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Rural Hospitals Built During Baby Boom Now Face Baby Bust
Rural regions like the one surrounding a southern Iowa town used to have a lot more babies and many more places to give birth to them.
At least 41 Iowa hospitals have shuttered their labor and delivery units since 2000. Those facilities, representing about a third of all Iowa hospitals, are located mostly in rural areas where birth numbers have plummeted. In some Iowa counties, annual numbers of births have fallen by three quarters since the height of the baby boom in the 1950s and 1960s, when many rural hospitals were built or expanded, state and federal records show.
Similar trends are playing out nationwide, as hospitals struggle to maintain staff and facilities to safely handle dwindling numbers of births. More than half of rural US hospitals now lack the service.
“People just aren’t having as many kids,” said Addie Comegys, who lives in southern Iowa and has regularly traveled 45 minutes each way for prenatal checkups at Oskaloosa’s hospital this summer. Her mother had six children, starting in the 1980s, when big families didn’t seem so rare.
“Now, if you have three kids, people are like, ‘Oh my gosh, are you ever going to stop?’ ” said Ms. Comegys, 29, who is expecting her second child in late August.
These days, many Americans choose to have small families or no children at all. Modern birth control methods help make such decisions stick. The trend is amplified in small towns when young adults move away, taking any childbearing potential with them.
Hospital leaders who close obstetrics units often cite declining birth numbers, along with staffing challenges and financial losses. The closures can be a particular challenge for pregnant women who lack the reliable transportation and flexible schedules needed to travel long distances for prenatal care and birthing services.
The baby boom peaked in 1957, when about 4.3 million children were born in the United States. The annual number of births dropped below 3.7 million by 2022, even though the overall US population nearly doubled over that same period.
West Virginia has seen the steepest decline in births, a 62% drop in those 65 years, according to federal data. Iowa’s births dropped 43% over that period. Of the state’s 99 counties, just four — all urban or suburban — recorded more births.
Births have increased in only 13 states since 1957. Most of them, such as Arizona, California, Florida, and Nevada, are places that have attracted waves of newcomers from other states and countries. But even those states have had obstetrics units close in rural areas.
In Iowa, Oskaloosa’s hospital has bucked the trend and kept its labor and delivery unit open, partly by pulling in patients from 14 other counties. Last year, the hospital even managed the rare feat of recruiting two obstetrician-gynecologists to expand its services.
The publicly owned hospital, called Mahaska Health, expects to deliver 250 babies this year, up from about 160 in previous years, CEO Kevin DeRonde said.
“It’s an essential service, and we needed to keep it going and grow it,” Mr. DeRonde said.
Many of the US hospitals that are now dropping obstetrics units were built or expanded in the mid-1900s, when America went on a rural-hospital building spree, thanks to federal funding from the Hill-Burton Act.
“It was an amazing program,” said Brock Slabach, chief operations officer for the National Rural Health Association. “Basically, if you were a county that wanted a hospital, they gave you the money.”
Mr. Slabach said that in addition to declining birth numbers, obstetrics units are experiencing a drop in occupancy because most patients go home after a night or two. In the past, patients typically spent several days in the hospital after giving birth.
Dwindling caseloads can raise safety concerns for obstetrics units.
A study published in JAMA in 2023 found that women were more likely to suffer serious complications if they gave birth in rural hospitals that handled 110 or fewer births a year. The authors said they didn’t support closing low-volume units because that could lead more women to have complications related to traveling for care. Instead, they recommended improving training and coordination among rural health providers.
Stephanie Radke, MD, a University of Iowa obstetrics and gynecology professor who studies access to birthing services, said it is almost inevitable that when rural birth numbers plunge, some obstetrics units will close. “We talk about that as a bad event, but we don’t really talk about why it happens,” she said.
Dr. Radke said maintaining a set number of obstetrics units is less important than ensuring good care for pregnant women and their babies. It’s difficult to maintain quality of care when the staff doesn’t consistently practice deliveries, she said, but it is hard to define that line. “What is realistic?” she said. “I don’t think a unit should be open that only delivers 50 babies a year.”
In some cases, she said, hospitals near each other have consolidated obstetrics units, pooling their resources into one program that has enough staffers and handles sufficient cases. “You’re not always really creating a care desert when that happens,” she said.
The decline in births has accelerated in many areas in recent years. Kenneth Johnson, a sociology professor and demographer at the University of New Hampshire, said it is understandable that many rural hospitals have closed obstetrics units. “I’m actually surprised some of them have lasted as long as they have,” he said.
Dr. Johnson said rural areas that have seen the steepest population declines tend to be far from cities and lack recreational attractions, such as mountains or large bodies of water. Some have avoided population losses by attracting immigrant workers, who tend to have larger families in the first generation or two after they move to the United States, he said.
Katy B. Kozhimannil, a University of Minnesota health policy professor who studies rural issues, said declining birth numbers and obstetric unit closures can create a vicious cycle. Fewer babies being born in a region can lead a birthing unit to shutter. Then the loss of such a unit can discourage young people from moving to the area, driving birth numbers even lower.
In many regions, people with private insurance, flexible schedules, and reliable transportation choose to travel to larger hospitals for their prenatal care and to give birth, Dr. Kozhimannil said. That leaves rural hospitals with a larger proportion of patients on Medicaid, a public program that pays about half what private insurance pays for the same services, she said.
Iowa ranks near the bottom of all states for obstetrician-gynecologists per capita. But Oskaloosa’s hospital hit the jackpot last year, when it recruited Taylar Swartz Summers, DO, and Garth Summers, DO, a married couple who both recently finished their obstetrics training. Dr. Swartz Summers grew up in the area, and she wanted to return to serve women there.
She hopes the number of obstetrics units will level off after the wave of closures. “It’s not even just for delivery, but we need access just to women’s healthcare in general,” she said. “I would love to see women’s healthcare be at the forefront of our government’s mind.”
Dr. Swartz Summers noted that the state has only one obstetrics training program, which is at the University of Iowa. She said she and her husband plan to help spark interest in rural obstetrics by hosting University of Iowa residency rotations at the Oskaloosa hospital.
Ms. Comegys, a patient of Dr. Swartz Summer’s, could have chosen a hospital birthing center closer to her home, but she wasn’t confident in its quality. Other hospitals in her region had shuttered their obstetrics units. She is grateful to have a flexible job, a reliable car, and a supportive family, so she can travel to Oskaloosa for checkups and to give birth there. She knows many other women are not so lucky, and she worries other obstetrics units are at risk.
“It’s sad, but I could see more closing,” she said.
A version of this article first appeared on Medscape.com.
Rural regions like the one surrounding a southern Iowa town used to have a lot more babies and many more places to give birth to them.
At least 41 Iowa hospitals have shuttered their labor and delivery units since 2000. Those facilities, representing about a third of all Iowa hospitals, are located mostly in rural areas where birth numbers have plummeted. In some Iowa counties, annual numbers of births have fallen by three quarters since the height of the baby boom in the 1950s and 1960s, when many rural hospitals were built or expanded, state and federal records show.
Similar trends are playing out nationwide, as hospitals struggle to maintain staff and facilities to safely handle dwindling numbers of births. More than half of rural US hospitals now lack the service.
“People just aren’t having as many kids,” said Addie Comegys, who lives in southern Iowa and has regularly traveled 45 minutes each way for prenatal checkups at Oskaloosa’s hospital this summer. Her mother had six children, starting in the 1980s, when big families didn’t seem so rare.
“Now, if you have three kids, people are like, ‘Oh my gosh, are you ever going to stop?’ ” said Ms. Comegys, 29, who is expecting her second child in late August.
These days, many Americans choose to have small families or no children at all. Modern birth control methods help make such decisions stick. The trend is amplified in small towns when young adults move away, taking any childbearing potential with them.
Hospital leaders who close obstetrics units often cite declining birth numbers, along with staffing challenges and financial losses. The closures can be a particular challenge for pregnant women who lack the reliable transportation and flexible schedules needed to travel long distances for prenatal care and birthing services.
The baby boom peaked in 1957, when about 4.3 million children were born in the United States. The annual number of births dropped below 3.7 million by 2022, even though the overall US population nearly doubled over that same period.
West Virginia has seen the steepest decline in births, a 62% drop in those 65 years, according to federal data. Iowa’s births dropped 43% over that period. Of the state’s 99 counties, just four — all urban or suburban — recorded more births.
Births have increased in only 13 states since 1957. Most of them, such as Arizona, California, Florida, and Nevada, are places that have attracted waves of newcomers from other states and countries. But even those states have had obstetrics units close in rural areas.
In Iowa, Oskaloosa’s hospital has bucked the trend and kept its labor and delivery unit open, partly by pulling in patients from 14 other counties. Last year, the hospital even managed the rare feat of recruiting two obstetrician-gynecologists to expand its services.
