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Patients With Asthma and COPD At Increased Cancer Risk From Microplastics
Individuals with asthma and chronic obstructive pulmonary disease (COPD) were more vulnerable than healthy controls to epithelial cell changes caused by microplastics exposure, based on data from a new simulation study.
Microplastic fibers present in the ambient air can be inhaled into the lungs and promote a range of complications including oxidative stress, local injury, and cytotoxicity, but data on the effects of microplastic fibers on individuals with obstructive lung diseases are limited, wrote Magdalena Poplinska-Goryca, MD, of the Medical University of Warsaw, Warsaw, Poland, and colleagues.
In a study published in Scientific Reports, the researchers identified 10 adults aged ≥ 18 years with asthma, eight adults aged ≥ 40 years with COPD, and 11 healthy adult controls. Individuals with more serious conditions such as severe asthma or COPD, unstable or uncontrolled disease, concomitant malignancies, or chronic or acute lung disease were excluded.
The researchers obtained nasal epithelial cells from all participants, and exposed these cells to microplastic fibers created by the researchers in a laboratory setting. Overall, asthmatic and COPD airway epithelial cells showed a different reaction to microplastic fibers stimulation compared to healthy epithelial cells. The most significant response was associated with Th2 inflammation, modulation of stress response, and carcinogenesis. No differences in cytotoxic or minor inflammatory effects on epithelial cells of patients with asthma or COPD were noted compared with healthy controls.
In addition, flow cytometric analysis showed increased CD24+ epithelial cells in asthma patients compared to controls after microplastics exposure.
“Many of the gene candidates selected from RNA-Seq analysis are related to cancer (upregulated in many cancer types according to the literature), and the activation of CD24 on primarily ciliated asthmatic epithelial cells after microplastic stimulation further supports this theory,” the researchers wrote.
The findings were limited by several factors including the use of nasal rather than bronchial epithelial cells, which would have yielded more information, the researchers noted. Also, patients with severe asthma and COPD were excluded, they said, because of the impact of oral steroid and antibiotic use by this patient group on epithelial cell immunology that could bias the results of epithelial response to microplastic fiber exposure.
However, the results suggest that “the structural impairment of the airway epithelium in obstructive diseases enhances the impact of microplastic particles compared to healthy epithelium,” the researchers concluded.
Current and Future Implications
The current study is important in addressing the increasing environmental presence of microplastics and their potential impact on respiratory health, said Seyedmohammad Pourshahid, MD, assistant professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
“By examining how microplastics interact with airway epithelial cells, particularly in individuals with asthma and COPD, the research aims to elucidate mechanisms that could contribute to disease progression or exacerbation,” he said.
“The study’s findings that microplastics did not induce a strong inflammatory response, unlike other pollutants such as PM2.5, were unexpected; instead, microplastics appeared to influence pathways related to airway remodeling and oxidative stress,” Pourshahid noted. “This suggests that microplastics may affect respiratory health through mechanisms distinct from traditional pollutants,” he said.
“While preliminary, this research highlights the potential role of environmental microplastic exposure in respiratory diseases,” Pourshahid told this news organization. “Clinicians should be aware of emerging environmental factors that could impact patient health, especially in individuals with asthma and COPD. This awareness may inform patient education and advocacy for reducing exposure to airborne microplastics,” he said.
More studies are needed to explore the long-term effects of microplastic exposure on respiratory health, particularly in vulnerable populations, said Pourshahid. Research with in vivo models is necessary to confirm the findings and assess potential clinical implications to confirm these findings and assess potential clinical implications, he said. “Understanding the prevalence and sources of daily microplastic exposure can inform public health strategies to mitigate risks,” he added.
The study was supported by the Jakub Potocki Foundation. Paplińska-Goryca and Pourshahid had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Individuals with asthma and chronic obstructive pulmonary disease (COPD) were more vulnerable than healthy controls to epithelial cell changes caused by microplastics exposure, based on data from a new simulation study.
Microplastic fibers present in the ambient air can be inhaled into the lungs and promote a range of complications including oxidative stress, local injury, and cytotoxicity, but data on the effects of microplastic fibers on individuals with obstructive lung diseases are limited, wrote Magdalena Poplinska-Goryca, MD, of the Medical University of Warsaw, Warsaw, Poland, and colleagues.
In a study published in Scientific Reports, the researchers identified 10 adults aged ≥ 18 years with asthma, eight adults aged ≥ 40 years with COPD, and 11 healthy adult controls. Individuals with more serious conditions such as severe asthma or COPD, unstable or uncontrolled disease, concomitant malignancies, or chronic or acute lung disease were excluded.
The researchers obtained nasal epithelial cells from all participants, and exposed these cells to microplastic fibers created by the researchers in a laboratory setting. Overall, asthmatic and COPD airway epithelial cells showed a different reaction to microplastic fibers stimulation compared to healthy epithelial cells. The most significant response was associated with Th2 inflammation, modulation of stress response, and carcinogenesis. No differences in cytotoxic or minor inflammatory effects on epithelial cells of patients with asthma or COPD were noted compared with healthy controls.
In addition, flow cytometric analysis showed increased CD24+ epithelial cells in asthma patients compared to controls after microplastics exposure.
“Many of the gene candidates selected from RNA-Seq analysis are related to cancer (upregulated in many cancer types according to the literature), and the activation of CD24 on primarily ciliated asthmatic epithelial cells after microplastic stimulation further supports this theory,” the researchers wrote.
The findings were limited by several factors including the use of nasal rather than bronchial epithelial cells, which would have yielded more information, the researchers noted. Also, patients with severe asthma and COPD were excluded, they said, because of the impact of oral steroid and antibiotic use by this patient group on epithelial cell immunology that could bias the results of epithelial response to microplastic fiber exposure.
However, the results suggest that “the structural impairment of the airway epithelium in obstructive diseases enhances the impact of microplastic particles compared to healthy epithelium,” the researchers concluded.
Current and Future Implications
The current study is important in addressing the increasing environmental presence of microplastics and their potential impact on respiratory health, said Seyedmohammad Pourshahid, MD, assistant professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
“By examining how microplastics interact with airway epithelial cells, particularly in individuals with asthma and COPD, the research aims to elucidate mechanisms that could contribute to disease progression or exacerbation,” he said.
“The study’s findings that microplastics did not induce a strong inflammatory response, unlike other pollutants such as PM2.5, were unexpected; instead, microplastics appeared to influence pathways related to airway remodeling and oxidative stress,” Pourshahid noted. “This suggests that microplastics may affect respiratory health through mechanisms distinct from traditional pollutants,” he said.
“While preliminary, this research highlights the potential role of environmental microplastic exposure in respiratory diseases,” Pourshahid told this news organization. “Clinicians should be aware of emerging environmental factors that could impact patient health, especially in individuals with asthma and COPD. This awareness may inform patient education and advocacy for reducing exposure to airborne microplastics,” he said.
More studies are needed to explore the long-term effects of microplastic exposure on respiratory health, particularly in vulnerable populations, said Pourshahid. Research with in vivo models is necessary to confirm the findings and assess potential clinical implications to confirm these findings and assess potential clinical implications, he said. “Understanding the prevalence and sources of daily microplastic exposure can inform public health strategies to mitigate risks,” he added.
The study was supported by the Jakub Potocki Foundation. Paplińska-Goryca and Pourshahid had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Individuals with asthma and chronic obstructive pulmonary disease (COPD) were more vulnerable than healthy controls to epithelial cell changes caused by microplastics exposure, based on data from a new simulation study.
Microplastic fibers present in the ambient air can be inhaled into the lungs and promote a range of complications including oxidative stress, local injury, and cytotoxicity, but data on the effects of microplastic fibers on individuals with obstructive lung diseases are limited, wrote Magdalena Poplinska-Goryca, MD, of the Medical University of Warsaw, Warsaw, Poland, and colleagues.
In a study published in Scientific Reports, the researchers identified 10 adults aged ≥ 18 years with asthma, eight adults aged ≥ 40 years with COPD, and 11 healthy adult controls. Individuals with more serious conditions such as severe asthma or COPD, unstable or uncontrolled disease, concomitant malignancies, or chronic or acute lung disease were excluded.
The researchers obtained nasal epithelial cells from all participants, and exposed these cells to microplastic fibers created by the researchers in a laboratory setting. Overall, asthmatic and COPD airway epithelial cells showed a different reaction to microplastic fibers stimulation compared to healthy epithelial cells. The most significant response was associated with Th2 inflammation, modulation of stress response, and carcinogenesis. No differences in cytotoxic or minor inflammatory effects on epithelial cells of patients with asthma or COPD were noted compared with healthy controls.
In addition, flow cytometric analysis showed increased CD24+ epithelial cells in asthma patients compared to controls after microplastics exposure.
“Many of the gene candidates selected from RNA-Seq analysis are related to cancer (upregulated in many cancer types according to the literature), and the activation of CD24 on primarily ciliated asthmatic epithelial cells after microplastic stimulation further supports this theory,” the researchers wrote.
The findings were limited by several factors including the use of nasal rather than bronchial epithelial cells, which would have yielded more information, the researchers noted. Also, patients with severe asthma and COPD were excluded, they said, because of the impact of oral steroid and antibiotic use by this patient group on epithelial cell immunology that could bias the results of epithelial response to microplastic fiber exposure.
However, the results suggest that “the structural impairment of the airway epithelium in obstructive diseases enhances the impact of microplastic particles compared to healthy epithelium,” the researchers concluded.
Current and Future Implications
The current study is important in addressing the increasing environmental presence of microplastics and their potential impact on respiratory health, said Seyedmohammad Pourshahid, MD, assistant professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
“By examining how microplastics interact with airway epithelial cells, particularly in individuals with asthma and COPD, the research aims to elucidate mechanisms that could contribute to disease progression or exacerbation,” he said.
