CHEST Physician

TOPLINE:

Long-term exposure to fine particulate matter is associated with higher fasting blood glucose (FBG) levels and an increased type 2 diabetes risk, significantly contributing to the diabetes-related health burden among women of reproductive age.

METHODOLOGY:

• Exposure to fine particulate matter < 2.5 µm (PM2.5) is a known risk factor for type 2 diabetes, but its effect on women of reproductive age, who undergo hormonal fluctuations during reproductive events, is not well studied.
• Researchers evaluated the association of long-term exposure to PM2.5 with FBG levels and diabetes risk in 20,076,032 eligible women of reproductive age (average age, 27.04 years) across 350 cities in China between 2010 and 2015.
• They assessed PM2.5 exposure at the participants’ residential addresses and calculated average long-term exposure at 1 (lag 1 year), 2 (lag 2 years), and 3 years (lag 3 years) before the survey date, as defined by the World Health Organization (WHO).
• The primary outcomes were FBG levels and diabetes prevalence (FBG, ≥ 7 mmol/L, classified as diabetes; FBG, 6.1-7 mmol/L, classified as prediabetes).
• The study also evaluated the diabetes burden attributed to long-term PM2.5 exposure as per the Chinese National Ambient Air Quality Standards (annual mean PM2.5 exposure limit, > 35 µg/m³) and the WHO air quality guideline (annual mean PM2.5 exposure limit, > 5 µg/m³).

TAKEAWAY:

• The median PM2.5 exposure levels over lag periods of 1, 2, and 3 years were 67, 67, and 66 µg/m³, respectively, exceeding the WHO limit by more than 13-fold.
• Each interquartile range increase in the 3-year average PM2.5 exposure by 27 μg/m³ raised FBG levels by 0.078 mmol/L (P < .05), risk for diabetes by 18% (odds ratio [OR], 1.18; 95% CI, 1.16-1.19), and risk for prediabetes by 5% (OR, 1.05; 95% CI, 1.04-1.05).
• Long-term exposure to PM2.5 > 5 µg/m³ and 35 µg/m³ in the previous 3 years corresponded to an additional 41.7 (95% CI, 39.3-44.0) and 78.6 (95% CI, 74.5-82.6) thousand cases of diabetes nationwide, respectively.
• A higher PM2.5 exposure increased FBG levels and risk for diabetes in women with overweight or obesity vs those without and in those aged ≥ 35 years vs < 35 years (P < .001).

IN PRACTICE:

“These findings carry significant public health implications for formulating effective intervention strategies and environmental policies to better protect women’s health, particularly in countries with relatively high levels of air pollution and a large population with diabetes, such as China,” the authors wrote.

SOURCE:

The study, led by Yang Shen, Key Laboratory of Public Health Safety of the Ministry of Education and National Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, China, was published online in Diabetes Care.

LIMITATIONS:

An error in the measurement of particulate matter exposure may have been possible as residential address estimates were used as a proxy for actual personal exposure. Questionnaires were used to retrospectively collect information on parameters such as smoking and alcohol consumption, which may have introduced recall bias. Data on potential confounders, such as diet and physical activity, were not included. Distinction between type 1 and type 2 diabetes was not reported owing to data collection–related limitations.

DISCLOSURES:

The study was supported by the National Key Research and Development Program of China, Henan Key Research and Development Program, State Key Laboratory of Resources and Environmental Information System, and Three-Year Public Health Action Plan of Shanghai. The authors declared no conflicts of interest.

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

TOPLINE:

Long-term exposure to fine particulate matter is associated with higher fasting blood glucose (FBG) levels and an increased type 2 diabetes risk, significantly contributing to the diabetes-related health burden among women of reproductive age.

METHODOLOGY:

• Exposure to fine particulate matter < 2.5 µm (PM2.5) is a known risk factor for type 2 diabetes, but its effect on women of reproductive age, who undergo hormonal fluctuations during reproductive events, is not well studied.
• Researchers evaluated the association of long-term exposure to PM2.5 with FBG levels and diabetes risk in 20,076,032 eligible women of reproductive age (average age, 27.04 years) across 350 cities in China between 2010 and 2015.
• They assessed PM2.5 exposure at the participants’ residential addresses and calculated average long-term exposure at 1 (lag 1 year), 2 (lag 2 years), and 3 years (lag 3 years) before the survey date, as defined by the World Health Organization (WHO).
• The primary outcomes were FBG levels and diabetes prevalence (FBG, ≥ 7 mmol/L, classified as diabetes; FBG, 6.1-7 mmol/L, classified as prediabetes).
• The study also evaluated the diabetes burden attributed to long-term PM2.5 exposure as per the Chinese National Ambient Air Quality Standards (annual mean PM2.5 exposure limit, > 35 µg/m³) and the WHO air quality guideline (annual mean PM2.5 exposure limit, > 5 µg/m³).

TAKEAWAY:

• The median PM2.5 exposure levels over lag periods of 1, 2, and 3 years were 67, 67, and 66 µg/m³, respectively, exceeding the WHO limit by more than 13-fold.
• Each interquartile range increase in the 3-year average PM2.5 exposure by 27 μg/m³ raised FBG levels by 0.078 mmol/L (P < .05), risk for diabetes by 18% (odds ratio [OR], 1.18; 95% CI, 1.16-1.19), and risk for prediabetes by 5% (OR, 1.05; 95% CI, 1.04-1.05).
• Long-term exposure to PM2.5 > 5 µg/m³ and 35 µg/m³ in the previous 3 years corresponded to an additional 41.7 (95% CI, 39.3-44.0) and 78.6 (95% CI, 74.5-82.6) thousand cases of diabetes nationwide, respectively.
• A higher PM2.5 exposure increased FBG levels and risk for diabetes in women with overweight or obesity vs those without and in those aged ≥ 35 years vs < 35 years (P < .001).

IN PRACTICE:

“These findings carry significant public health implications for formulating effective intervention strategies and environmental policies to better protect women’s health, particularly in countries with relatively high levels of air pollution and a large population with diabetes, such as China,” the authors wrote.

SOURCE:

The study, led by Yang Shen, Key Laboratory of Public Health Safety of the Ministry of Education and National Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, China, was published online in Diabetes Care.

LIMITATIONS:

An error in the measurement of particulate matter exposure may have been possible as residential address estimates were used as a proxy for actual personal exposure. Questionnaires were used to retrospectively collect information on parameters such as smoking and alcohol consumption, which may have introduced recall bias. Data on potential confounders, such as diet and physical activity, were not included. Distinction between type 1 and type 2 diabetes was not reported owing to data collection–related limitations.

DISCLOSURES:

The study was supported by the National Key Research and Development Program of China, Henan Key Research and Development Program, State Key Laboratory of Resources and Environmental Information System, and Three-Year Public Health Action Plan of Shanghai. The authors declared no conflicts of interest.

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

TOPLINE:

Long-term exposure to fine particulate matter is associated with higher fasting blood glucose (FBG) levels and an increased type 2 diabetes risk, significantly contributing to the diabetes-related health burden among women of reproductive age.

METHODOLOGY:

• Exposure to fine particulate matter < 2.5 µm (PM2.5) is a known risk factor for type 2 diabetes, but its effect on women of reproductive age, who undergo hormonal fluctuations during reproductive events, is not well studied.
• Researchers evaluated the association of long-term exposure to PM2.5 with FBG levels and diabetes risk in 20,076,032 eligible women of reproductive age (average age, 27.04 years) across 350 cities in China between 2010 and 2015.
• They assessed PM2.5 exposure at the participants’ residential addresses and calculated average long-term exposure at 1 (lag 1 year), 2 (lag 2 years), and 3 years (lag 3 years) before the survey date, as defined by the World Health Organization (WHO).
• The primary outcomes were FBG levels and diabetes prevalence (FBG, ≥ 7 mmol/L, classified as diabetes; FBG, 6.1-7 mmol/L, classified as prediabetes).
• The study also evaluated the diabetes burden attributed to long-term PM2.5 exposure as per the Chinese National Ambient Air Quality Standards (annual mean PM2.5 exposure limit, > 35 µg/m³) and the WHO air quality guideline (annual mean PM2.5 exposure limit, > 5 µg/m³).

TAKEAWAY:

• The median PM2.5 exposure levels over lag periods of 1, 2, and 3 years were 67, 67, and 66 µg/m³, respectively, exceeding the WHO limit by more than 13-fold.
• Each interquartile range increase in the 3-year average PM2.5 exposure by 27 μg/m³ raised FBG levels by 0.078 mmol/L (P < .05), risk for diabetes by 18% (odds ratio [OR], 1.18; 95% CI, 1.16-1.19), and risk for prediabetes by 5% (OR, 1.05; 95% CI, 1.04-1.05).
• Long-term exposure to PM2.5 > 5 µg/m³ and 35 µg/m³ in the previous 3 years corresponded to an additional 41.7 (95% CI, 39.3-44.0) and 78.6 (95% CI, 74.5-82.6) thousand cases of diabetes nationwide, respectively.
• A higher PM2.5 exposure increased FBG levels and risk for diabetes in women with overweight or obesity vs those without and in those aged ≥ 35 years vs < 35 years (P < .001).

IN PRACTICE:

“These findings carry significant public health implications for formulating effective intervention strategies and environmental policies to better protect women’s health, particularly in countries with relatively high levels of air pollution and a large population with diabetes, such as China,” the authors wrote.

SOURCE:

The study, led by Yang Shen, Key Laboratory of Public Health Safety of the Ministry of Education and National Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, China, was published online in Diabetes Care.

LIMITATIONS:

An error in the measurement of particulate matter exposure may have been possible as residential address estimates were used as a proxy for actual personal exposure. Questionnaires were used to retrospectively collect information on parameters such as smoking and alcohol consumption, which may have introduced recall bias. Data on potential confounders, such as diet and physical activity, were not included. Distinction between type 1 and type 2 diabetes was not reported owing to data collection–related limitations.

DISCLOSURES:

The study was supported by the National Key Research and Development Program of China, Henan Key Research and Development Program, State Key Laboratory of Resources and Environmental Information System, and Three-Year Public Health Action Plan of Shanghai. The authors declared no conflicts of interest.

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

TOPLINE:

Inebilizumab-cdon, a monoclonal antibody that depletes B cells, reduces the risk for flares without showing any new safety signals in patients with immunoglobulin G4-related disease (IgG4-RD) who have multiorgan disease and are on glucocorticoid therapy.

