Pulmonology

The Mine Safety and Health Administration (MSHA) has announced a new final rule designed to protect miners from the dangers of exposure to silica dust, according to a press release from the US Department of Labor.

Respirable crystalline silica, also known as silica dust or quartz dust, is a known carcinogen associated with a range of serious health conditions including silicosis, lung cancer, progressive massive fibrosis, chronic bronchitis, and kidney disease. 

The MSHA final rule reduces the permissible exposure limit of respirable crystalline silica to 50 micrograms per cubic meter of air for a miner›s full-shift exposure, which was calculated as an 8-hour time-weighted average. If a miner’s exposure exceeds this limit, mine operators must take immediate action to comply with it, according to the new final rule. 

“It is unconscionable that our nation’s miners have worked without adequate protection from silica dust despite it being a known health hazard for decades,” said Department of Labor acting secretary Julie Su, in the press release. “The Department of Labor has taken an important action to finally reduce miners’ exposure to toxic silica dust and protect them from suffering from preventable diseases,” she said. 

The final rule requires mine operators to prevent miners’ overexposures by using engineering controls and to use environmental evaluations and dust samplings to monitor their exposures. The rule also updates standards for respiratory protection to include the latest advances in equipment and practices to safeguard miners against a range of airborne hazards including silica dust, diesel particulate matter, and asbestos.

In addition, the rule requires metal and nonmetal mine operators to establish medical surveillance programs and provide periodic health examinations to minors at no cost, similar to existing programs for coal miners, according to the press release. 

Implementation of the rule will result in approximately 1067 lifetime avoided deaths and 3746 lifetime avoided cases of silica-related illness, according to MSHA. 

“Congress gave MSHA the authority to regulate toxic substances to protect miners from health hazards and made clear in the Mine Act that miners’ health and safety must always be our first priority and concern,” said Chris Williamson, assistant secretary for mine safety and health, in the press release. “To further advance this directive, MSHA is committed to working together with everyone in the mining community to implement this rule successfully. No miner should ever have to sacrifice their health or lungs to provide for their family,” he said.

A version of this article appeared on Medscape.com.

The Mine Safety and Health Administration (MSHA) has announced a new final rule designed to protect miners from the dangers of exposure to silica dust, according to a press release from the US Department of Labor.

Respirable crystalline silica, also known as silica dust or quartz dust, is a known carcinogen associated with a range of serious health conditions including silicosis, lung cancer, progressive massive fibrosis, chronic bronchitis, and kidney disease. 

The MSHA final rule reduces the permissible exposure limit of respirable crystalline silica to 50 micrograms per cubic meter of air for a miner›s full-shift exposure, which was calculated as an 8-hour time-weighted average. If a miner’s exposure exceeds this limit, mine operators must take immediate action to comply with it, according to the new final rule. 

“It is unconscionable that our nation’s miners have worked without adequate protection from silica dust despite it being a known health hazard for decades,” said Department of Labor acting secretary Julie Su, in the press release. “The Department of Labor has taken an important action to finally reduce miners’ exposure to toxic silica dust and protect them from suffering from preventable diseases,” she said. 

The final rule requires mine operators to prevent miners’ overexposures by using engineering controls and to use environmental evaluations and dust samplings to monitor their exposures. The rule also updates standards for respiratory protection to include the latest advances in equipment and practices to safeguard miners against a range of airborne hazards including silica dust, diesel particulate matter, and asbestos.

In addition, the rule requires metal and nonmetal mine operators to establish medical surveillance programs and provide periodic health examinations to minors at no cost, similar to existing programs for coal miners, according to the press release. 

Implementation of the rule will result in approximately 1067 lifetime avoided deaths and 3746 lifetime avoided cases of silica-related illness, according to MSHA. 

“Congress gave MSHA the authority to regulate toxic substances to protect miners from health hazards and made clear in the Mine Act that miners’ health and safety must always be our first priority and concern,” said Chris Williamson, assistant secretary for mine safety and health, in the press release. “To further advance this directive, MSHA is committed to working together with everyone in the mining community to implement this rule successfully. No miner should ever have to sacrifice their health or lungs to provide for their family,” he said.

A version of this article appeared on Medscape.com.

The Mine Safety and Health Administration (MSHA) has announced a new final rule designed to protect miners from the dangers of exposure to silica dust, according to a press release from the US Department of Labor.

Respirable crystalline silica, also known as silica dust or quartz dust, is a known carcinogen associated with a range of serious health conditions including silicosis, lung cancer, progressive massive fibrosis, chronic bronchitis, and kidney disease. 

The MSHA final rule reduces the permissible exposure limit of respirable crystalline silica to 50 micrograms per cubic meter of air for a miner›s full-shift exposure, which was calculated as an 8-hour time-weighted average. If a miner’s exposure exceeds this limit, mine operators must take immediate action to comply with it, according to the new final rule. 

“It is unconscionable that our nation’s miners have worked without adequate protection from silica dust despite it being a known health hazard for decades,” said Department of Labor acting secretary Julie Su, in the press release. “The Department of Labor has taken an important action to finally reduce miners’ exposure to toxic silica dust and protect them from suffering from preventable diseases,” she said. 

The final rule requires mine operators to prevent miners’ overexposures by using engineering controls and to use environmental evaluations and dust samplings to monitor their exposures. The rule also updates standards for respiratory protection to include the latest advances in equipment and practices to safeguard miners against a range of airborne hazards including silica dust, diesel particulate matter, and asbestos.

In addition, the rule requires metal and nonmetal mine operators to establish medical surveillance programs and provide periodic health examinations to minors at no cost, similar to existing programs for coal miners, according to the press release. 

Implementation of the rule will result in approximately 1067 lifetime avoided deaths and 3746 lifetime avoided cases of silica-related illness, according to MSHA. 

“Congress gave MSHA the authority to regulate toxic substances to protect miners from health hazards and made clear in the Mine Act that miners’ health and safety must always be our first priority and concern,” said Chris Williamson, assistant secretary for mine safety and health, in the press release. “To further advance this directive, MSHA is committed to working together with everyone in the mining community to implement this rule successfully. No miner should ever have to sacrifice their health or lungs to provide for their family,” he said.

A version of this article appeared on Medscape.com.

After cow-to-cow transmission of avian influenza A subtype H5N1 in US dairy herds led to a cow-to-human transmission in Texas, the Association of State and Territorial Health Officials convened a panel of experts for a scientific symposium on Thursday to talk about the public health implications.

“The risk to the general public remains low,” said Vivien Dugan, PhD, director of the Influenza Division at the Centers for Disease Control and Prevention (CDC). And should there be an outbreak, vaccine development measures are in place, she added.

From the sequencing data, “we can expect and anticipate that [the candidate vaccine viruses] will provide good protection,” she explained.

Establishing candidate vaccine viruses “are the precursor to moving into large-scale vaccine production,” Dr. Dugan explained. Should that be needed, the candidate viruses can be used by manufacturers to produce new vaccines.

The CDC is also actively partnering with commercial diagnostic developers and testing companies in case there is a need to scale-up testing, Dr. Dugan said.

The only current human case in the United States was reported on April 1 and confirmed by the CDC within 24 hours, reported Sonja Olsen, PhD, associate director for preparedness and response of the Influenza Division at the CDC.

The person had direct exposure to cattle and reported eye redness, consistent with conjunctivitis, as the only symptom. The person received treatment and has recovered, and there were no reports of illness among the person’s household contacts, Dr. Olsen said.
 

Person With the Virus Has Recovered

The only other detection of the virus in a human in the United States was in 2022 and it was associated with infected poultry exposure. That person also had mild illness and recovered, Dr. Olsen explained.

Since 1997, when the first case of human infection was reported globally, “there have been 909 [human cases] reported from 23 countries,” Dr. Olsen said. “About half [52%] of the human cases have resulted in death.” Only a small number of human cases have been reported since 2015, but since 2022, more than two dozen human cases have been reported to the World Health Organization.

Experience with the virus in the United States has been about a year behind that in Europe, said Rosemary Sifford, DVM, chief veterinary officer at the US Department of Agriculture. In the United States, the first detection — in January 2022 — was in wild birds; this was followed the next month by the first detection in a commercial poultry flock.

In March of this year, the United States had its first detection in cattle, specifically dairy cattle. But testing has shown that “it remains very much an avian virus. It’s not becoming a bovine virus,” Dr. Sifford reported.
 

Detected in Cattle

Earlier this week, in an effort to minimize the risk of disease spread, the USDA issued a federal order that requires the reporting of positive influenza tests in livestock and mandatory testing for influenza of dairy cattle before interstate movement.

“As of today, there are affected herds in 33 farms across eight states,” reported Dr. Olsen.

Tests are ongoing to determine how the virus is traveling, but “what we can say is that there’s a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herds,” Dr. Sifford reported. It is unclear whether that is happening during the milking of the cows or whether contaminated milk from a cow with a high viral load is transmitting the virus to other cattle.

“We are strongly encouraging producers to limit the movement of cattle, particularly lactating cattle, as much as possible,” she says.
 

Milk Is Likely the Source of Transmission

“We haven’t seen anything that would change our assessment that the commercial milk supply is safe,” says Donald Prater, DVM, acting director of the Center for Food Safety and Applied Nutrition at the US Food and Drug Administration (FDA).

In the federal and state milk safety system, he explained, nearly 99% of the commercial milk supply comes from farms that participate in the Grade A program and follow the Pasteurized Milk Ordinance, which outlines pasteurization requirements.

Because detection of the virus in dairy cattle is new, there are many questions to be answered in research, he reported. Among them:

• What level of virus might be leaving the farms from shedding by apparently healthy cows?
• Does any live virus survive the pasteurization process?
• Do different methods of pasteurization and dairy production have different effects on the viability of H5N1?
• Are effects different in various forms of dairy products, such as cheese and cream?

A critical question regarding the potential risk to humans is how much milk would have to be consumed for the virus to become an established infection. That information is essential to determine “what type of pasteurization criteria” are needed to provide “acceptable public health outcomes,” Dr. Prater said.

The CDC is currently using the flu surveillance system to monitor for H5N1 activity in people. The systems show no current indicators of unusual influenza activity in people.

A version of this article appeared on Medscape.com.

After cow-to-cow transmission of avian influenza A subtype H5N1 in US dairy herds led to a cow-to-human transmission in Texas, the Association of State and Territorial Health Officials convened a panel of experts for a scientific symposium on Thursday to talk about the public health implications.

“The risk to the general public remains low,” said Vivien Dugan, PhD, director of the Influenza Division at the Centers for Disease Control and Prevention (CDC). And should there be an outbreak, vaccine development measures are in place, she added.