The publicly owned hospital, called Mahaska Health, expects to deliver 250 babies this year, up from about 160 in previous years, CEO Kevin DeRonde said.
“It’s an essential service, and we needed to keep it going and grow it,” Mr. DeRonde said.
Many of the US hospitals that are now dropping obstetrics units were built or expanded in the mid-1900s, when America went on a rural-hospital building spree, thanks to federal funding from the Hill-Burton Act.
“It was an amazing program,” said Brock Slabach, chief operations officer for the National Rural Health Association. “Basically, if you were a county that wanted a hospital, they gave you the money.”
Mr. Slabach said that in addition to declining birth numbers, obstetrics units are experiencing a drop in occupancy because most patients go home after a night or two. In the past, patients typically spent several days in the hospital after giving birth.
Dwindling caseloads can raise safety concerns for obstetrics units.
A study published in JAMA in 2023 found that women were more likely to suffer serious complications if they gave birth in rural hospitals that handled 110 or fewer births a year. The authors said they didn’t support closing low-volume units because that could lead more women to have complications related to traveling for care. Instead, they recommended improving training and coordination among rural health providers.
Stephanie Radke, MD, a University of Iowa obstetrics and gynecology professor who studies access to birthing services, said it is almost inevitable that when rural birth numbers plunge, some obstetrics units will close. “We talk about that as a bad event, but we don’t really talk about why it happens,” she said.
Dr. Radke said maintaining a set number of obstetrics units is less important than ensuring good care for pregnant women and their babies. It’s difficult to maintain quality of care when the staff doesn’t consistently practice deliveries, she said, but it is hard to define that line. “What is realistic?” she said. “I don’t think a unit should be open that only delivers 50 babies a year.”
In some cases, she said, hospitals near each other have consolidated obstetrics units, pooling their resources into one program that has enough staffers and handles sufficient cases. “You’re not always really creating a care desert when that happens,” she said.
The decline in births has accelerated in many areas in recent years. Kenneth Johnson, a sociology professor and demographer at the University of New Hampshire, said it is understandable that many rural hospitals have closed obstetrics units. “I’m actually surprised some of them have lasted as long as they have,” he said.
Dr. Johnson said rural areas that have seen the steepest population declines tend to be far from cities and lack recreational attractions, such as mountains or large bodies of water. Some have avoided population losses by attracting immigrant workers, who tend to have larger families in the first generation or two after they move to the United States, he said.
Katy B. Kozhimannil, a University of Minnesota health policy professor who studies rural issues, said declining birth numbers and obstetric unit closures can create a vicious cycle. Fewer babies being born in a region can lead a birthing unit to shutter. Then the loss of such a unit can discourage young people from moving to the area, driving birth numbers even lower.
In many regions, people with private insurance, flexible schedules, and reliable transportation choose to travel to larger hospitals for their prenatal care and to give birth, Dr. Kozhimannil said. That leaves rural hospitals with a larger proportion of patients on Medicaid, a public program that pays about half what private insurance pays for the same services, she said.
Iowa ranks near the bottom of all states for obstetrician-gynecologists per capita. But Oskaloosa’s hospital hit the jackpot last year, when it recruited Taylar Swartz Summers, DO, and Garth Summers, DO, a married couple who both recently finished their obstetrics training. Dr. Swartz Summers grew up in the area, and she wanted to return to serve women there.
She hopes the number of obstetrics units will level off after the wave of closures. “It’s not even just for delivery, but we need access just to women’s healthcare in general,” she said. “I would love to see women’s healthcare be at the forefront of our government’s mind.”
Dr. Swartz Summers noted that the state has only one obstetrics training program, which is at the University of Iowa. She said she and her husband plan to help spark interest in rural obstetrics by hosting University of Iowa residency rotations at the Oskaloosa hospital.
Ms. Comegys, a patient of Dr. Swartz Summer’s, could have chosen a hospital birthing center closer to her home, but she wasn’t confident in its quality. Other hospitals in her region had shuttered their obstetrics units. She is grateful to have a flexible job, a reliable car, and a supportive family, so she can travel to Oskaloosa for checkups and to give birth there. She knows many other women are not so lucky, and she worries other obstetrics units are at risk.
“It’s sad, but I could see more closing,” she said.
A version of this article first appeared on Medscape.com.
Rural regions like the one surrounding a southern Iowa town used to have a lot more babies and many more places to give birth to them.
At least 41 Iowa hospitals have shuttered their labor and delivery units since 2000. Those facilities, representing about a third of all Iowa hospitals, are located mostly in rural areas where birth numbers have plummeted. In some Iowa counties, annual numbers of births have fallen by three quarters since the height of the baby boom in the 1950s and 1960s, when many rural hospitals were built or expanded, state and federal records show.
Similar trends are playing out nationwide, as hospitals struggle to maintain staff and facilities to safely handle dwindling numbers of births. More than half of rural US hospitals now lack the service.
“People just aren’t having as many kids,” said Addie Comegys, who lives in southern Iowa and has regularly traveled 45 minutes each way for prenatal checkups at Oskaloosa’s hospital this summer. Her mother had six children, starting in the 1980s, when big families didn’t seem so rare.
“Now, if you have three kids, people are like, ‘Oh my gosh, are you ever going to stop?’ ” said Ms. Comegys, 29, who is expecting her second child in late August.
These days, many Americans choose to have small families or no children at all. Modern birth control methods help make such decisions stick. The trend is amplified in small towns when young adults move away, taking any childbearing potential with them.
Hospital leaders who close obstetrics units often cite declining birth numbers, along with staffing challenges and financial losses. The closures can be a particular challenge for pregnant women who lack the reliable transportation and flexible schedules needed to travel long distances for prenatal care and birthing services.
The baby boom peaked in 1957, when about 4.3 million children were born in the United States. The annual number of births dropped below 3.7 million by 2022, even though the overall US population nearly doubled over that same period.
West Virginia has seen the steepest decline in births, a 62% drop in those 65 years, according to federal data. Iowa’s births dropped 43% over that period. Of the state’s 99 counties, just four — all urban or suburban — recorded more births.
Births have increased in only 13 states since 1957. Most of them, such as Arizona, California, Florida, and Nevada, are places that have attracted waves of newcomers from other states and countries. But even those states have had obstetrics units close in rural areas.
In Iowa, Oskaloosa’s hospital has bucked the trend and kept its labor and delivery unit open, partly by pulling in patients from 14 other counties. Last year, the hospital even managed the rare feat of recruiting two obstetrician-gynecologists to expand its services.
The publicly owned hospital, called Mahaska Health, expects to deliver 250 babies this year, up from about 160 in previous years, CEO Kevin DeRonde said.
“It’s an essential service, and we needed to keep it going and grow it,” Mr. DeRonde said.
Many of the US hospitals that are now dropping obstetrics units were built or expanded in the mid-1900s, when America went on a rural-hospital building spree, thanks to federal funding from the Hill-Burton Act.
“It was an amazing program,” said Brock Slabach, chief operations officer for the National Rural Health Association. “Basically, if you were a county that wanted a hospital, they gave you the money.”
Mr. Slabach said that in addition to declining birth numbers, obstetrics units are experiencing a drop in occupancy because most patients go home after a night or two. In the past, patients typically spent several days in the hospital after giving birth.
Dwindling caseloads can raise safety concerns for obstetrics units.
A study published in JAMA in 2023 found that women were more likely to suffer serious complications if they gave birth in rural hospitals that handled 110 or fewer births a year. The authors said they didn’t support closing low-volume units because that could lead more women to have complications related to traveling for care. Instead, they recommended improving training and coordination among rural health providers.
Stephanie Radke, MD, a University of Iowa obstetrics and gynecology professor who studies access to birthing services, said it is almost inevitable that when rural birth numbers plunge, some obstetrics units will close. “We talk about that as a bad event, but we don’t really talk about why it happens,” she said.
Dr. Radke said maintaining a set number of obstetrics units is less important than ensuring good care for pregnant women and their babies. It’s difficult to maintain quality of care when the staff doesn’t consistently practice deliveries, she said, but it is hard to define that line. “What is realistic?” she said. “I don’t think a unit should be open that only delivers 50 babies a year.”
In some cases, she said, hospitals near each other have consolidated obstetrics units, pooling their resources into one program that has enough staffers and handles sufficient cases. “You’re not always really creating a care desert when that happens,” she said.
The decline in births has accelerated in many areas in recent years. Kenneth Johnson, a sociology professor and demographer at the University of New Hampshire, said it is understandable that many rural hospitals have closed obstetrics units. “I’m actually surprised some of them have lasted as long as they have,” he said.
Dr. Johnson said rural areas that have seen the steepest population declines tend to be far from cities and lack recreational attractions, such as mountains or large bodies of water. Some have avoided population losses by attracting immigrant workers, who tend to have larger families in the first generation or two after they move to the United States, he said.
