Pulmonology

Adults with asthma who were newly prescribed mepolizumab showed significant improvement in symptoms after 1 year regardless of comorbidities, based on data from 822 individuals.

Comorbidities including chronic rhinosinusitis with polyps (CRSwNP), gastroesophageal reflux disease GERD), anxiety and depression, and chronic obstructive pulmonary disorder (COPD) are common in patients with severe asthma and add to the disease burden, wrote Mark C. Liu, MD, of Johns Hopkins University, Baltimore, and colleagues.

“Some comorbidities, such as CRSwNP, share pathophysiological mechanisms with severe asthma, with interleukin-5 (IL-5),” and treatments targeting IL-5 could improve outcomes, they said.

In the real-world REALITI-A study, mepolizumab, a humanized monoclonal antibody that targets IL-5, significantly reduced asthma exacerbation and oral corticosteroid use in severe asthma patients, they said.

To assess the impact of mepolizumab on patients with comorbidities, the researchers conducted a post hoc analysis of 822 adults with severe asthma, including 321 with CRSwNP, 309 with GERD, 203 with depression/anxiety, and 81 with COPD. The findings were published in the Journal of Allergy and Clinical Immunology: In Practice.

The main outcomes were the rate of clinically significant asthma exacerbations (CSEs) between the 12 months before and after mepolizumab initiation, and the changes from baseline in the daily maintenance use of oral corticosteroids (OCS).

Across all comorbidities, the rate of CSEs decreased significantly from the pretreatment period to the follow-up period, from 4.28 events per year to 1.23 events per year.

“A numerically greater reduction in the rate of CSEs was reported for patients with versus without CRSwNP, whereas the reverse was reported for patients with versus without COPD and depression/anxiety, although the confidence intervals were large for the with COPD subgroup,” the researchers wrote.

The median maintenance dose of oral corticosteroids decreased by at least 50% across all comorbidities after mepolizumab treatment; patients with CRSwNP had the greatest reduction (83%).

In addition, scores on the Asthma Control Questionnaire–5 decreased by at least 0.63 points, and least squared (LS) mean changes in forced expiratory volume per second (FEV₁) increased from baseline across all comorbidities after mepolizumab treatment by at least 74 mL.

Although patients with versus without CRSwNP had greater improvements, patients without GERD, depression/anxiety, and COPD had greater improvements than did those without the respective conditions with the exception of greater FEV₁ improvement in patients with vs. without COPD.

“Patients with severe asthma and comorbid CRSwNP are recognized as having a high disease burden, as demonstrated by more frequent exacerbations,” the researchers wrote in their discussion. “Mepolizumab may serve to reduce the disease burden of this high-risk group by targeting the common pathophysiological pathway of IL-5 and eosinophilic-driven inflammation because it has proven clinical benefits in treating asthma and CRSwNP separately and together,” and the current study findings support the use of mepolizumab for this population in particular, they said.

The findings were limited by several factors including the incomplete data for voluntary assessments, the post hoc design and relatively small numbers of patients in various subgroups, notably COPD, and the potential inaccurate diagnosis of COPD, the researchers noted.

“Nevertheless, because the amount of improvement in each outcome following mepolizumab treatment differed depending on the comorbidity in question, our findings highlight the impact that comorbidities and their prevalence and severity have on outcomes,” and the overall success of mepolizumab across clinical characteristics and comorbidities supports the generalizability of the findings to the larger population of adults with severe asthma, they concluded.

The study was supported by GlaxoSmithKline. Dr. Liu disclosed research funding from GSK, Boehringer Ingelheim, and Gossamer Bio, and participation on advisory boards for AstraZeneca, GSK, and Gossamer Bio.

Adults with asthma who were newly prescribed mepolizumab showed significant improvement in symptoms after 1 year regardless of comorbidities, based on data from 822 individuals.

Comorbidities including chronic rhinosinusitis with polyps (CRSwNP), gastroesophageal reflux disease GERD), anxiety and depression, and chronic obstructive pulmonary disorder (COPD) are common in patients with severe asthma and add to the disease burden, wrote Mark C. Liu, MD, of Johns Hopkins University, Baltimore, and colleagues.

“Some comorbidities, such as CRSwNP, share pathophysiological mechanisms with severe asthma, with interleukin-5 (IL-5),” and treatments targeting IL-5 could improve outcomes, they said.

In the real-world REALITI-A study, mepolizumab, a humanized monoclonal antibody that targets IL-5, significantly reduced asthma exacerbation and oral corticosteroid use in severe asthma patients, they said.

To assess the impact of mepolizumab on patients with comorbidities, the researchers conducted a post hoc analysis of 822 adults with severe asthma, including 321 with CRSwNP, 309 with GERD, 203 with depression/anxiety, and 81 with COPD. The findings were published in the Journal of Allergy and Clinical Immunology: In Practice.

The main outcomes were the rate of clinically significant asthma exacerbations (CSEs) between the 12 months before and after mepolizumab initiation, and the changes from baseline in the daily maintenance use of oral corticosteroids (OCS).

Across all comorbidities, the rate of CSEs decreased significantly from the pretreatment period to the follow-up period, from 4.28 events per year to 1.23 events per year.

“A numerically greater reduction in the rate of CSEs was reported for patients with versus without CRSwNP, whereas the reverse was reported for patients with versus without COPD and depression/anxiety, although the confidence intervals were large for the with COPD subgroup,” the researchers wrote.

The median maintenance dose of oral corticosteroids decreased by at least 50% across all comorbidities after mepolizumab treatment; patients with CRSwNP had the greatest reduction (83%).

In addition, scores on the Asthma Control Questionnaire–5 decreased by at least 0.63 points, and least squared (LS) mean changes in forced expiratory volume per second (FEV₁) increased from baseline across all comorbidities after mepolizumab treatment by at least 74 mL.

Although patients with versus without CRSwNP had greater improvements, patients without GERD, depression/anxiety, and COPD had greater improvements than did those without the respective conditions with the exception of greater FEV₁ improvement in patients with vs. without COPD.

“Patients with severe asthma and comorbid CRSwNP are recognized as having a high disease burden, as demonstrated by more frequent exacerbations,” the researchers wrote in their discussion. “Mepolizumab may serve to reduce the disease burden of this high-risk group by targeting the common pathophysiological pathway of IL-5 and eosinophilic-driven inflammation because it has proven clinical benefits in treating asthma and CRSwNP separately and together,” and the current study findings support the use of mepolizumab for this population in particular, they said.

The findings were limited by several factors including the incomplete data for voluntary assessments, the post hoc design and relatively small numbers of patients in various subgroups, notably COPD, and the potential inaccurate diagnosis of COPD, the researchers noted.

“Nevertheless, because the amount of improvement in each outcome following mepolizumab treatment differed depending on the comorbidity in question, our findings highlight the impact that comorbidities and their prevalence and severity have on outcomes,” and the overall success of mepolizumab across clinical characteristics and comorbidities supports the generalizability of the findings to the larger population of adults with severe asthma, they concluded.

The study was supported by GlaxoSmithKline. Dr. Liu disclosed research funding from GSK, Boehringer Ingelheim, and Gossamer Bio, and participation on advisory boards for AstraZeneca, GSK, and Gossamer Bio.

Adults with asthma who were newly prescribed mepolizumab showed significant improvement in symptoms after 1 year regardless of comorbidities, based on data from 822 individuals.

Comorbidities including chronic rhinosinusitis with polyps (CRSwNP), gastroesophageal reflux disease GERD), anxiety and depression, and chronic obstructive pulmonary disorder (COPD) are common in patients with severe asthma and add to the disease burden, wrote Mark C. Liu, MD, of Johns Hopkins University, Baltimore, and colleagues.

“Some comorbidities, such as CRSwNP, share pathophysiological mechanisms with severe asthma, with interleukin-5 (IL-5),” and treatments targeting IL-5 could improve outcomes, they said.

In the real-world REALITI-A study, mepolizumab, a humanized monoclonal antibody that targets IL-5, significantly reduced asthma exacerbation and oral corticosteroid use in severe asthma patients, they said.

To assess the impact of mepolizumab on patients with comorbidities, the researchers conducted a post hoc analysis of 822 adults with severe asthma, including 321 with CRSwNP, 309 with GERD, 203 with depression/anxiety, and 81 with COPD. The findings were published in the Journal of Allergy and Clinical Immunology: In Practice.

The main outcomes were the rate of clinically significant asthma exacerbations (CSEs) between the 12 months before and after mepolizumab initiation, and the changes from baseline in the daily maintenance use of oral corticosteroids (OCS).

Across all comorbidities, the rate of CSEs decreased significantly from the pretreatment period to the follow-up period, from 4.28 events per year to 1.23 events per year.

“A numerically greater reduction in the rate of CSEs was reported for patients with versus without CRSwNP, whereas the reverse was reported for patients with versus without COPD and depression/anxiety, although the confidence intervals were large for the with COPD subgroup,” the researchers wrote.

The median maintenance dose of oral corticosteroids decreased by at least 50% across all comorbidities after mepolizumab treatment; patients with CRSwNP had the greatest reduction (83%).

In addition, scores on the Asthma Control Questionnaire–5 decreased by at least 0.63 points, and least squared (LS) mean changes in forced expiratory volume per second (FEV₁) increased from baseline across all comorbidities after mepolizumab treatment by at least 74 mL.

Although patients with versus without CRSwNP had greater improvements, patients without GERD, depression/anxiety, and COPD had greater improvements than did those without the respective conditions with the exception of greater FEV₁ improvement in patients with vs. without COPD.

“Patients with severe asthma and comorbid CRSwNP are recognized as having a high disease burden, as demonstrated by more frequent exacerbations,” the researchers wrote in their discussion. “Mepolizumab may serve to reduce the disease burden of this high-risk group by targeting the common pathophysiological pathway of IL-5 and eosinophilic-driven inflammation because it has proven clinical benefits in treating asthma and CRSwNP separately and together,” and the current study findings support the use of mepolizumab for this population in particular, they said.

The findings were limited by several factors including the incomplete data for voluntary assessments, the post hoc design and relatively small numbers of patients in various subgroups, notably COPD, and the potential inaccurate diagnosis of COPD, the researchers noted.

“Nevertheless, because the amount of improvement in each outcome following mepolizumab treatment differed depending on the comorbidity in question, our findings highlight the impact that comorbidities and their prevalence and severity have on outcomes,” and the overall success of mepolizumab across clinical characteristics and comorbidities supports the generalizability of the findings to the larger population of adults with severe asthma, they concluded.

The study was supported by GlaxoSmithKline. Dr. Liu disclosed research funding from GSK, Boehringer Ingelheim, and Gossamer Bio, and participation on advisory boards for AstraZeneca, GSK, and Gossamer Bio.

AMSTERDAM – Systematic screening by primary care physicians for cardiovascular disease (CVD) in high-risk adults – those with type 2 diabetes, chronic obstructive pulmonary disease (COPD), or both – more than doubled the rate of incident CVD diagnosed, compared with usual care, in a Dutch study involving more than 1,200 people and 25 primary care practices.

Scaling up this program to larger populations could potentially uncover huge numbers of currently unrecognized people with CVD given the large number of adults with type 2 diabetes plus those with COPD, Amy Groenewegen, MD, said at the annual congress of the European Society of Cardiology.

“I think this screening is ready for routine use, but it could be followed by prospective studies that investigate whether it produces more benefits in patient-centered outcomes,” Dr. Groenewegen said in a press briefing. She stressed that it has not yet been clearly proven that patients with these chronic diseases are better off long term when their CVD is detected sooner using the tested approach.

“We need simple ways to identify relevant patients for additional screening and potential treatment” of CVD, commented Lars Kober, MD, designated discussant at the Congress and a cardiologist and professor at Rigshospitalet, Copenhagen University Hospital.
 

A ‘very simple’ symptom questionnaire

The study is important because it tested a “very simple” symptom questionnaire as the initial screening phase, yet resulted in a CVD diagnostic rate that was two- to threefold higher than in the control patients managed with usual care, Dr. Kober noted.

The Reviving the Early Diagnosis of CVD (RED-CVD) trial randomized 14 primary care practices in the Netherlands to apply a structured screening protocol to adults with type 2 diabetes or COPD, and another 11 practices that served as controls and provided their patients with usual care.

The study included 624 people in the screening arm and 592 in the usual-care arm. Their average age was about 68 years. In the screening arm, 87% had type 2 diabetes and 20% had COPD, including 6.3% with both. In the usual-care arm, 86% had type 2 diabetes, 21% had COPD, with 7.4% having both.

