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LOS ANGELES — Individuals with both uncontrolled epilepsy and sleep apnea are at significantly higher risk for mortality than those with epilepsy alone, according to a new analysis of over 2 million patient-years drawn from the Komodo Health Claims Database.

“A 10-year-old with uncontrolled epilepsy and central sleep apnea is about 200 times more likely to die than a general population 10-year-old. That’s comparable to a 10-year-old with {epilepsy and} congestive heart failure. Noncentral sleep apnea is comparable to being paralyzed. It’s a huge risk factor,” said poster presenter Dan Lloyd, advanced analytics lead at UCB, which sponsored the research.

The ordering of sleep apnea tests for patients with epilepsy is widely variable, according to Stefanie Dedeurwaerdere, PhD, who is the innovation and value creation lead at UCB. “Some doctors do that as a general practice, and some don’t. There’s no coherency in the way these studies are requested for epilepsy patients. We want to create some awareness around this topic,” she said, and added that treatment of sleep apnea may improve epileptic seizures.

The findings were presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

The study included mortality rates between January 2018 and December 2022, with a total of 2,355,410 patient-years and 968,993 patients, with an age distribution of 19.1% age 1 to less than 18 years, 23.7% age 18-35 years, and 57.2% age 36 years or older. Sleep apnea prevalences were 0.7% for central sleep apnea (CSA), 14.0% for obstructive sleep apnea (OSA), and 85.3% with no sleep apnea.

Among those aged 1-18 years, the standardized mortality ratio (SMR) for those with uncontrolled epilepsy was 27.7. For those with comorbid OSA, the SMR was 74.2, and for comorbid CSA, the SMR was 135.9. The association was less pronounced in older groups, dipping to 7.0, 11.3, and 19.5 in those aged 18-35 years, and 3.3, 3.1, and 2.8 among those aged 36 years or older.

Among the 1-18 age group, SMRs for other comorbidities included 132.3 for heart failure, 74.9 for hemiplegia/paraplegia, 55.3 for cerebrovascular disease, and 44.6 for chronic pulmonary disease.

Asked for comment, Gordon Buchanan, MD, PhD, welcomed the new work. “The results did not surprise me. I study sleep, epilepsy, and [sudden unexplained death in epilepsy (SUDEP)] in particular ... and every time I speak on these topics, someone asks me about risk of SUDEP in patients with sleep apnea. It’s great to finally have some data,” said Buchanan, a professor of neurology at the University of Iowa, Iowa City.

The authors found that patients undergoing continuous positive airway pressure (CPAP)/bi-level positive airway pressure therapy had a higher mortality risk than those not undergoing CPAP therapy but cautioned that uncontrolled confounders may be contributing to the effect.

Buchanan wondered if treatment with CPAP would be associated with a decreased mortality risk. “I think that would be interesting, but I know that, especially in children, it can be difficult to get them to remain compliant with CPAP. I think that would be interesting to know, if pushing harder to get the kids to comply with CPAP would reduce mortality,” he said.

The specific finding of heightened mortality associated with CSA is interesting, according to Buchanan. “We think of seizures propagating through the brain, maybe through direct synaptic connections or through spreading depolarization. So I think it would make sense that it would hit central regions that would then lead to sleep apnea.” 

The relationship between OSA and epilepsy is likely complex. Epilepsy medications and special diets may influence body composition, which could in turn affect the risk for OSA, as could medications associated with psychiatric comorbidities, according to Buchanan.

The study is retrospective and based on claims data. It does not prove causation, and claims data do not fully capture mortality, which may lead to conservative SMR estimates. The researchers did not control for socioeconomic status, treatment status, and other comorbidities or conditions.

Lloyd and Dedeurwaerdere are employees of UCB, which sponsored the study. Buchanan had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

LOS ANGELES — Individuals with both uncontrolled epilepsy and sleep apnea are at significantly higher risk for mortality than those with epilepsy alone, according to a new analysis of over 2 million patient-years drawn from the Komodo Health Claims Database.

“A 10-year-old with uncontrolled epilepsy and central sleep apnea is about 200 times more likely to die than a general population 10-year-old. That’s comparable to a 10-year-old with {epilepsy and} congestive heart failure. Noncentral sleep apnea is comparable to being paralyzed. It’s a huge risk factor,” said poster presenter Dan Lloyd, advanced analytics lead at UCB, which sponsored the research.

The ordering of sleep apnea tests for patients with epilepsy is widely variable, according to Stefanie Dedeurwaerdere, PhD, who is the innovation and value creation lead at UCB. “Some doctors do that as a general practice, and some don’t. There’s no coherency in the way these studies are requested for epilepsy patients. We want to create some awareness around this topic,” she said, and added that treatment of sleep apnea may improve epileptic seizures.

The findings were presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

The study included mortality rates between January 2018 and December 2022, with a total of 2,355,410 patient-years and 968,993 patients, with an age distribution of 19.1% age 1 to less than 18 years, 23.7% age 18-35 years, and 57.2% age 36 years or older. Sleep apnea prevalences were 0.7% for central sleep apnea (CSA), 14.0% for obstructive sleep apnea (OSA), and 85.3% with no sleep apnea.

Among those aged 1-18 years, the standardized mortality ratio (SMR) for those with uncontrolled epilepsy was 27.7. For those with comorbid OSA, the SMR was 74.2, and for comorbid CSA, the SMR was 135.9. The association was less pronounced in older groups, dipping to 7.0, 11.3, and 19.5 in those aged 18-35 years, and 3.3, 3.1, and 2.8 among those aged 36 years or older.

Among the 1-18 age group, SMRs for other comorbidities included 132.3 for heart failure, 74.9 for hemiplegia/paraplegia, 55.3 for cerebrovascular disease, and 44.6 for chronic pulmonary disease.

Asked for comment, Gordon Buchanan, MD, PhD, welcomed the new work. “The results did not surprise me. I study sleep, epilepsy, and [sudden unexplained death in epilepsy (SUDEP)] in particular ... and every time I speak on these topics, someone asks me about risk of SUDEP in patients with sleep apnea. It’s great to finally have some data,” said Buchanan, a professor of neurology at the University of Iowa, Iowa City.

The authors found that patients undergoing continuous positive airway pressure (CPAP)/bi-level positive airway pressure therapy had a higher mortality risk than those not undergoing CPAP therapy but cautioned that uncontrolled confounders may be contributing to the effect.

Buchanan wondered if treatment with CPAP would be associated with a decreased mortality risk. “I think that would be interesting, but I know that, especially in children, it can be difficult to get them to remain compliant with CPAP. I think that would be interesting to know, if pushing harder to get the kids to comply with CPAP would reduce mortality,” he said.

The specific finding of heightened mortality associated with CSA is interesting, according to Buchanan. “We think of seizures propagating through the brain, maybe through direct synaptic connections or through spreading depolarization. So I think it would make sense that it would hit central regions that would then lead to sleep apnea.” 

The relationship between OSA and epilepsy is likely complex. Epilepsy medications and special diets may influence body composition, which could in turn affect the risk for OSA, as could medications associated with psychiatric comorbidities, according to Buchanan.

The study is retrospective and based on claims data. It does not prove causation, and claims data do not fully capture mortality, which may lead to conservative SMR estimates. The researchers did not control for socioeconomic status, treatment status, and other comorbidities or conditions.

Lloyd and Dedeurwaerdere are employees of UCB, which sponsored the study. Buchanan had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

LOS ANGELES — Individuals with both uncontrolled epilepsy and sleep apnea are at significantly higher risk for mortality than those with epilepsy alone, according to a new analysis of over 2 million patient-years drawn from the Komodo Health Claims Database.

“A 10-year-old with uncontrolled epilepsy and central sleep apnea is about 200 times more likely to die than a general population 10-year-old. That’s comparable to a 10-year-old with {epilepsy and} congestive heart failure. Noncentral sleep apnea is comparable to being paralyzed. It’s a huge risk factor,” said poster presenter Dan Lloyd, advanced analytics lead at UCB, which sponsored the research.

The ordering of sleep apnea tests for patients with epilepsy is widely variable, according to Stefanie Dedeurwaerdere, PhD, who is the innovation and value creation lead at UCB. “Some doctors do that as a general practice, and some don’t. There’s no coherency in the way these studies are requested for epilepsy patients. We want to create some awareness around this topic,” she said, and added that treatment of sleep apnea may improve epileptic seizures.

The findings were presented at the American Epilepsy Society (AES) 78th Annual Meeting 2024.

The study included mortality rates between January 2018 and December 2022, with a total of 2,355,410 patient-years and 968,993 patients, with an age distribution of 19.1% age 1 to less than 18 years, 23.7% age 18-35 years, and 57.2% age 36 years or older. Sleep apnea prevalences were 0.7% for central sleep apnea (CSA), 14.0% for obstructive sleep apnea (OSA), and 85.3% with no sleep apnea.

Among those aged 1-18 years, the standardized mortality ratio (SMR) for those with uncontrolled epilepsy was 27.7. For those with comorbid OSA, the SMR was 74.2, and for comorbid CSA, the SMR was 135.9. The association was less pronounced in older groups, dipping to 7.0, 11.3, and 19.5 in those aged 18-35 years, and 3.3, 3.1, and 2.8 among those aged 36 years or older.

Among the 1-18 age group, SMRs for other comorbidities included 132.3 for heart failure, 74.9 for hemiplegia/paraplegia, 55.3 for cerebrovascular disease, and 44.6 for chronic pulmonary disease.

Asked for comment, Gordon Buchanan, MD, PhD, welcomed the new work. “The results did not surprise me. I study sleep, epilepsy, and [sudden unexplained death in epilepsy (SUDEP)] in particular ... and every time I speak on these topics, someone asks me about risk of SUDEP in patients with sleep apnea. It’s great to finally have some data,” said Buchanan, a professor of neurology at the University of Iowa, Iowa City.

The authors found that patients undergoing continuous positive airway pressure (CPAP)/bi-level positive airway pressure therapy had a higher mortality risk than those not undergoing CPAP therapy but cautioned that uncontrolled confounders may be contributing to the effect.

Buchanan wondered if treatment with CPAP would be associated with a decreased mortality risk. “I think that would be interesting, but I know that, especially in children, it can be difficult to get them to remain compliant with CPAP. I think that would be interesting to know, if pushing harder to get the kids to comply with CPAP would reduce mortality,” he said.

The specific finding of heightened mortality associated with CSA is interesting, according to Buchanan. “We think of seizures propagating through the brain, maybe through direct synaptic connections or through spreading depolarization. So I think it would make sense that it would hit central regions that would then lead to sleep apnea.” 

The relationship between OSA and epilepsy is likely complex. Epilepsy medications and special diets may influence body composition, which could in turn affect the risk for OSA, as could medications associated with psychiatric comorbidities, according to Buchanan.

The study is retrospective and based on claims data. It does not prove causation, and claims data do not fully capture mortality, which may lead to conservative SMR estimates. The researchers did not control for socioeconomic status, treatment status, and other comorbidities or conditions.

Lloyd and Dedeurwaerdere are employees of UCB, which sponsored the study. Buchanan had no relevant financial disclosures.

A version of this article appeared on Medscape.com.

Outpatient psychotherapy use in the United States rose sharply between 2018 and 2021, an increase that was driven primarily by young, urban professionals with higher family incomes, new data exposed significant disparities in access to this treatment type.

Results of a large population-based repeated cross-sectional study revealed that psychotherapy use increased significantly faster for women vs men, younger individuals vs their older counterparts, college graduates than those without a high school diploma, and privately insured vs publicly insured individuals.

Overall, psychotherapy use increased significantly faster among several socioeconomically advantaged groups, and inequalities were evident in teletherapy access. These trends and patterns highlight a need for clinical interventions and healthcare policies to broaden access to psychotherapy, including teletherapy, the authors noted.

“While psychotherapy access has expanded in the US, there’s concern that recent gains may not be equally distributed, despite or maybe because of the growth of teletherapy,” study author Mark Olfson, MD, MPH, Department of Psychiatry, Mailman School of Public Health, Columbia University, New York City, said in a press release.

“This increase in psychotherapy use, driven by the rise of teletherapy, has largely benefited socioeconomically advantaged adults with mild to moderate distress,” he added.

The findings were published online in JAMA Psychiatry.

 

Psychotherapy Uptick

Psychotherapy is among the most widely used methods for delivering mental health care in the United States. A recent study conducted by Olfson and colleagues showed that the percentage of US adults receiving psychotherapy increased from 6.5% in 2018 to 8.5% in 2021. However, it was unclear how this overall increase varied across different sociodemographic groups or levels of psychological distress.

Analyzing population-level trends in psychotherapy use can identify sociodemographic groups with declining access to services, providing valuable insights for developing initiatives to improve accessibility, the investigators noted.

To evaluate national trends in psychotherapy use, the researchers analyzed data from the 2018-2021 Medical Expenditure Panel Survey (MEPS). These are yearly surveys representing noninstitutionalized adults across the United States.

The study included 89,619 adults. Of these, 51.5% were women, nearly half were aged 35-64 years, and 62.2% were White individuals. The study used a repeated cross-sectional design with new, nationally representative samples of about 22,000 participants each year.

The investigators tracked the overall increase in psychotherapy use, especially among groups at higher risk for untreated mental health conditions. They also examined how video-based therapy (teletherapy) was being used, paying particular attention to differences in access among various demographic groups and levels of psychological distress, given ongoing concerns about equity in telehealth access.

Psychological distress was measured using the Kessler-6 scale, with scores ≥ 13 defining serious psychological distress, 1-12 defining mild to moderate distress, and 0 defining no distress.

Psychotherapy use increased across all racial and ethnic groups, with rates rising among Black (5.4% to 7.1%), Hispanic (4.1% to 5.8%), White (7.5% to 9.8%), and other, non-Hispanic (4.8% to 6.6%) individuals.