Katy B. Kozhimannil, a University of Minnesota health policy professor who studies rural issues, said declining birth numbers and obstetric unit closures can create a vicious cycle. Fewer babies being born in a region can lead a birthing unit to shutter. Then the loss of such a unit can discourage young people from moving to the area, driving birth numbers even lower.
In many regions, people with private insurance, flexible schedules, and reliable transportation choose to travel to larger hospitals for their prenatal care and to give birth, Dr. Kozhimannil said. That leaves rural hospitals with a larger proportion of patients on Medicaid, a public program that pays about half what private insurance pays for the same services, she said.
Iowa ranks near the bottom of all states for obstetrician-gynecologists per capita. But Oskaloosa’s hospital hit the jackpot last year, when it recruited Taylar Swartz Summers, DO, and Garth Summers, DO, a married couple who both recently finished their obstetrics training. Dr. Swartz Summers grew up in the area, and she wanted to return to serve women there.
She hopes the number of obstetrics units will level off after the wave of closures. “It’s not even just for delivery, but we need access just to women’s healthcare in general,” she said. “I would love to see women’s healthcare be at the forefront of our government’s mind.”
Dr. Swartz Summers noted that the state has only one obstetrics training program, which is at the University of Iowa. She said she and her husband plan to help spark interest in rural obstetrics by hosting University of Iowa residency rotations at the Oskaloosa hospital.
Ms. Comegys, a patient of Dr. Swartz Summer’s, could have chosen a hospital birthing center closer to her home, but she wasn’t confident in its quality. Other hospitals in her region had shuttered their obstetrics units. She is grateful to have a flexible job, a reliable car, and a supportive family, so she can travel to Oskaloosa for checkups and to give birth there. She knows many other women are not so lucky, and she worries other obstetrics units are at risk.
“It’s sad, but I could see more closing,” she said.
A version of this article first appeared on Medscape.com.
Almost 10% of Infected Pregnant People Develop Long COVID
Almost 1 in 10 pregnant people infected with COVID-19 end up developing long COVID, according to a study published in Obstetrics & Gynecology.
Researchers at University of Utah Health looked at the medical records of more than 1500 people who got COVID-19 while pregnant and checked their self-reported symptoms at least 6 months after infection, according to a news release from the school.
The scientists discovered that 9.3% of those people reported long COVID symptoms, such as fatigue and issues in their gut.
To make sure those long COVID symptoms were not actually symptoms of pregnancy, the research team did a second analysis of people who reported symptoms more than 12 weeks after giving birth. The risk of long COVID was about the same as in the first analysis.
“It was surprising to me that the prevalence was that high,” Torri D. Metz, MD, vice chair for research of obstetrics and gynecology at the school and co-leader of the study, said in the release. “This is something that does continue to affect otherwise reasonably healthy and young populations.”
The school said this is the first study to look at long COVID risks in pregnant people. Previous research found other dangers for pregnant people who get COVID, such as a higher chance of hospitalization or death, or complications such as preterm birth.
In the general population, research shows that 10%-20% of people who get COVID develop long COVID.
Dr. Metz said healthcare providers need to remain alert about long COVID, including in pregnant people.
“We need to have this on our radar as we’re seeing patients. It’s something we really don’t want to miss. And we want to get people referred to appropriate specialists who treat long COVID,” she said.
A version of this article first appeared on WebMD.com.
Almost 1 in 10 pregnant people infected with COVID-19 end up developing long COVID, according to a study published in Obstetrics & Gynecology.
Researchers at University of Utah Health looked at the medical records of more than 1500 people who got COVID-19 while pregnant and checked their self-reported symptoms at least 6 months after infection, according to a news release from the school.
The scientists discovered that 9.3% of those people reported long COVID symptoms, such as fatigue and issues in their gut.
To make sure those long COVID symptoms were not actually symptoms of pregnancy, the research team did a second analysis of people who reported symptoms more than 12 weeks after giving birth. The risk of long COVID was about the same as in the first analysis.
“It was surprising to me that the prevalence was that high,” Torri D. Metz, MD, vice chair for research of obstetrics and gynecology at the school and co-leader of the study, said in the release. “This is something that does continue to affect otherwise reasonably healthy and young populations.”
The school said this is the first study to look at long COVID risks in pregnant people. Previous research found other dangers for pregnant people who get COVID, such as a higher chance of hospitalization or death, or complications such as preterm birth.
In the general population, research shows that 10%-20% of people who get COVID develop long COVID.
Dr. Metz said healthcare providers need to remain alert about long COVID, including in pregnant people.
“We need to have this on our radar as we’re seeing patients. It’s something we really don’t want to miss. And we want to get people referred to appropriate specialists who treat long COVID,” she said.
A version of this article first appeared on WebMD.com.
Almost 1 in 10 pregnant people infected with COVID-19 end up developing long COVID, according to a study published in Obstetrics & Gynecology.
Researchers at University of Utah Health looked at the medical records of more than 1500 people who got COVID-19 while pregnant and checked their self-reported symptoms at least 6 months after infection, according to a news release from the school.
The scientists discovered that 9.3% of those people reported long COVID symptoms, such as fatigue and issues in their gut.
To make sure those long COVID symptoms were not actually symptoms of pregnancy, the research team did a second analysis of people who reported symptoms more than 12 weeks after giving birth. The risk of long COVID was about the same as in the first analysis.
“It was surprising to me that the prevalence was that high,” Torri D. Metz, MD, vice chair for research of obstetrics and gynecology at the school and co-leader of the study, said in the release. “This is something that does continue to affect otherwise reasonably healthy and young populations.”
The school said this is the first study to look at long COVID risks in pregnant people. Previous research found other dangers for pregnant people who get COVID, such as a higher chance of hospitalization or death, or complications such as preterm birth.
In the general population, research shows that 10%-20% of people who get COVID develop long COVID.
Dr. Metz said healthcare providers need to remain alert about long COVID, including in pregnant people.
“We need to have this on our radar as we’re seeing patients. It’s something we really don’t want to miss. And we want to get people referred to appropriate specialists who treat long COVID,” she said.
A version of this article first appeared on WebMD.com.
FROM OBSTETRICS & GYNECOLOGY
Endometriosis, Especially Severe Types, Boosts Ovarian Cancer Risk
Ovarian cancer risk was higher in women with endometriosis overall and markedly increased in those with severe forms, a large population-based cohort study found.
The findings, published in JAMA, suggest these women may benefit from counseling on ovarian cancer risk and prevention and potentially from targeted screening, according to a group led by Mollie E. Barnard, ScD, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.
While the absolute increase in number of cases was small, endometriosis patients overall had a more than fourfold higher risk for any type of ovarian cancer. Those with more severe forms, such as ovarian endometriomas or deep infiltrating endometriosis, had a nearly 10-fold higher risk of any type of ovarian cancer. In addition, those with more severe endometriosis had a 19-fold higher risk of type 1 (slow-growing) ovarian cancer and almost three times the risk of the more aggressive type 2.
“Given the rarity of ovarian cancer, the excess risk was relatively small, with 10-20 additional cases per 10,000 women. Nevertheless, women with endometriosis, notably the more severe subtypes, may be an important population for targeted cancer screening and prevention studies,” said corresponding author Karen C. Schliep, PhD, MSPH, associate professor in the university’s Division of Public Health.
Prior studies have shown modest associations between endometriosis and ovarian cancer, Dr. Schliep said in an interview. A 2021 systematic review and meta-analysis found endometriosis conferred nearly double the risk of ovarian cancer, although associations varied by ovarian cancer histotype. Few studies have been large enough to assess associations between endometriosis types — including superficial or peritoneal endometriosis vs ovarian endometriomas or deep infiltrating endometriosis and ovarian cancer histotypes such as low-grade serous, endometrioid, clear cell, and mucinous carcinomas (type 1), and the most aggressive and lethal form, high-grade serous type 2, she said in an interview. “Our large health administrative database of over 11 million individuals with linked electronic health and cancer registry data allowed us to answer this as yet poorly studied research question.”
Study Details
Drawing on Utah electronic health records from 1992 to 2019, the investigators matched 78,893 women with endometriosis in a 1:5 ratio to unaffected women. Cases were categorized as superficial endometriosis, ovarian endometriomas, deep infiltrating endometriosis, or other, and the types of endometriosis were matched to ovarian cancer histotypes.
The mean age of patients at first endometriosis diagnosis was 36 and the mean follow-up was 12 years. Compared with controls, endometriosis patients were more likely to be nulliparous (31% vs 24%) and to have had a hysterectomy (39% vs 6%) during follow-up.
There were 596 reported cases of ovarian cancer in the cohort. Those with incident endometriosis were 4.2 times more likely to develop ovarian cancer (95% CI, 3.59-4.91), 7.48 times more likely to develop type 1 ovarian cancer (95% CI, 5.80-9.65), and 2.70 times more likely to develop type 2 ovarian cancer (95% CI, 2.09-3.49) compared with those without endometriosis.