“The study’s findings that microplastics did not induce a strong inflammatory response, unlike other pollutants such as PM2.5, were unexpected; instead, microplastics appeared to influence pathways related to airway remodeling and oxidative stress,” Pourshahid noted. “This suggests that microplastics may affect respiratory health through mechanisms distinct from traditional pollutants,” he said.
“While preliminary, this research highlights the potential role of environmental microplastic exposure in respiratory diseases,” Pourshahid told this news organization. “Clinicians should be aware of emerging environmental factors that could impact patient health, especially in individuals with asthma and COPD. This awareness may inform patient education and advocacy for reducing exposure to airborne microplastics,” he said.
More studies are needed to explore the long-term effects of microplastic exposure on respiratory health, particularly in vulnerable populations, said Pourshahid. Research with in vivo models is necessary to confirm the findings and assess potential clinical implications to confirm these findings and assess potential clinical implications, he said. “Understanding the prevalence and sources of daily microplastic exposure can inform public health strategies to mitigate risks,” he added.
The study was supported by the Jakub Potocki Foundation. Paplińska-Goryca and Pourshahid had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Early-Onset Asthma May Slow Memory Development
Children with asthma scored significantly lower than those without asthma on measures of episodic memory, based on longitudinal data from nearly 500 individuals.
Animal models have shown associations between asthma and memory problems, but data for children are lacking, wrote Nicholas J. Christopher-Hayes, MA, of the University of California, Davis, and colleagues.
“Asthma is very frequent among children, and there is mounting evidence from rodent models that asthma may result in neural injury in the hippocampus, which in turn may cause memory loss,” Christopher-Hayes said in an interview. “Although there is also a good amount of research with older adults, very little research has been done with children, the period that is most frequently linked to asthma onset,” he said. Therefore, the researchers leveraged a large national study on child development to examine development of memory as a function of asthma exposure.
In this study published in JAMA Network Open, the researchers conducted both a longitudinal and cross-sectional analysis of data from the Adolescent Brain Cognitive Development Study, which began in 2015. Children were enrolled at ages 9-10 years with a follow-up assessment 1-2 years later.
The participants were categorized as early childhood-onset asthma (asthma at baseline and follow-up), later childhood-onset asthma (asthma at follow-up only), or no asthma history. The primary outcome of the longitudinal analysis was episodic memory. Approximately half of the participants were boys, and slightly more than half were White.
Overall, those with early-onset asthma showed significantly lower rates of longitudinal memory improvements at follow-up compared with the comparison group (P < .01).
Developmental memory improvement in children with later-onset asthma was not significantly different from the control individuals.
Secondary outcomes included processing speed and inhibition, and attention. In a cross-sectional analysis with a larger sample of 2062 children from the same database (1031 with any asthma), those with asthma scored significantly lower on measures not only of episodic memory but also processing speed and inhibition/attention than children with no asthma, with P values of .04, .01, and .02, respectively.
The results were limited by several factors, including the reliance on parent reports for indicators of asthma and the lack of data on the potential effect of prescription corticosteroid use on neurocognitive development, the researchers noted.
The mechanism behind the association remains unclear; the inflammation associated with asthma may disrupt neural processing and manifest as cognitive dysfunction, as has been seen in rodent models of asthma, the researchers wrote. “It is possible that associations between asthma and developmental trajectories emerge earlier for memory, perhaps due to its sensitivity to subtle hippocampal injury,” they noted.
Longer follow-up studies are needed to fully understand how childhood asthma predicts memory declines or difficulties in childhood and beyond, said Christopher-Hayes. “We also need additional studies to understand why children who were diagnosed earlier and had asthma for longer seem to be particularly affected,” he said.
The results of this study were consistent with previous findings and therefore not surprising, senior author Simona Ghetti, PhD, a professor of psychology at the University of California, Davis, said in an interview. However, the finding that the extent of exposure to asthma was associated with slower memory improvement in childhood was striking, she said. That children with an earlier asthma onset who had disease indicators for a longer period showed a slower development of memory over time, suggests that asthma exposure may affect the developmental trajectory of memory, Ghetti noted.
“Recommendations to clinicians are premature because we need a better understanding of the boundary conditions, such as the minimal level of asthma exposure that might generate memory difficulties,” said Ghetti.
“Nevertheless, our results underscore the importance of looking at asthma as a potential source of cognitive difficulty in children,” she said.
Asthma’s Extensive Effect
Evidence is mounting that a diagnosis of asthma may have implications outside the pulmonary system, Diego J. Maselli, MD, professor and chief of the Division of Pulmonary Diseases & Critical Care at UT Health, San Antonio, said in an interview.
“Asthmatics may be at risk of nasal polyps, allergic rhinitis, and other allergic conditions, but there is emerging of evidence inflammation associated with asthma may affect other organ systems,” said Maselli, who was not involved in the study.
“For example, chronic inflammation in asthmatics may increase the risk of cardiovascular disease,” he said.
Although less is known about the effects of asthma on the nervous system, animal models suggest that inflammation associated with asthma may result in neuronal injury and potential effects on memory, said Maselli.
The findings of this study provide evidence of potential detrimental effects on the memory of children with asthma but should be interpreted with caution, Maselli said. “Children with chronic medical conditions may have an inherent disadvantage compared with their peers due to the burden of their disease, medication utilization and side effects, absenteeism from school, physical limitations, and other disease-specific circumstances,” he noted.
“Uncontrolled asthma, in particular, has strong links to low socioeconomic factors that are closely tied to access to adequate medical care, nutrition, educational institutions, and other relevant contributors to normal cognitive development,” Maselli said. Although the authors account for some of these socioeconomic factors by evaluating income and race, other variables may have influenced the results, he added.
Overall, this study’s findings suggested that the diagnosis of asthma in children may be associated with memory deficits and may influence neurodevelopment; however, more research is needed to determine whether the findings are replicated in other cohorts, said Maselli. “In particular, evaluating the effects of the severity of asthma and different asthma endotypes would be crucial to identify children with a higher risk of memory or cognitive deficits and confirm these associations,” he said.
This study was funded by the Memory and Plasticity Program at the University of California, Davis, and by a Learning, Memory, and Plasticity Training Program Fellowship grant from the National Institutes of Health. The researchers and Maselli had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Children with asthma scored significantly lower than those without asthma on measures of episodic memory, based on longitudinal data from nearly 500 individuals.
Animal models have shown associations between asthma and memory problems, but data for children are lacking, wrote Nicholas J. Christopher-Hayes, MA, of the University of California, Davis, and colleagues.
“Asthma is very frequent among children, and there is mounting evidence from rodent models that asthma may result in neural injury in the hippocampus, which in turn may cause memory loss,” Christopher-Hayes said in an interview. “Although there is also a good amount of research with older adults, very little research has been done with children, the period that is most frequently linked to asthma onset,” he said. Therefore, the researchers leveraged a large national study on child development to examine development of memory as a function of asthma exposure.
In this study published in JAMA Network Open, the researchers conducted both a longitudinal and cross-sectional analysis of data from the Adolescent Brain Cognitive Development Study, which began in 2015. Children were enrolled at ages 9-10 years with a follow-up assessment 1-2 years later.
The participants were categorized as early childhood-onset asthma (asthma at baseline and follow-up), later childhood-onset asthma (asthma at follow-up only), or no asthma history. The primary outcome of the longitudinal analysis was episodic memory. Approximately half of the participants were boys, and slightly more than half were White.
Overall, those with early-onset asthma showed significantly lower rates of longitudinal memory improvements at follow-up compared with the comparison group (P < .01).
Developmental memory improvement in children with later-onset asthma was not significantly different from the control individuals.
Secondary outcomes included processing speed and inhibition, and attention. In a cross-sectional analysis with a larger sample of 2062 children from the same database (1031 with any asthma), those with asthma scored significantly lower on measures not only of episodic memory but also processing speed and inhibition/attention than children with no asthma, with P values of .04, .01, and .02, respectively.
The results were limited by several factors, including the reliance on parent reports for indicators of asthma and the lack of data on the potential effect of prescription corticosteroid use on neurocognitive development, the researchers noted.
The mechanism behind the association remains unclear; the inflammation associated with asthma may disrupt neural processing and manifest as cognitive dysfunction, as has been seen in rodent models of asthma, the researchers wrote. “It is possible that associations between asthma and developmental trajectories emerge earlier for memory, perhaps due to its sensitivity to subtle hippocampal injury,” they noted.
Longer follow-up studies are needed to fully understand how childhood asthma predicts memory declines or difficulties in childhood and beyond, said Christopher-Hayes. “We also need additional studies to understand why children who were diagnosed earlier and had asthma for longer seem to be particularly affected,” he said.
The results of this study were consistent with previous findings and therefore not surprising, senior author Simona Ghetti, PhD, a professor of psychology at the University of California, Davis, said in an interview. However, the finding that the extent of exposure to asthma was associated with slower memory improvement in childhood was striking, she said. That children with an earlier asthma onset who had disease indicators for a longer period showed a slower development of memory over time, suggests that asthma exposure may affect the developmental trajectory of memory, Ghetti noted.
“Recommendations to clinicians are premature because we need a better understanding of the boundary conditions, such as the minimal level of asthma exposure that might generate memory difficulties,” said Ghetti.
“Nevertheless, our results underscore the importance of looking at asthma as a potential source of cognitive difficulty in children,” she said.
Asthma’s Extensive Effect
Evidence is mounting that a diagnosis of asthma may have implications outside the pulmonary system, Diego J. Maselli, MD, professor and chief of the Division of Pulmonary Diseases & Critical Care at UT Health, San Antonio, said in an interview.
“Asthmatics may be at risk of nasal polyps, allergic rhinitis, and other allergic conditions, but there is emerging of evidence inflammation associated with asthma may affect other organ systems,” said Maselli, who was not involved in the study.
“For example, chronic inflammation in asthmatics may increase the risk of cardiovascular disease,” he said.
Although less is known about the effects of asthma on the nervous system, animal models suggest that inflammation associated with asthma may result in neuronal injury and potential effects on memory, said Maselli.
