Pediatrics

Technologies that allow people to monitor blood sugar and automate the administration of insulin have radically transformed the lives of patients – and children in particular – with type 1 diabetes. But the devices often come with a cost: Insulin pumps and continuous glucose monitors can irritate the skin at the points of contact, causing some people to stop using their pumps or monitors altogether.

Regular use of lipid-rich skin creams can reduce eczema in children who use insulin pumps and continuous glucose monitors to manage type 1 diabetes, Danish researchers reported last month. The article is currently undergoing peer review at The Lancet Diabetes and Endocrinology, and the authors said they hope their approach will deter more children from abandoning diabetes technology.

“A simple thing can actually change a lot,” said Anna Korsgaard Berg, MD, a pediatrician who specializes in diabetes care at Copenhagen University Hospital’s Steno Diabetes Center in Herlev, Denmark, and a coauthor of the new study. “Not all skin reactions can be solved by the skin care program, but it can help improve the issue.”

More than 1.5 million children and adolescents worldwide live with type 1 diabetes, a condition that requires continuous insulin infusion. Insulin pumps meet this need in many wealthier countries, and are often used in combination with sensors that measure a child’s glucose level. Both the American Diabetes Association and the International Society for Adolescent and Pediatric Diabetes recommend insulin pumps and continuous glucose monitors as core treatment tools.

Dr. Berg and colleagues, who have previously shown that as many as 90% of children who use these devices experience some kind of skin reaction, want to minimize the rate of such discomfort in hopes that fewer children stop using the devices. According to a 2014 study, 18% of people with type 1 diabetes who stopped using continuous glucose monitors did so because of skin irritation.
 

Lather on that lipid-rich lotion

Dr. Berg and colleagues studied 170 children and adolescents with type 1 diabetes (average age, 11 years) who use insulin pumps, continuous glucose monitors, or both. From March 2020 to July 2021, 112 children (55 girls) employed a skin care program developed for the study, while the other 58 (34 girls) did not receive any skin care advice.

The skin care group received instructions about how to gently insert and remove their insulin pumps or glucose monitors, to minimize skin damage. They also were told to avoid disinfectants such as alcohol, which can irritate skin. The children in this group used a cream containing 70% lipids to help rehydrate their skin, applying the salve each day a device was not inserted into their skin.

Eczema can be a real problem for kids who use insulin pumps and continuous glucose monitors to manage type 1 diabetes. Researchers found that regular use of lipid-rich skin creams can reduce its incidence.

Although insulin pumps and glucose monitors are kept in place for longer periods of time than they once were, Dr. Berg and colleagues noted, users do periodically remove them when bathing or when undergoing medical tests that involve x-rays. On days when the devices were not in place for a period of time, children in the skin care group were encouraged to follow the protocol.
 

Study results

One-third of children in the skin care group developed eczema or experienced a wound, compared with almost half of the children in the control group, according to the researchers. The absolute difference in developing eczema or wounds between the two groups was 12.9 % (95% confidence interval, –28.7% to 2.9%).

Children in the skin care group were much less likely to develop wounds, the researchers found, when they focused only on wounds and not eczema (odds ratio, 0.29, 95% CI, 0.12-0.68).

Dr. Berg said she would like to explore whether other techniques, such as a combination of patches, adhesives, or other lotions, yield even better results.

“Anything that can help people use technology more consistently is better for both quality of life and diabetes outcomes,” said Priya Prahalad, MD, a specialist in pediatric endocrinology and diabetes at Stanford Medicine Children’s Health in Palo Alto and Sunnyvale, Calif. 

Dr. Prahalad, who was not involved in the Danish study, said that although the sample sizes in the trial were relatively small, the data are “headed in the right direction.”

Pediatricians already recommend using moisturizing creams at the sites where pumps or glucose monitors are inserted into the skin, she noted. But the new study simply employed an especially moisturizing cream to mitigate skin damage.

Although one reason for skin irritation may be the repeated insertion and removal of devices, Dr. Berg and Dr. Prahalad stressed that the medical devices themselves may contain allergy-causing components. Device makers are not required to disclose what’s inside the boxes.

“I do not understand why the full content of a device is not by law mandatory to declare, when declaration by law is mandatory for many other products and drugs but not for medical devices,” Dr. Berg said.

Dr. Berg reports receiving lipid cream from Teva Pharmaceuticals and research support from Medtronic. Dr. Prahalad reports no relevant financial relationships.

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

Technologies that allow people to monitor blood sugar and automate the administration of insulin have radically transformed the lives of patients – and children in particular – with type 1 diabetes. But the devices often come with a cost: Insulin pumps and continuous glucose monitors can irritate the skin at the points of contact, causing some people to stop using their pumps or monitors altogether.

Regular use of lipid-rich skin creams can reduce eczema in children who use insulin pumps and continuous glucose monitors to manage type 1 diabetes, Danish researchers reported last month. The article is currently undergoing peer review at The Lancet Diabetes and Endocrinology, and the authors said they hope their approach will deter more children from abandoning diabetes technology.

“A simple thing can actually change a lot,” said Anna Korsgaard Berg, MD, a pediatrician who specializes in diabetes care at Copenhagen University Hospital’s Steno Diabetes Center in Herlev, Denmark, and a coauthor of the new study. “Not all skin reactions can be solved by the skin care program, but it can help improve the issue.”

More than 1.5 million children and adolescents worldwide live with type 1 diabetes, a condition that requires continuous insulin infusion. Insulin pumps meet this need in many wealthier countries, and are often used in combination with sensors that measure a child’s glucose level. Both the American Diabetes Association and the International Society for Adolescent and Pediatric Diabetes recommend insulin pumps and continuous glucose monitors as core treatment tools.

Dr. Berg and colleagues, who have previously shown that as many as 90% of children who use these devices experience some kind of skin reaction, want to minimize the rate of such discomfort in hopes that fewer children stop using the devices. According to a 2014 study, 18% of people with type 1 diabetes who stopped using continuous glucose monitors did so because of skin irritation.
 

Lather on that lipid-rich lotion

Dr. Berg and colleagues studied 170 children and adolescents with type 1 diabetes (average age, 11 years) who use insulin pumps, continuous glucose monitors, or both. From March 2020 to July 2021, 112 children (55 girls) employed a skin care program developed for the study, while the other 58 (34 girls) did not receive any skin care advice.

The skin care group received instructions about how to gently insert and remove their insulin pumps or glucose monitors, to minimize skin damage. They also were told to avoid disinfectants such as alcohol, which can irritate skin. The children in this group used a cream containing 70% lipids to help rehydrate their skin, applying the salve each day a device was not inserted into their skin.

Eczema can be a real problem for kids who use insulin pumps and continuous glucose monitors to manage type 1 diabetes. Researchers found that regular use of lipid-rich skin creams can reduce its incidence.

Although insulin pumps and glucose monitors are kept in place for longer periods of time than they once were, Dr. Berg and colleagues noted, users do periodically remove them when bathing or when undergoing medical tests that involve x-rays. On days when the devices were not in place for a period of time, children in the skin care group were encouraged to follow the protocol.
 

Study results

One-third of children in the skin care group developed eczema or experienced a wound, compared with almost half of the children in the control group, according to the researchers. The absolute difference in developing eczema or wounds between the two groups was 12.9 % (95% confidence interval, –28.7% to 2.9%).

Children in the skin care group were much less likely to develop wounds, the researchers found, when they focused only on wounds and not eczema (odds ratio, 0.29, 95% CI, 0.12-0.68).

Dr. Berg said she would like to explore whether other techniques, such as a combination of patches, adhesives, or other lotions, yield even better results.

“Anything that can help people use technology more consistently is better for both quality of life and diabetes outcomes,” said Priya Prahalad, MD, a specialist in pediatric endocrinology and diabetes at Stanford Medicine Children’s Health in Palo Alto and Sunnyvale, Calif. 

Dr. Prahalad, who was not involved in the Danish study, said that although the sample sizes in the trial were relatively small, the data are “headed in the right direction.”

Pediatricians already recommend using moisturizing creams at the sites where pumps or glucose monitors are inserted into the skin, she noted. But the new study simply employed an especially moisturizing cream to mitigate skin damage.