About a quarter of the study cohort had a history of a CVD diagnosis, but they were included for their potential for developing another form of CVD. The study considered three types of CVD: coronary artery disease, heart failure, and atrial fibrillation.

The CVD screening protocol began with an 11-question survey, completed by patients, that asked about their symptoms. The survey was devised by a research team at the University Medical Center Groningen, the Netherlands, who collaborated on the study.

The second phase for people who had suggestive symptoms was a physical examination, measurement of serum N-terminal pro-brain natriuretic peptide (elevated levels signal incident heart failure), and an ECG. People who continued to show findings consistent with CVD in this phase were then referred on a discretionary basis by the attending physician to a specialist.
 

More than doubling the CVD diagnosis rate

The screening program produced a total of 50 new CVD diagnoses in the screening cohort (8%) and 18 in the control, usual-care arm (3%), for the study’s primary endpoint. The greatest number of events involved heart failure, followed by coronary disease.

The screening questionnaire identified 70% of the people who completed it with suggestive symptoms, such as shortness of breath, claudication, or palpitations. The follow-up assessments of phase two narrowed the group with possible new CVD down to 44% of the people in this arm, and the participating physicians referred 39% to a specialist.

An analysis that adjusted for several demographic and clinical variables and excluded nonobstructive coronary disease as a new CVD diagnosis showed that the systematic screening approach resulted in 2.4-fold more new diagnoses than usual care, reported Dr. Groenewegen, an epidemiologist at University Medical Center Utrecht, the Netherlands.

RED-CVD received no commercial funding. Dr. Groenewegen disclosed no relevant financial relationships. Dr. Kober has received honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, and Novo Nordisk.

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

AMSTERDAM – Systematic screening by primary care physicians for cardiovascular disease (CVD) in high-risk adults – those with type 2 diabetes, chronic obstructive pulmonary disease (COPD), or both – more than doubled the rate of incident CVD diagnosed, compared with usual care, in a Dutch study involving more than 1,200 people and 25 primary care practices.

Scaling up this program to larger populations could potentially uncover huge numbers of currently unrecognized people with CVD given the large number of adults with type 2 diabetes plus those with COPD, Amy Groenewegen, MD, said at the annual congress of the European Society of Cardiology.

“I think this screening is ready for routine use, but it could be followed by prospective studies that investigate whether it produces more benefits in patient-centered outcomes,” Dr. Groenewegen said in a press briefing. She stressed that it has not yet been clearly proven that patients with these chronic diseases are better off long term when their CVD is detected sooner using the tested approach.

“We need simple ways to identify relevant patients for additional screening and potential treatment” of CVD, commented Lars Kober, MD, designated discussant at the Congress and a cardiologist and professor at Rigshospitalet, Copenhagen University Hospital.
 

A ‘very simple’ symptom questionnaire

The study is important because it tested a “very simple” symptom questionnaire as the initial screening phase, yet resulted in a CVD diagnostic rate that was two- to threefold higher than in the control patients managed with usual care, Dr. Kober noted.

The Reviving the Early Diagnosis of CVD (RED-CVD) trial randomized 14 primary care practices in the Netherlands to apply a structured screening protocol to adults with type 2 diabetes or COPD, and another 11 practices that served as controls and provided their patients with usual care.

The study included 624 people in the screening arm and 592 in the usual-care arm. Their average age was about 68 years. In the screening arm, 87% had type 2 diabetes and 20% had COPD, including 6.3% with both. In the usual-care arm, 86% had type 2 diabetes, 21% had COPD, with 7.4% having both.

About a quarter of the study cohort had a history of a CVD diagnosis, but they were included for their potential for developing another form of CVD. The study considered three types of CVD: coronary artery disease, heart failure, and atrial fibrillation.

The CVD screening protocol began with an 11-question survey, completed by patients, that asked about their symptoms. The survey was devised by a research team at the University Medical Center Groningen, the Netherlands, who collaborated on the study.

The second phase for people who had suggestive symptoms was a physical examination, measurement of serum N-terminal pro-brain natriuretic peptide (elevated levels signal incident heart failure), and an ECG. People who continued to show findings consistent with CVD in this phase were then referred on a discretionary basis by the attending physician to a specialist.
 

More than doubling the CVD diagnosis rate

The screening program produced a total of 50 new CVD diagnoses in the screening cohort (8%) and 18 in the control, usual-care arm (3%), for the study’s primary endpoint. The greatest number of events involved heart failure, followed by coronary disease.

The screening questionnaire identified 70% of the people who completed it with suggestive symptoms, such as shortness of breath, claudication, or palpitations. The follow-up assessments of phase two narrowed the group with possible new CVD down to 44% of the people in this arm, and the participating physicians referred 39% to a specialist.

An analysis that adjusted for several demographic and clinical variables and excluded nonobstructive coronary disease as a new CVD diagnosis showed that the systematic screening approach resulted in 2.4-fold more new diagnoses than usual care, reported Dr. Groenewegen, an epidemiologist at University Medical Center Utrecht, the Netherlands.

RED-CVD received no commercial funding. Dr. Groenewegen disclosed no relevant financial relationships. Dr. Kober has received honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, and Novo Nordisk.

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

AMSTERDAM – Systematic screening by primary care physicians for cardiovascular disease (CVD) in high-risk adults – those with type 2 diabetes, chronic obstructive pulmonary disease (COPD), or both – more than doubled the rate of incident CVD diagnosed, compared with usual care, in a Dutch study involving more than 1,200 people and 25 primary care practices.

Scaling up this program to larger populations could potentially uncover huge numbers of currently unrecognized people with CVD given the large number of adults with type 2 diabetes plus those with COPD, Amy Groenewegen, MD, said at the annual congress of the European Society of Cardiology.

“I think this screening is ready for routine use, but it could be followed by prospective studies that investigate whether it produces more benefits in patient-centered outcomes,” Dr. Groenewegen said in a press briefing. She stressed that it has not yet been clearly proven that patients with these chronic diseases are better off long term when their CVD is detected sooner using the tested approach.

“We need simple ways to identify relevant patients for additional screening and potential treatment” of CVD, commented Lars Kober, MD, designated discussant at the Congress and a cardiologist and professor at Rigshospitalet, Copenhagen University Hospital.
 

A ‘very simple’ symptom questionnaire

The study is important because it tested a “very simple” symptom questionnaire as the initial screening phase, yet resulted in a CVD diagnostic rate that was two- to threefold higher than in the control patients managed with usual care, Dr. Kober noted.

The Reviving the Early Diagnosis of CVD (RED-CVD) trial randomized 14 primary care practices in the Netherlands to apply a structured screening protocol to adults with type 2 diabetes or COPD, and another 11 practices that served as controls and provided their patients with usual care.

The study included 624 people in the screening arm and 592 in the usual-care arm. Their average age was about 68 years. In the screening arm, 87% had type 2 diabetes and 20% had COPD, including 6.3% with both. In the usual-care arm, 86% had type 2 diabetes, 21% had COPD, with 7.4% having both.

About a quarter of the study cohort had a history of a CVD diagnosis, but they were included for their potential for developing another form of CVD. The study considered three types of CVD: coronary artery disease, heart failure, and atrial fibrillation.

The CVD screening protocol began with an 11-question survey, completed by patients, that asked about their symptoms. The survey was devised by a research team at the University Medical Center Groningen, the Netherlands, who collaborated on the study.

The second phase for people who had suggestive symptoms was a physical examination, measurement of serum N-terminal pro-brain natriuretic peptide (elevated levels signal incident heart failure), and an ECG. People who continued to show findings consistent with CVD in this phase were then referred on a discretionary basis by the attending physician to a specialist.
 

More than doubling the CVD diagnosis rate

The screening program produced a total of 50 new CVD diagnoses in the screening cohort (8%) and 18 in the control, usual-care arm (3%), for the study’s primary endpoint. The greatest number of events involved heart failure, followed by coronary disease.

The screening questionnaire identified 70% of the people who completed it with suggestive symptoms, such as shortness of breath, claudication, or palpitations. The follow-up assessments of phase two narrowed the group with possible new CVD down to 44% of the people in this arm, and the participating physicians referred 39% to a specialist.

An analysis that adjusted for several demographic and clinical variables and excluded nonobstructive coronary disease as a new CVD diagnosis showed that the systematic screening approach resulted in 2.4-fold more new diagnoses than usual care, reported Dr. Groenewegen, an epidemiologist at University Medical Center Utrecht, the Netherlands.

RED-CVD received no commercial funding. Dr. Groenewegen disclosed no relevant financial relationships. Dr. Kober has received honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, and Novo Nordisk.

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

The American College of Rheumatology has released a summary of upcoming guidelines on screening, monitoring, and treatment for interstitial lung disease (ILD) in patients with systemic autoimmune rheumatic disease.

The recommendations apply to adults with rheumatic diseases at greater risk for ILD: rheumatoid arthritis, systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Sjögren’s disease (SjD), and idiopathic inflammatory myopathies (IIM).

“Interstitial lung disease is a major cause of morbidity and mortality across several systemic autoimmune rheumatic diseases,” Sindhu R. Johnson, MD, PhD, lead author of the new guidelines and director of the clinical epidemiology and health care research program at the University of Toronto, said in an ACR press release. “Guidance was needed for which tests to use for screening and monitoring this particular disease.”

The two documents are summaries of part of a larger manuscript currently awaiting peer review, according to the ACR, and the final guidelines are anticipated to be published by early 2024.

The recommendations were developed using “the best available evidence and consensus across a range of expert opinions and incorporated patient values and preferences,” according to the press release.

Highlights of recommendations for screening and monitoring ILD are:

• Providers can screen patients at higher risk for ILD with pulmonary function tests (PFTs) and high-resolution CT of the chest.
• PFTs, chest high-resolution CT, and ambulatory desaturation testing are conditionally recommended for monitoring ILD progression.
• It is conditionally recommended that providers do not use 6-minute walk test distance, chest radiography, or bronchoscopy for screening or monitoring disease.
• It is suggested that patients with IIM-ILD and SSc-ILD receive PFTs for monitoring every 3-6 months during the first year, then less frequently once stable.
• It is suggested that patients with RA-ILD, SjD-ILD, and MCTD-ILD receive PFTs every 3-12 months for the first year, then less frequently once stable.

Suggestions on how often to screen for ILD were not present in the summary documents, but will be made available in the larger manuscript, said Elana Bernstein, MD, director of the Columbia University Medical Center/New York–Presbyterian Hospital scleroderma program, New York. She is co–first author of the guidelines.

Nearly all recommendations are conditional, primarily because the certainty of evidence behind many of these recommendations is low or very low, she said in an interview. More clinical data on ILD in patients with rheumatic disease would help strengthen evidence, she said, particularly for best practices in frequency of testing. “We need more research on how often patients should be screened for ILD and how often they should be monitored for ILD progression,” she said. “That would enable us to provide recommendations, rather than just suggestions.”

Highlights of recommendations for ILD treatment are:

• The guidelines strongly recommend against using glucocorticoids for first-line ILD treatment in patients with SSc-ILD.
• Short-term glucocorticoids are conditionally recommended as a first-line ILD treatment for patients with systemic autoimmune rheumatic disease–related ILD (SARD-ILD), excluding SSc-ILD.
• Mycophenolate, azathioprine, rituximab, and cyclophosphamide are all potential first-line ILD treatment options for patients with SARD-ILD.
• It is conditionally recommended that patients with SARD-ILD do not receive leflunomide, methotrexate, tumor necrosis factor inhibitors, or abatacept as first-line ILD treatment.
• If SARD-ILD progresses despite first-line therapy, mycophenolate, rituximab, cyclophosphamide, and nintedanib are potential secondary treatment options.
• If RA-ILD progresses following initial therapy, pirfenidone is a treatment option.
• The guidelines conditionally recommend against pirfenidone as a secondary treatment option for SARD-ILD other than RA-ILD.

These summary guidelines appear “comprehensive,” but there has yet to be information published on the basis of these recommendations, Elizabeth Volkmann, MD, said in an interview.

“It’s important to understand that we don’t know whether most of these recommendations were just driven by expert opinion versus actual evidence from randomized, controlled clinical trials,” said Dr. Volkmann, who codirects the connective tissue disease–related interstitial lung disease program at the University of California, Los Angeles. She was not involved with creating the guidelines.

She expects that many of the recommendations for first- and second-line ILD treatment options were based on expert opinion, as there have been no randomized clinical trials looking at that specific topic, she said. For example, nintedanib is conditionally recommended as a first-line treatment option for SSc-ILD, but as a second-line treatment for SjD-ILD, IIM-ILD, and MCTD-ILD. “There’s no literature to support one or the other – whether nintedanib is first-line or second-line [treatment].”

