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Children on Medicaid With Asthma Receive Less Specialty Care
Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.
Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.
“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.
In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
Outpatient Visit Outcome
The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.
A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.
Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).
Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).
The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.
“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.
The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.
However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
Takeaways and Next Steps
“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.
As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.
“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.
“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
Improve Access and Expand Analysis
Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.
Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.
More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.
The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.
“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.
The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.
Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.
“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.
In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
Outpatient Visit Outcome
The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.
A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.
Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).
Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).
The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.
“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.
The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.
However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
Takeaways and Next Steps
“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.
As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.
“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.
“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
Improve Access and Expand Analysis
Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.
Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.
More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.
The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.
“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.
The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Primary care clinicians successfully manage many children with asthma, but data on specialist care according to insurance coverage are lacking, wrote Kimberley H. Geissler, PhD, of the University of Massachusetts Chan Medical School–Baystate, Springfield, Massachusetts, and colleagues.
Despite many interventions over time, “low-income children insured by Medicaid, many of whom are from minoritized racial and ethnic groups, continue to have worse outcomes and higher rates of poorly controlled asthma than children who are privately insured,” Dr. Geissler said in an interview.
“Because differences in whether a child sees an asthma specialist could contribute to these disparities, better understanding specialist use among both groups of kids may help inform potential solutions,” she said.
In a study published in JAMA Network Open, the researchers identified children with asthma aged 2-17 years using data from the Massachusetts All-Payer Claims Database for the years 2015-2020. The study population included 198,101 children and 432,455 child-year observations from children with asthma during a year when they met at least one of three criteria with any asthma diagnosis: One or more hospital visits, two or more outpatient visits, or at least one outpatient visit and at least one asthma medication.
Outpatient Visit Outcome
The primary outcome of asthma specialist care was defined as at least one outpatient visit with any asthma diagnosis to a clinician with a code of allergy and immunology, pulmonology, or otolaryngology.
A total of 66.2% of the child-year observations involved Medicaid and 33.8% involved private insurance. Approximately 15% of the children received asthma specialist care. However, nearly twice as many children with private insurance received asthma specialty care compared with those with Medicaid (20.6% vs 11.9%). In a full logistic regression analysis, children with Medicaid insurance were 55% less likely to receive asthma specialist treatment than children with private insurance.
Allergy and immunology was the most common specialty used, and the child-years for this specialty among children with Medicaid were less than half of those among children with private insurance (7.1% vs 15.9%).
Rates of persistent asthma were 20.0% and 16.9% in children with Medicaid and private insurance, respectively. Overall, children with persistent asthma were nearly four times as likely to receive asthma specialist care (adjusted odds ratio, 3.96). However, the difference in odds of receiving specialty care based on insurance type in favor of private insurance was greater among children with persistent asthma than among those without persistent asthma (−24.0 percentage points vs −20.8 percentage points).
The researchers found a similar pattern of difference in asthma specialty care in a sensitivity analysis limiting the results to child-year observations with at least one outpatient visit with any asthma diagnosis in a calendar year, although they also found a slight narrowing of the difference between the groups over time.
“Contrary to expectations, disparities in specialist care by insurance type were even more striking in children with persistent asthma,” the researchers wrote in their discussion. Notably, the growth of specialty drugs such as biologics for moderate to severe asthma are mainly prescribed by specialists, and ensuring access to specialists for children with Medicaid may reduce disparities in asthma control for those with severe or poorly controlled disease, they added.
The study findings were limited by several factors including the use only of data from Massachusetts, which may not generalize to other states, and the use of completed specialist visits without data on referrals, the researchers noted. Other limitations included a lack of data on asthma symptom frequency or control and on the setting in which an asthma diagnosis was made.
However, the results suggest a need for more attention to disparities in asthma care by insurance type, and more research is needed to determine whether these disparities persist in subsets of children with asthma, such as those with allergies or chronic medical conditions, they concluded.
Takeaways and Next Steps
“Perhaps unsurprisingly, children with private insurance were more likely to receive asthma specialist care than children with Medicaid,” Dr. Geissler told this news organization. The researchers expected a smaller gap between insurance types among children with persistent asthma, a marker for asthma severity, she said. However, “we found that the gap between those with Medicaid and those with private insurance is actually larger” for children with persistent asthma, she added.
As improved treatments for hard-to-control asthma become more available, pediatricians and primary care clinicians should follow the latest clinical guidelines for referring children to specialists for asthma care, said Dr. Geissler.
“Additionally, asthma specialists should ensure that their practices are accessible to children with Medicaid, as these families may face higher barriers to care; for example, transportation needs or scheduling challenges,” she said. Other strategies to overcome barriers to care might include electronic consultations with specialists or primary care–oriented interdisciplinary asthma clinics, which may be useful for all children with asthma but may particularly benefit those insured by Medicaid, she noted.
“Based on data limitations, we could not examine why we observed such big differences in specialist use by insurance type; for example, whether pediatricians were referring to specialists less for Medicaid-insured kids, or whether kids with Medicaid were less likely to see a specialist after a referral was made,” Dr. Geissler said. More research is needed to examine not only these factors but also the appropriateness of specialty care based on clinical guidelines to ensure high-quality evidence-based care for children with asthma who are insured by Medicaid, she said.
Improve Access and Expand Analysis
Asthma is a chronic and prevalent disease and requires a comprehensive approach that sometimes calls for specialist care, Anne Coates, MD, a pediatric pulmonologist in Portland, Maine, said in an interview.
Dr. Coates said she was surprised by the results of the current study but commended the authors for highlighting the limitations of the study, which illustrate areas for additional research. Notably, “the authors couldn’t observe referrals to specialists from primary care physicians; they used completed visits as a proxy,” Dr. Coates said.
More studies are needed to assess the completion of referral visits regardless of children’s insurance in order to better understand and address the barriers to specialty care, she added.
The current study is important because of the extent of asthma coupled with the significant number of children across the United States who are insured by Medicaid, especially underserved populations, she said.
“The burden of asthma differentially affects people of color who are living in lower resourced areas, and it is important in further research to understanding the barriers to helping people get the care they need,” Dr. Coates told this news organization. Some alternatives might include telehealth visits or even a hybrid visit to a primary care provider (PCP) who has high-speed internet, and the specialist could then conduct a telehealth visit from the PCP’s office, with the PCP acting as on-site eyes and ears, said Dr. Coates, who has used this strategy in her practice in Maine, where many patients live far from specialist care.
The study was supported by the National Heart, Lung, and Blood Institute and the University of Massachusetts Center for Clinical and Translational Science-Biostatistics, Epidemiology & Research Design Component. Dr. Geissler and Dr. Coates had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Could Tuberculosis Medication Management Be as Simple as Monitoring Sweat?
Analysis of finger sweat detected isoniazid in adults with tuberculosis (TB) for ≤ 6 hours after administration, based on data from a new pilot study.
Katherine Longman, a PhD student at the University of Surrey, Guildford, England, and colleagues wrote.
Although TB is treatable, “it is well known that insufficient drug dosing leads to treatment failure and drug resistance, and so ensuring that patients have sufficient drug exposure is important,” said corresponding author Melanie J. Bailey, PhD, also of the University of Surrey.
“This can be carried out using blood, but blood is painful to collect and difficult to transport. Finger sweat offers a completely noninvasive way to sample patients,” but its use to determine medication adherence has not been examined, she said.
In a pilot study published in the International Journal of Antimicrobial Agents, the researchers reviewed data from 10 adults with TB who provided finger sweat, blood, and saliva samples at several time points ≤ 6 hours after receiving a controlled dose of isoniazid (median of 300 mg daily). They used liquid chromatography–mass spectrometry to examine the samples.
Overall, “isoniazid and acetyl isoniazid were detected in at least one finger sweat sample from all patients,” with detection rates of 96% and 77%, respectively, the researchers wrote. Given the short half-life of isoniazid, they used a window of 1-6 hours after administration. Isoniazid was consistently detected between 1 and 6 hours after administration, while acetyl isoniazid had a noticeably higher detection rate at 6 hours.
The researchers also examined creatinine to account for variability in volume of sweat samples, and found that finger sweat was significantly correlated to isoniazid concentration. The maximum isoniazid to creatinine ratio in finger sweat occurred mainly in the first hour after drug administration, and the activity of isoniazid in finger sweat over time reflected isoniazid concentration in serum more closely after normalization to creatinine, they said. The Pearson’s correlation coefficient (r) was 0.98 (P < .001; one-tailed), with normalization to creatinine, compared with r = 0.52 without normalization (P = .051).
The study findings were limited by several factors including the lack of knowledge of the last drug dose and lack of confirmation testing with an established method of analysis, the researchers noted. However, the results support the potential of the finger sweat test as a screening tool to indicate patients’ nonadherence or to identify patients at risk of low medication exposure.
“We were surprised that we were able to detect the drug in so many patient samples because the sample volume is so low, and so detection is challenging,” said Dr. Bailey. “We were also surprised that fingerprint and drug levels correlated so well after normalizing to creatinine. This is exciting as it unlocks the possibility to test drug levels, as well as providing a yes/no test.”
In practice, the finger sweat technique could reduce the burden on clinics by offering a completely noninvasive way to test a patient’s medication adherence. Looking ahead, more research is needed to explore whether creatinine normalization is widely applicable, such as whether it works for patients with abnormal kidney function, she added.
Noninvasive Option May Mitigate Treatment Challenges
The current study presents a strategy that might address current limitations in TB management, said Krishna Thavarajah, MD, a pulmonologist and director of the interstitial lung disease program at Henry Ford Hospital, Detroit, Michigan, in an interview.
Both self-administered treatment and directly observed therapy (DOT) for TB therapy have limitations, including adherence as low as 50% for TB regimens, she said. In addition, “DOT availability and efficacy can be limited by cost, personnel availability from an administration perspective, and by distrust of those being treated.”
In the current study, “I was struck by the correlation between the sweat and serum values of [isoniazid] and by the level of sophistication of noninvasive testing, being able to normalize for creatinine to account for different volumes of sweat,” said Dr. Thavarajah. In clinical practice, finger sweat isoniazid could potentially serve as an adjunct or alternative to DOT in patients with TB.
Although adherence to the sampling protocol and possible patient distrust of the process (such as concerns over what else is being collected in their sweat) might be barriers to the use of a finger sweat strategy in the clinical setting, appropriate patient selection, patient training, and encouraging clinicians to incorporate this testing into practice could overcome these barriers, said Dr. Thavarajah.
However, more research is needed to study the finger sweat strategy in larger, real-world samples and to study accuracy and treatment adherence with monitoring in a population undergoing DOT, she said.
The study was supported by the Engineering & Physical Sciences Research Council and by Santander PhD Mobility Awards 2019. The researchers had no financial conflicts to disclose. Dr. Thavarajah had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Analysis of finger sweat detected isoniazid in adults with tuberculosis (TB) for ≤ 6 hours after administration, based on data from a new pilot study.
Katherine Longman, a PhD student at the University of Surrey, Guildford, England, and colleagues wrote.
Although TB is treatable, “it is well known that insufficient drug dosing leads to treatment failure and drug resistance, and so ensuring that patients have sufficient drug exposure is important,” said corresponding author Melanie J. Bailey, PhD, also of the University of Surrey.
“This can be carried out using blood, but blood is painful to collect and difficult to transport. Finger sweat offers a completely noninvasive way to sample patients,” but its use to determine medication adherence has not been examined, she said.
In a pilot study published in the International Journal of Antimicrobial Agents, the researchers reviewed data from 10 adults with TB who provided finger sweat, blood, and saliva samples at several time points ≤ 6 hours after receiving a controlled dose of isoniazid (median of 300 mg daily). They used liquid chromatography–mass spectrometry to examine the samples.
Overall, “isoniazid and acetyl isoniazid were detected in at least one finger sweat sample from all patients,” with detection rates of 96% and 77%, respectively, the researchers wrote. Given the short half-life of isoniazid, they used a window of 1-6 hours after administration. Isoniazid was consistently detected between 1 and 6 hours after administration, while acetyl isoniazid had a noticeably higher detection rate at 6 hours.
The researchers also examined creatinine to account for variability in volume of sweat samples, and found that finger sweat was significantly correlated to isoniazid concentration. The maximum isoniazid to creatinine ratio in finger sweat occurred mainly in the first hour after drug administration, and the activity of isoniazid in finger sweat over time reflected isoniazid concentration in serum more closely after normalization to creatinine, they said. The Pearson’s correlation coefficient (r) was 0.98 (P < .001; one-tailed), with normalization to creatinine, compared with r = 0.52 without normalization (P = .051).
The study findings were limited by several factors including the lack of knowledge of the last drug dose and lack of confirmation testing with an established method of analysis, the researchers noted. However, the results support the potential of the finger sweat test as a screening tool to indicate patients’ nonadherence or to identify patients at risk of low medication exposure.