Although one reason for skin irritation may be the repeated insertion and removal of devices, Dr. Berg and Dr. Prahalad stressed that the medical devices themselves may contain allergy-causing components. Device makers are not required to disclose what’s inside the boxes.

“I do not understand why the full content of a device is not by law mandatory to declare, when declaration by law is mandatory for many other products and drugs but not for medical devices,” Dr. Berg said.

Dr. Berg reports receiving lipid cream from Teva Pharmaceuticals and research support from Medtronic. Dr. Prahalad reports no relevant financial relationships.

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

Technologies that allow people to monitor blood sugar and automate the administration of insulin have radically transformed the lives of patients – and children in particular – with type 1 diabetes. But the devices often come with a cost: Insulin pumps and continuous glucose monitors can irritate the skin at the points of contact, causing some people to stop using their pumps or monitors altogether.

Regular use of lipid-rich skin creams can reduce eczema in children who use insulin pumps and continuous glucose monitors to manage type 1 diabetes, Danish researchers reported last month. The article is currently undergoing peer review at The Lancet Diabetes and Endocrinology, and the authors said they hope their approach will deter more children from abandoning diabetes technology.

“A simple thing can actually change a lot,” said Anna Korsgaard Berg, MD, a pediatrician who specializes in diabetes care at Copenhagen University Hospital’s Steno Diabetes Center in Herlev, Denmark, and a coauthor of the new study. “Not all skin reactions can be solved by the skin care program, but it can help improve the issue.”

More than 1.5 million children and adolescents worldwide live with type 1 diabetes, a condition that requires continuous insulin infusion. Insulin pumps meet this need in many wealthier countries, and are often used in combination with sensors that measure a child’s glucose level. Both the American Diabetes Association and the International Society for Adolescent and Pediatric Diabetes recommend insulin pumps and continuous glucose monitors as core treatment tools.

Dr. Berg and colleagues, who have previously shown that as many as 90% of children who use these devices experience some kind of skin reaction, want to minimize the rate of such discomfort in hopes that fewer children stop using the devices. According to a 2014 study, 18% of people with type 1 diabetes who stopped using continuous glucose monitors did so because of skin irritation.
 

Lather on that lipid-rich lotion

Dr. Berg and colleagues studied 170 children and adolescents with type 1 diabetes (average age, 11 years) who use insulin pumps, continuous glucose monitors, or both. From March 2020 to July 2021, 112 children (55 girls) employed a skin care program developed for the study, while the other 58 (34 girls) did not receive any skin care advice.

The skin care group received instructions about how to gently insert and remove their insulin pumps or glucose monitors, to minimize skin damage. They also were told to avoid disinfectants such as alcohol, which can irritate skin. The children in this group used a cream containing 70% lipids to help rehydrate their skin, applying the salve each day a device was not inserted into their skin.

Eczema can be a real problem for kids who use insulin pumps and continuous glucose monitors to manage type 1 diabetes. Researchers found that regular use of lipid-rich skin creams can reduce its incidence.

Although insulin pumps and glucose monitors are kept in place for longer periods of time than they once were, Dr. Berg and colleagues noted, users do periodically remove them when bathing or when undergoing medical tests that involve x-rays. On days when the devices were not in place for a period of time, children in the skin care group were encouraged to follow the protocol.
 

Study results

One-third of children in the skin care group developed eczema or experienced a wound, compared with almost half of the children in the control group, according to the researchers. The absolute difference in developing eczema or wounds between the two groups was 12.9 % (95% confidence interval, –28.7% to 2.9%).

Children in the skin care group were much less likely to develop wounds, the researchers found, when they focused only on wounds and not eczema (odds ratio, 0.29, 95% CI, 0.12-0.68).

Dr. Berg said she would like to explore whether other techniques, such as a combination of patches, adhesives, or other lotions, yield even better results.

“Anything that can help people use technology more consistently is better for both quality of life and diabetes outcomes,” said Priya Prahalad, MD, a specialist in pediatric endocrinology and diabetes at Stanford Medicine Children’s Health in Palo Alto and Sunnyvale, Calif. 

Dr. Prahalad, who was not involved in the Danish study, said that although the sample sizes in the trial were relatively small, the data are “headed in the right direction.”

Pediatricians already recommend using moisturizing creams at the sites where pumps or glucose monitors are inserted into the skin, she noted. But the new study simply employed an especially moisturizing cream to mitigate skin damage.

Although one reason for skin irritation may be the repeated insertion and removal of devices, Dr. Berg and Dr. Prahalad stressed that the medical devices themselves may contain allergy-causing components. Device makers are not required to disclose what’s inside the boxes.

“I do not understand why the full content of a device is not by law mandatory to declare, when declaration by law is mandatory for many other products and drugs but not for medical devices,” Dr. Berg said.

Dr. Berg reports receiving lipid cream from Teva Pharmaceuticals and research support from Medtronic. Dr. Prahalad reports no relevant financial relationships.

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

Considered fringe just a few years ago, oral immunotherapy (OIT) has entered mainstream conversation about treating food allergies – particularly in younger children.

The buzz surrounding OIT – which involves ingesting daily doses of the culprit food to raise the threshold that would trigger a reaction – grew with the approval, by the U.S. Food and Drug Administration of Palforzia, of the peanut OIT pill in January 2020. Yet many allergists remained wary about the treatment, a monthslong regimen that can itself trigger allergic reactions.

Now, accumulating research points to “a possible window of opportunity early in life, less than 3 years of age, for more successful disease remission,” Justin Schwartz, MD, PhD, an allergist at Cincinnati Children’s Hospital, told a crowd at the annual meeting of the American Academy of Allergy, Asthma, & Immunology.

His presentation about OIT in toddlers kicked off a 3-hour clinical practice course, one of several dozen conference offerings highlighting this emerging approach.

Several AAAAI posters add to prior studies (for example, DEVIL and IMPACT) suggesting that OIT proceeds more smoothly and faster during a child’s earliest years – a season fraught with accidental exposures and reactions.

One poster described a retrospective study of 73 children younger than 4 years who underwent OIT at the Cleveland Clinic Food Allergy Center. Sixty-four were treated for peanut allergies, and seven patients received OIT for multiple foods, including tree nuts, milk, wheat, and sesame.

Of the 80 total OIT courses, 76 (95%) reached maintenance – meaning the child tolerated a small amount (for example, 1-2 peanuts) without reacting – in a median of 104 days (~3.4 months).

That is “quite impressive,” said allergist Hugh Windom, MD, whose clinic in Sarasota, Fla., has offered OIT since 2012.

Older children typically have 80%-90% success and take longer (6-8 months) to reach maintenance because of busier schedules and reactions that slow them down, he said. In his clinic’s larger retrospective analysis of preschool-aged OIT patients, presented at the 2022 AAAAI meeting, 89% of patients with peanut allergies and 72% of children with multiple food allergies achieved maintenance.

In the Cleveland Clinic study, children with favorable lab test results after receiving the maintenance dose for 6 months were offered an oral food challenge. Of 24 patients who completed the challenge, 75% “passed with a normal serving size of the treated food (for example, two tablespoons of peanut butter),” Sarah Johnson, MD, lead author and Cleveland Clinic allergy/immunology fellow, said in an interview.

Plus, OIT seemed safer for toddlers. Although 41% of the children had reactions during clinic updosing and 48% had reactions at home, only ~3% of toddler OIT courses required epinephrine. By comparison, ~11% of treatments required epinephrine in a large OIT study of older children.

When a child reacts, “you might keep them on the dose or go a little slower,” said Johnson, who worked with allergist Jaclyn Bjelac, MD, on the study. These setbacks occurred less frequently in toddlers, allowing their OIT to “go a lot faster” than in older children. And so far, Dr. Johnson said, none of the toddlers have shown signs of eosinophilic esophagitis, a rare complication that can develop during OIT.

A smaller analysis of real-world outcomes in an academic clinical setting also found that OIT was well tolerated at very young ages. Since 2020, this ongoing study at UVA Children’s Hospital in Charlottesville has enrolled 22 peanut-allergic children (aged 6 months to 3 years) for OIT. Three patients have dropped out, four are in the buildup phrase, and 15 have reached maintenance dosing. None have reported having to use epinephrine.