The decision to publish the summary recommendations online prior to peer review is unusual, she said, as these recommendations could be altered during that process; however, Dr. Bernstein noted that was not likely.

By releasing the summary guideline now, the ACR can “get the needed information to clinicians earlier as the manuscript goes through its remaining stages and is finalized,” an ACR representative explained.

Prior to the expected publication of these guidelines in early 2024, Dr. Volkmann noted that the American Thoracic Society will be publishing guidelines on the treatment of SSc-ILD in the American Journal of Respiratory and Critical Care Medicine in September.

Dr. Bernstein reported grants/contracts with the Department of Defense, the Scleroderma Research Foundation, the National Institutes of Health, Eicos, Boehringer Ingelheim, Kadmon, and Pfizer. Dr. Volkmann has received consulting and speaking fees from Boehringer Ingelheim and GlaxoSmithKline and institutional support for performing studies on systemic sclerosis for Kadmon, Boehringer Ingelheim, Horizon, and Prometheus.

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

The American College of Rheumatology has released a summary of upcoming guidelines on screening, monitoring, and treatment for interstitial lung disease (ILD) in patients with systemic autoimmune rheumatic disease.

The recommendations apply to adults with rheumatic diseases at greater risk for ILD: rheumatoid arthritis, systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Sjögren’s disease (SjD), and idiopathic inflammatory myopathies (IIM).

“Interstitial lung disease is a major cause of morbidity and mortality across several systemic autoimmune rheumatic diseases,” Sindhu R. Johnson, MD, PhD, lead author of the new guidelines and director of the clinical epidemiology and health care research program at the University of Toronto, said in an ACR press release. “Guidance was needed for which tests to use for screening and monitoring this particular disease.”

The two documents are summaries of part of a larger manuscript currently awaiting peer review, according to the ACR, and the final guidelines are anticipated to be published by early 2024.

The recommendations were developed using “the best available evidence and consensus across a range of expert opinions and incorporated patient values and preferences,” according to the press release.

Highlights of recommendations for screening and monitoring ILD are:

• Providers can screen patients at higher risk for ILD with pulmonary function tests (PFTs) and high-resolution CT of the chest.
• PFTs, chest high-resolution CT, and ambulatory desaturation testing are conditionally recommended for monitoring ILD progression.
• It is conditionally recommended that providers do not use 6-minute walk test distance, chest radiography, or bronchoscopy for screening or monitoring disease.
• It is suggested that patients with IIM-ILD and SSc-ILD receive PFTs for monitoring every 3-6 months during the first year, then less frequently once stable.
• It is suggested that patients with RA-ILD, SjD-ILD, and MCTD-ILD receive PFTs every 3-12 months for the first year, then less frequently once stable.

Suggestions on how often to screen for ILD were not present in the summary documents, but will be made available in the larger manuscript, said Elana Bernstein, MD, director of the Columbia University Medical Center/New York–Presbyterian Hospital scleroderma program, New York. She is co–first author of the guidelines.

Nearly all recommendations are conditional, primarily because the certainty of evidence behind many of these recommendations is low or very low, she said in an interview. More clinical data on ILD in patients with rheumatic disease would help strengthen evidence, she said, particularly for best practices in frequency of testing. “We need more research on how often patients should be screened for ILD and how often they should be monitored for ILD progression,” she said. “That would enable us to provide recommendations, rather than just suggestions.”

Highlights of recommendations for ILD treatment are:

• The guidelines strongly recommend against using glucocorticoids for first-line ILD treatment in patients with SSc-ILD.
• Short-term glucocorticoids are conditionally recommended as a first-line ILD treatment for patients with systemic autoimmune rheumatic disease–related ILD (SARD-ILD), excluding SSc-ILD.
• Mycophenolate, azathioprine, rituximab, and cyclophosphamide are all potential first-line ILD treatment options for patients with SARD-ILD.
• It is conditionally recommended that patients with SARD-ILD do not receive leflunomide, methotrexate, tumor necrosis factor inhibitors, or abatacept as first-line ILD treatment.
• If SARD-ILD progresses despite first-line therapy, mycophenolate, rituximab, cyclophosphamide, and nintedanib are potential secondary treatment options.
• If RA-ILD progresses following initial therapy, pirfenidone is a treatment option.
• The guidelines conditionally recommend against pirfenidone as a secondary treatment option for SARD-ILD other than RA-ILD.

These summary guidelines appear “comprehensive,” but there has yet to be information published on the basis of these recommendations, Elizabeth Volkmann, MD, said in an interview.

“It’s important to understand that we don’t know whether most of these recommendations were just driven by expert opinion versus actual evidence from randomized, controlled clinical trials,” said Dr. Volkmann, who codirects the connective tissue disease–related interstitial lung disease program at the University of California, Los Angeles. She was not involved with creating the guidelines.

She expects that many of the recommendations for first- and second-line ILD treatment options were based on expert opinion, as there have been no randomized clinical trials looking at that specific topic, she said. For example, nintedanib is conditionally recommended as a first-line treatment option for SSc-ILD, but as a second-line treatment for SjD-ILD, IIM-ILD, and MCTD-ILD. “There’s no literature to support one or the other – whether nintedanib is first-line or second-line [treatment].”

The decision to publish the summary recommendations online prior to peer review is unusual, she said, as these recommendations could be altered during that process; however, Dr. Bernstein noted that was not likely.

By releasing the summary guideline now, the ACR can “get the needed information to clinicians earlier as the manuscript goes through its remaining stages and is finalized,” an ACR representative explained.

Prior to the expected publication of these guidelines in early 2024, Dr. Volkmann noted that the American Thoracic Society will be publishing guidelines on the treatment of SSc-ILD in the American Journal of Respiratory and Critical Care Medicine in September.

Dr. Bernstein reported grants/contracts with the Department of Defense, the Scleroderma Research Foundation, the National Institutes of Health, Eicos, Boehringer Ingelheim, Kadmon, and Pfizer. Dr. Volkmann has received consulting and speaking fees from Boehringer Ingelheim and GlaxoSmithKline and institutional support for performing studies on systemic sclerosis for Kadmon, Boehringer Ingelheim, Horizon, and Prometheus.

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

The American College of Rheumatology has released a summary of upcoming guidelines on screening, monitoring, and treatment for interstitial lung disease (ILD) in patients with systemic autoimmune rheumatic disease.

The recommendations apply to adults with rheumatic diseases at greater risk for ILD: rheumatoid arthritis, systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Sjögren’s disease (SjD), and idiopathic inflammatory myopathies (IIM).

“Interstitial lung disease is a major cause of morbidity and mortality across several systemic autoimmune rheumatic diseases,” Sindhu R. Johnson, MD, PhD, lead author of the new guidelines and director of the clinical epidemiology and health care research program at the University of Toronto, said in an ACR press release. “Guidance was needed for which tests to use for screening and monitoring this particular disease.”

The two documents are summaries of part of a larger manuscript currently awaiting peer review, according to the ACR, and the final guidelines are anticipated to be published by early 2024.

The recommendations were developed using “the best available evidence and consensus across a range of expert opinions and incorporated patient values and preferences,” according to the press release.

Highlights of recommendations for screening and monitoring ILD are:

• Providers can screen patients at higher risk for ILD with pulmonary function tests (PFTs) and high-resolution CT of the chest.
• PFTs, chest high-resolution CT, and ambulatory desaturation testing are conditionally recommended for monitoring ILD progression.
• It is conditionally recommended that providers do not use 6-minute walk test distance, chest radiography, or bronchoscopy for screening or monitoring disease.
• It is suggested that patients with IIM-ILD and SSc-ILD receive PFTs for monitoring every 3-6 months during the first year, then less frequently once stable.
• It is suggested that patients with RA-ILD, SjD-ILD, and MCTD-ILD receive PFTs every 3-12 months for the first year, then less frequently once stable.

Suggestions on how often to screen for ILD were not present in the summary documents, but will be made available in the larger manuscript, said Elana Bernstein, MD, director of the Columbia University Medical Center/New York–Presbyterian Hospital scleroderma program, New York. She is co–first author of the guidelines.

Nearly all recommendations are conditional, primarily because the certainty of evidence behind many of these recommendations is low or very low, she said in an interview. More clinical data on ILD in patients with rheumatic disease would help strengthen evidence, she said, particularly for best practices in frequency of testing. “We need more research on how often patients should be screened for ILD and how often they should be monitored for ILD progression,” she said. “That would enable us to provide recommendations, rather than just suggestions.”

Highlights of recommendations for ILD treatment are:

• The guidelines strongly recommend against using glucocorticoids for first-line ILD treatment in patients with SSc-ILD.
• Short-term glucocorticoids are conditionally recommended as a first-line ILD treatment for patients with systemic autoimmune rheumatic disease–related ILD (SARD-ILD), excluding SSc-ILD.
• Mycophenolate, azathioprine, rituximab, and cyclophosphamide are all potential first-line ILD treatment options for patients with SARD-ILD.
• It is conditionally recommended that patients with SARD-ILD do not receive leflunomide, methotrexate, tumor necrosis factor inhibitors, or abatacept as first-line ILD treatment.
• If SARD-ILD progresses despite first-line therapy, mycophenolate, rituximab, cyclophosphamide, and nintedanib are potential secondary treatment options.
• If RA-ILD progresses following initial therapy, pirfenidone is a treatment option.
• The guidelines conditionally recommend against pirfenidone as a secondary treatment option for SARD-ILD other than RA-ILD.

These summary guidelines appear “comprehensive,” but there has yet to be information published on the basis of these recommendations, Elizabeth Volkmann, MD, said in an interview.

“It’s important to understand that we don’t know whether most of these recommendations were just driven by expert opinion versus actual evidence from randomized, controlled clinical trials,” said Dr. Volkmann, who codirects the connective tissue disease–related interstitial lung disease program at the University of California, Los Angeles. She was not involved with creating the guidelines.

She expects that many of the recommendations for first- and second-line ILD treatment options were based on expert opinion, as there have been no randomized clinical trials looking at that specific topic, she said. For example, nintedanib is conditionally recommended as a first-line treatment option for SSc-ILD, but as a second-line treatment for SjD-ILD, IIM-ILD, and MCTD-ILD. “There’s no literature to support one or the other – whether nintedanib is first-line or second-line [treatment].”

The decision to publish the summary recommendations online prior to peer review is unusual, she said, as these recommendations could be altered during that process; however, Dr. Bernstein noted that was not likely.

By releasing the summary guideline now, the ACR can “get the needed information to clinicians earlier as the manuscript goes through its remaining stages and is finalized,” an ACR representative explained.

Prior to the expected publication of these guidelines in early 2024, Dr. Volkmann noted that the American Thoracic Society will be publishing guidelines on the treatment of SSc-ILD in the American Journal of Respiratory and Critical Care Medicine in September.

Dr. Bernstein reported grants/contracts with the Department of Defense, the Scleroderma Research Foundation, the National Institutes of Health, Eicos, Boehringer Ingelheim, Kadmon, and Pfizer. Dr. Volkmann has received consulting and speaking fees from Boehringer Ingelheim and GlaxoSmithKline and institutional support for performing studies on systemic sclerosis for Kadmon, Boehringer Ingelheim, Horizon, and Prometheus.

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

Systemic sclerosis patients with both interstitial lung disease and pulmonary hypertension had worse survival than those without both conditions, based on data from more than 3,000 individuals.

Pulmonary complications are now the most common causes of death in adults with systemic sclerosis (SSc), but the impact of patient characteristics and risk factors such as interstitial lung disease (ILD) and pulmonary hypertension (PH) on SSc outcomes remains unclear, wrote Pia Moinzadeh, MD, of University Hospital Cologne (Germany) and colleagues.

Although the role of ILD and PH in different SSc subtypes has been studied, larger studies of the effects of ILD and combining ILD and PH on outcomes are needed, since survival rates can change over time with new classification criteria, diagnostic tools, and improved therapies, they said.

In a study published in the journal Chest, the researchers reviewed data from 3,257 adults aged 18 years and older with SSc over a mean follow-up of 3.45 years. Participants were part of the German Network for Systemic Sclerosis (DNSS) that included 25 clinical centers in Germany. The participants were divided into SSc subsets: 54.2% with limited cutaneous SSc (lcSSc), 31.4% with diffuse cutaneous SSc (dcSSc), and 14.4% SSc overlapping syndromes.

The baseline prevalence of ILD was 34.5%, including 200 patients with ILD-PH and 923 with ILD but without PH. The baseline prevalence of PH without ILD was 4.5%. ILD was defined as SSc associated when other causes were excluded. PH was defined as an increase in mean arterial pressure of at least 25 mm Hg at rest, and also was defined by an estimated right ventricular systolic pressure greater than 35 mm Hg based on echocardiography.