Participants with mild to moderate distress experienced the greatest increases in psychotherapy use (8.6% to 11.2%, respectively).

After adjusting for age, sex, and level of psychological distress, investigators found that psychotherapy use increased to a greater degree among women (7.7% to 10.5%) vs men (5.2% to 6.3%), younger adults aged 18-34 years (8% to 11.9%) vs adults aged 65 years or older (3.6% to 4.6%), and college graduates (7.6% to 11.4%) than those without a high school diploma (5.5% to 7%).

 

A National Priority

Adults with higher incomes — defined as two to four times the federal poverty level — had greater increases in psychotherapy use (5.7% to 8.2%) than those below the poverty level (9.7% to 10%).

Unsurprisingly, privately insured individuals saw more significant increases (6.1% to 8.9%) than publicly insured individuals (8.8% to 8.8%). Also, there was a larger increase in psychotherapy use among employed individuals (5.7% to 8.9%) than among unemployed individuals (10.8% to 10.5%).

In addition, there was a significantly greater increase in psychotherapy use among urban residents (6.5% to 8.7%), whereas it declined among rural residents (6.4% to 5.9%).

Data on teletherapy use from 2021 revealed that 39.9% of adults receiving psychotherapy had one or more teletherapy visits.

Teletherapy use was higher among younger adults, women, college-educated individuals, those with higher incomes, those with private insurance, and those who lived in urban areas.

The authors noted that while teletherapy is intended to remove transportation and time barriers and was widely adopted during the pandemic, the findings show that those who were older, less educated, and with lower incomes were less likely to use it.

Notably, urban residents were more than twice as likely to use teletherapy than rural residents. Prior to the COVID-19 pandemic, teletherapy was viewed as a potential solution for individuals living in rural areas facing a shortage of mental health professionals, but study results showed that “teletherapy does not appear to have addressed this public health challenge,” the investigators wrote.

“The trends we are seeing underscore the need for targeted interventions and health policies that expand psychotherapy access to underserved groups,” said Olfson.

“Ensuring that individuals in psychological distress can access care is a national priority. Addressing technical and financial barriers to teletherapy could help bridge the gap in access and promote equity in mental health care,” he added.

Study limitations included a possible underreporting of psychotherapy use by participants. In addition, MEPS does not include nursing home residents, incarcerated, and unhoused individuals.

Study funding was not disclosed. Olfson reported no relevant disclosures.

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

Outpatient psychotherapy use in the United States rose sharply between 2018 and 2021, an increase that was driven primarily by young, urban professionals with higher family incomes, new data exposed significant disparities in access to this treatment type.

Results of a large population-based repeated cross-sectional study revealed that psychotherapy use increased significantly faster for women vs men, younger individuals vs their older counterparts, college graduates than those without a high school diploma, and privately insured vs publicly insured individuals.

Overall, psychotherapy use increased significantly faster among several socioeconomically advantaged groups, and inequalities were evident in teletherapy access. These trends and patterns highlight a need for clinical interventions and healthcare policies to broaden access to psychotherapy, including teletherapy, the authors noted.

“While psychotherapy access has expanded in the US, there’s concern that recent gains may not be equally distributed, despite or maybe because of the growth of teletherapy,” study author Mark Olfson, MD, MPH, Department of Psychiatry, Mailman School of Public Health, Columbia University, New York City, said in a press release.

“This increase in psychotherapy use, driven by the rise of teletherapy, has largely benefited socioeconomically advantaged adults with mild to moderate distress,” he added.

The findings were published online in JAMA Psychiatry.

 

Psychotherapy Uptick

Psychotherapy is among the most widely used methods for delivering mental health care in the United States. A recent study conducted by Olfson and colleagues showed that the percentage of US adults receiving psychotherapy increased from 6.5% in 2018 to 8.5% in 2021. However, it was unclear how this overall increase varied across different sociodemographic groups or levels of psychological distress.

Analyzing population-level trends in psychotherapy use can identify sociodemographic groups with declining access to services, providing valuable insights for developing initiatives to improve accessibility, the investigators noted.

To evaluate national trends in psychotherapy use, the researchers analyzed data from the 2018-2021 Medical Expenditure Panel Survey (MEPS). These are yearly surveys representing noninstitutionalized adults across the United States.

The study included 89,619 adults. Of these, 51.5% were women, nearly half were aged 35-64 years, and 62.2% were White individuals. The study used a repeated cross-sectional design with new, nationally representative samples of about 22,000 participants each year.

The investigators tracked the overall increase in psychotherapy use, especially among groups at higher risk for untreated mental health conditions. They also examined how video-based therapy (teletherapy) was being used, paying particular attention to differences in access among various demographic groups and levels of psychological distress, given ongoing concerns about equity in telehealth access.

Psychological distress was measured using the Kessler-6 scale, with scores ≥ 13 defining serious psychological distress, 1-12 defining mild to moderate distress, and 0 defining no distress.

Psychotherapy use increased across all racial and ethnic groups, with rates rising among Black (5.4% to 7.1%), Hispanic (4.1% to 5.8%), White (7.5% to 9.8%), and other, non-Hispanic (4.8% to 6.6%) individuals.

Participants with mild to moderate distress experienced the greatest increases in psychotherapy use (8.6% to 11.2%, respectively).

After adjusting for age, sex, and level of psychological distress, investigators found that psychotherapy use increased to a greater degree among women (7.7% to 10.5%) vs men (5.2% to 6.3%), younger adults aged 18-34 years (8% to 11.9%) vs adults aged 65 years or older (3.6% to 4.6%), and college graduates (7.6% to 11.4%) than those without a high school diploma (5.5% to 7%).

 

A National Priority

Adults with higher incomes — defined as two to four times the federal poverty level — had greater increases in psychotherapy use (5.7% to 8.2%) than those below the poverty level (9.7% to 10%).

Unsurprisingly, privately insured individuals saw more significant increases (6.1% to 8.9%) than publicly insured individuals (8.8% to 8.8%). Also, there was a larger increase in psychotherapy use among employed individuals (5.7% to 8.9%) than among unemployed individuals (10.8% to 10.5%).

In addition, there was a significantly greater increase in psychotherapy use among urban residents (6.5% to 8.7%), whereas it declined among rural residents (6.4% to 5.9%).

Data on teletherapy use from 2021 revealed that 39.9% of adults receiving psychotherapy had one or more teletherapy visits.

Teletherapy use was higher among younger adults, women, college-educated individuals, those with higher incomes, those with private insurance, and those who lived in urban areas.

The authors noted that while teletherapy is intended to remove transportation and time barriers and was widely adopted during the pandemic, the findings show that those who were older, less educated, and with lower incomes were less likely to use it.

Notably, urban residents were more than twice as likely to use teletherapy than rural residents. Prior to the COVID-19 pandemic, teletherapy was viewed as a potential solution for individuals living in rural areas facing a shortage of mental health professionals, but study results showed that “teletherapy does not appear to have addressed this public health challenge,” the investigators wrote.

“The trends we are seeing underscore the need for targeted interventions and health policies that expand psychotherapy access to underserved groups,” said Olfson.

“Ensuring that individuals in psychological distress can access care is a national priority. Addressing technical and financial barriers to teletherapy could help bridge the gap in access and promote equity in mental health care,” he added.

Study limitations included a possible underreporting of psychotherapy use by participants. In addition, MEPS does not include nursing home residents, incarcerated, and unhoused individuals.

Study funding was not disclosed. Olfson reported no relevant disclosures.

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

Outpatient psychotherapy use in the United States rose sharply between 2018 and 2021, an increase that was driven primarily by young, urban professionals with higher family incomes, new data exposed significant disparities in access to this treatment type.

Results of a large population-based repeated cross-sectional study revealed that psychotherapy use increased significantly faster for women vs men, younger individuals vs their older counterparts, college graduates than those without a high school diploma, and privately insured vs publicly insured individuals.

Overall, psychotherapy use increased significantly faster among several socioeconomically advantaged groups, and inequalities were evident in teletherapy access. These trends and patterns highlight a need for clinical interventions and healthcare policies to broaden access to psychotherapy, including teletherapy, the authors noted.

“While psychotherapy access has expanded in the US, there’s concern that recent gains may not be equally distributed, despite or maybe because of the growth of teletherapy,” study author Mark Olfson, MD, MPH, Department of Psychiatry, Mailman School of Public Health, Columbia University, New York City, said in a press release.

“This increase in psychotherapy use, driven by the rise of teletherapy, has largely benefited socioeconomically advantaged adults with mild to moderate distress,” he added.

The findings were published online in JAMA Psychiatry.

 

Psychotherapy Uptick

Psychotherapy is among the most widely used methods for delivering mental health care in the United States. A recent study conducted by Olfson and colleagues showed that the percentage of US adults receiving psychotherapy increased from 6.5% in 2018 to 8.5% in 2021. However, it was unclear how this overall increase varied across different sociodemographic groups or levels of psychological distress.

Analyzing population-level trends in psychotherapy use can identify sociodemographic groups with declining access to services, providing valuable insights for developing initiatives to improve accessibility, the investigators noted.

To evaluate national trends in psychotherapy use, the researchers analyzed data from the 2018-2021 Medical Expenditure Panel Survey (MEPS). These are yearly surveys representing noninstitutionalized adults across the United States.

The study included 89,619 adults. Of these, 51.5% were women, nearly half were aged 35-64 years, and 62.2% were White individuals. The study used a repeated cross-sectional design with new, nationally representative samples of about 22,000 participants each year.

The investigators tracked the overall increase in psychotherapy use, especially among groups at higher risk for untreated mental health conditions. They also examined how video-based therapy (teletherapy) was being used, paying particular attention to differences in access among various demographic groups and levels of psychological distress, given ongoing concerns about equity in telehealth access.

Psychological distress was measured using the Kessler-6 scale, with scores ≥ 13 defining serious psychological distress, 1-12 defining mild to moderate distress, and 0 defining no distress.

Psychotherapy use increased across all racial and ethnic groups, with rates rising among Black (5.4% to 7.1%), Hispanic (4.1% to 5.8%), White (7.5% to 9.8%), and other, non-Hispanic (4.8% to 6.6%) individuals.

Participants with mild to moderate distress experienced the greatest increases in psychotherapy use (8.6% to 11.2%, respectively).

After adjusting for age, sex, and level of psychological distress, investigators found that psychotherapy use increased to a greater degree among women (7.7% to 10.5%) vs men (5.2% to 6.3%), younger adults aged 18-34 years (8% to 11.9%) vs adults aged 65 years or older (3.6% to 4.6%), and college graduates (7.6% to 11.4%) than those without a high school diploma (5.5% to 7%).

 

A National Priority

Adults with higher incomes — defined as two to four times the federal poverty level — had greater increases in psychotherapy use (5.7% to 8.2%) than those below the poverty level (9.7% to 10%).

Unsurprisingly, privately insured individuals saw more significant increases (6.1% to 8.9%) than publicly insured individuals (8.8% to 8.8%). Also, there was a larger increase in psychotherapy use among employed individuals (5.7% to 8.9%) than among unemployed individuals (10.8% to 10.5%).

In addition, there was a significantly greater increase in psychotherapy use among urban residents (6.5% to 8.7%), whereas it declined among rural residents (6.4% to 5.9%).

Data on teletherapy use from 2021 revealed that 39.9% of adults receiving psychotherapy had one or more teletherapy visits.

Teletherapy use was higher among younger adults, women, college-educated individuals, those with higher incomes, those with private insurance, and those who lived in urban areas.

The authors noted that while teletherapy is intended to remove transportation and time barriers and was widely adopted during the pandemic, the findings show that those who were older, less educated, and with lower incomes were less likely to use it.

Notably, urban residents were more than twice as likely to use teletherapy than rural residents. Prior to the COVID-19 pandemic, teletherapy was viewed as a potential solution for individuals living in rural areas facing a shortage of mental health professionals, but study results showed that “teletherapy does not appear to have addressed this public health challenge,” the investigators wrote.

“The trends we are seeing underscore the need for targeted interventions and health policies that expand psychotherapy access to underserved groups,” said Olfson.

“Ensuring that individuals in psychological distress can access care is a national priority. Addressing technical and financial barriers to teletherapy could help bridge the gap in access and promote equity in mental health care,” he added.

Study limitations included a possible underreporting of psychotherapy use by participants. In addition, MEPS does not include nursing home residents, incarcerated, and unhoused individuals.

Study funding was not disclosed. Olfson reported no relevant disclosures.

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

TOPLINE:

Increased cutaneous carbonyl stress is linked to slower nerve conduction in patients with metabolically well-controlled, recent-onset type 2 diabetes (T2D) and can predict the development of neuropathic deficits over 5 years.

METHODOLOGY:

• Accumulation of advanced glycation end products (AGEs), which results from endogenous carbonyl stress, may be a potential target for preventing and treating the diabetic sensorimotor polyneuropathy (DSPN) that is a common complication of T2D.
• Researchers investigated novel cutaneous biomarkers for the development and progression of DSPN in 160 individuals with recent-onset T2D (diagnosed within 12 months or less) and 144 individuals with normal glucose tolerance, all recruited consecutively from the German Diabetes Study baseline cohort.
• Peripheral nerve function was assessed through nerve conduction studies, quantitative sensory testing, and clinical neuropathy scores.
• Skin biopsies were used to analyze intraepidermal nerve fiber density, endothelial integrity, cutaneous oxidative stress markers, and cutaneous carbonyl stress markers, including AGE autofluorescence and argpyrimidine area.
• Skin autofluorescence was measured noninvasively using an AGE reader device.
• A subgroup of 80 patients with T2D were reassessed after 5 years to evaluate the progression of neurophysiological deficits.