From the sequencing data, “we can expect and anticipate that [the candidate vaccine viruses] will provide good protection,” she explained.

Establishing candidate vaccine viruses “are the precursor to moving into large-scale vaccine production,” Dr. Dugan explained. Should that be needed, the candidate viruses can be used by manufacturers to produce new vaccines.

The CDC is also actively partnering with commercial diagnostic developers and testing companies in case there is a need to scale-up testing, Dr. Dugan said.

The only current human case in the United States was reported on April 1 and confirmed by the CDC within 24 hours, reported Sonja Olsen, PhD, associate director for preparedness and response of the Influenza Division at the CDC.

The person had direct exposure to cattle and reported eye redness, consistent with conjunctivitis, as the only symptom. The person received treatment and has recovered, and there were no reports of illness among the person’s household contacts, Dr. Olsen said.
 

Person With the Virus Has Recovered

The only other detection of the virus in a human in the United States was in 2022 and it was associated with infected poultry exposure. That person also had mild illness and recovered, Dr. Olsen explained.

Since 1997, when the first case of human infection was reported globally, “there have been 909 [human cases] reported from 23 countries,” Dr. Olsen said. “About half [52%] of the human cases have resulted in death.” Only a small number of human cases have been reported since 2015, but since 2022, more than two dozen human cases have been reported to the World Health Organization.

Experience with the virus in the United States has been about a year behind that in Europe, said Rosemary Sifford, DVM, chief veterinary officer at the US Department of Agriculture. In the United States, the first detection — in January 2022 — was in wild birds; this was followed the next month by the first detection in a commercial poultry flock.

In March of this year, the United States had its first detection in cattle, specifically dairy cattle. But testing has shown that “it remains very much an avian virus. It’s not becoming a bovine virus,” Dr. Sifford reported.
 

Detected in Cattle

Earlier this week, in an effort to minimize the risk of disease spread, the USDA issued a federal order that requires the reporting of positive influenza tests in livestock and mandatory testing for influenza of dairy cattle before interstate movement.

“As of today, there are affected herds in 33 farms across eight states,” reported Dr. Olsen.

Tests are ongoing to determine how the virus is traveling, but “what we can say is that there’s a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herds,” Dr. Sifford reported. It is unclear whether that is happening during the milking of the cows or whether contaminated milk from a cow with a high viral load is transmitting the virus to other cattle.

“We are strongly encouraging producers to limit the movement of cattle, particularly lactating cattle, as much as possible,” she says.
 

Milk Is Likely the Source of Transmission

“We haven’t seen anything that would change our assessment that the commercial milk supply is safe,” says Donald Prater, DVM, acting director of the Center for Food Safety and Applied Nutrition at the US Food and Drug Administration (FDA).

In the federal and state milk safety system, he explained, nearly 99% of the commercial milk supply comes from farms that participate in the Grade A program and follow the Pasteurized Milk Ordinance, which outlines pasteurization requirements.

Because detection of the virus in dairy cattle is new, there are many questions to be answered in research, he reported. Among them:

• What level of virus might be leaving the farms from shedding by apparently healthy cows?
• Does any live virus survive the pasteurization process?
• Do different methods of pasteurization and dairy production have different effects on the viability of H5N1?
• Are effects different in various forms of dairy products, such as cheese and cream?

A critical question regarding the potential risk to humans is how much milk would have to be consumed for the virus to become an established infection. That information is essential to determine “what type of pasteurization criteria” are needed to provide “acceptable public health outcomes,” Dr. Prater said.

The CDC is currently using the flu surveillance system to monitor for H5N1 activity in people. The systems show no current indicators of unusual influenza activity in people.

A version of this article appeared on Medscape.com.

After cow-to-cow transmission of avian influenza A subtype H5N1 in US dairy herds led to a cow-to-human transmission in Texas, the Association of State and Territorial Health Officials convened a panel of experts for a scientific symposium on Thursday to talk about the public health implications.

“The risk to the general public remains low,” said Vivien Dugan, PhD, director of the Influenza Division at the Centers for Disease Control and Prevention (CDC). And should there be an outbreak, vaccine development measures are in place, she added.

From the sequencing data, “we can expect and anticipate that [the candidate vaccine viruses] will provide good protection,” she explained.

Establishing candidate vaccine viruses “are the precursor to moving into large-scale vaccine production,” Dr. Dugan explained. Should that be needed, the candidate viruses can be used by manufacturers to produce new vaccines.

The CDC is also actively partnering with commercial diagnostic developers and testing companies in case there is a need to scale-up testing, Dr. Dugan said.

The only current human case in the United States was reported on April 1 and confirmed by the CDC within 24 hours, reported Sonja Olsen, PhD, associate director for preparedness and response of the Influenza Division at the CDC.

The person had direct exposure to cattle and reported eye redness, consistent with conjunctivitis, as the only symptom. The person received treatment and has recovered, and there were no reports of illness among the person’s household contacts, Dr. Olsen said.
 

Person With the Virus Has Recovered

The only other detection of the virus in a human in the United States was in 2022 and it was associated with infected poultry exposure. That person also had mild illness and recovered, Dr. Olsen explained.

Since 1997, when the first case of human infection was reported globally, “there have been 909 [human cases] reported from 23 countries,” Dr. Olsen said. “About half [52%] of the human cases have resulted in death.” Only a small number of human cases have been reported since 2015, but since 2022, more than two dozen human cases have been reported to the World Health Organization.

Experience with the virus in the United States has been about a year behind that in Europe, said Rosemary Sifford, DVM, chief veterinary officer at the US Department of Agriculture. In the United States, the first detection — in January 2022 — was in wild birds; this was followed the next month by the first detection in a commercial poultry flock.

In March of this year, the United States had its first detection in cattle, specifically dairy cattle. But testing has shown that “it remains very much an avian virus. It’s not becoming a bovine virus,” Dr. Sifford reported.
 

Detected in Cattle

Earlier this week, in an effort to minimize the risk of disease spread, the USDA issued a federal order that requires the reporting of positive influenza tests in livestock and mandatory testing for influenza of dairy cattle before interstate movement.

“As of today, there are affected herds in 33 farms across eight states,” reported Dr. Olsen.

Tests are ongoing to determine how the virus is traveling, but “what we can say is that there’s a high viral load in the milk in the cattle, and it appears that the transmission is happening mostly within the lactating herds,” Dr. Sifford reported. It is unclear whether that is happening during the milking of the cows or whether contaminated milk from a cow with a high viral load is transmitting the virus to other cattle.

“We are strongly encouraging producers to limit the movement of cattle, particularly lactating cattle, as much as possible,” she says.
 

Milk Is Likely the Source of Transmission

“We haven’t seen anything that would change our assessment that the commercial milk supply is safe,” says Donald Prater, DVM, acting director of the Center for Food Safety and Applied Nutrition at the US Food and Drug Administration (FDA).

In the federal and state milk safety system, he explained, nearly 99% of the commercial milk supply comes from farms that participate in the Grade A program and follow the Pasteurized Milk Ordinance, which outlines pasteurization requirements.

Because detection of the virus in dairy cattle is new, there are many questions to be answered in research, he reported. Among them:

• What level of virus might be leaving the farms from shedding by apparently healthy cows?
• Does any live virus survive the pasteurization process?
• Do different methods of pasteurization and dairy production have different effects on the viability of H5N1?
• Are effects different in various forms of dairy products, such as cheese and cream?

A critical question regarding the potential risk to humans is how much milk would have to be consumed for the virus to become an established infection. That information is essential to determine “what type of pasteurization criteria” are needed to provide “acceptable public health outcomes,” Dr. Prater said.

The CDC is currently using the flu surveillance system to monitor for H5N1 activity in people. The systems show no current indicators of unusual influenza activity in people.

A version of this article appeared on Medscape.com.

An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

An algorithm-driven risk assessment embedded in an electronic health record (EHR) helped clinicians reduce inappropriate broad-spectrum antibiotic prescribing by 17.4% and 28.4% in patients with UTIs and pneumonia, respectively, according to two related studies published in JAMA.

The randomized control trials included more than 200,000 adult patients with non–life threatening pneumonia or urinary tract infections (UTIs) in 59 hospitals owned by HCA Healthcare across the country. 

Researchers analyzed baseline prescribing behaviors over an 18-month period starting in April 2017, and data from a 15-month period of implementation of the new antibiotic system starting in April 2019.

They focused on the use of broad-spectrum antibiotics during the first 3 days of hospital admission, before microbiologic test results came back, and when clinicians are likely to err on the side of caution and prescribe one of the drugs, according to lead author Shruti K. Gohil, MD, MPH, associate medical director of epidemiology and infection prevention, infectious diseases at the University of California Irvine School of Medicine. 

“When a patient comes in with pneumonia or a UTI, it’s precisely because we are concerned that our patients have a multidrug-resistant organism that we end up using broad-spectrum antibiotics,” she said. 

Despite growing awareness of the need to reduce unnecessary antibiotic use, clinicians have still been slow to adopt a more conservative approach to prescribing, Dr. Gohil said. 

“What physicians have been needing is something to hang their hat on, to be able to say, ‘Okay, well, this one’s a low-risk person,’ ” Dr. Gohil said. 

The trials compared the impact of routine antibiotic activities with a stewardship bundle, called INSPIRE (Intelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection). 

Both groups received educational materials, quarterly coaching calls, prospective evaluations for antibiotic use, and were required to select a reason for prescribing an antibiotic. 

But prescribers in the intervention group took part in monthly coaching calls and feedback reports. In addition, if a clinician ordered a broad-spectrum antibiotic to treat pneumonia or a UTI outside of the intensive care unit within 72 hours of admission, an EHR prompt would pop up. The pop-up suggested a standard-spectrum antibiotic instead if patient risk for developing a multidrug-resistant (MDRO) version of either condition was less than 10%. 

An algorithm used data from the EHR calculated risk, using factors like patient demographics and history and MDRO infection at the community and hospital level. 

Prescribing rates were based on the number of days a patient received a broad-spectrum antibiotic during the first 72 hours of hospitalization. 

For the UTI intervention group, rates dropped by 17.4% (rate ratio [RR], 0.83; 95% CI, 0.77-0.89; P < .001), and 28.4% reduction in the pneumonia group (RR, 0.72; 95% CI, 0.66-0.78; P < .001). 

“We cannot know which element — prompt, education, or feedback — worked, but the data suggests that the prompt was the main driver,” Dr. Gohil said.

“In antibiotic stewardship, we have learned not only that doctors want to do the right thing, but that we as stewards need to make it easy for them do the right thing,” said Paul Pottinger, MD, professor of medicine at the Division of Allergy and Infectious Diseases at the University of Washington Medical Center in Seattle. 

