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Increasing primary care doctors’ knowledge of IPF could speed up diagnoses, suggests white paper
The nonspecific nature of the symptoms of idiopathic pulmonary fibrosis (IPF) especially in early stages, and the relative rarity of IPF compared with other conditions that have similar symptoms, may contribute to a delay in diagnosis in the primary care setting, wrote Daniel F. Dilling, MD, of Loyola University Chicago, Maywood, Ill., and colleagues in Chest: Clinical Perspectives (Dilling et al. State of Practice: Factors Driving Diagnostic Delays in Idiopathic Pulmonary Fibrosis. Chest. 2022).
“We have learned over and over again through research, and also through talking with our own patients with IPF, that there is often a long lag between the first signs of the disease and a diagnosis of IPF,” corresponding author Dr. Dilling said in an interview.
“Even some pulmonary specialists can be uncertain about how to approach the diagnosis when a CT scan or other test first suggests the possibility; this can cost a patient precious time, as being on drug therapy earlier can result in preservation of lung function,” he said. “By sounding the alarm bell with this paper, we hope to promote awareness and education/training within the primary care community as well as the pulmonary community, and also to make all of them aware of the possibility of referral to specialty ILD [interstitial lung disease] centers when desired and possible,” he added.
The researchers conducted a pair of online surveys to inform the development of improving education on IPF among primary care providers.
In the white paper, which can be accessed online, the authors reported results of the surveys. One included 100 general pulmonologists and the other included 306 primary care physicians (156 practiced family physicians and 150 practiced general internal medicine). The data were collected between April 11, 2022, and May 16, 2022. Participants were asked to respond to a patient case scenario of a 55-year-old woman with nonspecific symptoms such as shortness of breath on moderate exertion, cough, exhaustion, and trouble sleeping.
The PCPs were most likely to evaluate the patient for a cardiac condition (46%), 25% would evaluate for chronic obstructive pulmonary disease (COPD), and 23% for asthma. More than half (58%) ranked progressive fibrosing ILD as one of their bottom two diagnoses.
A total of 87% of PCPs said they would begin a diagnostic workup to evaluate symptoms if the patient had no preexisting respiratory disease, compared with 61% for patients with a respiratory diagnosis.
Although 93% of PCPs cited a chest x-ray as part of the initial patient workup, fewer than half said they would order an echocardiogram, spirometry, or pulmonary function test (PFT), and 11% said they would include diffusion capacity testing in the initial workup.
In addition, PCPs were less likely to ask patients about issues that might prompt an IPF diagnosis, such as exposures to agents through work, hobbies, the environment, or comorbidities.
In the pulmonology survey, more than 75% of respondents cited patient history, high-resolution tomography scan, serologic testing, and review for autoimmune disease symptoms as first steps in a diagnostic response to patients with suspected IPF.
Differences between PCPs’ and pulmonolgists’ responses
Both PCPs and pulmonologists responded to several questions to assess knowledge and opinion gaps related to IPF. Overall, pulmonologists were more likely than PCPs to cite both imaging and testing issues and waiting 6-8 weeks after symptom onset before imaging as contributing factors to diagnostic delays.
PCPs more often expressed beliefs that delayed diagnosis had little impact on a patient with IPF, and that the treatments may be worse than the disease.
Dr. Dilling said he was not surprised by the survey findings, as similar clues about the underdiagnosis of IPF have surfaced in prior studies.
“We need to get the word out to primary care physicians, to pulmonary physicians, and even to the public, that idiopathic pulmonary fibrosis and other forms of interstitial lung disease are out there and prevalent, and that making the right diagnosis in a timely way can lead to better outcomes for patients,” he said.
The take-home message for primary care is to think outside the COPD box, said Dr. Dilling. “Just because someone has shortness of breath or cough and used to smoke does not automatically mean that they have COPD,” he emphasized. “Listen carefully for crackles (rales) on exam. Get spirometry or PFTs before you secure the diagnosis of COPD, or else you will be missing all of your cases of pulmonary fibrosis; think of pulmonary fibrosis and use imaging to help guide your diagnosis,” he said.
The authors suggested several education goals for PCPs, including establishing the importance of early evaluation, outlining the correct approach to a patient workup, encouraging prompt referral, and empowering PCPs as part of the team approach to IPF patients’ care. For pulmonologists, only 11% of those surveyed said they were aware of the latest developments in antifibrotic research, and education efforts might include information about drug pipelines and clinical trials, as well as technology.
Looking ahead, “We need to better understand how to find the pulmonary fibrosis in the community,” Dr. Dilling said. This understanding may come in part from greater education and awareness, he noted. However, eventually there may be ways to enhance the reading of PFTs and of CT scans through artificial intelligence technologies that would not only prompt clinicians to recognize what they are seeing, but would prompt them to refer and send the patient on the correct diagnostic path as soon as possible, he added.
Key message: Include ILD in differential diagnosis of patients with shortness of breath and/or cough
Advances in diagnostics and therapies for interstitial lung disease can take time to be absorbed and adopted, and patients with ILD and pulmonologists caring for ILD, specifically IPF, continue to report delays in diagnosis and therapy, said Krishna Thavarajah, MD, a pulmonologist at Henry Ford Hospital, Detroit, Mich., in an interview.
The current study findings of the time to diagnosis and the approach to patient workups echo her own clinical experience, Dr. Thavarajah said. “There is a delay in IPF diagnosis as physicians look to more common diagnoses, such as cardiac disease or chronic obstructive pulmonary disease, prior to pursuit of additional workup, and the attitude toward treatment has, in some ways, lagged behind advances in therapy, including timing and feasibility of therapy for IPF,” she said.
The key message for primary care physicians is to include ILD in the differential diagnosis of patients with shortness of breath and/or cough, especially if the initial cardiac and pulmonary test (meaning at least a chest x-ray and pulmonary function tests, including a diffusion capacity) are not pointing to an alternative cause within 3 months of presentation, Dr. Thavarajah said.
Once IPF is diagnosed, primary care clinicians should know that there are FDA-approved therapies that improve survival, said Dr. Thavarajah. “There are identifiable and treatable comorbid conditions,” she added. “The statement of ‘time lost is lung lost’ sums up the care of an IPF patient; partnerships between primary care clinicians, pulmonologists, and referral centers can provide the patient multiple levels of support with quality-of-life interventions, treatments, and also clinical trials, delivered by a team of providers,” she said.
In the wake of the current study, more research is needed with outcome studies regarding educational interventions targeting primary care and pulmonologists on appropriate workup, timing of workup, and current therapy for IPF patients, she added.
The white paper received no outside funding. The authors and Dr. Thavarajah had no financial conflicts to disclose.
The nonspecific nature of the symptoms of idiopathic pulmonary fibrosis (IPF) especially in early stages, and the relative rarity of IPF compared with other conditions that have similar symptoms, may contribute to a delay in diagnosis in the primary care setting, wrote Daniel F. Dilling, MD, of Loyola University Chicago, Maywood, Ill., and colleagues in Chest: Clinical Perspectives (Dilling et al. State of Practice: Factors Driving Diagnostic Delays in Idiopathic Pulmonary Fibrosis. Chest. 2022).
“We have learned over and over again through research, and also through talking with our own patients with IPF, that there is often a long lag between the first signs of the disease and a diagnosis of IPF,” corresponding author Dr. Dilling said in an interview.
“Even some pulmonary specialists can be uncertain about how to approach the diagnosis when a CT scan or other test first suggests the possibility; this can cost a patient precious time, as being on drug therapy earlier can result in preservation of lung function,” he said. “By sounding the alarm bell with this paper, we hope to promote awareness and education/training within the primary care community as well as the pulmonary community, and also to make all of them aware of the possibility of referral to specialty ILD [interstitial lung disease] centers when desired and possible,” he added.
The researchers conducted a pair of online surveys to inform the development of improving education on IPF among primary care providers.
In the white paper, which can be accessed online, the authors reported results of the surveys. One included 100 general pulmonologists and the other included 306 primary care physicians (156 practiced family physicians and 150 practiced general internal medicine). The data were collected between April 11, 2022, and May 16, 2022. Participants were asked to respond to a patient case scenario of a 55-year-old woman with nonspecific symptoms such as shortness of breath on moderate exertion, cough, exhaustion, and trouble sleeping.
The PCPs were most likely to evaluate the patient for a cardiac condition (46%), 25% would evaluate for chronic obstructive pulmonary disease (COPD), and 23% for asthma. More than half (58%) ranked progressive fibrosing ILD as one of their bottom two diagnoses.
A total of 87% of PCPs said they would begin a diagnostic workup to evaluate symptoms if the patient had no preexisting respiratory disease, compared with 61% for patients with a respiratory diagnosis.
Although 93% of PCPs cited a chest x-ray as part of the initial patient workup, fewer than half said they would order an echocardiogram, spirometry, or pulmonary function test (PFT), and 11% said they would include diffusion capacity testing in the initial workup.
In addition, PCPs were less likely to ask patients about issues that might prompt an IPF diagnosis, such as exposures to agents through work, hobbies, the environment, or comorbidities.
In the pulmonology survey, more than 75% of respondents cited patient history, high-resolution tomography scan, serologic testing, and review for autoimmune disease symptoms as first steps in a diagnostic response to patients with suspected IPF.
Differences between PCPs’ and pulmonolgists’ responses
Both PCPs and pulmonologists responded to several questions to assess knowledge and opinion gaps related to IPF. Overall, pulmonologists were more likely than PCPs to cite both imaging and testing issues and waiting 6-8 weeks after symptom onset before imaging as contributing factors to diagnostic delays.
PCPs more often expressed beliefs that delayed diagnosis had little impact on a patient with IPF, and that the treatments may be worse than the disease.
Dr. Dilling said he was not surprised by the survey findings, as similar clues about the underdiagnosis of IPF have surfaced in prior studies.
“We need to get the word out to primary care physicians, to pulmonary physicians, and even to the public, that idiopathic pulmonary fibrosis and other forms of interstitial lung disease are out there and prevalent, and that making the right diagnosis in a timely way can lead to better outcomes for patients,” he said.
The take-home message for primary care is to think outside the COPD box, said Dr. Dilling. “Just because someone has shortness of breath or cough and used to smoke does not automatically mean that they have COPD,” he emphasized. “Listen carefully for crackles (rales) on exam. Get spirometry or PFTs before you secure the diagnosis of COPD, or else you will be missing all of your cases of pulmonary fibrosis; think of pulmonary fibrosis and use imaging to help guide your diagnosis,” he said.
The authors suggested several education goals for PCPs, including establishing the importance of early evaluation, outlining the correct approach to a patient workup, encouraging prompt referral, and empowering PCPs as part of the team approach to IPF patients’ care. For pulmonologists, only 11% of those surveyed said they were aware of the latest developments in antifibrotic research, and education efforts might include information about drug pipelines and clinical trials, as well as technology.
Looking ahead, “We need to better understand how to find the pulmonary fibrosis in the community,” Dr. Dilling said. This understanding may come in part from greater education and awareness, he noted. However, eventually there may be ways to enhance the reading of PFTs and of CT scans through artificial intelligence technologies that would not only prompt clinicians to recognize what they are seeing, but would prompt them to refer and send the patient on the correct diagnostic path as soon as possible, he added.