TAKEAWAY:

• Patients with recent-onset T2D had greater AGE autofluorescence and argpyrimidine area (P ≤ .05 for both) and lower nerve fiber density (P ≤ .05) than individuals with normal glucose tolerance.
• In patients with T2D, AGE autofluorescence was inversely associated with nerve conduction (P = .0002, P = .002, and P = .001 for peroneal motor, median motor, and sural sensory nerve conduction velocity, respectively) and positively associated with AGE reader measurements (P < .05); no such associations were observed in those with normal glucose tolerance.
• In the prospective T2D cohort, associations were noted between cutaneous markers for AGEs and endothelial cells at baseline and changes in nerve function indices over a 5-year period.

IN PRACTICE:

“Prospective analyses revealed some predictive value of cutaneous AGEs and lower endothelial integrity for declining nerve function, supporting the role of carbonyl stress in the development and progression of DSPN, representing a potential therapeutic target,” the authors wrote.

SOURCE:

The study was led by Gidon J. Bönhof, Department of Endocrinology and Diabetology, Medical Faculty, University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. It was published online in Diabetes Care.

LIMITATIONS:

The observational design of the study limited the ability to draw causal conclusions. The groups were not matched for age or body mass index. Various mechanisms related to DSPN were analyzed; however, specific pathways of AGEs were not studied in detail. The relatively low number of individuals with clinically manifested DSPN limited the exploration of different stages of the condition.

DISCLOSURES:

The study was supported by a German Center for Diabetes Research grant. The German Diabetes Study was supported by the German Diabetes Center funded by the German Federal Ministry of Health (Berlin), the Ministry of Innovation, Science, Research and Technology of North Rhine-Westphalia (Düsseldorf, Germany), and grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research e.V. No relevant conflicts of interest were reported.

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:

Increased cutaneous carbonyl stress is linked to slower nerve conduction in patients with metabolically well-controlled, recent-onset type 2 diabetes (T2D) and can predict the development of neuropathic deficits over 5 years.

METHODOLOGY:

• Accumulation of advanced glycation end products (AGEs), which results from endogenous carbonyl stress, may be a potential target for preventing and treating the diabetic sensorimotor polyneuropathy (DSPN) that is a common complication of T2D.
• Researchers investigated novel cutaneous biomarkers for the development and progression of DSPN in 160 individuals with recent-onset T2D (diagnosed within 12 months or less) and 144 individuals with normal glucose tolerance, all recruited consecutively from the German Diabetes Study baseline cohort.
• Peripheral nerve function was assessed through nerve conduction studies, quantitative sensory testing, and clinical neuropathy scores.
• Skin biopsies were used to analyze intraepidermal nerve fiber density, endothelial integrity, cutaneous oxidative stress markers, and cutaneous carbonyl stress markers, including AGE autofluorescence and argpyrimidine area.
• Skin autofluorescence was measured noninvasively using an AGE reader device.
• A subgroup of 80 patients with T2D were reassessed after 5 years to evaluate the progression of neurophysiological deficits.

TAKEAWAY:

• Patients with recent-onset T2D had greater AGE autofluorescence and argpyrimidine area (P ≤ .05 for both) and lower nerve fiber density (P ≤ .05) than individuals with normal glucose tolerance.
• In patients with T2D, AGE autofluorescence was inversely associated with nerve conduction (P = .0002, P = .002, and P = .001 for peroneal motor, median motor, and sural sensory nerve conduction velocity, respectively) and positively associated with AGE reader measurements (P < .05); no such associations were observed in those with normal glucose tolerance.
• In the prospective T2D cohort, associations were noted between cutaneous markers for AGEs and endothelial cells at baseline and changes in nerve function indices over a 5-year period.

IN PRACTICE:

“Prospective analyses revealed some predictive value of cutaneous AGEs and lower endothelial integrity for declining nerve function, supporting the role of carbonyl stress in the development and progression of DSPN, representing a potential therapeutic target,” the authors wrote.

SOURCE:

The study was led by Gidon J. Bönhof, Department of Endocrinology and Diabetology, Medical Faculty, University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. It was published online in Diabetes Care.

LIMITATIONS:

The observational design of the study limited the ability to draw causal conclusions. The groups were not matched for age or body mass index. Various mechanisms related to DSPN were analyzed; however, specific pathways of AGEs were not studied in detail. The relatively low number of individuals with clinically manifested DSPN limited the exploration of different stages of the condition.

DISCLOSURES:

The study was supported by a German Center for Diabetes Research grant. The German Diabetes Study was supported by the German Diabetes Center funded by the German Federal Ministry of Health (Berlin), the Ministry of Innovation, Science, Research and Technology of North Rhine-Westphalia (Düsseldorf, Germany), and grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research e.V. No relevant conflicts of interest were reported.

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:

Increased cutaneous carbonyl stress is linked to slower nerve conduction in patients with metabolically well-controlled, recent-onset type 2 diabetes (T2D) and can predict the development of neuropathic deficits over 5 years.

METHODOLOGY:

• Accumulation of advanced glycation end products (AGEs), which results from endogenous carbonyl stress, may be a potential target for preventing and treating the diabetic sensorimotor polyneuropathy (DSPN) that is a common complication of T2D.
• Researchers investigated novel cutaneous biomarkers for the development and progression of DSPN in 160 individuals with recent-onset T2D (diagnosed within 12 months or less) and 144 individuals with normal glucose tolerance, all recruited consecutively from the German Diabetes Study baseline cohort.
• Peripheral nerve function was assessed through nerve conduction studies, quantitative sensory testing, and clinical neuropathy scores.
• Skin biopsies were used to analyze intraepidermal nerve fiber density, endothelial integrity, cutaneous oxidative stress markers, and cutaneous carbonyl stress markers, including AGE autofluorescence and argpyrimidine area.
• Skin autofluorescence was measured noninvasively using an AGE reader device.
• A subgroup of 80 patients with T2D were reassessed after 5 years to evaluate the progression of neurophysiological deficits.

TAKEAWAY:

• Patients with recent-onset T2D had greater AGE autofluorescence and argpyrimidine area (P ≤ .05 for both) and lower nerve fiber density (P ≤ .05) than individuals with normal glucose tolerance.
• In patients with T2D, AGE autofluorescence was inversely associated with nerve conduction (P = .0002, P = .002, and P = .001 for peroneal motor, median motor, and sural sensory nerve conduction velocity, respectively) and positively associated with AGE reader measurements (P < .05); no such associations were observed in those with normal glucose tolerance.
• In the prospective T2D cohort, associations were noted between cutaneous markers for AGEs and endothelial cells at baseline and changes in nerve function indices over a 5-year period.

IN PRACTICE:

“Prospective analyses revealed some predictive value of cutaneous AGEs and lower endothelial integrity for declining nerve function, supporting the role of carbonyl stress in the development and progression of DSPN, representing a potential therapeutic target,” the authors wrote.

SOURCE:

The study was led by Gidon J. Bönhof, Department of Endocrinology and Diabetology, Medical Faculty, University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. It was published online in Diabetes Care.

LIMITATIONS:

The observational design of the study limited the ability to draw causal conclusions. The groups were not matched for age or body mass index. Various mechanisms related to DSPN were analyzed; however, specific pathways of AGEs were not studied in detail. The relatively low number of individuals with clinically manifested DSPN limited the exploration of different stages of the condition.

DISCLOSURES:

The study was supported by a German Center for Diabetes Research grant. The German Diabetes Study was supported by the German Diabetes Center funded by the German Federal Ministry of Health (Berlin), the Ministry of Innovation, Science, Research and Technology of North Rhine-Westphalia (Düsseldorf, Germany), and grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research e.V. No relevant conflicts of interest were reported.

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.

Veterans living in rural areas are often too far away from health care institutions to easily travel to their appointments. Even if they can drive, the cost of gas and other related travel expenses may be too much for some. Telehealth was meant to help relieve that problem, but poor internet access can mitigate its convenience and accessibility for those patients. Two proposals offer solutions. 

In February, Sens. Jon Ossoff (D-GA), Susan Collins (R-ME), and John Thune (R-SD) introduced the Rural Veterans Transportation to Care Act, a bill that would expand eligibility to the US Department of Veterans Affairs (VA) Highly Rural Transportation Grants, a program currently only available to counties with < 7 people per square mile.

“As I’ve sat down with veterans in rural areas across Georgia, one of their key concerns is lack of transportation,” Sen. Ossoff said. “That’s why I’m introducing this bipartisan bill to ensure veterans have more access to transportation services that can bring them to VA clinics and medical centers to get the care they need.”

Amanda Flener and her husband, John, a veteran wounded while serving in Iraq, were driving as long as 3 hours from Fitzgerald, Georgia (population 8900) to attend his medical appointments. In the last 2 years, Flener told the Daily Yonder she had put nearly 72,000 miles on her vehicle. Following hurricane Helene, she said, "We had been driving 30 miles just to get gas to power our generator … and we were fortunate to be able to do that.” 

Telehealth appointments can help fill coverage gaps, Flener said. But even while paying for the most expensive internet plan available in her county, the signal isn't always strong enough. Telehealth care is "progress, for sure," Flener said. "So, we pay for the best Wi-Fi we can get in our area, but it isn't always reliable enough to take the video calls from the VA." 

As a result, veterans and their caregivers could benefit not only from the bipartisan transportation proposal, but also from a decision announced in November. The VA is proposing to eliminate copayments for all VA telehealth services and establish a grant program to fund designated VA telehealth access points in non-VA facilities, with a focus on rural and medically underserved communities.

The program, called Accessing Telehealth through Local Area Stations (ATLAS), would provide funding to organizations — including nonprofits and private businesses — to offer veterans comfortable, private spaces equipped with high-speed internet access and the technology to remotely meet with VA clinicians. Grants would also provide designated funding to train on-site personnel to support the program.

These proposed changes would advance the VA’s and the Biden-Harris Administration’s ongoing efforts to lower costs and expand access to care for veterans. They also could make a life-changing difference for the 2.7 million rural veterans enrolled in VA health care.

According to a 2024 RAND study, just under half of military and veteran caregivers live in a county without a VA facility, and nearly half live in a primary care physician shortage area. For military/veteran caregivers in particular, the survey found, reduced access to support related to the more complicated care some patients require, greater distances to reach opportunities (eg, retail, economic, or social), and even differences in Wi-Fi/broadband internet access may create “unique needs.” The survey found that 24% of rural military/veteran caregivers did not have reliable broadband internet. 

“Waiving copays for telehealth services and launching this grant program are both major steps forward in ensuring veterans can access health care where and when they need it,” said VA Secretary Denis McDonough. “VA is the best and most affordable care in America for veterans — with these steps, we can make it easier for veterans to access their earned VA health care.”

 The rulemaking can be viewed in the Federal Register under public inspection, and is open for comment. The VA anticipates a notice of funding opportunity for this grant program following publication of the final rule.

Veterans living in rural areas are often too far away from health care institutions to easily travel to their appointments. Even if they can drive, the cost of gas and other related travel expenses may be too much for some. Telehealth was meant to help relieve that problem, but poor internet access can mitigate its convenience and accessibility for those patients. Two proposals offer solutions. 

In February, Sens. Jon Ossoff (D-GA), Susan Collins (R-ME), and John Thune (R-SD) introduced the Rural Veterans Transportation to Care Act, a bill that would expand eligibility to the US Department of Veterans Affairs (VA) Highly Rural Transportation Grants, a program currently only available to counties with < 7 people per square mile.

“As I’ve sat down with veterans in rural areas across Georgia, one of their key concerns is lack of transportation,” Sen. Ossoff said. “That’s why I’m introducing this bipartisan bill to ensure veterans have more access to transportation services that can bring them to VA clinics and medical centers to get the care they need.”

Amanda Flener and her husband, John, a veteran wounded while serving in Iraq, were driving as long as 3 hours from Fitzgerald, Georgia (population 8900) to attend his medical appointments. In the last 2 years, Flener told the Daily Yonder she had put nearly 72,000 miles on her vehicle. Following hurricane Helene, she said, "We had been driving 30 miles just to get gas to power our generator … and we were fortunate to be able to do that.” 

Telehealth appointments can help fill coverage gaps, Flener said. But even while paying for the most expensive internet plan available in her county, the signal isn't always strong enough. Telehealth care is "progress, for sure," Flener said. "So, we pay for the best Wi-Fi we can get in our area, but it isn't always reliable enough to take the video calls from the VA." 

As a result, veterans and their caregivers could benefit not only from the bipartisan transportation proposal, but also from a decision announced in November. The VA is proposing to eliminate copayments for all VA telehealth services and establish a grant program to fund designated VA telehealth access points in non-VA facilities, with a focus on rural and medically underserved communities.

The program, called Accessing Telehealth through Local Area Stations (ATLAS), would provide funding to organizations — including nonprofits and private businesses — to offer veterans comfortable, private spaces equipped with high-speed internet access and the technology to remotely meet with VA clinicians. Grants would also provide designated funding to train on-site personnel to support the program.

These proposed changes would advance the VA’s and the Biden-Harris Administration’s ongoing efforts to lower costs and expand access to care for veterans. They also could make a life-changing difference for the 2.7 million rural veterans enrolled in VA health care.

According to a 2024 RAND study, just under half of military and veteran caregivers live in a county without a VA facility, and nearly half live in a primary care physician shortage area. For military/veteran caregivers in particular, the survey found, reduced access to support related to the more complicated care some patients require, greater distances to reach opportunities (eg, retail, economic, or social), and even differences in Wi-Fi/broadband internet access may create “unique needs.” The survey found that 24% of rural military/veteran caregivers did not have reliable broadband internet. 

“Waiving copays for telehealth services and launching this grant program are both major steps forward in ensuring veterans can access health care where and when they need it,” said VA Secretary Denis McDonough. “VA is the best and most affordable care in America for veterans — with these steps, we can make it easier for veterans to access their earned VA health care.”

 The rulemaking can be viewed in the Federal Register under public inspection, and is open for comment. The VA anticipates a notice of funding opportunity for this grant program following publication of the final rule.