The findings of this study provide evidence of potential detrimental effects on the memory of children with asthma but should be interpreted with caution, Maselli said. “Children with chronic medical conditions may have an inherent disadvantage compared with their peers due to the burden of their disease, medication utilization and side effects, absenteeism from school, physical limitations, and other disease-specific circumstances,” he noted.
“Uncontrolled asthma, in particular, has strong links to low socioeconomic factors that are closely tied to access to adequate medical care, nutrition, educational institutions, and other relevant contributors to normal cognitive development,” Maselli said. Although the authors account for some of these socioeconomic factors by evaluating income and race, other variables may have influenced the results, he added.
Overall, this study’s findings suggested that the diagnosis of asthma in children may be associated with memory deficits and may influence neurodevelopment; however, more research is needed to determine whether the findings are replicated in other cohorts, said Maselli. “In particular, evaluating the effects of the severity of asthma and different asthma endotypes would be crucial to identify children with a higher risk of memory or cognitive deficits and confirm these associations,” he said.
This study was funded by the Memory and Plasticity Program at the University of California, Davis, and by a Learning, Memory, and Plasticity Training Program Fellowship grant from the National Institutes of Health. The researchers and Maselli had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Children with asthma scored significantly lower than those without asthma on measures of episodic memory, based on longitudinal data from nearly 500 individuals.
Animal models have shown associations between asthma and memory problems, but data for children are lacking, wrote Nicholas J. Christopher-Hayes, MA, of the University of California, Davis, and colleagues.
“Asthma is very frequent among children, and there is mounting evidence from rodent models that asthma may result in neural injury in the hippocampus, which in turn may cause memory loss,” Christopher-Hayes said in an interview. “Although there is also a good amount of research with older adults, very little research has been done with children, the period that is most frequently linked to asthma onset,” he said. Therefore, the researchers leveraged a large national study on child development to examine development of memory as a function of asthma exposure.
In this study published in JAMA Network Open, the researchers conducted both a longitudinal and cross-sectional analysis of data from the Adolescent Brain Cognitive Development Study, which began in 2015. Children were enrolled at ages 9-10 years with a follow-up assessment 1-2 years later.
The participants were categorized as early childhood-onset asthma (asthma at baseline and follow-up), later childhood-onset asthma (asthma at follow-up only), or no asthma history. The primary outcome of the longitudinal analysis was episodic memory. Approximately half of the participants were boys, and slightly more than half were White.
Overall, those with early-onset asthma showed significantly lower rates of longitudinal memory improvements at follow-up compared with the comparison group (P < .01).
Developmental memory improvement in children with later-onset asthma was not significantly different from the control individuals.
Secondary outcomes included processing speed and inhibition, and attention. In a cross-sectional analysis with a larger sample of 2062 children from the same database (1031 with any asthma), those with asthma scored significantly lower on measures not only of episodic memory but also processing speed and inhibition/attention than children with no asthma, with P values of .04, .01, and .02, respectively.
The results were limited by several factors, including the reliance on parent reports for indicators of asthma and the lack of data on the potential effect of prescription corticosteroid use on neurocognitive development, the researchers noted.
The mechanism behind the association remains unclear; the inflammation associated with asthma may disrupt neural processing and manifest as cognitive dysfunction, as has been seen in rodent models of asthma, the researchers wrote. “It is possible that associations between asthma and developmental trajectories emerge earlier for memory, perhaps due to its sensitivity to subtle hippocampal injury,” they noted.
Longer follow-up studies are needed to fully understand how childhood asthma predicts memory declines or difficulties in childhood and beyond, said Christopher-Hayes. “We also need additional studies to understand why children who were diagnosed earlier and had asthma for longer seem to be particularly affected,” he said.
The results of this study were consistent with previous findings and therefore not surprising, senior author Simona Ghetti, PhD, a professor of psychology at the University of California, Davis, said in an interview. However, the finding that the extent of exposure to asthma was associated with slower memory improvement in childhood was striking, she said. That children with an earlier asthma onset who had disease indicators for a longer period showed a slower development of memory over time, suggests that asthma exposure may affect the developmental trajectory of memory, Ghetti noted.
“Recommendations to clinicians are premature because we need a better understanding of the boundary conditions, such as the minimal level of asthma exposure that might generate memory difficulties,” said Ghetti.
“Nevertheless, our results underscore the importance of looking at asthma as a potential source of cognitive difficulty in children,” she said.
Asthma’s Extensive Effect
Evidence is mounting that a diagnosis of asthma may have implications outside the pulmonary system, Diego J. Maselli, MD, professor and chief of the Division of Pulmonary Diseases & Critical Care at UT Health, San Antonio, said in an interview.
“Asthmatics may be at risk of nasal polyps, allergic rhinitis, and other allergic conditions, but there is emerging of evidence inflammation associated with asthma may affect other organ systems,” said Maselli, who was not involved in the study.
“For example, chronic inflammation in asthmatics may increase the risk of cardiovascular disease,” he said.
Although less is known about the effects of asthma on the nervous system, animal models suggest that inflammation associated with asthma may result in neuronal injury and potential effects on memory, said Maselli.
The findings of this study provide evidence of potential detrimental effects on the memory of children with asthma but should be interpreted with caution, Maselli said. “Children with chronic medical conditions may have an inherent disadvantage compared with their peers due to the burden of their disease, medication utilization and side effects, absenteeism from school, physical limitations, and other disease-specific circumstances,” he noted.
“Uncontrolled asthma, in particular, has strong links to low socioeconomic factors that are closely tied to access to adequate medical care, nutrition, educational institutions, and other relevant contributors to normal cognitive development,” Maselli said. Although the authors account for some of these socioeconomic factors by evaluating income and race, other variables may have influenced the results, he added.
Overall, this study’s findings suggested that the diagnosis of asthma in children may be associated with memory deficits and may influence neurodevelopment; however, more research is needed to determine whether the findings are replicated in other cohorts, said Maselli. “In particular, evaluating the effects of the severity of asthma and different asthma endotypes would be crucial to identify children with a higher risk of memory or cognitive deficits and confirm these associations,” he said.
This study was funded by the Memory and Plasticity Program at the University of California, Davis, and by a Learning, Memory, and Plasticity Training Program Fellowship grant from the National Institutes of Health. The researchers and Maselli had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Highly Contagious Norovirus Cases Spike This Season
Current data from the CDC’s NoroSTAT monitoring system show 495 reported outbreaks during the period from August 1, 2024, to December 11, 2024, compared with 363 outbreaks during the same period last year. In addition, the total number of norovirus outbreaks in the current season are higher than those reported in the seasonal years: 2012-2020 and 2021-2024.
Circulating strains of norovirus change over time, which can affect disease burden and potential disease severity, Sara Mirza, MD, an epidemiologist in the CDC’s Division of Viral Diseases, said in an interview.
The numbers for the 2024 norovirus season (considered approximately November to April) have reached or exceeded the case numbers seen before the COVID-19 pandemic, Mirza said.
The increase in cases may be caused in part by a new predominant strain of norovirus. “For the fall/winter of 2024-2025 season, genogroup 2, genotype 17, known as GII.17, has become the most detected genotype (strain) in the US among laboratory confirmed outbreaks reported to CDC,” said Mirza. “At this time, there is no indication that GII.17 causes more severe illness or affects one population more than another, but we are continuing to conduct surveillance to assess,” she added.
Clinical Takeaways
“Norovirus affects all ages, but young children and older adults are most at risk from more severe outcomes,” said Mirza.
“Clinicians treating older patients for acute gastroenteritis should be aware of these elevated risks and be sure to include norovirus as a potentially serious diagnosis, particularly in vulnerable patients with other diseases and those living in congregate settings, such as nursing homes,” she said.
When treating a patient with norovirus during an outbreak, use soap and water for hand hygiene after caring for patients with suspected or confirmed norovirus gastroenteritis, said Mirza. If norovirus infection is suspected, PPE use is recommended for individuals in the patient care area, she added.
Although state, local, and territorial health departments are not required to report individual cases of norovirus to the CDC, healthcare providers are encouraged to report all outbreaks of acute gastroenteritis, including suspected outbreaks of norovirus, to the appropriate state, local, or territorial health department, said Mirza. “Health departments are encouraged to report all suspected and confirmed norovirus outbreaks through the National Outbreak Reporting System and CaliciNet,” she added.
“Infection control measures, such as thorough hand washing, cleaning and disinfecting surfaces with bleach, and patient isolation and contact precautions in congregate or healthcare settings are the best ways to prevent norovirus and keep it from spreading to others,” Mirza said.
Remind patients that alcohol-based hand sanitizer is ineffective against norovirus, because the virus’s protective protein shell prevents the alcohol from penetrating and inactivating the virus, Mirza emphasized. “Soap and water work to remove germs from hands,” she said.
Cruise Ship Considerations
Cruise ships continue to be sources of increased risk for norovirus, according the CDC. The CDC’s Vessel Sanitation Program (VSP) was created to help the cruise industry prevent public health issues such as norovirus outbreaks, and to provide guidance for actions to take in the event of outbreaks.
For example, the most recently reported outbreak of norovirus on a cruise ship reported to the VSP was January 4, 2025, and occurred on a Holland America cruise from December 30, 2024, through January 8, 2025. Overall, 4.0% of passengers and 1.0% of crew members reported illness. Following VSP guidance, the ship reported increased cleaning and disinfection procedures and the collection of stool specimens for testing, and isolation of ill passengers and crew.
Clinical Perspective
In clinical practice, the number of norovirus cases is significantly exceeding previous years, and the trend seems to be consistent nationwide, David J. Cennimo, MD, associate professor of medicine and pediatrics at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.
“Norovirus is incredibly contagious and spreads very quickly, which is how you get entire cruise ships infected at once,” he said. Norovirus is notoriously difficult to disinfect or kill, he added.
One possible contributor to the surge in cases is increased travel, especially during the holiday season, when people are coming together and sharing food, Cennimo noted. “We have seen many infections such as pneumonia return to levels approaching the period before the COVID-19 pandemic,” he said.