METHODOLOGY:

• IgG4-RD is an immune-mediated, fibroinflammatory condition that affects multiple organs, causing irreversible organ damage. MITIGATE is the first multinational, placebo-controlled trial involving patients with IgG4-RD.
• Researchers evaluated the efficacy and safety of inebilizumab in 135 adult patients at risk for flares due to a history of multiorgan disease and active disease requiring treatment with glucocorticoids.
• The patients were randomly assigned to receive 300-mg intravenous inebilizumab or placebo on day 1, day 15, and week 26.
• The primary endpoint was the time to the first treated and adjudicated IgG4-RD flare within 52 weeks.
• The secondary endpoints included the annualized flare rate, flare-free and treatment-free complete remission, and flare-free and corticosteroid-free complete remission.

TAKEAWAY:

• Compared with the placebo, inebilizumab reduced the risk for IgG4-RD flares by 87% during the 52-week trial period (hazard ratio, 0.13; P < .0001).
• All the secondary endpoints showed improvement following treatment with inebilizumab.
• The most common adverse reactions with inebilizumab, as observed in a previous trial for neuromyelitis optica spectrum disorder, were urinary tract infection and arthralgia.
• There were no new safety signals in the MITIGATE trial.

IN PRACTICE:

“These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD but also key insights into the nature of this condition,” John Stone, MD, MPH, principal investigator, said in a news release.

SOURCE:

Dr. Stone, a professor of medicine at the Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital, Boston, led this study.

LIMITATIONS:

This press release did not discuss any limitations of the current study.

DISCLOSURES:

This study was funded by Mitsubishi Tanabe Pharma and Hansoh Pharma and sponsored by Amgen. The author disclosures were not available.

A version of this article appeared on Medscape.com.

TOPLINE:

Inebilizumab-cdon, a monoclonal antibody that depletes B cells, reduces the risk for flares without showing any new safety signals in patients with immunoglobulin G4-related disease (IgG4-RD) who have multiorgan disease and are on glucocorticoid therapy.

METHODOLOGY:

• IgG4-RD is an immune-mediated, fibroinflammatory condition that affects multiple organs, causing irreversible organ damage. MITIGATE is the first multinational, placebo-controlled trial involving patients with IgG4-RD.
• Researchers evaluated the efficacy and safety of inebilizumab in 135 adult patients at risk for flares due to a history of multiorgan disease and active disease requiring treatment with glucocorticoids.
• The patients were randomly assigned to receive 300-mg intravenous inebilizumab or placebo on day 1, day 15, and week 26.
• The primary endpoint was the time to the first treated and adjudicated IgG4-RD flare within 52 weeks.
• The secondary endpoints included the annualized flare rate, flare-free and treatment-free complete remission, and flare-free and corticosteroid-free complete remission.

TAKEAWAY:

• Compared with the placebo, inebilizumab reduced the risk for IgG4-RD flares by 87% during the 52-week trial period (hazard ratio, 0.13; P < .0001).
• All the secondary endpoints showed improvement following treatment with inebilizumab.
• The most common adverse reactions with inebilizumab, as observed in a previous trial for neuromyelitis optica spectrum disorder, were urinary tract infection and arthralgia.
• There were no new safety signals in the MITIGATE trial.

IN PRACTICE:

“These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD but also key insights into the nature of this condition,” John Stone, MD, MPH, principal investigator, said in a news release.

SOURCE:

Dr. Stone, a professor of medicine at the Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital, Boston, led this study.

LIMITATIONS:

This press release did not discuss any limitations of the current study.

DISCLOSURES:

This study was funded by Mitsubishi Tanabe Pharma and Hansoh Pharma and sponsored by Amgen. The author disclosures were not available.

A version of this article appeared on Medscape.com.

TOPLINE:

Inebilizumab-cdon, a monoclonal antibody that depletes B cells, reduces the risk for flares without showing any new safety signals in patients with immunoglobulin G4-related disease (IgG4-RD) who have multiorgan disease and are on glucocorticoid therapy.

METHODOLOGY:

• IgG4-RD is an immune-mediated, fibroinflammatory condition that affects multiple organs, causing irreversible organ damage. MITIGATE is the first multinational, placebo-controlled trial involving patients with IgG4-RD.
• Researchers evaluated the efficacy and safety of inebilizumab in 135 adult patients at risk for flares due to a history of multiorgan disease and active disease requiring treatment with glucocorticoids.
• The patients were randomly assigned to receive 300-mg intravenous inebilizumab or placebo on day 1, day 15, and week 26.
• The primary endpoint was the time to the first treated and adjudicated IgG4-RD flare within 52 weeks.
• The secondary endpoints included the annualized flare rate, flare-free and treatment-free complete remission, and flare-free and corticosteroid-free complete remission.

TAKEAWAY:

• Compared with the placebo, inebilizumab reduced the risk for IgG4-RD flares by 87% during the 52-week trial period (hazard ratio, 0.13; P < .0001).
• All the secondary endpoints showed improvement following treatment with inebilizumab.
• The most common adverse reactions with inebilizumab, as observed in a previous trial for neuromyelitis optica spectrum disorder, were urinary tract infection and arthralgia.
• There were no new safety signals in the MITIGATE trial.

IN PRACTICE:

“These data mark a major milestone for the IgG4-RD community and provide substantial insight into not only how inebilizumab can help manage IgG4-RD but also key insights into the nature of this condition,” John Stone, MD, MPH, principal investigator, said in a news release.

SOURCE:

Dr. Stone, a professor of medicine at the Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital, Boston, led this study.

LIMITATIONS:

This press release did not discuss any limitations of the current study.

DISCLOSURES:

This study was funded by Mitsubishi Tanabe Pharma and Hansoh Pharma and sponsored by Amgen. The author disclosures were not available.

A version of this article appeared on Medscape.com.

When Ezra Spier was diagnosed with long COVID in late 2022, his main symptom, postexertional malaise, caused fatigue so severe that it forced him to quit his job as a technology entrepreneur. Since then, it’s been a tough road for Spier, 37, who said he wouldn’t wish his hellish condition on anyone. 

Last spring, he enrolled in a clinical trial of a new long COVID therapy at Stanford University, and he’s about to start another at the University of California, San Francisco. 

For Spier, who lives in Oakland, California, being part of the clinical trials connected him with people dealing with similar health issues while also moving the needle toward better treatments for everyone. Yet many potential participants are unaware that these clinical trials exist. Clinical trial researchers also express frustration over the challenge of enrolling participants.

That’s why Spier created a new website to help match long COVID patients with clinical trials that can help.

“I wanted a way to make long COVID clinical trials more accessible to the general public,” he said. Spier’s website, aptly named Long Covid Studies, launched in March. The site already includes details from about 550 trials globally and, in the future, will include many more.
 

It’s Not the Number of Studies, It’s Navigating Them

In all, nearly 9300 long COVID trials are listed on ClinicalTrials.gov. But many patients find the site difficult to navigate, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City. He said Spier’s website helps make trials easier for patients to manage in ways that remove the enrollment challenges.

“Ezra’s platform pulls data from ClinicalTrials.gov and puts it into a space that’s much easier for patients to manage,” said Dr. Putrino. The site only includes the most relevant information, such as the study location, eligibility, and purpose and how to sign up. 

Another of Spier’s goals is to make the process easier for patients who are already marginalized and often excluded from the healthcare system. Long COVID disproportionately impacts people in minority ethnic groups and women, as well as those who are impoverished or live in rural areas. 

According to the National Institutes of Health (NIH), 1 in 4 patients with severe long COVID-19 are Black or Hispanic whereas only 1 in 7 are White. Yet participation by White persons in clinical trials is much higher overall: 77% of participants are White, compared with only 14% for Black persons and 15% for Hispanic persons. Without more balanced representation, research becomes skewed and less accurate, said Grace McComsey, MD, who leads one of the 15 nationwide long COVID centers funded by the federal RECOVER (Researching COVID to Enhance Recovery) Initiative in Cleveland. 

Websites that are easier for the layperson to access would allow for wider participation, said McComsey.
 

Too Many Barriers to Entry

A study published in the Journal of Applied Gerontology found that transportation plays an outsized role in influencing study participation, which may also lead to less diverse participation.

Decentralized trials — in which participants receive therapy at home — also make enrolling in clinical trials easier for marginalized patients and those too sick to make it to a research center, said Dr. Putrino. Research published recently in The American Journal of Medicine demonstrated that for many patients, remote studies are the future of COVID research. The study, focusing on the efficacy of Paxlovid, recruited patients living in the 48 contiguous US states. Participation was entirely remote. 

“We need to have more consideration for bedbound and housebound patients in our research,” said Dr. Putrino. “Some people don’t have the ability to show up to a prestigious university to take part in an academic trial.”

Dr. Putrino and colleagues at Yale School of Medicine’s Yale COVID Recovery Study plan to release a paper in the near future on the methodology for running decentralized or remote studies that could provide guidance for researchers elsewhere. 

Decentralized studies serve a larger audience, but they’re also more expensive and cost has plagued long COVID research from the start, said Michael Peluso, MD, an assistant research professor of infectious medicine at UCSF School of Medicine, University of California, San Francisco. 

“You need to have a staff in place that’s trained to do home visits in order to conduct remote trials,” Dr. Peluso said, adding that his biggest challenge has been connecting patients to appropriate clinical trials. 

Individual eligibility has been an ongoing issue. For example, Dr. Peluso’s current trials are testing monoclonal antibodies — antibodies produced by cloning unique white blood cells to target viral persistence, which is thought to be a cause of long COVID. Only patients who were infected with certain variants of acute COVID are eligible because of the antibodies needed to target SARS-CoV-2 spike proteins. 

“This can lead to a lot of frustration among patients who might think they can participate, but aren’t eligible,” said Dr. Peluso.
 

Long Fight for Better Long COVID Research

For Spier, one of the hardest parts of his health issues and lack of energy is that they have sharply curtailed his social interactions with friends and colleagues. 

He has channeled his energies into researching new treatments that could potentially improve his symptoms. That research is partly what drove him to create the Long Covid Studies website.

His goal is still to help others with long COVID find trials that can improve their symptoms as well. The more people who participate, the closer scientists will come to providing effective treatments for everyone, he said.

“For all my frustrations, we’re still at the forefront of science globally,” he said. “And if we have the level of funding the NIH is equipped to provide, we can show the world what’s possible with long COVID research.”

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

When Ezra Spier was diagnosed with long COVID in late 2022, his main symptom, postexertional malaise, caused fatigue so severe that it forced him to quit his job as a technology entrepreneur. Since then, it’s been a tough road for Spier, 37, who said he wouldn’t wish his hellish condition on anyone. 

Last spring, he enrolled in a clinical trial of a new long COVID therapy at Stanford University, and he’s about to start another at the University of California, San Francisco. 

For Spier, who lives in Oakland, California, being part of the clinical trials connected him with people dealing with similar health issues while also moving the needle toward better treatments for everyone. Yet many potential participants are unaware that these clinical trials exist. Clinical trial researchers also express frustration over the challenge of enrolling participants.

That’s why Spier created a new website to help match long COVID patients with clinical trials that can help.