Veterans living in rural areas are often too far away from health care institutions to easily travel to their appointments. Even if they can drive, the cost of gas and other related travel expenses may be too much for some. Telehealth was meant to help relieve that problem, but poor internet access can mitigate its convenience and accessibility for those patients. Two proposals offer solutions. 

In February, Sens. Jon Ossoff (D-GA), Susan Collins (R-ME), and John Thune (R-SD) introduced the Rural Veterans Transportation to Care Act, a bill that would expand eligibility to the US Department of Veterans Affairs (VA) Highly Rural Transportation Grants, a program currently only available to counties with < 7 people per square mile.

“As I’ve sat down with veterans in rural areas across Georgia, one of their key concerns is lack of transportation,” Sen. Ossoff said. “That’s why I’m introducing this bipartisan bill to ensure veterans have more access to transportation services that can bring them to VA clinics and medical centers to get the care they need.”

Amanda Flener and her husband, John, a veteran wounded while serving in Iraq, were driving as long as 3 hours from Fitzgerald, Georgia (population 8900) to attend his medical appointments. In the last 2 years, Flener told the Daily Yonder she had put nearly 72,000 miles on her vehicle. Following hurricane Helene, she said, "We had been driving 30 miles just to get gas to power our generator … and we were fortunate to be able to do that.” 

Telehealth appointments can help fill coverage gaps, Flener said. But even while paying for the most expensive internet plan available in her county, the signal isn't always strong enough. Telehealth care is "progress, for sure," Flener said. "So, we pay for the best Wi-Fi we can get in our area, but it isn't always reliable enough to take the video calls from the VA." 

As a result, veterans and their caregivers could benefit not only from the bipartisan transportation proposal, but also from a decision announced in November. The VA is proposing to eliminate copayments for all VA telehealth services and establish a grant program to fund designated VA telehealth access points in non-VA facilities, with a focus on rural and medically underserved communities.

The program, called Accessing Telehealth through Local Area Stations (ATLAS), would provide funding to organizations — including nonprofits and private businesses — to offer veterans comfortable, private spaces equipped with high-speed internet access and the technology to remotely meet with VA clinicians. Grants would also provide designated funding to train on-site personnel to support the program.

These proposed changes would advance the VA’s and the Biden-Harris Administration’s ongoing efforts to lower costs and expand access to care for veterans. They also could make a life-changing difference for the 2.7 million rural veterans enrolled in VA health care.

According to a 2024 RAND study, just under half of military and veteran caregivers live in a county without a VA facility, and nearly half live in a primary care physician shortage area. For military/veteran caregivers in particular, the survey found, reduced access to support related to the more complicated care some patients require, greater distances to reach opportunities (eg, retail, economic, or social), and even differences in Wi-Fi/broadband internet access may create “unique needs.” The survey found that 24% of rural military/veteran caregivers did not have reliable broadband internet. 

“Waiving copays for telehealth services and launching this grant program are both major steps forward in ensuring veterans can access health care where and when they need it,” said VA Secretary Denis McDonough. “VA is the best and most affordable care in America for veterans — with these steps, we can make it easier for veterans to access their earned VA health care.”

 The rulemaking can be viewed in the Federal Register under public inspection, and is open for comment. The VA anticipates a notice of funding opportunity for this grant program following publication of the final rule.

TOPLINE:

The association persists even after accounting for adverse pregnancy outcomes. Women who have experienced infertility without fertility treatment show a 25% higher risk for systemic autoimmune rheumatic disease (SARD) up to 9 years after delivery, compared with those without infertility.

METHODOLOGY:

• Population-based cohort study analyzed 568,053 singleton births among 465,078 women aged 18-50 years without pre-existing SARD in Ontario, Canada, from 2012 to 2021.
• Participants were categorized into four groups: No infertility with unassisted conception (88.0%), infertility without fertility treatment (9.2%), infertility with noninvasive fertility treatment (1.4%), and infertility with invasive fertility treatment (1.4%).
• Researchers used marginal structural Cox proportional hazards models to generate hazard ratios and 95% CIs, adjusting for sociodemographic characteristics, comorbidities, smoking, and adverse pregnancy outcomes.
• Analysis included a median follow-up duration of 6.5 years (interquartile range: 4-9 years) from delivery date until SARD diagnosis, death, loss of health insurance, or study end.

TAKEAWAY:

• The incidence rate of SARD was 12.5 per 10,000 person-years in women with untreated infertility, compared with 9.3 per 10,000 person-years in women without infertility.
• Women with untreated infertility showed an elevated risk for SARD (controlled direct effect hazard ratio [HR], 1.25; 95% CI, 1.12-1.40) even after accounting for adverse pregnancy outcomes.
• Neither noninvasive fertility treatment (total effect HR, 1.06; 95% CI, 0.79-1.42) nor invasive fertility treatment (total effect HR, 0.97; 95% CI, 0.69-1.36) were associated with increased SARD risk.
• The association between untreated infertility and SARD persisted in analyses restricted to women aged < 38 years and in those without endometriosis or other autoimmune diseases.

IN PRACTICE:

“Future research efforts should seek to corroborate this association by infertility cause, with a focus on possible mechanisms related to ovulatory, ovarian, and sexual dysfunction. Greater health provider awareness of SARD symptoms and related gynecological issues that may present in women with infertility could facilitate earlier detection and treatment of SARD during the reproductive years,” wrote the authors of the study.

SOURCE:

The study was led by Natalie V. Scime of the Department of Health and Society, University of Toronto Scarborough in Ontario, Canada. It was published online in Human Reproduction.

LIMITATIONS:

Exposure and outcome misclassification was possible due to the use of published algorithms in health administrative data with unknown or imperfect sensitivity and specificity. The researchers noted that individual-level social and lifestyle factors and underlying causes of infertility were not available, and thus, were not included in the analysis.

DISCLOSURES:

This research received funding through a Banting Postdoctoral Fellowship to Scime and Canada Research Chair to Hilary K. Brown (2019-00158), with support from ICES, funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care. One coauthor disclosed consulting for Celltrion, Werfen, Organon, MitogenDx, AstraZeneca, Mallinckrodt Canada, and GlaxoSmithKline. All other authors reported 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:

The association persists even after accounting for adverse pregnancy outcomes. Women who have experienced infertility without fertility treatment show a 25% higher risk for systemic autoimmune rheumatic disease (SARD) up to 9 years after delivery, compared with those without infertility.

METHODOLOGY:

• Population-based cohort study analyzed 568,053 singleton births among 465,078 women aged 18-50 years without pre-existing SARD in Ontario, Canada, from 2012 to 2021.
• Participants were categorized into four groups: No infertility with unassisted conception (88.0%), infertility without fertility treatment (9.2%), infertility with noninvasive fertility treatment (1.4%), and infertility with invasive fertility treatment (1.4%).
• Researchers used marginal structural Cox proportional hazards models to generate hazard ratios and 95% CIs, adjusting for sociodemographic characteristics, comorbidities, smoking, and adverse pregnancy outcomes.
• Analysis included a median follow-up duration of 6.5 years (interquartile range: 4-9 years) from delivery date until SARD diagnosis, death, loss of health insurance, or study end.

TAKEAWAY:

• The incidence rate of SARD was 12.5 per 10,000 person-years in women with untreated infertility, compared with 9.3 per 10,000 person-years in women without infertility.
• Women with untreated infertility showed an elevated risk for SARD (controlled direct effect hazard ratio [HR], 1.25; 95% CI, 1.12-1.40) even after accounting for adverse pregnancy outcomes.
• Neither noninvasive fertility treatment (total effect HR, 1.06; 95% CI, 0.79-1.42) nor invasive fertility treatment (total effect HR, 0.97; 95% CI, 0.69-1.36) were associated with increased SARD risk.
• The association between untreated infertility and SARD persisted in analyses restricted to women aged < 38 years and in those without endometriosis or other autoimmune diseases.

IN PRACTICE:

“Future research efforts should seek to corroborate this association by infertility cause, with a focus on possible mechanisms related to ovulatory, ovarian, and sexual dysfunction. Greater health provider awareness of SARD symptoms and related gynecological issues that may present in women with infertility could facilitate earlier detection and treatment of SARD during the reproductive years,” wrote the authors of the study.

SOURCE:

The study was led by Natalie V. Scime of the Department of Health and Society, University of Toronto Scarborough in Ontario, Canada. It was published online in Human Reproduction.

LIMITATIONS:

Exposure and outcome misclassification was possible due to the use of published algorithms in health administrative data with unknown or imperfect sensitivity and specificity. The researchers noted that individual-level social and lifestyle factors and underlying causes of infertility were not available, and thus, were not included in the analysis.

DISCLOSURES:

This research received funding through a Banting Postdoctoral Fellowship to Scime and Canada Research Chair to Hilary K. Brown (2019-00158), with support from ICES, funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care. One coauthor disclosed consulting for Celltrion, Werfen, Organon, MitogenDx, AstraZeneca, Mallinckrodt Canada, and GlaxoSmithKline. All other authors reported 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:

The association persists even after accounting for adverse pregnancy outcomes. Women who have experienced infertility without fertility treatment show a 25% higher risk for systemic autoimmune rheumatic disease (SARD) up to 9 years after delivery, compared with those without infertility.

METHODOLOGY:

• Population-based cohort study analyzed 568,053 singleton births among 465,078 women aged 18-50 years without pre-existing SARD in Ontario, Canada, from 2012 to 2021.
• Participants were categorized into four groups: No infertility with unassisted conception (88.0%), infertility without fertility treatment (9.2%), infertility with noninvasive fertility treatment (1.4%), and infertility with invasive fertility treatment (1.4%).
• Researchers used marginal structural Cox proportional hazards models to generate hazard ratios and 95% CIs, adjusting for sociodemographic characteristics, comorbidities, smoking, and adverse pregnancy outcomes.
• Analysis included a median follow-up duration of 6.5 years (interquartile range: 4-9 years) from delivery date until SARD diagnosis, death, loss of health insurance, or study end.

TAKEAWAY:

• The incidence rate of SARD was 12.5 per 10,000 person-years in women with untreated infertility, compared with 9.3 per 10,000 person-years in women without infertility.
• Women with untreated infertility showed an elevated risk for SARD (controlled direct effect hazard ratio [HR], 1.25; 95% CI, 1.12-1.40) even after accounting for adverse pregnancy outcomes.
• Neither noninvasive fertility treatment (total effect HR, 1.06; 95% CI, 0.79-1.42) nor invasive fertility treatment (total effect HR, 0.97; 95% CI, 0.69-1.36) were associated with increased SARD risk.
• The association between untreated infertility and SARD persisted in analyses restricted to women aged < 38 years and in those without endometriosis or other autoimmune diseases.

IN PRACTICE:

“Future research efforts should seek to corroborate this association by infertility cause, with a focus on possible mechanisms related to ovulatory, ovarian, and sexual dysfunction. Greater health provider awareness of SARD symptoms and related gynecological issues that may present in women with infertility could facilitate earlier detection and treatment of SARD during the reproductive years,” wrote the authors of the study.

SOURCE:

The study was led by Natalie V. Scime of the Department of Health and Society, University of Toronto Scarborough in Ontario, Canada. It was published online in Human Reproduction.

LIMITATIONS:

Exposure and outcome misclassification was possible due to the use of published algorithms in health administrative data with unknown or imperfect sensitivity and specificity. The researchers noted that individual-level social and lifestyle factors and underlying causes of infertility were not available, and thus, were not included in the analysis.

DISCLOSURES:

This research received funding through a Banting Postdoctoral Fellowship to Scime and Canada Research Chair to Hilary K. Brown (2019-00158), with support from ICES, funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care. One coauthor disclosed consulting for Celltrion, Werfen, Organon, MitogenDx, AstraZeneca, Mallinckrodt Canada, and GlaxoSmithKline. All other authors reported 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:

Among pregnant patients with chronic hypertension, delivery at 39 weeks of gestation provides an optimal balance between stillbirth risk and neonatal outcomes. Analysis of 227,977 term singleton deliveries shows consistent findings across different patient subgroups.

METHODOLOGY:

• A population-based retrospective cohort study analyzed 227,977 nonanomalous singleton term births in the United States from 2014 to 2018 among patients with chronic hypertension.
• Researchers excluded pregnancies with superimposed preeclampsia, eclampsia, pregestational diabetes, and deliveries occurring before 37 weeks or at 43 or more weeks of gestation.
• Analysis compared rates of stillbirth, infant death within 1 year of life, and neonatal morbidity at each week of term pregnancy.
• Neonatal morbidity was defined as a composite of neonatal intensive care unit admission, ventilation for 6 hours or longer, a low 5-minute Apgar score (≤ 3), and seizures.

TAKEAWAY:

• The rate of stillbirth per 10,000 ongoing pregnancies increased with gestational age and was lowest at 38 weeks (6.5; 95% CI, 5.4-7.7).
• Rates of infant death and neonatal morbidity were lowest at 40 weeks (18.0/10,000 live births; 95% CI, 13.7-23.6) and 39 weeks (637/10,000 live births; 95% CI, 619-654), respectively.
• At 39 weeks of gestation, the risk for delivery was lower (651/10,000; 95% CI, 633-670) than the composite risk for expectant management (750/10,000; 95% CI, 720-781).
• According to the authors, findings were consistent for non-Hispanic Black patients and pregnancies complicated by fetal growth restriction.

IN PRACTICE:

“To prevent one case of stillbirth, infant death, or neonatal morbidity, an estimated 101 patients with chronic hypertension would need to deliver at 39 weeks of gestation as opposed to 40 weeks. Given the approximately 45,000 patients with chronic hypertension who deliver at term each year in the United States, a policy of delivery at 39 weeks of gestation theoretically would prevent 450 adverse perinatal events per year,” wrote the authors of the study.

SOURCE:

The study was led by Ira Hamilton, James Liu, Labeena Wajahat, and Robert Rossi, University of Cincinnati College of Medicine in Cincinnati. It was published online in O&G Open.