Three patients have completed 1 year of maintenance therapy, and another patient accidentally consumed ~3,000 mg of peanut protein (equivalent to ~10 peanuts) after 5 months of maintenance. All four “now incorporate peanut into their diets ad lib,” according to lead author and allergist Jonathan Hemler, MD, who directs the UVA pediatric food allergy program.

These findings are “really reassuring – because even if you may not offer OIT, you’re still going to get questions about it,” said Ama Alexis, MD, an allergist/immunologist in private practice in New York and a clinical assistant professor at NYU Grossmann School of Medicine, commenting on the Cleveland Clinic study.

“It’s great that we’re hearing and seeing so much about OIT,” she added. While training as an allergy/immunology fellow 15 years ago, many saw the treatment as dangerous – “an absolute no-no,” she said.

The AAAAI still considers OIT “investigational,” yet this year’s annual meeting featured 22 posters – plus a course, workshop, seminar, and oral abstract session – on the approach.

The “thought process has shifted,” Dr. Alexis said. “It’s good to see all these numbers, these results. I think once you’re comfortable, you should embrace new therapies.”

Dr. Schwartz has consulted for Shire/Takeda and has received research funding from Knopp Biosciences. Dr. Alexis consults for AbbVie, serves on advisory boards for Jansen and Eli Lilli, and is a member of Pfizer’s advisory board and speaker’s bureau. Dr. Johnson, Dr. Windom, and Dr. Hemler report no relevant financial relationships.

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

Considered fringe just a few years ago, oral immunotherapy (OIT) has entered mainstream conversation about treating food allergies – particularly in younger children.

The buzz surrounding OIT – which involves ingesting daily doses of the culprit food to raise the threshold that would trigger a reaction – grew with the approval, by the U.S. Food and Drug Administration of Palforzia, of the peanut OIT pill in January 2020. Yet many allergists remained wary about the treatment, a monthslong regimen that can itself trigger allergic reactions.

Now, accumulating research points to “a possible window of opportunity early in life, less than 3 years of age, for more successful disease remission,” Justin Schwartz, MD, PhD, an allergist at Cincinnati Children’s Hospital, told a crowd at the annual meeting of the American Academy of Allergy, Asthma, & Immunology.

His presentation about OIT in toddlers kicked off a 3-hour clinical practice course, one of several dozen conference offerings highlighting this emerging approach.

Several AAAAI posters add to prior studies (for example, DEVIL and IMPACT) suggesting that OIT proceeds more smoothly and faster during a child’s earliest years – a season fraught with accidental exposures and reactions.

One poster described a retrospective study of 73 children younger than 4 years who underwent OIT at the Cleveland Clinic Food Allergy Center. Sixty-four were treated for peanut allergies, and seven patients received OIT for multiple foods, including tree nuts, milk, wheat, and sesame.

Of the 80 total OIT courses, 76 (95%) reached maintenance – meaning the child tolerated a small amount (for example, 1-2 peanuts) without reacting – in a median of 104 days (~3.4 months).

That is “quite impressive,” said allergist Hugh Windom, MD, whose clinic in Sarasota, Fla., has offered OIT since 2012.

Older children typically have 80%-90% success and take longer (6-8 months) to reach maintenance because of busier schedules and reactions that slow them down, he said. In his clinic’s larger retrospective analysis of preschool-aged OIT patients, presented at the 2022 AAAAI meeting, 89% of patients with peanut allergies and 72% of children with multiple food allergies achieved maintenance.

In the Cleveland Clinic study, children with favorable lab test results after receiving the maintenance dose for 6 months were offered an oral food challenge. Of 24 patients who completed the challenge, 75% “passed with a normal serving size of the treated food (for example, two tablespoons of peanut butter),” Sarah Johnson, MD, lead author and Cleveland Clinic allergy/immunology fellow, said in an interview.

Plus, OIT seemed safer for toddlers. Although 41% of the children had reactions during clinic updosing and 48% had reactions at home, only ~3% of toddler OIT courses required epinephrine. By comparison, ~11% of treatments required epinephrine in a large OIT study of older children.

When a child reacts, “you might keep them on the dose or go a little slower,” said Johnson, who worked with allergist Jaclyn Bjelac, MD, on the study. These setbacks occurred less frequently in toddlers, allowing their OIT to “go a lot faster” than in older children. And so far, Dr. Johnson said, none of the toddlers have shown signs of eosinophilic esophagitis, a rare complication that can develop during OIT.

A smaller analysis of real-world outcomes in an academic clinical setting also found that OIT was well tolerated at very young ages. Since 2020, this ongoing study at UVA Children’s Hospital in Charlottesville has enrolled 22 peanut-allergic children (aged 6 months to 3 years) for OIT. Three patients have dropped out, four are in the buildup phrase, and 15 have reached maintenance dosing. None have reported having to use epinephrine.

Three patients have completed 1 year of maintenance therapy, and another patient accidentally consumed ~3,000 mg of peanut protein (equivalent to ~10 peanuts) after 5 months of maintenance. All four “now incorporate peanut into their diets ad lib,” according to lead author and allergist Jonathan Hemler, MD, who directs the UVA pediatric food allergy program.

These findings are “really reassuring – because even if you may not offer OIT, you’re still going to get questions about it,” said Ama Alexis, MD, an allergist/immunologist in private practice in New York and a clinical assistant professor at NYU Grossmann School of Medicine, commenting on the Cleveland Clinic study.

“It’s great that we’re hearing and seeing so much about OIT,” she added. While training as an allergy/immunology fellow 15 years ago, many saw the treatment as dangerous – “an absolute no-no,” she said.

The AAAAI still considers OIT “investigational,” yet this year’s annual meeting featured 22 posters – plus a course, workshop, seminar, and oral abstract session – on the approach.

The “thought process has shifted,” Dr. Alexis said. “It’s good to see all these numbers, these results. I think once you’re comfortable, you should embrace new therapies.”

Dr. Schwartz has consulted for Shire/Takeda and has received research funding from Knopp Biosciences. Dr. Alexis consults for AbbVie, serves on advisory boards for Jansen and Eli Lilli, and is a member of Pfizer’s advisory board and speaker’s bureau. Dr. Johnson, Dr. Windom, and Dr. Hemler report no relevant financial relationships.

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

Considered fringe just a few years ago, oral immunotherapy (OIT) has entered mainstream conversation about treating food allergies – particularly in younger children.

The buzz surrounding OIT – which involves ingesting daily doses of the culprit food to raise the threshold that would trigger a reaction – grew with the approval, by the U.S. Food and Drug Administration of Palforzia, of the peanut OIT pill in January 2020. Yet many allergists remained wary about the treatment, a monthslong regimen that can itself trigger allergic reactions.

Now, accumulating research points to “a possible window of opportunity early in life, less than 3 years of age, for more successful disease remission,” Justin Schwartz, MD, PhD, an allergist at Cincinnati Children’s Hospital, told a crowd at the annual meeting of the American Academy of Allergy, Asthma, & Immunology.

His presentation about OIT in toddlers kicked off a 3-hour clinical practice course, one of several dozen conference offerings highlighting this emerging approach.

Several AAAAI posters add to prior studies (for example, DEVIL and IMPACT) suggesting that OIT proceeds more smoothly and faster during a child’s earliest years – a season fraught with accidental exposures and reactions.

One poster described a retrospective study of 73 children younger than 4 years who underwent OIT at the Cleveland Clinic Food Allergy Center. Sixty-four were treated for peanut allergies, and seven patients received OIT for multiple foods, including tree nuts, milk, wheat, and sesame.

Of the 80 total OIT courses, 76 (95%) reached maintenance – meaning the child tolerated a small amount (for example, 1-2 peanuts) without reacting – in a median of 104 days (~3.4 months).

That is “quite impressive,” said allergist Hugh Windom, MD, whose clinic in Sarasota, Fla., has offered OIT since 2012.

Older children typically have 80%-90% success and take longer (6-8 months) to reach maintenance because of busier schedules and reactions that slow them down, he said. In his clinic’s larger retrospective analysis of preschool-aged OIT patients, presented at the 2022 AAAAI meeting, 89% of patients with peanut allergies and 72% of children with multiple food allergies achieved maintenance.