The prompt “is your easy button,” said Dr. Pottinger, who was not involved with either study. “The researchers made it simple, fast, and straightforward, so people don’t have to think about it too much.”

The studies showed similar safety outcomes for the control and intervention groups. Among patients with a UTI, those in the control group were transferred to the ICU after an average of 6.6 days compared to 7 days in the intervention group. Among patients with pneumonia, the average days to ICU transfer were 6.5 for the control group and 7.1 for the intervention group. 

“This study is a proof of concept that physicians want to do the right thing and are willing to trust this information,” Dr. Pottinger said. “And this also shows us that this tool can be refined and made even more precise over time.” 

The study was funded by the US Centers for Disease Control and Prevention and was led by the University of California Irvine, Harvard Pilgrim Healthcare Institute, and HCA Healthcare System. Various authors report funding and support from entities outside the submitted work. The full list can be found with the original articles.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hello. It’s Mark Kris reporting back after attending the New York Lung Cancer Foundation Summit here in New York. A large amount of discussion went on, but as usual, I was most interested in the perioperative space.

In previous videos, I’ve talked about this ongoing discussion of whether you should operate and give adjuvant therapy or give neoadjuvant therapy, and I’ve addressed that already. One thing I want to bring up – and as we move off of that argument, which frankly doesn’t have an answer today, with neoadjuvant therapy, having all the data to support it – is what are the patterns of recurrence now that we have more successful systemic therapies, both targeted therapies and checkpoint inhibitors?

I was taught early on by my surgical mentors that the issue here was systemic control. While they could do very successful surgery to get high levels of local control, they could not control systemic disease. Sadly, the tools we had early on with chemotherapy were just not good enough. Suddenly, we have better tools to control systemic spread. In the past, the vast majority of occurrences were systemic; they’re now local.

What I think we need to do as a group of practitioners trying to deal with the problems getting in the way of curing our patients is look at what the issue is now. Frankly, the big issue now, as systemic therapy has controlled metastatic disease, is recurrence in the chest.

We give adjuvant osimertinib. Please remember what the numbers are. In the osimertinib arm, of the 11 recurrences reported in the European Society for Medical Oncology presentation a few years back, nine of them were in the chest or mediastinal nodes. In the arm that got no osimertinib afterward, there were 46 recurrences, and 32 of those 46 recurrences were in the chest, either the lung or mediastinal nodes. Therefore, 74% of the recurrences are suddenly in the chest. What’s the issue here?

The issue is we need to find strategies to give better disease control in the chest, as we have made inroads in controlling systemic disease with the targeted therapies in the endothelial growth factor receptor space, and very likely the checkpoint inhibitors, too, as that data kind of filters out. We need to think about how better to get local control.

I think rather than continue to get into this argument of neoadjuvant vs adjuvant, we should move to what’s really hurting our patients. Again, the data I quoted you was from the ADAURA trial, which was adjuvant therapy, and I’m sure the neoadjuvant is going to show the same thing. It’s better systemic therapy but now, more trouble in the chest.

How are we going to deal with that? I’d like to throw out one strategy, and that is to rethink the role of radiation in these patients. Again, if the problem is local in the chest, lung, and lymph nodes, we have to think about local therapy. Yes, we’re not recommending it routinely for everybody, but now that we have better systemic control, we need to rethink our options. The obvious one to rethink is about giving radiotherapy.

We should also use what we learned in the earlier trials, which is that there is harm in giving excessive radiation to the heart. If you avoid the heart, you avoid the harm. We have better planning strategies for stereotactic body radiotherapy and more traditional radiation, and of course, we have proton therapy as well.

As we continue to struggle with the idea of that patient with stage II or III disease, whether to give adjuvant vs neoadjuvant therapy, please remember to consider their risk in 2024. Their risk for first recurrence is in the chest.

What are we going to do to better control disease in the chest? We have a challenge. I’m sure we can meet it if we put our heads together.

Dr. Kris is professor of medicine at Weill Cornell Medical College, and attending physician, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer, and PUMA.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hello. It’s Mark Kris reporting back after attending the New York Lung Cancer Foundation Summit here in New York. A large amount of discussion went on, but as usual, I was most interested in the perioperative space.

In previous videos, I’ve talked about this ongoing discussion of whether you should operate and give adjuvant therapy or give neoadjuvant therapy, and I’ve addressed that already. One thing I want to bring up – and as we move off of that argument, which frankly doesn’t have an answer today, with neoadjuvant therapy, having all the data to support it – is what are the patterns of recurrence now that we have more successful systemic therapies, both targeted therapies and checkpoint inhibitors?

I was taught early on by my surgical mentors that the issue here was systemic control. While they could do very successful surgery to get high levels of local control, they could not control systemic disease. Sadly, the tools we had early on with chemotherapy were just not good enough. Suddenly, we have better tools to control systemic spread. In the past, the vast majority of occurrences were systemic; they’re now local.

What I think we need to do as a group of practitioners trying to deal with the problems getting in the way of curing our patients is look at what the issue is now. Frankly, the big issue now, as systemic therapy has controlled metastatic disease, is recurrence in the chest.

We give adjuvant osimertinib. Please remember what the numbers are. In the osimertinib arm, of the 11 recurrences reported in the European Society for Medical Oncology presentation a few years back, nine of them were in the chest or mediastinal nodes. In the arm that got no osimertinib afterward, there were 46 recurrences, and 32 of those 46 recurrences were in the chest, either the lung or mediastinal nodes. Therefore, 74% of the recurrences are suddenly in the chest. What’s the issue here?

The issue is we need to find strategies to give better disease control in the chest, as we have made inroads in controlling systemic disease with the targeted therapies in the endothelial growth factor receptor space, and very likely the checkpoint inhibitors, too, as that data kind of filters out. We need to think about how better to get local control.

I think rather than continue to get into this argument of neoadjuvant vs adjuvant, we should move to what’s really hurting our patients. Again, the data I quoted you was from the ADAURA trial, which was adjuvant therapy, and I’m sure the neoadjuvant is going to show the same thing. It’s better systemic therapy but now, more trouble in the chest.

How are we going to deal with that? I’d like to throw out one strategy, and that is to rethink the role of radiation in these patients. Again, if the problem is local in the chest, lung, and lymph nodes, we have to think about local therapy. Yes, we’re not recommending it routinely for everybody, but now that we have better systemic control, we need to rethink our options. The obvious one to rethink is about giving radiotherapy.

We should also use what we learned in the earlier trials, which is that there is harm in giving excessive radiation to the heart. If you avoid the heart, you avoid the harm. We have better planning strategies for stereotactic body radiotherapy and more traditional radiation, and of course, we have proton therapy as well.

As we continue to struggle with the idea of that patient with stage II or III disease, whether to give adjuvant vs neoadjuvant therapy, please remember to consider their risk in 2024. Their risk for first recurrence is in the chest.

What are we going to do to better control disease in the chest? We have a challenge. I’m sure we can meet it if we put our heads together.

Dr. Kris is professor of medicine at Weill Cornell Medical College, and attending physician, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer, and PUMA.

A version of this article appeared on Medscape.com.

This transcript has been edited for clarity.

Hello. It’s Mark Kris reporting back after attending the New York Lung Cancer Foundation Summit here in New York. A large amount of discussion went on, but as usual, I was most interested in the perioperative space.

In previous videos, I’ve talked about this ongoing discussion of whether you should operate and give adjuvant therapy or give neoadjuvant therapy, and I’ve addressed that already. One thing I want to bring up – and as we move off of that argument, which frankly doesn’t have an answer today, with neoadjuvant therapy, having all the data to support it – is what are the patterns of recurrence now that we have more successful systemic therapies, both targeted therapies and checkpoint inhibitors?

I was taught early on by my surgical mentors that the issue here was systemic control. While they could do very successful surgery to get high levels of local control, they could not control systemic disease. Sadly, the tools we had early on with chemotherapy were just not good enough. Suddenly, we have better tools to control systemic spread. In the past, the vast majority of occurrences were systemic; they’re now local.

What I think we need to do as a group of practitioners trying to deal with the problems getting in the way of curing our patients is look at what the issue is now. Frankly, the big issue now, as systemic therapy has controlled metastatic disease, is recurrence in the chest.

We give adjuvant osimertinib. Please remember what the numbers are. In the osimertinib arm, of the 11 recurrences reported in the European Society for Medical Oncology presentation a few years back, nine of them were in the chest or mediastinal nodes. In the arm that got no osimertinib afterward, there were 46 recurrences, and 32 of those 46 recurrences were in the chest, either the lung or mediastinal nodes. Therefore, 74% of the recurrences are suddenly in the chest. What’s the issue here?

The issue is we need to find strategies to give better disease control in the chest, as we have made inroads in controlling systemic disease with the targeted therapies in the endothelial growth factor receptor space, and very likely the checkpoint inhibitors, too, as that data kind of filters out. We need to think about how better to get local control.

I think rather than continue to get into this argument of neoadjuvant vs adjuvant, we should move to what’s really hurting our patients. Again, the data I quoted you was from the ADAURA trial, which was adjuvant therapy, and I’m sure the neoadjuvant is going to show the same thing. It’s better systemic therapy but now, more trouble in the chest.

How are we going to deal with that? I’d like to throw out one strategy, and that is to rethink the role of radiation in these patients. Again, if the problem is local in the chest, lung, and lymph nodes, we have to think about local therapy. Yes, we’re not recommending it routinely for everybody, but now that we have better systemic control, we need to rethink our options. The obvious one to rethink is about giving radiotherapy.

We should also use what we learned in the earlier trials, which is that there is harm in giving excessive radiation to the heart. If you avoid the heart, you avoid the harm. We have better planning strategies for stereotactic body radiotherapy and more traditional radiation, and of course, we have proton therapy as well.

As we continue to struggle with the idea of that patient with stage II or III disease, whether to give adjuvant vs neoadjuvant therapy, please remember to consider their risk in 2024. Their risk for first recurrence is in the chest.

What are we going to do to better control disease in the chest? We have a challenge. I’m sure we can meet it if we put our heads together.

Dr. Kris is professor of medicine at Weill Cornell Medical College, and attending physician, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York. He disclosed ties with AstraZeneca, Roche/Genentech, Ariad Pharmaceuticals, Pfizer, and PUMA.

A version of this article appeared on Medscape.com.

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

In June 2023, the American Society of Anesthesiologists (ASA) recommended holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying.

In response, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures.

“It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles.

“We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.”

The study was published online in Gastroenterology.
 

Analyzing GLP-1 RA Use

Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.