The magnitudes of these associations varied by endometriosis subtype. Individuals diagnosed with deep infiltrating endometriosis and/or ovarian endometriomas had 9.66 times the risk of ovarian cancer vs individuals without endometriosis (95% CI, 7.77-12.00). “Women with, compared to without, more severe endometriosis had a 19-fold higher risk of type 1 ovarian cancer, including endometrioid, clear cell, mucinous, and low-grade serous,” Dr. Schliep said, with associated risk highest for malignant subtypes such as clear cell and endometrioid carcinoma (adjusted hazard ratios, 11.15 and 7.96, respectively.
According to Dr. Schliep, physicians should encourage endometriosis patients to be aware of but not worry about ovarian cancer risk because the likelihood of developing it remains low. For their part, patients can reduce their risk of cancer through a balanced diet with low intake of alcohol, regular exercise, a healthy weight, and abstention from smoking.
Her message for researchers is as follows: “We need more studies that explore how different types of endometriosis impact different types of ovarian cancer risk. These studies will guide improved ovarian cancer screening and prevention strategies among women with severe endometriosis, with or without other important ovarian cancer risk factors such as BRCA 1/2 variations.”
An accompanying editorial called the Utah study “eloquent” and noted its distinguishing contribution of observing associations between subtypes of endometriosis with overall risk for ovarian cancer as well as histologic subtypes of epithelial ovarian cancer.
Nevertheless, Michael T. McHale, MD, of the Department of Obstetrics, Gynecology, and Reproductive Sciences at Moores Cancer Center, UC San Diego Health, University of California, expressed some methodological concerns. Although the authors attempted to control for key confounders, he noted, the dataset could not provide details on the medical management of endometriosis, such as oral contraceptives or gonadotropin-releasing hormone agonists. “Additionally, there is a possibility that women in the control cohort could have had undiagnosed endometriosis,” he wrote.
Furthermore, making clinical recommendations from these reported observations, particularly with respect to deep infiltrating endometriosis, would require a clear and consistent definition of this type in the dataset over the entire study interval from 1992 to 2019 and for the state of Utah, which the authors did not provide.
“Despite this potential challenge, the increased risk associated with deep infiltrating and/or ovarian endometriosis was clearly significant,” Dr. McHale wrote.
And although the absolute number of ovarian cancers is limited, in his view, the increased risk is sufficiently significant to advise women who have completed childbearing or have alternative fertility options to consider “more definitive surgery.”
This study was supported by multiple not-for-profit agencies, including the National Cancer Institute, the University of Utah, the National Center for Research Resources, the Utah Department of Health and Human Services, the Utah Cancer Registry, the US Centers for Disease Control and Prevention, the Huntsman Cancer Foundation, the National Institutes of Health, and Doris Duke Foundation. Dr. Barnard reported grants from the National Cancer Institute during the conduct of the study and personal fees from Epi Excellence LLC outside the submitted work. Other coauthors reported similar funding from nonprofit agencies or private research organizations. Dr Schliep disclosed no competing interests. Dr McHale reported educational consulting for Eisai Training outside the submitted work.
Ovarian cancer risk was higher in women with endometriosis overall and markedly increased in those with severe forms, a large population-based cohort study found.
The findings, published in JAMA, suggest these women may benefit from counseling on ovarian cancer risk and prevention and potentially from targeted screening, according to a group led by Mollie E. Barnard, ScD, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.
While the absolute increase in number of cases was small, endometriosis patients overall had a more than fourfold higher risk for any type of ovarian cancer. Those with more severe forms, such as ovarian endometriomas or deep infiltrating endometriosis, had a nearly 10-fold higher risk of any type of ovarian cancer. In addition, those with more severe endometriosis had a 19-fold higher risk of type 1 (slow-growing) ovarian cancer and almost three times the risk of the more aggressive type 2.
“Given the rarity of ovarian cancer, the excess risk was relatively small, with 10-20 additional cases per 10,000 women. Nevertheless, women with endometriosis, notably the more severe subtypes, may be an important population for targeted cancer screening and prevention studies,” said corresponding author Karen C. Schliep, PhD, MSPH, associate professor in the university’s Division of Public Health.
Prior studies have shown modest associations between endometriosis and ovarian cancer, Dr. Schliep said in an interview. A 2021 systematic review and meta-analysis found endometriosis conferred nearly double the risk of ovarian cancer, although associations varied by ovarian cancer histotype. Few studies have been large enough to assess associations between endometriosis types — including superficial or peritoneal endometriosis vs ovarian endometriomas or deep infiltrating endometriosis and ovarian cancer histotypes such as low-grade serous, endometrioid, clear cell, and mucinous carcinomas (type 1), and the most aggressive and lethal form, high-grade serous type 2, she said in an interview. “Our large health administrative database of over 11 million individuals with linked electronic health and cancer registry data allowed us to answer this as yet poorly studied research question.”
Study Details
Drawing on Utah electronic health records from 1992 to 2019, the investigators matched 78,893 women with endometriosis in a 1:5 ratio to unaffected women. Cases were categorized as superficial endometriosis, ovarian endometriomas, deep infiltrating endometriosis, or other, and the types of endometriosis were matched to ovarian cancer histotypes.
The mean age of patients at first endometriosis diagnosis was 36 and the mean follow-up was 12 years. Compared with controls, endometriosis patients were more likely to be nulliparous (31% vs 24%) and to have had a hysterectomy (39% vs 6%) during follow-up.
There were 596 reported cases of ovarian cancer in the cohort. Those with incident endometriosis were 4.2 times more likely to develop ovarian cancer (95% CI, 3.59-4.91), 7.48 times more likely to develop type 1 ovarian cancer (95% CI, 5.80-9.65), and 2.70 times more likely to develop type 2 ovarian cancer (95% CI, 2.09-3.49) compared with those without endometriosis.
The magnitudes of these associations varied by endometriosis subtype. Individuals diagnosed with deep infiltrating endometriosis and/or ovarian endometriomas had 9.66 times the risk of ovarian cancer vs individuals without endometriosis (95% CI, 7.77-12.00). “Women with, compared to without, more severe endometriosis had a 19-fold higher risk of type 1 ovarian cancer, including endometrioid, clear cell, mucinous, and low-grade serous,” Dr. Schliep said, with associated risk highest for malignant subtypes such as clear cell and endometrioid carcinoma (adjusted hazard ratios, 11.15 and 7.96, respectively.
According to Dr. Schliep, physicians should encourage endometriosis patients to be aware of but not worry about ovarian cancer risk because the likelihood of developing it remains low. For their part, patients can reduce their risk of cancer through a balanced diet with low intake of alcohol, regular exercise, a healthy weight, and abstention from smoking.
Her message for researchers is as follows: “We need more studies that explore how different types of endometriosis impact different types of ovarian cancer risk. These studies will guide improved ovarian cancer screening and prevention strategies among women with severe endometriosis, with or without other important ovarian cancer risk factors such as BRCA 1/2 variations.”
An accompanying editorial called the Utah study “eloquent” and noted its distinguishing contribution of observing associations between subtypes of endometriosis with overall risk for ovarian cancer as well as histologic subtypes of epithelial ovarian cancer.
Nevertheless, Michael T. McHale, MD, of the Department of Obstetrics, Gynecology, and Reproductive Sciences at Moores Cancer Center, UC San Diego Health, University of California, expressed some methodological concerns. Although the authors attempted to control for key confounders, he noted, the dataset could not provide details on the medical management of endometriosis, such as oral contraceptives or gonadotropin-releasing hormone agonists. “Additionally, there is a possibility that women in the control cohort could have had undiagnosed endometriosis,” he wrote.
Furthermore, making clinical recommendations from these reported observations, particularly with respect to deep infiltrating endometriosis, would require a clear and consistent definition of this type in the dataset over the entire study interval from 1992 to 2019 and for the state of Utah, which the authors did not provide.
“Despite this potential challenge, the increased risk associated with deep infiltrating and/or ovarian endometriosis was clearly significant,” Dr. McHale wrote.
And although the absolute number of ovarian cancers is limited, in his view, the increased risk is sufficiently significant to advise women who have completed childbearing or have alternative fertility options to consider “more definitive surgery.”
This study was supported by multiple not-for-profit agencies, including the National Cancer Institute, the University of Utah, the National Center for Research Resources, the Utah Department of Health and Human Services, the Utah Cancer Registry, the US Centers for Disease Control and Prevention, the Huntsman Cancer Foundation, the National Institutes of Health, and Doris Duke Foundation. Dr. Barnard reported grants from the National Cancer Institute during the conduct of the study and personal fees from Epi Excellence LLC outside the submitted work. Other coauthors reported similar funding from nonprofit agencies or private research organizations. Dr Schliep disclosed no competing interests. Dr McHale reported educational consulting for Eisai Training outside the submitted work.