LIMITATIONS:

According to the authors, the study could not stratify chronic hypertension based on medication use, number of medications, or degree of control. The researchers note that exact timing of delivery in weeks and days was not reported, limiting precise understanding of optimal delivery timing. Additionally, the study could not examine rates of neonatal morbidity and mortality in patients who developed superimposed preeclampsia during expectant management.

DISCLOSURES:

The authors did not report any potential conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Among pregnant patients with chronic hypertension, delivery at 39 weeks of gestation provides an optimal balance between stillbirth risk and neonatal outcomes. Analysis of 227,977 term singleton deliveries shows consistent findings across different patient subgroups.

METHODOLOGY:

• A population-based retrospective cohort study analyzed 227,977 nonanomalous singleton term births in the United States from 2014 to 2018 among patients with chronic hypertension.
• Researchers excluded pregnancies with superimposed preeclampsia, eclampsia, pregestational diabetes, and deliveries occurring before 37 weeks or at 43 or more weeks of gestation.
• Analysis compared rates of stillbirth, infant death within 1 year of life, and neonatal morbidity at each week of term pregnancy.
• Neonatal morbidity was defined as a composite of neonatal intensive care unit admission, ventilation for 6 hours or longer, a low 5-minute Apgar score (≤ 3), and seizures.

TAKEAWAY:

• The rate of stillbirth per 10,000 ongoing pregnancies increased with gestational age and was lowest at 38 weeks (6.5; 95% CI, 5.4-7.7).
• Rates of infant death and neonatal morbidity were lowest at 40 weeks (18.0/10,000 live births; 95% CI, 13.7-23.6) and 39 weeks (637/10,000 live births; 95% CI, 619-654), respectively.
• At 39 weeks of gestation, the risk for delivery was lower (651/10,000; 95% CI, 633-670) than the composite risk for expectant management (750/10,000; 95% CI, 720-781).
• According to the authors, findings were consistent for non-Hispanic Black patients and pregnancies complicated by fetal growth restriction.

IN PRACTICE:

“To prevent one case of stillbirth, infant death, or neonatal morbidity, an estimated 101 patients with chronic hypertension would need to deliver at 39 weeks of gestation as opposed to 40 weeks. Given the approximately 45,000 patients with chronic hypertension who deliver at term each year in the United States, a policy of delivery at 39 weeks of gestation theoretically would prevent 450 adverse perinatal events per year,” wrote the authors of the study.

SOURCE:

The study was led by Ira Hamilton, James Liu, Labeena Wajahat, and Robert Rossi, University of Cincinnati College of Medicine in Cincinnati. It was published online in O&G Open.

LIMITATIONS:

According to the authors, the study could not stratify chronic hypertension based on medication use, number of medications, or degree of control. The researchers note that exact timing of delivery in weeks and days was not reported, limiting precise understanding of optimal delivery timing. Additionally, the study could not examine rates of neonatal morbidity and mortality in patients who developed superimposed preeclampsia during expectant management.

DISCLOSURES:

The authors did not report any potential conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Among pregnant patients with chronic hypertension, delivery at 39 weeks of gestation provides an optimal balance between stillbirth risk and neonatal outcomes. Analysis of 227,977 term singleton deliveries shows consistent findings across different patient subgroups.

METHODOLOGY:

• A population-based retrospective cohort study analyzed 227,977 nonanomalous singleton term births in the United States from 2014 to 2018 among patients with chronic hypertension.
• Researchers excluded pregnancies with superimposed preeclampsia, eclampsia, pregestational diabetes, and deliveries occurring before 37 weeks or at 43 or more weeks of gestation.
• Analysis compared rates of stillbirth, infant death within 1 year of life, and neonatal morbidity at each week of term pregnancy.
• Neonatal morbidity was defined as a composite of neonatal intensive care unit admission, ventilation for 6 hours or longer, a low 5-minute Apgar score (≤ 3), and seizures.

TAKEAWAY:

• The rate of stillbirth per 10,000 ongoing pregnancies increased with gestational age and was lowest at 38 weeks (6.5; 95% CI, 5.4-7.7).
• Rates of infant death and neonatal morbidity were lowest at 40 weeks (18.0/10,000 live births; 95% CI, 13.7-23.6) and 39 weeks (637/10,000 live births; 95% CI, 619-654), respectively.
• At 39 weeks of gestation, the risk for delivery was lower (651/10,000; 95% CI, 633-670) than the composite risk for expectant management (750/10,000; 95% CI, 720-781).
• According to the authors, findings were consistent for non-Hispanic Black patients and pregnancies complicated by fetal growth restriction.

IN PRACTICE:

“To prevent one case of stillbirth, infant death, or neonatal morbidity, an estimated 101 patients with chronic hypertension would need to deliver at 39 weeks of gestation as opposed to 40 weeks. Given the approximately 45,000 patients with chronic hypertension who deliver at term each year in the United States, a policy of delivery at 39 weeks of gestation theoretically would prevent 450 adverse perinatal events per year,” wrote the authors of the study.

SOURCE:

The study was led by Ira Hamilton, James Liu, Labeena Wajahat, and Robert Rossi, University of Cincinnati College of Medicine in Cincinnati. It was published online in O&G Open.

LIMITATIONS:

According to the authors, the study could not stratify chronic hypertension based on medication use, number of medications, or degree of control. The researchers note that exact timing of delivery in weeks and days was not reported, limiting precise understanding of optimal delivery timing. Additionally, the study could not examine rates of neonatal morbidity and mortality in patients who developed superimposed preeclampsia during expectant management.

DISCLOSURES:

The authors did not report any potential conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

An analysis of acne-specific patient-reported outcome measures (PROMs) identified LGBTQ+-noninclusive language in four of nine measures, with heteronormative terms used in three of six measures addressing intimate relationships. 

METHODOLOGY:

• Researchers conducted an inductive thematic analysis of 22 PROMs for acne, identified through a PubMed search.
• LGBTQ+-inclusive language was defined per the National Institutes of Health style guide.
• The analysis included 16 PROMs: Nine were acne-specific with 56 relevant items, 4 were dermatology-specific with 28 items, and 4 were health-related with 43 items.

TAKEAWAY:

• LGBTQ+-noninclusive language was identified in four of nine acne-specific PROMs — the Acne Disability Index (ADI), Acne Quality of Life Scale (AQOL), Acne-Quality of Life (Acne-QoL), and Cardiff Acne Disability Index (CADI) — but not in health-related or dermatology-specific PROMs.
• Among PROMs addressing intimate relationships, three of six acne-specific measures (CADI, ADI, and Acne-QoL) used heteronormative language, while three acne-specific PROMs, three dermatology-specific PROMs, and one health-related PROM used nonheteronormative terminology (such as “partner”).
• All PROMs contained items with nongendered pronouns (such as “I” or “you” instead of “he” or “she”). However, the AQOL included gendered language (“brothers” and “sisters,” rather than “siblings”).
• Two acne-specific PROMs demonstrated partial LGBTQ+ inclusivity, incorporating some but not all LGBTQ+ identities.

IN PRACTICE:

“Using LGBTQ+-inclusive language may promote the acquisition of accurate and relevant data for patient care and clinical trials and even enhance patient-clinician relationships,” the authors of the study wrote. “While demographics such as sex, age, race, and ethnicity are commonly considered during patient-reported outcome development and validation,” wrote the authors of an accompanying editorial, the study highlights that “sexual orientation and gender identity should also be considered to ensure these measures have similar performance across diverse populations.” 

SOURCE:

The study was led by Twan Sia, BA, Department of Dermatology, Stanford University School of Medicine in California. The authors of the editorial were John S. Barbieri, MD, MBA, Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts, and Mya L. Roberson, MSPH, PhD, University of North Carolina at Chapel Hill.

LIMITATIONS:

The study was limited to the analysis of only English-language PROMs. 

DISCLOSURES:

Two study authors disclosed receiving grants or personal fees from various sources, including pharmaceutical companies outside the submitted work. Barbieri disclosed receiving consulting fees from Dexcel Pharma and Honeydew Care; Roberson disclosed receiving consulting fees from the National Committee for Quality Assurance.

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:

An analysis of acne-specific patient-reported outcome measures (PROMs) identified LGBTQ+-noninclusive language in four of nine measures, with heteronormative terms used in three of six measures addressing intimate relationships. 

METHODOLOGY:

• Researchers conducted an inductive thematic analysis of 22 PROMs for acne, identified through a PubMed search.
• LGBTQ+-inclusive language was defined per the National Institutes of Health style guide.
• The analysis included 16 PROMs: Nine were acne-specific with 56 relevant items, 4 were dermatology-specific with 28 items, and 4 were health-related with 43 items.

TAKEAWAY:

• LGBTQ+-noninclusive language was identified in four of nine acne-specific PROMs — the Acne Disability Index (ADI), Acne Quality of Life Scale (AQOL), Acne-Quality of Life (Acne-QoL), and Cardiff Acne Disability Index (CADI) — but not in health-related or dermatology-specific PROMs.
• Among PROMs addressing intimate relationships, three of six acne-specific measures (CADI, ADI, and Acne-QoL) used heteronormative language, while three acne-specific PROMs, three dermatology-specific PROMs, and one health-related PROM used nonheteronormative terminology (such as “partner”).
• All PROMs contained items with nongendered pronouns (such as “I” or “you” instead of “he” or “she”). However, the AQOL included gendered language (“brothers” and “sisters,” rather than “siblings”).
• Two acne-specific PROMs demonstrated partial LGBTQ+ inclusivity, incorporating some but not all LGBTQ+ identities.

IN PRACTICE:

“Using LGBTQ+-inclusive language may promote the acquisition of accurate and relevant data for patient care and clinical trials and even enhance patient-clinician relationships,” the authors of the study wrote. “While demographics such as sex, age, race, and ethnicity are commonly considered during patient-reported outcome development and validation,” wrote the authors of an accompanying editorial, the study highlights that “sexual orientation and gender identity should also be considered to ensure these measures have similar performance across diverse populations.” 

SOURCE:

The study was led by Twan Sia, BA, Department of Dermatology, Stanford University School of Medicine in California. The authors of the editorial were John S. Barbieri, MD, MBA, Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts, and Mya L. Roberson, MSPH, PhD, University of North Carolina at Chapel Hill.

LIMITATIONS:

The study was limited to the analysis of only English-language PROMs. 

DISCLOSURES:

Two study authors disclosed receiving grants or personal fees from various sources, including pharmaceutical companies outside the submitted work. Barbieri disclosed receiving consulting fees from Dexcel Pharma and Honeydew Care; Roberson disclosed receiving consulting fees from the National Committee for Quality Assurance.

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:

An analysis of acne-specific patient-reported outcome measures (PROMs) identified LGBTQ+-noninclusive language in four of nine measures, with heteronormative terms used in three of six measures addressing intimate relationships. 

METHODOLOGY:

• Researchers conducted an inductive thematic analysis of 22 PROMs for acne, identified through a PubMed search.
• LGBTQ+-inclusive language was defined per the National Institutes of Health style guide.
• The analysis included 16 PROMs: Nine were acne-specific with 56 relevant items, 4 were dermatology-specific with 28 items, and 4 were health-related with 43 items.

TAKEAWAY:

• LGBTQ+-noninclusive language was identified in four of nine acne-specific PROMs — the Acne Disability Index (ADI), Acne Quality of Life Scale (AQOL), Acne-Quality of Life (Acne-QoL), and Cardiff Acne Disability Index (CADI) — but not in health-related or dermatology-specific PROMs.
• Among PROMs addressing intimate relationships, three of six acne-specific measures (CADI, ADI, and Acne-QoL) used heteronormative language, while three acne-specific PROMs, three dermatology-specific PROMs, and one health-related PROM used nonheteronormative terminology (such as “partner”).
• All PROMs contained items with nongendered pronouns (such as “I” or “you” instead of “he” or “she”). However, the AQOL included gendered language (“brothers” and “sisters,” rather than “siblings”).
• Two acne-specific PROMs demonstrated partial LGBTQ+ inclusivity, incorporating some but not all LGBTQ+ identities.

IN PRACTICE:

“Using LGBTQ+-inclusive language may promote the acquisition of accurate and relevant data for patient care and clinical trials and even enhance patient-clinician relationships,” the authors of the study wrote. “While demographics such as sex, age, race, and ethnicity are commonly considered during patient-reported outcome development and validation,” wrote the authors of an accompanying editorial, the study highlights that “sexual orientation and gender identity should also be considered to ensure these measures have similar performance across diverse populations.” 

SOURCE:

The study was led by Twan Sia, BA, Department of Dermatology, Stanford University School of Medicine in California. The authors of the editorial were John S. Barbieri, MD, MBA, Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts, and Mya L. Roberson, MSPH, PhD, University of North Carolina at Chapel Hill.

LIMITATIONS:

The study was limited to the analysis of only English-language PROMs. 

DISCLOSURES:

Two study authors disclosed receiving grants or personal fees from various sources, including pharmaceutical companies outside the submitted work. Barbieri disclosed receiving consulting fees from Dexcel Pharma and Honeydew Care; Roberson disclosed receiving consulting fees from the National Committee for Quality Assurance.

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:

Atherosclerotic cardiovascular disease (ASCVD) risk is higher with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) than with psoriasis.

METHODOLOGY:

• A retrospective matched longitudinal study compared the incidence and prevalence of ASCVD of 8138 individuals with CLE; 24,675 with SLE; 192,577 with psoriasis; and 81,380 control individuals.
• The disease-free control population was matched in a 10:1 ratio to the CLE population on the basis of age, sex, insurance type, and enrollment duration.
• Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident, with ASCVD incidence assessed by number of hospitalizations over 3 years.