For norovirus prevention, strict attention to sanitation and handwashing is a must at home or when traveling, said Cennimo. For clinicians, it is important to report outbreaks of GI illness so appropriate control measures can be taken, he said.
Visit the CDC’s website on norovirus prevention for more information.
Mirza and Cennimo had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Current data from the CDC’s NoroSTAT monitoring system show 495 reported outbreaks during the period from August 1, 2024, to December 11, 2024, compared with 363 outbreaks during the same period last year. In addition, the total number of norovirus outbreaks in the current season are higher than those reported in the seasonal years: 2012-2020 and 2021-2024.
Circulating strains of norovirus change over time, which can affect disease burden and potential disease severity, Sara Mirza, MD, an epidemiologist in the CDC’s Division of Viral Diseases, said in an interview.
The numbers for the 2024 norovirus season (considered approximately November to April) have reached or exceeded the case numbers seen before the COVID-19 pandemic, Mirza said.
The increase in cases may be caused in part by a new predominant strain of norovirus. “For the fall/winter of 2024-2025 season, genogroup 2, genotype 17, known as GII.17, has become the most detected genotype (strain) in the US among laboratory confirmed outbreaks reported to CDC,” said Mirza. “At this time, there is no indication that GII.17 causes more severe illness or affects one population more than another, but we are continuing to conduct surveillance to assess,” she added.
Clinical Takeaways
“Norovirus affects all ages, but young children and older adults are most at risk from more severe outcomes,” said Mirza.
“Clinicians treating older patients for acute gastroenteritis should be aware of these elevated risks and be sure to include norovirus as a potentially serious diagnosis, particularly in vulnerable patients with other diseases and those living in congregate settings, such as nursing homes,” she said.
When treating a patient with norovirus during an outbreak, use soap and water for hand hygiene after caring for patients with suspected or confirmed norovirus gastroenteritis, said Mirza. If norovirus infection is suspected, PPE use is recommended for individuals in the patient care area, she added.
Although state, local, and territorial health departments are not required to report individual cases of norovirus to the CDC, healthcare providers are encouraged to report all outbreaks of acute gastroenteritis, including suspected outbreaks of norovirus, to the appropriate state, local, or territorial health department, said Mirza. “Health departments are encouraged to report all suspected and confirmed norovirus outbreaks through the National Outbreak Reporting System and CaliciNet,” she added.
“Infection control measures, such as thorough hand washing, cleaning and disinfecting surfaces with bleach, and patient isolation and contact precautions in congregate or healthcare settings are the best ways to prevent norovirus and keep it from spreading to others,” Mirza said.
Remind patients that alcohol-based hand sanitizer is ineffective against norovirus, because the virus’s protective protein shell prevents the alcohol from penetrating and inactivating the virus, Mirza emphasized. “Soap and water work to remove germs from hands,” she said.
Cruise Ship Considerations
Cruise ships continue to be sources of increased risk for norovirus, according the CDC. The CDC’s Vessel Sanitation Program (VSP) was created to help the cruise industry prevent public health issues such as norovirus outbreaks, and to provide guidance for actions to take in the event of outbreaks.
For example, the most recently reported outbreak of norovirus on a cruise ship reported to the VSP was January 4, 2025, and occurred on a Holland America cruise from December 30, 2024, through January 8, 2025. Overall, 4.0% of passengers and 1.0% of crew members reported illness. Following VSP guidance, the ship reported increased cleaning and disinfection procedures and the collection of stool specimens for testing, and isolation of ill passengers and crew.
Clinical Perspective
In clinical practice, the number of norovirus cases is significantly exceeding previous years, and the trend seems to be consistent nationwide, David J. Cennimo, MD, associate professor of medicine and pediatrics at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.
“Norovirus is incredibly contagious and spreads very quickly, which is how you get entire cruise ships infected at once,” he said. Norovirus is notoriously difficult to disinfect or kill, he added.
One possible contributor to the surge in cases is increased travel, especially during the holiday season, when people are coming together and sharing food, Cennimo noted. “We have seen many infections such as pneumonia return to levels approaching the period before the COVID-19 pandemic,” he said.
For norovirus prevention, strict attention to sanitation and handwashing is a must at home or when traveling, said Cennimo. For clinicians, it is important to report outbreaks of GI illness so appropriate control measures can be taken, he said.
Visit the CDC’s website on norovirus prevention for more information.
Mirza and Cennimo had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Current data from the CDC’s NoroSTAT monitoring system show 495 reported outbreaks during the period from August 1, 2024, to December 11, 2024, compared with 363 outbreaks during the same period last year. In addition, the total number of norovirus outbreaks in the current season are higher than those reported in the seasonal years: 2012-2020 and 2021-2024.
Circulating strains of norovirus change over time, which can affect disease burden and potential disease severity, Sara Mirza, MD, an epidemiologist in the CDC’s Division of Viral Diseases, said in an interview.
The numbers for the 2024 norovirus season (considered approximately November to April) have reached or exceeded the case numbers seen before the COVID-19 pandemic, Mirza said.
The increase in cases may be caused in part by a new predominant strain of norovirus. “For the fall/winter of 2024-2025 season, genogroup 2, genotype 17, known as GII.17, has become the most detected genotype (strain) in the US among laboratory confirmed outbreaks reported to CDC,” said Mirza. “At this time, there is no indication that GII.17 causes more severe illness or affects one population more than another, but we are continuing to conduct surveillance to assess,” she added.
Clinical Takeaways
“Norovirus affects all ages, but young children and older adults are most at risk from more severe outcomes,” said Mirza.
“Clinicians treating older patients for acute gastroenteritis should be aware of these elevated risks and be sure to include norovirus as a potentially serious diagnosis, particularly in vulnerable patients with other diseases and those living in congregate settings, such as nursing homes,” she said.
When treating a patient with norovirus during an outbreak, use soap and water for hand hygiene after caring for patients with suspected or confirmed norovirus gastroenteritis, said Mirza. If norovirus infection is suspected, PPE use is recommended for individuals in the patient care area, she added.
Although state, local, and territorial health departments are not required to report individual cases of norovirus to the CDC, healthcare providers are encouraged to report all outbreaks of acute gastroenteritis, including suspected outbreaks of norovirus, to the appropriate state, local, or territorial health department, said Mirza. “Health departments are encouraged to report all suspected and confirmed norovirus outbreaks through the National Outbreak Reporting System and CaliciNet,” she added.
“Infection control measures, such as thorough hand washing, cleaning and disinfecting surfaces with bleach, and patient isolation and contact precautions in congregate or healthcare settings are the best ways to prevent norovirus and keep it from spreading to others,” Mirza said.
Remind patients that alcohol-based hand sanitizer is ineffective against norovirus, because the virus’s protective protein shell prevents the alcohol from penetrating and inactivating the virus, Mirza emphasized. “Soap and water work to remove germs from hands,” she said.
Cruise Ship Considerations
Cruise ships continue to be sources of increased risk for norovirus, according the CDC. The CDC’s Vessel Sanitation Program (VSP) was created to help the cruise industry prevent public health issues such as norovirus outbreaks, and to provide guidance for actions to take in the event of outbreaks.
For example, the most recently reported outbreak of norovirus on a cruise ship reported to the VSP was January 4, 2025, and occurred on a Holland America cruise from December 30, 2024, through January 8, 2025. Overall, 4.0% of passengers and 1.0% of crew members reported illness. Following VSP guidance, the ship reported increased cleaning and disinfection procedures and the collection of stool specimens for testing, and isolation of ill passengers and crew.
Clinical Perspective
In clinical practice, the number of norovirus cases is significantly exceeding previous years, and the trend seems to be consistent nationwide, David J. Cennimo, MD, associate professor of medicine and pediatrics at Rutgers New Jersey Medical School, Newark, New Jersey, said in an interview.
“Norovirus is incredibly contagious and spreads very quickly, which is how you get entire cruise ships infected at once,” he said. Norovirus is notoriously difficult to disinfect or kill, he added.
One possible contributor to the surge in cases is increased travel, especially during the holiday season, when people are coming together and sharing food, Cennimo noted. “We have seen many infections such as pneumonia return to levels approaching the period before the COVID-19 pandemic,” he said.
For norovirus prevention, strict attention to sanitation and handwashing is a must at home or when traveling, said Cennimo. For clinicians, it is important to report outbreaks of GI illness so appropriate control measures can be taken, he said.
Visit the CDC’s website on norovirus prevention for more information.
Mirza and Cennimo had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
First Human Bird Flu Death Confirmed in US; Overall Risk Remains Low
The first human patient in the United States with a confirmed case of avian influenza has died, according to a press release from the Louisiana Department of Health. The individual was older than 65 years and had underlying medical conditions and remains the only known human case in the state.
The patient contracted highly pathogenic avian influenza, also known as H5N1, through exposure to wild birds and a noncommercial backyard flock, according to the release.
The Centers for Disease Control and Prevention (CDC) conducted genetic sequencing of specimens of the virus collected from the Louisiana patient. The agency compared the sequences with sequences from dairy cows, wild birds, and poultry in various areas of the United States that were infected with the H5N1 virus.
The Louisiana patient was infected with the D1.1 genotype of the H5N1 virus. Although D1.1 is related to other D1.1 viruses found in recent human cases in Washington State and British Columbia, Canada, it is distinct from the widely spreading B3.13 genotype that has caused H5N1 outbreaks in dairy cows, poultry, and other animals and has been linked to sporadic human cases in the United States, according to the CDC.
Despite evidence of some changes in the virus between the Louisiana patient and samples from poultry on the patient’s property, “these changes would be more concerning if found in animal hosts or in early stages of infection,” according to the CDC. The CDC and the Louisiana Department of Health are conducting additional sequencing to facilitate further analysis.
In the meantime, the risk to the general public for H5N1 remains low, but individuals who work with or have recreational exposure to birds, poultry, or cows remain at increased risk.