Cedars-Sinai Medical Center

The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure.

Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users.

After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33.

An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31).

In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56).

“The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.”

More than 20 million endoscopies are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said.
 

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added.

At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded.

“We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.”

For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications.

“Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville.

Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.

A version of this article appeared on Medscape.com.

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

In June 2023, the American Society of Anesthesiologists (ASA) recommended holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying.

In response, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures.

“It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles.

“We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.”

The study was published online in Gastroenterology.
 

Analyzing GLP-1 RA Use

Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.

Cedars-Sinai Medical Center

The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure.

Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users.

After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33.

An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31).

In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56).

“The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.”

More than 20 million endoscopies are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said.
 

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added.

At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded.

“We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.”

For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications.

“Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville.

Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.

A version of this article appeared on Medscape.com.

The use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may lead to an increased risk for aspiration pneumonia after endoscopic procedures, according to a new large population-based study.

In June 2023, the American Society of Anesthesiologists (ASA) recommended holding GLP-1 RAs before an endoscopic or surgical procedure to reduce the risk for complications associated with anesthesia and delayed stomach emptying.

In response, the American Gastroenterological Association (AGA) published a rapid clinical practice update in November 2023 that found insufficient evidence to support patients stopping the medications before endoscopic procedures.

“It is known that GLP-1 RAs significantly reduce the motility of the stomach and small bowel. As more and more patients are being started on GLP-1 RAs at higher doses and longer half-life, the question became whether the current recommended fasting durations are enough to reasonably assume the stomach is empty prior to procedures that require sedation,” said senior author Ali Rezaie, MD, medical director of the GI Motility Program at Cedars-Sinai Medical Center in Los Angeles.

“We wanted to see if these medications in fact increased the chance of aspiration before the ASA suggestion went into effect,” he said. “However, this is not an easy task, as aspiration is a rare event and a large sample size is needed to confidently answer that question. That is why we evaluated nearly 1 million cases.”

The study was published online in Gastroenterology.
 

Analyzing GLP-1 RA Use

Dr. Rezaie and colleagues conducted a population-based, retrospective cohort study of the TriNetX dataset, which includes 114 million deidentified individual health records from 80 healthcare organizations. The research team analyzed nearly 1 million records for adult patients between ages 21 and 70 who underwent upper and lower endoscopies between January 2018 and December 2020.

Cedars-Sinai Medical Center

The researchers defined GLP-1 RA users as those who had the medication for more than 6 months and two or more refills within 6 months before the procedure. They adjusted for 59 factors that could affect gut motility or aspiration risks, such as obesity, numerous chronic diseases, and dozens of medications. The primary outcome was aspiration pneumonia within a month after the procedure.

Among 963,184 patients who underwent endoscopy, 46,935 (4.9%) were considered GLP-1 RA users. Among those, 20,099 GLP-1 RA users met the inclusion criteria and had their results compared with non-GLP-1 RA users.

After propensity score matching for the 59 potential confounders, GLP-1 RA use had a higher incidence rate of aspiration pneumonia (0.83% vs 0.63%) and was associated with a significantly higher risk for aspiration pneumonia, with a hazard ratio (HR) of 1.33.

An even higher risk was seen among patients with propofol-assisted endoscopies (HR, 1.49) but not among those without propofol (HR, 1.31).

In a subgroup analysis based on endoscopy type, an elevated risk was observed among patients who underwent upper endoscopy (HR, 1.82) and combined upper and lower endoscopy (HR, 2.26) but not lower endoscopy (HR, 0.56).

“The results were not necessarily surprising given the mechanism of action of GLP-1 RAs. However, for the first time, this was shown with a clinically relevant outcome, such as aspiration pneumonia,” Dr. Rezaie said. “Aspiration during sedation can have devastating consequences, and the 0.2% difference in risk of aspiration can have a significant effect on healthcare as well.”

More than 20 million endoscopies are performed across the United States annually. Based on the assumption that about 3% of those patients are taking GLP-1 RAs, about 1200 aspiration cases per year can be prevented by raising awareness, he said.
 

Considering Next Steps

The varying risk profiles observed with separate sedation and endoscopy types point to a need for more tailored guidance in managing GLP-1 RA use before a procedure, the study authors wrote.

Although holding the medications before endoscopy may disrupt diabetes management, the potential increased risk for aspiration could justify a change in practice, particularly for upper endoscopy and propofol-associated procedures, they added.

At the same time, additional studies are needed to understand the optimal drug withholding windows before endoscopies and other procedures, they concluded.

“We will need more data on what is the optimal duration of holding GLP-1 RAs,” Dr. Rezaie said. “But given our data and current ASA guidance, stopping these medications prior to elective procedures is the safe thing to do.”

For now, AGA guidance remains the same as offered in the November 2023 update, suggesting an individual approach for each patient on a GLP-1 RA rather than a “blanket statement” on how to manage all patients taking these medications.

“Overall, I believe that this study is important, but we require more high-level data to inform clinical decision-making regarding patients using GLP-1 receptor agonists prior to gastrointestinal endoscopy,” said Andrew Y. Wang, MD, AGAF, chief of gastroenterology and hepatology and director of interventional endoscopy at the University of Virginia in Charlottesville.

Dr. Wang, who wasn’t involved with this study, coauthored the AGA rapid clinical practice update. He and colleagues advised continuing with a procedure as planned for patients on GLP-1 RAs who followed standard preprocedure fasting instructions and didn’t have nausea, vomiting, dyspepsia, or abdominal distention.

A version of this article appeared on Medscape.com.

WIESBADEN, GERMANY — Crowded waiting rooms, long wait times, irritable patients, and aggression toward nursing staff and doctors are increasingly the reality in German emergency rooms. Clearly, emergencies belong in the emergency room. However, “In about half of all patients in the emergency room, there is no urgent medical emergency,” Norbert Schütz, MD, director of geriatrics and rheumatology at Helios Dr. Horst Schmidt Hospital in Wiesbaden, Germany, said at a press conference for the 130th Annual Meeting of the German Society of Internal Medicine (DGIM).

“In our daily medical practice, we repeatedly experience people either accessing our emergency departments and ambulances too quickly or lingering at home for too long when they have severe symptoms,” said Dr. Schütz, who organized the Patient Day during the Internist Congress.
 

DGIM Educates Patients

What is an emergency? “I think the public is quite well informed about conditions associated with loss of consciousness, severe pain, chest pain, or paralysis: Think stroke or heart attack. This is undoubtedly a success of recent years. The difficulty arises with everything in between. For instance, should I go to the hospital with severe headaches?” asked Dr. Schütz.

When is a patient a case for the emergency room, the physician on-call service, or the general practitioner? At the Patient Day in Wiesbaden, DGIM aims to educate and train interested parties with a dedicated lecture. The focus is on recognizing an emergency, specifically emergencies in children and mental illnesses.

“Our Patient Day aims to contribute to making the right decisions. We want to inform, answer questions, and alleviate fears,” said Dr. Schütz. Interested parties can refresh their emergency knowledge, tour ambulances, and have the equipment explained. The public also has the opportunity to learn about resuscitation techniques theoretically and practically.

“In general, the general practitioner should always be the first point of contact. They know their patients best and have the most background information,” explained Dr. Schütz. A trusting relationship is crucial for correctly assessing an unclear medical situation. “Should, for whatever reason, the general practitioner not be reachable, the physician on-call service can be reached,” said Dr. Schütz. It may happen, however, that neither the general practitioner nor the on-call physician is immediately available.
 

What Are Emergencies?

In cases of severe health impairment, urgency is required, and a severe emergency should be assumed in the following cases:

• Chest pain
• Circulatory disorder
• Disorders of consciousness
• Breathing difficulties
• Sudden weakness or numbness/paralysis
• Severe bleeding
• Allergic shock

“In such cases, the emergency departments of the hospitals are available around the clock, and if necessary, an emergency doctor should be present during transportation to the hospital,” said Dr. Schütz.

Classifying emergencies is challenging, especially with children. “Children often find it difficult to clearly categorize or describe symptoms,” said Dr. Schütz. A situation is critical if, for example, the child’s breathing or consciousness is impaired.

Mental emergencies pose a particular challenge for patients and relatives because the patient and relatives are often overwhelmed by the situation. If there are suicidal thoughts, the patient should present him- or herself immediately to an emergency room.

“Patients who come to the emergency room because they cannot get appointments with their general practitioner or specialist, for whatever reason, are no emergency. We also see this in the emergency room from time to time,” said Dr. Schütz. Emergency rooms are not intended for this purpose. “And generally, these are not emergencies.”
 

Four of 10 Cases

The number of patients in emergency rooms has steadily increased in recent years. Statistically, only 4 out of 10 cases are genuine emergencies, as detailed surveys of patients in the emergency rooms of northern German hospitals have shown.

In the PiNo Nord cross-sectional study, Martin Scherer, MD, of University Hospital Hamburg-Eppendorf in Hamburg, Germany, and his team examined the reasons why patients visit the emergency room. They interviewed 1175 patients in five hospitals and documented the medical diagnoses. Patients classified as “immediately” or “very urgently” in need of treatment were excluded.

The surveyed patients were on average 41.8 years old, 52.9% were men, and 54.7% of the patients indicated a low urgency of treatment. About 41% of the patients visited the emergency room on their own initiative, 17% stated they were referred or entrusted by their general practitioner, and 8% were referred by a specialist in the emergency room.

The strongest predictors for low subjective treatment urgency were musculoskeletal trauma (odds ratio [OR], 2.18), skin afflictions (OR, 2.15), and the unavailability of an open general practitioner’s office (OR, 1.70).

According to Dr. Scherer and his colleagues, the reasons for visiting an emergency room are diverse and can be based on the perceived structural conditions and individual patient preferences in addition to the urgency of the health problem.
 

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

WIESBADEN, GERMANY — Crowded waiting rooms, long wait times, irritable patients, and aggression toward nursing staff and doctors are increasingly the reality in German emergency rooms. Clearly, emergencies belong in the emergency room. However, “In about half of all patients in the emergency room, there is no urgent medical emergency,” Norbert Schütz, MD, director of geriatrics and rheumatology at Helios Dr. Horst Schmidt Hospital in Wiesbaden, Germany, said at a press conference for the 130th Annual Meeting of the German Society of Internal Medicine (DGIM).

“In our daily medical practice, we repeatedly experience people either accessing our emergency departments and ambulances too quickly or lingering at home for too long when they have severe symptoms,” said Dr. Schütz, who organized the Patient Day during the Internist Congress.
 