TAKEAWAY:

• Persons with CLE had higher ASCVD risk than control individuals (odds ratio [OR], 1.72; P < .001), similar to those with SLE (OR, 2.41; P < .001) but unlike those with psoriasis (OR, 1.03; P = .48).
• ASCVD incidence at 3 years was 24.8 per 1000 person-years for SLE, 15.2 per 1000 person-years for CLE, 14.0 per 1000 person-years for psoriasis, and 10.3 per 1000 person-years for controls.
• Multivariable Cox proportional regression modeling showed ASCVD risk was highest in those with SLE (hazard ratio [HR], 2.23; P < .001) vs CLE (HR, 1.32; P < .001) and psoriasis (HR, 1.06; P = .09).
• ASCVD prevalence was higher in individuals with CLE receiving systemic therapy (2.7%) than in those receiving no therapy (1.6%), suggesting a potential link between disease severity and CVD risk.

IN PRACTICE:

“Persons with CLE are at higher risk for ASCVD, and guidelines for the evaluation and management of ASCVD may improve their quality of care,” the authors wrote.

SOURCE:

The study was led by Henry W. Chen, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas. It was published online on December 4, 2024, in JAMA Dermatology.

LIMITATIONS: 

The study was limited by its relatively young population (median age, 49 years) and the exclusion of adults aged > 65 years on Medicare insurance plans. The database lacked race and ethnicity data, and the analysis was restricted to a shorter 3-year period. The study could not fully evaluate detailed risk factors such as blood pressure levels, cholesterol measurements, or glycemic control, nor could it accurately assess smoking status.

DISCLOSURES:

The research was supported by the Department of Dermatology at the University of Texas Southwestern Medical Center and a grant from the National Institutes of Health. Several authors reported receiving grants or personal fees from various pharmaceutical companies. One author reported being a deputy editor for diversity, equity, and inclusion at JAMA Cardiology. Additional disclosures are noted in the original article.

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:

Atherosclerotic cardiovascular disease (ASCVD) risk is higher with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) than with psoriasis.

METHODOLOGY:

• A retrospective matched longitudinal study compared the incidence and prevalence of ASCVD of 8138 individuals with CLE; 24,675 with SLE; 192,577 with psoriasis; and 81,380 control individuals.
• The disease-free control population was matched in a 10:1 ratio to the CLE population on the basis of age, sex, insurance type, and enrollment duration.
• Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident, with ASCVD incidence assessed by number of hospitalizations over 3 years.

TAKEAWAY:

• Persons with CLE had higher ASCVD risk than control individuals (odds ratio [OR], 1.72; P < .001), similar to those with SLE (OR, 2.41; P < .001) but unlike those with psoriasis (OR, 1.03; P = .48).
• ASCVD incidence at 3 years was 24.8 per 1000 person-years for SLE, 15.2 per 1000 person-years for CLE, 14.0 per 1000 person-years for psoriasis, and 10.3 per 1000 person-years for controls.
• Multivariable Cox proportional regression modeling showed ASCVD risk was highest in those with SLE (hazard ratio [HR], 2.23; P < .001) vs CLE (HR, 1.32; P < .001) and psoriasis (HR, 1.06; P = .09).
• ASCVD prevalence was higher in individuals with CLE receiving systemic therapy (2.7%) than in those receiving no therapy (1.6%), suggesting a potential link between disease severity and CVD risk.

IN PRACTICE:

“Persons with CLE are at higher risk for ASCVD, and guidelines for the evaluation and management of ASCVD may improve their quality of care,” the authors wrote.

SOURCE:

The study was led by Henry W. Chen, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas. It was published online on December 4, 2024, in JAMA Dermatology.

LIMITATIONS: 

The study was limited by its relatively young population (median age, 49 years) and the exclusion of adults aged > 65 years on Medicare insurance plans. The database lacked race and ethnicity data, and the analysis was restricted to a shorter 3-year period. The study could not fully evaluate detailed risk factors such as blood pressure levels, cholesterol measurements, or glycemic control, nor could it accurately assess smoking status.

DISCLOSURES:

The research was supported by the Department of Dermatology at the University of Texas Southwestern Medical Center and a grant from the National Institutes of Health. Several authors reported receiving grants or personal fees from various pharmaceutical companies. One author reported being a deputy editor for diversity, equity, and inclusion at JAMA Cardiology. Additional disclosures are noted in the original article.

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:

Atherosclerotic cardiovascular disease (ASCVD) risk is higher with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) than with psoriasis.

METHODOLOGY:

• A retrospective matched longitudinal study compared the incidence and prevalence of ASCVD of 8138 individuals with CLE; 24,675 with SLE; 192,577 with psoriasis; and 81,380 control individuals.
• The disease-free control population was matched in a 10:1 ratio to the CLE population on the basis of age, sex, insurance type, and enrollment duration.
• Prevalent ASCVD was defined as coronary artery disease, prior myocardial infarction, or cerebrovascular accident, with ASCVD incidence assessed by number of hospitalizations over 3 years.

TAKEAWAY:

• Persons with CLE had higher ASCVD risk than control individuals (odds ratio [OR], 1.72; P < .001), similar to those with SLE (OR, 2.41; P < .001) but unlike those with psoriasis (OR, 1.03; P = .48).
• ASCVD incidence at 3 years was 24.8 per 1000 person-years for SLE, 15.2 per 1000 person-years for CLE, 14.0 per 1000 person-years for psoriasis, and 10.3 per 1000 person-years for controls.
• Multivariable Cox proportional regression modeling showed ASCVD risk was highest in those with SLE (hazard ratio [HR], 2.23; P < .001) vs CLE (HR, 1.32; P < .001) and psoriasis (HR, 1.06; P = .09).
• ASCVD prevalence was higher in individuals with CLE receiving systemic therapy (2.7%) than in those receiving no therapy (1.6%), suggesting a potential link between disease severity and CVD risk.

IN PRACTICE:

“Persons with CLE are at higher risk for ASCVD, and guidelines for the evaluation and management of ASCVD may improve their quality of care,” the authors wrote.

SOURCE:

The study was led by Henry W. Chen, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas. It was published online on December 4, 2024, in JAMA Dermatology.

LIMITATIONS: 

The study was limited by its relatively young population (median age, 49 years) and the exclusion of adults aged > 65 years on Medicare insurance plans. The database lacked race and ethnicity data, and the analysis was restricted to a shorter 3-year period. The study could not fully evaluate detailed risk factors such as blood pressure levels, cholesterol measurements, or glycemic control, nor could it accurately assess smoking status.

DISCLOSURES:

The research was supported by the Department of Dermatology at the University of Texas Southwestern Medical Center and a grant from the National Institutes of Health. Several authors reported receiving grants or personal fees from various pharmaceutical companies. One author reported being a deputy editor for diversity, equity, and inclusion at JAMA Cardiology. Additional disclosures are noted in the original article.

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.

Phase 3 data support rilzabrutinib as a potential first-in-class oral Bruton tyrosine kinase (BTK) inhibitor for patients with previously treated immune thrombocytopenia (ITP). 

In the LUNA 3 trial, treatment with rilzabrutinib (Sanofi) led to rapid and durable platelet responses, reduced bleeding and need for rescue therapy, and improved health-related quality of life in patients with persistent or chronic immune thrombocytopenia. 

Notably, rilzabrutinib also “significantly improved fatigue, even among patients who did not have a significant platelet count rise,” said David J. Kuter, MD, DPhil, director of clinical hematology, Massachusetts General Hospital, Boston, who reported the findings during a press briefing at the American Society of Hematology (ASH) 2024 Annual Meeting.

Briefing moderator Charles Abrams, MD, University of Pennsylvania, Philadelphia, noted that LUNA 3 enrolled a “remarkably tough group of patients, really the hardest of the hard” and showed that rilzabrutinib was “well-tolerated and caused an increase in platelet counts.”

The study, Abrams added, demonstrates “significant progress” in treatment of a disease that has historically been viewed as “benign,” which is “good for our patients.”

Immune thrombocytopenia is a relatively rare autoimmune disease that affects 10 to 23 patients per 100,000 in the United States. For those with the condition, the body’s immune system attacks platelets, causing platelet counts to drop below 100,000/μL of blood. The disease leads to increased bleeding risk and thrombosis, impaired clotting and health-related quality of life, as well as greater fatigue. 

“People living with immune thrombocytopenia who cannot tolerate or do not respond to medications aimed at raising platelet counts are at risk of uncontrolled bleeding and often endure side effects from steroids and other available therapies,” Kuter noted in a Sanofi news release. 

Rilzabrutinib, which received fast-track designation in November 2020 from the US Food and Drug Administration to treat immune thrombocytopenia, is currently under regulatory review and has a target action date of August 29, 2025. 

In the LUNA 3 study, adults with persistent or chronic immune thrombocytopenia and severely low platelet counts (median, 15,000/μL) received oral rilzabrutinib 400 mg twice a day (133 patients) or placebo (69 patients) for up to 24 weeks during a blinded treatment period, followed by a 28-week open-label period.

Platelet response — defined as counts at or above 50,000/μL or counts between 30,000/μL and 50,000/μL but doubled from baseline — was achieved in nearly two thirds of patients taking rilzabrutinib compared with almost one third of patients taking placebo at week 13. 

The primary endpoint was durable platelet response, defined as the proportion of patients able to achieve platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded period, without the need for rescue therapy. 

No patient taking placebo met this endpoint, compared with 23% of patients taking rilzabrutinib (P < .0001).

For the combined double-blind and open-label periods, a durable response was achieved in 29% of the 133 patients randomized to rilzabrutinib and 25% of the 193 patients receiving the drug in the open-label period at the data cutoff. 

Rilzabrutinib also led to significant improvements in bleeding (based on the Immune Thrombocytopenic Purpura Bleeding Score), with a mean change from baseline at week 25 of –0.04 with rilzabrutinib versus 0.05 with placebo (P = .0006).

Patients on rilzabrutinib were three times more likely to achieve a platelet response than their peers on placebo (hazard ratio, 3.1; P < .0001), with a median time to first platelet response of 36 days (vs median not achieved by patients on placebo). Among patients randomized to rilzabrutinib who achieved a response, the median time to response was 15 days.

Compared with placebo, rilzabrutinib significantly reduced the need for rescue therapy by 52% (P = .0007).

Rilzabrutinib was also associated with significant and sustained improvement in physical fatigue (based on the Immune Thrombocytopenic Purpura Patient Assessment Questionnaire [ITP-PAQ] Item 10 score).

“To our surprise, those patients who got active therapy but did not have a durable response still had an improvement in their fatigue levels and that suggests rilzabrutinib may affect fatigue or have anti-inflammatory properties since BTK inhibition has many different elements to it,” Kuter said during the briefing. 

The most common treatment-related adverse events with rilzabrutinib versus placebo were mild to moderate (grade 1/2) diarrhea (23% vs 4%), nausea (17% vs 6%), headache (8% vs 1%), and abdominal pain (6% vs 1%). Rates of grade 2 or higher gastrointestinal adverse events were comparable between groups: 6% with rilzabrutinib versus 4% with placebo. In the rilzabrutinib group, one patient who had numerous risk factors had a treatment-related grade 3 peripheral embolism and one patient died due to pneumonia unrelated to treatment.

“I’m encouraged by the robust therapeutic effects I’ve seen in patients of the LUNA 3 study across all aspects of the disease, including clinically meaningful and sustained improvements in platelet count, quality of life metrics, reduction in bleeding, and a favorable safety profile,” Kuter said in the Sanofi news release. 

The LUNA 3 study was funded by Sanofi. Kuter has disclosed various relationships with Sanofi and other pharmaceutical companies.

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

Phase 3 data support rilzabrutinib as a potential first-in-class oral Bruton tyrosine kinase (BTK) inhibitor for patients with previously treated immune thrombocytopenia (ITP). 

In the LUNA 3 trial, treatment with rilzabrutinib (Sanofi) led to rapid and durable platelet responses, reduced bleeding and need for rescue therapy, and improved health-related quality of life in patients with persistent or chronic immune thrombocytopenia. 

Notably, rilzabrutinib also “significantly improved fatigue, even among patients who did not have a significant platelet count rise,” said David J. Kuter, MD, DPhil, director of clinical hematology, Massachusetts General Hospital, Boston, who reported the findings during a press briefing at the American Society of Hematology (ASH) 2024 Annual Meeting.

Briefing moderator Charles Abrams, MD, University of Pennsylvania, Philadelphia, noted that LUNA 3 enrolled a “remarkably tough group of patients, really the hardest of the hard” and showed that rilzabrutinib was “well-tolerated and caused an increase in platelet counts.”

The study, Abrams added, demonstrates “significant progress” in treatment of a disease that has historically been viewed as “benign,” which is “good for our patients.”

Immune thrombocytopenia is a relatively rare autoimmune disease that affects 10 to 23 patients per 100,000 in the United States. For those with the condition, the body’s immune system attacks platelets, causing platelet counts to drop below 100,000/μL of blood. The disease leads to increased bleeding risk and thrombosis, impaired clotting and health-related quality of life, as well as greater fatigue. 

“People living with immune thrombocytopenia who cannot tolerate or do not respond to medications aimed at raising platelet counts are at risk of uncontrolled bleeding and often endure side effects from steroids and other available therapies,” Kuter noted in a Sanofi news release. 

Rilzabrutinib, which received fast-track designation in November 2020 from the US Food and Drug Administration to treat immune thrombocytopenia, is currently under regulatory review and has a target action date of August 29, 2025. 

In the LUNA 3 study, adults with persistent or chronic immune thrombocytopenia and severely low platelet counts (median, 15,000/μL) received oral rilzabrutinib 400 mg twice a day (133 patients) or placebo (69 patients) for up to 24 weeks during a blinded treatment period, followed by a 28-week open-label period.

Platelet response — defined as counts at or above 50,000/μL or counts between 30,000/μL and 50,000/μL but doubled from baseline — was achieved in nearly two thirds of patients taking rilzabrutinib compared with almost one third of patients taking placebo at week 13. 

The primary endpoint was durable platelet response, defined as the proportion of patients able to achieve platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded period, without the need for rescue therapy. 