The CDC and the Louisiana Department of Health advise individuals to reduce the risk for H5N1 exposure by avoiding direct contact with wild birds or other animals infected or possibly infected with the virus, avoiding any contact with dead animals, and keeping pets away from sick or dead animals and their feces. Additional safety measures include avoiding uncooked food products such as unpasteurized raw milk or cheese from animals with suspected or confirmed infections and reporting sick or dead birds or animals to the US Department of Agriculture by calling 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab by calling 318-927-3441.
The CDC advises clinicians to consider H5N1 in patients presenting with conjunctivitis or signs of acute respiratory illness and a history of high-risk exposure, including handling sick or dead animals, notably birds and livestock, within 10 days before the onset of symptoms. Other risk factors include consuming uncooked or undercooked food, direct contact with areas contaminated with feces, direct contact with unpasteurized milk or other dairy products or with parts of potentially infected animals, and prolonged exposure to infected animals in a confined space.
Clinical symptoms also may include gastrointestinal complaints such as diarrhea, as well as fatigue, arthralgia, and headache. Patients with more severe H5N1 may experience shortness of breath, altered mental state, and seizures, and serious complications of the virus include pneumonia, acute respiratory distress syndrome, multiorgan failure, and sepsis, according to the CDC.
Clinicians who suspect H5N1 cases should contact their local public health departments. The CDC offers additional advice on evaluating and managing patients with novel influenza A viruses.
A Clinician’s Take
“Some symptoms of avian flu include fever, cough, sore throat, runny nose, fatigue, body aches or eye redness or irritation,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at The University of Tennessee Health Science Center, Memphis, said in an interview. “The timing to the development of symptoms after exposure is typically within 10 days. Avian influenza should be considered when individuals develop symptoms with a relevant exposure history,” she said.
Whenever possible, avoidance of sick or dead birds and other animals is ideal, but for those who must have contact with sick or dead birds, poultry, or other animals, personal protective equipment (PPE) including a respirator, goggles, and disposable gloves is recommended, said Mazumder.
“For those working in high-exposure settings, additional PPE including boots or boot covers, hair cover, and fluid-resistant coveralls are recommended,” she said. “Other protective measures include avoiding touching surfaces or materials contaminated with feces, mucus, and saliva from infected animals and avoid[ing] the consumption of raw milk, raw milk products, and undercooked meat from infected animals,” she added.
Hunters handling wild game should dress birds in the field, practice good hand hygiene, and use a respirator or well-fitting mask and gloves when handling the animals to help prevent disease, said Mazumder.
In addition, those working with confirmed or suspected H5N1 cases should monitor themselves for symptoms, said Mazumder. “Those who become ill within 10 days of exposure to an infected animal or source should isolate from household members and avoid going to work or school until infection is excluded. It is important to reach out to a healthcare professional if you think you may have been exposed or if you think you are infected,” she said.
There is no currently available vaccine for H5N1 infection, but oseltamivir can be used for chemoprophylaxis and treatment, said Mazumder. “The seasonal flu vaccine does not protect against avian influenza; however, it is still important to ensure that you are up to date on the latest flu vaccine to prevent the possibility of a coinfection with seasonal flu and avian flu,” she emphasized.
More research is needed to better understand how the influenza virus is transmitted, said Mazumder. “The potential for the virus to evolve and mutate, and how it affects different hosts, are all factors that can impact public health decisions,” she said. “In addition, further research into finding a vaccine and improving surveillance methods are necessary for disease prevention,” she said.
Mazumder had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The first human patient in the United States with a confirmed case of avian influenza has died, according to a press release from the Louisiana Department of Health. The individual was older than 65 years and had underlying medical conditions and remains the only known human case in the state.
The patient contracted highly pathogenic avian influenza, also known as H5N1, through exposure to wild birds and a noncommercial backyard flock, according to the release.
The Centers for Disease Control and Prevention (CDC) conducted genetic sequencing of specimens of the virus collected from the Louisiana patient. The agency compared the sequences with sequences from dairy cows, wild birds, and poultry in various areas of the United States that were infected with the H5N1 virus.
The Louisiana patient was infected with the D1.1 genotype of the H5N1 virus. Although D1.1 is related to other D1.1 viruses found in recent human cases in Washington State and British Columbia, Canada, it is distinct from the widely spreading B3.13 genotype that has caused H5N1 outbreaks in dairy cows, poultry, and other animals and has been linked to sporadic human cases in the United States, according to the CDC.
Despite evidence of some changes in the virus between the Louisiana patient and samples from poultry on the patient’s property, “these changes would be more concerning if found in animal hosts or in early stages of infection,” according to the CDC. The CDC and the Louisiana Department of Health are conducting additional sequencing to facilitate further analysis.
In the meantime, the risk to the general public for H5N1 remains low, but individuals who work with or have recreational exposure to birds, poultry, or cows remain at increased risk.
The CDC and the Louisiana Department of Health advise individuals to reduce the risk for H5N1 exposure by avoiding direct contact with wild birds or other animals infected or possibly infected with the virus, avoiding any contact with dead animals, and keeping pets away from sick or dead animals and their feces. Additional safety measures include avoiding uncooked food products such as unpasteurized raw milk or cheese from animals with suspected or confirmed infections and reporting sick or dead birds or animals to the US Department of Agriculture by calling 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab by calling 318-927-3441.
The CDC advises clinicians to consider H5N1 in patients presenting with conjunctivitis or signs of acute respiratory illness and a history of high-risk exposure, including handling sick or dead animals, notably birds and livestock, within 10 days before the onset of symptoms. Other risk factors include consuming uncooked or undercooked food, direct contact with areas contaminated with feces, direct contact with unpasteurized milk or other dairy products or with parts of potentially infected animals, and prolonged exposure to infected animals in a confined space.
Clinical symptoms also may include gastrointestinal complaints such as diarrhea, as well as fatigue, arthralgia, and headache. Patients with more severe H5N1 may experience shortness of breath, altered mental state, and seizures, and serious complications of the virus include pneumonia, acute respiratory distress syndrome, multiorgan failure, and sepsis, according to the CDC.
Clinicians who suspect H5N1 cases should contact their local public health departments. The CDC offers additional advice on evaluating and managing patients with novel influenza A viruses.
A Clinician’s Take
“Some symptoms of avian flu include fever, cough, sore throat, runny nose, fatigue, body aches or eye redness or irritation,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at The University of Tennessee Health Science Center, Memphis, said in an interview. “The timing to the development of symptoms after exposure is typically within 10 days. Avian influenza should be considered when individuals develop symptoms with a relevant exposure history,” she said.
Whenever possible, avoidance of sick or dead birds and other animals is ideal, but for those who must have contact with sick or dead birds, poultry, or other animals, personal protective equipment (PPE) including a respirator, goggles, and disposable gloves is recommended, said Mazumder.
“For those working in high-exposure settings, additional PPE including boots or boot covers, hair cover, and fluid-resistant coveralls are recommended,” she said. “Other protective measures include avoiding touching surfaces or materials contaminated with feces, mucus, and saliva from infected animals and avoid[ing] the consumption of raw milk, raw milk products, and undercooked meat from infected animals,” she added.
Hunters handling wild game should dress birds in the field, practice good hand hygiene, and use a respirator or well-fitting mask and gloves when handling the animals to help prevent disease, said Mazumder.
In addition, those working with confirmed or suspected H5N1 cases should monitor themselves for symptoms, said Mazumder. “Those who become ill within 10 days of exposure to an infected animal or source should isolate from household members and avoid going to work or school until infection is excluded. It is important to reach out to a healthcare professional if you think you may have been exposed or if you think you are infected,” she said.
There is no currently available vaccine for H5N1 infection, but oseltamivir can be used for chemoprophylaxis and treatment, said Mazumder. “The seasonal flu vaccine does not protect against avian influenza; however, it is still important to ensure that you are up to date on the latest flu vaccine to prevent the possibility of a coinfection with seasonal flu and avian flu,” she emphasized.
More research is needed to better understand how the influenza virus is transmitted, said Mazumder. “The potential for the virus to evolve and mutate, and how it affects different hosts, are all factors that can impact public health decisions,” she said. “In addition, further research into finding a vaccine and improving surveillance methods are necessary for disease prevention,” she said.
Mazumder had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The first human patient in the United States with a confirmed case of avian influenza has died, according to a press release from the Louisiana Department of Health. The individual was older than 65 years and had underlying medical conditions and remains the only known human case in the state.
The patient contracted highly pathogenic avian influenza, also known as H5N1, through exposure to wild birds and a noncommercial backyard flock, according to the release.
The Centers for Disease Control and Prevention (CDC) conducted genetic sequencing of specimens of the virus collected from the Louisiana patient. The agency compared the sequences with sequences from dairy cows, wild birds, and poultry in various areas of the United States that were infected with the H5N1 virus.
The Louisiana patient was infected with the D1.1 genotype of the H5N1 virus. Although D1.1 is related to other D1.1 viruses found in recent human cases in Washington State and British Columbia, Canada, it is distinct from the widely spreading B3.13 genotype that has caused H5N1 outbreaks in dairy cows, poultry, and other animals and has been linked to sporadic human cases in the United States, according to the CDC.
Despite evidence of some changes in the virus between the Louisiana patient and samples from poultry on the patient’s property, “these changes would be more concerning if found in animal hosts or in early stages of infection,” according to the CDC. The CDC and the Louisiana Department of Health are conducting additional sequencing to facilitate further analysis.
In the meantime, the risk to the general public for H5N1 remains low, but individuals who work with or have recreational exposure to birds, poultry, or cows remain at increased risk.
The CDC and the Louisiana Department of Health advise individuals to reduce the risk for H5N1 exposure by avoiding direct contact with wild birds or other animals infected or possibly infected with the virus, avoiding any contact with dead animals, and keeping pets away from sick or dead animals and their feces. Additional safety measures include avoiding uncooked food products such as unpasteurized raw milk or cheese from animals with suspected or confirmed infections and reporting sick or dead birds or animals to the US Department of Agriculture by calling 1-866-536-7593 or the Louisiana Department of Agriculture and Forestry Diagnostic Lab by calling 318-927-3441.