“We were surprised that we were able to detect the drug in so many patient samples because the sample volume is so low, and so detection is challenging,” said Dr. Bailey. “We were also surprised that fingerprint and drug levels correlated so well after normalizing to creatinine. This is exciting as it unlocks the possibility to test drug levels, as well as providing a yes/no test.”
In practice, the finger sweat technique could reduce the burden on clinics by offering a completely noninvasive way to test a patient’s medication adherence. Looking ahead, more research is needed to explore whether creatinine normalization is widely applicable, such as whether it works for patients with abnormal kidney function, she added.
Noninvasive Option May Mitigate Treatment Challenges
The current study presents a strategy that might address current limitations in TB management, said Krishna Thavarajah, MD, a pulmonologist and director of the interstitial lung disease program at Henry Ford Hospital, Detroit, Michigan, in an interview.
Both self-administered treatment and directly observed therapy (DOT) for TB therapy have limitations, including adherence as low as 50% for TB regimens, she said. In addition, “DOT availability and efficacy can be limited by cost, personnel availability from an administration perspective, and by distrust of those being treated.”
In the current study, “I was struck by the correlation between the sweat and serum values of [isoniazid] and by the level of sophistication of noninvasive testing, being able to normalize for creatinine to account for different volumes of sweat,” said Dr. Thavarajah. In clinical practice, finger sweat isoniazid could potentially serve as an adjunct or alternative to DOT in patients with TB.
Although adherence to the sampling protocol and possible patient distrust of the process (such as concerns over what else is being collected in their sweat) might be barriers to the use of a finger sweat strategy in the clinical setting, appropriate patient selection, patient training, and encouraging clinicians to incorporate this testing into practice could overcome these barriers, said Dr. Thavarajah.
However, more research is needed to study the finger sweat strategy in larger, real-world samples and to study accuracy and treatment adherence with monitoring in a population undergoing DOT, she said.
The study was supported by the Engineering & Physical Sciences Research Council and by Santander PhD Mobility Awards 2019. The researchers had no financial conflicts to disclose. Dr. Thavarajah had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
Analysis of finger sweat detected isoniazid in adults with tuberculosis (TB) for ≤ 6 hours after administration, based on data from a new pilot study.
Katherine Longman, a PhD student at the University of Surrey, Guildford, England, and colleagues wrote.
Although TB is treatable, “it is well known that insufficient drug dosing leads to treatment failure and drug resistance, and so ensuring that patients have sufficient drug exposure is important,” said corresponding author Melanie J. Bailey, PhD, also of the University of Surrey.
“This can be carried out using blood, but blood is painful to collect and difficult to transport. Finger sweat offers a completely noninvasive way to sample patients,” but its use to determine medication adherence has not been examined, she said.
In a pilot study published in the International Journal of Antimicrobial Agents, the researchers reviewed data from 10 adults with TB who provided finger sweat, blood, and saliva samples at several time points ≤ 6 hours after receiving a controlled dose of isoniazid (median of 300 mg daily). They used liquid chromatography–mass spectrometry to examine the samples.
Overall, “isoniazid and acetyl isoniazid were detected in at least one finger sweat sample from all patients,” with detection rates of 96% and 77%, respectively, the researchers wrote. Given the short half-life of isoniazid, they used a window of 1-6 hours after administration. Isoniazid was consistently detected between 1 and 6 hours after administration, while acetyl isoniazid had a noticeably higher detection rate at 6 hours.
The researchers also examined creatinine to account for variability in volume of sweat samples, and found that finger sweat was significantly correlated to isoniazid concentration. The maximum isoniazid to creatinine ratio in finger sweat occurred mainly in the first hour after drug administration, and the activity of isoniazid in finger sweat over time reflected isoniazid concentration in serum more closely after normalization to creatinine, they said. The Pearson’s correlation coefficient (r) was 0.98 (P < .001; one-tailed), with normalization to creatinine, compared with r = 0.52 without normalization (P = .051).
The study findings were limited by several factors including the lack of knowledge of the last drug dose and lack of confirmation testing with an established method of analysis, the researchers noted. However, the results support the potential of the finger sweat test as a screening tool to indicate patients’ nonadherence or to identify patients at risk of low medication exposure.
“We were surprised that we were able to detect the drug in so many patient samples because the sample volume is so low, and so detection is challenging,” said Dr. Bailey. “We were also surprised that fingerprint and drug levels correlated so well after normalizing to creatinine. This is exciting as it unlocks the possibility to test drug levels, as well as providing a yes/no test.”
In practice, the finger sweat technique could reduce the burden on clinics by offering a completely noninvasive way to test a patient’s medication adherence. Looking ahead, more research is needed to explore whether creatinine normalization is widely applicable, such as whether it works for patients with abnormal kidney function, she added.
Noninvasive Option May Mitigate Treatment Challenges
The current study presents a strategy that might address current limitations in TB management, said Krishna Thavarajah, MD, a pulmonologist and director of the interstitial lung disease program at Henry Ford Hospital, Detroit, Michigan, in an interview.
Both self-administered treatment and directly observed therapy (DOT) for TB therapy have limitations, including adherence as low as 50% for TB regimens, she said. In addition, “DOT availability and efficacy can be limited by cost, personnel availability from an administration perspective, and by distrust of those being treated.”
In the current study, “I was struck by the correlation between the sweat and serum values of [isoniazid] and by the level of sophistication of noninvasive testing, being able to normalize for creatinine to account for different volumes of sweat,” said Dr. Thavarajah. In clinical practice, finger sweat isoniazid could potentially serve as an adjunct or alternative to DOT in patients with TB.
Although adherence to the sampling protocol and possible patient distrust of the process (such as concerns over what else is being collected in their sweat) might be barriers to the use of a finger sweat strategy in the clinical setting, appropriate patient selection, patient training, and encouraging clinicians to incorporate this testing into practice could overcome these barriers, said Dr. Thavarajah.
However, more research is needed to study the finger sweat strategy in larger, real-world samples and to study accuracy and treatment adherence with monitoring in a population undergoing DOT, she said.
The study was supported by the Engineering & Physical Sciences Research Council and by Santander PhD Mobility Awards 2019. The researchers had no financial conflicts to disclose. Dr. Thavarajah had no financial conflicts to disclose.
A version of this article first appeared on Medscape.com.
FROM THE INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
Walking and Education Plan Improves Low Back Pain in Older Adults
An intervention combining an individualized walking program and education and significantly reduced low back pain recurrence in adults, compared with controls, based on data from approximately 700 individuals.
Exercise, including walking, is recommended to prevent recurrence of low back pain, but data on the effectiveness and cost-effectiveness of walking as an intervention are lacking, wrote Natasha C. Pocovi, PhD, of Macquarie University, Sydney, Australia, and colleagues.
In a study known as WalkBack, published in the Lancet, the researchers randomized 351 adults aged 18 years and older with a history of more than two prior episodes of low back pain to an intervention and 350 to no intervention.
The intervention consisted of six sessions of education and progressive walking with a physiotherapist over 6 months; both intervention and control groups were followed for a minimum of 12 months and a maximum of 36 months. The mean age of the participants was 54 years, and 81% were female. The primary outcome was the number of days to recurrence of low back pain severe enough to limit activity, based on monthly self-reports.
The intervention was significantly more effective at preventing activity-limiting low back pain recurrence, compared with no intervention (hazard ratio, 0.72; P = .0002), with a median of 208 days and 112 days to recurrence in the intervention and control groups, respectively.
The risk of any low back pain recurrence also was significantly reduced in the intervention group, compared with the controls (HR, 0.80; P = .0066); as was the risk of care-seeking recurrence of low back pain (HR, 0.57; P < .0001).
Overall, the experience of at least one adverse event over 12 months was similar between the intervention and control groups (52% and 54%, respectively), but significantly more adverse events related to lower extremities occurred in the intervention group, compared with the control group (100 vs 54). The intervention also was more likely to be cost effective, compared with a no-treatment control, the researchers wrote.
The findings were limited by several factors including the relatively homogeneous population and that neither the therapists nor participants were masked to group allocation. In addition, the study was conducted during the COVID-19 pandemic, so a telehealth model of video consultations was used instead of in-person meetings, but this protocol change allowed for inclusion of participants from diverse locations including rural and remote areas, the researchers said.
More research is needed to assess the implementation of a walking and exercise intervention as part of a discharge plan after an episode of low back pain and to examine the effectiveness of an intervention involving fewer sessions and a range of healthcare providers, they added. However, the results support the value of the intervention, which has a strong potential for successful implementation because of accessibility and low cost.
Preventive Interventions Need More Real-World Research
“Preventive interventions for back pain are an important yet neglected consideration,” Diarmuid Denneny, a doctoral candidate at Brunel University London, and Jackie Walumbe, PhD, of the University of Oxford (England), wrote in an accompanying editorial.
Although recurrence of low back pain is common, guidance on prevention and management is lacking, they said. Strengths of the current study include attention to patient and public preferences in the study design; however, the majority of the participants were of relatively high socioeconomic status and 89% reported post-secondary education.
“Given that pain is known to have a higher impact on marginalized and minoritized groups and those experiencing socioeconomic deprivation, we recommend caution in extrapolating these findings to different contexts,” the editorialists wrote.
They also cautioned that the complex nature of the intervention, which included not only walking but education and physiotherapist appointments, might make it difficult to isolate walking as the key factor in the patients’ improvement. The editorialists also emphasized the need for studies of similar interventions conducted by alternative providers including exercise professionals and digital platforms.
However, the WalkBack trial represents progress toward greater support for individuals with recurrent back pain and may be a foundation for other research involving how other forms of physical activity compare in improving back pain, with attention to the role of publish health in delivering physical activity interventions, they said.
The study was supported by the National Health and Medical Research Council, Australia. Dr. Pocovi disclosed scholarships funded by the National Health and Medical Research Council Low Back Pain Centre of Research Excellence (ANZBACK) and Macquarie University. Mr. Denneny disclosed support from an Economic and Social Research Council fellowship, and disclosed consulting fees from Live Well with Pain and Leva clinic; a grant from the Chartered Society of Physiotherapy. Dr. Walumbe disclosed travel support from the Chartered Society of Physiotherapy Charitable Trust.
An intervention combining an individualized walking program and education and significantly reduced low back pain recurrence in adults, compared with controls, based on data from approximately 700 individuals.
Exercise, including walking, is recommended to prevent recurrence of low back pain, but data on the effectiveness and cost-effectiveness of walking as an intervention are lacking, wrote Natasha C. Pocovi, PhD, of Macquarie University, Sydney, Australia, and colleagues.
In a study known as WalkBack, published in the Lancet, the researchers randomized 351 adults aged 18 years and older with a history of more than two prior episodes of low back pain to an intervention and 350 to no intervention.
The intervention consisted of six sessions of education and progressive walking with a physiotherapist over 6 months; both intervention and control groups were followed for a minimum of 12 months and a maximum of 36 months. The mean age of the participants was 54 years, and 81% were female. The primary outcome was the number of days to recurrence of low back pain severe enough to limit activity, based on monthly self-reports.
The intervention was significantly more effective at preventing activity-limiting low back pain recurrence, compared with no intervention (hazard ratio, 0.72; P = .0002), with a median of 208 days and 112 days to recurrence in the intervention and control groups, respectively.
The risk of any low back pain recurrence also was significantly reduced in the intervention group, compared with the controls (HR, 0.80; P = .0066); as was the risk of care-seeking recurrence of low back pain (HR, 0.57; P < .0001).
Overall, the experience of at least one adverse event over 12 months was similar between the intervention and control groups (52% and 54%, respectively), but significantly more adverse events related to lower extremities occurred in the intervention group, compared with the control group (100 vs 54). The intervention also was more likely to be cost effective, compared with a no-treatment control, the researchers wrote.
The findings were limited by several factors including the relatively homogeneous population and that neither the therapists nor participants were masked to group allocation. In addition, the study was conducted during the COVID-19 pandemic, so a telehealth model of video consultations was used instead of in-person meetings, but this protocol change allowed for inclusion of participants from diverse locations including rural and remote areas, the researchers said.
More research is needed to assess the implementation of a walking and exercise intervention as part of a discharge plan after an episode of low back pain and to examine the effectiveness of an intervention involving fewer sessions and a range of healthcare providers, they added. However, the results support the value of the intervention, which has a strong potential for successful implementation because of accessibility and low cost.
Preventive Interventions Need More Real-World Research
“Preventive interventions for back pain are an important yet neglected consideration,” Diarmuid Denneny, a doctoral candidate at Brunel University London, and Jackie Walumbe, PhD, of the University of Oxford (England), wrote in an accompanying editorial.