Key message: Include ILD in differential diagnosis of patients with shortness of breath and/or cough
Advances in diagnostics and therapies for interstitial lung disease can take time to be absorbed and adopted, and patients with ILD and pulmonologists caring for ILD, specifically IPF, continue to report delays in diagnosis and therapy, said Krishna Thavarajah, MD, a pulmonologist at Henry Ford Hospital, Detroit, Mich., in an interview.
The current study findings of the time to diagnosis and the approach to patient workups echo her own clinical experience, Dr. Thavarajah said. “There is a delay in IPF diagnosis as physicians look to more common diagnoses, such as cardiac disease or chronic obstructive pulmonary disease, prior to pursuit of additional workup, and the attitude toward treatment has, in some ways, lagged behind advances in therapy, including timing and feasibility of therapy for IPF,” she said.
The key message for primary care physicians is to include ILD in the differential diagnosis of patients with shortness of breath and/or cough, especially if the initial cardiac and pulmonary test (meaning at least a chest x-ray and pulmonary function tests, including a diffusion capacity) are not pointing to an alternative cause within 3 months of presentation, Dr. Thavarajah said.
Once IPF is diagnosed, primary care clinicians should know that there are FDA-approved therapies that improve survival, said Dr. Thavarajah. “There are identifiable and treatable comorbid conditions,” she added. “The statement of ‘time lost is lung lost’ sums up the care of an IPF patient; partnerships between primary care clinicians, pulmonologists, and referral centers can provide the patient multiple levels of support with quality-of-life interventions, treatments, and also clinical trials, delivered by a team of providers,” she said.
In the wake of the current study, more research is needed with outcome studies regarding educational interventions targeting primary care and pulmonologists on appropriate workup, timing of workup, and current therapy for IPF patients, she added.
The white paper received no outside funding. The authors and Dr. Thavarajah had no financial conflicts to disclose.
The nonspecific nature of the symptoms of idiopathic pulmonary fibrosis (IPF) especially in early stages, and the relative rarity of IPF compared with other conditions that have similar symptoms, may contribute to a delay in diagnosis in the primary care setting, wrote Daniel F. Dilling, MD, of Loyola University Chicago, Maywood, Ill., and colleagues in Chest: Clinical Perspectives (Dilling et al. State of Practice: Factors Driving Diagnostic Delays in Idiopathic Pulmonary Fibrosis. Chest. 2022).
“We have learned over and over again through research, and also through talking with our own patients with IPF, that there is often a long lag between the first signs of the disease and a diagnosis of IPF,” corresponding author Dr. Dilling said in an interview.
“Even some pulmonary specialists can be uncertain about how to approach the diagnosis when a CT scan or other test first suggests the possibility; this can cost a patient precious time, as being on drug therapy earlier can result in preservation of lung function,” he said. “By sounding the alarm bell with this paper, we hope to promote awareness and education/training within the primary care community as well as the pulmonary community, and also to make all of them aware of the possibility of referral to specialty ILD [interstitial lung disease] centers when desired and possible,” he added.
The researchers conducted a pair of online surveys to inform the development of improving education on IPF among primary care providers.
In the white paper, which can be accessed online, the authors reported results of the surveys. One included 100 general pulmonologists and the other included 306 primary care physicians (156 practiced family physicians and 150 practiced general internal medicine). The data were collected between April 11, 2022, and May 16, 2022. Participants were asked to respond to a patient case scenario of a 55-year-old woman with nonspecific symptoms such as shortness of breath on moderate exertion, cough, exhaustion, and trouble sleeping.
The PCPs were most likely to evaluate the patient for a cardiac condition (46%), 25% would evaluate for chronic obstructive pulmonary disease (COPD), and 23% for asthma. More than half (58%) ranked progressive fibrosing ILD as one of their bottom two diagnoses.
A total of 87% of PCPs said they would begin a diagnostic workup to evaluate symptoms if the patient had no preexisting respiratory disease, compared with 61% for patients with a respiratory diagnosis.
Although 93% of PCPs cited a chest x-ray as part of the initial patient workup, fewer than half said they would order an echocardiogram, spirometry, or pulmonary function test (PFT), and 11% said they would include diffusion capacity testing in the initial workup.
In addition, PCPs were less likely to ask patients about issues that might prompt an IPF diagnosis, such as exposures to agents through work, hobbies, the environment, or comorbidities.
In the pulmonology survey, more than 75% of respondents cited patient history, high-resolution tomography scan, serologic testing, and review for autoimmune disease symptoms as first steps in a diagnostic response to patients with suspected IPF.
Differences between PCPs’ and pulmonolgists’ responses
Both PCPs and pulmonologists responded to several questions to assess knowledge and opinion gaps related to IPF. Overall, pulmonologists were more likely than PCPs to cite both imaging and testing issues and waiting 6-8 weeks after symptom onset before imaging as contributing factors to diagnostic delays.
PCPs more often expressed beliefs that delayed diagnosis had little impact on a patient with IPF, and that the treatments may be worse than the disease.
Dr. Dilling said he was not surprised by the survey findings, as similar clues about the underdiagnosis of IPF have surfaced in prior studies.
“We need to get the word out to primary care physicians, to pulmonary physicians, and even to the public, that idiopathic pulmonary fibrosis and other forms of interstitial lung disease are out there and prevalent, and that making the right diagnosis in a timely way can lead to better outcomes for patients,” he said.
The take-home message for primary care is to think outside the COPD box, said Dr. Dilling. “Just because someone has shortness of breath or cough and used to smoke does not automatically mean that they have COPD,” he emphasized. “Listen carefully for crackles (rales) on exam. Get spirometry or PFTs before you secure the diagnosis of COPD, or else you will be missing all of your cases of pulmonary fibrosis; think of pulmonary fibrosis and use imaging to help guide your diagnosis,” he said.
The authors suggested several education goals for PCPs, including establishing the importance of early evaluation, outlining the correct approach to a patient workup, encouraging prompt referral, and empowering PCPs as part of the team approach to IPF patients’ care. For pulmonologists, only 11% of those surveyed said they were aware of the latest developments in antifibrotic research, and education efforts might include information about drug pipelines and clinical trials, as well as technology.
Looking ahead, “We need to better understand how to find the pulmonary fibrosis in the community,” Dr. Dilling said. This understanding may come in part from greater education and awareness, he noted. However, eventually there may be ways to enhance the reading of PFTs and of CT scans through artificial intelligence technologies that would not only prompt clinicians to recognize what they are seeing, but would prompt them to refer and send the patient on the correct diagnostic path as soon as possible, he added.
Key message: Include ILD in differential diagnosis of patients with shortness of breath and/or cough
Advances in diagnostics and therapies for interstitial lung disease can take time to be absorbed and adopted, and patients with ILD and pulmonologists caring for ILD, specifically IPF, continue to report delays in diagnosis and therapy, said Krishna Thavarajah, MD, a pulmonologist at Henry Ford Hospital, Detroit, Mich., in an interview.
The current study findings of the time to diagnosis and the approach to patient workups echo her own clinical experience, Dr. Thavarajah said. “There is a delay in IPF diagnosis as physicians look to more common diagnoses, such as cardiac disease or chronic obstructive pulmonary disease, prior to pursuit of additional workup, and the attitude toward treatment has, in some ways, lagged behind advances in therapy, including timing and feasibility of therapy for IPF,” she said.
The key message for primary care physicians is to include ILD in the differential diagnosis of patients with shortness of breath and/or cough, especially if the initial cardiac and pulmonary test (meaning at least a chest x-ray and pulmonary function tests, including a diffusion capacity) are not pointing to an alternative cause within 3 months of presentation, Dr. Thavarajah said.
Once IPF is diagnosed, primary care clinicians should know that there are FDA-approved therapies that improve survival, said Dr. Thavarajah. “There are identifiable and treatable comorbid conditions,” she added. “The statement of ‘time lost is lung lost’ sums up the care of an IPF patient; partnerships between primary care clinicians, pulmonologists, and referral centers can provide the patient multiple levels of support with quality-of-life interventions, treatments, and also clinical trials, delivered by a team of providers,” she said.
In the wake of the current study, more research is needed with outcome studies regarding educational interventions targeting primary care and pulmonologists on appropriate workup, timing of workup, and current therapy for IPF patients, she added.
The white paper received no outside funding. The authors and Dr. Thavarajah had no financial conflicts to disclose.
FROM CHEST CLINICAL PERSPECTIVES
Psoriasis, psoriatic arthritis insurance coverage remains restrictive
Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.
Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.
In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.
Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.
Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.
The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.
All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.
Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.
“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.
The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.
“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.
The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.
The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.
The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.
Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.
Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.
In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.
Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.
Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.
The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.
All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.
Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.
“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.
The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.
“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.
The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.
The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.
The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.
Insurance coverage for specialty drugs to treat psoriasis and psoriatic arthritis varies extensively among insurance companies and often restricts coverage beyond the drug labels, according to a review of data from commercial health plans in the United States.
Although specialty medications have demonstrated effectiveness for psoriasis and psoriatic arthritis, data on insurance coverage for these indications are limited and costs are often a barrier to treatment, Christine Learned, of Tufts Medical Center, Boston, and colleagues wrote.
In a study published in the Journal of Psoriasis and Psoriatic Arthritis, the researchers used the Tufts Medical Center Specialty Drug Evidence and Coverage database, which includes information on 158 specialty drugs covered by 17 U.S. commercial health plans, to review data on a total of 11 medications indicated for psoriasis (etanercept, adalimumab, certolizumab pegol, secukinumab, ixekizumab, brodalumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and apremilast) and 11 indicated for psoriatic arthritis (etanercept, adalimumab, certolizumab pegol, golimumab, secukinumab, ixekizumab, ustekinumab, guselkumab, tofacitinib, apremilast, and abatacept) at the time of the study.
Overall, an average of 78.6% and 66.8% of insurance plans were more restrictive than the Food and Drug Association label in coverage of specialty medications for psoriasis and psoriatic arthritis, respectively.
Disease severity affected insurance coverage for psoriasis. The percentage of plans with a body surface area requirement for specialty medications ranged from 11% for apremilast to 39% for tildrakizumab, adalimumab, and certolizumab pegol. The percentage of plans with exceptions for special body locations affected by psoriasis ranged from 6% for risankizumab and brodalumab to 39% for certolizumab pegol. In addition, 6% of plans had Psoriasis Area and Severity Index requirements for etanercept and ixekizumab, and 11% had PASI requirements for adalimumab, certolizumab pegol, and tildrakizumab.
The percentage of plans with prescriber restrictions for both psoriasis and psoriatic arthritis ranged from 33% to 50%.
All 11 medications for psoriatic arthritis were approved as first-line treatments by at least one plan, compared with 3 the 11 medications with indications for psoriasis. However, medications for both psoriasis and psoriatic arthritis were approved mainly as second-line therapies.
Study designs may impact insurance coverage, as randomized, controlled trials are often used as the basis for coverage decisions for psoriasis, while coverage for psoriatic arthritis is more often based on clinical guidelines, the researchers explained.
“Our analysis confirms that variability exists for the indications of psoriasis and psoriatic arthritis,” they wrote.
The comorbidities associated with psoriasis are not always considered in insurance coverage, and coverage complications may contribute to the persistent undertreatment of many patients with psoriasis, the researchers added.
