Network Open.

A growing population of childhood cancer survivors faces an increased risk for premature death in the years following their diagnosis. However, associations between social determinants of health, modifiable health conditions, and late mortality in childhood cancer survivors remain unclear.

To assess late mortality, the study team analyzed data on 9,440 participants (median age at assessment, 27.5 years; range, 5.3-71.9 years) who lived at least 5 years after being diagnosed with a childhood cancer between 1962 and 2012.

During a median follow-up of about 18 years, childhood cancer survivors had an increased rate of both all-cause and health-related late mortality (standardized mortality rate, 7.6 for both). Among specific health-related causes of death, SMRs were 16.0 for subsequent neoplasms, 9.0 for pulmonary causes, 4.2 for cardiac causes, and 4.3 for other health-related causes.

To evaluate ties between modifiable chronic health conditions, social determinants, and late mortality, the researchers restricted their analysis to 3,407 adult study participants for whom relevant data were available. Modifiable chronic health conditions included dyslipidemia, hypertension, diabetes, underweight or obesity, bone mineral deficiency, and hypothyroidism.

After adjusting for individual factors, including age at diagnosis and treatment, as well as neighborhood-level factors, the researchers observed a significantly increased risk for death among survivors with one or more modifiable chronic health conditions of grade 2 or higher (relative risk, 2.2), two chronic health conditions of grade 2 or higher (RR, 2.6) or three chronic health conditions of grade 2 or higher (RR, 3.6).

These findings suggest that “increased late mortality experienced by childhood cancer survivors in adulthood may not be predetermined by treatment-related risk factors alone,” the researchers said.

In addition, survivors living in the most disadvantaged areas, as measured by the area deprivation index (ADI), had a five- to eightfold increased risk of late death from any cause compared with those living in the least disadvantaged areas, even after adjusting for modifiable chronic health conditions, cancer treatment, demographics, and individual socioeconomic factors.

The findings have important public health implications, Dr. Ehrhardt and colleagues said. The results can, for instance, help identify and stratify cancer survivors at higher lifetime risk for specific chronic conditions and late death. 

This risk-stratified approach to care, however, is “relatively static” and does not account for risk factors acquired after cancer diagnosis and treatment, such as social determinants of health.

That is why also focusing on socioeconomic factors is important, and transitional care services following cancer treatment should consider that survivors in disadvantaged neighborhoods may lack supportive resources to address health issues, potentially leading to increased risk for death, the researchers said.

The knowledge that living in a resource-poor neighborhood may raise the risk for late death in childhood cancer survivors “strengthens support for public health policies that will direct resources to such regions and facilitate a multipronged approach to risk mitigation,” the authors concluded.

This study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. The authors reported no relevant financial relationships.

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

Modifiable chronic health conditions and socioeconomic factors may raise the risk for death in adult survivors of childhood cancer, according to new data from the St. Jude Lifetime Cohort.

Survivors with a greater number and severity of modifiable chronic health conditions as well as those living in the most versus least resource-deprived areas had a significantly higher risk of all-cause and health-related late death.

Finding ways to mitigate these factors “will be important to improving health outcomes and developing risk-stratification strategies to optimize care delivery to survivors at varying risk of adverse health events,” the researchers wrote.

The study indicates that treating chronic health conditions alone may not be enough to increase a cancer survivor’s lifespan; improving local environments matters too.

“It is important for clinicians to ask patients about their specific situation,” first author Matthew J. Ehrhardt, MD, department of oncology, St. Jude Children’s Research Hospital, Memphis, said in a news release. “It’s easy to prescribe medications or to tell people to exercise. It takes more time and more thoughtfulness to sit and understand environments in which they are residing.”

“As clinicians, we may have limited ability to modify some of those factors. But we can work closely with the rest of the health care team, such as social workers, for example, to help survivors to identify and access local resources,” Dr. Ehrhardt added.

The study was published online in JAMA Network Open.

A growing population of childhood cancer survivors faces an increased risk for premature death in the years following their diagnosis. However, associations between social determinants of health, modifiable health conditions, and late mortality in childhood cancer survivors remain unclear.

To assess late mortality, the study team analyzed data on 9,440 participants (median age at assessment, 27.5 years; range, 5.3-71.9 years) who lived at least 5 years after being diagnosed with a childhood cancer between 1962 and 2012.

During a median follow-up of about 18 years, childhood cancer survivors had an increased rate of both all-cause and health-related late mortality (standardized mortality rate, 7.6 for both). Among specific health-related causes of death, SMRs were 16.0 for subsequent neoplasms, 9.0 for pulmonary causes, 4.2 for cardiac causes, and 4.3 for other health-related causes.

To evaluate ties between modifiable chronic health conditions, social determinants, and late mortality, the researchers restricted their analysis to 3,407 adult study participants for whom relevant data were available. Modifiable chronic health conditions included dyslipidemia, hypertension, diabetes, underweight or obesity, bone mineral deficiency, and hypothyroidism.

After adjusting for individual factors, including age at diagnosis and treatment, as well as neighborhood-level factors, the researchers observed a significantly increased risk for death among survivors with one or more modifiable chronic health conditions of grade 2 or higher (relative risk, 2.2), two chronic health conditions of grade 2 or higher (RR, 2.6) or three chronic health conditions of grade 2 or higher (RR, 3.6).