By the end of the study period, 47.6% of SSc patients had ILD, 15.2% had ILD-PH, and 6.5% had pulmonary arterial hypertension (PAH). Of the SSc patients with ILD, 57.3% had dcSSc; the prevalence of PAH was not significantly different between the SSc subtypes. Patients with dcSSc were more likely to develop ILD-PH (52.2%) and ILD without PH (52.1%); patients with lcSSc were more likely to have PAH (64.9%) or no pulmonary involvement (64.1%).

“For all subsets, a significant increase in the frequency of SSc-ILD was observed during follow-ups,” the researchers noted.

Overall survival at 5 years was worst for patients with both ILD and PH (79.1%). Five-year OS for patients with PAH was 85.0%. OS at 5 years was significantly better for patients with ILD without PH (92.8%) and those with no pulmonary involvement (96.4%), compared with the ILD and PH patients (P < 0.001).

In a multivariate analysis, the risk of death was more than five times higher for patients with ILD-PH, compared with the reference group of patients without pulmonary involvement (hazard ratio, 5.3). Factors associated with reduced risk of death included female sex (HR, 0.3), higher body mass index (HR, 0.9), and higher diffusing capacity of the lung for carbon monoxide (HR, 0.98).

The findings were limited by several factors including the incomplete data for patients enrolled early in the registry, lack of complete radiology data, and the inability to determine whether the association between pulmonary involvement and survival was related to ILD or to pulmonary vascular disease, the researchers noted.

However, the results suggest that a combination of ILD and PH is the main predictor of death in patients with SSc and ILD, although the overall survival for SSc patients with and without pulmonary involvement has improved in recent decades thanks to improved therapies, multidisciplinary care, and greater attention to the disease worldwide, they concluded.

The study received no outside funding. Dr. Moinzadeh disclosed lecture fees from Boehringer Ingelheim.

Systemic sclerosis patients with both interstitial lung disease and pulmonary hypertension had worse survival than those without both conditions, based on data from more than 3,000 individuals.

Pulmonary complications are now the most common causes of death in adults with systemic sclerosis (SSc), but the impact of patient characteristics and risk factors such as interstitial lung disease (ILD) and pulmonary hypertension (PH) on SSc outcomes remains unclear, wrote Pia Moinzadeh, MD, of University Hospital Cologne (Germany) and colleagues.

Although the role of ILD and PH in different SSc subtypes has been studied, larger studies of the effects of ILD and combining ILD and PH on outcomes are needed, since survival rates can change over time with new classification criteria, diagnostic tools, and improved therapies, they said.

In a study published in the journal Chest, the researchers reviewed data from 3,257 adults aged 18 years and older with SSc over a mean follow-up of 3.45 years. Participants were part of the German Network for Systemic Sclerosis (DNSS) that included 25 clinical centers in Germany. The participants were divided into SSc subsets: 54.2% with limited cutaneous SSc (lcSSc), 31.4% with diffuse cutaneous SSc (dcSSc), and 14.4% SSc overlapping syndromes.

The baseline prevalence of ILD was 34.5%, including 200 patients with ILD-PH and 923 with ILD but without PH. The baseline prevalence of PH without ILD was 4.5%. ILD was defined as SSc associated when other causes were excluded. PH was defined as an increase in mean arterial pressure of at least 25 mm Hg at rest, and also was defined by an estimated right ventricular systolic pressure greater than 35 mm Hg based on echocardiography.

By the end of the study period, 47.6% of SSc patients had ILD, 15.2% had ILD-PH, and 6.5% had pulmonary arterial hypertension (PAH). Of the SSc patients with ILD, 57.3% had dcSSc; the prevalence of PAH was not significantly different between the SSc subtypes. Patients with dcSSc were more likely to develop ILD-PH (52.2%) and ILD without PH (52.1%); patients with lcSSc were more likely to have PAH (64.9%) or no pulmonary involvement (64.1%).

“For all subsets, a significant increase in the frequency of SSc-ILD was observed during follow-ups,” the researchers noted.

Overall survival at 5 years was worst for patients with both ILD and PH (79.1%). Five-year OS for patients with PAH was 85.0%. OS at 5 years was significantly better for patients with ILD without PH (92.8%) and those with no pulmonary involvement (96.4%), compared with the ILD and PH patients (P < 0.001).

In a multivariate analysis, the risk of death was more than five times higher for patients with ILD-PH, compared with the reference group of patients without pulmonary involvement (hazard ratio, 5.3). Factors associated with reduced risk of death included female sex (HR, 0.3), higher body mass index (HR, 0.9), and higher diffusing capacity of the lung for carbon monoxide (HR, 0.98).

The findings were limited by several factors including the incomplete data for patients enrolled early in the registry, lack of complete radiology data, and the inability to determine whether the association between pulmonary involvement and survival was related to ILD or to pulmonary vascular disease, the researchers noted.

However, the results suggest that a combination of ILD and PH is the main predictor of death in patients with SSc and ILD, although the overall survival for SSc patients with and without pulmonary involvement has improved in recent decades thanks to improved therapies, multidisciplinary care, and greater attention to the disease worldwide, they concluded.

The study received no outside funding. Dr. Moinzadeh disclosed lecture fees from Boehringer Ingelheim.

Systemic sclerosis patients with both interstitial lung disease and pulmonary hypertension had worse survival than those without both conditions, based on data from more than 3,000 individuals.

Pulmonary complications are now the most common causes of death in adults with systemic sclerosis (SSc), but the impact of patient characteristics and risk factors such as interstitial lung disease (ILD) and pulmonary hypertension (PH) on SSc outcomes remains unclear, wrote Pia Moinzadeh, MD, of University Hospital Cologne (Germany) and colleagues.

Although the role of ILD and PH in different SSc subtypes has been studied, larger studies of the effects of ILD and combining ILD and PH on outcomes are needed, since survival rates can change over time with new classification criteria, diagnostic tools, and improved therapies, they said.

In a study published in the journal Chest, the researchers reviewed data from 3,257 adults aged 18 years and older with SSc over a mean follow-up of 3.45 years. Participants were part of the German Network for Systemic Sclerosis (DNSS) that included 25 clinical centers in Germany. The participants were divided into SSc subsets: 54.2% with limited cutaneous SSc (lcSSc), 31.4% with diffuse cutaneous SSc (dcSSc), and 14.4% SSc overlapping syndromes.

The baseline prevalence of ILD was 34.5%, including 200 patients with ILD-PH and 923 with ILD but without PH. The baseline prevalence of PH without ILD was 4.5%. ILD was defined as SSc associated when other causes were excluded. PH was defined as an increase in mean arterial pressure of at least 25 mm Hg at rest, and also was defined by an estimated right ventricular systolic pressure greater than 35 mm Hg based on echocardiography.

By the end of the study period, 47.6% of SSc patients had ILD, 15.2% had ILD-PH, and 6.5% had pulmonary arterial hypertension (PAH). Of the SSc patients with ILD, 57.3% had dcSSc; the prevalence of PAH was not significantly different between the SSc subtypes. Patients with dcSSc were more likely to develop ILD-PH (52.2%) and ILD without PH (52.1%); patients with lcSSc were more likely to have PAH (64.9%) or no pulmonary involvement (64.1%).

“For all subsets, a significant increase in the frequency of SSc-ILD was observed during follow-ups,” the researchers noted.

Overall survival at 5 years was worst for patients with both ILD and PH (79.1%). Five-year OS for patients with PAH was 85.0%. OS at 5 years was significantly better for patients with ILD without PH (92.8%) and those with no pulmonary involvement (96.4%), compared with the ILD and PH patients (P < 0.001).

In a multivariate analysis, the risk of death was more than five times higher for patients with ILD-PH, compared with the reference group of patients without pulmonary involvement (hazard ratio, 5.3). Factors associated with reduced risk of death included female sex (HR, 0.3), higher body mass index (HR, 0.9), and higher diffusing capacity of the lung for carbon monoxide (HR, 0.98).

The findings were limited by several factors including the incomplete data for patients enrolled early in the registry, lack of complete radiology data, and the inability to determine whether the association between pulmonary involvement and survival was related to ILD or to pulmonary vascular disease, the researchers noted.

However, the results suggest that a combination of ILD and PH is the main predictor of death in patients with SSc and ILD, although the overall survival for SSc patients with and without pulmonary involvement has improved in recent decades thanks to improved therapies, multidisciplinary care, and greater attention to the disease worldwide, they concluded.

The study received no outside funding. Dr. Moinzadeh disclosed lecture fees from Boehringer Ingelheim.

PARIS – Oxygen therapy is used too often in patients with respiratory difficulties, says one expert, and should be given only when oxygen saturation levels (SpO₂) drop below 93%, as per the current guidelines. Florian Negrello, MD, an emergency medicine specialist at University Hospital of Martinique in Fort-de-France, reiterated this message at the 2023 conference held by France’s emergency medicine society (Urgences 2023). The recommendation is intended to prevent hyperoxia; increasing evidence indicates the harmful effects of such a state on the body. 

“This is a real problem. Oxygen therapy is given all too readily despite studies now showing that excess oxygen is harmful, especially in patients with head trauma, ischemic stroke, or cardiac arrest,” stated the session’s moderator, Patrick Plaisance, MD, PhD, a doctor at Lariboisière Hospital in Paris. 
 

No proven hypoxia

Described as difficulty breathing or shortness of breath, dyspnea is common in the emergency department, occurring in 5%-9% of patients. Close to 20% of intensive care unit admissions involve patients with dyspnea. “Since this is a very subjective symptom, it’s possible it’s being underdiagnosed,” said Dr. Negrello.

Lower respiratory tract infection, acute heart failure, chronic obstructive pulmonary disease, and exacerbation of asthma are the four main diagnoses linked to dyspnea, but this symptom is also seen in several medical conditions (gastrointestinal, metabolic, neurologic, etc.), he noted. 

Often seen as a harmless treatment option, oxygen therapy is commonly administered to patients with breathing difficulties even when no hypoxemia is documented. This is particularly the case for patients brought into hospital via ambulance who are treated with oxygen without even having had their blood oxygen levels, SpO₂, and partial pressure of oxygen checked. 

In the United States, one of the few studies published on the topic showed that one-third of patients transported via ambulance are put on oxygen, with SpO₂ being measured in just 5% of these cases. Finally, just 17% of patients receiving oxygen were experiencing hypoxia, defined as SpO₂ < 94%. 
 

Oxidative stress 

Recently, several research studies have revealed the potential dangers of unjustified use of oxygen, which can lead to hyperoxia and increased mortality in hospitalized patients. 

A meta-analysis reported a linear relationship between severe hyperoxia, in-hospital mortality, and length of stay in intensive care. Another study revealed a greater mortality rate in patients with acute respiratory distress syndrome (ARDS) experiencing an episode of hyperoxia, regardless of the severity of ARDS. 

Oxygen toxicity in intensive care is said to be linked to oxidative stress caused by increased growth of reactive oxygen species but also to the systemic inflammation caused by hyperoxia, explained Dr. Negrello. Excess oxygen may also cause lung lesions with necrosis, the severity of which is proportional to the fraction of inspired oxygen and the length of exposure. 

According to the most up-to-date international recommendations published in 2018 on the use of oxygen therapy in treating acute conditions, oxygen should not be used when SpO₂ ≥ 93%. When treatment has been started, it must be stopped when SpO₂ reaches 96%. SpO₂ cannot be maintained above 96%, according to experts. 

These threshold values can be found in the COVID-19 treatment guidelines produced by the French-Language Society of Respiratory Medicine, with oxygen therapy being recommended when SpO₂ < 92%, added Dr. Negrello. The aim is to maintain normal oxygen levels, with SpO₂ between 92% and 96%. 
 

Use sparingly 

For patients with COPD, the target levels are lower, due to the risk of hypercapnia (higher than normal carbon dioxide levels in the blood). Oxygen saturation levels should then be kept between 88% and 92%, “by using the minimum amount of oxygen necessary,” per the guidelines. 

“Oxygen should be used sparingly,” concluded Dr. Negrello. “To treat our patients without harming them, we must be able to use it at the right time, meaning when a patient really has low blood oxygen, by focusing on normal saturation levels as the end goal.”

SpO₂ measurement is the first step to be taken to determine oxygen requirements, followed by, if necessary, blood gas analysis once the patient has been admitted, he explained. 