“Insurance restrictions may blunt provider and patient autonomy in selection of specialty medications and have the potential to diminish a provider’s ability to tailor regimens so as to optimize outcomes while minimizing risks,” they emphasized.
The study findings were limited by the inclusion only of publicly available policy information; therefore, some plans’ restrictions may have been missed in the analysis, the researchers said.
The results suggest that patients should review their insurance coverage of specialty drugs when choosing a health plan, and clinicians should factor in a patient’s plan a likely drug access when considering treatment options, they concluded.
The study received no outside funding. Ms. Learned had no relevant financial conflicts to disclose, but two coauthors reported financial relationships with pharmaceutical companies that manufacturer drugs for psoriasis and psoriatic arthritis.
FROM THE JOURNAL OF PSORIASIS AND PSORIATIC ARTHRITIS
Corticosteroids found to curb progression in community-acquired pneumonia
Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.
Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.
Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.
In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.
Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).
Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).
“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.
The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.
Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.
Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.
In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.
Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).
Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).
“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.
The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Adults hospitalized with community-acquired pneumonia were less likely to need mechanical ventilation after treatment with corticosteroids, but mortality was unaffected, based on data from a meta-analysis of nearly 4,000 patients.
Community-acquired pneumonia (CAP) remains a leading cause of morbidity and mortality in adults, but no routinely used strategies are associated with improvements in mortality, disease severity, or length of hospital stay, wrote Naveed Saleem, MSc, of University College, London, and colleagues.
Corticosteroids are recommended for various infectious diseases including bacterial meningitis, septic shock, and tuberculosis, as well as for COVID-19 pneumonia, because of their ability to reduce systemic inflammation, but have not been well studied in CAP, they noted.
In a study published in Chest, the researchers identified 16 randomized, controlled trials that compared the use of corticosteroids to standard care in CAP management. Of these, 9 were sponsored by pharmaceutical companies, 4 were open-label, and 11 were double-blind. The primary outcome was all-cause mortality; secondary outcomes were ICU admission, mechanical ventilation, treatment failure, readmission, and adverse events.
Although corticosteroids had no significant impact on the primary outcome of all-cause mortality, (relative risk 0.51, P = .001). The relative risk for the primary outcome of all-cause mortality was 0.85 (P = .17). Corticosteroids had no significant impact on the other secondary outcomes of ICU admission (RR 0.66), treatment failure (RR 0.78), and the incidence of adverse events (RR 1.10). However, data from five studies showed an increase in hospital admission rates for patients who received corticosteroids (RR 1.20, P = .008).
Overall, the risk of total adverse events was similar in patients who received corticosteroids vs. standard of care (55.8% vs. 48.5%). However, 27.2% of patients reported at least one adverse event related to corticosteroids. Incidence of most adverse events including gastrointestinal bleeding and secondary infections were similar between the groups, but patients who received corticosteroids had a significantly higher incidence of new-onset hyperglycemia compared to standard care patients (17.6% vs. 9.5%, P = .0001).
“Despite an increased risk of hyperglycemia associated with steroid use, we found no association between corticosteroid use and infectious complications,” the researchers wrote in their discussion. The optimal type, dose, and duration of corticosteroids for hospitalized CAP patients has yet to be determined, and the type of corticosteroid may affect outcomes, they added.
The study findings were limited by several factors, including the consideration of hospitalized patients only, not those in the community, and by the inability to adjust for differing diagnostic criteria, illness severity at baseline, or other therapeutic interventions, the researchers noted. Larger studies are needed to assess mortality benefit, and longer follow-up is needed to identify causes of readmission, they said. However, the results suggest that corticosteroids may be useful for preventing the need for mechanical ventilation in hospitalized patients with bacterial pneumonia, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL CHEST®
Mindfulness eases asthma burden
Adults with asthma who received mindfulness training showed significant improvement in symptoms compared to those who did not receive such training, based on data from 73 individuals.
Although previous research shows the contribution of psychological factors to poor asthma control and exacerbations, the ability of mindfulness-based stress reduction (MBSR) to improve asthma symptoms in particular has not been well studied, wrote Estelle T. Higgins, BA, of the University of Wisconsin, Madison, and colleagues.
they wrote. The researchers hypothesized that MBSR training would reduce the effect of psychological distress on asthma control and inflammation compared to asthma patients in a waitlist control group.
In a study published in Brain, Behavior, & Immunity – Health, the researchers randomized 38 adults with asthma to a program of MBSR and 24 to a waitlist. The participants ranged in age from 18 to 65 years, with a mean of 38.1 years, and 43 were female. All patients had an asthma diagnosis for at least 6 months; airway inflammation was based on measures of fraction of exhaled nitric oxide (FeNO) ≥ 30 ppb, 138 blood eosinophil count ≥ 150 cells/mcL, or percent sputum eosinophils ≥ 2% of total leukocytes. Individuals with ongoing medical conditions other than asthma were excluded.
The MBSR group had seven clinical data collection visits at approximately 1-month intervals. MBSR training sessions occurred within classes offered to the community over a period of 8 weekly sessions and one 6-hour retreat, and included breath-focused attention, body scan, and mindful awareness in seated positions, walking, and yoga. Participants completed questionnaires about mindfulness, distress, depression, and anxiety symptoms. These were assessed at baseline, post intervention, and at study completion. Chronic stress level was determined at baseline only.
The primary outcome was asthma control based on the Asthma Control Questionnaire 6-item version (ACQ6) Minimally Important Difference.
Overall, asthma control improved significantly among those randomized to MBSR compared to waitlisted controls (P = .01) and this difference persisted at 4 months after the intervention.
Nearly one-third (32%) of the MBSR participants met the criteria for clinically significant improvement in asthma symptoms, compared to 12% of those on the wait list.
In addition, MBSR-related improvement in asthma control was significantly associated with a reduced distress (P = .043), and was especially effective for individuals with the highest levels of depressive symptoms at baseline, the researchers noted. Individuals who received MBSR also showed significantly reduced levels of exhaled nitric oxide compared to waitlist controls (P < .05).
The study findings were limited by the lack of an active control group, the researchers noted. “Though a wait-list control group was employed to control for variation in outcome measures over time, it is possible that effects reported here were driven by factors that are not specific to training in mindfulness, such as social support or expectancy effects,” they wrote. However, the results support the value of mindfulness in reducing psychological stress, FeNO, and impairments related to asthma that were sustained over time, they said. The results also support the potential of MBSR to both augment and reduce the need for pharmacological treatment in asthma, and mindfulness may be an effective way to improve overall disease control by reducing the contribution of psychological factors to asthma morbidity, they concluded.
The study was supported by the National Center for Complementary and Integrative Health. Coauthor Richard J. Davidson, MD, is the founder and president, and serves on the board of directors for the nonprofit organization, Healthy Minds Innovations Inc. The researchers had no financial conflicts to disclose.
Adults with asthma who received mindfulness training showed significant improvement in symptoms compared to those who did not receive such training, based on data from 73 individuals.
Although previous research shows the contribution of psychological factors to poor asthma control and exacerbations, the ability of mindfulness-based stress reduction (MBSR) to improve asthma symptoms in particular has not been well studied, wrote Estelle T. Higgins, BA, of the University of Wisconsin, Madison, and colleagues.
they wrote. The researchers hypothesized that MBSR training would reduce the effect of psychological distress on asthma control and inflammation compared to asthma patients in a waitlist control group.
In a study published in Brain, Behavior, & Immunity – Health, the researchers randomized 38 adults with asthma to a program of MBSR and 24 to a waitlist. The participants ranged in age from 18 to 65 years, with a mean of 38.1 years, and 43 were female. All patients had an asthma diagnosis for at least 6 months; airway inflammation was based on measures of fraction of exhaled nitric oxide (FeNO) ≥ 30 ppb, 138 blood eosinophil count ≥ 150 cells/mcL, or percent sputum eosinophils ≥ 2% of total leukocytes. Individuals with ongoing medical conditions other than asthma were excluded.
The MBSR group had seven clinical data collection visits at approximately 1-month intervals. MBSR training sessions occurred within classes offered to the community over a period of 8 weekly sessions and one 6-hour retreat, and included breath-focused attention, body scan, and mindful awareness in seated positions, walking, and yoga. Participants completed questionnaires about mindfulness, distress, depression, and anxiety symptoms. These were assessed at baseline, post intervention, and at study completion. Chronic stress level was determined at baseline only.
The primary outcome was asthma control based on the Asthma Control Questionnaire 6-item version (ACQ6) Minimally Important Difference.
Overall, asthma control improved significantly among those randomized to MBSR compared to waitlisted controls (P = .01) and this difference persisted at 4 months after the intervention.
Nearly one-third (32%) of the MBSR participants met the criteria for clinically significant improvement in asthma symptoms, compared to 12% of those on the wait list.
In addition, MBSR-related improvement in asthma control was significantly associated with a reduced distress (P = .043), and was especially effective for individuals with the highest levels of depressive symptoms at baseline, the researchers noted. Individuals who received MBSR also showed significantly reduced levels of exhaled nitric oxide compared to waitlist controls (P < .05).
The study findings were limited by the lack of an active control group, the researchers noted. “Though a wait-list control group was employed to control for variation in outcome measures over time, it is possible that effects reported here were driven by factors that are not specific to training in mindfulness, such as social support or expectancy effects,” they wrote. However, the results support the value of mindfulness in reducing psychological stress, FeNO, and impairments related to asthma that were sustained over time, they said. The results also support the potential of MBSR to both augment and reduce the need for pharmacological treatment in asthma, and mindfulness may be an effective way to improve overall disease control by reducing the contribution of psychological factors to asthma morbidity, they concluded.
The study was supported by the National Center for Complementary and Integrative Health. Coauthor Richard J. Davidson, MD, is the founder and president, and serves on the board of directors for the nonprofit organization, Healthy Minds Innovations Inc. The researchers had no financial conflicts to disclose.
Adults with asthma who received mindfulness training showed significant improvement in symptoms compared to those who did not receive such training, based on data from 73 individuals.
Although previous research shows the contribution of psychological factors to poor asthma control and exacerbations, the ability of mindfulness-based stress reduction (MBSR) to improve asthma symptoms in particular has not been well studied, wrote Estelle T. Higgins, BA, of the University of Wisconsin, Madison, and colleagues.
they wrote. The researchers hypothesized that MBSR training would reduce the effect of psychological distress on asthma control and inflammation compared to asthma patients in a waitlist control group.
In a study published in Brain, Behavior, & Immunity – Health, the researchers randomized 38 adults with asthma to a program of MBSR and 24 to a waitlist. The participants ranged in age from 18 to 65 years, with a mean of 38.1 years, and 43 were female. All patients had an asthma diagnosis for at least 6 months; airway inflammation was based on measures of fraction of exhaled nitric oxide (FeNO) ≥ 30 ppb, 138 blood eosinophil count ≥ 150 cells/mcL, or percent sputum eosinophils ≥ 2% of total leukocytes. Individuals with ongoing medical conditions other than asthma were excluded.
The MBSR group had seven clinical data collection visits at approximately 1-month intervals. MBSR training sessions occurred within classes offered to the community over a period of 8 weekly sessions and one 6-hour retreat, and included breath-focused attention, body scan, and mindful awareness in seated positions, walking, and yoga. Participants completed questionnaires about mindfulness, distress, depression, and anxiety symptoms. These were assessed at baseline, post intervention, and at study completion. Chronic stress level was determined at baseline only.