These findings suggest that “increased late mortality experienced by childhood cancer survivors in adulthood may not be predetermined by treatment-related risk factors alone,” the researchers said.

In addition, survivors living in the most disadvantaged areas, as measured by the area deprivation index (ADI), had a five- to eightfold increased risk of late death from any cause compared with those living in the least disadvantaged areas, even after adjusting for modifiable chronic health conditions, cancer treatment, demographics, and individual socioeconomic factors.

The findings have important public health implications, Dr. Ehrhardt and colleagues said. The results can, for instance, help identify and stratify cancer survivors at higher lifetime risk for specific chronic conditions and late death. 

This risk-stratified approach to care, however, is “relatively static” and does not account for risk factors acquired after cancer diagnosis and treatment, such as social determinants of health.

That is why also focusing on socioeconomic factors is important, and transitional care services following cancer treatment should consider that survivors in disadvantaged neighborhoods may lack supportive resources to address health issues, potentially leading to increased risk for death, the researchers said.

The knowledge that living in a resource-poor neighborhood may raise the risk for late death in childhood cancer survivors “strengthens support for public health policies that will direct resources to such regions and facilitate a multipronged approach to risk mitigation,” the authors concluded.

This study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. The authors reported no relevant financial relationships.

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

Modifiable chronic health conditions and socioeconomic factors may raise the risk for death in adult survivors of childhood cancer, according to new data from the St. Jude Lifetime Cohort.

Survivors with a greater number and severity of modifiable chronic health conditions as well as those living in the most versus least resource-deprived areas had a significantly higher risk of all-cause and health-related late death.

Finding ways to mitigate these factors “will be important to improving health outcomes and developing risk-stratification strategies to optimize care delivery to survivors at varying risk of adverse health events,” the researchers wrote.

The study indicates that treating chronic health conditions alone may not be enough to increase a cancer survivor’s lifespan; improving local environments matters too.

“It is important for clinicians to ask patients about their specific situation,” first author Matthew J. Ehrhardt, MD, department of oncology, St. Jude Children’s Research Hospital, Memphis, said in a news release. “It’s easy to prescribe medications or to tell people to exercise. It takes more time and more thoughtfulness to sit and understand environments in which they are residing.”

“As clinicians, we may have limited ability to modify some of those factors. But we can work closely with the rest of the health care team, such as social workers, for example, to help survivors to identify and access local resources,” Dr. Ehrhardt added.

The study was published online in JAMA Network Open.

A growing population of childhood cancer survivors faces an increased risk for premature death in the years following their diagnosis. However, associations between social determinants of health, modifiable health conditions, and late mortality in childhood cancer survivors remain unclear.

To assess late mortality, the study team analyzed data on 9,440 participants (median age at assessment, 27.5 years; range, 5.3-71.9 years) who lived at least 5 years after being diagnosed with a childhood cancer between 1962 and 2012.

During a median follow-up of about 18 years, childhood cancer survivors had an increased rate of both all-cause and health-related late mortality (standardized mortality rate, 7.6 for both). Among specific health-related causes of death, SMRs were 16.0 for subsequent neoplasms, 9.0 for pulmonary causes, 4.2 for cardiac causes, and 4.3 for other health-related causes.

To evaluate ties between modifiable chronic health conditions, social determinants, and late mortality, the researchers restricted their analysis to 3,407 adult study participants for whom relevant data were available. Modifiable chronic health conditions included dyslipidemia, hypertension, diabetes, underweight or obesity, bone mineral deficiency, and hypothyroidism.

After adjusting for individual factors, including age at diagnosis and treatment, as well as neighborhood-level factors, the researchers observed a significantly increased risk for death among survivors with one or more modifiable chronic health conditions of grade 2 or higher (relative risk, 2.2), two chronic health conditions of grade 2 or higher (RR, 2.6) or three chronic health conditions of grade 2 or higher (RR, 3.6).

These findings suggest that “increased late mortality experienced by childhood cancer survivors in adulthood may not be predetermined by treatment-related risk factors alone,” the researchers said.

In addition, survivors living in the most disadvantaged areas, as measured by the area deprivation index (ADI), had a five- to eightfold increased risk of late death from any cause compared with those living in the least disadvantaged areas, even after adjusting for modifiable chronic health conditions, cancer treatment, demographics, and individual socioeconomic factors.

The findings have important public health implications, Dr. Ehrhardt and colleagues said. The results can, for instance, help identify and stratify cancer survivors at higher lifetime risk for specific chronic conditions and late death. 

This risk-stratified approach to care, however, is “relatively static” and does not account for risk factors acquired after cancer diagnosis and treatment, such as social determinants of health.

That is why also focusing on socioeconomic factors is important, and transitional care services following cancer treatment should consider that survivors in disadvantaged neighborhoods may lack supportive resources to address health issues, potentially leading to increased risk for death, the researchers said.

The knowledge that living in a resource-poor neighborhood may raise the risk for late death in childhood cancer survivors “strengthens support for public health policies that will direct resources to such regions and facilitate a multipronged approach to risk mitigation,” the authors concluded.

This study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. The authors reported no relevant financial relationships.

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