DGIM Educates Patients

What is an emergency? “I think the public is quite well informed about conditions associated with loss of consciousness, severe pain, chest pain, or paralysis: Think stroke or heart attack. This is undoubtedly a success of recent years. The difficulty arises with everything in between. For instance, should I go to the hospital with severe headaches?” asked Dr. Schütz.

When is a patient a case for the emergency room, the physician on-call service, or the general practitioner? At the Patient Day in Wiesbaden, DGIM aims to educate and train interested parties with a dedicated lecture. The focus is on recognizing an emergency, specifically emergencies in children and mental illnesses.

“Our Patient Day aims to contribute to making the right decisions. We want to inform, answer questions, and alleviate fears,” said Dr. Schütz. Interested parties can refresh their emergency knowledge, tour ambulances, and have the equipment explained. The public also has the opportunity to learn about resuscitation techniques theoretically and practically.

“In general, the general practitioner should always be the first point of contact. They know their patients best and have the most background information,” explained Dr. Schütz. A trusting relationship is crucial for correctly assessing an unclear medical situation. “Should, for whatever reason, the general practitioner not be reachable, the physician on-call service can be reached,” said Dr. Schütz. It may happen, however, that neither the general practitioner nor the on-call physician is immediately available.
 

What Are Emergencies?

In cases of severe health impairment, urgency is required, and a severe emergency should be assumed in the following cases:

• Chest pain
• Circulatory disorder
• Disorders of consciousness
• Breathing difficulties
• Sudden weakness or numbness/paralysis
• Severe bleeding
• Allergic shock

“In such cases, the emergency departments of the hospitals are available around the clock, and if necessary, an emergency doctor should be present during transportation to the hospital,” said Dr. Schütz.

Classifying emergencies is challenging, especially with children. “Children often find it difficult to clearly categorize or describe symptoms,” said Dr. Schütz. A situation is critical if, for example, the child’s breathing or consciousness is impaired.

Mental emergencies pose a particular challenge for patients and relatives because the patient and relatives are often overwhelmed by the situation. If there are suicidal thoughts, the patient should present him- or herself immediately to an emergency room.

“Patients who come to the emergency room because they cannot get appointments with their general practitioner or specialist, for whatever reason, are no emergency. We also see this in the emergency room from time to time,” said Dr. Schütz. Emergency rooms are not intended for this purpose. “And generally, these are not emergencies.”
 

Four of 10 Cases

The number of patients in emergency rooms has steadily increased in recent years. Statistically, only 4 out of 10 cases are genuine emergencies, as detailed surveys of patients in the emergency rooms of northern German hospitals have shown.

In the PiNo Nord cross-sectional study, Martin Scherer, MD, of University Hospital Hamburg-Eppendorf in Hamburg, Germany, and his team examined the reasons why patients visit the emergency room. They interviewed 1175 patients in five hospitals and documented the medical diagnoses. Patients classified as “immediately” or “very urgently” in need of treatment were excluded.

The surveyed patients were on average 41.8 years old, 52.9% were men, and 54.7% of the patients indicated a low urgency of treatment. About 41% of the patients visited the emergency room on their own initiative, 17% stated they were referred or entrusted by their general practitioner, and 8% were referred by a specialist in the emergency room.

The strongest predictors for low subjective treatment urgency were musculoskeletal trauma (odds ratio [OR], 2.18), skin afflictions (OR, 2.15), and the unavailability of an open general practitioner’s office (OR, 1.70).

According to Dr. Scherer and his colleagues, the reasons for visiting an emergency room are diverse and can be based on the perceived structural conditions and individual patient preferences in addition to the urgency of the health problem.
 

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

WIESBADEN, GERMANY — Crowded waiting rooms, long wait times, irritable patients, and aggression toward nursing staff and doctors are increasingly the reality in German emergency rooms. Clearly, emergencies belong in the emergency room. However, “In about half of all patients in the emergency room, there is no urgent medical emergency,” Norbert Schütz, MD, director of geriatrics and rheumatology at Helios Dr. Horst Schmidt Hospital in Wiesbaden, Germany, said at a press conference for the 130th Annual Meeting of the German Society of Internal Medicine (DGIM).

“In our daily medical practice, we repeatedly experience people either accessing our emergency departments and ambulances too quickly or lingering at home for too long when they have severe symptoms,” said Dr. Schütz, who organized the Patient Day during the Internist Congress.
 

DGIM Educates Patients

What is an emergency? “I think the public is quite well informed about conditions associated with loss of consciousness, severe pain, chest pain, or paralysis: Think stroke or heart attack. This is undoubtedly a success of recent years. The difficulty arises with everything in between. For instance, should I go to the hospital with severe headaches?” asked Dr. Schütz.

When is a patient a case for the emergency room, the physician on-call service, or the general practitioner? At the Patient Day in Wiesbaden, DGIM aims to educate and train interested parties with a dedicated lecture. The focus is on recognizing an emergency, specifically emergencies in children and mental illnesses.

“Our Patient Day aims to contribute to making the right decisions. We want to inform, answer questions, and alleviate fears,” said Dr. Schütz. Interested parties can refresh their emergency knowledge, tour ambulances, and have the equipment explained. The public also has the opportunity to learn about resuscitation techniques theoretically and practically.

“In general, the general practitioner should always be the first point of contact. They know their patients best and have the most background information,” explained Dr. Schütz. A trusting relationship is crucial for correctly assessing an unclear medical situation. “Should, for whatever reason, the general practitioner not be reachable, the physician on-call service can be reached,” said Dr. Schütz. It may happen, however, that neither the general practitioner nor the on-call physician is immediately available.
 

What Are Emergencies?

In cases of severe health impairment, urgency is required, and a severe emergency should be assumed in the following cases:

• Chest pain
• Circulatory disorder
• Disorders of consciousness
• Breathing difficulties
• Sudden weakness or numbness/paralysis
• Severe bleeding
• Allergic shock

“In such cases, the emergency departments of the hospitals are available around the clock, and if necessary, an emergency doctor should be present during transportation to the hospital,” said Dr. Schütz.

Classifying emergencies is challenging, especially with children. “Children often find it difficult to clearly categorize or describe symptoms,” said Dr. Schütz. A situation is critical if, for example, the child’s breathing or consciousness is impaired.

Mental emergencies pose a particular challenge for patients and relatives because the patient and relatives are often overwhelmed by the situation. If there are suicidal thoughts, the patient should present him- or herself immediately to an emergency room.

“Patients who come to the emergency room because they cannot get appointments with their general practitioner or specialist, for whatever reason, are no emergency. We also see this in the emergency room from time to time,” said Dr. Schütz. Emergency rooms are not intended for this purpose. “And generally, these are not emergencies.”
 

Four of 10 Cases

The number of patients in emergency rooms has steadily increased in recent years. Statistically, only 4 out of 10 cases are genuine emergencies, as detailed surveys of patients in the emergency rooms of northern German hospitals have shown.

In the PiNo Nord cross-sectional study, Martin Scherer, MD, of University Hospital Hamburg-Eppendorf in Hamburg, Germany, and his team examined the reasons why patients visit the emergency room. They interviewed 1175 patients in five hospitals and documented the medical diagnoses. Patients classified as “immediately” or “very urgently” in need of treatment were excluded.

The surveyed patients were on average 41.8 years old, 52.9% were men, and 54.7% of the patients indicated a low urgency of treatment. About 41% of the patients visited the emergency room on their own initiative, 17% stated they were referred or entrusted by their general practitioner, and 8% were referred by a specialist in the emergency room.

The strongest predictors for low subjective treatment urgency were musculoskeletal trauma (odds ratio [OR], 2.18), skin afflictions (OR, 2.15), and the unavailability of an open general practitioner’s office (OR, 1.70).

According to Dr. Scherer and his colleagues, the reasons for visiting an emergency room are diverse and can be based on the perceived structural conditions and individual patient preferences in addition to the urgency of the health problem.
 

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

SAN DIEGO — When should patients with advanced or metastatic non–small cell lung cancer receive osimertinib plus platinum-based chemotherapy in the frontline setting and when is osimertinib enough on its own?

That is a question brewing among some oncologists now that the US Food and Drug Administration (FDA) has approved osimertinib (Tagrisso, AstraZeneca) for both indications in patients with epidermal growth factor receptor (EGFR) mutations.

An answer began to emerge in research presented at the American Association for Cancer Research annual meeting.

An exploratory analysis of the FLAURA2 trial found that, when patients have EGFR mutations on baseline circulating tumor DNA (ctDNA) testing, the combination treatment can extend progression-free survival (PFS). In this patient group, those receiving osimertinib alongside pemetrexed plus cisplatin or carboplatin had a 9-month PFS advantage compared with those who received osimertinib alone.

Conversely, when patients do not have EGFR mutations following baseline ctDNA testing, osimertinib alone appears to offer similar PFS outcomes to the combination therapy, but with less toxicity.

“Baseline detection of plasma EGFR mutations may identify a subgroup of patients who derive most benefit from the addition of platinum-pemetrexed to osimertinib as first-line treatment of EGFR-mutated advance non–small cell lung cancer,” investigator Pasi A. Jänne, MD, PhD, a lung cancer oncologist at the Dana-Farber Cancer Institute, Boston, said during his presentation.

The FLAURA2 trial randomized 557 patients equally to daily osimertinib either alone or with pemetrexed plus cisplatin or carboplatin every 3 weeks for four cycles followed by pemetrexed every 3 weeks until disease progression or unacceptable toxicity.

Patients were tested for Ex19del or L858R EGFR mutations at baseline and at 3 and 6 weeks; baseline mutations were found in 73% of evaluable patients.

In patients with baseline mutations, the median PFS was 24.8 months with the combination therapy vs 13.9 months with osimertinib alone (hazard ratio [HR], 0.60).

In patients without baseline mutations, the median PFS was similar in both groups — 33.3 months with the combination vs 30.3 months with monotherapy (HR, 0.93; 95% CI, 0.51-1.72).

The investigators also found that having baseline mutations was associated with worse outcomes regardless of study arm, and mutation clearance was associated with improved outcomes. Clearance occurred more quickly among patients receiving the combination treatment, but almost 90% of patients in both arms cleared their mutations by week 6.

“As we move forward and think about which of our patients we would treat with the combination ... the presence of baseline EGFR mutations in ctDNA may be one of the features that goes into the conversation,” Dr. Jänne said.

Study discussant Marina Chiara Garassino, MD, a thoracic oncologist at the University of Chicago, agreed that this trial can help oncologists make this kind of treatment decision.

Patients with baseline EGFR mutations also tended to have larger tumors, more brain metastases, and worse performance scores; the combination therapy makes sense when such factors are present in patients with baseline EGFR mutations, Dr. Garassino said.