The primary outcome was asthma control based on the Asthma Control Questionnaire 6-item version (ACQ6) Minimally Important Difference.
Overall, asthma control improved significantly among those randomized to MBSR compared to waitlisted controls (P = .01) and this difference persisted at 4 months after the intervention.
Nearly one-third (32%) of the MBSR participants met the criteria for clinically significant improvement in asthma symptoms, compared to 12% of those on the wait list.
In addition, MBSR-related improvement in asthma control was significantly associated with a reduced distress (P = .043), and was especially effective for individuals with the highest levels of depressive symptoms at baseline, the researchers noted. Individuals who received MBSR also showed significantly reduced levels of exhaled nitric oxide compared to waitlist controls (P < .05).
The study findings were limited by the lack of an active control group, the researchers noted. “Though a wait-list control group was employed to control for variation in outcome measures over time, it is possible that effects reported here were driven by factors that are not specific to training in mindfulness, such as social support or expectancy effects,” they wrote. However, the results support the value of mindfulness in reducing psychological stress, FeNO, and impairments related to asthma that were sustained over time, they said. The results also support the potential of MBSR to both augment and reduce the need for pharmacological treatment in asthma, and mindfulness may be an effective way to improve overall disease control by reducing the contribution of psychological factors to asthma morbidity, they concluded.
The study was supported by the National Center for Complementary and Integrative Health. Coauthor Richard J. Davidson, MD, is the founder and president, and serves on the board of directors for the nonprofit organization, Healthy Minds Innovations Inc. The researchers had no financial conflicts to disclose.
FROM BRAIN, BEHAVIOR, & IMMUNITY – HEALTH
CRP levels could predict SSRI success
C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.
In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.
CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).
The researchers compared efficacy in different groups according to CRP levels.
Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).
A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.
“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.
No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.
No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.
The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.
However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.
In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.
CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).
The researchers compared efficacy in different groups according to CRP levels.
Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).
A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.
“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.
No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.
No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.
The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.
However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
C-reactive protein (CRP) has been shown to predict antidepressant treatment outcomes in depressed patients, but previous studies have been small and under restricted conditions, and data from large, real-world studies are lacking, wrote Yuqian Pan of First Affiliated Hospital of Zhengzhou University, Henan, China, and colleagues.
In a study published in the Journal of Affective Disorders , the researchers identified depressed patients aged 12-60 years who had tested CRP levels. The participants were followed through outpatient visits or telephone interviews to collect information on medication use and assess efficacy based on the Clinical Global Impressions–Improvement scale.
CRP was separated into the low CRP group of 709 patients (CRP < 1 mg/L) and a high CRP group of 209 patients (CRP ≥ 1 mg/L). The primary outcome was efficacy defined as effective and ineffective for high and low CRP levels in patients using different medications: Selected serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors, (SNRIs), melatonin receptor agonists (MTs), and norepinephrinergic and specific serotonergic antidepressants (NaSSAs).
The researchers compared efficacy in different groups according to CRP levels.
Overall, patients with low CRP showed significantly greater efficacy with SSRIs than did those with high CRP (hazard ratio [HR], 1.257, P = .047). SNRIs were more effective than SSRIs for treating patients with high CRP levels (HR, 1.652, P = .037).
A possible reason for the difference in efficacy is the correlation between CRP and body mass index; previous studies have shown that SSRIs may be less effective in obese individuals, the researchers said.
“Another possible explanation is that at high levels of inflammation, neurons, microglia, and macrophages respond to inflammatory challenges at the cellular level by activating metabolic pathways,” they said.
No significant changes in CRP levels were observed before and after starting medication use, which supports the stability of CRP as a biomarker under normal circumstances.
No difference in efficacy appeared between SSRIs and SNRIs in patients with low CRP, “which may indicate that SNRIs have stronger anti-inflammatory effects than SSRIs,” a finding consistent with previous studies, they said.
The study findings were limited by several factors including the small number of patients taking MT and NaSSA, the irregular time intervals for before and after SSRI treatment in 90 patients, the lack of classification by antidepressant type, and the potential for recall bias, the researchers noted.
However, the results suggest that CRP could predict the efficacy of SSRIs in depressed patients in a real-world setting, which may inform treatment decisions, they said.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF AFFECTIVE DISORDERS
Community-level actions could mitigate maternal mortality
Maternal mortality in the United States has been rising for several decades, but actions taken at the community level, as well as larger public health initiatives, have the potential to slow this trend, according to experts at a webinar sponsored by the National Institute for Health Care Management.
Maternal mortality in the United States increased by 14% from 2018 to 2020, according to data from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
However, more than 80% of pregnancy-related deaths are preventable, according to 2017-2019 data from the Maternal Mortality Review Committees published online by the CDC. MMRCs include representatives of diverse clinical and nonclinical backgrounds who review the circumstances of pregnancy-related deaths.
In a webinar presented on Sept. 20, the NIHCM enlisted a panel of experts to discuss maternal mortality, the effect of changes to reproductive rights, and potential strategies to improve maternal health outcomes.
Maternal mortality is defined as “death while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of pregnancy, from any cause related to pregnancy or its management,” according to the CDC.
Importantly, mortality rates in the United States are approximately three times higher in Black women compared with White women, said Ndidiamaka Amutah-Onukagha, PhD, MPH, of the Tufts University Center for Black Maternal Health & Reproductive Justice. Dr. Amutah-Onukagha addressed some of the potential issues that appear to drive the disparity in care.
The lack of diversity in the health care workforce has a significant effect on patient outcomes, Dr. Amutah-Onukagha said. Overall, Black newborns are more than twice as likely as White newborns to die during their first year of life, but this number is cut in half when Black infants are cared for by Black physicians, she emphasized.
Other factors that may affect disparities in maternal health care include limited access to prenatal care, discriminatory hospital protocols, and mistreatment by health care professionals, said Dr. Amutah-Onukagha. She cited data showing that maternal mortality rates were higher in rural compared with urban areas. “According to the American Hospital Association, half of rural hospitals have no obstetric care, leaving mothers in maternity care deserts; this exacerbates existing disparities,” she said.
In the webinar, Sindhu Srinivas, MD, a maternal-fetal medicine specialist at the University of Pennsylvania, explained how patient, community, and system factors play a role in the disparities in maternal care.
Overall, Black women have to travel further to receive care, which has implications for high-risk pregnancies, and patients on Medicaid have to wait longer for care, and are less likely to be referred, she added. Black women also have higher rates of preexisting conditions compared with other populations that put them in the high-risk category, such as high blood pressure, diabetes, obesity, or being HIV positive, she said.
Other factors contributing to persistent disparities in maternal care include sociodemographics, patient beliefs and knowledge, and psychological issues including stress, said Dr. Srinivas. Community factors, such as social networks, safety, and poverty, also play a role, as do clinician factors of implicit bias and communication skills, she said.
Strategies to reduce disparity
Dr. Srinivas presented several strategies to reduce disparities at various levels. At the policy level, interventions such as establishing a Maternal Mortality Review Committee, establishing a perinatal quality collaborative, and extending Medicaid for a full year postpartum could help improve outcomes, she said. Dr. Srinivas also encouraged clinicians to report maternal mortality data stratified by race and ethnicity, and to participate in the Alliance for Innovation on Maternal Health program (AIM), an initiative in partnership with the American College of Obstetrics and Gynecology.
Dr. Srinivas also proposed maternal health policies to develop payment models “to sustain and scale innovative solutions, and “preserve access to contraception and abortion care.”
For clinicians looking to have an immediate impact, the panelists agreed that working with community health centers can make a significant difference by improving access to maternal care. Consider opportunities for partnership between hospitals and health care delivery centers in the community, said Dr. Srinivas.
Also, don’t underestimate the value of doulas in the birthing process, Dr. Amutah-Onukagha said. She urged clinicians to advocate for doula reimbursement and to take advantage of opportunities for doulas to work with pregnant individuals at the community levels. Data suggest that doulas are associated with increased maternal care visits and with breastfeeding, she noted.
Adam Myers, MD, of the Blue Cross Blue Shield Association, also contributed to the webinar discussion with a key point: Having financial means and commercial coverage is not a buffer against adverse maternal outcomes for racial minorities.
Dr. Myers cited the latest Health of America Report, which included data up to April 2021 with surveys of Medicaid members and their experiences. According to the report, rates of severe maternal mortality (SMM) increased by 9% for commercially and Medicaid-insured women between 2018 and 2020.
Among commercially insured women, SMM was 53% higher among Black women than White women; among Medicaid-insured women, Black women had a 73% higher rate of SMM, compared with White women.
In addition, the report showed that significantly more mothers of color were not able to complete the recommended series of prenatal visits, mainly for reasons of scheduling and transportation, which were greater barriers than COVID-19, Dr. Myers said.
Based on the data, one specific risk profile rose to the top: “We believe women of color aged 35 or higher with comorbid conditions should be treated as very high risk for SMM,” Dr. Myers emphasized. He stressed the need to focus on transportation and scheduling barriers and expressed support for partnerships and health care delivery centers in the community to mitigate these issues.
Finally, Dr. Srinivas encouraged clinicians to have confidence in their expertise and make themselves heard to help their patients and improve maternal health for all. “Use your voice,” said Dr. Srinivas, “As physicians we don’t think of that as an important aspect of our work, or that we can’t articulate, but remember that we are experts, and sharing stories of patients who are impacted is incredibly powerful,” she said.
The presenters had no relevant financial conflicts to disclose.
Maternal mortality in the United States has been rising for several decades, but actions taken at the community level, as well as larger public health initiatives, have the potential to slow this trend, according to experts at a webinar sponsored by the National Institute for Health Care Management.
Maternal mortality in the United States increased by 14% from 2018 to 2020, according to data from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
However, more than 80% of pregnancy-related deaths are preventable, according to 2017-2019 data from the Maternal Mortality Review Committees published online by the CDC. MMRCs include representatives of diverse clinical and nonclinical backgrounds who review the circumstances of pregnancy-related deaths.
In a webinar presented on Sept. 20, the NIHCM enlisted a panel of experts to discuss maternal mortality, the effect of changes to reproductive rights, and potential strategies to improve maternal health outcomes.
Maternal mortality is defined as “death while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of pregnancy, from any cause related to pregnancy or its management,” according to the CDC.
Importantly, mortality rates in the United States are approximately three times higher in Black women compared with White women, said Ndidiamaka Amutah-Onukagha, PhD, MPH, of the Tufts University Center for Black Maternal Health & Reproductive Justice. Dr. Amutah-Onukagha addressed some of the potential issues that appear to drive the disparity in care.
The lack of diversity in the health care workforce has a significant effect on patient outcomes, Dr. Amutah-Onukagha said. Overall, Black newborns are more than twice as likely as White newborns to die during their first year of life, but this number is cut in half when Black infants are cared for by Black physicians, she emphasized.
Other factors that may affect disparities in maternal health care include limited access to prenatal care, discriminatory hospital protocols, and mistreatment by health care professionals, said Dr. Amutah-Onukagha. She cited data showing that maternal mortality rates were higher in rural compared with urban areas. “According to the American Hospital Association, half of rural hospitals have no obstetric care, leaving mothers in maternity care deserts; this exacerbates existing disparities,” she said.