“I wanted a way to make long COVID clinical trials more accessible to the general public,” he said. Spier’s website, aptly named Long Covid Studies, launched in March. The site already includes details from about 550 trials globally and, in the future, will include many more.
 

It’s Not the Number of Studies, It’s Navigating Them

In all, nearly 9300 long COVID trials are listed on ClinicalTrials.gov. But many patients find the site difficult to navigate, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City. He said Spier’s website helps make trials easier for patients to manage in ways that remove the enrollment challenges.

“Ezra’s platform pulls data from ClinicalTrials.gov and puts it into a space that’s much easier for patients to manage,” said Dr. Putrino. The site only includes the most relevant information, such as the study location, eligibility, and purpose and how to sign up. 

Another of Spier’s goals is to make the process easier for patients who are already marginalized and often excluded from the healthcare system. Long COVID disproportionately impacts people in minority ethnic groups and women, as well as those who are impoverished or live in rural areas. 

According to the National Institutes of Health (NIH), 1 in 4 patients with severe long COVID-19 are Black or Hispanic whereas only 1 in 7 are White. Yet participation by White persons in clinical trials is much higher overall: 77% of participants are White, compared with only 14% for Black persons and 15% for Hispanic persons. Without more balanced representation, research becomes skewed and less accurate, said Grace McComsey, MD, who leads one of the 15 nationwide long COVID centers funded by the federal RECOVER (Researching COVID to Enhance Recovery) Initiative in Cleveland. 

Websites that are easier for the layperson to access would allow for wider participation, said McComsey.
 

Too Many Barriers to Entry

A study published in the Journal of Applied Gerontology found that transportation plays an outsized role in influencing study participation, which may also lead to less diverse participation.

Decentralized trials — in which participants receive therapy at home — also make enrolling in clinical trials easier for marginalized patients and those too sick to make it to a research center, said Dr. Putrino. Research published recently in The American Journal of Medicine demonstrated that for many patients, remote studies are the future of COVID research. The study, focusing on the efficacy of Paxlovid, recruited patients living in the 48 contiguous US states. Participation was entirely remote. 

“We need to have more consideration for bedbound and housebound patients in our research,” said Dr. Putrino. “Some people don’t have the ability to show up to a prestigious university to take part in an academic trial.”

Dr. Putrino and colleagues at Yale School of Medicine’s Yale COVID Recovery Study plan to release a paper in the near future on the methodology for running decentralized or remote studies that could provide guidance for researchers elsewhere. 

Decentralized studies serve a larger audience, but they’re also more expensive and cost has plagued long COVID research from the start, said Michael Peluso, MD, an assistant research professor of infectious medicine at UCSF School of Medicine, University of California, San Francisco. 

“You need to have a staff in place that’s trained to do home visits in order to conduct remote trials,” Dr. Peluso said, adding that his biggest challenge has been connecting patients to appropriate clinical trials. 

Individual eligibility has been an ongoing issue. For example, Dr. Peluso’s current trials are testing monoclonal antibodies — antibodies produced by cloning unique white blood cells to target viral persistence, which is thought to be a cause of long COVID. Only patients who were infected with certain variants of acute COVID are eligible because of the antibodies needed to target SARS-CoV-2 spike proteins. 

“This can lead to a lot of frustration among patients who might think they can participate, but aren’t eligible,” said Dr. Peluso.
 

Long Fight for Better Long COVID Research

For Spier, one of the hardest parts of his health issues and lack of energy is that they have sharply curtailed his social interactions with friends and colleagues. 

He has channeled his energies into researching new treatments that could potentially improve his symptoms. That research is partly what drove him to create the Long Covid Studies website.

His goal is still to help others with long COVID find trials that can improve their symptoms as well. The more people who participate, the closer scientists will come to providing effective treatments for everyone, he said.

“For all my frustrations, we’re still at the forefront of science globally,” he said. “And if we have the level of funding the NIH is equipped to provide, we can show the world what’s possible with long COVID research.”

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

When Ezra Spier was diagnosed with long COVID in late 2022, his main symptom, postexertional malaise, caused fatigue so severe that it forced him to quit his job as a technology entrepreneur. Since then, it’s been a tough road for Spier, 37, who said he wouldn’t wish his hellish condition on anyone. 

Last spring, he enrolled in a clinical trial of a new long COVID therapy at Stanford University, and he’s about to start another at the University of California, San Francisco. 

For Spier, who lives in Oakland, California, being part of the clinical trials connected him with people dealing with similar health issues while also moving the needle toward better treatments for everyone. Yet many potential participants are unaware that these clinical trials exist. Clinical trial researchers also express frustration over the challenge of enrolling participants.

That’s why Spier created a new website to help match long COVID patients with clinical trials that can help.

“I wanted a way to make long COVID clinical trials more accessible to the general public,” he said. Spier’s website, aptly named Long Covid Studies, launched in March. The site already includes details from about 550 trials globally and, in the future, will include many more.
 

It’s Not the Number of Studies, It’s Navigating Them

In all, nearly 9300 long COVID trials are listed on ClinicalTrials.gov. But many patients find the site difficult to navigate, said David F. Putrino, PhD, who runs the long COVID clinic at Mount Sinai Health System in New York City. He said Spier’s website helps make trials easier for patients to manage in ways that remove the enrollment challenges.

“Ezra’s platform pulls data from ClinicalTrials.gov and puts it into a space that’s much easier for patients to manage,” said Dr. Putrino. The site only includes the most relevant information, such as the study location, eligibility, and purpose and how to sign up. 

Another of Spier’s goals is to make the process easier for patients who are already marginalized and often excluded from the healthcare system. Long COVID disproportionately impacts people in minority ethnic groups and women, as well as those who are impoverished or live in rural areas. 

According to the National Institutes of Health (NIH), 1 in 4 patients with severe long COVID-19 are Black or Hispanic whereas only 1 in 7 are White. Yet participation by White persons in clinical trials is much higher overall: 77% of participants are White, compared with only 14% for Black persons and 15% for Hispanic persons. Without more balanced representation, research becomes skewed and less accurate, said Grace McComsey, MD, who leads one of the 15 nationwide long COVID centers funded by the federal RECOVER (Researching COVID to Enhance Recovery) Initiative in Cleveland. 

Websites that are easier for the layperson to access would allow for wider participation, said McComsey.
 

Too Many Barriers to Entry

A study published in the Journal of Applied Gerontology found that transportation plays an outsized role in influencing study participation, which may also lead to less diverse participation.

Decentralized trials — in which participants receive therapy at home — also make enrolling in clinical trials easier for marginalized patients and those too sick to make it to a research center, said Dr. Putrino. Research published recently in The American Journal of Medicine demonstrated that for many patients, remote studies are the future of COVID research. The study, focusing on the efficacy of Paxlovid, recruited patients living in the 48 contiguous US states. Participation was entirely remote. 

“We need to have more consideration for bedbound and housebound patients in our research,” said Dr. Putrino. “Some people don’t have the ability to show up to a prestigious university to take part in an academic trial.”

Dr. Putrino and colleagues at Yale School of Medicine’s Yale COVID Recovery Study plan to release a paper in the near future on the methodology for running decentralized or remote studies that could provide guidance for researchers elsewhere. 

Decentralized studies serve a larger audience, but they’re also more expensive and cost has plagued long COVID research from the start, said Michael Peluso, MD, an assistant research professor of infectious medicine at UCSF School of Medicine, University of California, San Francisco. 

“You need to have a staff in place that’s trained to do home visits in order to conduct remote trials,” Dr. Peluso said, adding that his biggest challenge has been connecting patients to appropriate clinical trials. 

Individual eligibility has been an ongoing issue. For example, Dr. Peluso’s current trials are testing monoclonal antibodies — antibodies produced by cloning unique white blood cells to target viral persistence, which is thought to be a cause of long COVID. Only patients who were infected with certain variants of acute COVID are eligible because of the antibodies needed to target SARS-CoV-2 spike proteins. 

“This can lead to a lot of frustration among patients who might think they can participate, but aren’t eligible,” said Dr. Peluso.
 

Long Fight for Better Long COVID Research

For Spier, one of the hardest parts of his health issues and lack of energy is that they have sharply curtailed his social interactions with friends and colleagues. 

He has channeled his energies into researching new treatments that could potentially improve his symptoms. That research is partly what drove him to create the Long Covid Studies website.

His goal is still to help others with long COVID find trials that can improve their symptoms as well. The more people who participate, the closer scientists will come to providing effective treatments for everyone, he said.

“For all my frustrations, we’re still at the forefront of science globally,” he said. “And if we have the level of funding the NIH is equipped to provide, we can show the world what’s possible with long COVID research.”

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

Non-respiratory symptoms including poor sleep, fatigue, pain, anxiety, and depressive symptoms were prevalent among adults with cystic fibrosis (AwCF) and persisted after 1 year of follow-up, based on data from more than 200 individuals in a study presented at the American Thoracic Society (ATS) 2024 International Conference.

“People with cystic fibrosis have qualitatively reported burden from extrapulmonary symptoms that were not being addressed by their health care providers; this is the first study to examine these symptoms concurrently in a large sample over time,” said lead author Kristin A. Riekert, PhD, of Johns Hopkins University, Baltimore, in an interview.

Previous cross-sectional studies have shown a high prevalence of poor sleep quality, fatigue, pain, depression, and anxiety among AwCF, but longitudinal data showing the persistence of symptoms are lacking, Dr. Riekert and colleagues noted in their abstract.
 

Sleep Quality, Anxiety, and Other Assessments

The researchers recruited a total of 236 AwCF aged 18 years and older from two cystic fibrosis (CF) centers between April 2021 and August 2022. They examined the prevalence of poor sleep quality, fatigue pain, depression, and anxiety in AwCF on the basis of five assessments: At baseline and at 3, 6, 9, and 12 months.

Participants were assessed via an online survey using the Fatigue Severity Scale (cutoff, > 4), Pittsburgh Sleep Quality Index (cutoff, > 5), Patient Health Questionnaire (cutoff, > 9), Generalized Anxiety Disorder (cutoff, > 9), and PROMIS Pain Intensity (cutoff, > 50 T score). Chronic symptoms were defined as positive scores on four or more assessments for individuals who completed four or five time-point assessments. The mean age of the participants was 37 years, 52% were women, 95% were non-Hispanic White, and 86% had been prescribed CF modulator therapy.

At 12 months, 62% of participants reported poor sleep, and 34% reported fatigue. In addition, 17% reported depressive symptoms, 14% reported anxiety symptoms, and 7% reported pain at 12 months.

Overall, 49% of participants met the criteria for chronic poor sleep quality, and 29% met the criteria for chronic fatigue, with positive assessments at four or more time points over the course of a year. In addition, 40%, 30%, and 18% of participants reported taking medication in the past 7 days for pain, mental health, and sleep, respectively.