Ovarian cancer risk was higher in women with endometriosis overall and markedly increased in those with severe forms, a large population-based cohort study found.
The findings, published in JAMA, suggest these women may benefit from counseling on ovarian cancer risk and prevention and potentially from targeted screening, according to a group led by Mollie E. Barnard, ScD, of the Huntsman Cancer Institute at the University of Utah in Salt Lake City.
While the absolute increase in number of cases was small, endometriosis patients overall had a more than fourfold higher risk for any type of ovarian cancer. Those with more severe forms, such as ovarian endometriomas or deep infiltrating endometriosis, had a nearly 10-fold higher risk of any type of ovarian cancer. In addition, those with more severe endometriosis had a 19-fold higher risk of type 1 (slow-growing) ovarian cancer and almost three times the risk of the more aggressive type 2.
“Given the rarity of ovarian cancer, the excess risk was relatively small, with 10-20 additional cases per 10,000 women. Nevertheless, women with endometriosis, notably the more severe subtypes, may be an important population for targeted cancer screening and prevention studies,” said corresponding author Karen C. Schliep, PhD, MSPH, associate professor in the university’s Division of Public Health.
Prior studies have shown modest associations between endometriosis and ovarian cancer, Dr. Schliep said in an interview. A 2021 systematic review and meta-analysis found endometriosis conferred nearly double the risk of ovarian cancer, although associations varied by ovarian cancer histotype. Few studies have been large enough to assess associations between endometriosis types — including superficial or peritoneal endometriosis vs ovarian endometriomas or deep infiltrating endometriosis and ovarian cancer histotypes such as low-grade serous, endometrioid, clear cell, and mucinous carcinomas (type 1), and the most aggressive and lethal form, high-grade serous type 2, she said in an interview. “Our large health administrative database of over 11 million individuals with linked electronic health and cancer registry data allowed us to answer this as yet poorly studied research question.”
Study Details
Drawing on Utah electronic health records from 1992 to 2019, the investigators matched 78,893 women with endometriosis in a 1:5 ratio to unaffected women. Cases were categorized as superficial endometriosis, ovarian endometriomas, deep infiltrating endometriosis, or other, and the types of endometriosis were matched to ovarian cancer histotypes.
The mean age of patients at first endometriosis diagnosis was 36 and the mean follow-up was 12 years. Compared with controls, endometriosis patients were more likely to be nulliparous (31% vs 24%) and to have had a hysterectomy (39% vs 6%) during follow-up.
There were 596 reported cases of ovarian cancer in the cohort. Those with incident endometriosis were 4.2 times more likely to develop ovarian cancer (95% CI, 3.59-4.91), 7.48 times more likely to develop type 1 ovarian cancer (95% CI, 5.80-9.65), and 2.70 times more likely to develop type 2 ovarian cancer (95% CI, 2.09-3.49) compared with those without endometriosis.
The magnitudes of these associations varied by endometriosis subtype. Individuals diagnosed with deep infiltrating endometriosis and/or ovarian endometriomas had 9.66 times the risk of ovarian cancer vs individuals without endometriosis (95% CI, 7.77-12.00). “Women with, compared to without, more severe endometriosis had a 19-fold higher risk of type 1 ovarian cancer, including endometrioid, clear cell, mucinous, and low-grade serous,” Dr. Schliep said, with associated risk highest for malignant subtypes such as clear cell and endometrioid carcinoma (adjusted hazard ratios, 11.15 and 7.96, respectively.
According to Dr. Schliep, physicians should encourage endometriosis patients to be aware of but not worry about ovarian cancer risk because the likelihood of developing it remains low. For their part, patients can reduce their risk of cancer through a balanced diet with low intake of alcohol, regular exercise, a healthy weight, and abstention from smoking.
Her message for researchers is as follows: “We need more studies that explore how different types of endometriosis impact different types of ovarian cancer risk. These studies will guide improved ovarian cancer screening and prevention strategies among women with severe endometriosis, with or without other important ovarian cancer risk factors such as BRCA 1/2 variations.”
An accompanying editorial called the Utah study “eloquent” and noted its distinguishing contribution of observing associations between subtypes of endometriosis with overall risk for ovarian cancer as well as histologic subtypes of epithelial ovarian cancer.
Nevertheless, Michael T. McHale, MD, of the Department of Obstetrics, Gynecology, and Reproductive Sciences at Moores Cancer Center, UC San Diego Health, University of California, expressed some methodological concerns. Although the authors attempted to control for key confounders, he noted, the dataset could not provide details on the medical management of endometriosis, such as oral contraceptives or gonadotropin-releasing hormone agonists. “Additionally, there is a possibility that women in the control cohort could have had undiagnosed endometriosis,” he wrote.
Furthermore, making clinical recommendations from these reported observations, particularly with respect to deep infiltrating endometriosis, would require a clear and consistent definition of this type in the dataset over the entire study interval from 1992 to 2019 and for the state of Utah, which the authors did not provide.
“Despite this potential challenge, the increased risk associated with deep infiltrating and/or ovarian endometriosis was clearly significant,” Dr. McHale wrote.
And although the absolute number of ovarian cancers is limited, in his view, the increased risk is sufficiently significant to advise women who have completed childbearing or have alternative fertility options to consider “more definitive surgery.”
This study was supported by multiple not-for-profit agencies, including the National Cancer Institute, the University of Utah, the National Center for Research Resources, the Utah Department of Health and Human Services, the Utah Cancer Registry, the US Centers for Disease Control and Prevention, the Huntsman Cancer Foundation, the National Institutes of Health, and Doris Duke Foundation. Dr. Barnard reported grants from the National Cancer Institute during the conduct of the study and personal fees from Epi Excellence LLC outside the submitted work. Other coauthors reported similar funding from nonprofit agencies or private research organizations. Dr Schliep disclosed no competing interests. Dr McHale reported educational consulting for Eisai Training outside the submitted work.
FROM JAMA
Penalty for No-Shows?
Earlier in 2024 the French government proposed fining patients €5 ($5.36 at the time of writing) for no-show doctor appointments.
The rationale is that there are 27 million missed medical appointments annually in France (just based on population size, I’d guess it’s higher in the United States) and that they not only waste time, but also keep people who need to be seen sooner from getting in.
The penalty wouldn’t be automatic, and it’s up to the physician to decide if a patient’s excuse is valid. As I understand it, the €5 is paid as a fine to the national healthcare service, and not to the physician (I may be wrong on that).
In many ways I agree with this. Given the patchwork of regulations and insurance rules we face in the United States, it’s almost impossible to penalize patients for missed visits unless you don’t take insurance at all.
Some people have legitimate reasons for no-showing. Cars break, family emergencies happen, storms roll in. Even the most punctual of us sometimes just space on something. If someone calls in at the last minute to say “I can’t make it” I’m more forgiving than if we never hear from them at all. That’s why it’s good to have the doctors, who know the people they’re dealing with, make the final call.
Of course, there are those who will just lie and make up an excuse, and sometimes it’s tricky to know who is or isn’t worth penalizing. Some people just don’t care, or are dishonest, or both.
$5.36 isn’t a huge amount for most. But it’s still symbolic. It forces people to, as they say, “have skin in the game.” Yes, they may still have a copay, but that’s only paid if they show up. This puts them in the position of being penalized for thoughtlessness.
Is it a great idea? Not really. I suspect most of us would dismiss it rather than fight with the patient.
But there aren’t any easy answers, and I’d like to see how, if they go ahead with the proposal, it plays out. If it works, I hope we won’t be too far behind.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
Earlier in 2024 the French government proposed fining patients €5 ($5.36 at the time of writing) for no-show doctor appointments.
The rationale is that there are 27 million missed medical appointments annually in France (just based on population size, I’d guess it’s higher in the United States) and that they not only waste time, but also keep people who need to be seen sooner from getting in.
The penalty wouldn’t be automatic, and it’s up to the physician to decide if a patient’s excuse is valid. As I understand it, the €5 is paid as a fine to the national healthcare service, and not to the physician (I may be wrong on that).
In many ways I agree with this. Given the patchwork of regulations and insurance rules we face in the United States, it’s almost impossible to penalize patients for missed visits unless you don’t take insurance at all.
Some people have legitimate reasons for no-showing. Cars break, family emergencies happen, storms roll in. Even the most punctual of us sometimes just space on something. If someone calls in at the last minute to say “I can’t make it” I’m more forgiving than if we never hear from them at all. That’s why it’s good to have the doctors, who know the people they’re dealing with, make the final call.
Of course, there are those who will just lie and make up an excuse, and sometimes it’s tricky to know who is or isn’t worth penalizing. Some people just don’t care, or are dishonest, or both.
$5.36 isn’t a huge amount for most. But it’s still symbolic. It forces people to, as they say, “have skin in the game.” Yes, they may still have a copay, but that’s only paid if they show up. This puts them in the position of being penalized for thoughtlessness.