In the webinar, Sindhu Srinivas, MD, a maternal-fetal medicine specialist at the University of Pennsylvania, explained how patient, community, and system factors play a role in the disparities in maternal care.
Overall, Black women have to travel further to receive care, which has implications for high-risk pregnancies, and patients on Medicaid have to wait longer for care, and are less likely to be referred, she added. Black women also have higher rates of preexisting conditions compared with other populations that put them in the high-risk category, such as high blood pressure, diabetes, obesity, or being HIV positive, she said.
Other factors contributing to persistent disparities in maternal care include sociodemographics, patient beliefs and knowledge, and psychological issues including stress, said Dr. Srinivas. Community factors, such as social networks, safety, and poverty, also play a role, as do clinician factors of implicit bias and communication skills, she said.
Strategies to reduce disparity
Dr. Srinivas presented several strategies to reduce disparities at various levels. At the policy level, interventions such as establishing a Maternal Mortality Review Committee, establishing a perinatal quality collaborative, and extending Medicaid for a full year postpartum could help improve outcomes, she said. Dr. Srinivas also encouraged clinicians to report maternal mortality data stratified by race and ethnicity, and to participate in the Alliance for Innovation on Maternal Health program (AIM), an initiative in partnership with the American College of Obstetrics and Gynecology.
Dr. Srinivas also proposed maternal health policies to develop payment models “to sustain and scale innovative solutions, and “preserve access to contraception and abortion care.”
For clinicians looking to have an immediate impact, the panelists agreed that working with community health centers can make a significant difference by improving access to maternal care. Consider opportunities for partnership between hospitals and health care delivery centers in the community, said Dr. Srinivas.
Also, don’t underestimate the value of doulas in the birthing process, Dr. Amutah-Onukagha said. She urged clinicians to advocate for doula reimbursement and to take advantage of opportunities for doulas to work with pregnant individuals at the community levels. Data suggest that doulas are associated with increased maternal care visits and with breastfeeding, she noted.
Adam Myers, MD, of the Blue Cross Blue Shield Association, also contributed to the webinar discussion with a key point: Having financial means and commercial coverage is not a buffer against adverse maternal outcomes for racial minorities.
Dr. Myers cited the latest Health of America Report, which included data up to April 2021 with surveys of Medicaid members and their experiences. According to the report, rates of severe maternal mortality (SMM) increased by 9% for commercially and Medicaid-insured women between 2018 and 2020.
Among commercially insured women, SMM was 53% higher among Black women than White women; among Medicaid-insured women, Black women had a 73% higher rate of SMM, compared with White women.
In addition, the report showed that significantly more mothers of color were not able to complete the recommended series of prenatal visits, mainly for reasons of scheduling and transportation, which were greater barriers than COVID-19, Dr. Myers said.
Based on the data, one specific risk profile rose to the top: “We believe women of color aged 35 or higher with comorbid conditions should be treated as very high risk for SMM,” Dr. Myers emphasized. He stressed the need to focus on transportation and scheduling barriers and expressed support for partnerships and health care delivery centers in the community to mitigate these issues.
Finally, Dr. Srinivas encouraged clinicians to have confidence in their expertise and make themselves heard to help their patients and improve maternal health for all. “Use your voice,” said Dr. Srinivas, “As physicians we don’t think of that as an important aspect of our work, or that we can’t articulate, but remember that we are experts, and sharing stories of patients who are impacted is incredibly powerful,” she said.
The presenters had no relevant financial conflicts to disclose.
Maternal mortality in the United States has been rising for several decades, but actions taken at the community level, as well as larger public health initiatives, have the potential to slow this trend, according to experts at a webinar sponsored by the National Institute for Health Care Management.
Maternal mortality in the United States increased by 14% from 2018 to 2020, according to data from the Centers for Disease Control and Prevention’s National Center for Health Statistics.
However, more than 80% of pregnancy-related deaths are preventable, according to 2017-2019 data from the Maternal Mortality Review Committees published online by the CDC. MMRCs include representatives of diverse clinical and nonclinical backgrounds who review the circumstances of pregnancy-related deaths.
In a webinar presented on Sept. 20, the NIHCM enlisted a panel of experts to discuss maternal mortality, the effect of changes to reproductive rights, and potential strategies to improve maternal health outcomes.
Maternal mortality is defined as “death while pregnant or within 42 days of the end of pregnancy, irrespective of the duration and site of pregnancy, from any cause related to pregnancy or its management,” according to the CDC.
Importantly, mortality rates in the United States are approximately three times higher in Black women compared with White women, said Ndidiamaka Amutah-Onukagha, PhD, MPH, of the Tufts University Center for Black Maternal Health & Reproductive Justice. Dr. Amutah-Onukagha addressed some of the potential issues that appear to drive the disparity in care.
The lack of diversity in the health care workforce has a significant effect on patient outcomes, Dr. Amutah-Onukagha said. Overall, Black newborns are more than twice as likely as White newborns to die during their first year of life, but this number is cut in half when Black infants are cared for by Black physicians, she emphasized.
Other factors that may affect disparities in maternal health care include limited access to prenatal care, discriminatory hospital protocols, and mistreatment by health care professionals, said Dr. Amutah-Onukagha. She cited data showing that maternal mortality rates were higher in rural compared with urban areas. “According to the American Hospital Association, half of rural hospitals have no obstetric care, leaving mothers in maternity care deserts; this exacerbates existing disparities,” she said.
In the webinar, Sindhu Srinivas, MD, a maternal-fetal medicine specialist at the University of Pennsylvania, explained how patient, community, and system factors play a role in the disparities in maternal care.
Overall, Black women have to travel further to receive care, which has implications for high-risk pregnancies, and patients on Medicaid have to wait longer for care, and are less likely to be referred, she added. Black women also have higher rates of preexisting conditions compared with other populations that put them in the high-risk category, such as high blood pressure, diabetes, obesity, or being HIV positive, she said.
Other factors contributing to persistent disparities in maternal care include sociodemographics, patient beliefs and knowledge, and psychological issues including stress, said Dr. Srinivas. Community factors, such as social networks, safety, and poverty, also play a role, as do clinician factors of implicit bias and communication skills, she said.
Strategies to reduce disparity
Dr. Srinivas presented several strategies to reduce disparities at various levels. At the policy level, interventions such as establishing a Maternal Mortality Review Committee, establishing a perinatal quality collaborative, and extending Medicaid for a full year postpartum could help improve outcomes, she said. Dr. Srinivas also encouraged clinicians to report maternal mortality data stratified by race and ethnicity, and to participate in the Alliance for Innovation on Maternal Health program (AIM), an initiative in partnership with the American College of Obstetrics and Gynecology.
Dr. Srinivas also proposed maternal health policies to develop payment models “to sustain and scale innovative solutions, and “preserve access to contraception and abortion care.”
For clinicians looking to have an immediate impact, the panelists agreed that working with community health centers can make a significant difference by improving access to maternal care. Consider opportunities for partnership between hospitals and health care delivery centers in the community, said Dr. Srinivas.
Also, don’t underestimate the value of doulas in the birthing process, Dr. Amutah-Onukagha said. She urged clinicians to advocate for doula reimbursement and to take advantage of opportunities for doulas to work with pregnant individuals at the community levels. Data suggest that doulas are associated with increased maternal care visits and with breastfeeding, she noted.
Adam Myers, MD, of the Blue Cross Blue Shield Association, also contributed to the webinar discussion with a key point: Having financial means and commercial coverage is not a buffer against adverse maternal outcomes for racial minorities.
Dr. Myers cited the latest Health of America Report, which included data up to April 2021 with surveys of Medicaid members and their experiences. According to the report, rates of severe maternal mortality (SMM) increased by 9% for commercially and Medicaid-insured women between 2018 and 2020.
Among commercially insured women, SMM was 53% higher among Black women than White women; among Medicaid-insured women, Black women had a 73% higher rate of SMM, compared with White women.
In addition, the report showed that significantly more mothers of color were not able to complete the recommended series of prenatal visits, mainly for reasons of scheduling and transportation, which were greater barriers than COVID-19, Dr. Myers said.
Based on the data, one specific risk profile rose to the top: “We believe women of color aged 35 or higher with comorbid conditions should be treated as very high risk for SMM,” Dr. Myers emphasized. He stressed the need to focus on transportation and scheduling barriers and expressed support for partnerships and health care delivery centers in the community to mitigate these issues.
Finally, Dr. Srinivas encouraged clinicians to have confidence in their expertise and make themselves heard to help their patients and improve maternal health for all. “Use your voice,” said Dr. Srinivas, “As physicians we don’t think of that as an important aspect of our work, or that we can’t articulate, but remember that we are experts, and sharing stories of patients who are impacted is incredibly powerful,” she said.
The presenters had no relevant financial conflicts to disclose.
Tralokinumab earns EU recommendation to expand age range for atopic dermatitis to include adolescents
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Esophageal motility issues may promote respiratory disease
Individuals with esophageal dysmotility had significantly higher scores on measures of airway reflux symptoms, based on data from 441 patients.
Many patients with chronic respiratory diseases experience persistent symptoms despite optimal treatment, and the reason is often unclear and frustrating for clinicians and patients, Dominic L. Sykes, MD, of Hull (England) University Teaching Hospitals NHS Trust, and colleagues wrote.
Although more studies in recent years have explored the association between gastroesophageal reflux and respiratory diseases such as asthma and chronic obstructive pulmonary disease, data on a potential link between esophageal motility and respiratory disease in adults are limited, they noted.
In a study published in Respiratory Medicine, the researchers reviewed data from 441 adults with refractory respiratory symptoms who were treated at a single center between Jan. 1, 2011, and Dec. 1, 2021. Symptoms included persistent cough and breathlessness despite optimal medication. The participants underwent examination with high-resolution esophageal manometry (HROM). Airway reflux was measured using the Hull Airways Reflux Questionnaire (HARQ). The mean age of the patients was 56.5 years, and 64% were women.
Overall, the most common diagnoses were chronic cough (77%), asthma (10%), and interstitial lung disease (7%). The prevalence of esophageal dysmotility was 66%. Patients with esophageal dysmotility had significantly higher HARQ scores than those with normal motility (40.6 vs. 35.3; P < .001). Approximately one-third of the patients had normal motility (34.5%) on HROM, 54% had ineffective esophageal motility, 7.3% had absent contractility, 3.2% had esophageal-gastric junction outflow obstruction, 0.5% had distal esophageal spasm, 0.5% has achalasia, and one patient had hypercontractile esophagus.
No significant differences in manometric diagnoses appeared between men and women. In addition, HARQ scores showed a significant inverse correlation with esophageal contractility as measured by distal contractile integral (DCI).
“The proportion of patients with esophageal dysmotility is consistently high over a range of respiratory diseases, including interstitial lung disease (72%), airways disease (57%), and chronic cough (68%),” and the findings suggest that esophageal disease may play a role in patients with persistent respiratory symptoms, they noted.
The study authors proposed that “impaired peristaltic activity of the esophagus, leading to aspiration of gaseous nonacidic refluxate into the airways, may be a contributor in the development and progression of respiratory disease.” They added that the HARQ offers clinicians a useful screening tool for assessing the need for esophageal study in patients with persistent respiratory symptoms that should be used before considering antireflux surgery.