The CDC advises clinicians to consider H5N1 in patients presenting with conjunctivitis or signs of acute respiratory illness and a history of high-risk exposure, including handling sick or dead animals, notably birds and livestock, within 10 days before the onset of symptoms. Other risk factors include consuming uncooked or undercooked food, direct contact with areas contaminated with feces, direct contact with unpasteurized milk or other dairy products or with parts of potentially infected animals, and prolonged exposure to infected animals in a confined space.
Clinical symptoms also may include gastrointestinal complaints such as diarrhea, as well as fatigue, arthralgia, and headache. Patients with more severe H5N1 may experience shortness of breath, altered mental state, and seizures, and serious complications of the virus include pneumonia, acute respiratory distress syndrome, multiorgan failure, and sepsis, according to the CDC.
Clinicians who suspect H5N1 cases should contact their local public health departments. The CDC offers additional advice on evaluating and managing patients with novel influenza A viruses.
A Clinician’s Take
“Some symptoms of avian flu include fever, cough, sore throat, runny nose, fatigue, body aches or eye redness or irritation,” Shirin A. Mazumder, MD, associate professor and infectious disease specialist at The University of Tennessee Health Science Center, Memphis, said in an interview. “The timing to the development of symptoms after exposure is typically within 10 days. Avian influenza should be considered when individuals develop symptoms with a relevant exposure history,” she said.
Whenever possible, avoidance of sick or dead birds and other animals is ideal, but for those who must have contact with sick or dead birds, poultry, or other animals, personal protective equipment (PPE) including a respirator, goggles, and disposable gloves is recommended, said Mazumder.
“For those working in high-exposure settings, additional PPE including boots or boot covers, hair cover, and fluid-resistant coveralls are recommended,” she said. “Other protective measures include avoiding touching surfaces or materials contaminated with feces, mucus, and saliva from infected animals and avoid[ing] the consumption of raw milk, raw milk products, and undercooked meat from infected animals,” she added.
Hunters handling wild game should dress birds in the field, practice good hand hygiene, and use a respirator or well-fitting mask and gloves when handling the animals to help prevent disease, said Mazumder.
In addition, those working with confirmed or suspected H5N1 cases should monitor themselves for symptoms, said Mazumder. “Those who become ill within 10 days of exposure to an infected animal or source should isolate from household members and avoid going to work or school until infection is excluded. It is important to reach out to a healthcare professional if you think you may have been exposed or if you think you are infected,” she said.
There is no currently available vaccine for H5N1 infection, but oseltamivir can be used for chemoprophylaxis and treatment, said Mazumder. “The seasonal flu vaccine does not protect against avian influenza; however, it is still important to ensure that you are up to date on the latest flu vaccine to prevent the possibility of a coinfection with seasonal flu and avian flu,” she emphasized.
More research is needed to better understand how the influenza virus is transmitted, said Mazumder. “The potential for the virus to evolve and mutate, and how it affects different hosts, are all factors that can impact public health decisions,” she said. “In addition, further research into finding a vaccine and improving surveillance methods are necessary for disease prevention,” she said.
Mazumder had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FDA Adds Boxed Warning for Liver Injury to Fezolinetant
The Food and Drug Administration (FDA) has added a boxed warning about liver injury to fezolinetant (Veozah), a drug often prescribed for hot flashes in menopausal women, according to an FDA statement.
The warning is based on data from a postmarketing report of an individual who experienced elevated liver blood test values as well as symptoms of liver injury after approximately 40 days of taking fezolinetant, according to the statement.
The boxed warning is in addition to the existing warning about elevated liver blood test values and requirements for liver blood testing in the prescribing information.
The updated information also includes recommendations to increase the frequency of liver blood testing to monthly testing for 2 months after starting fezolinetant, then following the previous recommendations for testing at 3, 6, and 9 months.
In addition, the new information advises patients to discontinue the drug immediately and contact their prescribing healthcare professional if signs of liver injury occur, according to the statement. These signs may include nausea, vomiting, unusual itching, light-colored stool, jaundice, dark urine, abdominal swelling, or pain in the right upper abdomen.
The risk for liver injury is real, but rare, said Kathryn Marko, MD, assistant professor of obstetrics and gynecology at George Washington University, Washington, DC, in an interview.
Clinicians should advise patients that their liver function will be monitored closely if they take fezolinetant, Marko said. If elevations in liver function tests occur, they often return to normal after stopping the drug.
Clinical Implications and Research Gaps
The boxed warning may affect prescribing patterns in that patients or clinicians may fear the risk for liver injury, Marko said. “In addition, patients may be hesitant to start a medication that requires frequent blood test monitoring.” However, many alternative treatments are available for vasomotor symptoms of menopause, including hormonal and nonhormonal therapies, and patients and physicians should work together to come up with the best option for each individual.
“More research is needed to discover new therapies for menopause,” said Marko. “Veozah is unique in its mechanism of action, and it would be wonderful to see more new medications coming down the pipeline.”
Marko had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has added a boxed warning about liver injury to fezolinetant (Veozah), a drug often prescribed for hot flashes in menopausal women, according to an FDA statement.
The warning is based on data from a postmarketing report of an individual who experienced elevated liver blood test values as well as symptoms of liver injury after approximately 40 days of taking fezolinetant, according to the statement.
The boxed warning is in addition to the existing warning about elevated liver blood test values and requirements for liver blood testing in the prescribing information.
The updated information also includes recommendations to increase the frequency of liver blood testing to monthly testing for 2 months after starting fezolinetant, then following the previous recommendations for testing at 3, 6, and 9 months.
In addition, the new information advises patients to discontinue the drug immediately and contact their prescribing healthcare professional if signs of liver injury occur, according to the statement. These signs may include nausea, vomiting, unusual itching, light-colored stool, jaundice, dark urine, abdominal swelling, or pain in the right upper abdomen.
The risk for liver injury is real, but rare, said Kathryn Marko, MD, assistant professor of obstetrics and gynecology at George Washington University, Washington, DC, in an interview.
Clinicians should advise patients that their liver function will be monitored closely if they take fezolinetant, Marko said. If elevations in liver function tests occur, they often return to normal after stopping the drug.
Clinical Implications and Research Gaps
The boxed warning may affect prescribing patterns in that patients or clinicians may fear the risk for liver injury, Marko said. “In addition, patients may be hesitant to start a medication that requires frequent blood test monitoring.” However, many alternative treatments are available for vasomotor symptoms of menopause, including hormonal and nonhormonal therapies, and patients and physicians should work together to come up with the best option for each individual.
“More research is needed to discover new therapies for menopause,” said Marko. “Veozah is unique in its mechanism of action, and it would be wonderful to see more new medications coming down the pipeline.”
Marko had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
The Food and Drug Administration (FDA) has added a boxed warning about liver injury to fezolinetant (Veozah), a drug often prescribed for hot flashes in menopausal women, according to an FDA statement.
The warning is based on data from a postmarketing report of an individual who experienced elevated liver blood test values as well as symptoms of liver injury after approximately 40 days of taking fezolinetant, according to the statement.
The boxed warning is in addition to the existing warning about elevated liver blood test values and requirements for liver blood testing in the prescribing information.
The updated information also includes recommendations to increase the frequency of liver blood testing to monthly testing for 2 months after starting fezolinetant, then following the previous recommendations for testing at 3, 6, and 9 months.
In addition, the new information advises patients to discontinue the drug immediately and contact their prescribing healthcare professional if signs of liver injury occur, according to the statement. These signs may include nausea, vomiting, unusual itching, light-colored stool, jaundice, dark urine, abdominal swelling, or pain in the right upper abdomen.
The risk for liver injury is real, but rare, said Kathryn Marko, MD, assistant professor of obstetrics and gynecology at George Washington University, Washington, DC, in an interview.
Clinicians should advise patients that their liver function will be monitored closely if they take fezolinetant, Marko said. If elevations in liver function tests occur, they often return to normal after stopping the drug.
Clinical Implications and Research Gaps
The boxed warning may affect prescribing patterns in that patients or clinicians may fear the risk for liver injury, Marko said. “In addition, patients may be hesitant to start a medication that requires frequent blood test monitoring.” However, many alternative treatments are available for vasomotor symptoms of menopause, including hormonal and nonhormonal therapies, and patients and physicians should work together to come up with the best option for each individual.
“More research is needed to discover new therapies for menopause,” said Marko. “Veozah is unique in its mechanism of action, and it would be wonderful to see more new medications coming down the pipeline.”
Marko had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FDA Approves IL-31 Inhibitor for Atopic Dermatitis
according to a press release from the manufacturer, Galderma.
Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company.
Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids.
At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.
At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies.
In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.
Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively).
Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.
According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.
In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.
ARCADIA is funded by Galderma.
A version of this article first appeared on Medscape.com.
according to a press release from the manufacturer, Galderma.
Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company.
Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids.
At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.
At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies.
In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.
Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively).
Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.
According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.
In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.
ARCADIA is funded by Galderma.
A version of this article first appeared on Medscape.com.
according to a press release from the manufacturer, Galderma.
Nemolizumab (Nemluvio), a monoclonal antibody administered subcutaneously, targets the interleukin (IL)–31 receptor. IL-31 is known to promote itching and inflammation in atopic dermatitis, according to the company.
Approval was based on data from the phase 3 ARCADIA 1 and ARCADIA 2 clinical trials, recently published in The Lancet, which included 1728 patients aged 12 years and older with moderate to severe atopic dermatitis and pruritus who had an inadequate response to topical steroids.