Questioned at the end of his session on how long oxygen therapy can be given for, Dr. Negrello reiterated that the risk for death is correlated with the length of time spent in a state of hyperoxia but that it is difficult to establish a maximum timeframe to be adhered to strictly. 

Given that excess oxygen is harmful to patients in intensive care, “it would be better, when in doubt, to focus on physiological levels” and simply stop treatment when target saturation levels are reached. 

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

PARIS – Oxygen therapy is used too often in patients with respiratory difficulties, says one expert, and should be given only when oxygen saturation levels (SpO₂) drop below 93%, as per the current guidelines. Florian Negrello, MD, an emergency medicine specialist at University Hospital of Martinique in Fort-de-France, reiterated this message at the 2023 conference held by France’s emergency medicine society (Urgences 2023). The recommendation is intended to prevent hyperoxia; increasing evidence indicates the harmful effects of such a state on the body. 

“This is a real problem. Oxygen therapy is given all too readily despite studies now showing that excess oxygen is harmful, especially in patients with head trauma, ischemic stroke, or cardiac arrest,” stated the session’s moderator, Patrick Plaisance, MD, PhD, a doctor at Lariboisière Hospital in Paris. 
 

No proven hypoxia

Described as difficulty breathing or shortness of breath, dyspnea is common in the emergency department, occurring in 5%-9% of patients. Close to 20% of intensive care unit admissions involve patients with dyspnea. “Since this is a very subjective symptom, it’s possible it’s being underdiagnosed,” said Dr. Negrello.

Lower respiratory tract infection, acute heart failure, chronic obstructive pulmonary disease, and exacerbation of asthma are the four main diagnoses linked to dyspnea, but this symptom is also seen in several medical conditions (gastrointestinal, metabolic, neurologic, etc.), he noted. 

Often seen as a harmless treatment option, oxygen therapy is commonly administered to patients with breathing difficulties even when no hypoxemia is documented. This is particularly the case for patients brought into hospital via ambulance who are treated with oxygen without even having had their blood oxygen levels, SpO₂, and partial pressure of oxygen checked. 

In the United States, one of the few studies published on the topic showed that one-third of patients transported via ambulance are put on oxygen, with SpO₂ being measured in just 5% of these cases. Finally, just 17% of patients receiving oxygen were experiencing hypoxia, defined as SpO₂ < 94%. 
 

Oxidative stress 

Recently, several research studies have revealed the potential dangers of unjustified use of oxygen, which can lead to hyperoxia and increased mortality in hospitalized patients. 

A meta-analysis reported a linear relationship between severe hyperoxia, in-hospital mortality, and length of stay in intensive care. Another study revealed a greater mortality rate in patients with acute respiratory distress syndrome (ARDS) experiencing an episode of hyperoxia, regardless of the severity of ARDS. 

Oxygen toxicity in intensive care is said to be linked to oxidative stress caused by increased growth of reactive oxygen species but also to the systemic inflammation caused by hyperoxia, explained Dr. Negrello. Excess oxygen may also cause lung lesions with necrosis, the severity of which is proportional to the fraction of inspired oxygen and the length of exposure. 

According to the most up-to-date international recommendations published in 2018 on the use of oxygen therapy in treating acute conditions, oxygen should not be used when SpO₂ ≥ 93%. When treatment has been started, it must be stopped when SpO₂ reaches 96%. SpO₂ cannot be maintained above 96%, according to experts. 

These threshold values can be found in the COVID-19 treatment guidelines produced by the French-Language Society of Respiratory Medicine, with oxygen therapy being recommended when SpO₂ < 92%, added Dr. Negrello. The aim is to maintain normal oxygen levels, with SpO₂ between 92% and 96%. 
 

Use sparingly 

For patients with COPD, the target levels are lower, due to the risk of hypercapnia (higher than normal carbon dioxide levels in the blood). Oxygen saturation levels should then be kept between 88% and 92%, “by using the minimum amount of oxygen necessary,” per the guidelines. 

“Oxygen should be used sparingly,” concluded Dr. Negrello. “To treat our patients without harming them, we must be able to use it at the right time, meaning when a patient really has low blood oxygen, by focusing on normal saturation levels as the end goal.”

SpO₂ measurement is the first step to be taken to determine oxygen requirements, followed by, if necessary, blood gas analysis once the patient has been admitted, he explained. 

Questioned at the end of his session on how long oxygen therapy can be given for, Dr. Negrello reiterated that the risk for death is correlated with the length of time spent in a state of hyperoxia but that it is difficult to establish a maximum timeframe to be adhered to strictly. 

Given that excess oxygen is harmful to patients in intensive care, “it would be better, when in doubt, to focus on physiological levels” and simply stop treatment when target saturation levels are reached. 

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

PARIS – Oxygen therapy is used too often in patients with respiratory difficulties, says one expert, and should be given only when oxygen saturation levels (SpO₂) drop below 93%, as per the current guidelines. Florian Negrello, MD, an emergency medicine specialist at University Hospital of Martinique in Fort-de-France, reiterated this message at the 2023 conference held by France’s emergency medicine society (Urgences 2023). The recommendation is intended to prevent hyperoxia; increasing evidence indicates the harmful effects of such a state on the body. 

“This is a real problem. Oxygen therapy is given all too readily despite studies now showing that excess oxygen is harmful, especially in patients with head trauma, ischemic stroke, or cardiac arrest,” stated the session’s moderator, Patrick Plaisance, MD, PhD, a doctor at Lariboisière Hospital in Paris. 
 

No proven hypoxia

Described as difficulty breathing or shortness of breath, dyspnea is common in the emergency department, occurring in 5%-9% of patients. Close to 20% of intensive care unit admissions involve patients with dyspnea. “Since this is a very subjective symptom, it’s possible it’s being underdiagnosed,” said Dr. Negrello.

Lower respiratory tract infection, acute heart failure, chronic obstructive pulmonary disease, and exacerbation of asthma are the four main diagnoses linked to dyspnea, but this symptom is also seen in several medical conditions (gastrointestinal, metabolic, neurologic, etc.), he noted. 

Often seen as a harmless treatment option, oxygen therapy is commonly administered to patients with breathing difficulties even when no hypoxemia is documented. This is particularly the case for patients brought into hospital via ambulance who are treated with oxygen without even having had their blood oxygen levels, SpO₂, and partial pressure of oxygen checked. 

In the United States, one of the few studies published on the topic showed that one-third of patients transported via ambulance are put on oxygen, with SpO₂ being measured in just 5% of these cases. Finally, just 17% of patients receiving oxygen were experiencing hypoxia, defined as SpO₂ < 94%. 
 

Oxidative stress 

Recently, several research studies have revealed the potential dangers of unjustified use of oxygen, which can lead to hyperoxia and increased mortality in hospitalized patients. 

A meta-analysis reported a linear relationship between severe hyperoxia, in-hospital mortality, and length of stay in intensive care. Another study revealed a greater mortality rate in patients with acute respiratory distress syndrome (ARDS) experiencing an episode of hyperoxia, regardless of the severity of ARDS. 

Oxygen toxicity in intensive care is said to be linked to oxidative stress caused by increased growth of reactive oxygen species but also to the systemic inflammation caused by hyperoxia, explained Dr. Negrello. Excess oxygen may also cause lung lesions with necrosis, the severity of which is proportional to the fraction of inspired oxygen and the length of exposure. 

According to the most up-to-date international recommendations published in 2018 on the use of oxygen therapy in treating acute conditions, oxygen should not be used when SpO₂ ≥ 93%. When treatment has been started, it must be stopped when SpO₂ reaches 96%. SpO₂ cannot be maintained above 96%, according to experts. 

These threshold values can be found in the COVID-19 treatment guidelines produced by the French-Language Society of Respiratory Medicine, with oxygen therapy being recommended when SpO₂ < 92%, added Dr. Negrello. The aim is to maintain normal oxygen levels, with SpO₂ between 92% and 96%. 
 

Use sparingly 

For patients with COPD, the target levels are lower, due to the risk of hypercapnia (higher than normal carbon dioxide levels in the blood). Oxygen saturation levels should then be kept between 88% and 92%, “by using the minimum amount of oxygen necessary,” per the guidelines. 

“Oxygen should be used sparingly,” concluded Dr. Negrello. “To treat our patients without harming them, we must be able to use it at the right time, meaning when a patient really has low blood oxygen, by focusing on normal saturation levels as the end goal.”

SpO₂ measurement is the first step to be taken to determine oxygen requirements, followed by, if necessary, blood gas analysis once the patient has been admitted, he explained. 

Questioned at the end of his session on how long oxygen therapy can be given for, Dr. Negrello reiterated that the risk for death is correlated with the length of time spent in a state of hyperoxia but that it is difficult to establish a maximum timeframe to be adhered to strictly. 

Given that excess oxygen is harmful to patients in intensive care, “it would be better, when in doubt, to focus on physiological levels” and simply stop treatment when target saturation levels are reached. 

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Clinicians are using dupilumab off label to treat a wider range of allergic conditions in adults and children.

The drug, marketed as Dupixent, is currently approved in the United States to treat atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, and prurigo nodularis in adults. Dupilumab is also approved to treat eosinophilic esophagitis in patients aged 12 years and older and atopic dermatitis and asthma in some patients as young as age 6 months.

As the roster of approved and off-label indications grows, skin specialists said, pediatricians and other primary care providers should become familiar with the drug – given the increasing likelihood that their patients may be taking the medication.

The U.S. Food and Drug Administration first approved dupilumab in 2017 for eczema and has continued to add new treatment indications, the most recent being for prurigo nodularis, in 2022. Sanofi, which markets the drug with Regeneron, announced in April 2022 that some 430,000 patients worldwide were taking the drug – a figure it hoped to raise by 1.5 million by 2025.
 

A well-tolerated – if expensive – drug

Dupilumab, an interleukin-4 (IL-4) receptor alpha-antagonist biologic, blocks both IL-4 and IL-13 signaling, Marlys Fassett, MD, PhD, associate professor of dermatology at the University of California, San Francisco, told this news organization.

Dr. Fassett said she prescribes the drug off label for chronic idiopathic urticaria, including in older patients, and finds that the side effects in older patients are similar to those in younger people. The medication costs $36,000 per year, although some patients can get it more cheaply.

“Dupixent is a super-safe drug because it doesn’t immunosuppress any other part of the immune system, so you still have good antibacterial, antiviral, and antifungal immunity,” she added. “That makes perfect sense as a biological mechanism, and it’s been found safe in clinical trials.”

Case reports of potential adverse reactions to dupilumab have included ocular surface disease, lichen planus, and rash on the face and neck.

“We’re still learning about complications and are watching patients carefully,” said Marissa J. Perman, MD, section chief of dermatology at Children’s Hospital of Philadelphia.

Many people with atopic dermatitis also have other allergic conditions, such as contact dermatitis, asthma, prurigo nodularis, allergic rhinitis, and seasonal allergies. Each of these conditions has a pathway that depends on IL-4 receptors, Dr. Fassett said.

“It’s amazing how many conditions Dupixent improves. Sometimes we prescribe on-label Dupixent for atopic dermatitis, and inadvertently, the drug also improves that patient’s other, off-label conditions,” Dr. Fassett said. “I think that’s the best evidence that Dupixent works in these off-label cases.”

Lindsay C. Strowd, MD, associate professor of dermatology at Wake Forest University, Winston-Salem, N.C., said she uses off-label dupilumab to treat bullous pemphigoid and intense pruritus of unknown etiology.

“And several times I have treated drug reaction with eosinophilia and systemic symptoms, a rare adverse drug reaction that causes a rash and eosinophilia,” Dr. Strowd added.

Tissa Hata, MD, professor of medicine and clinical service chief at the University of California, San Diego, mainly treats elderly patients. She uses dupilumab to treat bullous pemphigoid and chronic pruritus. “There have been reports of using Dupixent to treat adult alopecia areata, chronic urticaria, localized scleroderma, and even keloids,” she told this news organization.

As a pediatric dermatologist, Dr. Perman treats children with atopic dermatitis as young as 3 months of age. She also uses dupilumab for alopecia areata, graft vs. host disease, and pruritus not otherwise specified.

Conjunctivitis and facial redness are two side effects Dr. Fassett sometimes sees with dupilumab. They occur similarly with all conditions and in all age groups. “We don’t know why they occur, and we don’t always know how to alleviate them,” she said. “So a small number of patients stop using Dupixent because they can’t tolerate those two side effects.

“We’re not worried about infection risk,” Dr. Fassett said. “Your patients may have heard of dupilumab as an immunosuppressant, but its immunosuppression is very focused. You can reassure them that they’re not at increased risk for viral or bacterial infections when they’re on this drug.”