Although recurrence of low back pain is common, guidance on prevention and management is lacking, they said. Strengths of the current study include attention to patient and public preferences in the study design; however, the majority of the participants were of relatively high socioeconomic status and 89% reported post-secondary education.
“Given that pain is known to have a higher impact on marginalized and minoritized groups and those experiencing socioeconomic deprivation, we recommend caution in extrapolating these findings to different contexts,” the editorialists wrote.
They also cautioned that the complex nature of the intervention, which included not only walking but education and physiotherapist appointments, might make it difficult to isolate walking as the key factor in the patients’ improvement. The editorialists also emphasized the need for studies of similar interventions conducted by alternative providers including exercise professionals and digital platforms.
However, the WalkBack trial represents progress toward greater support for individuals with recurrent back pain and may be a foundation for other research involving how other forms of physical activity compare in improving back pain, with attention to the role of publish health in delivering physical activity interventions, they said.
The study was supported by the National Health and Medical Research Council, Australia. Dr. Pocovi disclosed scholarships funded by the National Health and Medical Research Council Low Back Pain Centre of Research Excellence (ANZBACK) and Macquarie University. Mr. Denneny disclosed support from an Economic and Social Research Council fellowship, and disclosed consulting fees from Live Well with Pain and Leva clinic; a grant from the Chartered Society of Physiotherapy. Dr. Walumbe disclosed travel support from the Chartered Society of Physiotherapy Charitable Trust.
An intervention combining an individualized walking program and education and significantly reduced low back pain recurrence in adults, compared with controls, based on data from approximately 700 individuals.
Exercise, including walking, is recommended to prevent recurrence of low back pain, but data on the effectiveness and cost-effectiveness of walking as an intervention are lacking, wrote Natasha C. Pocovi, PhD, of Macquarie University, Sydney, Australia, and colleagues.
In a study known as WalkBack, published in the Lancet, the researchers randomized 351 adults aged 18 years and older with a history of more than two prior episodes of low back pain to an intervention and 350 to no intervention.
The intervention consisted of six sessions of education and progressive walking with a physiotherapist over 6 months; both intervention and control groups were followed for a minimum of 12 months and a maximum of 36 months. The mean age of the participants was 54 years, and 81% were female. The primary outcome was the number of days to recurrence of low back pain severe enough to limit activity, based on monthly self-reports.
The intervention was significantly more effective at preventing activity-limiting low back pain recurrence, compared with no intervention (hazard ratio, 0.72; P = .0002), with a median of 208 days and 112 days to recurrence in the intervention and control groups, respectively.
The risk of any low back pain recurrence also was significantly reduced in the intervention group, compared with the controls (HR, 0.80; P = .0066); as was the risk of care-seeking recurrence of low back pain (HR, 0.57; P < .0001).
Overall, the experience of at least one adverse event over 12 months was similar between the intervention and control groups (52% and 54%, respectively), but significantly more adverse events related to lower extremities occurred in the intervention group, compared with the control group (100 vs 54). The intervention also was more likely to be cost effective, compared with a no-treatment control, the researchers wrote.
The findings were limited by several factors including the relatively homogeneous population and that neither the therapists nor participants were masked to group allocation. In addition, the study was conducted during the COVID-19 pandemic, so a telehealth model of video consultations was used instead of in-person meetings, but this protocol change allowed for inclusion of participants from diverse locations including rural and remote areas, the researchers said.
More research is needed to assess the implementation of a walking and exercise intervention as part of a discharge plan after an episode of low back pain and to examine the effectiveness of an intervention involving fewer sessions and a range of healthcare providers, they added. However, the results support the value of the intervention, which has a strong potential for successful implementation because of accessibility and low cost.
Preventive Interventions Need More Real-World Research
“Preventive interventions for back pain are an important yet neglected consideration,” Diarmuid Denneny, a doctoral candidate at Brunel University London, and Jackie Walumbe, PhD, of the University of Oxford (England), wrote in an accompanying editorial.
Although recurrence of low back pain is common, guidance on prevention and management is lacking, they said. Strengths of the current study include attention to patient and public preferences in the study design; however, the majority of the participants were of relatively high socioeconomic status and 89% reported post-secondary education.
“Given that pain is known to have a higher impact on marginalized and minoritized groups and those experiencing socioeconomic deprivation, we recommend caution in extrapolating these findings to different contexts,” the editorialists wrote.
They also cautioned that the complex nature of the intervention, which included not only walking but education and physiotherapist appointments, might make it difficult to isolate walking as the key factor in the patients’ improvement. The editorialists also emphasized the need for studies of similar interventions conducted by alternative providers including exercise professionals and digital platforms.
However, the WalkBack trial represents progress toward greater support for individuals with recurrent back pain and may be a foundation for other research involving how other forms of physical activity compare in improving back pain, with attention to the role of publish health in delivering physical activity interventions, they said.
The study was supported by the National Health and Medical Research Council, Australia. Dr. Pocovi disclosed scholarships funded by the National Health and Medical Research Council Low Back Pain Centre of Research Excellence (ANZBACK) and Macquarie University. Mr. Denneny disclosed support from an Economic and Social Research Council fellowship, and disclosed consulting fees from Live Well with Pain and Leva clinic; a grant from the Chartered Society of Physiotherapy. Dr. Walumbe disclosed travel support from the Chartered Society of Physiotherapy Charitable Trust.
FROM THE LANCET
FDA Grants New Pediatric Arthritis Indications for Upadacitinib
Upadacitinib (Rinvoq) is now indicated for patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who cannot tolerate or achieve adequate disease response with one or more tumor necrosis factor (TNF) blockers, according to a press release from manufacturer AbbVie.
For the youngest patients, upadacitinib is also available as a weight-based oral solution (Rinvoq LQ) in addition to the previously available tablets, according to the company. JIA, which includes pJIA and juvenile PsA, affects nearly 300,000 children and adolescents in the United States, and alternatives to TNF inhibitor (TNFi) therapy are limited, according to the company. 
“Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options,” Aarat Patel, MD, a pediatric rheumatologist at Bon Secours Rheumatology Center, Richmond, Virginia, said in the press release. “Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families,” he said.
Upadacitinib, a Janus kinase (JAK) inhibitor, is being studied for multiple immune-mediated inflammatory diseases. The new indication was supported by data from adults with rheumatoid arthritis (RA) and PsA, 51 pediatric patients with pJIA and active polyarthritis, and safety data from 83 pediatric patients aged 2 years to younger than 18 years with pJIA and active polyarthritis.
In the studies, the drug’s safety in pediatric patients was similar to the known safety profile in adults, which includes increased risk for serious infections such as tuberculosis, cancer, immune system problems, blood clots, and serious allergic reactions to components of the drug, according to the press release. However, the safety and effectiveness of upadacitinib for pJIA and PsA in patients younger than 2 years are unknown.
“Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation,” according to the press release.
Currently, upadacitinib’s only other pediatric indication is for moderate to severe atopic dermatitis in children aged 12 years or older. Upadacitinib also is indicated for treatment of adults with moderate to severe RA, active PsA, active ankylosing spondylitis, active nonradiographic axial spondyloarthritis, and moderate to severe ulcerative colitis and Crohn’s disease, but safety and efficacy for its use in treatment of these conditions in children and adolescents is unknown.
Upadacitinib also is being studied in phase 3 trials for treatment of conditions including alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo, according to the press release.
Full prescribing information and safety data for upadacitinib are available here.
A version of this article appeared on Medscape.com.
Upadacitinib (Rinvoq) is now indicated for patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who cannot tolerate or achieve adequate disease response with one or more tumor necrosis factor (TNF) blockers, according to a press release from manufacturer AbbVie.
For the youngest patients, upadacitinib is also available as a weight-based oral solution (Rinvoq LQ) in addition to the previously available tablets, according to the company. JIA, which includes pJIA and juvenile PsA, affects nearly 300,000 children and adolescents in the United States, and alternatives to TNF inhibitor (TNFi) therapy are limited, according to the company.
“Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options,” Aarat Patel, MD, a pediatric rheumatologist at Bon Secours Rheumatology Center, Richmond, Virginia, said in the press release. “Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families,” he said.
Upadacitinib, a Janus kinase (JAK) inhibitor, is being studied for multiple immune-mediated inflammatory diseases. The new indication was supported by data from adults with rheumatoid arthritis (RA) and PsA, 51 pediatric patients with pJIA and active polyarthritis, and safety data from 83 pediatric patients aged 2 years to younger than 18 years with pJIA and active polyarthritis.
In the studies, the drug’s safety in pediatric patients was similar to the known safety profile in adults, which includes increased risk for serious infections such as tuberculosis, cancer, immune system problems, blood clots, and serious allergic reactions to components of the drug, according to the press release. However, the safety and effectiveness of upadacitinib for pJIA and PsA in patients younger than 2 years are unknown.
“Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation,” according to the press release.
Currently, upadacitinib’s only other pediatric indication is for moderate to severe atopic dermatitis in children aged 12 years or older. Upadacitinib also is indicated for treatment of adults with moderate to severe RA, active PsA, active ankylosing spondylitis, active nonradiographic axial spondyloarthritis, and moderate to severe ulcerative colitis and Crohn’s disease, but safety and efficacy for its use in treatment of these conditions in children and adolescents is unknown.
Upadacitinib also is being studied in phase 3 trials for treatment of conditions including alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo, according to the press release.
Full prescribing information and safety data for upadacitinib are available here.
A version of this article appeared on Medscape.com.
Upadacitinib (Rinvoq) is now indicated for patients aged 2 years or older with active polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic arthritis (PsA) who cannot tolerate or achieve adequate disease response with one or more tumor necrosis factor (TNF) blockers, according to a press release from manufacturer AbbVie.
For the youngest patients, upadacitinib is also available as a weight-based oral solution (Rinvoq LQ) in addition to the previously available tablets, according to the company. JIA, which includes pJIA and juvenile PsA, affects nearly 300,000 children and adolescents in the United States, and alternatives to TNF inhibitor (TNFi) therapy are limited, according to the company.
“Pediatric patients with pJIA and PsA can be severely limited in their ability to complete daily physical tasks and participate in everyday activities. Understanding their needs today and knowing the likelihood of disease in adulthood underscores the need for additional treatment options,” Aarat Patel, MD, a pediatric rheumatologist at Bon Secours Rheumatology Center, Richmond, Virginia, said in the press release. “Having a treatment option available for patients who do not respond well to a TNFi addresses a need for the healthcare community, patients, and their families,” he said.
Upadacitinib, a Janus kinase (JAK) inhibitor, is being studied for multiple immune-mediated inflammatory diseases. The new indication was supported by data from adults with rheumatoid arthritis (RA) and PsA, 51 pediatric patients with pJIA and active polyarthritis, and safety data from 83 pediatric patients aged 2 years to younger than 18 years with pJIA and active polyarthritis.
In the studies, the drug’s safety in pediatric patients was similar to the known safety profile in adults, which includes increased risk for serious infections such as tuberculosis, cancer, immune system problems, blood clots, and serious allergic reactions to components of the drug, according to the press release. However, the safety and effectiveness of upadacitinib for pJIA and PsA in patients younger than 2 years are unknown.
“Upadacitinib plasma exposures in pediatric patients with pJIA and PsA at the recommended dosage are predicted to be comparable to those observed in adults with RA and PsA based on population pharmacokinetic modeling and simulation,” according to the press release.
Currently, upadacitinib’s only other pediatric indication is for moderate to severe atopic dermatitis in children aged 12 years or older. Upadacitinib also is indicated for treatment of adults with moderate to severe RA, active PsA, active ankylosing spondylitis, active nonradiographic axial spondyloarthritis, and moderate to severe ulcerative colitis and Crohn’s disease, but safety and efficacy for its use in treatment of these conditions in children and adolescents is unknown.
Upadacitinib also is being studied in phase 3 trials for treatment of conditions including alopecia areata, ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn’s disease, giant cell arteritis, hidradenitis suppurativa, psoriatic arthritis, RA, systemic lupus erythematosus, Takayasu arteritis, ulcerative colitis, and vitiligo, according to the press release.
Full prescribing information and safety data for upadacitinib are available here.
A version of this article appeared on Medscape.com.
Cystic Fibrosis Patients Also Experience Poor Sleep, Fatigue, Depression
Non-respiratory symptoms including poor sleep, fatigue, pain, anxiety, and depressive symptoms were prevalent among adults with cystic fibrosis (AwCF) and persisted after 1 year of follow-up, based on data from more than 200 individuals in a study presented at the American Thoracic Society (ATS) 2024 International Conference.
“People with cystic fibrosis have qualitatively reported burden from extrapulmonary symptoms that were not being addressed by their health care providers; this is the first study to examine these symptoms concurrently in a large sample over time,” said lead author Kristin A. Riekert, PhD, of Johns Hopkins University, Baltimore, in an interview.