At week 16, significantly more patients randomized to nemolizumab every 4 weeks met the co-primary endpoints, compared with those taking placebo. The co-primary endpoints were an Investigator Global Assessment (IGA) score of 0 (clear skin) or 1 (almost clear skin), with an improvement of at least 2 points from baseline to 16 weeks, and an improvement of at least 75% on the Eczema Area and Severity Index score from baseline to 16 weeks (EASI-75 response). All patients in both trials also received background treatment with topical corticosteroids and/or topical calcineurin inhibitors.
At 16 weeks, 36% and 38% of patients taking nemolizumab met the IGA criteria in ARCADIA 1 and ARCADIA 2, respectively, compared with 25% and 26% of those taking placebo. Similarly, 44% and 42% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, achieved EASI-75, compared with 29% and 30% of those taking placebo. Differences between treatment and placebo groups were significant in both studies.
In addition, patients reported significant improvement in all key secondary endpoints, including itch, as early as week 1, and improvement in sleep by week 16, according to the study findings.
Safety profiles were similar between the treatment and placebo groups in both studies; the most common adverse reactions (reported by at least 1% of patients in each group) were headache (5% vs 4%), followed by arthralgia, urticaria, and myalgia (2% or less). In ARCADIA 1 and ARCADIA 2, 50% and 41% of patients taking nemolizumab reported at least one treatment-emergent adverse event, similar to the placebo groups (45% and 44%, respectively).
Serious treatment-emergent adverse events occurred in 1% and 3% of those taking nemolizumab in ARCADIA 1 and ARCADIA 2, respectively, and 1% in the placebo groups in both studies. Ten serious treatment-emergent adverse events potentially related to nemolizumab were reported in five patients in ARCADIA 2. No deaths were reported in either study.
According to the prescribing information, safety profiles were similar between treatment and placebo groups in the subset of adolescents aged 12-17 years.
In August 2024, the FDA approved nemolizumab for the treatment of prurigo nodularis in adults. Authorization applications for nemolizumab for atopic dermatitis and prurigo nodularis are under review by regulatory authorities in Australia, Singapore, Switzerland, Canada, Brazil, and South Korea, according to Galderma.
ARCADIA is funded by Galderma.
A version of this article first appeared on Medscape.com.
More Biologics May Be Breaking Through for COPD
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 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 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 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.
Pertussis Cases Spike in November
Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).
Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.
None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.
The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.
Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.
Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.
A version of this article first appeared on Medscape.com.
Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).
Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.
None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.
The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.
Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.
Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.
A version of this article first appeared on Medscape.com.
Six times as many cases of pertussis were reported in the United States for the week ending November 16, 2024, as the same week in 2023, according to new data from the Centers for Disease Control and Prevention (CDC).
Of the 434 cases reported for the week ending November 16, 2024, a majority (109) occurred in the East North Central region, mostly in Ohio (93). Another 70 cases occurred in the West North Central region, with 32 cases and 37 cases in Missouri and Nebraska, respectively.
None of the 75 cases in the Middle Atlantic region occurred in New Jersey or New York City; 38 were reported elsewhere in New York, and 37 in Pennsylvania. The South Atlantic region reported 55 cases, including 29 in Florida. The East South Central and West South Central regions reported 11 and 20 cases, respectively. The Mountain and Pacific regions reported 31 (20 in Arizona) and 47 (20 in Washington State) cases, respectively.
The CDC tracks pertussis cases through a national surveillance system, but many cases are likely unrecognized and unreported, according to the CDC.
Although vaccines for pertussis (whooping cough) provide protection, their effectiveness decreases over time, and the CDC expects rates to increase in vaccinated and unvaccinated populations as case levels rebound with the lifting of pandemic mitigation strategies such as masking and remote learning.
Recent CDC data reported by Medscape Medical News showed an association between lower vaccination rates and 2024’s uptick in pertussis cases.
A version of this article first appeared on Medscape.com.
RSV Infections Take Toll on Adults
based on new data from more than 67,000 cases.
RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.
“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.
The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.
The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).
The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.
Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.
Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.
A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.
The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.
However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.”
Don’t Underestimate RSV Impact
The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.
“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.
The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “
Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.
The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.
The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.
However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.”
Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.
The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
based on new data from more than 67,000 cases.
RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.
“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.
The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.
The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).
The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.
Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.
Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.
A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.
The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.
However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.”
Don’t Underestimate RSV Impact
The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.
“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.
The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “
Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.
The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.
The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.
However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.”
Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.
The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
based on new data from more than 67,000 cases.
RSV remains a top cause of acute respiratory tract infections among adults in the United States, with an estimated 159,000 hospitalizations in those aged 65 years or older, wrote Suzanne N. Landi, MPH, PhD, of Pfizer in New York City, and colleagues in a study published in JAMA Network Open.
“Currently, limited estimates exist to determine the risk of hospitalization following outpatient RSV disease diagnoses in the United States,” said corresponding author Joshua T. Swan, PharmD, MPH, in an interview.
The current study was conducted to inform development of clinical trials, said Swan, senior director and category clinician in internal medicine and disease development at Pfizer, the sponsor of the study. These trials would assess the efficacy of an outpatient RSV antiviral treatment in preventing RSV-related hospitalization within 28 days among adults at a high risk for progression to severe illness, he said.
The authors reviewed data from 67,239 adults aged 18 years or older with medically attended RSV infections between October 1, 2016, and September 30, 2022. The data came from three databases: Optum (2771 patients), TriNetX (7442 patients), and Veradigm Network Electronic Health Record (VNEHR; 57,026 patients).
The primary outcome was all-cause hospitalization within 28 days of medically attended RSV.
Overall, the proportions of patients hospitalized within 28 days of infection were 6.2%, 6.0%, and 4.5% in Optum, TriNetX, and VNEHR databases, respectively.
Approximately two thirds of the patients (62%-67% across the three databases) were women, and 14.0%-54.5% were aged 65 years or older. The researchers also identified comorbidity prevalences of 20.0%-30.5% for chronic obstructive pulmonary disease (COPD), 14.6%-24.4% for heart failure (HF), and 14.6%-24.4% for asthma.
A majority of the patients (ranging from 74.5% to 90.6% across the three databases) fell into a high-risk subgroup, defined as age 65 years or older with asthma, COPD, and HF. In this high-risk group, the proportions of hospitalizations were 7.6%, 8.5%, and 6.5% for Optum, TriNetX, and VNEHR, respectively.
The findings were limited by several factors, including the use only of data from outpatient settings, which cannot be used to estimate the RSV burden in the general population, and the reliance only on diagnosis or procedure codes to identify comorbidities, the researchers noted.
However, “the absolute risk of hospitalization of 1 out of 20 patients observed in our study represents significant and meaningful risk for vulnerable adults, in a disease where much of the public’s attention has historically focused on risk of hospitalization for young children,” Swan said. “These results highlight the unmet medical need for outpatient interventions and preventive measures that can reduce hospitalizations.”
Don’t Underestimate RSV Impact
The current study highlights the fact that RSV is a major cause of respiratory viral illness, said David R. Manoff, MD, associate professor of clinical thoracic medicine and surgery at Temple University, Philadelphia, in an interview.
“Historically, influenza, and, more recently, COVID-19 infection have generally been thought of as more likely to cause harm and, thus, have been more emphasized in terms of both vaccination and treatment,” said Manoff, who was not involved in the study.
The current study provides new evidence that infection with RSV can be far more serious than often recognized and a major potential source of both hospitalization and morbidity, Manoff said. In fact, data published in Morbidity and Mortality Weekly Report in 2023 showed that the risks of needing oxygen, intensive care unit (ICU) admission, intubation, and death were actually higher in patients hospitalized with RSV infections than in those hospitalized with influenza or COVID-19. “
Understanding which population is hospitalized in the first place is vital to targeting prevention measures,” he added.
The new data are consistent with previous studies showing that most patients with RSV infection have primarily upper respiratory tract infection–type symptoms, but that a minority will develop lower respiratory tract disease, Manoff noted.
The findings add to the argument for implementation of RSV vaccination, especially in high-risk individuals, and support the need for RSV testing when patients present for care, he said.
However, more research is needed to reflect recent numbers, Manoff said. The study timeframe of 2016-2022 not only precedes commercially available RSV vaccines but also includes the period of increased isolation and masking seen during the COVID-19 pandemic years of 2020-2021. “We need to see if the same trends continue in the post-pandemic era.”
Additionally, the studies leading to approval of the RSV vaccine showed a reduction in hospitalization with RSV, and it is important to see how this reduction translates in real-world data and whether the RSV vaccines are reducing need for ICU admission, intubation, and death, Manoff said.
The study was funded by Pfizer, and Swan is a Pfizer employee. Manoff had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Slim Silver Lining Appears for STI Rates
The persistent epidemic of sexually transmitted infections (STIs) in the United States is showing signs of a slowdown in cases of syphilis, gonorrhea, and chlamydia, according to the latest data from the Centers for Disease Control and Prevention (CDC).
More than 2.4 million cases of these three nationally notifiable STIs were reported in the United States in 2023 but represent a 1.8% decrease from 2022, based on a new CDC report, Sexually Transmitted Infections Surveillance, 2023.
The 2023 report indicates a 7.2% decrease in gonorrhea, which accounts for most of the decrease.
Although syphilis cases increased overall, they did so by only 1% compared with double-digit increases in previous years, according to the report. Primary and secondary syphilis decreased by 10%, compared with 2022 overall, with a 13% decrease in cases among gay and bisexual men.
Congenital syphilis rates increased by 3%. However, the 3% increase represents a significant drop from the 30% increases each year in recent years, according to the report.
Chlamydia rates remained essentially stable, with a decrease of less than 1.0% overall. Reported chlamydia rates increased by 1.3% among men and decreased by 1.7% among women.
Despite the declines, overall disparities persist, with higher rates of STIs among gay and bisexual men, as well as American Indian/Alaska Native, Black/African American, and Hispanic/Latino populations, according to the report.
CDC Cautiously Optimistic
The CDC is “guardedly optimistic that the new data represent a turning point in terms of syphilis and gonorrhea,” said Bradley Stoner, MD, director of the CDC’s Division of STD Prevention, in an interview.