The findings suggest that patients with CF might benefit from routine assessments of non-pulmonary symptoms in clinical care and from access to health care providers, including mental health professionals, to address non-pulmonary concerns, the researchers wrote in their abstract.

“We delayed starting the study until elexacaftor/tezacaftor/ivacaftor (ETI) was FDA-approved because there was an assumption that people with CF would have less fatigue because of respiratory improvements from ETI,” Dr. Riekert told this news organization. “Instead, the prevalence of fatigue and poor sleep quality was higher and more chronic than we had anticipated,” she noted.

However, “we were pleasantly surprised that depression and anxiety, while still prevalent, were less prevalent and chronic than previously reported,” Dr. Riekert said in an interview. “We attribute this to the CF Foundation’s mental health initiative that has increased the frequency of annual screening for depression and anxiety and provided resources to help people with cystic fibrosis obtain mental health services,” she said.

The study findings suggest that clinicians should assess people with CF for chronic fatigue and poor sleep along with depression and anxiety and provide treatment or referral, Dr. Riekert said. “For example, cognitive behavioral therapy can effectively treat all the symptoms that were measured in our study,” she noted.

Limitations of the study include the lack of data on how the non-respiratory symptoms interact with respiratory symptoms or pulmonary exacerbations, said Dr. Riekert. “While we assessed these symptoms five times, it was for a year; longer-term follow-up seems merited given our findings,” she said. In addition, “we need to study approaches to make cognitive behavioral therapy and other therapy more accessible for people with cystic fibrosis,” Dr. Riekert said.
 

Targeting Non-Pulmonary Dimensions of CF Care

The current study highlights an aspect of quality of life that is often forgotten when managing adults with CF and may affect their well-being despite effective therapy to improve function and prolong life, said Wissam Chatila, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

The high incidence of poor sleep, fatigue, depression, and anxiety seen in the current study was “somewhat surprising,” Dr. Chatila said. Also somewhat surprising was the chronicity of the symptoms considering the cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies (designed to correct the malfunctioning protein made by the CFTR gene) that have changed the face of CF, he noted.

However, recent growth in the number of adult patients with CF (more than 50% in certain countries) has led to a change in pathologies that physicians have to manage, and the current study addresses some of the emerging pathologies, said Dr. Chatila.

“Beyond demonstrating survival data from registries and other epidemiologic studies, this study sheds light on the need to address patient-reported outcomes that may or may not be directly related to the pulmonary and GI effects of the CFTR modulators,” he said. “Recognizing the extent of the dysfunction that many CF patients continue to suffer from will eventually lead to identifying factors that contribute to poor outcomes and the mechanisms involved,” he added.

Overall, the current study illustrates the potential benefits of offering personalized medicine to adults with CF that improves not only their physical function but also their mental health, Dr. Chatila said.

The study was funded by the Cystic Fibrosis Foundation. Dr. Riekert had no financial conflicts to disclose. Dr. Chatila had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Non-respiratory symptoms including poor sleep, fatigue, pain, anxiety, and depressive symptoms were prevalent among adults with cystic fibrosis (AwCF) and persisted after 1 year of follow-up, based on data from more than 200 individuals in a study presented at the American Thoracic Society (ATS) 2024 International Conference.

“People with cystic fibrosis have qualitatively reported burden from extrapulmonary symptoms that were not being addressed by their health care providers; this is the first study to examine these symptoms concurrently in a large sample over time,” said lead author Kristin A. Riekert, PhD, of Johns Hopkins University, Baltimore, in an interview.

Previous cross-sectional studies have shown a high prevalence of poor sleep quality, fatigue, pain, depression, and anxiety among AwCF, but longitudinal data showing the persistence of symptoms are lacking, Dr. Riekert and colleagues noted in their abstract.
 

Sleep Quality, Anxiety, and Other Assessments

The researchers recruited a total of 236 AwCF aged 18 years and older from two cystic fibrosis (CF) centers between April 2021 and August 2022. They examined the prevalence of poor sleep quality, fatigue pain, depression, and anxiety in AwCF on the basis of five assessments: At baseline and at 3, 6, 9, and 12 months.

Participants were assessed via an online survey using the Fatigue Severity Scale (cutoff, > 4), Pittsburgh Sleep Quality Index (cutoff, > 5), Patient Health Questionnaire (cutoff, > 9), Generalized Anxiety Disorder (cutoff, > 9), and PROMIS Pain Intensity (cutoff, > 50 T score). Chronic symptoms were defined as positive scores on four or more assessments for individuals who completed four or five time-point assessments. The mean age of the participants was 37 years, 52% were women, 95% were non-Hispanic White, and 86% had been prescribed CF modulator therapy.

At 12 months, 62% of participants reported poor sleep, and 34% reported fatigue. In addition, 17% reported depressive symptoms, 14% reported anxiety symptoms, and 7% reported pain at 12 months.

Overall, 49% of participants met the criteria for chronic poor sleep quality, and 29% met the criteria for chronic fatigue, with positive assessments at four or more time points over the course of a year. In addition, 40%, 30%, and 18% of participants reported taking medication in the past 7 days for pain, mental health, and sleep, respectively.

The findings suggest that patients with CF might benefit from routine assessments of non-pulmonary symptoms in clinical care and from access to health care providers, including mental health professionals, to address non-pulmonary concerns, the researchers wrote in their abstract.

“We delayed starting the study until elexacaftor/tezacaftor/ivacaftor (ETI) was FDA-approved because there was an assumption that people with CF would have less fatigue because of respiratory improvements from ETI,” Dr. Riekert told this news organization. “Instead, the prevalence of fatigue and poor sleep quality was higher and more chronic than we had anticipated,” she noted.

However, “we were pleasantly surprised that depression and anxiety, while still prevalent, were less prevalent and chronic than previously reported,” Dr. Riekert said in an interview. “We attribute this to the CF Foundation’s mental health initiative that has increased the frequency of annual screening for depression and anxiety and provided resources to help people with cystic fibrosis obtain mental health services,” she said.

The study findings suggest that clinicians should assess people with CF for chronic fatigue and poor sleep along with depression and anxiety and provide treatment or referral, Dr. Riekert said. “For example, cognitive behavioral therapy can effectively treat all the symptoms that were measured in our study,” she noted.

Limitations of the study include the lack of data on how the non-respiratory symptoms interact with respiratory symptoms or pulmonary exacerbations, said Dr. Riekert. “While we assessed these symptoms five times, it was for a year; longer-term follow-up seems merited given our findings,” she said. In addition, “we need to study approaches to make cognitive behavioral therapy and other therapy more accessible for people with cystic fibrosis,” Dr. Riekert said.
 

Targeting Non-Pulmonary Dimensions of CF Care

The current study highlights an aspect of quality of life that is often forgotten when managing adults with CF and may affect their well-being despite effective therapy to improve function and prolong life, said Wissam Chatila, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

The high incidence of poor sleep, fatigue, depression, and anxiety seen in the current study was “somewhat surprising,” Dr. Chatila said. Also somewhat surprising was the chronicity of the symptoms considering the cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies (designed to correct the malfunctioning protein made by the CFTR gene) that have changed the face of CF, he noted.

However, recent growth in the number of adult patients with CF (more than 50% in certain countries) has led to a change in pathologies that physicians have to manage, and the current study addresses some of the emerging pathologies, said Dr. Chatila.

“Beyond demonstrating survival data from registries and other epidemiologic studies, this study sheds light on the need to address patient-reported outcomes that may or may not be directly related to the pulmonary and GI effects of the CFTR modulators,” he said. “Recognizing the extent of the dysfunction that many CF patients continue to suffer from will eventually lead to identifying factors that contribute to poor outcomes and the mechanisms involved,” he added.

Overall, the current study illustrates the potential benefits of offering personalized medicine to adults with CF that improves not only their physical function but also their mental health, Dr. Chatila said.

The study was funded by the Cystic Fibrosis Foundation. Dr. Riekert had no financial conflicts to disclose. Dr. Chatila had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Non-respiratory symptoms including poor sleep, fatigue, pain, anxiety, and depressive symptoms were prevalent among adults with cystic fibrosis (AwCF) and persisted after 1 year of follow-up, based on data from more than 200 individuals in a study presented at the American Thoracic Society (ATS) 2024 International Conference.

“People with cystic fibrosis have qualitatively reported burden from extrapulmonary symptoms that were not being addressed by their health care providers; this is the first study to examine these symptoms concurrently in a large sample over time,” said lead author Kristin A. Riekert, PhD, of Johns Hopkins University, Baltimore, in an interview.

Previous cross-sectional studies have shown a high prevalence of poor sleep quality, fatigue, pain, depression, and anxiety among AwCF, but longitudinal data showing the persistence of symptoms are lacking, Dr. Riekert and colleagues noted in their abstract.
 

Sleep Quality, Anxiety, and Other Assessments

The researchers recruited a total of 236 AwCF aged 18 years and older from two cystic fibrosis (CF) centers between April 2021 and August 2022. They examined the prevalence of poor sleep quality, fatigue pain, depression, and anxiety in AwCF on the basis of five assessments: At baseline and at 3, 6, 9, and 12 months.

Participants were assessed via an online survey using the Fatigue Severity Scale (cutoff, > 4), Pittsburgh Sleep Quality Index (cutoff, > 5), Patient Health Questionnaire (cutoff, > 9), Generalized Anxiety Disorder (cutoff, > 9), and PROMIS Pain Intensity (cutoff, > 50 T score). Chronic symptoms were defined as positive scores on four or more assessments for individuals who completed four or five time-point assessments. The mean age of the participants was 37 years, 52% were women, 95% were non-Hispanic White, and 86% had been prescribed CF modulator therapy.

At 12 months, 62% of participants reported poor sleep, and 34% reported fatigue. In addition, 17% reported depressive symptoms, 14% reported anxiety symptoms, and 7% reported pain at 12 months.

Overall, 49% of participants met the criteria for chronic poor sleep quality, and 29% met the criteria for chronic fatigue, with positive assessments at four or more time points over the course of a year. In addition, 40%, 30%, and 18% of participants reported taking medication in the past 7 days for pain, mental health, and sleep, respectively.

The findings suggest that patients with CF might benefit from routine assessments of non-pulmonary symptoms in clinical care and from access to health care providers, including mental health professionals, to address non-pulmonary concerns, the researchers wrote in their abstract.

“We delayed starting the study until elexacaftor/tezacaftor/ivacaftor (ETI) was FDA-approved because there was an assumption that people with CF would have less fatigue because of respiratory improvements from ETI,” Dr. Riekert told this news organization. “Instead, the prevalence of fatigue and poor sleep quality was higher and more chronic than we had anticipated,” she noted.