The study findings were limited by several factors including the lack of lung function data for patients with airway disease and ILD and the inability to show causality between esophageal dysmotility and refractory respiratory symptoms, the researchers noted. Other limitations include the retrospective design, and the lack of data on symptom severity and the subsequent impact on outcomes.
However, the results support the need for additional research into the relationship between esophageal dysmotility, lung function, and symptom burden in chronic respiratory disease, and may inform investigations of therapeutic targets, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Individuals with esophageal dysmotility had significantly higher scores on measures of airway reflux symptoms, based on data from 441 patients.
Many patients with chronic respiratory diseases experience persistent symptoms despite optimal treatment, and the reason is often unclear and frustrating for clinicians and patients, Dominic L. Sykes, MD, of Hull (England) University Teaching Hospitals NHS Trust, and colleagues wrote.
Although more studies in recent years have explored the association between gastroesophageal reflux and respiratory diseases such as asthma and chronic obstructive pulmonary disease, data on a potential link between esophageal motility and respiratory disease in adults are limited, they noted.
In a study published in Respiratory Medicine, the researchers reviewed data from 441 adults with refractory respiratory symptoms who were treated at a single center between Jan. 1, 2011, and Dec. 1, 2021. Symptoms included persistent cough and breathlessness despite optimal medication. The participants underwent examination with high-resolution esophageal manometry (HROM). Airway reflux was measured using the Hull Airways Reflux Questionnaire (HARQ). The mean age of the patients was 56.5 years, and 64% were women.
Overall, the most common diagnoses were chronic cough (77%), asthma (10%), and interstitial lung disease (7%). The prevalence of esophageal dysmotility was 66%. Patients with esophageal dysmotility had significantly higher HARQ scores than those with normal motility (40.6 vs. 35.3; P < .001). Approximately one-third of the patients had normal motility (34.5%) on HROM, 54% had ineffective esophageal motility, 7.3% had absent contractility, 3.2% had esophageal-gastric junction outflow obstruction, 0.5% had distal esophageal spasm, 0.5% has achalasia, and one patient had hypercontractile esophagus.
No significant differences in manometric diagnoses appeared between men and women. In addition, HARQ scores showed a significant inverse correlation with esophageal contractility as measured by distal contractile integral (DCI).
“The proportion of patients with esophageal dysmotility is consistently high over a range of respiratory diseases, including interstitial lung disease (72%), airways disease (57%), and chronic cough (68%),” and the findings suggest that esophageal disease may play a role in patients with persistent respiratory symptoms, they noted.
The study authors proposed that “impaired peristaltic activity of the esophagus, leading to aspiration of gaseous nonacidic refluxate into the airways, may be a contributor in the development and progression of respiratory disease.” They added that the HARQ offers clinicians a useful screening tool for assessing the need for esophageal study in patients with persistent respiratory symptoms that should be used before considering antireflux surgery.
The study findings were limited by several factors including the lack of lung function data for patients with airway disease and ILD and the inability to show causality between esophageal dysmotility and refractory respiratory symptoms, the researchers noted. Other limitations include the retrospective design, and the lack of data on symptom severity and the subsequent impact on outcomes.
However, the results support the need for additional research into the relationship between esophageal dysmotility, lung function, and symptom burden in chronic respiratory disease, and may inform investigations of therapeutic targets, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
Individuals with esophageal dysmotility had significantly higher scores on measures of airway reflux symptoms, based on data from 441 patients.
Many patients with chronic respiratory diseases experience persistent symptoms despite optimal treatment, and the reason is often unclear and frustrating for clinicians and patients, Dominic L. Sykes, MD, of Hull (England) University Teaching Hospitals NHS Trust, and colleagues wrote.
Although more studies in recent years have explored the association between gastroesophageal reflux and respiratory diseases such as asthma and chronic obstructive pulmonary disease, data on a potential link between esophageal motility and respiratory disease in adults are limited, they noted.
In a study published in Respiratory Medicine, the researchers reviewed data from 441 adults with refractory respiratory symptoms who were treated at a single center between Jan. 1, 2011, and Dec. 1, 2021. Symptoms included persistent cough and breathlessness despite optimal medication. The participants underwent examination with high-resolution esophageal manometry (HROM). Airway reflux was measured using the Hull Airways Reflux Questionnaire (HARQ). The mean age of the patients was 56.5 years, and 64% were women.
Overall, the most common diagnoses were chronic cough (77%), asthma (10%), and interstitial lung disease (7%). The prevalence of esophageal dysmotility was 66%. Patients with esophageal dysmotility had significantly higher HARQ scores than those with normal motility (40.6 vs. 35.3; P < .001). Approximately one-third of the patients had normal motility (34.5%) on HROM, 54% had ineffective esophageal motility, 7.3% had absent contractility, 3.2% had esophageal-gastric junction outflow obstruction, 0.5% had distal esophageal spasm, 0.5% has achalasia, and one patient had hypercontractile esophagus.
No significant differences in manometric diagnoses appeared between men and women. In addition, HARQ scores showed a significant inverse correlation with esophageal contractility as measured by distal contractile integral (DCI).
“The proportion of patients with esophageal dysmotility is consistently high over a range of respiratory diseases, including interstitial lung disease (72%), airways disease (57%), and chronic cough (68%),” and the findings suggest that esophageal disease may play a role in patients with persistent respiratory symptoms, they noted.
The study authors proposed that “impaired peristaltic activity of the esophagus, leading to aspiration of gaseous nonacidic refluxate into the airways, may be a contributor in the development and progression of respiratory disease.” They added that the HARQ offers clinicians a useful screening tool for assessing the need for esophageal study in patients with persistent respiratory symptoms that should be used before considering antireflux surgery.
The study findings were limited by several factors including the lack of lung function data for patients with airway disease and ILD and the inability to show causality between esophageal dysmotility and refractory respiratory symptoms, the researchers noted. Other limitations include the retrospective design, and the lack of data on symptom severity and the subsequent impact on outcomes.
However, the results support the need for additional research into the relationship between esophageal dysmotility, lung function, and symptom burden in chronic respiratory disease, and may inform investigations of therapeutic targets, they concluded.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM RESPIRATORY MEDICINE
Inhaled vasodilator type has no impact on outcomes
based on data from more than 11,000 patients.
Mechanically ventilated patients with severe acute respiratory failure may be treated with inhaled vasodilators using nitric oxide or epoprostenol to improve oxygenation, but data on practice patterns and head-to-head comparisons of effectiveness for the two options are limited, wrote Nicholas A. Bosch, MD, of Boston University, and colleagues.
In a study published in the journal Chest, the researchers used the Premier Healthcare Database to emulate a cluster randomized trial. The study population included 11,200 patients aged 18 years and older who were hospitalized at one of 303 hospitals with acute respiratory failure or acute respiratory distress between 2016 and 2020.
The patients received either nitric oxide (iNO) or epoprostenol (iEpo) during a hospital stay. A total of 6,366 patients received iNO first, 4,720 received iEpo first, and 114 received both on the same day. The median age of the patients was 58 years, and 64.6% of patients received neuromuscular blockades on the day they began vasodilator therapy. The primary outcome for effectiveness was successful extubation within 28 days of receiving a vasodilator. The outcomes for evaluating practice patterns included the choice of first inhaled vasodilator, days of invasive mechanical ventilation before starting a vasodilator, duration of use, proportion of patients who switched between iNO and iEpo, and the proportion who received each type of vasodilator.
A total of 104 hospitals (34.3%) used iNO exclusively, and 118 hospitals (38.9%) used iEpo exclusively. No differences in successful extubation rates appeared between these iNO and iEpo groups (37.0% vs. 34.7%; hazard ratio, 0.97). In addition, no differences were observed between the iNO and iEpo hospitals in total hospital costs or patient deaths or discharge to hospice, and the results persisted in a multivariate analysis.
Overall, the results were similar in a subgroup analysis, although patients receiving iNO were more likely to have successful extubation after controlling for organ dysfunction, the researchers noted.
“Our study provides stronger and more robust evidence that there are no differences in patient outcomes based on inhaled vasodilator type,” and suggest that either type may be used for patients whom clinicians think would benefit, the researchers wrote in their discussion. However, neither vasodilator type has been shown to significantly improve mortality, they noted.
The findings were limited by several factors including the observational design, lack of data on medication dose, and the use of nonrandom samples of hospitalizations and patients with laboratory and vital signs data, the researchers noted. The study also did not identify the specific indication for inhaled vasodilator therapy, and did not adjust for other therapies such as prone positioning or adherence to lung protective ventilation, they said.
However, the results were strengthened by the large sample size and more precise estimates of effectiveness than previous smaller studies, and suggest similar outcomes for patients and costs for hospitals, they concluded.
The study was funded by the National Institutes of Health National Center for Advancing Translational Sciences. Lead author Dr. Bosch also was supported by NIH/NCATS, the National Heart, Lung, and Blood Institute, and the Department of Defense. The researchers had no financial conflicts to disclose.
based on data from more than 11,000 patients.
Mechanically ventilated patients with severe acute respiratory failure may be treated with inhaled vasodilators using nitric oxide or epoprostenol to improve oxygenation, but data on practice patterns and head-to-head comparisons of effectiveness for the two options are limited, wrote Nicholas A. Bosch, MD, of Boston University, and colleagues.
In a study published in the journal Chest, the researchers used the Premier Healthcare Database to emulate a cluster randomized trial. The study population included 11,200 patients aged 18 years and older who were hospitalized at one of 303 hospitals with acute respiratory failure or acute respiratory distress between 2016 and 2020.
The patients received either nitric oxide (iNO) or epoprostenol (iEpo) during a hospital stay. A total of 6,366 patients received iNO first, 4,720 received iEpo first, and 114 received both on the same day. The median age of the patients was 58 years, and 64.6% of patients received neuromuscular blockades on the day they began vasodilator therapy. The primary outcome for effectiveness was successful extubation within 28 days of receiving a vasodilator. The outcomes for evaluating practice patterns included the choice of first inhaled vasodilator, days of invasive mechanical ventilation before starting a vasodilator, duration of use, proportion of patients who switched between iNO and iEpo, and the proportion who received each type of vasodilator.
A total of 104 hospitals (34.3%) used iNO exclusively, and 118 hospitals (38.9%) used iEpo exclusively. No differences in successful extubation rates appeared between these iNO and iEpo groups (37.0% vs. 34.7%; hazard ratio, 0.97). In addition, no differences were observed between the iNO and iEpo hospitals in total hospital costs or patient deaths or discharge to hospice, and the results persisted in a multivariate analysis.
Overall, the results were similar in a subgroup analysis, although patients receiving iNO were more likely to have successful extubation after controlling for organ dysfunction, the researchers noted.
“Our study provides stronger and more robust evidence that there are no differences in patient outcomes based on inhaled vasodilator type,” and suggest that either type may be used for patients whom clinicians think would benefit, the researchers wrote in their discussion. However, neither vasodilator type has been shown to significantly improve mortality, they noted.
The findings were limited by several factors including the observational design, lack of data on medication dose, and the use of nonrandom samples of hospitalizations and patients with laboratory and vital signs data, the researchers noted. The study also did not identify the specific indication for inhaled vasodilator therapy, and did not adjust for other therapies such as prone positioning or adherence to lung protective ventilation, they said.