In the Cleveland Clinic study, children with favorable lab test results after receiving the maintenance dose for 6 months were offered an oral food challenge. Of 24 patients who completed the challenge, 75% “passed with a normal serving size of the treated food (for example, two tablespoons of peanut butter),” Sarah Johnson, MD, lead author and Cleveland Clinic allergy/immunology fellow, said in an interview.

Plus, OIT seemed safer for toddlers. Although 41% of the children had reactions during clinic updosing and 48% had reactions at home, only ~3% of toddler OIT courses required epinephrine. By comparison, ~11% of treatments required epinephrine in a large OIT study of older children.

When a child reacts, “you might keep them on the dose or go a little slower,” said Johnson, who worked with allergist Jaclyn Bjelac, MD, on the study. These setbacks occurred less frequently in toddlers, allowing their OIT to “go a lot faster” than in older children. And so far, Dr. Johnson said, none of the toddlers have shown signs of eosinophilic esophagitis, a rare complication that can develop during OIT.

A smaller analysis of real-world outcomes in an academic clinical setting also found that OIT was well tolerated at very young ages. Since 2020, this ongoing study at UVA Children’s Hospital in Charlottesville has enrolled 22 peanut-allergic children (aged 6 months to 3 years) for OIT. Three patients have dropped out, four are in the buildup phrase, and 15 have reached maintenance dosing. None have reported having to use epinephrine.

Three patients have completed 1 year of maintenance therapy, and another patient accidentally consumed ~3,000 mg of peanut protein (equivalent to ~10 peanuts) after 5 months of maintenance. All four “now incorporate peanut into their diets ad lib,” according to lead author and allergist Jonathan Hemler, MD, who directs the UVA pediatric food allergy program.

These findings are “really reassuring – because even if you may not offer OIT, you’re still going to get questions about it,” said Ama Alexis, MD, an allergist/immunologist in private practice in New York and a clinical assistant professor at NYU Grossmann School of Medicine, commenting on the Cleveland Clinic study.

“It’s great that we’re hearing and seeing so much about OIT,” she added. While training as an allergy/immunology fellow 15 years ago, many saw the treatment as dangerous – “an absolute no-no,” she said.

The AAAAI still considers OIT “investigational,” yet this year’s annual meeting featured 22 posters – plus a course, workshop, seminar, and oral abstract session – on the approach.

The “thought process has shifted,” Dr. Alexis said. “It’s good to see all these numbers, these results. I think once you’re comfortable, you should embrace new therapies.”

Dr. Schwartz has consulted for Shire/Takeda and has received research funding from Knopp Biosciences. Dr. Alexis consults for AbbVie, serves on advisory boards for Jansen and Eli Lilli, and is a member of Pfizer’s advisory board and speaker’s bureau. Dr. Johnson, Dr. Windom, and Dr. Hemler report no relevant financial relationships.

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

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

No significant differences emerged in gut microbial diversity in preterm infants who exclusively received human milk products, compared with those receiving bovine milk formula or fortifiers, a randomized controlled trial found. Nor were any differences noted in the secondary endpoint of clinical outcomes in the U.K. study, published online in JAMA Network Open.

Newcastle University

The finding was unanticipated, according to lead author Nicholas D. Embleton, MBBS, MD, a professor of neonatal medicine at Newcastle University in England. “Over the last 10 years we’ve focused particularly on the role of the microbiome to better understand causal mechanisms of necrotizing enterocolitis, or NEC,” he said in an interview. “We anticipated that an exclusive human milk diet would have measurable impacts on microbiome diversity as a potential mechanism [in] disease modulation as part of the mechanism by which exclusive human milk diets benefit preterm infants.”

Shortfalls in a mother’s own milk supply often necessitate the use of bovine formula or pasteurized human milk from donor milk banks or commercial suppliers.

The effect of an exclusive human milk diet versus one containing bovine products on vulnerable preterm infants is unclear, but some studies have shown lower rates of key neonatal morbidities, possibly mediated by the gut microbiome. In two randomized controlled trials, for example, one showed a lower rate of NEC with donated human milk while the other showed no difference.

Neither, however, was powered to detect a clinically important difference in surgical NEC.
 

Milk and the microbiome

The current study’s primary endpoint was the effect of an exclusive human milk diet on gut bacterial richness and diversity, as well as the proportions of specific microbial taxa in preterm infants from enrollment to 34 weeks’ postmenstrual age.

Conducted at four neonatal intensive care units in the United Kingdom from 2017 to 2020, the study recruited 126 infants born at less than 30 weeks’ gestation and fed exclusively with their own mother’s milk before 72 hours of age. With a median gestational age of 27 weeks and a median birth weight of just over 900 grams, the babies were randomized 1:1 either to their own mother’s milk plus a pasteurized ready-to-feed human milk product or to their mother’s milk plus a standard preterm formula (controls). Stool samples were collected to analyze intestinal microbiota.

In terms of clinical outcomes, four infants died in the standard-care control group and eight in the intervention group at a median postnatal age of 25 days and 15 days, respectively, but none died primarily of NEC. Formula and ready-to-feed human milk both represented less than 1% of all fluid intake, respectively.

Although there were no effects on overall measures of gut bacterial diversity, there were some insignificant effects on specific bacterial taxa previously associated with human milk feeding. “These findings suggest that the clinical impact of human milk-derived products is not modulated via microbiomic mechanisms,” the authors wrote.

Human milk could benefit, however, via components such as specific oligosaccharides, which act largely by modulating the growth of friendly Bifidobacteria and other species, Dr. Embleton said. “However, it’s possible these oligosaccharides might also directly interact via the gut epithelium as a signaling molecule. And, of course, there are many other components that might also act directly on the gut without changing the microbiome.”

*Commenting on the study but not involved in it, Brenda L. Poindexter, MD, MS, chief of the division of neonatology at Children’s Healthcare of Atlanta and Emory University, called it “incredibly important,” especially in the context of the claims of superiority made by the manufacturers of human-milk-based fortifiers. “These findings convincingly debunk the notion that the use of bovine-derived fortifiers increases risk of morbidities such as NEC through the mechanism of alterations in the microbiome, Dr. Poindexter said.

 “They refute that claim as there was no difference in NEC between the groups and, interestingly, no impact on the microbiome. One of the hypothesized mechanisms for those who purport that bovine fortifiers are ‘bad’ is that they alter the microbiome, which increases risk of NEC,” she said. “The only limitation is that the study was not powered to detect a difference in NEC, but it is incredibly important nonetheless.”

The current findings differ somewhat from those of a similar trial from 2022 showing lower microbial diversity and higher relative abundances of Enterobacteriaceae and lower abundances of Clostridium sensu stricto in preterm infants receiving an exclusive human milk diet. “These results highlight how nutrient fortifiers impact the microbiota of very-low-birth-weight infants during a critical developmental window,” the authors wrote.

Dr. Embleton conceded that his group’s study set the bar deliberately high to avoid finding too many differences purely due to chance, and it therefore might have missed bacterial changes present in low proportions. “Also, the technique we used, 16s rRNA, doesn’t explore the microbiome at the strain level, so there may have been changes we didn’t detect.”

He added that the study populations also had a relatively high usage of mother’s own milk and findings may differ in other populations and settings where the use of mother’s own milk is much lower. Furthermore, the differences reported by individual hospitals in the babies’ gut microbiomes were more significant than most feeding interventions.

So can mothers needing to use nonhuman supplements be reassured by the results? “It is difficult to know how parents may interpret our findings. We need more studies powered to detect differences in functional outcomes before we can draw conclusions and share those findings in a way parents can understand,” Dr. Embleton said. “At present, there is perhaps a too simplistic message that cow milk formula is ‘harmful.’ ”

Most babies exposed to cow’s milk fortifier or formula do not develop NEC, and many with NEC have only ever received their own mother’s milk or donor milk, he added. “It could be that with advances in pasteurization or other similar techniques the quality and therefore the functional benefits of human milk can be better preserved.”

More research is needed on the mechanisms of preterm feeding interventions, including donor human milk, fortifiers, and probiotics, Dr. Embleton said. “The gut microbiome in preterm infants is complex and very different from that in term infants.”