Is it a great idea? Not really. I suspect most of us would dismiss it rather than fight with the patient.
But there aren’t any easy answers, and I’d like to see how, if they go ahead with the proposal, it plays out. If it works, I hope we won’t be too far behind.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
Earlier in 2024 the French government proposed fining patients €5 ($5.36 at the time of writing) for no-show doctor appointments.
The rationale is that there are 27 million missed medical appointments annually in France (just based on population size, I’d guess it’s higher in the United States) and that they not only waste time, but also keep people who need to be seen sooner from getting in.
The penalty wouldn’t be automatic, and it’s up to the physician to decide if a patient’s excuse is valid. As I understand it, the €5 is paid as a fine to the national healthcare service, and not to the physician (I may be wrong on that).
In many ways I agree with this. Given the patchwork of regulations and insurance rules we face in the United States, it’s almost impossible to penalize patients for missed visits unless you don’t take insurance at all.
Some people have legitimate reasons for no-showing. Cars break, family emergencies happen, storms roll in. Even the most punctual of us sometimes just space on something. If someone calls in at the last minute to say “I can’t make it” I’m more forgiving than if we never hear from them at all. That’s why it’s good to have the doctors, who know the people they’re dealing with, make the final call.
Of course, there are those who will just lie and make up an excuse, and sometimes it’s tricky to know who is or isn’t worth penalizing. Some people just don’t care, or are dishonest, or both.
$5.36 isn’t a huge amount for most. But it’s still symbolic. It forces people to, as they say, “have skin in the game.” Yes, they may still have a copay, but that’s only paid if they show up. This puts them in the position of being penalized for thoughtlessness.
Is it a great idea? Not really. I suspect most of us would dismiss it rather than fight with the patient.
But there aren’t any easy answers, and I’d like to see how, if they go ahead with the proposal, it plays out. If it works, I hope we won’t be too far behind.
Dr. Block has a solo neurology practice in Scottsdale, Arizona.
Study Finds Potential benefits of Spironolactone for Women with HS
TOPLINE:
according to the results of a single-center retrospective study.
METHODOLOGY:
- This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
- The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
- Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.
TAKEAWAY:
- Overall, 31 patients (20%) showed improvements with spironolactone treatment.
- A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
- Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
- Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).
IN PRACTICE:
Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”
SOURCE:
The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.
LIMITATIONS:
Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.
DISCLOSURES:
This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
according to the results of a single-center retrospective study.
METHODOLOGY:
- This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
- The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
- Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.
TAKEAWAY:
- Overall, 31 patients (20%) showed improvements with spironolactone treatment.
- A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
- Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
- Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).
IN PRACTICE:
Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”
SOURCE:
The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.
LIMITATIONS:
Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.
DISCLOSURES:
This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
according to the results of a single-center retrospective study.
METHODOLOGY:
- This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
- The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
- Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.
TAKEAWAY:
- Overall, 31 patients (20%) showed improvements with spironolactone treatment.
- A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
- Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
- Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).
IN PRACTICE:
Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”
SOURCE:
The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.
LIMITATIONS:
Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.
DISCLOSURES:
This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Studies Show Dupilumab Effects In Children with Both Atopic Dermatitis and Alopecia
TOPLINE:
(AA) in a review.
METHODOLOGY:
- Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
- The review included four case reports, two case series, and one retrospective chart review.
- Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
- The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).
TAKEAWAY:
- Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
- Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
- There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
- Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.
IN PRACTICE:
“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.”
SOURCE:
The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology.
LIMITATIONS:
Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.
DISCLOSURES:
The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
(AA) in a review.
METHODOLOGY:
- Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
- The review included four case reports, two case series, and one retrospective chart review.
- Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
- The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).
TAKEAWAY:
- Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
- Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
- There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
- Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.
IN PRACTICE:
“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.”
SOURCE:
The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology.
LIMITATIONS:
Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.
DISCLOSURES:
The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
(AA) in a review.
METHODOLOGY:
- Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
- The review included four case reports, two case series, and one retrospective chart review.
- Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
- The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).
TAKEAWAY:
- Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
- Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
- There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
- Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.
IN PRACTICE:
“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.”
SOURCE:
The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology.
LIMITATIONS:
Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.
DISCLOSURES:
The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Study Estimates Global Prevalence of Seborrheic Dermatitis
TOPLINE:
, according to a meta-analysis that also found a higher prevalence in adults than in children.
METHODOLOGY:
- Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
- The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
- The primary outcome was the pooled prevalence of seborrheic dermatitis.
TAKEAWAY:
- The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
- The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
- A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.
IN PRACTICE:
The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.
SOURCE:
The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.
LIMITATIONS:
Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.
DISCLOSURES:
Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
, according to a meta-analysis that also found a higher prevalence in adults than in children.
METHODOLOGY:
- Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
- The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
- The primary outcome was the pooled prevalence of seborrheic dermatitis.
TAKEAWAY:
- The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
- The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
- A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.
IN PRACTICE:
The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.
SOURCE:
The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.
LIMITATIONS:
Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.
DISCLOSURES:
Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
, according to a meta-analysis that also found a higher prevalence in adults than in children.
METHODOLOGY:
- Researchers conducted a meta-analysis of 121 studies, which included 1,260,163 people with clinician-diagnosed seborrheic dermatitis.
- The included studies represented nine countries; most were from India (n = 18), Turkey (n = 13), and the United States (n = 8).
- The primary outcome was the pooled prevalence of seborrheic dermatitis.
TAKEAWAY:
- The overall pooled prevalence of seborrheic dermatitis was 4.38%, 4.08% in clinical settings, and 4.71% in the studies conducted in the general population.
- The prevalence of seborrheic dermatitis was higher among adults (5.64%) than in children (3.7%) and neonates (0.23%).
- A significant variation was observed across countries, with South Africa having the highest prevalence at 8.82%, followed by the United States at 5.86% and Turkey at 3.74%, while India had the lowest prevalence at 2.62%.
IN PRACTICE:
The global prevalence in this meta-analysis was “higher than previous large-scale global estimates, with notable geographic and sociodemographic variability, highlighting the potential impact of environmental factors and cultural practices,” the authors wrote.
SOURCE:
The study was led by Meredith Tyree Polaskey, MS, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois, and was published online on July 3, 2024, in the JAMA Dermatology.
LIMITATIONS:
Interpretation of the findings is limited by research gaps in Central Asia, much of Sub-Saharan Africa, Eastern Europe, Southeast Asia, Latin America (excluding Brazil), and the Caribbean, along with potential underreporting in regions with restricted healthcare access and significant heterogeneity across studies.
DISCLOSURES:
Funding information was not available. One author reported serving as an advisor, consultant, speaker, and/or investigator for multiple pharmaceutical companies, including AbbVie, Amgen, and Pfizer.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
How Common Are Life-Threatening Infections In Infants with Pustules, Vesicles?
TOPLINE:
, according to the findings from a retrospective study.
METHODOLOGY:
- Researchers reviewed the electronic medical records of infants aged ≤ 60 days who received a pediatric dermatology consultation at six US academic institutions between September 2013 and August 2019.
- Among 879 consults, 183 afebrile infants were identified as having presented with pustules, vesicles, and/or bullae.
- Infectious disease workups included blood cultures, urine cultures, lumbar punctures, and HSV testing using viral skin culture, direct immunofluorescence assay, and/or polymerase chain reaction.
- Patients were categorized by gestational age as preterm (< 37 weeks), full-term (37-42 weeks), and post-term (≥ 42 weeks).
- Overall, 67.8% of infants had pustules, 31.1% had vesicles, and 10.4% had bullae.
TAKEAWAY:
- None of the cases showed positive cerebrospinal fluid or pathogenic blood cultures. In 122 of the cases (66.6%), a noninfectious cause was diagnosed, and an infectious cause was diagnosed in 71 cases (38.8%; some patients had more than one diagnosis).
- Of the 127 newborns evaluated for HSV infection, nine (7.1%) tested positive, of whom seven (5.5%) had disease affecting the skin, eye, and mouth and were full- term infants, and two (1.6%) had disseminated HSV and were preterm infants.
- Angioinvasive fungal infection was diagnosed in five infants (2.7%), all of whom were preterm infants (< 28 weeks gestational age).
- The risk for life-threatening disease was higher in preterm infants born before 32 weeks of gestational age (P < .01) compared with those born after 32 weeks.
IN PRACTICE:
“Full-term, well-appearing, afebrile infants ≤ 60 days of age presenting with pustules or vesicles may not require full SBI [serious bacterial infection] work-up, although larger studies are needed,” the authors concluded. Testing for HSV, they added, “is recommended in all infants with vesicles, grouped pustules, or pustules accompanied by punched out or grouped erosions,” and preterm infants “should be assessed for disseminated fungal infection and HSV in the setting of fluid-filled skin lesions.”
SOURCE:
The study was led by Sonora Yun, BA, Columbia University, New York City, and was published online in Pediatrics.