However, the results were strengthened by the large sample size and more precise estimates of effectiveness than previous smaller studies, and suggest similar outcomes for patients and costs for hospitals, they concluded.
The study was funded by the National Institutes of Health National Center for Advancing Translational Sciences. Lead author Dr. Bosch also was supported by NIH/NCATS, the National Heart, Lung, and Blood Institute, and the Department of Defense. The researchers had no financial conflicts to disclose.
based on data from more than 11,000 patients.
Mechanically ventilated patients with severe acute respiratory failure may be treated with inhaled vasodilators using nitric oxide or epoprostenol to improve oxygenation, but data on practice patterns and head-to-head comparisons of effectiveness for the two options are limited, wrote Nicholas A. Bosch, MD, of Boston University, and colleagues.
In a study published in the journal Chest, the researchers used the Premier Healthcare Database to emulate a cluster randomized trial. The study population included 11,200 patients aged 18 years and older who were hospitalized at one of 303 hospitals with acute respiratory failure or acute respiratory distress between 2016 and 2020.
The patients received either nitric oxide (iNO) or epoprostenol (iEpo) during a hospital stay. A total of 6,366 patients received iNO first, 4,720 received iEpo first, and 114 received both on the same day. The median age of the patients was 58 years, and 64.6% of patients received neuromuscular blockades on the day they began vasodilator therapy. The primary outcome for effectiveness was successful extubation within 28 days of receiving a vasodilator. The outcomes for evaluating practice patterns included the choice of first inhaled vasodilator, days of invasive mechanical ventilation before starting a vasodilator, duration of use, proportion of patients who switched between iNO and iEpo, and the proportion who received each type of vasodilator.
A total of 104 hospitals (34.3%) used iNO exclusively, and 118 hospitals (38.9%) used iEpo exclusively. No differences in successful extubation rates appeared between these iNO and iEpo groups (37.0% vs. 34.7%; hazard ratio, 0.97). In addition, no differences were observed between the iNO and iEpo hospitals in total hospital costs or patient deaths or discharge to hospice, and the results persisted in a multivariate analysis.
Overall, the results were similar in a subgroup analysis, although patients receiving iNO were more likely to have successful extubation after controlling for organ dysfunction, the researchers noted.
“Our study provides stronger and more robust evidence that there are no differences in patient outcomes based on inhaled vasodilator type,” and suggest that either type may be used for patients whom clinicians think would benefit, the researchers wrote in their discussion. However, neither vasodilator type has been shown to significantly improve mortality, they noted.
The findings were limited by several factors including the observational design, lack of data on medication dose, and the use of nonrandom samples of hospitalizations and patients with laboratory and vital signs data, the researchers noted. The study also did not identify the specific indication for inhaled vasodilator therapy, and did not adjust for other therapies such as prone positioning or adherence to lung protective ventilation, they said.
However, the results were strengthened by the large sample size and more precise estimates of effectiveness than previous smaller studies, and suggest similar outcomes for patients and costs for hospitals, they concluded.
The study was funded by the National Institutes of Health National Center for Advancing Translational Sciences. Lead author Dr. Bosch also was supported by NIH/NCATS, the National Heart, Lung, and Blood Institute, and the Department of Defense. The researchers had no financial conflicts to disclose.
FROM CHEST
Congenital cytomegalovirus declined in wake of COVID-19
Congenital cytomegalovirus cases declined significantly during the COVID-19 pandemic, compared with a period before the pandemic, based on data from nearly 20,000 newborns.
A study originated to explore racial and ethnic differences in congenital cytomegalovirus (cCMV) began in 2016, but was halted in April 2020 because of the COVID-19 pandemic, wrote Mark R. Schleiss, MD, of the University of Minnesota, Minneapolis, and colleagues. The study resumed for a period from August 2020 to December 2021, and the researchers compared data on cCMV before and during the pandemic. The prepandemic period included data from April 2016 to March 2020.
“We have been screening for congenital CMV infection in Minnesota for 6 years as a part of a multicenter collaborative study that I lead as the primary investigator,” Dr. Schleiss said in an interview. “Our efforts have contributed to the decision, vetted through the Minnesota Legislature and signed into law in 2021 (the “Vivian Act”), to begin universal screening for all newborns in Minnesota in 2023. In the context of this ongoing screening/surveillance study, it was important and scientifically very interesting to examine the impact of the COVID-19 pandemic on the risk of congenital CMV infection,” he explained.
The findings were published in a research letter in JAMA Network Open. A total of 15,697 newborns were screened before the pandemic and 4,222 were screened during the pandemic period at six hospitals. The majority of the mothers participating during the prepandemic and pandemic periods were non-Hispanic White (71% and 60%, respectively).
Overall, the percentage screened prevalence for cCMV was 79% in the prepandemic period and 21% during the pandemic, with rates of 4.5 per 1,000 and 1.4 per 1,000, respectively.
Although the highest percentage of cCMV cases occurred in newborns of mothers aged 25 years and older (86%), the prevalence was highest among newborns of mothers aged 24 years and younger (6.0 per 1,000). The prevalence of cCMV overall was higher in infants of non-Hispanic Black mothers vs. non-Hispanic White mothers, but not significantly different (5.1 per 1,000 vs. 4.6 per 1,000) and among second newborns vs. first newborns (6.0 vs. 3.2 per 1,000, respectively).
Factors related to COVID-19, including reduced day care attendance, behavioral changes, and mitigation measures at childcare facilities such as smaller classes and increased hand hygiene and disinfection may have contributed to this decrease in cCMV in the pandemic period, the researchers wrote in their discussion.
The comparable prevalence in newborns of non-Hispanic Black and White mothers contrasts with previous studies showing a higher prevalence in children of non-Hispanic Black mothers, the researchers noted in their discussion.
The study was limited by several factors, including the variation in time points for enrollment at different sites and the exclusion of families in the newborn nursery with positive COVID-19 results during the pandemic, they wrote. More research is needed on the potential effects of behavioral interventions to reduce CMV risk during pregnancy, as well as future CMV vaccination for childbearing-aged women and young children, they concluded.
However, the researchers were surprised by the impact of COVID-19 on the prevalence of cCMV, Dr. Schleiss said in an interview. “We have had the knowledge for many years that CMV infections in young women are commonly acquired through interactions with their toddlers. These interactions – sharing food, wiping drool and nasal discharge from the toddler’s nose, changing diapers, kissing the child on the mouth – can transmit CMV,” he said. In addition, toddlers may acquire CMV from group day care; the child then sheds CMV and transmits the virus to their pregnant mother, who then transmits the virus across the placenta, leading to cCMV infection in the newborn, Dr. Schleiss explained.
Although the researchers expected a decrease in CMV in the wake of closures of group day care, increased home schooling, decreased interactions among children, hygienic precautions, and social isolation, the decrease exceeded their expectations, said Dr. Schleiss. “Our previous work showed that in the 5-year period leading up to the pandemic, about one baby in every 200 births was born with CMV. Between August 2020 and December 2021, the number decreased to one baby in every 1,000 births,” a difference he and his team found striking.
The message from the study is that CMV can be prevented, said Dr. Schleiss. “Hygienic precautions during pregnancy had a big impact. Since congenital CMV infection is the most common congenital infection in the United States, and probably globally, that causes disabilities in children, the implications are highly significant,” he said. “The hygienic precautions we all have engaged in during the pandemic, such as masking, handwashing, and infection prevention behaviors, were almost certainly responsible for the reduction in CMV transmission, which in turn protected mothers and newborns from the potentially devastating effects of the CMV virus,” he noted.
Looking ahead, “Vaccines are moving forward in clinical trials that aim to confer immunity on young women of childbearing age to protect future pregnancies against transmission of CMV to the newborn infant; it would be very important to examine in future studies whether hygienic precautions would have the same impact as a potential vaccine,” Dr. Schleiss said. More research is needed to examine the effect of education of women about CMV transmission, he added. “We think it is very important to share this knowledge from our study with the pediatric community, since pediatricians can be important in counseling women about future pregnancies and the risks of CMV acquisition and transmission,” he noted.
Implications for other viruses
Although CMV poses minimal risk for healthy populations, irreversible complications for infants born with congenital CMV, especially hearing loss, are very concerning, said Catherine Haut, DNP, CPNP-AC/PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview.
“The study of viral transmission during a time of isolation, masking, and other mitigation procedures for COVID-19 assists in awareness that other viruses may also be limited with the use of these measures,” she said.
Dr. Haut was not surprised by the findings, given that CMV is transmitted primarily through direct contact with body fluids and that more than 50% of American adults have been infected by age 40, according to the Centers for Disease Control and Prevention, she said.
The take-home message for pediatricians, Dr. Haut said, is measures to prevent transmission of viral infection can yield significant positive health outcomes for the pediatric population; however, the effect of isolation, which has been associated with a higher rate of mental health problems, should not be ignored.
“Despite appropriate statistical analyses and presentation of findings in this study, the population sampled during the pandemic was less than 30% of the pre-COVID sampling, representing a study limitation,” and conducting research in a single state limits generalizability, Dr. Haut noted. “I agree with the authors that additional study is necessary to better understand prevention measures and apply these methods to reduce CMV transmission. Pursuit of CMV immunization opportunities is also needed,” she said.
The study was supported by the Centers for Disease Control and Prevention, the National Vaccine Program Office, the Minnesota Department of Health Newborn Screening Program, and the University of South Carolina Disability Research and Dissemination Center. Lead author Dr. Schleiss disclosed grants from the CDC, the National Institutes of Health, and the DRDC during the conduct of the study; he also disclosed receiving personal fees from Moderna, Sanofi, GlaxoSmithKline, and Merck unrelated to the study. Dr. Haut had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
Congenital cytomegalovirus cases declined significantly during the COVID-19 pandemic, compared with a period before the pandemic, based on data from nearly 20,000 newborns.
A study originated to explore racial and ethnic differences in congenital cytomegalovirus (cCMV) began in 2016, but was halted in April 2020 because of the COVID-19 pandemic, wrote Mark R. Schleiss, MD, of the University of Minnesota, Minneapolis, and colleagues. The study resumed for a period from August 2020 to December 2021, and the researchers compared data on cCMV before and during the pandemic. The prepandemic period included data from April 2016 to March 2020.
“We have been screening for congenital CMV infection in Minnesota for 6 years as a part of a multicenter collaborative study that I lead as the primary investigator,” Dr. Schleiss said in an interview. “Our efforts have contributed to the decision, vetted through the Minnesota Legislature and signed into law in 2021 (the “Vivian Act”), to begin universal screening for all newborns in Minnesota in 2023. In the context of this ongoing screening/surveillance study, it was important and scientifically very interesting to examine the impact of the COVID-19 pandemic on the risk of congenital CMV infection,” he explained.
The findings were published in a research letter in JAMA Network Open. A total of 15,697 newborns were screened before the pandemic and 4,222 were screened during the pandemic period at six hospitals. The majority of the mothers participating during the prepandemic and pandemic periods were non-Hispanic White (71% and 60%, respectively).
Overall, the percentage screened prevalence for cCMV was 79% in the prepandemic period and 21% during the pandemic, with rates of 4.5 per 1,000 and 1.4 per 1,000, respectively.