The study was sponsored by Newcastle Hospitals NHS Foundation Trust and funded by Prolacta Biosciences, which provided human milk formula and fortifier. Dr. Embleton reported financial ties to Danone Early Life Nutrition, Nestlé Nutrition Institute Lecture, Astarte Lecture, and NeoKare outside of the submitted work. Several coauthors reported similar ties to multiple private companies and various research funding bodies. Dr. Poindexter has no conflicts of interest.

*This story was updated on March 3, 2023.

HONOLULU – Combining cryotherapy, salicylic acid, and fluorouracil (5-FU) can improve the efficacy of treating common warts, but topical or intralesional cidofovir may be required for recalcitrant lesions or those located in areas that are challenging to treat, according to John S. Barbieri, MD, MBA.

“There are 5 million office visits per year in the United States for warts and molluscum, and they’re most common in pediatrics,” Dr. Barbieri, of the department of dermatology at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “In fact, some studies have suggested that one in three children in primary school suffers from warts.”

Doug Brunk/MDedge News

According to a 2012 Cochrane review of topical therapies for warts, first-line treatments such as salicylic acid, cryotherapy, 5-FU, or Candida antigen injection often have modest efficacy when used alone. For example, the authors found that salicylic acid and cryotherapy cleared warts in about 60%-70% of cases, respectively, but clearance rates were improved by combining the two therapies.

In an earlier literature review and meta-analysis, investigators evaluated the effect of 5-FU plus salicylic acid or salicylic acid alone. The therapeutic effect for common warts across all studies was a 63.4% response rate (complete healing) for 5-FU/SA vversus 23.1% for the 5-FU–free controls, respectively. For plantar warts, the response rate was 63% versus 11%, respectively.

“But what about the person with multiple warts or those in challenging locations where you might worry about destructive treatments hurting the nail fold or causing nail dystrophy?” Dr. Barbieri asked. “Maybe they’ve used salicylic acid or intralesional Candida and they’re still not getting better. What can we do for these patients?”

Emerging research suggests that topical cidofovir can be a valuable option for recalcitrant warts or those in sensitive locations. In a case report of a 10-year-old boy with more than 50 severe verrucous papules on his hands and face that were recalcitrant to multiple conventional therapies, topical 1% cidofovir applied daily for 8 weeks was effective, with no adverse side effects. A young female patient who presented to Dr. Barbieri with multiple warts around the nail matrix of several fingers experienced complete clearance after treatment with topical cidofovir, he said. Other researchers found this approach to be effective for plantar warts as well, in a report of two brothers with severe combined immunodeficiency after hematopoietic stem cell transplantation with persistent warts that did not respond to traditional topical treatments.

David Carillet/Dreamstime

“Topical cidofovir is typically a painless treatment, which is nice, especially for our pediatric patients who might be afraid of other therapies like or cryotherapy or intralesional injections,” One limitation is that it is “a bit expensive,” Dr. Barbieri said. “To have topical cidofovir compounded is typically $100-$300, depending on the quantity and strength that you ask for.”

Intralesional cidofovir is another treatment option. In a retrospective study of 58 patients, Dr. Barbieri and colleagues evaluated the outcome of intralesional cidofovir treatment of warts in immunocompromised and nonimmunocompromised patients. Rates of improvement ranged from 98.3% to 100%, while resolution rates ranged from 75.9% to 97.6%.

“Most of the patients had warts for more than 5 years and almost half of them had recalcitrant warts,” Dr. Barbieri said. “These were mostly adult patients, but I think this is a treatment that can work in younger populations as well. About 10%-15% had HIV or cancer or diabetes or were transplant recipients, but despite these challenges and despite these recalcitrant warts, about 100% had improvement.”

He pointed out that cidofovir is available as a 75 mg/mL vial that comes with a 5 mL single-use vial. He dilutes this with normal saline to create a 15 mg/mL solution.

“If you want to be efficient you can try to schedule multiple patients together on the same day as a single vial is sufficient to treat about 25 patients,” assuming about 1 mL is injected per patient, he said. “The challenge with intralesional cidofovir is that it’s painful beyond just the needle part of the injection. Sometimes a nerve block can be helpful. But this can be an effective treatment for patients with recalcitrant warts or those with comorbidities.”

Other intralesional therapies to try for recalcitrant warts, he said, include bleomycin (1 U/mL solution, 1-2 mL per treatment, spaced every 2-4 weeks), and 5-FU (a 4:1 mixture of 5-FU [50 mg/mL] and 2% lidocaine).

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Medscape and this news organization are owned by the same parent company.

HONOLULU – Combining cryotherapy, salicylic acid, and fluorouracil (5-FU) can improve the efficacy of treating common warts, but topical or intralesional cidofovir may be required for recalcitrant lesions or those located in areas that are challenging to treat, according to John S. Barbieri, MD, MBA.

“There are 5 million office visits per year in the United States for warts and molluscum, and they’re most common in pediatrics,” Dr. Barbieri, of the department of dermatology at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “In fact, some studies have suggested that one in three children in primary school suffers from warts.”

Doug Brunk/MDedge News

According to a 2012 Cochrane review of topical therapies for warts, first-line treatments such as salicylic acid, cryotherapy, 5-FU, or Candida antigen injection often have modest efficacy when used alone. For example, the authors found that salicylic acid and cryotherapy cleared warts in about 60%-70% of cases, respectively, but clearance rates were improved by combining the two therapies.

In an earlier literature review and meta-analysis, investigators evaluated the effect of 5-FU plus salicylic acid or salicylic acid alone. The therapeutic effect for common warts across all studies was a 63.4% response rate (complete healing) for 5-FU/SA vversus 23.1% for the 5-FU–free controls, respectively. For plantar warts, the response rate was 63% versus 11%, respectively.

“But what about the person with multiple warts or those in challenging locations where you might worry about destructive treatments hurting the nail fold or causing nail dystrophy?” Dr. Barbieri asked. “Maybe they’ve used salicylic acid or intralesional Candida and they’re still not getting better. What can we do for these patients?”

Emerging research suggests that topical cidofovir can be a valuable option for recalcitrant warts or those in sensitive locations. In a case report of a 10-year-old boy with more than 50 severe verrucous papules on his hands and face that were recalcitrant to multiple conventional therapies, topical 1% cidofovir applied daily for 8 weeks was effective, with no adverse side effects. A young female patient who presented to Dr. Barbieri with multiple warts around the nail matrix of several fingers experienced complete clearance after treatment with topical cidofovir, he said. Other researchers found this approach to be effective for plantar warts as well, in a report of two brothers with severe combined immunodeficiency after hematopoietic stem cell transplantation with persistent warts that did not respond to traditional topical treatments.

David Carillet/Dreamstime

“Topical cidofovir is typically a painless treatment, which is nice, especially for our pediatric patients who might be afraid of other therapies like or cryotherapy or intralesional injections,” One limitation is that it is “a bit expensive,” Dr. Barbieri said. “To have topical cidofovir compounded is typically $100-$300, depending on the quantity and strength that you ask for.”

Intralesional cidofovir is another treatment option. In a retrospective study of 58 patients, Dr. Barbieri and colleagues evaluated the outcome of intralesional cidofovir treatment of warts in immunocompromised and nonimmunocompromised patients. Rates of improvement ranged from 98.3% to 100%, while resolution rates ranged from 75.9% to 97.6%.

“Most of the patients had warts for more than 5 years and almost half of them had recalcitrant warts,” Dr. Barbieri said. “These were mostly adult patients, but I think this is a treatment that can work in younger populations as well. About 10%-15% had HIV or cancer or diabetes or were transplant recipients, but despite these challenges and despite these recalcitrant warts, about 100% had improvement.”

He pointed out that cidofovir is available as a 75 mg/mL vial that comes with a 5 mL single-use vial. He dilutes this with normal saline to create a 15 mg/mL solution.

“If you want to be efficient you can try to schedule multiple patients together on the same day as a single vial is sufficient to treat about 25 patients,” assuming about 1 mL is injected per patient, he said. “The challenge with intralesional cidofovir is that it’s painful beyond just the needle part of the injection. Sometimes a nerve block can be helpful. But this can be an effective treatment for patients with recalcitrant warts or those with comorbidities.”