The wrinkle in the findings is that the study used digital droplet polymerase chain reaction (Biodesix) to test for EGFR mutations, which is not commonly used. Clinicians often use next-generation sequencing, which is less sensitive and can lead to false negatives.

It makes it difficult to know how to apply the findings to everyday practice, but Janne hopes a study will be done to correlate next-generation sequencing detection with outcomes.

The study was funded by AstraZeneca, maker of osimertinib, and researchers included AstraZeneca employees. Dr. Jänne is a consultant for and reported research funding from the company. He is a co-inventor on an EGFR mutations patent. Dr. Garassino is also an AstraZeneca consultant and reported institutional financial interests in the company.
 

A version of this article appeared on Medscape.com.

SAN DIEGO — When should patients with advanced or metastatic non–small cell lung cancer receive osimertinib plus platinum-based chemotherapy in the frontline setting and when is osimertinib enough on its own?

That is a question brewing among some oncologists now that the US Food and Drug Administration (FDA) has approved osimertinib (Tagrisso, AstraZeneca) for both indications in patients with epidermal growth factor receptor (EGFR) mutations.

An answer began to emerge in research presented at the American Association for Cancer Research annual meeting.

An exploratory analysis of the FLAURA2 trial found that, when patients have EGFR mutations on baseline circulating tumor DNA (ctDNA) testing, the combination treatment can extend progression-free survival (PFS). In this patient group, those receiving osimertinib alongside pemetrexed plus cisplatin or carboplatin had a 9-month PFS advantage compared with those who received osimertinib alone.

Conversely, when patients do not have EGFR mutations following baseline ctDNA testing, osimertinib alone appears to offer similar PFS outcomes to the combination therapy, but with less toxicity.

“Baseline detection of plasma EGFR mutations may identify a subgroup of patients who derive most benefit from the addition of platinum-pemetrexed to osimertinib as first-line treatment of EGFR-mutated advance non–small cell lung cancer,” investigator Pasi A. Jänne, MD, PhD, a lung cancer oncologist at the Dana-Farber Cancer Institute, Boston, said during his presentation.

The FLAURA2 trial randomized 557 patients equally to daily osimertinib either alone or with pemetrexed plus cisplatin or carboplatin every 3 weeks for four cycles followed by pemetrexed every 3 weeks until disease progression or unacceptable toxicity.

Patients were tested for Ex19del or L858R EGFR mutations at baseline and at 3 and 6 weeks; baseline mutations were found in 73% of evaluable patients.

In patients with baseline mutations, the median PFS was 24.8 months with the combination therapy vs 13.9 months with osimertinib alone (hazard ratio [HR], 0.60).

In patients without baseline mutations, the median PFS was similar in both groups — 33.3 months with the combination vs 30.3 months with monotherapy (HR, 0.93; 95% CI, 0.51-1.72).

The investigators also found that having baseline mutations was associated with worse outcomes regardless of study arm, and mutation clearance was associated with improved outcomes. Clearance occurred more quickly among patients receiving the combination treatment, but almost 90% of patients in both arms cleared their mutations by week 6.

“As we move forward and think about which of our patients we would treat with the combination ... the presence of baseline EGFR mutations in ctDNA may be one of the features that goes into the conversation,” Dr. Jänne said.

Study discussant Marina Chiara Garassino, MD, a thoracic oncologist at the University of Chicago, agreed that this trial can help oncologists make this kind of treatment decision.

Patients with baseline EGFR mutations also tended to have larger tumors, more brain metastases, and worse performance scores; the combination therapy makes sense when such factors are present in patients with baseline EGFR mutations, Dr. Garassino said.

The wrinkle in the findings is that the study used digital droplet polymerase chain reaction (Biodesix) to test for EGFR mutations, which is not commonly used. Clinicians often use next-generation sequencing, which is less sensitive and can lead to false negatives.

It makes it difficult to know how to apply the findings to everyday practice, but Janne hopes a study will be done to correlate next-generation sequencing detection with outcomes.

The study was funded by AstraZeneca, maker of osimertinib, and researchers included AstraZeneca employees. Dr. Jänne is a consultant for and reported research funding from the company. He is a co-inventor on an EGFR mutations patent. Dr. Garassino is also an AstraZeneca consultant and reported institutional financial interests in the company.
 

A version of this article appeared on Medscape.com.

SAN DIEGO — When should patients with advanced or metastatic non–small cell lung cancer receive osimertinib plus platinum-based chemotherapy in the frontline setting and when is osimertinib enough on its own?

That is a question brewing among some oncologists now that the US Food and Drug Administration (FDA) has approved osimertinib (Tagrisso, AstraZeneca) for both indications in patients with epidermal growth factor receptor (EGFR) mutations.

An answer began to emerge in research presented at the American Association for Cancer Research annual meeting.

An exploratory analysis of the FLAURA2 trial found that, when patients have EGFR mutations on baseline circulating tumor DNA (ctDNA) testing, the combination treatment can extend progression-free survival (PFS). In this patient group, those receiving osimertinib alongside pemetrexed plus cisplatin or carboplatin had a 9-month PFS advantage compared with those who received osimertinib alone.

Conversely, when patients do not have EGFR mutations following baseline ctDNA testing, osimertinib alone appears to offer similar PFS outcomes to the combination therapy, but with less toxicity.

“Baseline detection of plasma EGFR mutations may identify a subgroup of patients who derive most benefit from the addition of platinum-pemetrexed to osimertinib as first-line treatment of EGFR-mutated advance non–small cell lung cancer,” investigator Pasi A. Jänne, MD, PhD, a lung cancer oncologist at the Dana-Farber Cancer Institute, Boston, said during his presentation.

The FLAURA2 trial randomized 557 patients equally to daily osimertinib either alone or with pemetrexed plus cisplatin or carboplatin every 3 weeks for four cycles followed by pemetrexed every 3 weeks until disease progression or unacceptable toxicity.

Patients were tested for Ex19del or L858R EGFR mutations at baseline and at 3 and 6 weeks; baseline mutations were found in 73% of evaluable patients.

In patients with baseline mutations, the median PFS was 24.8 months with the combination therapy vs 13.9 months with osimertinib alone (hazard ratio [HR], 0.60).

In patients without baseline mutations, the median PFS was similar in both groups — 33.3 months with the combination vs 30.3 months with monotherapy (HR, 0.93; 95% CI, 0.51-1.72).

The investigators also found that having baseline mutations was associated with worse outcomes regardless of study arm, and mutation clearance was associated with improved outcomes. Clearance occurred more quickly among patients receiving the combination treatment, but almost 90% of patients in both arms cleared their mutations by week 6.

“As we move forward and think about which of our patients we would treat with the combination ... the presence of baseline EGFR mutations in ctDNA may be one of the features that goes into the conversation,” Dr. Jänne said.

Study discussant Marina Chiara Garassino, MD, a thoracic oncologist at the University of Chicago, agreed that this trial can help oncologists make this kind of treatment decision.

Patients with baseline EGFR mutations also tended to have larger tumors, more brain metastases, and worse performance scores; the combination therapy makes sense when such factors are present in patients with baseline EGFR mutations, Dr. Garassino said.

The wrinkle in the findings is that the study used digital droplet polymerase chain reaction (Biodesix) to test for EGFR mutations, which is not commonly used. Clinicians often use next-generation sequencing, which is less sensitive and can lead to false negatives.

It makes it difficult to know how to apply the findings to everyday practice, but Janne hopes a study will be done to correlate next-generation sequencing detection with outcomes.

The study was funded by AstraZeneca, maker of osimertinib, and researchers included AstraZeneca employees. Dr. Jänne is a consultant for and reported research funding from the company. He is a co-inventor on an EGFR mutations patent. Dr. Garassino is also an AstraZeneca consultant and reported institutional financial interests in the company.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Exposure to furan, a chemical present in agricultural products, stabilizers, pharmaceuticals, and heat-processed foods, shows a significant positive correlation with the prevalence and respiratory mortality of chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey database from 2013 to 2018 and identified 270 adults with a diagnosis of COPD and 7212 without.
• Exposure to furan was based on blood furan levels, and participants were divided into five groups on the basis of quartiles of log10-transformed blood furan levels.
• The researchers used a restricted cubic spline analysis to examine the association between COPD risk and blood furan levels and mediating analysis to explore the impact of inflammation.
• The primary outcome of the study was respiratory mortality.

TAKEAWAY:

• Ten COPD patients died of respiratory diseases; adjusted analysis showed a positive correlation between log10-transformed blood furan levels and respiratory mortality in COPD patients (hazard ratio, 41.00, P = .003).
• In a logistic regression analysis, log10-transformed blood furan levels were significantly associated with increased risk for COPD; individuals in the fifth quartile had significantly increased risk compared with the first quartile (odds ratio, 4.47; P = .006).
• COPD demonstrated a significant positive association with monocytes, neutrophils, and basophils, which showed mediated proportions of 8.73%, 20.90%, and 10.94%, respectively, in the relationship between furan exposure and prevalence of COPD (P < .05 for all).

IN PRACTICE:

“The implication [of the findings] is that reducing exposure to furan in the environment could potentially lower the incidence of COPD and improve the prognosis for COPD patients,” but large-scale prospective cohort studies are needed, the researchers wrote in their conclusion.

SOURCE:

The lead author of the study was Di Sun, MD, of Capital Medical University, Beijing, China. The study was published online in BMC Public Health.

LIMITATIONS:

The cross-sectional design prevented establishment of a causal relationship between furan exposure and COPD; lack of data on the conditions of furan exposure and the reliance on self-reports for COPD diagnosis were among the factors that limited the study findings.

DISCLOSURES:

The study was supported by the High Level Public Health Technology Talent Construction Project and Reform and Development Program of Beijing Institute of Respiratory Medicine. The researchers had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Exposure to furan, a chemical present in agricultural products, stabilizers, pharmaceuticals, and heat-processed foods, shows a significant positive correlation with the prevalence and respiratory mortality of chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey database from 2013 to 2018 and identified 270 adults with a diagnosis of COPD and 7212 without.
• Exposure to furan was based on blood furan levels, and participants were divided into five groups on the basis of quartiles of log10-transformed blood furan levels.
• The researchers used a restricted cubic spline analysis to examine the association between COPD risk and blood furan levels and mediating analysis to explore the impact of inflammation.
• The primary outcome of the study was respiratory mortality.