LIMITATIONS:
The data were limited by the sample size and very low incidence of serious infections. Infants probably had atypical or severe presentations that warranted pediatric dermatology consultation, which may have led to overrepresentation of infectious disease rates. The study inclusion was restricted to those who received a dermatology consult; therefore, the findings may not be generalizable to outpatient primary care.
DISCLOSURES:
This study did not receive any external funding. The authors declared that they had no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
, according to the findings from a retrospective study.
METHODOLOGY:
- Researchers reviewed the electronic medical records of infants aged ≤ 60 days who received a pediatric dermatology consultation at six US academic institutions between September 2013 and August 2019.
- Among 879 consults, 183 afebrile infants were identified as having presented with pustules, vesicles, and/or bullae.
- Infectious disease workups included blood cultures, urine cultures, lumbar punctures, and HSV testing using viral skin culture, direct immunofluorescence assay, and/or polymerase chain reaction.
- Patients were categorized by gestational age as preterm (< 37 weeks), full-term (37-42 weeks), and post-term (≥ 42 weeks).
- Overall, 67.8% of infants had pustules, 31.1% had vesicles, and 10.4% had bullae.
TAKEAWAY:
- None of the cases showed positive cerebrospinal fluid or pathogenic blood cultures. In 122 of the cases (66.6%), a noninfectious cause was diagnosed, and an infectious cause was diagnosed in 71 cases (38.8%; some patients had more than one diagnosis).
- Of the 127 newborns evaluated for HSV infection, nine (7.1%) tested positive, of whom seven (5.5%) had disease affecting the skin, eye, and mouth and were full- term infants, and two (1.6%) had disseminated HSV and were preterm infants.
- Angioinvasive fungal infection was diagnosed in five infants (2.7%), all of whom were preterm infants (< 28 weeks gestational age).
- The risk for life-threatening disease was higher in preterm infants born before 32 weeks of gestational age (P < .01) compared with those born after 32 weeks.
IN PRACTICE:
“Full-term, well-appearing, afebrile infants ≤ 60 days of age presenting with pustules or vesicles may not require full SBI [serious bacterial infection] work-up, although larger studies are needed,” the authors concluded. Testing for HSV, they added, “is recommended in all infants with vesicles, grouped pustules, or pustules accompanied by punched out or grouped erosions,” and preterm infants “should be assessed for disseminated fungal infection and HSV in the setting of fluid-filled skin lesions.”
SOURCE:
The study was led by Sonora Yun, BA, Columbia University, New York City, and was published online in Pediatrics.
LIMITATIONS:
The data were limited by the sample size and very low incidence of serious infections. Infants probably had atypical or severe presentations that warranted pediatric dermatology consultation, which may have led to overrepresentation of infectious disease rates. The study inclusion was restricted to those who received a dermatology consult; therefore, the findings may not be generalizable to outpatient primary care.
DISCLOSURES:
This study did not receive any external funding. The authors declared that they had no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
, according to the findings from a retrospective study.
METHODOLOGY:
- Researchers reviewed the electronic medical records of infants aged ≤ 60 days who received a pediatric dermatology consultation at six US academic institutions between September 2013 and August 2019.
- Among 879 consults, 183 afebrile infants were identified as having presented with pustules, vesicles, and/or bullae.
- Infectious disease workups included blood cultures, urine cultures, lumbar punctures, and HSV testing using viral skin culture, direct immunofluorescence assay, and/or polymerase chain reaction.
- Patients were categorized by gestational age as preterm (< 37 weeks), full-term (37-42 weeks), and post-term (≥ 42 weeks).
- Overall, 67.8% of infants had pustules, 31.1% had vesicles, and 10.4% had bullae.
TAKEAWAY:
- None of the cases showed positive cerebrospinal fluid or pathogenic blood cultures. In 122 of the cases (66.6%), a noninfectious cause was diagnosed, and an infectious cause was diagnosed in 71 cases (38.8%; some patients had more than one diagnosis).
- Of the 127 newborns evaluated for HSV infection, nine (7.1%) tested positive, of whom seven (5.5%) had disease affecting the skin, eye, and mouth and were full- term infants, and two (1.6%) had disseminated HSV and were preterm infants.
- Angioinvasive fungal infection was diagnosed in five infants (2.7%), all of whom were preterm infants (< 28 weeks gestational age).
- The risk for life-threatening disease was higher in preterm infants born before 32 weeks of gestational age (P < .01) compared with those born after 32 weeks.
IN PRACTICE:
“Full-term, well-appearing, afebrile infants ≤ 60 days of age presenting with pustules or vesicles may not require full SBI [serious bacterial infection] work-up, although larger studies are needed,” the authors concluded. Testing for HSV, they added, “is recommended in all infants with vesicles, grouped pustules, or pustules accompanied by punched out or grouped erosions,” and preterm infants “should be assessed for disseminated fungal infection and HSV in the setting of fluid-filled skin lesions.”
SOURCE:
The study was led by Sonora Yun, BA, Columbia University, New York City, and was published online in Pediatrics.
LIMITATIONS:
The data were limited by the sample size and very low incidence of serious infections. Infants probably had atypical or severe presentations that warranted pediatric dermatology consultation, which may have led to overrepresentation of infectious disease rates. The study inclusion was restricted to those who received a dermatology consult; therefore, the findings may not be generalizable to outpatient primary care.
DISCLOSURES:
This study did not receive any external funding. The authors declared that they had no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Topical PDE4 Inhibitor Now Approved for Atopic Dermatitis in Children, Adults
On July 9, the
aged 6 years or older.Roflumilast cream 0.15%, which has been developed by Arcutis Biotherapeutics and is marketed under the brand name Zoryve, is a steroid-free topical phosphodiesterase-4 inhibitor that was previously approved in a higher concentration to treat seborrheic dermatitis and plaque psoriasis.
According to a press release from Arcutis, approval for AD was supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials. In two identical phase 3 studies known as INTEGUMENT-1 and INTEGUMENT-2, about 40% of children and adults treated with roflumilast cream 0.15% achieved a Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5% vs 25.2%; P < .0001; INTEGUMENT-2: 39% vs 16.9%; P < .0001), with significant improvement as early as week 1 (P < .0001).
Among children and adults who participated in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% achieved a 75% reduction in their Eczema Area and Severity Index scores, respectively. According to the company, there were no adverse reactions in the combined phase 3 pivotal trials that occurred in more than 2.9% of participants in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
The product is expected to be available commercially at the end of July 2024, according to Arcutis. Roflumilast cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 6 years or older; roflumilast foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients aged 9 years or older.
A version of this article first appeared on Medscape.com.
On July 9, the
aged 6 years or older.Roflumilast cream 0.15%, which has been developed by Arcutis Biotherapeutics and is marketed under the brand name Zoryve, is a steroid-free topical phosphodiesterase-4 inhibitor that was previously approved in a higher concentration to treat seborrheic dermatitis and plaque psoriasis.
According to a press release from Arcutis, approval for AD was supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials. In two identical phase 3 studies known as INTEGUMENT-1 and INTEGUMENT-2, about 40% of children and adults treated with roflumilast cream 0.15% achieved a Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5% vs 25.2%; P < .0001; INTEGUMENT-2: 39% vs 16.9%; P < .0001), with significant improvement as early as week 1 (P < .0001).
Among children and adults who participated in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% achieved a 75% reduction in their Eczema Area and Severity Index scores, respectively. According to the company, there were no adverse reactions in the combined phase 3 pivotal trials that occurred in more than 2.9% of participants in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
The product is expected to be available commercially at the end of July 2024, according to Arcutis. Roflumilast cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 6 years or older; roflumilast foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients aged 9 years or older.
A version of this article first appeared on Medscape.com.
On July 9, the
aged 6 years or older.Roflumilast cream 0.15%, which has been developed by Arcutis Biotherapeutics and is marketed under the brand name Zoryve, is a steroid-free topical phosphodiesterase-4 inhibitor that was previously approved in a higher concentration to treat seborrheic dermatitis and plaque psoriasis.
According to a press release from Arcutis, approval for AD was supported by positive results from three phase 3 studies, a phase 2 dose-ranging study, and two phase 1 pharmacokinetic trials. In two identical phase 3 studies known as INTEGUMENT-1 and INTEGUMENT-2, about 40% of children and adults treated with roflumilast cream 0.15% achieved a Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) at week 4 (INTEGUMENT-1: 41.5% vs 25.2%; P < .0001; INTEGUMENT-2: 39% vs 16.9%; P < .0001), with significant improvement as early as week 1 (P < .0001).
Among children and adults who participated in the INTEGUMENT studies for 28 and 56 weeks, 61.3% and 65.7% achieved a 75% reduction in their Eczema Area and Severity Index scores, respectively. According to the company, there were no adverse reactions in the combined phase 3 pivotal trials that occurred in more than 2.9% of participants in either arm. The most common adverse reactions included headache (2.9%), nausea (1.9%), application-site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).