Previous cross-sectional studies have shown a high prevalence of poor sleep quality, fatigue, pain, depression, and anxiety among AwCF, but longitudinal data showing the persistence of symptoms are lacking, Dr. Riekert and colleagues noted in their abstract.
Sleep Quality, Anxiety, and Other Assessments
The researchers recruited a total of 236 AwCF aged 18 years and older from two cystic fibrosis (CF) centers between April 2021 and August 2022. They examined the prevalence of poor sleep quality, fatigue pain, depression, and anxiety in AwCF on the basis of five assessments: At baseline and at 3, 6, 9, and 12 months.
Participants were assessed via an online survey using the Fatigue Severity Scale (cutoff, > 4), Pittsburgh Sleep Quality Index (cutoff, > 5), Patient Health Questionnaire (cutoff, > 9), Generalized Anxiety Disorder (cutoff, > 9), and PROMIS Pain Intensity (cutoff, > 50 T score). Chronic symptoms were defined as positive scores on four or more assessments for individuals who completed four or five time-point assessments. The mean age of the participants was 37 years, 52% were women, 95% were non-Hispanic White, and 86% had been prescribed CF modulator therapy.
Overall, 49% of participants met the criteria for chronic poor sleep quality, and 29% met the criteria for chronic fatigue, with positive assessments at four or more time points over the course of a year. In addition, 40%, 30%, and 18% of participants reported taking medication in the past 7 days for pain, mental health, and sleep, respectively.
The findings suggest that patients with CF might benefit from routine assessments of non-pulmonary symptoms in clinical care and from access to health care providers, including mental health professionals, to address non-pulmonary concerns, the researchers wrote in their abstract.
“We delayed starting the study until elexacaftor/tezacaftor/ivacaftor (ETI) was FDA-approved because there was an assumption that people with CF would have less fatigue because of respiratory improvements from ETI,” Dr. Riekert told this news organization. “Instead, the prevalence of fatigue and poor sleep quality was higher and more chronic than we had anticipated,” she noted.
However, “we were pleasantly surprised that depression and anxiety, while still prevalent, were less prevalent and chronic than previously reported,” Dr. Riekert said in an interview. “We attribute this to the CF Foundation’s mental health initiative that has increased the frequency of annual screening for depression and anxiety and provided resources to help people with cystic fibrosis obtain mental health services,” she said.
The study findings suggest that clinicians should assess people with CF for chronic fatigue and poor sleep along with depression and anxiety and provide treatment or referral, Dr. Riekert said. “For example, cognitive behavioral therapy can effectively treat all the symptoms that were measured in our study,” she noted.
Limitations of the study include the lack of data on how the non-respiratory symptoms interact with respiratory symptoms or pulmonary exacerbations, said Dr. Riekert. “While we assessed these symptoms five times, it was for a year; longer-term follow-up seems merited given our findings,” she said. In addition, “we need to study approaches to make cognitive behavioral therapy and other therapy more accessible for people with cystic fibrosis,” Dr. Riekert said.
Targeting Non-Pulmonary Dimensions of CF Care
The current study highlights an aspect of quality of life that is often forgotten when managing adults with CF and may affect their well-being despite effective therapy to improve function and prolong life, said Wissam Chatila, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
The high incidence of poor sleep, fatigue, depression, and anxiety seen in the current study was “somewhat surprising,” Dr. Chatila said. Also somewhat surprising was the chronicity of the symptoms considering the cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies (designed to correct the malfunctioning protein made by the CFTR gene) that have changed the face of CF, he noted.
However, recent growth in the number of adult patients with CF (more than 50% in certain countries) has led to a change in pathologies that physicians have to manage, and the current study addresses some of the emerging pathologies, said Dr. Chatila.
“Beyond demonstrating survival data from registries and other epidemiologic studies, this study sheds light on the need to address patient-reported outcomes that may or may not be directly related to the pulmonary and GI effects of the CFTR modulators,” he said. “Recognizing the extent of the dysfunction that many CF patients continue to suffer from will eventually lead to identifying factors that contribute to poor outcomes and the mechanisms involved,” he added.
Overall, the current study illustrates the potential benefits of offering personalized medicine to adults with CF that improves not only their physical function but also their mental health, Dr. Chatila said.
The study was funded by the Cystic Fibrosis Foundation. Dr. Riekert had no financial conflicts to disclose. Dr. Chatila had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Non-respiratory symptoms including poor sleep, fatigue, pain, anxiety, and depressive symptoms were prevalent among adults with cystic fibrosis (AwCF) and persisted after 1 year of follow-up, based on data from more than 200 individuals in a study presented at the American Thoracic Society (ATS) 2024 International Conference.
“People with cystic fibrosis have qualitatively reported burden from extrapulmonary symptoms that were not being addressed by their health care providers; this is the first study to examine these symptoms concurrently in a large sample over time,” said lead author Kristin A. Riekert, PhD, of Johns Hopkins University, Baltimore, in an interview.
Previous cross-sectional studies have shown a high prevalence of poor sleep quality, fatigue, pain, depression, and anxiety among AwCF, but longitudinal data showing the persistence of symptoms are lacking, Dr. Riekert and colleagues noted in their abstract.
Sleep Quality, Anxiety, and Other Assessments
The researchers recruited a total of 236 AwCF aged 18 years and older from two cystic fibrosis (CF) centers between April 2021 and August 2022. They examined the prevalence of poor sleep quality, fatigue pain, depression, and anxiety in AwCF on the basis of five assessments: At baseline and at 3, 6, 9, and 12 months.
Participants were assessed via an online survey using the Fatigue Severity Scale (cutoff, > 4), Pittsburgh Sleep Quality Index (cutoff, > 5), Patient Health Questionnaire (cutoff, > 9), Generalized Anxiety Disorder (cutoff, > 9), and PROMIS Pain Intensity (cutoff, > 50 T score). Chronic symptoms were defined as positive scores on four or more assessments for individuals who completed four or five time-point assessments. The mean age of the participants was 37 years, 52% were women, 95% were non-Hispanic White, and 86% had been prescribed CF modulator therapy.
Overall, 49% of participants met the criteria for chronic poor sleep quality, and 29% met the criteria for chronic fatigue, with positive assessments at four or more time points over the course of a year. In addition, 40%, 30%, and 18% of participants reported taking medication in the past 7 days for pain, mental health, and sleep, respectively.
The findings suggest that patients with CF might benefit from routine assessments of non-pulmonary symptoms in clinical care and from access to health care providers, including mental health professionals, to address non-pulmonary concerns, the researchers wrote in their abstract.
“We delayed starting the study until elexacaftor/tezacaftor/ivacaftor (ETI) was FDA-approved because there was an assumption that people with CF would have less fatigue because of respiratory improvements from ETI,” Dr. Riekert told this news organization. “Instead, the prevalence of fatigue and poor sleep quality was higher and more chronic than we had anticipated,” she noted.
However, “we were pleasantly surprised that depression and anxiety, while still prevalent, were less prevalent and chronic than previously reported,” Dr. Riekert said in an interview. “We attribute this to the CF Foundation’s mental health initiative that has increased the frequency of annual screening for depression and anxiety and provided resources to help people with cystic fibrosis obtain mental health services,” she said.
The study findings suggest that clinicians should assess people with CF for chronic fatigue and poor sleep along with depression and anxiety and provide treatment or referral, Dr. Riekert said. “For example, cognitive behavioral therapy can effectively treat all the symptoms that were measured in our study,” she noted.
Limitations of the study include the lack of data on how the non-respiratory symptoms interact with respiratory symptoms or pulmonary exacerbations, said Dr. Riekert. “While we assessed these symptoms five times, it was for a year; longer-term follow-up seems merited given our findings,” she said. In addition, “we need to study approaches to make cognitive behavioral therapy and other therapy more accessible for people with cystic fibrosis,” Dr. Riekert said.
Targeting Non-Pulmonary Dimensions of CF Care
The current study highlights an aspect of quality of life that is often forgotten when managing adults with CF and may affect their well-being despite effective therapy to improve function and prolong life, said Wissam Chatila, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
The high incidence of poor sleep, fatigue, depression, and anxiety seen in the current study was “somewhat surprising,” Dr. Chatila said. Also somewhat surprising was the chronicity of the symptoms considering the cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies (designed to correct the malfunctioning protein made by the CFTR gene) that have changed the face of CF, he noted.
However, recent growth in the number of adult patients with CF (more than 50% in certain countries) has led to a change in pathologies that physicians have to manage, and the current study addresses some of the emerging pathologies, said Dr. Chatila.
“Beyond demonstrating survival data from registries and other epidemiologic studies, this study sheds light on the need to address patient-reported outcomes that may or may not be directly related to the pulmonary and GI effects of the CFTR modulators,” he said. “Recognizing the extent of the dysfunction that many CF patients continue to suffer from will eventually lead to identifying factors that contribute to poor outcomes and the mechanisms involved,” he added.
Overall, the current study illustrates the potential benefits of offering personalized medicine to adults with CF that improves not only their physical function but also their mental health, Dr. Chatila said.
The study was funded by the Cystic Fibrosis Foundation. Dr. Riekert had no financial conflicts to disclose. Dr. Chatila had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Non-respiratory symptoms including poor sleep, fatigue, pain, anxiety, and depressive symptoms were prevalent among adults with cystic fibrosis (AwCF) and persisted after 1 year of follow-up, based on data from more than 200 individuals in a study presented at the American Thoracic Society (ATS) 2024 International Conference.
“People with cystic fibrosis have qualitatively reported burden from extrapulmonary symptoms that were not being addressed by their health care providers; this is the first study to examine these symptoms concurrently in a large sample over time,” said lead author Kristin A. Riekert, PhD, of Johns Hopkins University, Baltimore, in an interview.
Previous cross-sectional studies have shown a high prevalence of poor sleep quality, fatigue, pain, depression, and anxiety among AwCF, but longitudinal data showing the persistence of symptoms are lacking, Dr. Riekert and colleagues noted in their abstract.
Sleep Quality, Anxiety, and Other Assessments
The researchers recruited a total of 236 AwCF aged 18 years and older from two cystic fibrosis (CF) centers between April 2021 and August 2022. They examined the prevalence of poor sleep quality, fatigue pain, depression, and anxiety in AwCF on the basis of five assessments: At baseline and at 3, 6, 9, and 12 months.
Participants were assessed via an online survey using the Fatigue Severity Scale (cutoff, > 4), Pittsburgh Sleep Quality Index (cutoff, > 5), Patient Health Questionnaire (cutoff, > 9), Generalized Anxiety Disorder (cutoff, > 9), and PROMIS Pain Intensity (cutoff, > 50 T score). Chronic symptoms were defined as positive scores on four or more assessments for individuals who completed four or five time-point assessments. The mean age of the participants was 37 years, 52% were women, 95% were non-Hispanic White, and 86% had been prescribed CF modulator therapy.
Overall, 49% of participants met the criteria for chronic poor sleep quality, and 29% met the criteria for chronic fatigue, with positive assessments at four or more time points over the course of a year. In addition, 40%, 30%, and 18% of participants reported taking medication in the past 7 days for pain, mental health, and sleep, respectively.
The findings suggest that patients with CF might benefit from routine assessments of non-pulmonary symptoms in clinical care and from access to health care providers, including mental health professionals, to address non-pulmonary concerns, the researchers wrote in their abstract.
“We delayed starting the study until elexacaftor/tezacaftor/ivacaftor (ETI) was FDA-approved because there was an assumption that people with CF would have less fatigue because of respiratory improvements from ETI,” Dr. Riekert told this news organization. “Instead, the prevalence of fatigue and poor sleep quality was higher and more chronic than we had anticipated,” she noted.
However, “we were pleasantly surprised that depression and anxiety, while still prevalent, were less prevalent and chronic than previously reported,” Dr. Riekert said in an interview. “We attribute this to the CF Foundation’s mental health initiative that has increased the frequency of annual screening for depression and anxiety and provided resources to help people with cystic fibrosis obtain mental health services,” she said.
The study findings suggest that clinicians should assess people with CF for chronic fatigue and poor sleep along with depression and anxiety and provide treatment or referral, Dr. Riekert said. “For example, cognitive behavioral therapy can effectively treat all the symptoms that were measured in our study,” she noted.
Limitations of the study include the lack of data on how the non-respiratory symptoms interact with respiratory symptoms or pulmonary exacerbations, said Dr. Riekert. “While we assessed these symptoms five times, it was for a year; longer-term follow-up seems merited given our findings,” she said. In addition, “we need to study approaches to make cognitive behavioral therapy and other therapy more accessible for people with cystic fibrosis,” Dr. Riekert said.