Other intralesional therapies to try for recalcitrant warts, he said, include bleomycin (1 U/mL solution, 1-2 mL per treatment, spaced every 2-4 weeks), and 5-FU (a 4:1 mixture of 5-FU [50 mg/mL] and 2% lidocaine).

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Medscape and this news organization are owned by the same parent company.

HONOLULU – Combining cryotherapy, salicylic acid, and fluorouracil (5-FU) can improve the efficacy of treating common warts, but topical or intralesional cidofovir may be required for recalcitrant lesions or those located in areas that are challenging to treat, according to John S. Barbieri, MD, MBA.

“There are 5 million office visits per year in the United States for warts and molluscum, and they’re most common in pediatrics,” Dr. Barbieri, of the department of dermatology at Brigham and Women’s Hospital, Boston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “In fact, some studies have suggested that one in three children in primary school suffers from warts.”

Doug Brunk/MDedge News

According to a 2012 Cochrane review of topical therapies for warts, first-line treatments such as salicylic acid, cryotherapy, 5-FU, or Candida antigen injection often have modest efficacy when used alone. For example, the authors found that salicylic acid and cryotherapy cleared warts in about 60%-70% of cases, respectively, but clearance rates were improved by combining the two therapies.

In an earlier literature review and meta-analysis, investigators evaluated the effect of 5-FU plus salicylic acid or salicylic acid alone. The therapeutic effect for common warts across all studies was a 63.4% response rate (complete healing) for 5-FU/SA vversus 23.1% for the 5-FU–free controls, respectively. For plantar warts, the response rate was 63% versus 11%, respectively.

“But what about the person with multiple warts or those in challenging locations where you might worry about destructive treatments hurting the nail fold or causing nail dystrophy?” Dr. Barbieri asked. “Maybe they’ve used salicylic acid or intralesional Candida and they’re still not getting better. What can we do for these patients?”

Emerging research suggests that topical cidofovir can be a valuable option for recalcitrant warts or those in sensitive locations. In a case report of a 10-year-old boy with more than 50 severe verrucous papules on his hands and face that were recalcitrant to multiple conventional therapies, topical 1% cidofovir applied daily for 8 weeks was effective, with no adverse side effects. A young female patient who presented to Dr. Barbieri with multiple warts around the nail matrix of several fingers experienced complete clearance after treatment with topical cidofovir, he said. Other researchers found this approach to be effective for plantar warts as well, in a report of two brothers with severe combined immunodeficiency after hematopoietic stem cell transplantation with persistent warts that did not respond to traditional topical treatments.

David Carillet/Dreamstime

“Topical cidofovir is typically a painless treatment, which is nice, especially for our pediatric patients who might be afraid of other therapies like or cryotherapy or intralesional injections,” One limitation is that it is “a bit expensive,” Dr. Barbieri said. “To have topical cidofovir compounded is typically $100-$300, depending on the quantity and strength that you ask for.”

Intralesional cidofovir is another treatment option. In a retrospective study of 58 patients, Dr. Barbieri and colleagues evaluated the outcome of intralesional cidofovir treatment of warts in immunocompromised and nonimmunocompromised patients. Rates of improvement ranged from 98.3% to 100%, while resolution rates ranged from 75.9% to 97.6%.

“Most of the patients had warts for more than 5 years and almost half of them had recalcitrant warts,” Dr. Barbieri said. “These were mostly adult patients, but I think this is a treatment that can work in younger populations as well. About 10%-15% had HIV or cancer or diabetes or were transplant recipients, but despite these challenges and despite these recalcitrant warts, about 100% had improvement.”

He pointed out that cidofovir is available as a 75 mg/mL vial that comes with a 5 mL single-use vial. He dilutes this with normal saline to create a 15 mg/mL solution.

“If you want to be efficient you can try to schedule multiple patients together on the same day as a single vial is sufficient to treat about 25 patients,” assuming about 1 mL is injected per patient, he said. “The challenge with intralesional cidofovir is that it’s painful beyond just the needle part of the injection. Sometimes a nerve block can be helpful. But this can be an effective treatment for patients with recalcitrant warts or those with comorbidities.”

Other intralesional therapies to try for recalcitrant warts, he said, include bleomycin (1 U/mL solution, 1-2 mL per treatment, spaced every 2-4 weeks), and 5-FU (a 4:1 mixture of 5-FU [50 mg/mL] and 2% lidocaine).

Dr. Barbieri disclosed that he receives consulting fees from Dexcel for work unrelated to his presentation. Medscape and this news organization are owned by the same parent company.

Pediatricians have long charted the vitals of children and adolescents – height, weight, blood pressure – to ensure that kids are healthy and developing as they should. This is the core of the profession. But today the American Academy of Pediatrics recommends that pediatricians also perform maternal depression screenings, childhood depression screenings, autism screenings, and suicide risk screenings once children become 12 years old in addition to other screenings. Specific screening tools might include the Modified Checklist for Autism in Toddlers (MCHAT) for autism screening, the PHQ2 and PHQ9 (part of the longer Patient Health Questionnaire) for depression screening, and the Suicide Behavior Questionnaire Revised (SBQ-R) for suicide screening.

The AAP’s list of recommended screenings – which are developed by various research groups and endorsed by AAP – includes approximately 30 screenings in all, which vary somewhat depending on age. Seven screenings are mental and behavioral health assessments that would, depending on the screening results, require other expertise to address.

“We all want to keep [children] healthy. We actually do want to do these screenings, because they can be very helpful,” said Herschel Lessin, MD, of the Children’s Medical Group in Hopewell Junction, N.Y. Dr. Lessin’s concern is that he may not have anywhere to refer children and their families if he conducts a screening that flags something concerning such as a deeply depressed teenager. Sometimes first appointments with mental health professionals are not available for months.

“Sure – they want us to screen for depression, they want us to screen for anxiety. OK, you get a positive. What do you do? Well, guess what – there are no resources for children and mental health in this country,” Dr. Lessin said.

In Dr. Lessin’s view, economic realities prevent pediatricians from performing detailed psychological screenings anyway – no matter how useful or evidence based they might be, even if mental health support was abundant. He estimates that his practice conducts 20-25 visits a day, around 20 minutes each, of which maybe a dozen are well-child visits, just to keep the doors open. If he thoroughly screened every child or adolescent in the manner recommended by the AAP, Dr. Lessin said, he could do a fraction of that volume and would have to close his doors as a result.

Beside the time burden, insurers reimburse developmental and psychological screenings at low rates, Dr. Lessin said, even with claims that accurately itemize every screening delivered.

“Insurance companies refuse to pay adequately for any of this stuff. They expect me to do it for free, or do it for pennies,” Dr. Lessin said. He said that the natural result of such an arrangement is that some pediatricians stop taking insurance and only work with families that can afford their rates, further entrenching unequal health care by catering to wealthy families who can afford to pay for longer visits. Other pediatricians just don’t do all of the recommended screenings.

“I don’t want it to sound like I’m whining about being paid. They don’t adequately resource what they expect us to do, which is to be society’s social worker,” Dr. Lessin said.
 

Practical advice for interpreting and prioritizing screenings

Other pediatricians called for screening developers to include guidance for pediatricians about how to counsel families when a screening turns up a concerning result.

“What can we do as pediatricians in that moment to help that family?” asked Karalyn Kinsella, MD, of Pediatric Associates of Cheshire in Cheshire, Conn.

Sometimes the path forward is clear, as with an autism screening; in those cases, Dr. Kinsella said, Connecticut requires referral for a full autism evaluation from birth to age 3. But for other situations, such as an anxiety screening, it is less clear how to proceed.

Dr. Kinsella said that in her experience in-person appointments with a mental health professional, compared with telehealth, work best for her patients. This enables the teenager to find a good fit with a therapist, which can take time when first appointments are so elusive. Any support for pediatricians to bridge the gap until therapy is established is welcome.

“It would be great if it came along with some training – just a brief training – of some ways we can help families before they get into a therapist, or before it gets to the point that they need therapy,” Dr. Kinsella said.

Dr. Kinsella stressed that pediatricians need to use their own judgment when interpreting screening results. Sometimes the MCHAT will miss cases of autism, for example, or the PHQ9 will flag a teenager for depression who is actually just fidgety and having some trouble sleeping.