However, “we were pleasantly surprised that depression and anxiety, while still prevalent, were less prevalent and chronic than previously reported,” Dr. Riekert said in an interview. “We attribute this to the CF Foundation’s mental health initiative that has increased the frequency of annual screening for depression and anxiety and provided resources to help people with cystic fibrosis obtain mental health services,” she said.

The study findings suggest that clinicians should assess people with CF for chronic fatigue and poor sleep along with depression and anxiety and provide treatment or referral, Dr. Riekert said. “For example, cognitive behavioral therapy can effectively treat all the symptoms that were measured in our study,” she noted.

Limitations of the study include the lack of data on how the non-respiratory symptoms interact with respiratory symptoms or pulmonary exacerbations, said Dr. Riekert. “While we assessed these symptoms five times, it was for a year; longer-term follow-up seems merited given our findings,” she said. In addition, “we need to study approaches to make cognitive behavioral therapy and other therapy more accessible for people with cystic fibrosis,” Dr. Riekert said.
 

Targeting Non-Pulmonary Dimensions of CF Care

The current study highlights an aspect of quality of life that is often forgotten when managing adults with CF and may affect their well-being despite effective therapy to improve function and prolong life, said Wissam Chatila, MD, professor of thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

The high incidence of poor sleep, fatigue, depression, and anxiety seen in the current study was “somewhat surprising,” Dr. Chatila said. Also somewhat surprising was the chronicity of the symptoms considering the cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies (designed to correct the malfunctioning protein made by the CFTR gene) that have changed the face of CF, he noted.

However, recent growth in the number of adult patients with CF (more than 50% in certain countries) has led to a change in pathologies that physicians have to manage, and the current study addresses some of the emerging pathologies, said Dr. Chatila.

“Beyond demonstrating survival data from registries and other epidemiologic studies, this study sheds light on the need to address patient-reported outcomes that may or may not be directly related to the pulmonary and GI effects of the CFTR modulators,” he said. “Recognizing the extent of the dysfunction that many CF patients continue to suffer from will eventually lead to identifying factors that contribute to poor outcomes and the mechanisms involved,” he added.

Overall, the current study illustrates the potential benefits of offering personalized medicine to adults with CF that improves not only their physical function but also their mental health, Dr. Chatila said.

The study was funded by the Cystic Fibrosis Foundation. Dr. Riekert had no financial conflicts to disclose. Dr. Chatila had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

CHICAGO — Osimertinib (Tagrisso) may soon have approvals across all stages of epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC).

The third-generation EGFR tyrosine kinase inhibitor (TKI) already carries indications for metastatic disease and for adjuvant use in earlier-stage EGFR-mutated NSCLC.

Results from the phase 3 LAURA trial, presented at the American Society of Clinical Oncology (ASCO) annual meeting and funded by AstraZeneca, will likely lead to an approval for the remaining indication: Unresectable stage III disease.

Among patients randomized to either osimertinib or placebo following definitive chemoradiation, osimertinib extended median progression-free survival by 33.5 months compared with placebo — 39.1 vs 5.6 months, respectively (hazard ratio, 0.16; P = .001).

The news was greeted with a standing ovation at the meeting where it was presented by lead investigator and medical oncologist Suresh S. Ramalingam, MD, a lung cancer specialist at Emory University, Atlanta.

David R. Spigel, MD, a discussant on the trial, called the results “outstanding.”

“To have an 84% reduction in the risk of cancer progression or death is meaningful,” said Dr. Spigel, a medical oncologist at the Sarah Cannon Research Institute, Nashville, Tennessee, who reported ties to AstraZeneca. “This will be practice changing as soon as the label gets expanded.”

In the trial, investigators randomized 216 patients with unresectable stage III EGFR-mutated NSCLC who had not progressed after definitive platinum-based chemoradiation to receive either 80 mg osimertinib (n = 143) or placebo (n = 73). Baseline characteristics were generally balanced between the study arms, with a mostly even split between stage III subtypes.

Patients were staged by biopsy or CT at baseline plus MRI to confirm the absence of brain lesions. Subsequent imaging was repeated at regular intervals.

Twelve-month progression-free survival, assessed by blinded independent central review, was 74% with osimertinib vs 22% with placebo. At 24 months, the rates were 65% and 13%, respectively.

The progression-free survival benefit held across numerous subgroups but was statistically significant only among Asian individuals, who made up over 80% of both study arms.

Although the data are immature, osimertinib is also showing a trend toward improved overall survival, despite 81% of placebo patients crossing over to osimertinib after progression, Dr. Ramalingam reported. Mature overall survival results are expected within 2 years.

Based on these results, “osimertinib will become the new standard of care” after definitive chemoradiation in this patient population, Dr. Ramalingam said.

EGFR mutation testing “is now critical for stage III patients to ensure optimal” treatment, he added. Nearly a third of patients with NSCLC present with stage III disease, and the majority are unresectable. Of those, about a third are EGFR mutated.

Placebo was a fair comparator in the trial, Dr. Ramalingam stressed. While the current standard of care for unresectable stage III disease is 1 year of durvalumab after chemoradiation, durvalumab has proven ineffective in EGFR-mutated disease and often isn›t used in the setting.

If the control arm had been on durvalumab, patients would have needed to wait until it was safe to give them an EGFR TKI after progression, which didn’t seem to be in their best interest, he told this news organization.

A total of 68% of patients receiving placebo developed new lesions during the study, including brain metastases in 29%. New lesions developed in 22% of those on osimertinib, with new brain lesions in 8%.

The incidence of radiation pneumonitis, the most common adverse event, was 48% with osimertinib and 38% with placebo. Skin rash, diarrhea, and other known TKI side effects were also more common with osimertinib.

Treatment-related grade 3 or worse adverse events occurred in 13% of osimertinib patients vs 3% of placebo patients. Overall, 8% of osimertinib patients developed interstitial lung disease; most cases were low grade, but one person died.

About half of patients interrupted osimertinib dosing due to side effects, with a minority discontinuing.

Another study discussant, medical oncologist Lecia Sequist, MD, called the results “practice-changing” and said the findings support immediate consolidation with osimertinib instead of waiting for patients to progress.

Dr. Sequist, who reported ties to AstraZeneca, noted that patients were treated with osimertinib until progression, not for a limited duration as in past EGFR TKI trials, raising the possibility of indefinite, life-long treatment.

Treating until progression acknowledges the fact that for most patients, unresectable stage III NSCLC can’t be cured. However, she said a minority of patients might not need indefinite treatment — an important cohort to identify, given the drug costs more than $18,000 a month.

The study was funded by osimertinib maker AstraZeneca. Investigators included employees. Dr. Ramalingam, Dr. Spigel, and Dr. Sequist are advisers for and disclosed research funding from AstraZeneca. Dr. Spigel also disclosed travel funding.

A version of this article appeared on Medscape.com.

CHICAGO — Osimertinib (Tagrisso) may soon have approvals across all stages of epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC).

The third-generation EGFR tyrosine kinase inhibitor (TKI) already carries indications for metastatic disease and for adjuvant use in earlier-stage EGFR-mutated NSCLC.

Results from the phase 3 LAURA trial, presented at the American Society of Clinical Oncology (ASCO) annual meeting and funded by AstraZeneca, will likely lead to an approval for the remaining indication: Unresectable stage III disease.

Among patients randomized to either osimertinib or placebo following definitive chemoradiation, osimertinib extended median progression-free survival by 33.5 months compared with placebo — 39.1 vs 5.6 months, respectively (hazard ratio, 0.16; P = .001).

The news was greeted with a standing ovation at the meeting where it was presented by lead investigator and medical oncologist Suresh S. Ramalingam, MD, a lung cancer specialist at Emory University, Atlanta.

David R. Spigel, MD, a discussant on the trial, called the results “outstanding.”

“To have an 84% reduction in the risk of cancer progression or death is meaningful,” said Dr. Spigel, a medical oncologist at the Sarah Cannon Research Institute, Nashville, Tennessee, who reported ties to AstraZeneca. “This will be practice changing as soon as the label gets expanded.”

In the trial, investigators randomized 216 patients with unresectable stage III EGFR-mutated NSCLC who had not progressed after definitive platinum-based chemoradiation to receive either 80 mg osimertinib (n = 143) or placebo (n = 73). Baseline characteristics were generally balanced between the study arms, with a mostly even split between stage III subtypes.

Patients were staged by biopsy or CT at baseline plus MRI to confirm the absence of brain lesions. Subsequent imaging was repeated at regular intervals.

Twelve-month progression-free survival, assessed by blinded independent central review, was 74% with osimertinib vs 22% with placebo. At 24 months, the rates were 65% and 13%, respectively.

The progression-free survival benefit held across numerous subgroups but was statistically significant only among Asian individuals, who made up over 80% of both study arms.

Although the data are immature, osimertinib is also showing a trend toward improved overall survival, despite 81% of placebo patients crossing over to osimertinib after progression, Dr. Ramalingam reported. Mature overall survival results are expected within 2 years.

Based on these results, “osimertinib will become the new standard of care” after definitive chemoradiation in this patient population, Dr. Ramalingam said.

EGFR mutation testing “is now critical for stage III patients to ensure optimal” treatment, he added. Nearly a third of patients with NSCLC present with stage III disease, and the majority are unresectable. Of those, about a third are EGFR mutated.

Placebo was a fair comparator in the trial, Dr. Ramalingam stressed. While the current standard of care for unresectable stage III disease is 1 year of durvalumab after chemoradiation, durvalumab has proven ineffective in EGFR-mutated disease and often isn›t used in the setting.

If the control arm had been on durvalumab, patients would have needed to wait until it was safe to give them an EGFR TKI after progression, which didn’t seem to be in their best interest, he told this news organization.

A total of 68% of patients receiving placebo developed new lesions during the study, including brain metastases in 29%. New lesions developed in 22% of those on osimertinib, with new brain lesions in 8%.

The incidence of radiation pneumonitis, the most common adverse event, was 48% with osimertinib and 38% with placebo. Skin rash, diarrhea, and other known TKI side effects were also more common with osimertinib.

Treatment-related grade 3 or worse adverse events occurred in 13% of osimertinib patients vs 3% of placebo patients. Overall, 8% of osimertinib patients developed interstitial lung disease; most cases were low grade, but one person died.

About half of patients interrupted osimertinib dosing due to side effects, with a minority discontinuing.

Another study discussant, medical oncologist Lecia Sequist, MD, called the results “practice-changing” and said the findings support immediate consolidation with osimertinib instead of waiting for patients to progress.

Dr. Sequist, who reported ties to AstraZeneca, noted that patients were treated with osimertinib until progression, not for a limited duration as in past EGFR TKI trials, raising the possibility of indefinite, life-long treatment.

Treating until progression acknowledges the fact that for most patients, unresectable stage III NSCLC can’t be cured. However, she said a minority of patients might not need indefinite treatment — an important cohort to identify, given the drug costs more than $18,000 a month.