Targeting Non-Pulmonary Dimensions of CF Care
The current study highlights an aspect of quality of life that is often forgotten when managing adults with CF and may affect their well-being despite effective therapy to improve function and prolong life, said Wissam Chatila, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
The high incidence of poor sleep, fatigue, depression, and anxiety seen in the current study was “somewhat surprising,” Dr. Chatila said. Also somewhat surprising was the chronicity of the symptoms considering the cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies (designed to correct the malfunctioning protein made by the CFTR gene) that have changed the face of CF, he noted.
However, recent growth in the number of adult patients with CF (more than 50% in certain countries) has led to a change in pathologies that physicians have to manage, and the current study addresses some of the emerging pathologies, said Dr. Chatila.
“Beyond demonstrating survival data from registries and other epidemiologic studies, this study sheds light on the need to address patient-reported outcomes that may or may not be directly related to the pulmonary and GI effects of the CFTR modulators,” he said. “Recognizing the extent of the dysfunction that many CF patients continue to suffer from will eventually lead to identifying factors that contribute to poor outcomes and the mechanisms involved,” he added.
Overall, the current study illustrates the potential benefits of offering personalized medicine to adults with CF that improves not only their physical function but also their mental health, Dr. Chatila said.
The study was funded by the Cystic Fibrosis Foundation. Dr. Riekert had no financial conflicts to disclose. Dr. Chatila had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Patients With Hypersensitivity Pneumonitis Want More Disease Information
Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.
HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues.
Surveys Conducted to Understand Patient Concerns
To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.
The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.
The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).
The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.
Findings Will Fuel Needed Education
Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted.
“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.
The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.
In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.
“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.
The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.
HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues.
Surveys Conducted to Understand Patient Concerns
To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.
The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.
The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).
The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.
Findings Will Fuel Needed Education
Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted.
“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.
The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.
In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.
“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.
The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.
HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues.
Surveys Conducted to Understand Patient Concerns
To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.
The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.
The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).
The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.
Findings Will Fuel Needed Education
Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.
“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted.
“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.
The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.
In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.
“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.
The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Age, Race, and Insurance Status May Effect Initial Sarcoidosis Severity
presented at the American Thoracic Society’s International Conference 2024.
“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.
Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.
No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.
“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.
For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.
“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
Pinpointing Persistent Disparities
“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.
The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.
“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.
Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.
In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.
The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
presented at the American Thoracic Society’s International Conference 2024.
“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.
Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.
No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.
“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.
For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.
“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
Pinpointing Persistent Disparities
“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.
The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.
“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.
Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.
In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.
The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
presented at the American Thoracic Society’s International Conference 2024.
“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.
Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.
No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.
“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.
For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.
“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
Pinpointing Persistent Disparities
“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.
The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.
“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.
Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.
In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.
The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.
A version of this article appeared on Medscape.com.
Anti-Müllerian Hormone Predicts Chemo Benefits in BC
The new findings also show that women with low baseline anti-Müllerian hormone (AMH) of less than 10 pg/mL do not benefit from chemotherapy. In fact, AMH levels were a better predictor of chemotherapy benefit than self-reported premenopausal status, age, and other hormone levels.
“We may be overtreating some of our patients” with invasive breast cancer and low AMH levels, Kevin Kalinsky, MD, of the Winship Cancer Institute of Emory University, Atlanta, said in a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO).
The potential implication of the study is that clinicians may be able to stop giving chemotherapy to a subset of breast cancer patients who will not benefit from it, he said in the presentation.
New Analysis Singles Out AMH Levels
In a new analysis of data from the RxPONDER trial, Dr. Kalinsky shared data from 1,016 patients who were younger than 55 years of age and self-reported as premenopausal.
The original RxPONDER trial (also known as SWOG S1007) was a randomized, phase 3 trial designed to evaluate the benefit of endocrine therapy (ET) alone vs. ET plus chemotherapy in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) invasive breast cancer and low recurrence scores (25 or less with genomic testing by Oncotype DX), Dr. Kalinsky said in his presentation.
The researchers found no improvement in invasive disease-free survival (IDFS) with the addition of chemotherapy to ET overall, but significant IDFS improvement occurred with added chemotherapy to ET in the subgroup of self-reported premenopausal women (hazard ratio 0.60).
To better identify the impact of menopausal status on patients who would benefit or not benefit from chemotherapy in the new analysis, the researchers assessed baseline serum samples of serum estradiol, progesterone, follicular stimulating hormone(FSH), luteinizing hormone, AMH, and inhibin B.
The primary outcomes were associations of these markers (continuous and dichotomized) with IDFS and distant relapse-free survival with prognosis and prediction of chemotherapy benefit, based on Cox regression analysis.
Of the six markers analyzed, only AMH showed an association with chemotherapy benefits. “AMH is more stable and reliable during the menstrual cycle” compared to other hormones such as FSH and estradiol. Also, AMH levels ≥ 10 pg/mL are considered a standard cutoff to define normal ovarian reserve, Dr. Kalinsky said in his presentation.
A total of 209 patients (21%) had low AMH (less than 10 pg/mL) and were considered postmenopausal, and 806 (79%) were considered premenopausal, with AMH levels of 10 pg/mL or higher.
Chemotherapy plus ET was significantly more beneficial than ET alone in the premenopausal patients with AMH levels ≥ 10 pg/mL (hazard ratio 0.48), Dr. Kalinsky said. By contrast, no chemotherapy benefit was seen in the patients deemed postmenopausal, with low AMH levels (HR 1.21).
In the patients with AMH of 10 pg/mL or higher, the absolute 5-year IDFS benefit of chemotherapy was 7.8%, compared to no notable difference for those with low AMH levels.
Similarly, 5-year DRFS with chemotherapy in patients with AMH of 10 pg/mL or higher was 4.4% (HR 0.41), with no benefit for those with low AMH (HR 1.50).
The findings were limited by the post hoc design and lack of longitudinal data, Dr. Kalinsky said.
During the question-and-answer session, Dr. Kalinsky said that he hoped the data could be incorporated into a clinical model “to further refine patients who need chemotherapy or don’t.” The results suggest that the reproductive hormone AMH can be used to identify premenopausal women with HR+/HER2- invasive breast cancer and intermediate risk based on oncotype scores who would likely benefit from chemotherapy, while those with lower AMH who could forgo it, Dr. Kalinsky concluded.
AMH May Ultimately Inform Chemotherapy Choices
The findings are “thoughtful and intriguing” and may inform which patients benefit from adjuvant chemotherapy and which may not, said Lisa A. Carey, MD, of Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, who served as discussant for the abstract.
Dr. Carey noted as a caveat that AMH is not currently recommended by the American College of Obstetricians and Gynecologists for menopause prediction. However, AMH is “a very credible biomarker of ovarian reserve,” she said in her presentation.
As for clinical implications, the lack of chemotherapy benefit in patients with low AMH at baseline suggests that at least part of the benefits of chemotherapy come from ovarian suppression, Dr. Carey said.
Current assessments of menopausal status are often crude, she noted, and AMH may be helpful when menopausal status is clinically unclear.
Dr. Carey agreed the findings were limited by the post hoc design, and longitudinal data are needed. However, the clinical implications are real if the results are validated, she said, and longitudinal data will be explored in the currently enrolling NRG BR009 OFSET trial.
Clinical Challenges of Menopausal Status
Since the original RxPONDER showed a benefit of chemotherapy for premenopausal women, but not for postmenopausal women with the same low recurrence score, the medical oncology community has worked to determine how much of the benefit seen was related to the ovarian suppression associated with chemotherapy, Megan Kruse, MD, of the Cleveland Clinic, said in an interview.
“Determining a woman’s menopausal status can be challenging in the clinic, as many women have had hysterectomy but have intact ovaries or may have significantly irregular periods, which can lead to confusion about the best endocrine therapy to recommend and how to categorize risk when it comes to Oncotype DX testing,” said Dr. Kruse. She was not involved in the RxPONDER study, but commented on the study in a podcast for ASCO Daily News in advance of the ASCO meeting.
“I was surprised that only AMH showed an association with chemotherapy benefit, as we often obtain estradiol/FSH levels in clinic to try to help with the menopausal assessment,” Dr. Kruse said in an interview. However, in clinical practice, the data may help discuss systemic therapy in patients who are near clinical menopause and trying to decide whether the potential added benefit of chemotherapy is worth the associated toxicity, she said.
“My hope is that new data allow for a more informed, individualized decision-making process,” she added.
Potential barriers to incorporate AMH into chemotherapy decisions in clinical practice include the need for insurance coverage for AMH levels, Dr. Kruse said in an interview. “The [AMH] levels also can be dynamic, so checking one point in time and making such a significant clinical decision based on one level is also a bit concerning,” she said.
Looking ahead, Dr. Kruse emphasized the need to complete the NRG BR-009 OFSET trial. That trial is designed to answer the question of whether adjuvant chemotherapy added to ovarian suppression (OS) plus ET is superior to OS plus ET for premenopausal women with early stage high-risk node negative or 1-3 lymph nodes positive breast cancer with an RS score of 25 or lower, she said.
“This extra analysis of the RxPONDER trial helps to further understand how premenopausal women may best benefit from adjuvant treatments,” Malinda T. West, MD, of the University of Wisconsin, Madison, said in an interview. The new study is important because it shows the ability of serum AMH to help predict ovarian reserve and imminent menopause, said Dr. West, who was not involved in the study.
In clinical practice, the study provides further insight into how premenopausal women may benefit from added chemotherapy and the role of ovarian suppression, Dr. West said.
The study was supported by the Breast Cancer Research Foundation, the National Institutes of Health/National Institute of General Medical Sciences/National Cancer Institute, Exact Sciences Corporation (previously Genomic Health), and the Hope Foundation for Cancer Research.
Dr. Kalinsky disclosed that immediate family members are employed by EQRx and GRAIL, with stock or other ownership interests in these companies. He disclosed consulting or advisory roles with 4D Pharma, AstraZeneca, Cullinan Oncology, Daiichi Sankyo/AstraZeneca, eFFECTOR Therapeutics, Genentech/Roche, Immunomedics, Lilly, Menarini Silicon Biosystems, Merck, Mersana, Myovant Sciences, Novartis, Oncosec, Prelude Therapeutics, Puma Biotechnology, RayzeBio, Seagen, and Takeda. Dr. Kalinsky further disclosed research funding to his institution from Ascentage Pharma, AstraZeneca, Daiichi Sankyo, Genentech/Roche, Lilly, Novartis, and Seagen, and relationships with Genentech and Immunomedics.
Dr. Carey disclosed research funding to her institution from AstraZeneca, Genentech/Roche, Gilead Sciences, Lilly, NanoString Technologies, Novartis, Seagen, and Veracyte. She disclosed an uncompensated relationship with Seagen, and uncompensated relationships between her institution and Genentech/Roche, GlaxoSmithKline, Lilly, and Novartis.
Dr. Kruse disclosed consulting or advisory roles with Novartis Oncology, Puma Biotechnology, Immunomedics, Eisai, Seattle Genetics, and Lilly.
Dr. West had no financial conflicts to disclose.
The new findings also show that women with low baseline anti-Müllerian hormone (AMH) of less than 10 pg/mL do not benefit from chemotherapy. In fact, AMH levels were a better predictor of chemotherapy benefit than self-reported premenopausal status, age, and other hormone levels.
“We may be overtreating some of our patients” with invasive breast cancer and low AMH levels, Kevin Kalinsky, MD, of the Winship Cancer Institute of Emory University, Atlanta, said in a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO).
The potential implication of the study is that clinicians may be able to stop giving chemotherapy to a subset of breast cancer patients who will not benefit from it, he said in the presentation.
New Analysis Singles Out AMH Levels
In a new analysis of data from the RxPONDER trial, Dr. Kalinsky shared data from 1,016 patients who were younger than 55 years of age and self-reported as premenopausal.
The original RxPONDER trial (also known as SWOG S1007) was a randomized, phase 3 trial designed to evaluate the benefit of endocrine therapy (ET) alone vs. ET plus chemotherapy in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) invasive breast cancer and low recurrence scores (25 or less with genomic testing by Oncotype DX), Dr. Kalinsky said in his presentation.
The researchers found no improvement in invasive disease-free survival (IDFS) with the addition of chemotherapy to ET overall, but significant IDFS improvement occurred with added chemotherapy to ET in the subgroup of self-reported premenopausal women (hazard ratio 0.60).
To better identify the impact of menopausal status on patients who would benefit or not benefit from chemotherapy in the new analysis, the researchers assessed baseline serum samples of serum estradiol, progesterone, follicular stimulating hormone(FSH), luteinizing hormone, AMH, and inhibin B.
The primary outcomes were associations of these markers (continuous and dichotomized) with IDFS and distant relapse-free survival with prognosis and prediction of chemotherapy benefit, based on Cox regression analysis.