In her view, the existence of such screens – which might also include screenings for drug abuse, toxic stress, or food insecurity, along with autism, anxiety, and maternal or child depression – is a good development, despite their imperfections and the difficulties of getting help in a timely manner.

“Twenty years ago we really didn’t have any screens,” Dr. Kinsella said.

But it may be that there are now too many recommended screens in pediatrics, even if they all individually have value.

“In the adult world, screenings haven’t mushroomed as in pediatrics” said Dr. Timothy J. Joos, MD, MPH, who practices combined internal medicine and pediatrics at Neighborcare Health in Seattle. Recommended adult health screenings are largely driven by the work of the United States Preventive Services Task Force, which requires a high level of evidence before a screening is recommended. The pediatrics screening world, in Dr. Joos’s view, is populated by a more diffuse set of actors and has therefore inevitably resulted in a profusion of recommended screenings.

Although its main focus is adults, Dr. Joos noted that the USPSTF has evaluated many of the pediatric screenings currently endorsed by AAP. Sometimes there is strong evidence for these screenings, such as universal screening for depression and anxiety in older children. But Dr. Joos noted that per the USPSTF, many of the screenings now recommended by AAP on asymptomatic children for autism, high cholesterol, high blood pressure, or anemia don’t have strong evidence on a population level.

“In many cases, we have a good screen, but it just lacks the research,” Dr. Joos said. Nonetheless, every screening is recommended with “equal weight,” Dr. Joos said, calling for AAP to offer a more prioritized approach to screening rather than an “all comers” approach.

“If you don’t set priorities, you don’t have priorities,” Dr. Joos said, which leads to untenable expectations for what can be accomplished during short visits.
 

AAP responds

Susan Kressly, MD, who chairs AAP’s Section on Administration and Practice and is a consultant based in Sanibel, Fla., said that we know that using targeting screenings will miss a significant proportion of patients whom you could better assist and care for; for example, if you just go by your gut feeling about whether kids are using drugs or alcohol and just screen those kids. Every screening endorsed by AAP has some degree of evidence for use at a population level rather than case by case, Dr. Kressly noted.

This doesn’t mean that every single screening must be done at each and every recommended interval, she emphasized.

“The first priority is what’s important to the patient and the family. While we understand that screening is at a population health level, there should be some intelligent use and prioritization of these screening tools,” Dr. Kressly said. As examples, Dr. Kressly noted that there is no need to keep administering autism screenings in families whose children already receive autism services, or to ask a teenager questions about anxiety they had answered 6 weeks earlier.

The screenings should be seen as a tool for enhancing relationships with children and their families, not as a series of endless tasks, Dr. Kressly concluded.

Dr. Lessin’s priority is that pediatricians get more support – time, money, training, adequately resourced mental health care – to carry out their expanded role.

“Pediatricians are pretty nice. We want to do the right thing, but everything blocks us from doing it,” Dr. Lessin said.

Dr. Joos, Dr. Kinsella, and Dr. Lessin are on the MDedge Pediatric News Editorial Advisory Board.

Pediatricians have long charted the vitals of children and adolescents – height, weight, blood pressure – to ensure that kids are healthy and developing as they should. This is the core of the profession. But today the American Academy of Pediatrics recommends that pediatricians also perform maternal depression screenings, childhood depression screenings, autism screenings, and suicide risk screenings once children become 12 years old in addition to other screenings. Specific screening tools might include the Modified Checklist for Autism in Toddlers (MCHAT) for autism screening, the PHQ2 and PHQ9 (part of the longer Patient Health Questionnaire) for depression screening, and the Suicide Behavior Questionnaire Revised (SBQ-R) for suicide screening.

The AAP’s list of recommended screenings – which are developed by various research groups and endorsed by AAP – includes approximately 30 screenings in all, which vary somewhat depending on age. Seven screenings are mental and behavioral health assessments that would, depending on the screening results, require other expertise to address.

“We all want to keep [children] healthy. We actually do want to do these screenings, because they can be very helpful,” said Herschel Lessin, MD, of the Children’s Medical Group in Hopewell Junction, N.Y. Dr. Lessin’s concern is that he may not have anywhere to refer children and their families if he conducts a screening that flags something concerning such as a deeply depressed teenager. Sometimes first appointments with mental health professionals are not available for months.

“Sure – they want us to screen for depression, they want us to screen for anxiety. OK, you get a positive. What do you do? Well, guess what – there are no resources for children and mental health in this country,” Dr. Lessin said.

In Dr. Lessin’s view, economic realities prevent pediatricians from performing detailed psychological screenings anyway – no matter how useful or evidence based they might be, even if mental health support was abundant. He estimates that his practice conducts 20-25 visits a day, around 20 minutes each, of which maybe a dozen are well-child visits, just to keep the doors open. If he thoroughly screened every child or adolescent in the manner recommended by the AAP, Dr. Lessin said, he could do a fraction of that volume and would have to close his doors as a result.

Beside the time burden, insurers reimburse developmental and psychological screenings at low rates, Dr. Lessin said, even with claims that accurately itemize every screening delivered.

“Insurance companies refuse to pay adequately for any of this stuff. They expect me to do it for free, or do it for pennies,” Dr. Lessin said. He said that the natural result of such an arrangement is that some pediatricians stop taking insurance and only work with families that can afford their rates, further entrenching unequal health care by catering to wealthy families who can afford to pay for longer visits. Other pediatricians just don’t do all of the recommended screenings.

“I don’t want it to sound like I’m whining about being paid. They don’t adequately resource what they expect us to do, which is to be society’s social worker,” Dr. Lessin said.
 

Practical advice for interpreting and prioritizing screenings

Other pediatricians called for screening developers to include guidance for pediatricians about how to counsel families when a screening turns up a concerning result.

“What can we do as pediatricians in that moment to help that family?” asked Karalyn Kinsella, MD, of Pediatric Associates of Cheshire in Cheshire, Conn.

Sometimes the path forward is clear, as with an autism screening; in those cases, Dr. Kinsella said, Connecticut requires referral for a full autism evaluation from birth to age 3. But for other situations, such as an anxiety screening, it is less clear how to proceed.

Dr. Kinsella said that in her experience in-person appointments with a mental health professional, compared with telehealth, work best for her patients. This enables the teenager to find a good fit with a therapist, which can take time when first appointments are so elusive. Any support for pediatricians to bridge the gap until therapy is established is welcome.

“It would be great if it came along with some training – just a brief training – of some ways we can help families before they get into a therapist, or before it gets to the point that they need therapy,” Dr. Kinsella said.

Dr. Kinsella stressed that pediatricians need to use their own judgment when interpreting screening results. Sometimes the MCHAT will miss cases of autism, for example, or the PHQ9 will flag a teenager for depression who is actually just fidgety and having some trouble sleeping.

In her view, the existence of such screens – which might also include screenings for drug abuse, toxic stress, or food insecurity, along with autism, anxiety, and maternal or child depression – is a good development, despite their imperfections and the difficulties of getting help in a timely manner.

“Twenty years ago we really didn’t have any screens,” Dr. Kinsella said.

But it may be that there are now too many recommended screens in pediatrics, even if they all individually have value.

“In the adult world, screenings haven’t mushroomed as in pediatrics” said Dr. Timothy J. Joos, MD, MPH, who practices combined internal medicine and pediatrics at Neighborcare Health in Seattle. Recommended adult health screenings are largely driven by the work of the United States Preventive Services Task Force, which requires a high level of evidence before a screening is recommended. The pediatrics screening world, in Dr. Joos’s view, is populated by a more diffuse set of actors and has therefore inevitably resulted in a profusion of recommended screenings.

Although its main focus is adults, Dr. Joos noted that the USPSTF has evaluated many of the pediatric screenings currently endorsed by AAP. Sometimes there is strong evidence for these screenings, such as universal screening for depression and anxiety in older children. But Dr. Joos noted that per the USPSTF, many of the screenings now recommended by AAP on asymptomatic children for autism, high cholesterol, high blood pressure, or anemia don’t have strong evidence on a population level.

“In many cases, we have a good screen, but it just lacks the research,” Dr. Joos said. Nonetheless, every screening is recommended with “equal weight,” Dr. Joos said, calling for AAP to offer a more prioritized approach to screening rather than an “all comers” approach.