Although the highest percentage of cCMV cases occurred in newborns of mothers aged 25 years and older (86%), the prevalence was highest among newborns of mothers aged 24 years and younger (6.0 per 1,000). The prevalence of cCMV overall was higher in infants of non-Hispanic Black mothers vs. non-Hispanic White mothers, but not significantly different (5.1 per 1,000 vs. 4.6 per 1,000) and among second newborns vs. first newborns (6.0 vs. 3.2 per 1,000, respectively).
Factors related to COVID-19, including reduced day care attendance, behavioral changes, and mitigation measures at childcare facilities such as smaller classes and increased hand hygiene and disinfection may have contributed to this decrease in cCMV in the pandemic period, the researchers wrote in their discussion.
The comparable prevalence in newborns of non-Hispanic Black and White mothers contrasts with previous studies showing a higher prevalence in children of non-Hispanic Black mothers, the researchers noted in their discussion.
The study was limited by several factors, including the variation in time points for enrollment at different sites and the exclusion of families in the newborn nursery with positive COVID-19 results during the pandemic, they wrote. More research is needed on the potential effects of behavioral interventions to reduce CMV risk during pregnancy, as well as future CMV vaccination for childbearing-aged women and young children, they concluded.
However, the researchers were surprised by the impact of COVID-19 on the prevalence of cCMV, Dr. Schleiss said in an interview. “We have had the knowledge for many years that CMV infections in young women are commonly acquired through interactions with their toddlers. These interactions – sharing food, wiping drool and nasal discharge from the toddler’s nose, changing diapers, kissing the child on the mouth – can transmit CMV,” he said. In addition, toddlers may acquire CMV from group day care; the child then sheds CMV and transmits the virus to their pregnant mother, who then transmits the virus across the placenta, leading to cCMV infection in the newborn, Dr. Schleiss explained.
Although the researchers expected a decrease in CMV in the wake of closures of group day care, increased home schooling, decreased interactions among children, hygienic precautions, and social isolation, the decrease exceeded their expectations, said Dr. Schleiss. “Our previous work showed that in the 5-year period leading up to the pandemic, about one baby in every 200 births was born with CMV. Between August 2020 and December 2021, the number decreased to one baby in every 1,000 births,” a difference he and his team found striking.
The message from the study is that CMV can be prevented, said Dr. Schleiss. “Hygienic precautions during pregnancy had a big impact. Since congenital CMV infection is the most common congenital infection in the United States, and probably globally, that causes disabilities in children, the implications are highly significant,” he said. “The hygienic precautions we all have engaged in during the pandemic, such as masking, handwashing, and infection prevention behaviors, were almost certainly responsible for the reduction in CMV transmission, which in turn protected mothers and newborns from the potentially devastating effects of the CMV virus,” he noted.
Looking ahead, “Vaccines are moving forward in clinical trials that aim to confer immunity on young women of childbearing age to protect future pregnancies against transmission of CMV to the newborn infant; it would be very important to examine in future studies whether hygienic precautions would have the same impact as a potential vaccine,” Dr. Schleiss said. More research is needed to examine the effect of education of women about CMV transmission, he added. “We think it is very important to share this knowledge from our study with the pediatric community, since pediatricians can be important in counseling women about future pregnancies and the risks of CMV acquisition and transmission,” he noted.
Implications for other viruses
Although CMV poses minimal risk for healthy populations, irreversible complications for infants born with congenital CMV, especially hearing loss, are very concerning, said Catherine Haut, DNP, CPNP-AC/PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview.
“The study of viral transmission during a time of isolation, masking, and other mitigation procedures for COVID-19 assists in awareness that other viruses may also be limited with the use of these measures,” she said.
Dr. Haut was not surprised by the findings, given that CMV is transmitted primarily through direct contact with body fluids and that more than 50% of American adults have been infected by age 40, according to the Centers for Disease Control and Prevention, she said.
The take-home message for pediatricians, Dr. Haut said, is measures to prevent transmission of viral infection can yield significant positive health outcomes for the pediatric population; however, the effect of isolation, which has been associated with a higher rate of mental health problems, should not be ignored.
“Despite appropriate statistical analyses and presentation of findings in this study, the population sampled during the pandemic was less than 30% of the pre-COVID sampling, representing a study limitation,” and conducting research in a single state limits generalizability, Dr. Haut noted. “I agree with the authors that additional study is necessary to better understand prevention measures and apply these methods to reduce CMV transmission. Pursuit of CMV immunization opportunities is also needed,” she said.
The study was supported by the Centers for Disease Control and Prevention, the National Vaccine Program Office, the Minnesota Department of Health Newborn Screening Program, and the University of South Carolina Disability Research and Dissemination Center. Lead author Dr. Schleiss disclosed grants from the CDC, the National Institutes of Health, and the DRDC during the conduct of the study; he also disclosed receiving personal fees from Moderna, Sanofi, GlaxoSmithKline, and Merck unrelated to the study. Dr. Haut had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
Congenital cytomegalovirus cases declined significantly during the COVID-19 pandemic, compared with a period before the pandemic, based on data from nearly 20,000 newborns.
A study originated to explore racial and ethnic differences in congenital cytomegalovirus (cCMV) began in 2016, but was halted in April 2020 because of the COVID-19 pandemic, wrote Mark R. Schleiss, MD, of the University of Minnesota, Minneapolis, and colleagues. The study resumed for a period from August 2020 to December 2021, and the researchers compared data on cCMV before and during the pandemic. The prepandemic period included data from April 2016 to March 2020.
“We have been screening for congenital CMV infection in Minnesota for 6 years as a part of a multicenter collaborative study that I lead as the primary investigator,” Dr. Schleiss said in an interview. “Our efforts have contributed to the decision, vetted through the Minnesota Legislature and signed into law in 2021 (the “Vivian Act”), to begin universal screening for all newborns in Minnesota in 2023. In the context of this ongoing screening/surveillance study, it was important and scientifically very interesting to examine the impact of the COVID-19 pandemic on the risk of congenital CMV infection,” he explained.
The findings were published in a research letter in JAMA Network Open. A total of 15,697 newborns were screened before the pandemic and 4,222 were screened during the pandemic period at six hospitals. The majority of the mothers participating during the prepandemic and pandemic periods were non-Hispanic White (71% and 60%, respectively).
Overall, the percentage screened prevalence for cCMV was 79% in the prepandemic period and 21% during the pandemic, with rates of 4.5 per 1,000 and 1.4 per 1,000, respectively.
Although the highest percentage of cCMV cases occurred in newborns of mothers aged 25 years and older (86%), the prevalence was highest among newborns of mothers aged 24 years and younger (6.0 per 1,000). The prevalence of cCMV overall was higher in infants of non-Hispanic Black mothers vs. non-Hispanic White mothers, but not significantly different (5.1 per 1,000 vs. 4.6 per 1,000) and among second newborns vs. first newborns (6.0 vs. 3.2 per 1,000, respectively).
Factors related to COVID-19, including reduced day care attendance, behavioral changes, and mitigation measures at childcare facilities such as smaller classes and increased hand hygiene and disinfection may have contributed to this decrease in cCMV in the pandemic period, the researchers wrote in their discussion.
The comparable prevalence in newborns of non-Hispanic Black and White mothers contrasts with previous studies showing a higher prevalence in children of non-Hispanic Black mothers, the researchers noted in their discussion.
The study was limited by several factors, including the variation in time points for enrollment at different sites and the exclusion of families in the newborn nursery with positive COVID-19 results during the pandemic, they wrote. More research is needed on the potential effects of behavioral interventions to reduce CMV risk during pregnancy, as well as future CMV vaccination for childbearing-aged women and young children, they concluded.
However, the researchers were surprised by the impact of COVID-19 on the prevalence of cCMV, Dr. Schleiss said in an interview. “We have had the knowledge for many years that CMV infections in young women are commonly acquired through interactions with their toddlers. These interactions – sharing food, wiping drool and nasal discharge from the toddler’s nose, changing diapers, kissing the child on the mouth – can transmit CMV,” he said. In addition, toddlers may acquire CMV from group day care; the child then sheds CMV and transmits the virus to their pregnant mother, who then transmits the virus across the placenta, leading to cCMV infection in the newborn, Dr. Schleiss explained.
Although the researchers expected a decrease in CMV in the wake of closures of group day care, increased home schooling, decreased interactions among children, hygienic precautions, and social isolation, the decrease exceeded their expectations, said Dr. Schleiss. “Our previous work showed that in the 5-year period leading up to the pandemic, about one baby in every 200 births was born with CMV. Between August 2020 and December 2021, the number decreased to one baby in every 1,000 births,” a difference he and his team found striking.
The message from the study is that CMV can be prevented, said Dr. Schleiss. “Hygienic precautions during pregnancy had a big impact. Since congenital CMV infection is the most common congenital infection in the United States, and probably globally, that causes disabilities in children, the implications are highly significant,” he said. “The hygienic precautions we all have engaged in during the pandemic, such as masking, handwashing, and infection prevention behaviors, were almost certainly responsible for the reduction in CMV transmission, which in turn protected mothers and newborns from the potentially devastating effects of the CMV virus,” he noted.
Looking ahead, “Vaccines are moving forward in clinical trials that aim to confer immunity on young women of childbearing age to protect future pregnancies against transmission of CMV to the newborn infant; it would be very important to examine in future studies whether hygienic precautions would have the same impact as a potential vaccine,” Dr. Schleiss said. More research is needed to examine the effect of education of women about CMV transmission, he added. “We think it is very important to share this knowledge from our study with the pediatric community, since pediatricians can be important in counseling women about future pregnancies and the risks of CMV acquisition and transmission,” he noted.
Implications for other viruses
Although CMV poses minimal risk for healthy populations, irreversible complications for infants born with congenital CMV, especially hearing loss, are very concerning, said Catherine Haut, DNP, CPNP-AC/PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview.
“The study of viral transmission during a time of isolation, masking, and other mitigation procedures for COVID-19 assists in awareness that other viruses may also be limited with the use of these measures,” she said.
Dr. Haut was not surprised by the findings, given that CMV is transmitted primarily through direct contact with body fluids and that more than 50% of American adults have been infected by age 40, according to the Centers for Disease Control and Prevention, she said.
The take-home message for pediatricians, Dr. Haut said, is measures to prevent transmission of viral infection can yield significant positive health outcomes for the pediatric population; however, the effect of isolation, which has been associated with a higher rate of mental health problems, should not be ignored.
“Despite appropriate statistical analyses and presentation of findings in this study, the population sampled during the pandemic was less than 30% of the pre-COVID sampling, representing a study limitation,” and conducting research in a single state limits generalizability, Dr. Haut noted. “I agree with the authors that additional study is necessary to better understand prevention measures and apply these methods to reduce CMV transmission. Pursuit of CMV immunization opportunities is also needed,” she said.
The study was supported by the Centers for Disease Control and Prevention, the National Vaccine Program Office, the Minnesota Department of Health Newborn Screening Program, and the University of South Carolina Disability Research and Dissemination Center. Lead author Dr. Schleiss disclosed grants from the CDC, the National Institutes of Health, and the DRDC during the conduct of the study; he also disclosed receiving personal fees from Moderna, Sanofi, GlaxoSmithKline, and Merck unrelated to the study. Dr. Haut had no financial conflicts to disclose and serves on the Editorial Advisory Board of Pediatric News.
FROM JAMA NETWORK OPEN