Of the six markers analyzed, only AMH showed an association with chemotherapy benefits. “AMH is more stable and reliable during the menstrual cycle” compared to other hormones such as FSH and estradiol. Also, AMH levels ≥ 10 pg/mL are considered a standard cutoff to define normal ovarian reserve, Dr. Kalinsky said in his presentation.
A total of 209 patients (21%) had low AMH (less than 10 pg/mL) and were considered postmenopausal, and 806 (79%) were considered premenopausal, with AMH levels of 10 pg/mL or higher.
Chemotherapy plus ET was significantly more beneficial than ET alone in the premenopausal patients with AMH levels ≥ 10 pg/mL (hazard ratio 0.48), Dr. Kalinsky said. By contrast, no chemotherapy benefit was seen in the patients deemed postmenopausal, with low AMH levels (HR 1.21).
In the patients with AMH of 10 pg/mL or higher, the absolute 5-year IDFS benefit of chemotherapy was 7.8%, compared to no notable difference for those with low AMH levels.
Similarly, 5-year DRFS with chemotherapy in patients with AMH of 10 pg/mL or higher was 4.4% (HR 0.41), with no benefit for those with low AMH (HR 1.50).
The findings were limited by the post hoc design and lack of longitudinal data, Dr. Kalinsky said.
During the question-and-answer session, Dr. Kalinsky said that he hoped the data could be incorporated into a clinical model “to further refine patients who need chemotherapy or don’t.” The results suggest that the reproductive hormone AMH can be used to identify premenopausal women with HR+/HER2- invasive breast cancer and intermediate risk based on oncotype scores who would likely benefit from chemotherapy, while those with lower AMH who could forgo it, Dr. Kalinsky concluded.
AMH May Ultimately Inform Chemotherapy Choices
The findings are “thoughtful and intriguing” and may inform which patients benefit from adjuvant chemotherapy and which may not, said Lisa A. Carey, MD, of Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, who served as discussant for the abstract.
Dr. Carey noted as a caveat that AMH is not currently recommended by the American College of Obstetricians and Gynecologists for menopause prediction. However, AMH is “a very credible biomarker of ovarian reserve,” she said in her presentation.
As for clinical implications, the lack of chemotherapy benefit in patients with low AMH at baseline suggests that at least part of the benefits of chemotherapy come from ovarian suppression, Dr. Carey said.
Current assessments of menopausal status are often crude, she noted, and AMH may be helpful when menopausal status is clinically unclear.
Dr. Carey agreed the findings were limited by the post hoc design, and longitudinal data are needed. However, the clinical implications are real if the results are validated, she said, and longitudinal data will be explored in the currently enrolling NRG BR009 OFSET trial.
Clinical Challenges of Menopausal Status
Since the original RxPONDER showed a benefit of chemotherapy for premenopausal women, but not for postmenopausal women with the same low recurrence score, the medical oncology community has worked to determine how much of the benefit seen was related to the ovarian suppression associated with chemotherapy, Megan Kruse, MD, of the Cleveland Clinic, said in an interview.
“Determining a woman’s menopausal status can be challenging in the clinic, as many women have had hysterectomy but have intact ovaries or may have significantly irregular periods, which can lead to confusion about the best endocrine therapy to recommend and how to categorize risk when it comes to Oncotype DX testing,” said Dr. Kruse. She was not involved in the RxPONDER study, but commented on the study in a podcast for ASCO Daily News in advance of the ASCO meeting.
“I was surprised that only AMH showed an association with chemotherapy benefit, as we often obtain estradiol/FSH levels in clinic to try to help with the menopausal assessment,” Dr. Kruse said in an interview. However, in clinical practice, the data may help discuss systemic therapy in patients who are near clinical menopause and trying to decide whether the potential added benefit of chemotherapy is worth the associated toxicity, she said.
“My hope is that new data allow for a more informed, individualized decision-making process,” she added.
Potential barriers to incorporate AMH into chemotherapy decisions in clinical practice include the need for insurance coverage for AMH levels, Dr. Kruse said in an interview. “The [AMH] levels also can be dynamic, so checking one point in time and making such a significant clinical decision based on one level is also a bit concerning,” she said.
Looking ahead, Dr. Kruse emphasized the need to complete the NRG BR-009 OFSET trial. That trial is designed to answer the question of whether adjuvant chemotherapy added to ovarian suppression (OS) plus ET is superior to OS plus ET for premenopausal women with early stage high-risk node negative or 1-3 lymph nodes positive breast cancer with an RS score of 25 or lower, she said.
“This extra analysis of the RxPONDER trial helps to further understand how premenopausal women may best benefit from adjuvant treatments,” Malinda T. West, MD, of the University of Wisconsin, Madison, said in an interview. The new study is important because it shows the ability of serum AMH to help predict ovarian reserve and imminent menopause, said Dr. West, who was not involved in the study.
In clinical practice, the study provides further insight into how premenopausal women may benefit from added chemotherapy and the role of ovarian suppression, Dr. West said.
The study was supported by the Breast Cancer Research Foundation, the National Institutes of Health/National Institute of General Medical Sciences/National Cancer Institute, Exact Sciences Corporation (previously Genomic Health), and the Hope Foundation for Cancer Research.
Dr. Kalinsky disclosed that immediate family members are employed by EQRx and GRAIL, with stock or other ownership interests in these companies. He disclosed consulting or advisory roles with 4D Pharma, AstraZeneca, Cullinan Oncology, Daiichi Sankyo/AstraZeneca, eFFECTOR Therapeutics, Genentech/Roche, Immunomedics, Lilly, Menarini Silicon Biosystems, Merck, Mersana, Myovant Sciences, Novartis, Oncosec, Prelude Therapeutics, Puma Biotechnology, RayzeBio, Seagen, and Takeda. Dr. Kalinsky further disclosed research funding to his institution from Ascentage Pharma, AstraZeneca, Daiichi Sankyo, Genentech/Roche, Lilly, Novartis, and Seagen, and relationships with Genentech and Immunomedics.
Dr. Carey disclosed research funding to her institution from AstraZeneca, Genentech/Roche, Gilead Sciences, Lilly, NanoString Technologies, Novartis, Seagen, and Veracyte. She disclosed an uncompensated relationship with Seagen, and uncompensated relationships between her institution and Genentech/Roche, GlaxoSmithKline, Lilly, and Novartis.
Dr. Kruse disclosed consulting or advisory roles with Novartis Oncology, Puma Biotechnology, Immunomedics, Eisai, Seattle Genetics, and Lilly.
Dr. West had no financial conflicts to disclose.
The new findings also show that women with low baseline anti-Müllerian hormone (AMH) of less than 10 pg/mL do not benefit from chemotherapy. In fact, AMH levels were a better predictor of chemotherapy benefit than self-reported premenopausal status, age, and other hormone levels.
“We may be overtreating some of our patients” with invasive breast cancer and low AMH levels, Kevin Kalinsky, MD, of the Winship Cancer Institute of Emory University, Atlanta, said in a presentation at the annual meeting of the American Society of Clinical Oncology (ASCO).
The potential implication of the study is that clinicians may be able to stop giving chemotherapy to a subset of breast cancer patients who will not benefit from it, he said in the presentation.
New Analysis Singles Out AMH Levels
In a new analysis of data from the RxPONDER trial, Dr. Kalinsky shared data from 1,016 patients who were younger than 55 years of age and self-reported as premenopausal.
The original RxPONDER trial (also known as SWOG S1007) was a randomized, phase 3 trial designed to evaluate the benefit of endocrine therapy (ET) alone vs. ET plus chemotherapy in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) invasive breast cancer and low recurrence scores (25 or less with genomic testing by Oncotype DX), Dr. Kalinsky said in his presentation.
The researchers found no improvement in invasive disease-free survival (IDFS) with the addition of chemotherapy to ET overall, but significant IDFS improvement occurred with added chemotherapy to ET in the subgroup of self-reported premenopausal women (hazard ratio 0.60).
To better identify the impact of menopausal status on patients who would benefit or not benefit from chemotherapy in the new analysis, the researchers assessed baseline serum samples of serum estradiol, progesterone, follicular stimulating hormone(FSH), luteinizing hormone, AMH, and inhibin B.
The primary outcomes were associations of these markers (continuous and dichotomized) with IDFS and distant relapse-free survival with prognosis and prediction of chemotherapy benefit, based on Cox regression analysis.
Of the six markers analyzed, only AMH showed an association with chemotherapy benefits. “AMH is more stable and reliable during the menstrual cycle” compared to other hormones such as FSH and estradiol. Also, AMH levels ≥ 10 pg/mL are considered a standard cutoff to define normal ovarian reserve, Dr. Kalinsky said in his presentation.
A total of 209 patients (21%) had low AMH (less than 10 pg/mL) and were considered postmenopausal, and 806 (79%) were considered premenopausal, with AMH levels of 10 pg/mL or higher.
Chemotherapy plus ET was significantly more beneficial than ET alone in the premenopausal patients with AMH levels ≥ 10 pg/mL (hazard ratio 0.48), Dr. Kalinsky said. By contrast, no chemotherapy benefit was seen in the patients deemed postmenopausal, with low AMH levels (HR 1.21).
In the patients with AMH of 10 pg/mL or higher, the absolute 5-year IDFS benefit of chemotherapy was 7.8%, compared to no notable difference for those with low AMH levels.
Similarly, 5-year DRFS with chemotherapy in patients with AMH of 10 pg/mL or higher was 4.4% (HR 0.41), with no benefit for those with low AMH (HR 1.50).
The findings were limited by the post hoc design and lack of longitudinal data, Dr. Kalinsky said.
During the question-and-answer session, Dr. Kalinsky said that he hoped the data could be incorporated into a clinical model “to further refine patients who need chemotherapy or don’t.” The results suggest that the reproductive hormone AMH can be used to identify premenopausal women with HR+/HER2- invasive breast cancer and intermediate risk based on oncotype scores who would likely benefit from chemotherapy, while those with lower AMH who could forgo it, Dr. Kalinsky concluded.
AMH May Ultimately Inform Chemotherapy Choices
The findings are “thoughtful and intriguing” and may inform which patients benefit from adjuvant chemotherapy and which may not, said Lisa A. Carey, MD, of Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, who served as discussant for the abstract.
Dr. Carey noted as a caveat that AMH is not currently recommended by the American College of Obstetricians and Gynecologists for menopause prediction. However, AMH is “a very credible biomarker of ovarian reserve,” she said in her presentation.
As for clinical implications, the lack of chemotherapy benefit in patients with low AMH at baseline suggests that at least part of the benefits of chemotherapy come from ovarian suppression, Dr. Carey said.
Current assessments of menopausal status are often crude, she noted, and AMH may be helpful when menopausal status is clinically unclear.
Dr. Carey agreed the findings were limited by the post hoc design, and longitudinal data are needed. However, the clinical implications are real if the results are validated, she said, and longitudinal data will be explored in the currently enrolling NRG BR009 OFSET trial.
Clinical Challenges of Menopausal Status
Since the original RxPONDER showed a benefit of chemotherapy for premenopausal women, but not for postmenopausal women with the same low recurrence score, the medical oncology community has worked to determine how much of the benefit seen was related to the ovarian suppression associated with chemotherapy, Megan Kruse, MD, of the Cleveland Clinic, said in an interview.
“Determining a woman’s menopausal status can be challenging in the clinic, as many women have had hysterectomy but have intact ovaries or may have significantly irregular periods, which can lead to confusion about the best endocrine therapy to recommend and how to categorize risk when it comes to Oncotype DX testing,” said Dr. Kruse. She was not involved in the RxPONDER study, but commented on the study in a podcast for ASCO Daily News in advance of the ASCO meeting.
“I was surprised that only AMH showed an association with chemotherapy benefit, as we often obtain estradiol/FSH levels in clinic to try to help with the menopausal assessment,” Dr. Kruse said in an interview. However, in clinical practice, the data may help discuss systemic therapy in patients who are near clinical menopause and trying to decide whether the potential added benefit of chemotherapy is worth the associated toxicity, she said.
“My hope is that new data allow for a more informed, individualized decision-making process,” she added.
Potential barriers to incorporate AMH into chemotherapy decisions in clinical practice include the need for insurance coverage for AMH levels, Dr. Kruse said in an interview. “The [AMH] levels also can be dynamic, so checking one point in time and making such a significant clinical decision based on one level is also a bit concerning,” she said.
Looking ahead, Dr. Kruse emphasized the need to complete the NRG BR-009 OFSET trial. That trial is designed to answer the question of whether adjuvant chemotherapy added to ovarian suppression (OS) plus ET is superior to OS plus ET for premenopausal women with early stage high-risk node negative or 1-3 lymph nodes positive breast cancer with an RS score of 25 or lower, she said.