No patient taking placebo met this endpoint, compared with 23% of patients taking rilzabrutinib (P < .0001).

For the combined double-blind and open-label periods, a durable response was achieved in 29% of the 133 patients randomized to rilzabrutinib and 25% of the 193 patients receiving the drug in the open-label period at the data cutoff. 

Rilzabrutinib also led to significant improvements in bleeding (based on the Immune Thrombocytopenic Purpura Bleeding Score), with a mean change from baseline at week 25 of –0.04 with rilzabrutinib versus 0.05 with placebo (P = .0006).

Patients on rilzabrutinib were three times more likely to achieve a platelet response than their peers on placebo (hazard ratio, 3.1; P < .0001), with a median time to first platelet response of 36 days (vs median not achieved by patients on placebo). Among patients randomized to rilzabrutinib who achieved a response, the median time to response was 15 days.

Compared with placebo, rilzabrutinib significantly reduced the need for rescue therapy by 52% (P = .0007).

Rilzabrutinib was also associated with significant and sustained improvement in physical fatigue (based on the Immune Thrombocytopenic Purpura Patient Assessment Questionnaire [ITP-PAQ] Item 10 score).

“To our surprise, those patients who got active therapy but did not have a durable response still had an improvement in their fatigue levels and that suggests rilzabrutinib may affect fatigue or have anti-inflammatory properties since BTK inhibition has many different elements to it,” Kuter said during the briefing. 

The most common treatment-related adverse events with rilzabrutinib versus placebo were mild to moderate (grade 1/2) diarrhea (23% vs 4%), nausea (17% vs 6%), headache (8% vs 1%), and abdominal pain (6% vs 1%). Rates of grade 2 or higher gastrointestinal adverse events were comparable between groups: 6% with rilzabrutinib versus 4% with placebo. In the rilzabrutinib group, one patient who had numerous risk factors had a treatment-related grade 3 peripheral embolism and one patient died due to pneumonia unrelated to treatment.

“I’m encouraged by the robust therapeutic effects I’ve seen in patients of the LUNA 3 study across all aspects of the disease, including clinically meaningful and sustained improvements in platelet count, quality of life metrics, reduction in bleeding, and a favorable safety profile,” Kuter said in the Sanofi news release. 

The LUNA 3 study was funded by Sanofi. Kuter has disclosed various relationships with Sanofi and other pharmaceutical companies.

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

Phase 3 data support rilzabrutinib as a potential first-in-class oral Bruton tyrosine kinase (BTK) inhibitor for patients with previously treated immune thrombocytopenia (ITP). 

In the LUNA 3 trial, treatment with rilzabrutinib (Sanofi) led to rapid and durable platelet responses, reduced bleeding and need for rescue therapy, and improved health-related quality of life in patients with persistent or chronic immune thrombocytopenia. 

Notably, rilzabrutinib also “significantly improved fatigue, even among patients who did not have a significant platelet count rise,” said David J. Kuter, MD, DPhil, director of clinical hematology, Massachusetts General Hospital, Boston, who reported the findings during a press briefing at the American Society of Hematology (ASH) 2024 Annual Meeting.

Briefing moderator Charles Abrams, MD, University of Pennsylvania, Philadelphia, noted that LUNA 3 enrolled a “remarkably tough group of patients, really the hardest of the hard” and showed that rilzabrutinib was “well-tolerated and caused an increase in platelet counts.”

The study, Abrams added, demonstrates “significant progress” in treatment of a disease that has historically been viewed as “benign,” which is “good for our patients.”

Immune thrombocytopenia is a relatively rare autoimmune disease that affects 10 to 23 patients per 100,000 in the United States. For those with the condition, the body’s immune system attacks platelets, causing platelet counts to drop below 100,000/μL of blood. The disease leads to increased bleeding risk and thrombosis, impaired clotting and health-related quality of life, as well as greater fatigue. 

“People living with immune thrombocytopenia who cannot tolerate or do not respond to medications aimed at raising platelet counts are at risk of uncontrolled bleeding and often endure side effects from steroids and other available therapies,” Kuter noted in a Sanofi news release. 

Rilzabrutinib, which received fast-track designation in November 2020 from the US Food and Drug Administration to treat immune thrombocytopenia, is currently under regulatory review and has a target action date of August 29, 2025. 

In the LUNA 3 study, adults with persistent or chronic immune thrombocytopenia and severely low platelet counts (median, 15,000/μL) received oral rilzabrutinib 400 mg twice a day (133 patients) or placebo (69 patients) for up to 24 weeks during a blinded treatment period, followed by a 28-week open-label period.

Platelet response — defined as counts at or above 50,000/μL or counts between 30,000/μL and 50,000/μL but doubled from baseline — was achieved in nearly two thirds of patients taking rilzabrutinib compared with almost one third of patients taking placebo at week 13. 

The primary endpoint was durable platelet response, defined as the proportion of patients able to achieve platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded period, without the need for rescue therapy. 

No patient taking placebo met this endpoint, compared with 23% of patients taking rilzabrutinib (P < .0001).

For the combined double-blind and open-label periods, a durable response was achieved in 29% of the 133 patients randomized to rilzabrutinib and 25% of the 193 patients receiving the drug in the open-label period at the data cutoff. 

Rilzabrutinib also led to significant improvements in bleeding (based on the Immune Thrombocytopenic Purpura Bleeding Score), with a mean change from baseline at week 25 of –0.04 with rilzabrutinib versus 0.05 with placebo (P = .0006).

Patients on rilzabrutinib were three times more likely to achieve a platelet response than their peers on placebo (hazard ratio, 3.1; P < .0001), with a median time to first platelet response of 36 days (vs median not achieved by patients on placebo). Among patients randomized to rilzabrutinib who achieved a response, the median time to response was 15 days.

Compared with placebo, rilzabrutinib significantly reduced the need for rescue therapy by 52% (P = .0007).

Rilzabrutinib was also associated with significant and sustained improvement in physical fatigue (based on the Immune Thrombocytopenic Purpura Patient Assessment Questionnaire [ITP-PAQ] Item 10 score).

“To our surprise, those patients who got active therapy but did not have a durable response still had an improvement in their fatigue levels and that suggests rilzabrutinib may affect fatigue or have anti-inflammatory properties since BTK inhibition has many different elements to it,” Kuter said during the briefing. 

The most common treatment-related adverse events with rilzabrutinib versus placebo were mild to moderate (grade 1/2) diarrhea (23% vs 4%), nausea (17% vs 6%), headache (8% vs 1%), and abdominal pain (6% vs 1%). Rates of grade 2 or higher gastrointestinal adverse events were comparable between groups: 6% with rilzabrutinib versus 4% with placebo. In the rilzabrutinib group, one patient who had numerous risk factors had a treatment-related grade 3 peripheral embolism and one patient died due to pneumonia unrelated to treatment.

“I’m encouraged by the robust therapeutic effects I’ve seen in patients of the LUNA 3 study across all aspects of the disease, including clinically meaningful and sustained improvements in platelet count, quality of life metrics, reduction in bleeding, and a favorable safety profile,” Kuter said in the Sanofi news release. 

The LUNA 3 study was funded by Sanofi. Kuter has disclosed various relationships with Sanofi and other pharmaceutical companies.

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

New biologic drugs for chronic obstructive pulmonary disease (COPD) are finally here, said Stephen Rennard, MD, in a presentation in a session on new drugs at the 2024 GOLD International COPD Conference.

The inflammatory pathways associated with COPD are diverse and offer a range of potential targets for biologics, said Rennard, a professor of pulmonary, critical care, and sleep medicine at the University of Nebraska Medical Center, Omaha. 

The therapeutic goals of biologics remain the same as with other treatments for COPD, namely restoration of normal inflammatory response and alteration of disease progression, as well as restoration of lost structure and function and improvement of systemic effects, Rennard said in his presentation. Most studies of new and up-and-coming drugs have improvement in acute exacerbation of COPD as the primary outcome.

 

The Biology Behind the Biologics

T2 inflammation is “an inflammatory cascade led by IL [interleukin]-4, IL-13, and IL-5,” Mona Bafadhel, MD, chair of Respiratory Medicine at King’s College London in England, said in her presentation during the session.

Bafadhel, who served as one of the investigators on the BOREAS and NOTUS studies, explained some of the science behind the development of the new biologics.

Eosinophils are powerful regulators of immune response and inflammation by stimulating T-cell production and affecting other immune cell types, she noted.

In the context of COPD and drug development, high blood eosinophil counts have been associated with increased COPD-related exacerbations, Bafadhel said. She cited data from a Dutch study of more than 7000 patients with COPD (with and without clinical diagnoses), in which absolute eosinophil counts ≥ 3.3% were associated with increased risk for severe exacerbations of 32% and 84% across all patients with COPD and clinical COPD, respectively.

Understanding the mechanisms of the eosinophil in COPD is important for research and development, Bafadhel said. Along with standardizing measurement of T2 inflammatory markers (IL-4, IL-13, and IL-5), more research is needed to fully understand the role of eosinophils in immunoregulation and repair.

 

Fitting the Biologic to the Patient

Several recent studies of up-and-coming biologics have focused on subsets of COPD patients, said Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at The University of Manchester in England, in his presentation at the meeting. In September 2024, the Food and Drug Administration approved dupilumab as the first biologic treatment for patients with uncontrolled COPD and type 2 inflammation on the basis of eosinophil counts. Singh cited data from the BOREAS and NOTUS studies in which dupilumab significantly reduced exacerbations and improved lung function in these patients, compared with a placebo.

Mepolizumab, a biologic approved for asthma, is not currently approved for COPD, but data from a 2017 study showed a trend toward reduced exacerbations, compared with placebo, in a subset of patients with high blood eosinophil counts, Singh said.

In addition, a recent unpublished phase 3 study (MATINEE) showed a reduction in the annualized rate of exacerbations, compared with placebo, on the basis of up to 2 years’ follow-up.

Singh also highlighted data from a phase 2a study of astegolimab, a biologic drug that focuses on the IL-33 receptor, in which COPD exacerbation rates were not significantly different between treatment and placebo groups. However, astegolimab has shown safety and efficacy in adults with severe asthma and is under development in phase 3 trials for COPD.

Tezepelumab, which was approved by the FDA in 2021 as an add-on therapy for severe asthma in patients aged 12 years or older, is also in development as a therapy for COPD exacerbations, Singh said.

In a study presented at the 2024 American Thoracic Society annual meeting, Singh and colleagues found that tezepelumab at a subcutaneous dose of 420 mg every 4 weeks reduced the annualized rate of moderate or severe COPD exacerbations compared with placebo based on data from approximately 300 patients, although the difference was not statistically significant.

Itepekimab, another biologic, showed promise in a phase 2a genetic association study involving current and former smokers with moderate to severe COPD, Singh said.

In that study, published in 2022 in The Lancet Respiratory Medicine, itepekimab failed to meet the primary endpoint in the overall study population of reduced annualized rate of moderate to severe exacerbations; however, a subgroup analysis of former smokers showed a significant (42%) reduction in exacerbations, Singh said in his presentation. Two phase 3 clinical studies (AERIFY-1/2) are ongoing to confirm the safety and efficacy of itepekimab in former smokers with COPD.

 

Takeaways and Next Steps

“These therapies provide the first new classes of medications approved for COPD in nearly 20 years,” said David M. Mannino, MD, of the University of Kentucky, Lexington, in an interview. “Dupilumab will be available to a subset of patients who are poorly controlled and have evidence of high eosinophils in their blood and is only used once every 2 weeks,” added Mannino, who has served as a consultant to companies developing COPD drugs.

Both dupilumab and ensifentrine, a phosphodiesterase (PDE) 3 and PDE4 inhibitor also recently approved for maintenance treatment of COPD, have been shown in clinical trials to reduce exacerbations and improve symptoms, said Mannino. Both offer additional options for patients who continue to have symptoms and exacerbations in spite of their current therapy.

Some barriers to the use of biologics in practice include the high cost. “Access and overcoming insurance-related issues such as preauthorization and high copays will be a challenge,” he said. Also, because dupilumab is an injectable drug, some patient training will be required.

Newer biologic therapies in development are also injectables, but some studies are examining longer time intervals as long as every 6 months, which could be a major advancement for some patients. The newer therapies in development are similar to dupilumab in that they will be injected therapies. Some in development are looking at longer time intervals as long as every 6 months, which may be a major advancement for some patients. “All of these therapies, however, are currently targeting more advanced or serious disease,” he said.

Looking ahead, more therapies are needed for the treatment of early COPD, as well as therapies that can be administered to a large number of patients at a reasonable cost, Mannino added.

Rennard disclosed serving as a consultant for Verona Pharma, Sanofi, Beyond Air, RS BioTherapeutics, RespirAI, and Roche, as well as speaker fees from Sanofi and temporary ownership interest while employed by AstraZeneca. Rennard is also the founder of Great Plains Biometrix. Bafadhel disclosed funding from the National Institute for Health Research (NIHR), grants from Asthma + Lung UK, Horizon Europe, NIHR, and AstraZeneca to her institution, and honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Pfizer. Singh disclosed relationships including speaking sponsorships, honoraria, and advisory board memberships for Adovate, Aerogen, Almirall, Apogee, Arrowhead, AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, Cipla, Connect Biopharm, Covis, CSL Behring, DevPro Biopharm, Elpen, Empirico, EpiEndo, Genentech, Generate Biomedicines, GlaxoSmithKline, Glenmark, Kamada, Kinaset Therapeutics, Kymera, Menarini, MicroA, OM Pharma, Orion, Pieris Pharmaceuticals, Pulmatrix, Revolo, Roivant Sciences, Sanofi, Synairgen, Tetherex, Teva, Theravance Biopharma, Upstream, and Verona Pharma. Mannino disclosed serving as a consultant to multiple companies currently developing COPD therapies (AstraZeneca, GlaxoSmithKline, Roche, Regeneron, Sanofi, Genentech, Amgen, and Chiesi).