The study was funded by osimertinib maker AstraZeneca. Investigators included employees. Dr. Ramalingam, Dr. Spigel, and Dr. Sequist are advisers for and disclosed research funding from AstraZeneca. Dr. Spigel also disclosed travel funding.

A version of this article appeared on Medscape.com.

CHICAGO — Osimertinib (Tagrisso) may soon have approvals across all stages of epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC).

The third-generation EGFR tyrosine kinase inhibitor (TKI) already carries indications for metastatic disease and for adjuvant use in earlier-stage EGFR-mutated NSCLC.

Results from the phase 3 LAURA trial, presented at the American Society of Clinical Oncology (ASCO) annual meeting and funded by AstraZeneca, will likely lead to an approval for the remaining indication: Unresectable stage III disease.

Among patients randomized to either osimertinib or placebo following definitive chemoradiation, osimertinib extended median progression-free survival by 33.5 months compared with placebo — 39.1 vs 5.6 months, respectively (hazard ratio, 0.16; P = .001).

The news was greeted with a standing ovation at the meeting where it was presented by lead investigator and medical oncologist Suresh S. Ramalingam, MD, a lung cancer specialist at Emory University, Atlanta.

David R. Spigel, MD, a discussant on the trial, called the results “outstanding.”

“To have an 84% reduction in the risk of cancer progression or death is meaningful,” said Dr. Spigel, a medical oncologist at the Sarah Cannon Research Institute, Nashville, Tennessee, who reported ties to AstraZeneca. “This will be practice changing as soon as the label gets expanded.”

In the trial, investigators randomized 216 patients with unresectable stage III EGFR-mutated NSCLC who had not progressed after definitive platinum-based chemoradiation to receive either 80 mg osimertinib (n = 143) or placebo (n = 73). Baseline characteristics were generally balanced between the study arms, with a mostly even split between stage III subtypes.

Patients were staged by biopsy or CT at baseline plus MRI to confirm the absence of brain lesions. Subsequent imaging was repeated at regular intervals.

Twelve-month progression-free survival, assessed by blinded independent central review, was 74% with osimertinib vs 22% with placebo. At 24 months, the rates were 65% and 13%, respectively.

The progression-free survival benefit held across numerous subgroups but was statistically significant only among Asian individuals, who made up over 80% of both study arms.

Although the data are immature, osimertinib is also showing a trend toward improved overall survival, despite 81% of placebo patients crossing over to osimertinib after progression, Dr. Ramalingam reported. Mature overall survival results are expected within 2 years.

Based on these results, “osimertinib will become the new standard of care” after definitive chemoradiation in this patient population, Dr. Ramalingam said.

EGFR mutation testing “is now critical for stage III patients to ensure optimal” treatment, he added. Nearly a third of patients with NSCLC present with stage III disease, and the majority are unresectable. Of those, about a third are EGFR mutated.

Placebo was a fair comparator in the trial, Dr. Ramalingam stressed. While the current standard of care for unresectable stage III disease is 1 year of durvalumab after chemoradiation, durvalumab has proven ineffective in EGFR-mutated disease and often isn›t used in the setting.

If the control arm had been on durvalumab, patients would have needed to wait until it was safe to give them an EGFR TKI after progression, which didn’t seem to be in their best interest, he told this news organization.

A total of 68% of patients receiving placebo developed new lesions during the study, including brain metastases in 29%. New lesions developed in 22% of those on osimertinib, with new brain lesions in 8%.

The incidence of radiation pneumonitis, the most common adverse event, was 48% with osimertinib and 38% with placebo. Skin rash, diarrhea, and other known TKI side effects were also more common with osimertinib.

Treatment-related grade 3 or worse adverse events occurred in 13% of osimertinib patients vs 3% of placebo patients. Overall, 8% of osimertinib patients developed interstitial lung disease; most cases were low grade, but one person died.

About half of patients interrupted osimertinib dosing due to side effects, with a minority discontinuing.

Another study discussant, medical oncologist Lecia Sequist, MD, called the results “practice-changing” and said the findings support immediate consolidation with osimertinib instead of waiting for patients to progress.

Dr. Sequist, who reported ties to AstraZeneca, noted that patients were treated with osimertinib until progression, not for a limited duration as in past EGFR TKI trials, raising the possibility of indefinite, life-long treatment.

Treating until progression acknowledges the fact that for most patients, unresectable stage III NSCLC can’t be cured. However, she said a minority of patients might not need indefinite treatment — an important cohort to identify, given the drug costs more than $18,000 a month.

The study was funded by osimertinib maker AstraZeneca. Investigators included employees. Dr. Ramalingam, Dr. Spigel, and Dr. Sequist are advisers for and disclosed research funding from AstraZeneca. Dr. Spigel also disclosed travel funding.

A version of this article appeared on Medscape.com.

Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.

HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues. 

“Lack of knowledge about HP and its therapeutics contributes to significant uncertainty and impacts quality of life,” the researchers wrote in their abstract. 

Surveys Conducted to Understand Patient Concerns

To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.

The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.

The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).

The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.

Findings Will Fuel Needed Education

Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted. 

“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.

The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.

In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.

“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.

The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.

HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues. 

“Lack of knowledge about HP and its therapeutics contributes to significant uncertainty and impacts quality of life,” the researchers wrote in their abstract. 

Surveys Conducted to Understand Patient Concerns

To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.

The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.

The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).

The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.

Findings Will Fuel Needed Education

Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted. 

“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.

The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.

In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.

“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.

The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Adults with hypersensitivity pneumonitis (HP) expressed interest in more knowledge of prognosis, etiology, treatment, and living well with the disease, based on new survey data presented at the American Thoracic Society International Conference.

HP is caused by environmental exposure and is often incurable, and patients are challenged with identifying and mitigating the exposure with limited guidance, wrote Janani Varadarajan, MD, of Weill Cornell Medicine, New York, and colleagues. 

“Lack of knowledge about HP and its therapeutics contributes to significant uncertainty and impacts quality of life,” the researchers wrote in their abstract. 

Surveys Conducted to Understand Patient Concerns

To better identify patient-perceived HP knowledge gaps and develop educational resources, the researchers assessed 21 adults diagnosed with HP. Patients underwent interviews using nominal group technique (NGT) for group consensus and completed a survey on educational preferences. The mean age of the participants was 69.5 years, and 81% were women.

The researchers conducted five NGTs. Participants were asked two questions: What questions about your HP do you have that keep you awake at night?” and “What information do you want about your HP that you cannot find?” They also voted on responses that were grouped by theme.

The top themes that emerged from the interviews were concerns about natural history and prognosis of HP (28.3%), current treatment options and therapeutic research (22.5%), epidemiology and etiology (17.5%), living well with HP (15.4%), origin and management of symptoms (8.3%), identifying and mitigating exposures (4.6%), and methods of information uptake and dissemination (3.3%).

The findings were limited by the relatively small sample size. However, the results will inform the development of educational materials on the virtual Patient Activated Learning System, the researchers noted in their abstract. “This curriculum will be a component of a larger support intervention that aims to improve patient knowledge, self-efficacy, and HRQOL [health-related quality of life],” they said.

Findings Will Fuel Needed Education

Recognizing more interstitial lung disease (ILD) has led to diagnosing more hypersensitivity pneumonitis, and it is important to keep patients’ concerns in mind, said Aamir Ajmeri, MD, assistant professor of clinical thoracic medicine and surgery at the Lewis Katz School of Medicine at Temple University, Philadelphia, in an interview.

“If patients research ILD online, most of the literature is based on idiopathic pulmonary fibrosis,” he said. “IPF literature can be frightening because patients will see a median 2- to 5-year survival rate from time of diagnosis, the need for lung transplant, and progressive hypoxemia; however, all of this may not be true in HP,” he noted. 

“HP is more of a spectrum, but it is more difficult for patient to understand when we say ‘your lungs have reacted to something in your environment,’ and they will ask ‘what can I do to change this?’” Dr. Ajmeri told this news organization. “That is why these types of studies, where we recognize what patients need and how they can learn more about their diagnosis, are very important,” he said.

The study findings were not surprising, Dr. Ajmeri said. “We have a large cohort of patients with HP at Temple Health, and these are the same questions they ask me and my colleagues,” he said. “It can be tough for patients to grasp this diagnosis. We know it is related to something inhaled from the environment, but it may be difficult to pinpoint,” he said.

In patient-centered research, patients can help shed light onto the needs that are unmet for the disease process by asking hypothesis-generating questions, Dr. Ajmeri said. For example, he said he is frequently asked by patients why HP continues to recur after they have remediated a home (potential source of exposure) and been on medication.

“The study was limited in part by the small sample size but captured a good representation of what patients are asking their physicians about,” Dr. Ajmeri said. Although it is always preferable to have more patients, the findings are important, “and the educational materials that they will lead to are greatly needed,” he said.

The study was supported by the Stony Wold-Herbert Fund, the American Lung Association Catalyst Award, and the National Heart, Lung, and Blood Institute. The researchers had no financial conflicts to disclose. Dr. Ajmeri had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

LONG BEACH, CALIFORNIA — A small fraction of patients with pulmonary embolism (PE) who are eligible for advanced therapies are actually getting them, reported investigators who conducted a big data analysis.

“Advanced PE therapy seems to be vulnerable to disparate use, and perhaps underuse,” Sahil Parikh, MD, a cardiovascular interventionalist at the Columbia University Medical Center in New York, said when he presented results from the REAL-PE study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 Scientific Sessions.

The underuse of advanced PE therapies is “the controversy,” Dr. Parikh said after his presentation. “It remains unclear what the role of invasive therapy is in the management of so-called high-intermediate–risk people. There isn’t a Class 1 guideline recommendation, and there is a very rapidly evolving trend that we’re increasingly treating these patients invasively,” he said.

“However, if you come to these meetings [such as SCAI], you might think everyone is getting one of these devices, but these data show that’s not the case,” Dr. Parikh said.

The analysis mined deidentified data from Truveta, a collective of health systems that provides regulatory-grade electronic health record data for research. The database included 105 million diagnoses made from January 1, 2018, to May 5, 2023; according to the diagnosis codes, 435,296 of these were for pulmonary embolism, and according to the procedure codes, 2072 patients — 0.48% of all patients with a PE diagnosis — received advanced therapy.

The researchers accessed data on patients treated with ultrasound-assisted catheter-directed thrombolysis or mechanical thrombectomy, identified from claims codes. Patient characteristics — age, race, ethnicity, sex, comorbidities, and diagnoses — were also accessed for the analysis. Earlier results were published in the January issue of the Journal of the Society for Cardiovascular Angioplasty Interventions. 
 