“I don’t think there are any different safety signals to watch for with on-label vs. off-label Dupixent use,” Dr. Strowd added. “In general, the medicine is very safe.”

Dr. Hata said she is impressed with dupilumab’s safety in her elderly patients. All her patients older than 85 years who have taken the drug for bullous pemphigoid have tolerated it well, she said.

“Dupixent seems to be a safe alternative for elderly patients with pruritus because they often cannot tolerate sedating antihistamines due to the risk of falling,” Dr. Hata said. “And UV therapy may be difficult for elderly patients due to problems with transport.”

Although some of Dr. Hata’s elderly patients with atopic dermatitis have discontinued use of the drug after developing conjunctivitis, none taking the drug off label have discontinued it because of side effects, she noted.

“Dupixent manages the condition, but it is not a cure,” Dr. Fassett noted. “Based on the current data, we think it’s safe and effective to take long term, potentially for life.”

Making injections less bothersome

Dupilumab is injected subcutaneously from a single-dose prefilled syringe or a prefilled pen (syringe hidden in an opaque sheath), typically in the thigh, arm, abdomen, or buttocks. According to Sanofi and Regeneron, patients receive dupilumab injections every 2 to 4 weeks in doses based on their age and weight.

“The medication is somewhat viscous, so taking the syringe or pen out of the refrigerator ahead of time to warm it up can make the experience less painful,” Dr. Strowd advised. “For pediatric patients, I sometimes prescribe topical lidocaine applied 30 minutes before injection.”

Dr. Hata suggested icing the skin prior to injecting or distracting the patient by tapping a different area of the skin.

For her pediatric patients, Dr. Perman said she uses “lots of distraction, EMLA cream, and having one person hold the child while a second person injects.”

Clinic and pharmacy staff may show patients how to inject properly, Dr. Fassett added; and the product website provides injection tutorials.
 

Off-label dupixent can be expensive, difficult to obtain

The list price per injection, regardless of dose, is around $1,800. But according to the company’s website, most patients have health insurance or qualify for other assistance, so “very few patients pay the list price.”

Even so, “due to cost and insurance coverage hurdles, obtaining Dupixent for off-label use can be difficult,” Dr. Strowd said.

“In academic medicine, we can obtain drugs for our patients that community doctors may not get approval for,” Dr. Fassett added. “Community doctors can use information in the medical literature and in news articles to press insurance companies to spend money to provide their patients with Dupixent.”

The experts who commented have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

Any parent might naturally assume that their newborn is at little risk from respiratory syncytial virus (RSV), which in healthy infants has been thought to cause mild symptoms similar to having a cold. But a new study challenges the assumption that only infirm children are at risk for the worst outcomes from RSV, finding that more than 80% of infants hospitalized with the infection were otherwise healthy before they developed the lung disease.

The researchers, who published their study in JAMA Network Open, said the results reinforce the importance of a new preventive injection that can lower the risk for severe RSV infection in babies.

“RSV is the number one cause of hospitalizations in young infants,” said Natasha Halasa, MD, MPH, an infectious disease specialist at Vanderbilt University Medical Center in Nashville, Tenn., and the lead author of the new study. But “the vast majority of kids didn’t have underlying medical conditions” when they got sick.

Every infant in the study was in an intensive care unit for at least 24 hours, Dr. Halasa said, and most babies gave no prior indication that RSV would affect them so profoundly.

“Two to three of every 100 babies in the United States will be hospitalized for RSV in their first year of life,” added study author Angela Campbell, MD, MPH, of the Coronavirus and Other Respiratory Viruses Division of the Centers for Disease Control and Prevention in Atlanta. 

Until recently, only one treatment was available for children up to age 2 at high risk for RSV, the monoclonal antibody palivizumab (Synagis). Palivizumab is reserved for children who are born prematurely, are immunocompromised, or have chronic heart or lung disease. The injection is given monthly during the 5-month peak of RSV season, from fall to spring.

In July, the Food and Drug Administration approved, and the CDC has since recommended, a new monoclonal antibody called nirsevimab (Beyfortus) to prevent the worst effects of RSV. Nirsevimab is intended for all newborns under age 8 months who were born during the RSV season, or babies who will be entering that season before reaching 8 months. The injection is given only once and can act for 150 days. The FDA and CDC actions came following a clinical trial showing that nirsevimab lowers the risk for hospitalization from RSV among infants by more than 75%.

“We’re very excited that this product exists now,” Dr. Campbell said.
 

Chart reviews during the ‘tripledemic’

In fall 2022 the United States experienced a “tripledemic” of elevated hospitalizations for COVID-19, influenza, and RSV. For the new study, Dr. Halasa and her colleagues examined the medical records of 600 infants (under age 1; average age, 2.6 months) admitted to U.S. ICUs for lower respiratory tract infections caused by RSV from October to December 2022, during the height of the tripledemic. 

More than 60% of admissions, 361, were boys; 44% were White, 23% were Hispanic, 16% were Black, 10% were unknown race, 5% were multiple race, and 2% were Asian. 

Of the 600 infants, 572 (95.3%) required oxygen at the hospital and 487 (81.2%) had no underlying medical conditions linked to higher risk from RSV. The other infants had at least one ailment, such as a cardiac or lung condition, that could result in more severe RSV outcomes.

The 169 preemies in the study population were more likely to be intubated in the ICU than were those born at term. But 90 of the 143 total recorded intubations happened among full-term infants. Two children in the study group died.

Christopher Horvat, MD, MHA, who works in the pediatric ICU at the University of Pittsburgh Medical Center, called the new study “important,” adding that it shows “the RSV burden is substantial for children who are otherwise healthy.” Dr. Horvat, who was not involved in the work, said the new data highlight the value of preventive measures to prevent any repeat of the tripledemic.

On the same day the new study was published, the American Academy of Pediatrics (AAP) released a statement calling for widespread access to nirsevimab.

“The American Academy of Pediatrics recommends that all infants – and especially those at high risk – receive the new preventive antibody, nirsevimab, to protect against severe disease caused by respiratory syncytial virus (RSV), which is common, highly contagious, and sometimes deadly,” the organization said in a statement.

The AAP called for the CDC and the Centers for Medicaid & Medicare Services to work together to ensure that any parent in America can obtain nirsevimab for their children if needed. Anyone who cannot access nirsevimab this year, the AAP said, should rely on the older treatment palivizumab instead.

The sources in this story reported no relevant financial relationships.
 

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

The Food and Drug Administration has issued a warning letter to AstraZeneca over the pharmaceutical company’s advertising of the efficacy of a treatment for chronic obstructive pulmonary disease (COPD).

Promotional materials for the drug Breztri (budesonide/formoterol fumarate/glycopyrrolate inhaled) suggest that the drug has a positive effect on all-cause mortality for COPD patients, but the referenced clinical trial does not support that claim, the FDA letter states.

The FDA issued the warning letter on Aug. 4 and published the letter online on Aug. 15.

The sales aid highlights a 49% observed relative difference in time to all-cause mortality (ACM) over 1 year between Breztri and long-acting muscarinic antagonist/long-acting beta agonist (LAMA/LABA) inhalers.

Because of “statistical testing hierarchy failure” as well as confounding factors such as the removal of patients from inhaled corticosteroids (ICS) prior to entering the treatment arm of the trial, “no conclusions about the effect of Breztri on ACM can be drawn from the [clinical] trial,” the FDA wrote. “To date, no drug has been shown to improve ACM in COPD.”

The Breztri sales aid also states that there was a 20% reduction of severe exacerbations in patients using Breztri compared with patients using ICS/LABA. However, in the cited clinical trial, “the reduction in severe exacerbations was not statistically significant for patients treated with Breztri relative to comparator groups,” according to the FDA.

AstraZeneca has 15 working days from the receipt of the letter to respond in writing with “any plan for discontinuing use of such communications, or for ceasing distribution of Breztri,” the agency wrote.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration has issued a warning letter to AstraZeneca over the pharmaceutical company’s advertising of the efficacy of a treatment for chronic obstructive pulmonary disease (COPD).

Promotional materials for the drug Breztri (budesonide/formoterol fumarate/glycopyrrolate inhaled) suggest that the drug has a positive effect on all-cause mortality for COPD patients, but the referenced clinical trial does not support that claim, the FDA letter states.

The FDA issued the warning letter on Aug. 4 and published the letter online on Aug. 15.

The sales aid highlights a 49% observed relative difference in time to all-cause mortality (ACM) over 1 year between Breztri and long-acting muscarinic antagonist/long-acting beta agonist (LAMA/LABA) inhalers.

Because of “statistical testing hierarchy failure” as well as confounding factors such as the removal of patients from inhaled corticosteroids (ICS) prior to entering the treatment arm of the trial, “no conclusions about the effect of Breztri on ACM can be drawn from the [clinical] trial,” the FDA wrote. “To date, no drug has been shown to improve ACM in COPD.”

The Breztri sales aid also states that there was a 20% reduction of severe exacerbations in patients using Breztri compared with patients using ICS/LABA. However, in the cited clinical trial, “the reduction in severe exacerbations was not statistically significant for patients treated with Breztri relative to comparator groups,” according to the FDA.

AstraZeneca has 15 working days from the receipt of the letter to respond in writing with “any plan for discontinuing use of such communications, or for ceasing distribution of Breztri,” the agency wrote.
 

A version of this article appeared on Medscape.com.

The Food and Drug Administration has issued a warning letter to AstraZeneca over the pharmaceutical company’s advertising of the efficacy of a treatment for chronic obstructive pulmonary disease (COPD).

Promotional materials for the drug Breztri (budesonide/formoterol fumarate/glycopyrrolate inhaled) suggest that the drug has a positive effect on all-cause mortality for COPD patients, but the referenced clinical trial does not support that claim, the FDA letter states.

The FDA issued the warning letter on Aug. 4 and published the letter online on Aug. 15.

The sales aid highlights a 49% observed relative difference in time to all-cause mortality (ACM) over 1 year between Breztri and long-acting muscarinic antagonist/long-acting beta agonist (LAMA/LABA) inhalers.

Because of “statistical testing hierarchy failure” as well as confounding factors such as the removal of patients from inhaled corticosteroids (ICS) prior to entering the treatment arm of the trial, “no conclusions about the effect of Breztri on ACM can be drawn from the [clinical] trial,” the FDA wrote. “To date, no drug has been shown to improve ACM in COPD.”

The Breztri sales aid also states that there was a 20% reduction of severe exacerbations in patients using Breztri compared with patients using ICS/LABA. However, in the cited clinical trial, “the reduction in severe exacerbations was not statistically significant for patients treated with Breztri relative to comparator groups,” according to the FDA.

AstraZeneca has 15 working days from the receipt of the letter to respond in writing with “any plan for discontinuing use of such communications, or for ceasing distribution of Breztri,” the agency wrote.
 

A version of this article appeared on Medscape.com.

NEW YORK – Newer invasive procedures for gastroesophageal reflux disease (GERD) are associated with lower risks of postprocedural complications when performed to improve control of bronchiectasis or other serious lung diseases, according to a surgeon who addressed the 6th World Bronchiectasis & NTM Conference.

“The options are not what they were 20 or 30 years ago,” according to Tanuja Damani, MD, surgical director of the Center for Esophageal and Foregut Health, NYU Langone Health, New York.

The more favorable benefit-to-risk ratio of the newer options might make them more attractive to consider earlier for control of GERD in worsening lung disease than interventions have in the past, Dr. Damani suggested.

The association between the presence of GERD and increased severity of bronchiectasis or many other lung diseases is well established, according to Dr. Damani. In the case of bronchiectasis, GERD not only impairs lung function and quality of life, but is strongly linked to greater symptom burden, more exacerbations, more hospitalizations, and even increased mortality.

Proton pump inhibitors (PPIs) are effective in reducing intragastric acid, a source of irritation and discomfort when the contents of the stomach are refluxed past the lower esophageal sphincter (LES), but Dr. Damani explained that this therapy is often inadequate. Control of intragastric acid is an oversimplification of a more complex pathophysiology.

“It is not just the lower esophageal sphincter,” she said, explaining that other factors, particularly hiatal hernias that often contribute to transient LES relaxations, can play an important role in postprandial transit of gastric contents into the esophagus.

“Any procedure aimed at reinforcing just the LES [without addressing other mechanisms of GERD] are destined to fail,” Dr. Damani said.

She backed up this assertion with examples. These include the many endoscopic procedures designed to strengthen the barrier function of the LES, such as the Stretta procedure or transoral incisionless fundoplication (TIF). Neither addresses the hiatal hernia. Both typically provide immediate symptom relief, but acid in the lower esophagus and symptoms return over time. This has been shown with pH testing, which Dr. Damani called the gold standard for monitoring GERD control.