“This extra analysis of the RxPONDER trial helps to further understand how premenopausal women may best benefit from adjuvant treatments,” Malinda T. West, MD, of the University of Wisconsin, Madison, said in an interview. The new study is important because it shows the ability of serum AMH to help predict ovarian reserve and imminent menopause, said Dr. West, who was not involved in the study.
In clinical practice, the study provides further insight into how premenopausal women may benefit from added chemotherapy and the role of ovarian suppression, Dr. West said.
The study was supported by the Breast Cancer Research Foundation, the National Institutes of Health/National Institute of General Medical Sciences/National Cancer Institute, Exact Sciences Corporation (previously Genomic Health), and the Hope Foundation for Cancer Research.
Dr. Kalinsky disclosed that immediate family members are employed by EQRx and GRAIL, with stock or other ownership interests in these companies. He disclosed consulting or advisory roles with 4D Pharma, AstraZeneca, Cullinan Oncology, Daiichi Sankyo/AstraZeneca, eFFECTOR Therapeutics, Genentech/Roche, Immunomedics, Lilly, Menarini Silicon Biosystems, Merck, Mersana, Myovant Sciences, Novartis, Oncosec, Prelude Therapeutics, Puma Biotechnology, RayzeBio, Seagen, and Takeda. Dr. Kalinsky further disclosed research funding to his institution from Ascentage Pharma, AstraZeneca, Daiichi Sankyo, Genentech/Roche, Lilly, Novartis, and Seagen, and relationships with Genentech and Immunomedics.
Dr. Carey disclosed research funding to her institution from AstraZeneca, Genentech/Roche, Gilead Sciences, Lilly, NanoString Technologies, Novartis, Seagen, and Veracyte. She disclosed an uncompensated relationship with Seagen, and uncompensated relationships between her institution and Genentech/Roche, GlaxoSmithKline, Lilly, and Novartis.
Dr. Kruse disclosed consulting or advisory roles with Novartis Oncology, Puma Biotechnology, Immunomedics, Eisai, Seattle Genetics, and Lilly.
Dr. West had no financial conflicts to disclose.
FROM ASCO 2024
Internists Feel Underpaid, But Job Satisfaction Persists
A majority of internal medicine physicians report feeling underpaid, but approximately half say that potential pay was not a factor in their decision to choose the specialty, based on data from Medscape’s annual Internist Compensation Report.
Data from the Mercer consulting firm cited in the Medscape report showed an increase of 3% in 2023 over 2022 earnings for physicians in the United States overall. However, on a list of 29 specialties included in the report, internal medicine ranked near the bottom for annual compensation.
The report, based on data from 7000 physicians across the United States, showed that 58% of internal medicine physicians think physicians in general are underpaid, while 33% said that “most physicians are paid about right,” and 8% said that physicians are overpaid. Similarly, when asked about their personal compensation, 55% said that internists are not fairly paid, given their work demands.
Despite concerns about pay, 65% of the internists surveyed said that they were not taking on extra work to boost their incomes. Although less than half (45%) reported being happy with their current pay, 49% said that pay was not a factor in their choice of internal medicine.
Among internists, 60% reported opportunities for bonuses, but the average primary care provider bonus in 2023 was $27,000, compared with an average of $51,000 for bonus pay among specialists.
Money was relatively low on the list as being the most rewarding part of the job for an internist, according to the report. While 34% of respondents cited being good at their jobs and finding answers and diagnoses as the most rewarding part of their jobs, only 9% said “making good money at a job I like” was the most rewarding. The most commonly cited most challenging part of the job was “having so many rules and regulations (22%).”
In addition, approximately two thirds of respondents said other medical businesses (such as telemedicine, retailer clinics, and nonphysician healthcare providers) had no impact on their income, nor did competing physician practices.
More than half (58%) of the respondents were women and the most common age group (based on 5-year increments) was 50-54 years (15%).
Regular Pay Assessment Increases Awareness
Assessing physician compensation annually or at regular intervals allows organizations and physicians to know their financial situation and compensation/benefits compared with other professionals, said Noel Deep, MD, an internal medicine physician in group practice in Antigo, Wisconsin, in an interview. “During the COVID-19 pandemic, many individual practices and employed physicians saw a decline in their revenue due to decrease in routine patient visits to the clinician offices, and decrease in routine and preventative procedures,” he noted.
“The findings from the current report were not unexpected, as certain specialties are more lucrative than primary care,” Dr. Deep said. “Specialties such as orthopedics, plastic surgery, and cardiology have the potential not only to generate more income for those specialist physicians, but also for the healthcare organizations that employ them,” he said.
Job Satisfaction Remains Important
As a practicing internist, Dr. Deep agreed that many internal medicine physicians would state that the satisfaction that their job and caring for patients brings to them is more important than the financial aspect of their practice.
“I am asked on occasion if I had an opportunity to go back to medical school and make a choice, whether I would have picked a different specialty. My answer is no,” Dr. Deep said.
“I would have picked internal medicine because of the satisfaction that it brings me,” he said.
Dr. Deep shared some potential strategies for employers to recruit and retain internal medicine physicians. If employers could incentivize internal medicine and other primary care specialties with higher signing bonuses and try to make their annual bonuses comparable to surgical specialties, that would help ensure that internal medicine specialists feel they are being paid fairly for their work, he said. “Decreasing the bureaucratic burden and involving physicians in decision-making and determination of compensation would also help,” he said.
Dr. Deep had no financial conflicts to disclose, and serves on the Editorial Advisory Board of Internal Medicine News.
A majority of internal medicine physicians report feeling underpaid, but approximately half say that potential pay was not a factor in their decision to choose the specialty, based on data from Medscape’s annual Internist Compensation Report.
Data from the Mercer consulting firm cited in the Medscape report showed an increase of 3% in 2023 over 2022 earnings for physicians in the United States overall. However, on a list of 29 specialties included in the report, internal medicine ranked near the bottom for annual compensation.
The report, based on data from 7000 physicians across the United States, showed that 58% of internal medicine physicians think physicians in general are underpaid, while 33% said that “most physicians are paid about right,” and 8% said that physicians are overpaid. Similarly, when asked about their personal compensation, 55% said that internists are not fairly paid, given their work demands.
Despite concerns about pay, 65% of the internists surveyed said that they were not taking on extra work to boost their incomes. Although less than half (45%) reported being happy with their current pay, 49% said that pay was not a factor in their choice of internal medicine.
Among internists, 60% reported opportunities for bonuses, but the average primary care provider bonus in 2023 was $27,000, compared with an average of $51,000 for bonus pay among specialists.
Money was relatively low on the list as being the most rewarding part of the job for an internist, according to the report. While 34% of respondents cited being good at their jobs and finding answers and diagnoses as the most rewarding part of their jobs, only 9% said “making good money at a job I like” was the most rewarding. The most commonly cited most challenging part of the job was “having so many rules and regulations (22%).”
In addition, approximately two thirds of respondents said other medical businesses (such as telemedicine, retailer clinics, and nonphysician healthcare providers) had no impact on their income, nor did competing physician practices.
More than half (58%) of the respondents were women and the most common age group (based on 5-year increments) was 50-54 years (15%).
Regular Pay Assessment Increases Awareness
Assessing physician compensation annually or at regular intervals allows organizations and physicians to know their financial situation and compensation/benefits compared with other professionals, said Noel Deep, MD, an internal medicine physician in group practice in Antigo, Wisconsin, in an interview. “During the COVID-19 pandemic, many individual practices and employed physicians saw a decline in their revenue due to decrease in routine patient visits to the clinician offices, and decrease in routine and preventative procedures,” he noted.
“The findings from the current report were not unexpected, as certain specialties are more lucrative than primary care,” Dr. Deep said. “Specialties such as orthopedics, plastic surgery, and cardiology have the potential not only to generate more income for those specialist physicians, but also for the healthcare organizations that employ them,” he said.
Job Satisfaction Remains Important
As a practicing internist, Dr. Deep agreed that many internal medicine physicians would state that the satisfaction that their job and caring for patients brings to them is more important than the financial aspect of their practice.
“I am asked on occasion if I had an opportunity to go back to medical school and make a choice, whether I would have picked a different specialty. My answer is no,” Dr. Deep said.
“I would have picked internal medicine because of the satisfaction that it brings me,” he said.
Dr. Deep shared some potential strategies for employers to recruit and retain internal medicine physicians. If employers could incentivize internal medicine and other primary care specialties with higher signing bonuses and try to make their annual bonuses comparable to surgical specialties, that would help ensure that internal medicine specialists feel they are being paid fairly for their work, he said. “Decreasing the bureaucratic burden and involving physicians in decision-making and determination of compensation would also help,” he said.
Dr. Deep had no financial conflicts to disclose, and serves on the Editorial Advisory Board of Internal Medicine News.
A majority of internal medicine physicians report feeling underpaid, but approximately half say that potential pay was not a factor in their decision to choose the specialty, based on data from Medscape’s annual Internist Compensation Report.
Data from the Mercer consulting firm cited in the Medscape report showed an increase of 3% in 2023 over 2022 earnings for physicians in the United States overall. However, on a list of 29 specialties included in the report, internal medicine ranked near the bottom for annual compensation.
The report, based on data from 7000 physicians across the United States, showed that 58% of internal medicine physicians think physicians in general are underpaid, while 33% said that “most physicians are paid about right,” and 8% said that physicians are overpaid. Similarly, when asked about their personal compensation, 55% said that internists are not fairly paid, given their work demands.
Despite concerns about pay, 65% of the internists surveyed said that they were not taking on extra work to boost their incomes. Although less than half (45%) reported being happy with their current pay, 49% said that pay was not a factor in their choice of internal medicine.
Among internists, 60% reported opportunities for bonuses, but the average primary care provider bonus in 2023 was $27,000, compared with an average of $51,000 for bonus pay among specialists.
Money was relatively low on the list as being the most rewarding part of the job for an internist, according to the report. While 34% of respondents cited being good at their jobs and finding answers and diagnoses as the most rewarding part of their jobs, only 9% said “making good money at a job I like” was the most rewarding. The most commonly cited most challenging part of the job was “having so many rules and regulations (22%).”
In addition, approximately two thirds of respondents said other medical businesses (such as telemedicine, retailer clinics, and nonphysician healthcare providers) had no impact on their income, nor did competing physician practices.
More than half (58%) of the respondents were women and the most common age group (based on 5-year increments) was 50-54 years (15%).
Regular Pay Assessment Increases Awareness
Assessing physician compensation annually or at regular intervals allows organizations and physicians to know their financial situation and compensation/benefits compared with other professionals, said Noel Deep, MD, an internal medicine physician in group practice in Antigo, Wisconsin, in an interview. “During the COVID-19 pandemic, many individual practices and employed physicians saw a decline in their revenue due to decrease in routine patient visits to the clinician offices, and decrease in routine and preventative procedures,” he noted.
“The findings from the current report were not unexpected, as certain specialties are more lucrative than primary care,” Dr. Deep said. “Specialties such as orthopedics, plastic surgery, and cardiology have the potential not only to generate more income for those specialist physicians, but also for the healthcare organizations that employ them,” he said.
Job Satisfaction Remains Important
As a practicing internist, Dr. Deep agreed that many internal medicine physicians would state that the satisfaction that their job and caring for patients brings to them is more important than the financial aspect of their practice.
“I am asked on occasion if I had an opportunity to go back to medical school and make a choice, whether I would have picked a different specialty. My answer is no,” Dr. Deep said.
“I would have picked internal medicine because of the satisfaction that it brings me,” he said.
Dr. Deep shared some potential strategies for employers to recruit and retain internal medicine physicians. If employers could incentivize internal medicine and other primary care specialties with higher signing bonuses and try to make their annual bonuses comparable to surgical specialties, that would help ensure that internal medicine specialists feel they are being paid fairly for their work, he said. “Decreasing the bureaucratic burden and involving physicians in decision-making and determination of compensation would also help,” he said.
Dr. Deep had no financial conflicts to disclose, and serves on the Editorial Advisory Board of Internal Medicine News.
Vaginal Ring Use Raises Risk for Certain STIs
Use of combined contraceptive vaginal rings was associated with an increased risk for several types of sexually transmitted infections (STIs), based on data from a pair of studies presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).
Previous research has shown that the use of a combined contraceptive vaginal ring (CCVR) may promote changes in immunity in the female genital tract by upregulating immune-related genes in the endocervix and immune mediators within the cervicovaginal fluid, wrote Amy Arceneaux, BS, a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, and colleagues.
The infection rates in the female genital tract can vary according to hormones in the local environment and continued safety analysis is needed as the use of CCVR continues to rise, the researchers noted.
In a retrospective chart review, the researchers assessed de-identified data from TriNetX, a patient database, including 30,796 women who received etonogestrel and ethinyl estradiol CCVRs without segesterone and an equal number who were using oral contraceptive pills (OCP) without vaginal hormones. Patients were matched for age, race, and ethnicity.