TAKEAWAY:

• Ten COPD patients died of respiratory diseases; adjusted analysis showed a positive correlation between log10-transformed blood furan levels and respiratory mortality in COPD patients (hazard ratio, 41.00, P = .003).
• In a logistic regression analysis, log10-transformed blood furan levels were significantly associated with increased risk for COPD; individuals in the fifth quartile had significantly increased risk compared with the first quartile (odds ratio, 4.47; P = .006).
• COPD demonstrated a significant positive association with monocytes, neutrophils, and basophils, which showed mediated proportions of 8.73%, 20.90%, and 10.94%, respectively, in the relationship between furan exposure and prevalence of COPD (P < .05 for all).

IN PRACTICE:

“The implication [of the findings] is that reducing exposure to furan in the environment could potentially lower the incidence of COPD and improve the prognosis for COPD patients,” but large-scale prospective cohort studies are needed, the researchers wrote in their conclusion.

SOURCE:

The lead author of the study was Di Sun, MD, of Capital Medical University, Beijing, China. The study was published online in BMC Public Health.

LIMITATIONS:

The cross-sectional design prevented establishment of a causal relationship between furan exposure and COPD; lack of data on the conditions of furan exposure and the reliance on self-reports for COPD diagnosis were among the factors that limited the study findings.

DISCLOSURES:

The study was supported by the High Level Public Health Technology Talent Construction Project and Reform and Development Program of Beijing Institute of Respiratory Medicine. The researchers had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Exposure to furan, a chemical present in agricultural products, stabilizers, pharmaceuticals, and heat-processed foods, shows a significant positive correlation with the prevalence and respiratory mortality of chronic obstructive pulmonary disease (COPD).

METHODOLOGY:

• The researchers reviewed data from the National Health and Nutrition Examination Survey database from 2013 to 2018 and identified 270 adults with a diagnosis of COPD and 7212 without.
• Exposure to furan was based on blood furan levels, and participants were divided into five groups on the basis of quartiles of log10-transformed blood furan levels.
• The researchers used a restricted cubic spline analysis to examine the association between COPD risk and blood furan levels and mediating analysis to explore the impact of inflammation.
• The primary outcome of the study was respiratory mortality.

TAKEAWAY:

• Ten COPD patients died of respiratory diseases; adjusted analysis showed a positive correlation between log10-transformed blood furan levels and respiratory mortality in COPD patients (hazard ratio, 41.00, P = .003).
• In a logistic regression analysis, log10-transformed blood furan levels were significantly associated with increased risk for COPD; individuals in the fifth quartile had significantly increased risk compared with the first quartile (odds ratio, 4.47; P = .006).
• COPD demonstrated a significant positive association with monocytes, neutrophils, and basophils, which showed mediated proportions of 8.73%, 20.90%, and 10.94%, respectively, in the relationship between furan exposure and prevalence of COPD (P < .05 for all).

IN PRACTICE:

“The implication [of the findings] is that reducing exposure to furan in the environment could potentially lower the incidence of COPD and improve the prognosis for COPD patients,” but large-scale prospective cohort studies are needed, the researchers wrote in their conclusion.

SOURCE:

The lead author of the study was Di Sun, MD, of Capital Medical University, Beijing, China. The study was published online in BMC Public Health.

LIMITATIONS:

The cross-sectional design prevented establishment of a causal relationship between furan exposure and COPD; lack of data on the conditions of furan exposure and the reliance on self-reports for COPD diagnosis were among the factors that limited the study findings.

DISCLOSURES:

The study was supported by the High Level Public Health Technology Talent Construction Project and Reform and Development Program of Beijing Institute of Respiratory Medicine. The researchers had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

A drug prototype known as NZ-97 showed promise for treating pulmonary disease by stimulating growth of new stem cells to repair damaged tissue, based on data from a new proof-of-concept study.

In many pulmonary diseases, insufficient stem cells allow damage to progress, but researchers have developed a lung-targeted, drug-like small molecule to stimulate the growth of lung stem cells, according to data published in Proceedings of the National Academy of Sciences.

Michael J. Bollong, PhD, associate professor in the department of chemistry at Scripps Research, San Diego, and colleagues used ReFRAME, a drug repurposing library and database created by the Calibr-Skaggs Institute for Innovative Medicines (the drug discovery arm of Scripps Research) to test existing drugs as foundations to promote stem cell growth and repair in the lungs.

“At present, there are no drugs which promote regenerative repair of the lung,” Dr. Bollong said in an interview. “This is especially important in idiopathic pulmonary fibrosis, as this disease is driven by an insufficiency of the stem cell population of the lower airway, alveolar type 2 cells (AEC2s), to proliferate and to regenerate the gas exchange epithelium,” he said.

The researchers identified dipeptidyl peptidase 4 (DPP4) inhibitors as potential tools to help promote production of stem cells in the lower airway called AEC2s. Dysfunction of AEC2 is thought to play a key role in the pathogenesis of idiopathic pulmonary fibrosis, the researchers noted in the study. They created a new and highly soluble DPP4 inhibitor known as NZ-97 that could be administered via intratracheal injection.

In a mouse model of lung disease, NZ-97 induced the growth of AEC2 cells and improved damaged lung tissue. “Importantly, NZ-97 demonstrated good tolerability when dosed intratracheally every day in naive animals,” the researchers wrote in the study.

In addition, 1 month of treatment with 0.5 mg/kg of NZ-97 every fourth day showed no detectable changes in alveolar structure, increased inflammation, or cellular hyperplasia.

The current research “identifies a novel mechanism for promoting alveolar repair” and treating not only idiopathic pulmonary fibrosis (IPF) but potentially other pulmonary diseases, such as chronic obstructive pulmonary disease, Dr. Bollong said.

“Here we reported a drug prototype, NZ-97, a locally delivered and lung-retained molecule that inhibits DPP4 in the lumen of the lung,” Bollong explained. The NZ-97 prototype drug is chemically similar to CMR316, a new clinical drug candidate from researchers at Calibr-Skaggs that is scheduled to start a phase 1 clinical trial later in the summer of 2024, according to Dr. Bollong.

CMR316 is designed to be delivered once a week in mist form via a nebulizer. “If CMR316 demonstrates ameliorative efficacy in IPF, it could provide a novel avenue for regenerating the lung and could be added on top of standard-of-care anti-fibrotic drugs to delay or potentially even reverse disease progression,” Dr. Bollong told this news organization.

“The key challenge will be understanding if the identified regenerative mechanism will show ameliorative efficacy in a clinical trial,” Dr. Bollong said. “While we have shown effects in animal models and patient-derived cells, the degree and duration of the ameliorative effect in patients will ultimately be determined in the clinic.”

Looking ahead, the CMR316 phase 1 clinical trial is designed to evaluate safety and target engagement, Dr. Bollong said. Dr. Bollong’s lab continues to collaborate with Calibr to develop other regenerative approaches to the treatment of disease in other organs, he said.
 

Meeting the Need for Regenerative Treatment

The current study and the ongoing research into NZ-97 address the need for regenerative therapies in pulmonary disease, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, Texas, said in an interview.

“Identifying DPP4 inhibitors, particularly NZ-97, as potential agents for expanding type 2 alveolar epithelial cells (AEC2s) represents a promising therapeutic strategy to stimulate the regeneration of damaged alveolar epithelium,” she said. “The AEC2s play a crucial role in lung repair, and targeting these could potentially ameliorate various lung diseases that currently lack effective treatments,” she explained.

“DPP4 inhibitors are well-established in diabetes management and have known biological actions; however, the successful repurposing and effectiveness of NZ-97 in promoting lung repair are surprising to some extent,” said Dr. Narendra. “This surprise stems from this medication’s novel application and efficacy in a pulmonary context, showing significant potential where traditional DPP4 inhibitors required higher, potentially unsafe doses to achieve similar effects,” she said.

Should research prove successful, NZ-97 could offer substantial clinical benefits for treating pulmonary diseases such as IPF and other conditions involving alveolar damage. By enhancing AEC2 proliferation, NZ-97 may improve patient outcomes by mitigating lung damage and promoting regenerative repair, possibly reducing the dependency on more invasive treatments like lung transplantation.

More research on NZ-97 is needed in order to identify potential barriers to its use, Dr. Narendra said. “Further studies are needed to evaluate the long-term effects of NZ-97, understand its mechanisms in human lung tissue, and determine its safety and efficacy in clinical settings.”

Dr. Narendra had no financial conflicts to disclose but served on the Editorial Board of Chest Physician.
 

A version of this article appeared on Medscape.com.

A drug prototype known as NZ-97 showed promise for treating pulmonary disease by stimulating growth of new stem cells to repair damaged tissue, based on data from a new proof-of-concept study.

In many pulmonary diseases, insufficient stem cells allow damage to progress, but researchers have developed a lung-targeted, drug-like small molecule to stimulate the growth of lung stem cells, according to data published in Proceedings of the National Academy of Sciences.

Michael J. Bollong, PhD, associate professor in the department of chemistry at Scripps Research, San Diego, and colleagues used ReFRAME, a drug repurposing library and database created by the Calibr-Skaggs Institute for Innovative Medicines (the drug discovery arm of Scripps Research) to test existing drugs as foundations to promote stem cell growth and repair in the lungs.

“At present, there are no drugs which promote regenerative repair of the lung,” Dr. Bollong said in an interview. “This is especially important in idiopathic pulmonary fibrosis, as this disease is driven by an insufficiency of the stem cell population of the lower airway, alveolar type 2 cells (AEC2s), to proliferate and to regenerate the gas exchange epithelium,” he said.

The researchers identified dipeptidyl peptidase 4 (DPP4) inhibitors as potential tools to help promote production of stem cells in the lower airway called AEC2s. Dysfunction of AEC2 is thought to play a key role in the pathogenesis of idiopathic pulmonary fibrosis, the researchers noted in the study. They created a new and highly soluble DPP4 inhibitor known as NZ-97 that could be administered via intratracheal injection.

In a mouse model of lung disease, NZ-97 induced the growth of AEC2 cells and improved damaged lung tissue. “Importantly, NZ-97 demonstrated good tolerability when dosed intratracheally every day in naive animals,” the researchers wrote in the study.

In addition, 1 month of treatment with 0.5 mg/kg of NZ-97 every fourth day showed no detectable changes in alveolar structure, increased inflammation, or cellular hyperplasia.

The current research “identifies a novel mechanism for promoting alveolar repair” and treating not only idiopathic pulmonary fibrosis (IPF) but potentially other pulmonary diseases, such as chronic obstructive pulmonary disease, Dr. Bollong said.

“Here we reported a drug prototype, NZ-97, a locally delivered and lung-retained molecule that inhibits DPP4 in the lumen of the lung,” Bollong explained. The NZ-97 prototype drug is chemically similar to CMR316, a new clinical drug candidate from researchers at Calibr-Skaggs that is scheduled to start a phase 1 clinical trial later in the summer of 2024, according to Dr. Bollong.