NEW YORK – Newer invasive procedures for gastroesophageal reflux disease (GERD) are associated with lower risks of postprocedural complications when performed to improve control of bronchiectasis or other serious lung diseases, according to a surgeon who addressed the 6th World Bronchiectasis & NTM Conference.

“The options are not what they were 20 or 30 years ago,” according to Tanuja Damani, MD, surgical director of the Center for Esophageal and Foregut Health, NYU Langone Health, New York.

The more favorable benefit-to-risk ratio of the newer options might make them more attractive to consider earlier for control of GERD in worsening lung disease than interventions have in the past, Dr. Damani suggested.

The association between the presence of GERD and increased severity of bronchiectasis or many other lung diseases is well established, according to Dr. Damani. In the case of bronchiectasis, GERD not only impairs lung function and quality of life, but is strongly linked to greater symptom burden, more exacerbations, more hospitalizations, and even increased mortality.

Proton pump inhibitors (PPIs) are effective in reducing intragastric acid, a source of irritation and discomfort when the contents of the stomach are refluxed past the lower esophageal sphincter (LES), but Dr. Damani explained that this therapy is often inadequate. Control of intragastric acid is an oversimplification of a more complex pathophysiology.

“It is not just the lower esophageal sphincter,” she said, explaining that other factors, particularly hiatal hernias that often contribute to transient LES relaxations, can play an important role in postprandial transit of gastric contents into the esophagus.

“Any procedure aimed at reinforcing just the LES [without addressing other mechanisms of GERD] are destined to fail,” Dr. Damani said.

She backed up this assertion with examples. These include the many endoscopic procedures designed to strengthen the barrier function of the LES, such as the Stretta procedure or transoral incisionless fundoplication (TIF). Neither addresses the hiatal hernia. Both typically provide immediate symptom relief, but acid in the lower esophagus and symptoms return over time. This has been shown with pH testing, which Dr. Damani called the gold standard for monitoring GERD control.

NEW YORK – Newer invasive procedures for gastroesophageal reflux disease (GERD) are associated with lower risks of postprocedural complications when performed to improve control of bronchiectasis or other serious lung diseases, according to a surgeon who addressed the 6th World Bronchiectasis & NTM Conference.

“The options are not what they were 20 or 30 years ago,” according to Tanuja Damani, MD, surgical director of the Center for Esophageal and Foregut Health, NYU Langone Health, New York.

The more favorable benefit-to-risk ratio of the newer options might make them more attractive to consider earlier for control of GERD in worsening lung disease than interventions have in the past, Dr. Damani suggested.

The association between the presence of GERD and increased severity of bronchiectasis or many other lung diseases is well established, according to Dr. Damani. In the case of bronchiectasis, GERD not only impairs lung function and quality of life, but is strongly linked to greater symptom burden, more exacerbations, more hospitalizations, and even increased mortality.

Proton pump inhibitors (PPIs) are effective in reducing intragastric acid, a source of irritation and discomfort when the contents of the stomach are refluxed past the lower esophageal sphincter (LES), but Dr. Damani explained that this therapy is often inadequate. Control of intragastric acid is an oversimplification of a more complex pathophysiology.

“It is not just the lower esophageal sphincter,” she said, explaining that other factors, particularly hiatal hernias that often contribute to transient LES relaxations, can play an important role in postprandial transit of gastric contents into the esophagus.

“Any procedure aimed at reinforcing just the LES [without addressing other mechanisms of GERD] are destined to fail,” Dr. Damani said.

She backed up this assertion with examples. These include the many endoscopic procedures designed to strengthen the barrier function of the LES, such as the Stretta procedure or transoral incisionless fundoplication (TIF). Neither addresses the hiatal hernia. Both typically provide immediate symptom relief, but acid in the lower esophagus and symptoms return over time. This has been shown with pH testing, which Dr. Damani called the gold standard for monitoring GERD control.

The utility of artificial intelligence in pulmonology has focused mainly on using image datasets to detect and diagnose lung malignancies, but now a growing number of AI models are emerging that apply machine learning to improve predictability for other pulmonary conditions, including pulmonary infections, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD).

These applications are moving beyond the traditional AI model of collecting data from a multitude of images to cast a wider data net that includes electronic health records.

Also on the horizon, ChatGPT technology is poised to have an impact. But pulmonologists and their practices have a number of barriers to clear before they feel a meaningful impact from AI.

The imperative, said AI researcher Ishanu Chattopadhyay, PhD, is to create transformative models that can detect lung disease early on. Dr. Chattopadhyay, an assistant professor of medicine at the University of Chicago and its Institute for Genomics and Systems Biology, and fellow researchers developed an AI algorithm that uses comorbidity signatures in electronic health records to screen for idiopathic pulmonary fibrosis (IPF) (Nature Med. 2022 Sep 29. doi: 10.1038/s41591-022-02010-y).

“If you could do this when somebody walks into a primary care setting and they are barely suspecting something is going on with them or when they don’t have the typical risk factors, there is a certain fraction of these people who do have IPF and they will almost invariably be diagnosed late and/or misdiagnosed,” Dr. Chattopadhyay said, citing a study that found 55% of patients with IPF have had at least one misdiagnosis and 38% have two or more misdiagnoses (BMC Pulm Med. 2018 Jan 17. doi: 10.1186/s12890-017-0560-x).

Harnessing massive data sets

AI models cull data sets, whether banks of radiographic images or files in an EHR, to extract telltale signatures of a disease state. Dr. Chattopadhyay and his team’s model used three databases with almost 3 million participants and 54,247 positive cases of IPF. Hospitals in Scotland have deployed what they’ve claimed are the first AI models to predict COPD built with 55,000 patient records from a regional National Health Service database. Another AI model for staging COPD, developed by researchers in the United States and Romania, used more than 18,000 medical records from 588 patients to identify physiological signals predictive of COPD (Advanced Sci. 2023 Feb 19. doi: 10.1002/advs.202203485).

Said Dr. Chattopadhyay: “If I can bring in AI which doesn’t just look at radiological images but actually gets it back where someone walks into primary care using only the information that is available at that point in the patient files and asking for nothing more, it raises a flag reliably that gets you a pulmonary referral that will hopefully reduce the misdiagnosis and late diagnosis.”

Victor Tseng, MD, medical director for pulmonology at Ansible Health in Mountain View, Calif., who’s researching the potential of AI in pulmonology, speculated on what functions AI can perform in the clinic. “I think you will start to see much more interventional sort of clinically patient care–facing applications,” he said. That would include acting as a triage layer to direct patient queries to a nurse, physician, or another practitioner, providing patient instructions, serving as therapeutic software, coordinating care, integrating supply chain issues,” he said.

 

AI vs. spirometry for COPD

Researchers in the United States and Romania, led by Paul Bogdan, PhD, at the University of Southern California Viterbi School of Engineering, developed a model that predicted COPD with an accuracy of almost 99% (98.66%) and avoids many of the shortcomings of spirometry, Dr. Bogdan said.

USC Viterbi School of Engineering

The models developed by Dr. Bogdan and collaborators use a different principle than existing AI platforms, Dr. Bogdan said. They analyze the properties of the data. As he explained it, they exploit what he called the “geometry of these data” to make inferences and decisions on a patient’s risk for COPD.

“Deep learning is very good for images, for videos, but it doesn’t work that well for signals,” said Mihai Udrescu, PhD, one of the Romanian collaborators. “But if we process the data with the technique brought up by Paul [Bogdan] and his team at USC, deep learning also works well on physiological signals.”

Dr. Paul Bogdan

Said Dr. Bogdan, “Nobody thought about using physiological signals to predict COPD before this work. They used spirometry, but spirometry is cumbersome and several steps have to be performed in order to have an accurate spirometry.” His team’s AI models extract and analyze risk data based on 10 minutes of monitoring.

This technology also has the potential to improve accessibility of COPD screening, Dr. Udrescu said. “It can democratize the access to the health care because you don’t need to travel for 100 or 200 miles to see a specialist,” he said. “You just send an app to the mobile phone of a patient, the person puts on a smart watch and wears it for a couple of minutes and the data is either recorded locally or is transmitted and it is analyzed.” The computations can be done locally and in a matter of minutes, he said.

In Scotland, a 12-month feasibility study is underway to evaluate an AI model to identify COPD patients at greatest risk for adverse events. A press release from Lenus, the company developing the technology, said the study will use a COPD multidisciplinary team to consider real-time AI model outputs to enable proactive patient encounters and reduce emergency care visits.

Researchers in Paris built an AI model that showed a 68% accuracy in distinguishing people with asthma from people with COPD in administrative medical databases (BMC Pulmon Med. 2022 Sep 20. doi: 10.1186/s12890-022-02144-2). They found that asthma patients were younger than those with COPD (a mean of 49.9 vs. 72.1 years) and that COPD occurred mostly in men (68% vs. 33%). And an international team of researchers reported that an AI model that used chest CT scans determined that ever-smokers with COPD who met the imaging criteria for bronchiectasis were more prone to disease exacerbations (Radiology. 2022 Dec 13. doi: 10.1148/radiol.221109). 

 

AI in idiopathic pulmonary fibrosis

The AI model that Dr. Chattopadhyay and collaborators developed had an 88% accuracy in predicting IPF. The model, known as the zero-burden comorbidity risk score for IPF (ZCoR-IPF), identified IPF cases in adults age 45 and older 1-4 years sooner than in a variety of pulmonology practice settings.

The model accounted for about 700 different features of IPF, Dr. Chattopadhyay said, but it deviated from standard AI risk models in that it used a machine learning algorithm to extract disease features that aren’t well understood or even known. “We do not know what all the risk factors of IPF are,” he said. “People who don’t have all the risk factors still get IPF. So we have to step back from the raw EHR data from where the features are being generated automatically, and then you can apply standard ML tools.”

Researchers at Nagoya University in Japan also reported on an AI algorithm for predicting IPF that used 646,800 high-resolution CT images and medical records data from 1,068 patients. Their algorithm had an average diagnostic accuracy of 83.6% and, they reported, demonstrated good accuracy even in patients with signs of interstitial pneumonia or who had surgical lung biopsies (Respirology. 2022 Dec 13. doi: 10.1111/resp.14310).

 

Chat GPT: The next frontier in AI

Dr. Tseng last year led a group of researchers that fed questions from the United States Medical Licensing Exam to a ChatGPT model, which found it answered 60%-65% of questions correctly (PLOS Digit Health. 2023 Feb 9. doi: 10.1371/journal.pdig.0000198). As Dr. Tseng pointed out, that’s good enough to get a medical license.

It may be a matter of time before ChatGPT technology finds its way into the clinic, Dr. Tseng said. A quick ChatGPT query of how it could be used in medicine yielded 12 different answers, from patient triage to providing basic first aid instructions in an emergency.

Dr. Tseng, who’s pulmonology practice places an emphasis on virtual care delivery, went deeper than the ChatGPT answer. “If you’re a respiratory therapist and you’re trying to execute a complicated medical care plan written by a physician, there’s a natural disconnect between our language and their language,” he said. “What we have found is that GPT has significantly harmonized the care plan. And that’s amazing because you end up with this single-stream understanding of the care plan, where the language is halfway between a bedside clinician, like the respiratory therapist or nurse, and is also something that a physician can understand and take the bigger sort of direction of care from.”

 

Barriers to AI in clinic

Numerous barriers face widespread adoption of AI tools in the clinic, Dr. Tseng said, including physician and staff anxiety about learning new technology. “AI tools, for all purposes, are supposed to allay the cognitive burden and the tedium burden on clinicians, but end up actually costing more time,” he said.

Health care organizations will also need to retool for AI, a group of medical informatics and digital health experts, led by Laurie Lovett Novak, PhD, reported (JAMIA Open. 2023 May 3. doi: 10.1093/jamiaopen/ooad028). But it’s coming nonetheless, Dr. Novak, an associate professor of biomedical informatics at Vanderbilt University Medical Center in Nashville, Tenn., said in an interview.

“In the near future, managers in clinics and inpatient units will be overseeing care that involves numerous AI-based technologies, including predictive analytics, imaging tools, language models, and others,” she said. “Organizations need to support managers by implementing capabilities for algorithmo-vigilance.”

That would include dealing with what she called “algorithmic drift” – when the accuracy of an AI model wanes because of changes in the underlying data – and ensuring that models are unbiased and aren’t used in a way that contributes to inequities in health care. “These new organizational capabilities will demand new tools and new competencies,” she said. That would include policies and processes drawing guidance from medical societies for legal and regulatory direction for managers, staff training, and software documentation.