Less Intervention for Black Patients and Women

White patients were more likely to receive advanced therapy than were Black patients (0.5% vs 0.37%; P = .000), Dr. Parikh reported, and women were less likely to receive advanced therapy than were men (0.41% vs 0.55%; P = .000).

The only discernable differences in outcomes were in major bleeding events in the 7 days after the procedure, which affected more White patients than it did Black patients (13.9% vs 9.3%) and affected more women than it did men (16.6% vs 11.1%).

What’s noteworthy about this study is that it demonstrates the potential of advanced data analytics to identify disparities in care and outcomes, Dr. Parikh said during his presentation. “These analyses provide a means of evaluating disparities in real clinical practice, both in the area of PE and otherwise, and may also be used for real-time monitoring of clinical decision-making and decisional support,” he said. “We do think that both novel and established therapies can benefit equally from similar types of analyses.”
 

Big Data Signaling Disparities

“That’s where these data are helpful,” Dr. Parikh explained. They provide “a real snapshot of how many procedures are being performed and in what kinds of patients. The low number of patients getting the procedure would suggest that there are probably more patients who would be eligible for treatment based on some of the emerging consensus documents, and they’re not receiving them.”

The data are “hypotheses generating,” Dr. Parikh said in an interview. “These hypotheses have to be evaluated further in more granular databases.”

REAL-PE is also a “clarion call” for clinical trials of investigative devices going forward, he said. “In those trials, we need to endeavor to enroll enough women and men, minority and nonminority patients so that we can make meaningful assessments of differences in efficacy and safety.”

This study is “real proof that big data can be used to provide information on outcomes for patients in a very rapid manner; that’s really exciting,” said Ethan Korngold, MD, chair of structural and interventional cardiology at the Providence Health Institute in Portland, Oregon. “This is an area of great research with great innovation, and it’s proof that, with these type of techniques using artificial intelligence and big data, we can generate data quickly on how we’re doing and what kind of patients we’re reaching.”

Findings like these may also help identify sources of the disparities, Dr. Korngold added. 

“This shows we need to be reaching every patient with advanced therapies,” he said. “Different hospitals have different capabilities and different expertise in this area and they reach different patient populations. A lot of the difference in utilization stems from this fact,” he said.

“It just underscores the fact that we need to standardize our treatment approaches, and then we need to reach every person who’s suffering from this disease,” Dr. Korngold said.

A version of this article appeared on Medscape.com.

LONG BEACH, CALIFORNIA — A small fraction of patients with pulmonary embolism (PE) who are eligible for advanced therapies are actually getting them, reported investigators who conducted a big data analysis.

“Advanced PE therapy seems to be vulnerable to disparate use, and perhaps underuse,” Sahil Parikh, MD, a cardiovascular interventionalist at the Columbia University Medical Center in New York, said when he presented results from the REAL-PE study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 Scientific Sessions.

The underuse of advanced PE therapies is “the controversy,” Dr. Parikh said after his presentation. “It remains unclear what the role of invasive therapy is in the management of so-called high-intermediate–risk people. There isn’t a Class 1 guideline recommendation, and there is a very rapidly evolving trend that we’re increasingly treating these patients invasively,” he said.

“However, if you come to these meetings [such as SCAI], you might think everyone is getting one of these devices, but these data show that’s not the case,” Dr. Parikh said.

The analysis mined deidentified data from Truveta, a collective of health systems that provides regulatory-grade electronic health record data for research. The database included 105 million diagnoses made from January 1, 2018, to May 5, 2023; according to the diagnosis codes, 435,296 of these were for pulmonary embolism, and according to the procedure codes, 2072 patients — 0.48% of all patients with a PE diagnosis — received advanced therapy.

The researchers accessed data on patients treated with ultrasound-assisted catheter-directed thrombolysis or mechanical thrombectomy, identified from claims codes. Patient characteristics — age, race, ethnicity, sex, comorbidities, and diagnoses — were also accessed for the analysis. Earlier results were published in the January issue of the Journal of the Society for Cardiovascular Angioplasty Interventions. 
 

Less Intervention for Black Patients and Women

White patients were more likely to receive advanced therapy than were Black patients (0.5% vs 0.37%; P = .000), Dr. Parikh reported, and women were less likely to receive advanced therapy than were men (0.41% vs 0.55%; P = .000).

The only discernable differences in outcomes were in major bleeding events in the 7 days after the procedure, which affected more White patients than it did Black patients (13.9% vs 9.3%) and affected more women than it did men (16.6% vs 11.1%).

What’s noteworthy about this study is that it demonstrates the potential of advanced data analytics to identify disparities in care and outcomes, Dr. Parikh said during his presentation. “These analyses provide a means of evaluating disparities in real clinical practice, both in the area of PE and otherwise, and may also be used for real-time monitoring of clinical decision-making and decisional support,” he said. “We do think that both novel and established therapies can benefit equally from similar types of analyses.”
 

Big Data Signaling Disparities

“That’s where these data are helpful,” Dr. Parikh explained. They provide “a real snapshot of how many procedures are being performed and in what kinds of patients. The low number of patients getting the procedure would suggest that there are probably more patients who would be eligible for treatment based on some of the emerging consensus documents, and they’re not receiving them.”

The data are “hypotheses generating,” Dr. Parikh said in an interview. “These hypotheses have to be evaluated further in more granular databases.”

REAL-PE is also a “clarion call” for clinical trials of investigative devices going forward, he said. “In those trials, we need to endeavor to enroll enough women and men, minority and nonminority patients so that we can make meaningful assessments of differences in efficacy and safety.”

This study is “real proof that big data can be used to provide information on outcomes for patients in a very rapid manner; that’s really exciting,” said Ethan Korngold, MD, chair of structural and interventional cardiology at the Providence Health Institute in Portland, Oregon. “This is an area of great research with great innovation, and it’s proof that, with these type of techniques using artificial intelligence and big data, we can generate data quickly on how we’re doing and what kind of patients we’re reaching.”

Findings like these may also help identify sources of the disparities, Dr. Korngold added. 

“This shows we need to be reaching every patient with advanced therapies,” he said. “Different hospitals have different capabilities and different expertise in this area and they reach different patient populations. A lot of the difference in utilization stems from this fact,” he said.

“It just underscores the fact that we need to standardize our treatment approaches, and then we need to reach every person who’s suffering from this disease,” Dr. Korngold said.

A version of this article appeared on Medscape.com.

LONG BEACH, CALIFORNIA — A small fraction of patients with pulmonary embolism (PE) who are eligible for advanced therapies are actually getting them, reported investigators who conducted a big data analysis.

“Advanced PE therapy seems to be vulnerable to disparate use, and perhaps underuse,” Sahil Parikh, MD, a cardiovascular interventionalist at the Columbia University Medical Center in New York, said when he presented results from the REAL-PE study at the Society for Cardiovascular Angiography and Interventions (SCAI) 2024 Scientific Sessions.

The underuse of advanced PE therapies is “the controversy,” Dr. Parikh said after his presentation. “It remains unclear what the role of invasive therapy is in the management of so-called high-intermediate–risk people. There isn’t a Class 1 guideline recommendation, and there is a very rapidly evolving trend that we’re increasingly treating these patients invasively,” he said.

“However, if you come to these meetings [such as SCAI], you might think everyone is getting one of these devices, but these data show that’s not the case,” Dr. Parikh said.

The analysis mined deidentified data from Truveta, a collective of health systems that provides regulatory-grade electronic health record data for research. The database included 105 million diagnoses made from January 1, 2018, to May 5, 2023; according to the diagnosis codes, 435,296 of these were for pulmonary embolism, and according to the procedure codes, 2072 patients — 0.48% of all patients with a PE diagnosis — received advanced therapy.

The researchers accessed data on patients treated with ultrasound-assisted catheter-directed thrombolysis or mechanical thrombectomy, identified from claims codes. Patient characteristics — age, race, ethnicity, sex, comorbidities, and diagnoses — were also accessed for the analysis. Earlier results were published in the January issue of the Journal of the Society for Cardiovascular Angioplasty Interventions. 
 

Less Intervention for Black Patients and Women

White patients were more likely to receive advanced therapy than were Black patients (0.5% vs 0.37%; P = .000), Dr. Parikh reported, and women were less likely to receive advanced therapy than were men (0.41% vs 0.55%; P = .000).

The only discernable differences in outcomes were in major bleeding events in the 7 days after the procedure, which affected more White patients than it did Black patients (13.9% vs 9.3%) and affected more women than it did men (16.6% vs 11.1%).

What’s noteworthy about this study is that it demonstrates the potential of advanced data analytics to identify disparities in care and outcomes, Dr. Parikh said during his presentation. “These analyses provide a means of evaluating disparities in real clinical practice, both in the area of PE and otherwise, and may also be used for real-time monitoring of clinical decision-making and decisional support,” he said. “We do think that both novel and established therapies can benefit equally from similar types of analyses.”
 

Big Data Signaling Disparities

“That’s where these data are helpful,” Dr. Parikh explained. They provide “a real snapshot of how many procedures are being performed and in what kinds of patients. The low number of patients getting the procedure would suggest that there are probably more patients who would be eligible for treatment based on some of the emerging consensus documents, and they’re not receiving them.”

The data are “hypotheses generating,” Dr. Parikh said in an interview. “These hypotheses have to be evaluated further in more granular databases.”

REAL-PE is also a “clarion call” for clinical trials of investigative devices going forward, he said. “In those trials, we need to endeavor to enroll enough women and men, minority and nonminority patients so that we can make meaningful assessments of differences in efficacy and safety.”

This study is “real proof that big data can be used to provide information on outcomes for patients in a very rapid manner; that’s really exciting,” said Ethan Korngold, MD, chair of structural and interventional cardiology at the Providence Health Institute in Portland, Oregon. “This is an area of great research with great innovation, and it’s proof that, with these type of techniques using artificial intelligence and big data, we can generate data quickly on how we’re doing and what kind of patients we’re reaching.”

Findings like these may also help identify sources of the disparities, Dr. Korngold added. 

“This shows we need to be reaching every patient with advanced therapies,” he said. “Different hospitals have different capabilities and different expertise in this area and they reach different patient populations. A lot of the difference in utilization stems from this fact,” he said.

“It just underscores the fact that we need to standardize our treatment approaches, and then we need to reach every person who’s suffering from this disease,” Dr. Korngold said.

A version of this article appeared on Medscape.com.

Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Socioeconomic factors were associated with greater disease severity at the time of initial presentation in adults with sarcoidosis, based on a new study of more than 700 individuals presented at the American Thoracic Society’s International Conference 2024.

“We know socioeconomic status plays an important role in health outcomes; however, there is little research into the impact of socioeconomic status on patients with sarcoidosis, particularly with disease severity,” said lead author Joshua Boron, MD, of Virginia Commonwealth University, Richmond, Virginia, in an interview. Identification of patients at higher risk of developing severe lung disease can help clinicians stratify these patients, he said.