CMR316 is designed to be delivered once a week in mist form via a nebulizer. “If CMR316 demonstrates ameliorative efficacy in IPF, it could provide a novel avenue for regenerating the lung and could be added on top of standard-of-care anti-fibrotic drugs to delay or potentially even reverse disease progression,” Dr. Bollong told this news organization.

“The key challenge will be understanding if the identified regenerative mechanism will show ameliorative efficacy in a clinical trial,” Dr. Bollong said. “While we have shown effects in animal models and patient-derived cells, the degree and duration of the ameliorative effect in patients will ultimately be determined in the clinic.”

Looking ahead, the CMR316 phase 1 clinical trial is designed to evaluate safety and target engagement, Dr. Bollong said. Dr. Bollong’s lab continues to collaborate with Calibr to develop other regenerative approaches to the treatment of disease in other organs, he said.
 

Meeting the Need for Regenerative Treatment

The current study and the ongoing research into NZ-97 address the need for regenerative therapies in pulmonary disease, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, Texas, said in an interview.

“Identifying DPP4 inhibitors, particularly NZ-97, as potential agents for expanding type 2 alveolar epithelial cells (AEC2s) represents a promising therapeutic strategy to stimulate the regeneration of damaged alveolar epithelium,” she said. “The AEC2s play a crucial role in lung repair, and targeting these could potentially ameliorate various lung diseases that currently lack effective treatments,” she explained.

“DPP4 inhibitors are well-established in diabetes management and have known biological actions; however, the successful repurposing and effectiveness of NZ-97 in promoting lung repair are surprising to some extent,” said Dr. Narendra. “This surprise stems from this medication’s novel application and efficacy in a pulmonary context, showing significant potential where traditional DPP4 inhibitors required higher, potentially unsafe doses to achieve similar effects,” she said.

Should research prove successful, NZ-97 could offer substantial clinical benefits for treating pulmonary diseases such as IPF and other conditions involving alveolar damage. By enhancing AEC2 proliferation, NZ-97 may improve patient outcomes by mitigating lung damage and promoting regenerative repair, possibly reducing the dependency on more invasive treatments like lung transplantation.

More research on NZ-97 is needed in order to identify potential barriers to its use, Dr. Narendra said. “Further studies are needed to evaluate the long-term effects of NZ-97, understand its mechanisms in human lung tissue, and determine its safety and efficacy in clinical settings.”

Dr. Narendra had no financial conflicts to disclose but served on the Editorial Board of Chest Physician.
 

A version of this article appeared on Medscape.com.

A drug prototype known as NZ-97 showed promise for treating pulmonary disease by stimulating growth of new stem cells to repair damaged tissue, based on data from a new proof-of-concept study.

In many pulmonary diseases, insufficient stem cells allow damage to progress, but researchers have developed a lung-targeted, drug-like small molecule to stimulate the growth of lung stem cells, according to data published in Proceedings of the National Academy of Sciences.

Michael J. Bollong, PhD, associate professor in the department of chemistry at Scripps Research, San Diego, and colleagues used ReFRAME, a drug repurposing library and database created by the Calibr-Skaggs Institute for Innovative Medicines (the drug discovery arm of Scripps Research) to test existing drugs as foundations to promote stem cell growth and repair in the lungs.

“At present, there are no drugs which promote regenerative repair of the lung,” Dr. Bollong said in an interview. “This is especially important in idiopathic pulmonary fibrosis, as this disease is driven by an insufficiency of the stem cell population of the lower airway, alveolar type 2 cells (AEC2s), to proliferate and to regenerate the gas exchange epithelium,” he said.

The researchers identified dipeptidyl peptidase 4 (DPP4) inhibitors as potential tools to help promote production of stem cells in the lower airway called AEC2s. Dysfunction of AEC2 is thought to play a key role in the pathogenesis of idiopathic pulmonary fibrosis, the researchers noted in the study. They created a new and highly soluble DPP4 inhibitor known as NZ-97 that could be administered via intratracheal injection.

In a mouse model of lung disease, NZ-97 induced the growth of AEC2 cells and improved damaged lung tissue. “Importantly, NZ-97 demonstrated good tolerability when dosed intratracheally every day in naive animals,” the researchers wrote in the study.

In addition, 1 month of treatment with 0.5 mg/kg of NZ-97 every fourth day showed no detectable changes in alveolar structure, increased inflammation, or cellular hyperplasia.

The current research “identifies a novel mechanism for promoting alveolar repair” and treating not only idiopathic pulmonary fibrosis (IPF) but potentially other pulmonary diseases, such as chronic obstructive pulmonary disease, Dr. Bollong said.

“Here we reported a drug prototype, NZ-97, a locally delivered and lung-retained molecule that inhibits DPP4 in the lumen of the lung,” Bollong explained. The NZ-97 prototype drug is chemically similar to CMR316, a new clinical drug candidate from researchers at Calibr-Skaggs that is scheduled to start a phase 1 clinical trial later in the summer of 2024, according to Dr. Bollong.

CMR316 is designed to be delivered once a week in mist form via a nebulizer. “If CMR316 demonstrates ameliorative efficacy in IPF, it could provide a novel avenue for regenerating the lung and could be added on top of standard-of-care anti-fibrotic drugs to delay or potentially even reverse disease progression,” Dr. Bollong told this news organization.

“The key challenge will be understanding if the identified regenerative mechanism will show ameliorative efficacy in a clinical trial,” Dr. Bollong said. “While we have shown effects in animal models and patient-derived cells, the degree and duration of the ameliorative effect in patients will ultimately be determined in the clinic.”

Looking ahead, the CMR316 phase 1 clinical trial is designed to evaluate safety and target engagement, Dr. Bollong said. Dr. Bollong’s lab continues to collaborate with Calibr to develop other regenerative approaches to the treatment of disease in other organs, he said.
 

Meeting the Need for Regenerative Treatment

The current study and the ongoing research into NZ-97 address the need for regenerative therapies in pulmonary disease, Dharani K. Narendra, MD, of Baylor College of Medicine, Houston, Texas, said in an interview.

“Identifying DPP4 inhibitors, particularly NZ-97, as potential agents for expanding type 2 alveolar epithelial cells (AEC2s) represents a promising therapeutic strategy to stimulate the regeneration of damaged alveolar epithelium,” she said. “The AEC2s play a crucial role in lung repair, and targeting these could potentially ameliorate various lung diseases that currently lack effective treatments,” she explained.

“DPP4 inhibitors are well-established in diabetes management and have known biological actions; however, the successful repurposing and effectiveness of NZ-97 in promoting lung repair are surprising to some extent,” said Dr. Narendra. “This surprise stems from this medication’s novel application and efficacy in a pulmonary context, showing significant potential where traditional DPP4 inhibitors required higher, potentially unsafe doses to achieve similar effects,” she said.

Should research prove successful, NZ-97 could offer substantial clinical benefits for treating pulmonary diseases such as IPF and other conditions involving alveolar damage. By enhancing AEC2 proliferation, NZ-97 may improve patient outcomes by mitigating lung damage and promoting regenerative repair, possibly reducing the dependency on more invasive treatments like lung transplantation.

More research on NZ-97 is needed in order to identify potential barriers to its use, Dr. Narendra said. “Further studies are needed to evaluate the long-term effects of NZ-97, understand its mechanisms in human lung tissue, and determine its safety and efficacy in clinical settings.”

Dr. Narendra had no financial conflicts to disclose but served on the Editorial Board of Chest Physician.
 

A version of this article appeared on Medscape.com.

TOPLINE:

The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.

METHODOLOGY:

• MDA5 antibody-positive DM is a rare DM subtype associated with ILD, which is categorized into rapidly progressive ILD (RPILD) and chronic ILD, with the former having a particularly high mortality rate.
• In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
• The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.

TAKEAWAY:

• Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
• ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
• The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
• Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.

IN PRACTICE:

“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.

SOURCE:

This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.

LIMITATIONS:

Study limitations were the study’s retrospective design and small sample size.

DISCLOSURES:

No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.

METHODOLOGY:

• MDA5 antibody-positive DM is a rare DM subtype associated with ILD, which is categorized into rapidly progressive ILD (RPILD) and chronic ILD, with the former having a particularly high mortality rate.
• In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
• The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.

TAKEAWAY:

• Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
• ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
• The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
• Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.

IN PRACTICE:

“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.

SOURCE:

This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.

LIMITATIONS:

Study limitations were the study’s retrospective design and small sample size.

DISCLOSURES:

No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.

A version of this article appeared on Medscape.com.

TOPLINE:

The time interval between onset of interstitial lung disease (ILD) and diagnosis of anti–melanoma differentiation-associated gene 5 (MDA5) antibody-positive dermatomyositis (DM) “has not been well described,” the authors say.

METHODOLOGY:

• MDA5 antibody-positive DM is a rare DM subtype associated with ILD, which is categorized into rapidly progressive ILD (RPILD) and chronic ILD, with the former having a particularly high mortality rate.
• In this retrospective cohort study using electronic medical records, researchers evaluated 774 patients with DM between 2008 and 2023 to learn more about the time interval between ILD and the time of an MDA5 antibody-positive DM diagnosis, which has not been well described.
• The primary outcome was ILD diagnosis and time in days between documented ILD and MDA5 antibody-positive DM diagnoses.

TAKEAWAY:

• Overall, 14 patients with DM (1.8%) were diagnosed with MDA5 antibody-positive DM in dermatology, rheumatology, or pulmonology departments (nine women and five men; age, 24-77 years; 79% were White and 7% were Black).
• ILD was diagnosed in 9 of the 14 patients (64%); 6 of the 14 (43%) met the criteria for RPILD. Two cases were diagnosed concurrently and two prior to MDA5 antibody-positive DM diagnosis.
• The median time between ILD and MDA5 antibody-positive DM diagnoses was 163 days.
• Gottron papules/sign and midfacial erythema were the most common dermatologic findings, and no association was seen between cutaneous signs and type of ILD.

IN PRACTICE:

“Establishing an accurate timeline between MDA5 antibody-positive DM and ILD can promote urgency among dermatologists to evaluate extracutaneous manifestations in their management of patients with DM for more accurate risk stratification and appropriate treatment,” the authors wrote.

SOURCE:

This study, led by Rachel R. Lin, from the University of Miami, Miami, Florida, was published online as a research letter in JAMA Dermatology.

LIMITATIONS:

Study limitations were the study’s retrospective design and small sample size.

DISCLOSURES:

No information on study funding was provided. One author reported personal fees from argenX outside this submitted work. Other authors did not disclose any competing interests.

A version of this article appeared on Medscape.com.