The product is expected to be available commercially at the end of July 2024, according to Arcutis. Roflumilast cream 0.3% is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients aged 6 years or older; roflumilast foam 0.3% is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients aged 9 years or older.
A version of this article first appeared on Medscape.com.
Can Diabetes Lead to a False-Positive Alcohol Test?
This transcript has been edited for clarity.
I’m going to tell you the story of two patients with diabetes who had false-positive alcohol tests.
The first patient is a patient of mine with type 1 diabetes. He was in a car accident. He hit the car in front of him that hit the car in front of them. Because the cars were quite damaged, the police were summoned.
At the scene, he had a breathalyzer test. He flunked the breathalyzer test, and he was charged with a DUI. The woman in the middle car got out of her car and said her neck hurt. This then rose this to the level of a DUI with injury to one of the other people, and my patient was charged with a felony. He was taken to jail.
He told them at the scene and at the jail that he had type 1 diabetes. The reason this is so important is because type 1 diabetes can cause a false-positive breathalyzer test. In particular, this patient of mine had not been eating all day long. He’d been getting his basal insulin through the pump, but he had not given any bolus doses of insulin. He was actually quite ketotic.
When he was put in jail, they took away his cell phone so he could no longer see his glucose levels, and they took away the controller for his Omnipod system. He basically had no way to give bolus doses of insulin. Fortunately, the Omnipod system lasted for a day and a half just by giving him basal. The jail physicians did not give him insulin until he’d been in jail for 3 days.
This is someone with type 1 diabetes, and their protocol for insulin has something to do with high glucose levels and giving something like a sliding scale of insulin. They were not really prepared for managing somebody with type 1 diabetes who was on an automated insulin delivery system.
I, along with my patient’s parents, worked very hard to get the jail doctors to finally give him Lantus. Inherent in all of this, it made me aware of a number of different issues. The first is that breathalyzer tests can be falsely positive in people with type 1 diabetes if they are ketotic; therefore, people with type 1 diabetes should ask for a blood test to test their alcohol levels if they think it could be a false positive.
Second, we need to actually figure out a way to help people with type 1 diabetes who happen to be in jail or in prison because if they don’t have access to a smartphone, they’re not going to be able to run their devices. We need to make sure that devices have receivers that can be used, particularly continuous glucose monitors (CGMs), because CGM is the standard of care for patients and should be so for people who are incarcerated.
The second case is much shorter and isn’t mine, but it was a letter in The New England Journal of Medicine about a man who was on probation, who was having urine tests to show that he had not been consuming alcohol. He was started on empagliflozin, which, interestingly, made his urine test become falsely positive.
Why? Well, it’s thought it’s because it caused fermentation of the sugar with the bacteria that was in his urine because the people who were processing the sample hadn’t done it correctly, and they kept it out at room temperature for a prolonged period of time before testing it. The urine samples should be kept refrigerated to prevent this from happening.
These are two people who had false-positive tests because they had diabetes. I think it’s important that we realize that this can happen, and we need to help our patients deal with these situations.
Dr. Peters is professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I’m going to tell you the story of two patients with diabetes who had false-positive alcohol tests.
The first patient is a patient of mine with type 1 diabetes. He was in a car accident. He hit the car in front of him that hit the car in front of them. Because the cars were quite damaged, the police were summoned.
At the scene, he had a breathalyzer test. He flunked the breathalyzer test, and he was charged with a DUI. The woman in the middle car got out of her car and said her neck hurt. This then rose this to the level of a DUI with injury to one of the other people, and my patient was charged with a felony. He was taken to jail.
He told them at the scene and at the jail that he had type 1 diabetes. The reason this is so important is because type 1 diabetes can cause a false-positive breathalyzer test. In particular, this patient of mine had not been eating all day long. He’d been getting his basal insulin through the pump, but he had not given any bolus doses of insulin. He was actually quite ketotic.
When he was put in jail, they took away his cell phone so he could no longer see his glucose levels, and they took away the controller for his Omnipod system. He basically had no way to give bolus doses of insulin. Fortunately, the Omnipod system lasted for a day and a half just by giving him basal. The jail physicians did not give him insulin until he’d been in jail for 3 days.
This is someone with type 1 diabetes, and their protocol for insulin has something to do with high glucose levels and giving something like a sliding scale of insulin. They were not really prepared for managing somebody with type 1 diabetes who was on an automated insulin delivery system.
I, along with my patient’s parents, worked very hard to get the jail doctors to finally give him Lantus. Inherent in all of this, it made me aware of a number of different issues. The first is that breathalyzer tests can be falsely positive in people with type 1 diabetes if they are ketotic; therefore, people with type 1 diabetes should ask for a blood test to test their alcohol levels if they think it could be a false positive.
Second, we need to actually figure out a way to help people with type 1 diabetes who happen to be in jail or in prison because if they don’t have access to a smartphone, they’re not going to be able to run their devices. We need to make sure that devices have receivers that can be used, particularly continuous glucose monitors (CGMs), because CGM is the standard of care for patients and should be so for people who are incarcerated.
The second case is much shorter and isn’t mine, but it was a letter in The New England Journal of Medicine about a man who was on probation, who was having urine tests to show that he had not been consuming alcohol. He was started on empagliflozin, which, interestingly, made his urine test become falsely positive.
Why? Well, it’s thought it’s because it caused fermentation of the sugar with the bacteria that was in his urine because the people who were processing the sample hadn’t done it correctly, and they kept it out at room temperature for a prolonged period of time before testing it. The urine samples should be kept refrigerated to prevent this from happening.
These are two people who had false-positive tests because they had diabetes. I think it’s important that we realize that this can happen, and we need to help our patients deal with these situations.
Dr. Peters is professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
I’m going to tell you the story of two patients with diabetes who had false-positive alcohol tests.
The first patient is a patient of mine with type 1 diabetes. He was in a car accident. He hit the car in front of him that hit the car in front of them. Because the cars were quite damaged, the police were summoned.
At the scene, he had a breathalyzer test. He flunked the breathalyzer test, and he was charged with a DUI. The woman in the middle car got out of her car and said her neck hurt. This then rose this to the level of a DUI with injury to one of the other people, and my patient was charged with a felony. He was taken to jail.
He told them at the scene and at the jail that he had type 1 diabetes. The reason this is so important is because type 1 diabetes can cause a false-positive breathalyzer test. In particular, this patient of mine had not been eating all day long. He’d been getting his basal insulin through the pump, but he had not given any bolus doses of insulin. He was actually quite ketotic.
When he was put in jail, they took away his cell phone so he could no longer see his glucose levels, and they took away the controller for his Omnipod system. He basically had no way to give bolus doses of insulin. Fortunately, the Omnipod system lasted for a day and a half just by giving him basal. The jail physicians did not give him insulin until he’d been in jail for 3 days.
This is someone with type 1 diabetes, and their protocol for insulin has something to do with high glucose levels and giving something like a sliding scale of insulin. They were not really prepared for managing somebody with type 1 diabetes who was on an automated insulin delivery system.
I, along with my patient’s parents, worked very hard to get the jail doctors to finally give him Lantus. Inherent in all of this, it made me aware of a number of different issues. The first is that breathalyzer tests can be falsely positive in people with type 1 diabetes if they are ketotic; therefore, people with type 1 diabetes should ask for a blood test to test their alcohol levels if they think it could be a false positive.
Second, we need to actually figure out a way to help people with type 1 diabetes who happen to be in jail or in prison because if they don’t have access to a smartphone, they’re not going to be able to run their devices. We need to make sure that devices have receivers that can be used, particularly continuous glucose monitors (CGMs), because CGM is the standard of care for patients and should be so for people who are incarcerated.
The second case is much shorter and isn’t mine, but it was a letter in The New England Journal of Medicine about a man who was on probation, who was having urine tests to show that he had not been consuming alcohol. He was started on empagliflozin, which, interestingly, made his urine test become falsely positive.
Why? Well, it’s thought it’s because it caused fermentation of the sugar with the bacteria that was in his urine because the people who were processing the sample hadn’t done it correctly, and they kept it out at room temperature for a prolonged period of time before testing it. The urine samples should be kept refrigerated to prevent this from happening.
These are two people who had false-positive tests because they had diabetes. I think it’s important that we realize that this can happen, and we need to help our patients deal with these situations.
Dr. Peters is professor, Department of Clinical Medicine, Keck School of Medicine; Director, University of Southern California Westside Center for Diabetes, University of Southern California, Los Angeles. She reported conflicts of interest with Abbott Diabetes Care, Becton Dickinson, Boehringer Ingelheim, Eli Lilly, Lexicon Pharmaceuticals, Livongo, Medscape, Merck, Novo Nordisk, Omada Health, OptumHealth, Sanofi, Zafgen, Dexcom, MannKind, and AstraZeneca.
A version of this article first appeared on Medscape.com.