Overall use of CCVRs was significantly associated with an increased risk for Herpes simplex virus 2 (HSV-2; relative risk [RR], 1.790), acute vaginitis (RR, 1.722), subacute/chronic vaginitis (RR, 1.904), subacute/chronic vulvitis (RR, 1.969), acute vulvitis (RR, 1.894), candidiasis (RR, 1.464), trichomoniasis (RR, 2.162), and pelvic inflammatory disease (RR, 2.984; P < .0005 for all).
By contrast, use of CCVRs was significantly associated with a decreased risk for chlamydia (RR, 0.760; P = .047). No differences in risk appeared for gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP groups.
Another study presented at the meeting, led by Kathleen Karam, BS, also a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, focused on outcomes on vaginal health and infection risk in women who used CCVRs compared with women who did not use hormones.
The study by Ms. Karam and colleagues included de-identified TriNetX data for two cohorts of 274,743 women.
Overall, the researchers found a significantly increased risk for gonorrhea, HSV-2, vaginitis, vulvitis, pelvic inflammatory disease, anogenital warts, and candidiasis in women using CCVR compared with those using no hormonal contraception, while the risk for chlamydia, syphilis, and HIV was decreased in women using CCVR compared with those using no hormonal contraception.
“I was pleasantly surprised by the finding that the group of women using the hormonal contraception vaginal ring had decreased risk for HIV and syphilis infections,” said Kathleen L. Vincent, MD, of the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, and senior author on both studies, in an interview. She hypothesized that the estrogen released from the ring might have contributed to the decreased risk for those infections.
The findings of both studies were limited primarily by the retrospective design, but the results suggest a need for further study of the effect of local hormone delivery on the vaginal mucosa, the researchers wrote.
Although the study population was large, the lack of randomization can allow for differences in the behaviors or risk-taking of the groups, Dr. Vincent said in an interview.
“The fact that there were STIs that were increased and some that were decreased with use of the vaginal ring tells us that there were women with similar behaviors in both groups, or we might have seen STIs only in one group,” she said. “Additional research could be done to look at varying time courses of outcomes after initiation of the vaginal ring or to go more in-depth with matching the groups at baseline based on a history of risky behaviors,” she noted.
Data Inform Multipurpose Prevention Technology
Dr. Vincent and her colleague, Richard Pyles, PhD, have a 15-year history of studying vaginal drug and hormone effects on the vaginal mucosa in women and preclinical and cell models. “Based on that work, it was plausible for estrogen to be protective for several types of infections,” she said. The availability of TriNetX allowed the researchers to explore these relationships in a large database of women in the studies presented at the meeting. “We began with a basic science observation in an animal model and grew it into this clinical study because of the available TriNetX system that supported extensive medical record review,” Dr. Pyles noted.
The take-home messages from the current research remain that vaginal rings delivering hormones are indicated only for contraception or birth control, not for protection against STIs or HIV, and women at an increased risk for these infections should protect themselves by using condoms, Dr. Vincent said.
However, “the real clinical implication is for the future for the drugs that we call MPTs or multi-purpose prevention technologies,” Dr. Vincent said.
“This could be a vaginal ring that releases medications for birth control and prevention of HIV or an STI,” she explained.
The findings from the studies presented at the meeting have great potential for an MPT on which Dr. Vincent and Dr. Pyles are working that would provide protection against both HIV and pregnancy. “For HIV prevention, the hormonal vaginal ring components have potential to work synergistically with the HIV prevention drug rather than working against each other, and this could be realized as a need for less HIV prevention drug, and subsequently fewer potential side effects from that drug,” said Dr. Vincent.
The studies received no outside funding. The researchers had no financial conflicts to disclose.
Use of combined contraceptive vaginal rings was associated with an increased risk for several types of sexually transmitted infections (STIs), based on data from a pair of studies presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).
Previous research has shown that the use of a combined contraceptive vaginal ring (CCVR) may promote changes in immunity in the female genital tract by upregulating immune-related genes in the endocervix and immune mediators within the cervicovaginal fluid, wrote Amy Arceneaux, BS, a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, and colleagues.
The infection rates in the female genital tract can vary according to hormones in the local environment and continued safety analysis is needed as the use of CCVR continues to rise, the researchers noted.
In a retrospective chart review, the researchers assessed de-identified data from TriNetX, a patient database, including 30,796 women who received etonogestrel and ethinyl estradiol CCVRs without segesterone and an equal number who were using oral contraceptive pills (OCP) without vaginal hormones. Patients were matched for age, race, and ethnicity.
Overall use of CCVRs was significantly associated with an increased risk for Herpes simplex virus 2 (HSV-2; relative risk [RR], 1.790), acute vaginitis (RR, 1.722), subacute/chronic vaginitis (RR, 1.904), subacute/chronic vulvitis (RR, 1.969), acute vulvitis (RR, 1.894), candidiasis (RR, 1.464), trichomoniasis (RR, 2.162), and pelvic inflammatory disease (RR, 2.984; P < .0005 for all).
By contrast, use of CCVRs was significantly associated with a decreased risk for chlamydia (RR, 0.760; P = .047). No differences in risk appeared for gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP groups.
Another study presented at the meeting, led by Kathleen Karam, BS, also a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, focused on outcomes on vaginal health and infection risk in women who used CCVRs compared with women who did not use hormones.
The study by Ms. Karam and colleagues included de-identified TriNetX data for two cohorts of 274,743 women.
Overall, the researchers found a significantly increased risk for gonorrhea, HSV-2, vaginitis, vulvitis, pelvic inflammatory disease, anogenital warts, and candidiasis in women using CCVR compared with those using no hormonal contraception, while the risk for chlamydia, syphilis, and HIV was decreased in women using CCVR compared with those using no hormonal contraception.
“I was pleasantly surprised by the finding that the group of women using the hormonal contraception vaginal ring had decreased risk for HIV and syphilis infections,” said Kathleen L. Vincent, MD, of the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, and senior author on both studies, in an interview. She hypothesized that the estrogen released from the ring might have contributed to the decreased risk for those infections.
The findings of both studies were limited primarily by the retrospective design, but the results suggest a need for further study of the effect of local hormone delivery on the vaginal mucosa, the researchers wrote.
Although the study population was large, the lack of randomization can allow for differences in the behaviors or risk-taking of the groups, Dr. Vincent said in an interview.
“The fact that there were STIs that were increased and some that were decreased with use of the vaginal ring tells us that there were women with similar behaviors in both groups, or we might have seen STIs only in one group,” she said. “Additional research could be done to look at varying time courses of outcomes after initiation of the vaginal ring or to go more in-depth with matching the groups at baseline based on a history of risky behaviors,” she noted.
Data Inform Multipurpose Prevention Technology
Dr. Vincent and her colleague, Richard Pyles, PhD, have a 15-year history of studying vaginal drug and hormone effects on the vaginal mucosa in women and preclinical and cell models. “Based on that work, it was plausible for estrogen to be protective for several types of infections,” she said. The availability of TriNetX allowed the researchers to explore these relationships in a large database of women in the studies presented at the meeting. “We began with a basic science observation in an animal model and grew it into this clinical study because of the available TriNetX system that supported extensive medical record review,” Dr. Pyles noted.
The take-home messages from the current research remain that vaginal rings delivering hormones are indicated only for contraception or birth control, not for protection against STIs or HIV, and women at an increased risk for these infections should protect themselves by using condoms, Dr. Vincent said.
However, “the real clinical implication is for the future for the drugs that we call MPTs or multi-purpose prevention technologies,” Dr. Vincent said.
“This could be a vaginal ring that releases medications for birth control and prevention of HIV or an STI,” she explained.
The findings from the studies presented at the meeting have great potential for an MPT on which Dr. Vincent and Dr. Pyles are working that would provide protection against both HIV and pregnancy. “For HIV prevention, the hormonal vaginal ring components have potential to work synergistically with the HIV prevention drug rather than working against each other, and this could be realized as a need for less HIV prevention drug, and subsequently fewer potential side effects from that drug,” said Dr. Vincent.
The studies received no outside funding. The researchers had no financial conflicts to disclose.
Use of combined contraceptive vaginal rings was associated with an increased risk for several types of sexually transmitted infections (STIs), based on data from a pair of studies presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG).
Previous research has shown that the use of a combined contraceptive vaginal ring (CCVR) may promote changes in immunity in the female genital tract by upregulating immune-related genes in the endocervix and immune mediators within the cervicovaginal fluid, wrote Amy Arceneaux, BS, a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, and colleagues.
The infection rates in the female genital tract can vary according to hormones in the local environment and continued safety analysis is needed as the use of CCVR continues to rise, the researchers noted.
In a retrospective chart review, the researchers assessed de-identified data from TriNetX, a patient database, including 30,796 women who received etonogestrel and ethinyl estradiol CCVRs without segesterone and an equal number who were using oral contraceptive pills (OCP) without vaginal hormones. Patients were matched for age, race, and ethnicity.
Overall use of CCVRs was significantly associated with an increased risk for Herpes simplex virus 2 (HSV-2; relative risk [RR], 1.790), acute vaginitis (RR, 1.722), subacute/chronic vaginitis (RR, 1.904), subacute/chronic vulvitis (RR, 1.969), acute vulvitis (RR, 1.894), candidiasis (RR, 1.464), trichomoniasis (RR, 2.162), and pelvic inflammatory disease (RR, 2.984; P < .0005 for all).
By contrast, use of CCVRs was significantly associated with a decreased risk for chlamydia (RR, 0.760; P = .047). No differences in risk appeared for gonorrhea, syphilis, HIV, or anogenital warts between the CCVR and OCP groups.
Another study presented at the meeting, led by Kathleen Karam, BS, also a medical student at the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, focused on outcomes on vaginal health and infection risk in women who used CCVRs compared with women who did not use hormones.
The study by Ms. Karam and colleagues included de-identified TriNetX data for two cohorts of 274,743 women.
Overall, the researchers found a significantly increased risk for gonorrhea, HSV-2, vaginitis, vulvitis, pelvic inflammatory disease, anogenital warts, and candidiasis in women using CCVR compared with those using no hormonal contraception, while the risk for chlamydia, syphilis, and HIV was decreased in women using CCVR compared with those using no hormonal contraception.
“I was pleasantly surprised by the finding that the group of women using the hormonal contraception vaginal ring had decreased risk for HIV and syphilis infections,” said Kathleen L. Vincent, MD, of the University of Texas Medical Branch John Sealy School of Medicine, Galveston, Texas, and senior author on both studies, in an interview. She hypothesized that the estrogen released from the ring might have contributed to the decreased risk for those infections.
The findings of both studies were limited primarily by the retrospective design, but the results suggest a need for further study of the effect of local hormone delivery on the vaginal mucosa, the researchers wrote.
Although the study population was large, the lack of randomization can allow for differences in the behaviors or risk-taking of the groups, Dr. Vincent said in an interview.
“The fact that there were STIs that were increased and some that were decreased with use of the vaginal ring tells us that there were women with similar behaviors in both groups, or we might have seen STIs only in one group,” she said. “Additional research could be done to look at varying time courses of outcomes after initiation of the vaginal ring or to go more in-depth with matching the groups at baseline based on a history of risky behaviors,” she noted.
Data Inform Multipurpose Prevention Technology
Dr. Vincent and her colleague, Richard Pyles, PhD, have a 15-year history of studying vaginal drug and hormone effects on the vaginal mucosa in women and preclinical and cell models. “Based on that work, it was plausible for estrogen to be protective for several types of infections,” she said. The availability of TriNetX allowed the researchers to explore these relationships in a large database of women in the studies presented at the meeting. “We began with a basic science observation in an animal model and grew it into this clinical study because of the available TriNetX system that supported extensive medical record review,” Dr. Pyles noted.
The take-home messages from the current research remain that vaginal rings delivering hormones are indicated only for contraception or birth control, not for protection against STIs or HIV, and women at an increased risk for these infections should protect themselves by using condoms, Dr. Vincent said.
However, “the real clinical implication is for the future for the drugs that we call MPTs or multi-purpose prevention technologies,” Dr. Vincent said.
“This could be a vaginal ring that releases medications for birth control and prevention of HIV or an STI,” she explained.
The findings from the studies presented at the meeting have great potential for an MPT on which Dr. Vincent and Dr. Pyles are working that would provide protection against both HIV and pregnancy. “For HIV prevention, the hormonal vaginal ring components have potential to work synergistically with the HIV prevention drug rather than working against each other, and this could be realized as a need for less HIV prevention drug, and subsequently fewer potential side effects from that drug,” said Dr. Vincent.
The studies received no outside funding. The researchers had no financial conflicts to disclose.
FROM ACOG 2024