“If you don’t set priorities, you don’t have priorities,” Dr. Joos said, which leads to untenable expectations for what can be accomplished during short visits.
 

AAP responds

Susan Kressly, MD, who chairs AAP’s Section on Administration and Practice and is a consultant based in Sanibel, Fla., said that we know that using targeting screenings will miss a significant proportion of patients whom you could better assist and care for; for example, if you just go by your gut feeling about whether kids are using drugs or alcohol and just screen those kids. Every screening endorsed by AAP has some degree of evidence for use at a population level rather than case by case, Dr. Kressly noted.

This doesn’t mean that every single screening must be done at each and every recommended interval, she emphasized.

“The first priority is what’s important to the patient and the family. While we understand that screening is at a population health level, there should be some intelligent use and prioritization of these screening tools,” Dr. Kressly said. As examples, Dr. Kressly noted that there is no need to keep administering autism screenings in families whose children already receive autism services, or to ask a teenager questions about anxiety they had answered 6 weeks earlier.

The screenings should be seen as a tool for enhancing relationships with children and their families, not as a series of endless tasks, Dr. Kressly concluded.

Dr. Lessin’s priority is that pediatricians get more support – time, money, training, adequately resourced mental health care – to carry out their expanded role.

“Pediatricians are pretty nice. We want to do the right thing, but everything blocks us from doing it,” Dr. Lessin said.

Dr. Joos, Dr. Kinsella, and Dr. Lessin are on the MDedge Pediatric News Editorial Advisory Board.

Pediatricians have long charted the vitals of children and adolescents – height, weight, blood pressure – to ensure that kids are healthy and developing as they should. This is the core of the profession. But today the American Academy of Pediatrics recommends that pediatricians also perform maternal depression screenings, childhood depression screenings, autism screenings, and suicide risk screenings once children become 12 years old in addition to other screenings. Specific screening tools might include the Modified Checklist for Autism in Toddlers (MCHAT) for autism screening, the PHQ2 and PHQ9 (part of the longer Patient Health Questionnaire) for depression screening, and the Suicide Behavior Questionnaire Revised (SBQ-R) for suicide screening.

The AAP’s list of recommended screenings – which are developed by various research groups and endorsed by AAP – includes approximately 30 screenings in all, which vary somewhat depending on age. Seven screenings are mental and behavioral health assessments that would, depending on the screening results, require other expertise to address.

“We all want to keep [children] healthy. We actually do want to do these screenings, because they can be very helpful,” said Herschel Lessin, MD, of the Children’s Medical Group in Hopewell Junction, N.Y. Dr. Lessin’s concern is that he may not have anywhere to refer children and their families if he conducts a screening that flags something concerning such as a deeply depressed teenager. Sometimes first appointments with mental health professionals are not available for months.

“Sure – they want us to screen for depression, they want us to screen for anxiety. OK, you get a positive. What do you do? Well, guess what – there are no resources for children and mental health in this country,” Dr. Lessin said.

In Dr. Lessin’s view, economic realities prevent pediatricians from performing detailed psychological screenings anyway – no matter how useful or evidence based they might be, even if mental health support was abundant. He estimates that his practice conducts 20-25 visits a day, around 20 minutes each, of which maybe a dozen are well-child visits, just to keep the doors open. If he thoroughly screened every child or adolescent in the manner recommended by the AAP, Dr. Lessin said, he could do a fraction of that volume and would have to close his doors as a result.

Beside the time burden, insurers reimburse developmental and psychological screenings at low rates, Dr. Lessin said, even with claims that accurately itemize every screening delivered.

“Insurance companies refuse to pay adequately for any of this stuff. They expect me to do it for free, or do it for pennies,” Dr. Lessin said. He said that the natural result of such an arrangement is that some pediatricians stop taking insurance and only work with families that can afford their rates, further entrenching unequal health care by catering to wealthy families who can afford to pay for longer visits. Other pediatricians just don’t do all of the recommended screenings.

“I don’t want it to sound like I’m whining about being paid. They don’t adequately resource what they expect us to do, which is to be society’s social worker,” Dr. Lessin said.
 

Practical advice for interpreting and prioritizing screenings

Other pediatricians called for screening developers to include guidance for pediatricians about how to counsel families when a screening turns up a concerning result.

“What can we do as pediatricians in that moment to help that family?” asked Karalyn Kinsella, MD, of Pediatric Associates of Cheshire in Cheshire, Conn.

Sometimes the path forward is clear, as with an autism screening; in those cases, Dr. Kinsella said, Connecticut requires referral for a full autism evaluation from birth to age 3. But for other situations, such as an anxiety screening, it is less clear how to proceed.

Dr. Kinsella said that in her experience in-person appointments with a mental health professional, compared with telehealth, work best for her patients. This enables the teenager to find a good fit with a therapist, which can take time when first appointments are so elusive. Any support for pediatricians to bridge the gap until therapy is established is welcome.

“It would be great if it came along with some training – just a brief training – of some ways we can help families before they get into a therapist, or before it gets to the point that they need therapy,” Dr. Kinsella said.

Dr. Kinsella stressed that pediatricians need to use their own judgment when interpreting screening results. Sometimes the MCHAT will miss cases of autism, for example, or the PHQ9 will flag a teenager for depression who is actually just fidgety and having some trouble sleeping.

In her view, the existence of such screens – which might also include screenings for drug abuse, toxic stress, or food insecurity, along with autism, anxiety, and maternal or child depression – is a good development, despite their imperfections and the difficulties of getting help in a timely manner.

“Twenty years ago we really didn’t have any screens,” Dr. Kinsella said.

But it may be that there are now too many recommended screens in pediatrics, even if they all individually have value.

“In the adult world, screenings haven’t mushroomed as in pediatrics” said Dr. Timothy J. Joos, MD, MPH, who practices combined internal medicine and pediatrics at Neighborcare Health in Seattle. Recommended adult health screenings are largely driven by the work of the United States Preventive Services Task Force, which requires a high level of evidence before a screening is recommended. The pediatrics screening world, in Dr. Joos’s view, is populated by a more diffuse set of actors and has therefore inevitably resulted in a profusion of recommended screenings.

Although its main focus is adults, Dr. Joos noted that the USPSTF has evaluated many of the pediatric screenings currently endorsed by AAP. Sometimes there is strong evidence for these screenings, such as universal screening for depression and anxiety in older children. But Dr. Joos noted that per the USPSTF, many of the screenings now recommended by AAP on asymptomatic children for autism, high cholesterol, high blood pressure, or anemia don’t have strong evidence on a population level.

“In many cases, we have a good screen, but it just lacks the research,” Dr. Joos said. Nonetheless, every screening is recommended with “equal weight,” Dr. Joos said, calling for AAP to offer a more prioritized approach to screening rather than an “all comers” approach.

“If you don’t set priorities, you don’t have priorities,” Dr. Joos said, which leads to untenable expectations for what can be accomplished during short visits.
 

AAP responds

Susan Kressly, MD, who chairs AAP’s Section on Administration and Practice and is a consultant based in Sanibel, Fla., said that we know that using targeting screenings will miss a significant proportion of patients whom you could better assist and care for; for example, if you just go by your gut feeling about whether kids are using drugs or alcohol and just screen those kids. Every screening endorsed by AAP has some degree of evidence for use at a population level rather than case by case, Dr. Kressly noted.

This doesn’t mean that every single screening must be done at each and every recommended interval, she emphasized.

“The first priority is what’s important to the patient and the family. While we understand that screening is at a population health level, there should be some intelligent use and prioritization of these screening tools,” Dr. Kressly said. As examples, Dr. Kressly noted that there is no need to keep administering autism screenings in families whose children already receive autism services, or to ask a teenager questions about anxiety they had answered 6 weeks earlier.

The screenings should be seen as a tool for enhancing relationships with children and their families, not as a series of endless tasks, Dr. Kressly concluded.

Dr. Lessin’s priority is that pediatricians get more support – time, money, training, adequately resourced mental health care – to carry out their expanded role.

“Pediatricians are pretty nice. We want to do the right thing, but everything blocks us from doing it,” Dr. Lessin said.

Dr. Joos, Dr. Kinsella, and Dr. Lessin are on the MDedge Pediatric News Editorial Advisory Board.

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.