However, a tremendous amount of work remains to be done, notably in addressing disparities in care, said Stoner.
New techniques for diagnosis and treatment, such as the increased use of doxycycline (doxy PEP) for the prevention of STIs after sex for high-risk populations with a history of STIs, are likely contributing to the overall decrease, Stoner said. Other contributing factors include improved communication and awareness of STI treatment options at the community level in emergency departments, substance use facilities, and syringe use programs.
Although the United States has not yet turned the corner in reducing STIs, “We are at an inflection point in the epidemic after years of increases,” Stoner told this news organization. “The CDC is committed to keeping the momentum going and turning things around.” Although congenital syphilis rates are slowing down, it remains a significant problem with severe outcomes for mothers and infants, he noted.
The message to healthcare providers on the front lines is to increase awareness, screen widely, and provide effective treatments, Stoner emphasized.
Looking ahead, more research is needed to identify the settings in which prevention tools can be best utilized, such as urgent care or other programs, said Stoner. “My hope is that implementation science research will give us some clues.” In addition, better tools for detection and treatment of STIs are always needed, notably better diagnostics for syphilis, which still requires a blood test, although research is underway for more efficient testing.
Spotlight on Disparities, Syphilis
“I think these are very nuanced results,” said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, in an interview. “I am happy, on first pass, to see that STI rates have declined.” However, a closer look reveals that most of the improvements are driven by the 7% drop in gonorrhea, while chlamydia and syphilis rates are relatively stable.
The decreases may reflect that the public is receiving the messaging about the need for screening and safer sex. “Clinicians also have been educated on the need for screening,” Cennimo said. However, “we are still 90% above the [STI] rates from 20 years ago.”
Clinicians also must recognize the disparities in STI rates by race and other demographics, Cennimo said. The current report “is a call to make sure that STI and other medical services are targeted to specific groups as needed and are widely available, especially in under-resourced areas.”
“I am still dismayed by the high syphilis rates, which are also resulting in congenital syphilis,” Cennimo said. “Syphilis in pregnancy is very dangerous, and any case of congenital syphilis is a failure of preventive care and screening; it is a potentially devastating disease.
“We have good treatments for STIs, but we must continue to monitor for resistance,” said Cennimo. “More work is needed to reach high-risk individuals and to provide preventive care and screening.”
The research was supported by the CDC. Stoner and Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
The persistent epidemic of sexually transmitted infections (STIs) in the United States is showing signs of a slowdown in cases of syphilis, gonorrhea, and chlamydia, according to the latest data from the Centers for Disease Control and Prevention (CDC).
More than 2.4 million cases of these three nationally notifiable STIs were reported in the United States in 2023 but represent a 1.8% decrease from 2022, based on a new CDC report, Sexually Transmitted Infections Surveillance, 2023.
The 2023 report indicates a 7.2% decrease in gonorrhea, which accounts for most of the decrease.
Although syphilis cases increased overall, they did so by only 1% compared with double-digit increases in previous years, according to the report. Primary and secondary syphilis decreased by 10%, compared with 2022 overall, with a 13% decrease in cases among gay and bisexual men.
Congenital syphilis rates increased by 3%. However, the 3% increase represents a significant drop from the 30% increases each year in recent years, according to the report.
Chlamydia rates remained essentially stable, with a decrease of less than 1.0% overall. Reported chlamydia rates increased by 1.3% among men and decreased by 1.7% among women.
Despite the declines, overall disparities persist, with higher rates of STIs among gay and bisexual men, as well as American Indian/Alaska Native, Black/African American, and Hispanic/Latino populations, according to the report.
CDC Cautiously Optimistic
The CDC is “guardedly optimistic that the new data represent a turning point in terms of syphilis and gonorrhea,” said Bradley Stoner, MD, director of the CDC’s Division of STD Prevention, in an interview.
However, a tremendous amount of work remains to be done, notably in addressing disparities in care, said Stoner.
New techniques for diagnosis and treatment, such as the increased use of doxycycline (doxy PEP) for the prevention of STIs after sex for high-risk populations with a history of STIs, are likely contributing to the overall decrease, Stoner said. Other contributing factors include improved communication and awareness of STI treatment options at the community level in emergency departments, substance use facilities, and syringe use programs.
Although the United States has not yet turned the corner in reducing STIs, “We are at an inflection point in the epidemic after years of increases,” Stoner told this news organization. “The CDC is committed to keeping the momentum going and turning things around.” Although congenital syphilis rates are slowing down, it remains a significant problem with severe outcomes for mothers and infants, he noted.
The message to healthcare providers on the front lines is to increase awareness, screen widely, and provide effective treatments, Stoner emphasized.
Looking ahead, more research is needed to identify the settings in which prevention tools can be best utilized, such as urgent care or other programs, said Stoner. “My hope is that implementation science research will give us some clues.” In addition, better tools for detection and treatment of STIs are always needed, notably better diagnostics for syphilis, which still requires a blood test, although research is underway for more efficient testing.
Spotlight on Disparities, Syphilis
“I think these are very nuanced results,” said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, in an interview. “I am happy, on first pass, to see that STI rates have declined.” However, a closer look reveals that most of the improvements are driven by the 7% drop in gonorrhea, while chlamydia and syphilis rates are relatively stable.
The decreases may reflect that the public is receiving the messaging about the need for screening and safer sex. “Clinicians also have been educated on the need for screening,” Cennimo said. However, “we are still 90% above the [STI] rates from 20 years ago.”
Clinicians also must recognize the disparities in STI rates by race and other demographics, Cennimo said. The current report “is a call to make sure that STI and other medical services are targeted to specific groups as needed and are widely available, especially in under-resourced areas.”
“I am still dismayed by the high syphilis rates, which are also resulting in congenital syphilis,” Cennimo said. “Syphilis in pregnancy is very dangerous, and any case of congenital syphilis is a failure of preventive care and screening; it is a potentially devastating disease.
“We have good treatments for STIs, but we must continue to monitor for resistance,” said Cennimo. “More work is needed to reach high-risk individuals and to provide preventive care and screening.”
The research was supported by the CDC. Stoner and Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
The persistent epidemic of sexually transmitted infections (STIs) in the United States is showing signs of a slowdown in cases of syphilis, gonorrhea, and chlamydia, according to the latest data from the Centers for Disease Control and Prevention (CDC).
More than 2.4 million cases of these three nationally notifiable STIs were reported in the United States in 2023 but represent a 1.8% decrease from 2022, based on a new CDC report, Sexually Transmitted Infections Surveillance, 2023.
The 2023 report indicates a 7.2% decrease in gonorrhea, which accounts for most of the decrease.
Although syphilis cases increased overall, they did so by only 1% compared with double-digit increases in previous years, according to the report. Primary and secondary syphilis decreased by 10%, compared with 2022 overall, with a 13% decrease in cases among gay and bisexual men.
Congenital syphilis rates increased by 3%. However, the 3% increase represents a significant drop from the 30% increases each year in recent years, according to the report.
Chlamydia rates remained essentially stable, with a decrease of less than 1.0% overall. Reported chlamydia rates increased by 1.3% among men and decreased by 1.7% among women.
Despite the declines, overall disparities persist, with higher rates of STIs among gay and bisexual men, as well as American Indian/Alaska Native, Black/African American, and Hispanic/Latino populations, according to the report.
CDC Cautiously Optimistic
The CDC is “guardedly optimistic that the new data represent a turning point in terms of syphilis and gonorrhea,” said Bradley Stoner, MD, director of the CDC’s Division of STD Prevention, in an interview.
However, a tremendous amount of work remains to be done, notably in addressing disparities in care, said Stoner.
New techniques for diagnosis and treatment, such as the increased use of doxycycline (doxy PEP) for the prevention of STIs after sex for high-risk populations with a history of STIs, are likely contributing to the overall decrease, Stoner said. Other contributing factors include improved communication and awareness of STI treatment options at the community level in emergency departments, substance use facilities, and syringe use programs.
Although the United States has not yet turned the corner in reducing STIs, “We are at an inflection point in the epidemic after years of increases,” Stoner told this news organization. “The CDC is committed to keeping the momentum going and turning things around.” Although congenital syphilis rates are slowing down, it remains a significant problem with severe outcomes for mothers and infants, he noted.
The message to healthcare providers on the front lines is to increase awareness, screen widely, and provide effective treatments, Stoner emphasized.
Looking ahead, more research is needed to identify the settings in which prevention tools can be best utilized, such as urgent care or other programs, said Stoner. “My hope is that implementation science research will give us some clues.” In addition, better tools for detection and treatment of STIs are always needed, notably better diagnostics for syphilis, which still requires a blood test, although research is underway for more efficient testing.
Spotlight on Disparities, Syphilis
“I think these are very nuanced results,” said David J. Cennimo, MD, associate professor of medicine and pediatrics in the Division of Infectious Disease at Rutgers New Jersey Medical School, Newark, in an interview. “I am happy, on first pass, to see that STI rates have declined.” However, a closer look reveals that most of the improvements are driven by the 7% drop in gonorrhea, while chlamydia and syphilis rates are relatively stable.
The decreases may reflect that the public is receiving the messaging about the need for screening and safer sex. “Clinicians also have been educated on the need for screening,” Cennimo said. However, “we are still 90% above the [STI] rates from 20 years ago.”
Clinicians also must recognize the disparities in STI rates by race and other demographics, Cennimo said. The current report “is a call to make sure that STI and other medical services are targeted to specific groups as needed and are widely available, especially in under-resourced areas.”
“I am still dismayed by the high syphilis rates, which are also resulting in congenital syphilis,” Cennimo said. “Syphilis in pregnancy is very dangerous, and any case of congenital syphilis is a failure of preventive care and screening; it is a potentially devastating disease.
“We have good treatments for STIs, but we must continue to monitor for resistance,” said Cennimo. “More work is needed to reach high-risk individuals and to provide preventive care and screening.”
The research was supported by the CDC. Stoner and Cennimo had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.