A version of this article appeared on Medscape.com.

New biologic drugs for chronic obstructive pulmonary disease (COPD) are finally here, said Stephen Rennard, MD, in a presentation in a session on new drugs at the 2024 GOLD International COPD Conference.

The inflammatory pathways associated with COPD are diverse and offer a range of potential targets for biologics, said Rennard, a professor of pulmonary, critical care, and sleep medicine at the University of Nebraska Medical Center, Omaha. 

The therapeutic goals of biologics remain the same as with other treatments for COPD, namely restoration of normal inflammatory response and alteration of disease progression, as well as restoration of lost structure and function and improvement of systemic effects, Rennard said in his presentation. Most studies of new and up-and-coming drugs have improvement in acute exacerbation of COPD as the primary outcome.

 

The Biology Behind the Biologics

T2 inflammation is “an inflammatory cascade led by IL [interleukin]-4, IL-13, and IL-5,” Mona Bafadhel, MD, chair of Respiratory Medicine at King’s College London in England, said in her presentation during the session.

Bafadhel, who served as one of the investigators on the BOREAS and NOTUS studies, explained some of the science behind the development of the new biologics.

Eosinophils are powerful regulators of immune response and inflammation by stimulating T-cell production and affecting other immune cell types, she noted.

In the context of COPD and drug development, high blood eosinophil counts have been associated with increased COPD-related exacerbations, Bafadhel said. She cited data from a Dutch study of more than 7000 patients with COPD (with and without clinical diagnoses), in which absolute eosinophil counts ≥ 3.3% were associated with increased risk for severe exacerbations of 32% and 84% across all patients with COPD and clinical COPD, respectively.

Understanding the mechanisms of the eosinophil in COPD is important for research and development, Bafadhel said. Along with standardizing measurement of T2 inflammatory markers (IL-4, IL-13, and IL-5), more research is needed to fully understand the role of eosinophils in immunoregulation and repair.

 

Fitting the Biologic to the Patient

Several recent studies of up-and-coming biologics have focused on subsets of COPD patients, said Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at The University of Manchester in England, in his presentation at the meeting. In September 2024, the Food and Drug Administration approved dupilumab as the first biologic treatment for patients with uncontrolled COPD and type 2 inflammation on the basis of eosinophil counts. Singh cited data from the BOREAS and NOTUS studies in which dupilumab significantly reduced exacerbations and improved lung function in these patients, compared with a placebo.

Mepolizumab, a biologic approved for asthma, is not currently approved for COPD, but data from a 2017 study showed a trend toward reduced exacerbations, compared with placebo, in a subset of patients with high blood eosinophil counts, Singh said.

In addition, a recent unpublished phase 3 study (MATINEE) showed a reduction in the annualized rate of exacerbations, compared with placebo, on the basis of up to 2 years’ follow-up.

Singh also highlighted data from a phase 2a study of astegolimab, a biologic drug that focuses on the IL-33 receptor, in which COPD exacerbation rates were not significantly different between treatment and placebo groups. However, astegolimab has shown safety and efficacy in adults with severe asthma and is under development in phase 3 trials for COPD.

Tezepelumab, which was approved by the FDA in 2021 as an add-on therapy for severe asthma in patients aged 12 years or older, is also in development as a therapy for COPD exacerbations, Singh said.

In a study presented at the 2024 American Thoracic Society annual meeting, Singh and colleagues found that tezepelumab at a subcutaneous dose of 420 mg every 4 weeks reduced the annualized rate of moderate or severe COPD exacerbations compared with placebo based on data from approximately 300 patients, although the difference was not statistically significant.

Itepekimab, another biologic, showed promise in a phase 2a genetic association study involving current and former smokers with moderate to severe COPD, Singh said.

In that study, published in 2022 in The Lancet Respiratory Medicine, itepekimab failed to meet the primary endpoint in the overall study population of reduced annualized rate of moderate to severe exacerbations; however, a subgroup analysis of former smokers showed a significant (42%) reduction in exacerbations, Singh said in his presentation. Two phase 3 clinical studies (AERIFY-1/2) are ongoing to confirm the safety and efficacy of itepekimab in former smokers with COPD.

 

Takeaways and Next Steps

“These therapies provide the first new classes of medications approved for COPD in nearly 20 years,” said David M. Mannino, MD, of the University of Kentucky, Lexington, in an interview. “Dupilumab will be available to a subset of patients who are poorly controlled and have evidence of high eosinophils in their blood and is only used once every 2 weeks,” added Mannino, who has served as a consultant to companies developing COPD drugs.

Both dupilumab and ensifentrine, a phosphodiesterase (PDE) 3 and PDE4 inhibitor also recently approved for maintenance treatment of COPD, have been shown in clinical trials to reduce exacerbations and improve symptoms, said Mannino. Both offer additional options for patients who continue to have symptoms and exacerbations in spite of their current therapy.

Some barriers to the use of biologics in practice include the high cost. “Access and overcoming insurance-related issues such as preauthorization and high copays will be a challenge,” he said. Also, because dupilumab is an injectable drug, some patient training will be required.

Newer biologic therapies in development are also injectables, but some studies are examining longer time intervals as long as every 6 months, which could be a major advancement for some patients. The newer therapies in development are similar to dupilumab in that they will be injected therapies. Some in development are looking at longer time intervals as long as every 6 months, which may be a major advancement for some patients. “All of these therapies, however, are currently targeting more advanced or serious disease,” he said.

Looking ahead, more therapies are needed for the treatment of early COPD, as well as therapies that can be administered to a large number of patients at a reasonable cost, Mannino added.

Rennard disclosed serving as a consultant for Verona Pharma, Sanofi, Beyond Air, RS BioTherapeutics, RespirAI, and Roche, as well as speaker fees from Sanofi and temporary ownership interest while employed by AstraZeneca. Rennard is also the founder of Great Plains Biometrix. Bafadhel disclosed funding from the National Institute for Health Research (NIHR), grants from Asthma + Lung UK, Horizon Europe, NIHR, and AstraZeneca to her institution, and honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Pfizer. Singh disclosed relationships including speaking sponsorships, honoraria, and advisory board memberships for Adovate, Aerogen, Almirall, Apogee, Arrowhead, AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, Cipla, Connect Biopharm, Covis, CSL Behring, DevPro Biopharm, Elpen, Empirico, EpiEndo, Genentech, Generate Biomedicines, GlaxoSmithKline, Glenmark, Kamada, Kinaset Therapeutics, Kymera, Menarini, MicroA, OM Pharma, Orion, Pieris Pharmaceuticals, Pulmatrix, Revolo, Roivant Sciences, Sanofi, Synairgen, Tetherex, Teva, Theravance Biopharma, Upstream, and Verona Pharma. Mannino disclosed serving as a consultant to multiple companies currently developing COPD therapies (AstraZeneca, GlaxoSmithKline, Roche, Regeneron, Sanofi, Genentech, Amgen, and Chiesi).

A version of this article appeared on Medscape.com.

New biologic drugs for chronic obstructive pulmonary disease (COPD) are finally here, said Stephen Rennard, MD, in a presentation in a session on new drugs at the 2024 GOLD International COPD Conference.

The inflammatory pathways associated with COPD are diverse and offer a range of potential targets for biologics, said Rennard, a professor of pulmonary, critical care, and sleep medicine at the University of Nebraska Medical Center, Omaha. 

The therapeutic goals of biologics remain the same as with other treatments for COPD, namely restoration of normal inflammatory response and alteration of disease progression, as well as restoration of lost structure and function and improvement of systemic effects, Rennard said in his presentation. Most studies of new and up-and-coming drugs have improvement in acute exacerbation of COPD as the primary outcome.

 

The Biology Behind the Biologics

T2 inflammation is “an inflammatory cascade led by IL [interleukin]-4, IL-13, and IL-5,” Mona Bafadhel, MD, chair of Respiratory Medicine at King’s College London in England, said in her presentation during the session.

Bafadhel, who served as one of the investigators on the BOREAS and NOTUS studies, explained some of the science behind the development of the new biologics.

Eosinophils are powerful regulators of immune response and inflammation by stimulating T-cell production and affecting other immune cell types, she noted.

In the context of COPD and drug development, high blood eosinophil counts have been associated with increased COPD-related exacerbations, Bafadhel said. She cited data from a Dutch study of more than 7000 patients with COPD (with and without clinical diagnoses), in which absolute eosinophil counts ≥ 3.3% were associated with increased risk for severe exacerbations of 32% and 84% across all patients with COPD and clinical COPD, respectively.

Understanding the mechanisms of the eosinophil in COPD is important for research and development, Bafadhel said. Along with standardizing measurement of T2 inflammatory markers (IL-4, IL-13, and IL-5), more research is needed to fully understand the role of eosinophils in immunoregulation and repair.

 

Fitting the Biologic to the Patient

Several recent studies of up-and-coming biologics have focused on subsets of COPD patients, said Dave Singh, MD, professor of clinical pharmacology and respiratory medicine at The University of Manchester in England, in his presentation at the meeting. In September 2024, the Food and Drug Administration approved dupilumab as the first biologic treatment for patients with uncontrolled COPD and type 2 inflammation on the basis of eosinophil counts. Singh cited data from the BOREAS and NOTUS studies in which dupilumab significantly reduced exacerbations and improved lung function in these patients, compared with a placebo.

Mepolizumab, a biologic approved for asthma, is not currently approved for COPD, but data from a 2017 study showed a trend toward reduced exacerbations, compared with placebo, in a subset of patients with high blood eosinophil counts, Singh said.

In addition, a recent unpublished phase 3 study (MATINEE) showed a reduction in the annualized rate of exacerbations, compared with placebo, on the basis of up to 2 years’ follow-up.

Singh also highlighted data from a phase 2a study of astegolimab, a biologic drug that focuses on the IL-33 receptor, in which COPD exacerbation rates were not significantly different between treatment and placebo groups. However, astegolimab has shown safety and efficacy in adults with severe asthma and is under development in phase 3 trials for COPD.

Tezepelumab, which was approved by the FDA in 2021 as an add-on therapy for severe asthma in patients aged 12 years or older, is also in development as a therapy for COPD exacerbations, Singh said.

In a study presented at the 2024 American Thoracic Society annual meeting, Singh and colleagues found that tezepelumab at a subcutaneous dose of 420 mg every 4 weeks reduced the annualized rate of moderate or severe COPD exacerbations compared with placebo based on data from approximately 300 patients, although the difference was not statistically significant.

Itepekimab, another biologic, showed promise in a phase 2a genetic association study involving current and former smokers with moderate to severe COPD, Singh said.

In that study, published in 2022 in The Lancet Respiratory Medicine, itepekimab failed to meet the primary endpoint in the overall study population of reduced annualized rate of moderate to severe exacerbations; however, a subgroup analysis of former smokers showed a significant (42%) reduction in exacerbations, Singh said in his presentation. Two phase 3 clinical studies (AERIFY-1/2) are ongoing to confirm the safety and efficacy of itepekimab in former smokers with COPD.

 

Takeaways and Next Steps

“These therapies provide the first new classes of medications approved for COPD in nearly 20 years,” said David M. Mannino, MD, of the University of Kentucky, Lexington, in an interview. “Dupilumab will be available to a subset of patients who are poorly controlled and have evidence of high eosinophils in their blood and is only used once every 2 weeks,” added Mannino, who has served as a consultant to companies developing COPD drugs.

Both dupilumab and ensifentrine, a phosphodiesterase (PDE) 3 and PDE4 inhibitor also recently approved for maintenance treatment of COPD, have been shown in clinical trials to reduce exacerbations and improve symptoms, said Mannino. Both offer additional options for patients who continue to have symptoms and exacerbations in spite of their current therapy.

Some barriers to the use of biologics in practice include the high cost. “Access and overcoming insurance-related issues such as preauthorization and high copays will be a challenge,” he said. Also, because dupilumab is an injectable drug, some patient training will be required.

Newer biologic therapies in development are also injectables, but some studies are examining longer time intervals as long as every 6 months, which could be a major advancement for some patients. The newer therapies in development are similar to dupilumab in that they will be injected therapies. Some in development are looking at longer time intervals as long as every 6 months, which may be a major advancement for some patients. “All of these therapies, however, are currently targeting more advanced or serious disease,” he said.

Looking ahead, more therapies are needed for the treatment of early COPD, as well as therapies that can be administered to a large number of patients at a reasonable cost, Mannino added.

Rennard disclosed serving as a consultant for Verona Pharma, Sanofi, Beyond Air, RS BioTherapeutics, RespirAI, and Roche, as well as speaker fees from Sanofi and temporary ownership interest while employed by AstraZeneca. Rennard is also the founder of Great Plains Biometrix. Bafadhel disclosed funding from the National Institute for Health Research (NIHR), grants from Asthma + Lung UK, Horizon Europe, NIHR, and AstraZeneca to her institution, and honoraria from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, and Pfizer. Singh disclosed relationships including speaking sponsorships, honoraria, and advisory board memberships for Adovate, Aerogen, Almirall, Apogee, Arrowhead, AstraZeneca, Bial, Boehringer Ingelheim, Chiesi, Cipla, Connect Biopharm, Covis, CSL Behring, DevPro Biopharm, Elpen, Empirico, EpiEndo, Genentech, Generate Biomedicines, GlaxoSmithKline, Glenmark, Kamada, Kinaset Therapeutics, Kymera, Menarini, MicroA, OM Pharma, Orion, Pieris Pharmaceuticals, Pulmatrix, Revolo, Roivant Sciences, Sanofi, Synairgen, Tetherex, Teva, Theravance Biopharma, Upstream, and Verona Pharma. Mannino disclosed serving as a consultant to multiple companies currently developing COPD therapies (AstraZeneca, GlaxoSmithKline, Roche, Regeneron, Sanofi, Genentech, Amgen, and Chiesi).

A version of this article appeared on Medscape.com.