Overall, the risk for severe lung disease at initial presentation was nearly three times higher in patients with no insurance than in those with private insurance and nearly three times higher in Black patients than in White patients (odds ratio [OR], 2.97 and 2.83, respectively). In addition, older age was associated with increased risk of fibrosis, with an OR of 1.03 per year increase in age.

No differences in fibrosis at presentation occurred based on sex or median income, and no difference in the likelihood of fibrosis at presentation appeared between patients with Medicaid vs private insurance.

“We were surprised at the degree of risk associated with no insurance,” said Dr. Boron. The researchers also were surprised at the lack of association between higher risk of severe stage lung disease in sarcoidosis patients and zip code estimates of household income as an indicator of socioeconomic status, he said.

For clinical practice, the study findings highlight the potentially increased risk for fibrotic lung disease among patients who are older, uninsured, and African American, said Dr. Boron.

“A limitation of our study was the utilization of zip code based on the US Census Bureau to get an estimation of average household income — a particular limitation in our city because of gentrification over the past few decades,” Dr. Boron said in an interview. “Utilizing area deprivation indices could be a better marker for identifying household income and give a more accurate representation of the true impact of socioeconomic disparities and severity of sarcoidosis at presentation,” he said.
 

Pinpointing Persistent Disparities

“We know there are multiple sources of disparities in the sarcoidosis population,” said Rohit Gupta, MD, director of the sarcoidosis program at Temple University Hospital, Philadelphia, in an interview.

The current study identified the relationship between several socioeconomic factors and sarcoidosis severity, showing greater disease severity in people experiencing socioeconomic inequalities, said Dr. Gupta, who was not involved in the study.

“I have personally seen this [disparity] in clinic,” said Dr. Gupta. However, supporting data are limited, aside from recent studies published in the last few years by researchers at the Cleveland Clinic and Johns Hopkins University, Baltimore, he said. The current study reflects those previous findings that people suffering from inequality have worse medical care, he added.

Overall, the findings were not surprising, “as we know this cohort of patients have chronic disease and worse morbidity and, in some cases, higher mortality,” but the results reinforce the need to pay closer attention to socioeconomic factors, said Dr. Gupta.

In practice, “we might use these findings as a reminder that when we see these patients for the first time, we should pay closer attention because they might need higher care,” he said. “The study also suggests these patients are coming late to a center of excellence,” he noted. When patients with socioeconomic disparities are seen for sarcoidosis at community hospitals and small centers, providers should keep in mind that their disease might progress faster and, therefore, send them to advanced centers earlier, he said.

The study was limited to the use of data from a single center and by the retrospective design, Dr. Gupta said. “Additional research should focus on building better platforms to understand these disparities,” he emphasized, so clinicians can develop plans not only to identify inequalities but also to address them.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Gupta had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.

The approval is based on the positive results from the phase 3 ConquerRSV clinical trial, published in The New England Journal of Medicine in December 2023. The study, conducted in approximately 37,000 adults aged 60 years or older in 22 countries, found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% after a median 3.7 months of follow-up.

An additional longer-term analysis showed continued protection over 8.6 months median follow-up. No serious safety concerns were identified. The most reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna has also filed for approval in multiple markets around the world, and says it expects mRESVIA to be available in the United States in time for the 2024-2025 respiratory virus season.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.

The approval is based on the positive results from the phase 3 ConquerRSV clinical trial, published in The New England Journal of Medicine in December 2023. The study, conducted in approximately 37,000 adults aged 60 years or older in 22 countries, found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% after a median 3.7 months of follow-up.

An additional longer-term analysis showed continued protection over 8.6 months median follow-up. No serious safety concerns were identified. The most reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna has also filed for approval in multiple markets around the world, and says it expects mRESVIA to be available in the United States in time for the 2024-2025 respiratory virus season.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345, Moderna), a vaccine for respiratory syncytial virus (RSV).

The mRNA vaccine is approved for adults aged 60 years or older to prevent lower respiratory tract disease caused by RSV. It is the third vaccine to be approved for RSV in the past year after Arexvy from GSK and Abrysvo by Pfizer.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” Stéphane Bancel, chief executive officer of Moderna, said in a news release. “mRESVIA protects older adults from the severe outcomes of RSV infection. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19.”

mRESVIA is a single-dose vaccine available in prefilled syringes, which the company says are designed to maximize ease of administration, saving vaccinators’ time, and reducing the risk for administrative errors.

The approval is based on the positive results from the phase 3 ConquerRSV clinical trial, published in The New England Journal of Medicine in December 2023. The study, conducted in approximately 37,000 adults aged 60 years or older in 22 countries, found a vaccine efficacy against RSV lower respiratory tract disease of 83.7% after a median 3.7 months of follow-up.

An additional longer-term analysis showed continued protection over 8.6 months median follow-up. No serious safety concerns were identified. The most reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna has also filed for approval in multiple markets around the world, and says it expects mRESVIA to be available in the United States in time for the 2024-2025 respiratory virus season.

A version of this article appeared on Medscape.com.

Adding durvalumab as consolidation treatment following concurrent chemoradiation (cCRT) adds 2 years of life and increases progression-free survival by 24%, compared with placebo, in patients with limited stage small cell lung cancer (LS-SCLC).

These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.

Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.

“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
 

ADRIATIC Methods and Results

The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.

The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.

After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
 

New Standard of Care for Patients with LS-SCLC

“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.

“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.

Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”

Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.

“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.

“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.

“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”

The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.

Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.

Dr. Campbell has served as an advisor for Novocure and Genentech.

Adding durvalumab as consolidation treatment following concurrent chemoradiation (cCRT) adds 2 years of life and increases progression-free survival by 24%, compared with placebo, in patients with limited stage small cell lung cancer (LS-SCLC).

These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.

Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.

“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
 

ADRIATIC Methods and Results

The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.

The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.

After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
 

New Standard of Care for Patients with LS-SCLC

“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.

“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.

Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”

Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.

“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.

“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.

“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”

The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.

Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.

Dr. Campbell has served as an advisor for Novocure and Genentech.

Adding durvalumab as consolidation treatment following concurrent chemoradiation (cCRT) adds 2 years of life and increases progression-free survival by 24%, compared with placebo, in patients with limited stage small cell lung cancer (LS-SCLC).

These are results of the ADRIATIC trial, the first planned interim analysis of the randomized, phase 3, double-blind, placebo-controlled multicenter study comparing the PD-L 1 antibody durvalumab vs placebo in patients with stage I-III limited stage disease and prior concurrent chemoradiotherapy.

Lead author David R. Spigel, MD, drew several rounds of applause from an enthusiastic audience when he presented this data, at the plenary session of the annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago.

“ADRIATIC is the first positive, global phase 3 trial of immunotherapy in limited stage SCLC,” said Lauren Byers, MD, the discussant in the session.

“This groundbreaking trial sets a new standard of care with consolidative durvalumab following concurrent chemoradiation,” continued Dr. Byers, who is professor and thoracic section chief in the Department of Thoracic/Head and Neck Medical Oncology at the University of Texas MD Andersen Cancer Center in Houston, Texas.
 

ADRIATIC Methods and Results

The new study enrolled 730 patients and randomized them between 1 and 42 days after concurrent chemoradiation to one of three treatments: durvalumab 1500 mg; durvalumab plus tremelimumab 75 mg; or placebo. Treatment was continued for a maximum of 24 months, or until progression or intolerable toxicity.

The study had dual primary endpoints of overall survival (OS) and progression-free survival (PFS) for durvalumab vs placebo. The researchers have not yet looked at the results for the secondary endpoints of OS and PFS for patients treated with durvalumab plus tremelimumab vs placebo.

After a median follow-up of 3 years, there was a median OS of 55.9 months in the durvalumab-treated patients, compared with 33.4 months in the placebo arm (hazard ratio [HR], 0.73), and, at a median follow-up of 2 years, there was median PFS of 16.6 months vs 9.2 months respectively (HR, 0.76).
 

New Standard of Care for Patients with LS-SCLC

“This study had a very good safety profile,” said Dr. Spigel, who is also a medical oncologist and the chief scientific officer at Sarah Cannon Research Institute in Nashville, Tennessee, during his presentation.

“Looking at severe grade 3 or 4 events, these were nearly identical in either arm at 24%. Looking at any-grade immune-mediated AEs, these were 31.2% and 10.2% respectively, and then looking at radiation pneumonitis or pneumonitis, the rates were 38.2% in the durvalumab arm, compared with 30.2% in the placebo arm,” Dr. Spigel said.

Noting that there have been no major advances in the treatment of LS-SCLC for several decades, with most patients experiencing recurrences within 2 years of the cCRT standard of care, Dr. Spigel said “consolidation durvalumab will become the new standard of care for patients with LS-SCLC who have not progressed after cCRT.”

Toby Campbell, MD, a thoracic oncologist, who is professor and chief of Palliative Care at the University of Wisconsin, in Madison, Wisconsin, agrees.

“I take care of patients with small cell lung cancer, an aggressive cancer with high symptom burden that devastates patients and families in its wake,” said Dr. Campbell, during an interview. “About 15% of patients luckily present when the cancer is still contained in the chest and is potentially curable. However, with current treatments we give, which include chemotherapy together with radiation, we are ‘successful’ at curing one in four people.

“This study presents a new treatment option which makes a big difference to patients like mine,” Dr. Campbell continued. “For example, at the 2-year time point, nearly half of patients are still cancer-free. These folks have the opportunity to live their lives more fully, unburdened by the symptoms and dread this disease brings. If approved, I think this treatment would immediately be appropriate to use in clinic.

“Further, oncologists are comfortable using this medication as it is already FDA-approved and used similarly in non–small cell lung cancer.”

The study was funded by AstraZeneca. Dr. Spigel discloses consulting or advisory roles with Abbvie, Amgen, AstraZeneca, Bristol-Myers Squibb, Genentech/Roche, GlaxoSmithKline, Ipsen, Jazz Pharmaceuticals, Lyell Immunopharma, MedImmune, Monte Rosa Therapeutics, Novartis, Novocure, and Sanofi/Aventis. He has also received research funding from many companies, and travel, accommodations, and other expense reimbursements from AstraZeneca, Genentech, and Novartis.

Dr. Byers discloses honoraria from and consulting or advisory roles with Abbvie, Amgen, Arrowhead Pharmaceuticals, AstraZeneca, Beigene, Boehringer Ingelheim, Chugai Pharma, Daiichi Sankyo, Genentech, Jazz Pharmaceuticals, Merck, Dohme, Novartis, and Puma Biotechnology. He also has received research funding from Amgen, AstraZeneca, and Jazz Pharmaceuticals.

Dr. Campbell has served as an advisor for Novocure and Genentech.