Dr. Tseng envisioned how AI would work in the clinic. “I personally think that, at some time in the near future, AI-driven care coordination, where the AI basically handles appointment scheduling, patient motivation, patient engagement and acts as their health navigator, will be superior to any human health navigator on the whole, only for the reason that AI is indefatigable,” Dr. Tseng said. “It doesn’t get tired, it doesn’t get burned out, and these health navigation care coordination roles are notoriously difficult.”

The physicians and researchers interviewed for this report had no relevant relationships to disclose.

The utility of artificial intelligence in pulmonology has focused mainly on using image datasets to detect and diagnose lung malignancies, but now a growing number of AI models are emerging that apply machine learning to improve predictability for other pulmonary conditions, including pulmonary infections, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD).

These applications are moving beyond the traditional AI model of collecting data from a multitude of images to cast a wider data net that includes electronic health records.

Also on the horizon, ChatGPT technology is poised to have an impact. But pulmonologists and their practices have a number of barriers to clear before they feel a meaningful impact from AI.

The imperative, said AI researcher Ishanu Chattopadhyay, PhD, is to create transformative models that can detect lung disease early on. Dr. Chattopadhyay, an assistant professor of medicine at the University of Chicago and its Institute for Genomics and Systems Biology, and fellow researchers developed an AI algorithm that uses comorbidity signatures in electronic health records to screen for idiopathic pulmonary fibrosis (IPF) (Nature Med. 2022 Sep 29. doi: 10.1038/s41591-022-02010-y).

“If you could do this when somebody walks into a primary care setting and they are barely suspecting something is going on with them or when they don’t have the typical risk factors, there is a certain fraction of these people who do have IPF and they will almost invariably be diagnosed late and/or misdiagnosed,” Dr. Chattopadhyay said, citing a study that found 55% of patients with IPF have had at least one misdiagnosis and 38% have two or more misdiagnoses (BMC Pulm Med. 2018 Jan 17. doi: 10.1186/s12890-017-0560-x).

Harnessing massive data sets

AI models cull data sets, whether banks of radiographic images or files in an EHR, to extract telltale signatures of a disease state. Dr. Chattopadhyay and his team’s model used three databases with almost 3 million participants and 54,247 positive cases of IPF. Hospitals in Scotland have deployed what they’ve claimed are the first AI models to predict COPD built with 55,000 patient records from a regional National Health Service database. Another AI model for staging COPD, developed by researchers in the United States and Romania, used more than 18,000 medical records from 588 patients to identify physiological signals predictive of COPD (Advanced Sci. 2023 Feb 19. doi: 10.1002/advs.202203485).

Said Dr. Chattopadhyay: “If I can bring in AI which doesn’t just look at radiological images but actually gets it back where someone walks into primary care using only the information that is available at that point in the patient files and asking for nothing more, it raises a flag reliably that gets you a pulmonary referral that will hopefully reduce the misdiagnosis and late diagnosis.”

Victor Tseng, MD, medical director for pulmonology at Ansible Health in Mountain View, Calif., who’s researching the potential of AI in pulmonology, speculated on what functions AI can perform in the clinic. “I think you will start to see much more interventional sort of clinically patient care–facing applications,” he said. That would include acting as a triage layer to direct patient queries to a nurse, physician, or another practitioner, providing patient instructions, serving as therapeutic software, coordinating care, integrating supply chain issues,” he said.

 

AI vs. spirometry for COPD

Researchers in the United States and Romania, led by Paul Bogdan, PhD, at the University of Southern California Viterbi School of Engineering, developed a model that predicted COPD with an accuracy of almost 99% (98.66%) and avoids many of the shortcomings of spirometry, Dr. Bogdan said.

USC Viterbi School of Engineering

The models developed by Dr. Bogdan and collaborators use a different principle than existing AI platforms, Dr. Bogdan said. They analyze the properties of the data. As he explained it, they exploit what he called the “geometry of these data” to make inferences and decisions on a patient’s risk for COPD.

“Deep learning is very good for images, for videos, but it doesn’t work that well for signals,” said Mihai Udrescu, PhD, one of the Romanian collaborators. “But if we process the data with the technique brought up by Paul [Bogdan] and his team at USC, deep learning also works well on physiological signals.”

Dr. Paul Bogdan

Said Dr. Bogdan, “Nobody thought about using physiological signals to predict COPD before this work. They used spirometry, but spirometry is cumbersome and several steps have to be performed in order to have an accurate spirometry.” His team’s AI models extract and analyze risk data based on 10 minutes of monitoring.

This technology also has the potential to improve accessibility of COPD screening, Dr. Udrescu said. “It can democratize the access to the health care because you don’t need to travel for 100 or 200 miles to see a specialist,” he said. “You just send an app to the mobile phone of a patient, the person puts on a smart watch and wears it for a couple of minutes and the data is either recorded locally or is transmitted and it is analyzed.” The computations can be done locally and in a matter of minutes, he said.

In Scotland, a 12-month feasibility study is underway to evaluate an AI model to identify COPD patients at greatest risk for adverse events. A press release from Lenus, the company developing the technology, said the study will use a COPD multidisciplinary team to consider real-time AI model outputs to enable proactive patient encounters and reduce emergency care visits.

Researchers in Paris built an AI model that showed a 68% accuracy in distinguishing people with asthma from people with COPD in administrative medical databases (BMC Pulmon Med. 2022 Sep 20. doi: 10.1186/s12890-022-02144-2). They found that asthma patients were younger than those with COPD (a mean of 49.9 vs. 72.1 years) and that COPD occurred mostly in men (68% vs. 33%). And an international team of researchers reported that an AI model that used chest CT scans determined that ever-smokers with COPD who met the imaging criteria for bronchiectasis were more prone to disease exacerbations (Radiology. 2022 Dec 13. doi: 10.1148/radiol.221109). 

 

AI in idiopathic pulmonary fibrosis

The AI model that Dr. Chattopadhyay and collaborators developed had an 88% accuracy in predicting IPF. The model, known as the zero-burden comorbidity risk score for IPF (ZCoR-IPF), identified IPF cases in adults age 45 and older 1-4 years sooner than in a variety of pulmonology practice settings.

The model accounted for about 700 different features of IPF, Dr. Chattopadhyay said, but it deviated from standard AI risk models in that it used a machine learning algorithm to extract disease features that aren’t well understood or even known. “We do not know what all the risk factors of IPF are,” he said. “People who don’t have all the risk factors still get IPF. So we have to step back from the raw EHR data from where the features are being generated automatically, and then you can apply standard ML tools.”

Researchers at Nagoya University in Japan also reported on an AI algorithm for predicting IPF that used 646,800 high-resolution CT images and medical records data from 1,068 patients. Their algorithm had an average diagnostic accuracy of 83.6% and, they reported, demonstrated good accuracy even in patients with signs of interstitial pneumonia or who had surgical lung biopsies (Respirology. 2022 Dec 13. doi: 10.1111/resp.14310).

 

Chat GPT: The next frontier in AI

Dr. Tseng last year led a group of researchers that fed questions from the United States Medical Licensing Exam to a ChatGPT model, which found it answered 60%-65% of questions correctly (PLOS Digit Health. 2023 Feb 9. doi: 10.1371/journal.pdig.0000198). As Dr. Tseng pointed out, that’s good enough to get a medical license.

It may be a matter of time before ChatGPT technology finds its way into the clinic, Dr. Tseng said. A quick ChatGPT query of how it could be used in medicine yielded 12 different answers, from patient triage to providing basic first aid instructions in an emergency.

Dr. Tseng, who’s pulmonology practice places an emphasis on virtual care delivery, went deeper than the ChatGPT answer. “If you’re a respiratory therapist and you’re trying to execute a complicated medical care plan written by a physician, there’s a natural disconnect between our language and their language,” he said. “What we have found is that GPT has significantly harmonized the care plan. And that’s amazing because you end up with this single-stream understanding of the care plan, where the language is halfway between a bedside clinician, like the respiratory therapist or nurse, and is also something that a physician can understand and take the bigger sort of direction of care from.”

 

Barriers to AI in clinic

Numerous barriers face widespread adoption of AI tools in the clinic, Dr. Tseng said, including physician and staff anxiety about learning new technology. “AI tools, for all purposes, are supposed to allay the cognitive burden and the tedium burden on clinicians, but end up actually costing more time,” he said.

Health care organizations will also need to retool for AI, a group of medical informatics and digital health experts, led by Laurie Lovett Novak, PhD, reported (JAMIA Open. 2023 May 3. doi: 10.1093/jamiaopen/ooad028). But it’s coming nonetheless, Dr. Novak, an associate professor of biomedical informatics at Vanderbilt University Medical Center in Nashville, Tenn., said in an interview.

“In the near future, managers in clinics and inpatient units will be overseeing care that involves numerous AI-based technologies, including predictive analytics, imaging tools, language models, and others,” she said. “Organizations need to support managers by implementing capabilities for algorithmo-vigilance.”

That would include dealing with what she called “algorithmic drift” – when the accuracy of an AI model wanes because of changes in the underlying data – and ensuring that models are unbiased and aren’t used in a way that contributes to inequities in health care. “These new organizational capabilities will demand new tools and new competencies,” she said. That would include policies and processes drawing guidance from medical societies for legal and regulatory direction for managers, staff training, and software documentation.

Dr. Tseng envisioned how AI would work in the clinic. “I personally think that, at some time in the near future, AI-driven care coordination, where the AI basically handles appointment scheduling, patient motivation, patient engagement and acts as their health navigator, will be superior to any human health navigator on the whole, only for the reason that AI is indefatigable,” Dr. Tseng said. “It doesn’t get tired, it doesn’t get burned out, and these health navigation care coordination roles are notoriously difficult.”

The physicians and researchers interviewed for this report had no relevant relationships to disclose.

The utility of artificial intelligence in pulmonology has focused mainly on using image datasets to detect and diagnose lung malignancies, but now a growing number of AI models are emerging that apply machine learning to improve predictability for other pulmonary conditions, including pulmonary infections, pulmonary fibrosis, and chronic obstructive pulmonary disease (COPD).

These applications are moving beyond the traditional AI model of collecting data from a multitude of images to cast a wider data net that includes electronic health records.

Also on the horizon, ChatGPT technology is poised to have an impact. But pulmonologists and their practices have a number of barriers to clear before they feel a meaningful impact from AI.

The imperative, said AI researcher Ishanu Chattopadhyay, PhD, is to create transformative models that can detect lung disease early on. Dr. Chattopadhyay, an assistant professor of medicine at the University of Chicago and its Institute for Genomics and Systems Biology, and fellow researchers developed an AI algorithm that uses comorbidity signatures in electronic health records to screen for idiopathic pulmonary fibrosis (IPF) (Nature Med. 2022 Sep 29. doi: 10.1038/s41591-022-02010-y).

“If you could do this when somebody walks into a primary care setting and they are barely suspecting something is going on with them or when they don’t have the typical risk factors, there is a certain fraction of these people who do have IPF and they will almost invariably be diagnosed late and/or misdiagnosed,” Dr. Chattopadhyay said, citing a study that found 55% of patients with IPF have had at least one misdiagnosis and 38% have two or more misdiagnoses (BMC Pulm Med. 2018 Jan 17. doi: 10.1186/s12890-017-0560-x).

Harnessing massive data sets

AI models cull data sets, whether banks of radiographic images or files in an EHR, to extract telltale signatures of a disease state. Dr. Chattopadhyay and his team’s model used three databases with almost 3 million participants and 54,247 positive cases of IPF. Hospitals in Scotland have deployed what they’ve claimed are the first AI models to predict COPD built with 55,000 patient records from a regional National Health Service database. Another AI model for staging COPD, developed by researchers in the United States and Romania, used more than 18,000 medical records from 588 patients to identify physiological signals predictive of COPD (Advanced Sci. 2023 Feb 19. doi: 10.1002/advs.202203485).

Said Dr. Chattopadhyay: “If I can bring in AI which doesn’t just look at radiological images but actually gets it back where someone walks into primary care using only the information that is available at that point in the patient files and asking for nothing more, it raises a flag reliably that gets you a pulmonary referral that will hopefully reduce the misdiagnosis and late diagnosis.”

Victor Tseng, MD, medical director for pulmonology at Ansible Health in Mountain View, Calif., who’s researching the potential of AI in pulmonology, speculated on what functions AI can perform in the clinic. “I think you will start to see much more interventional sort of clinically patient care–facing applications,” he said. That would include acting as a triage layer to direct patient queries to a nurse, physician, or another practitioner, providing patient instructions, serving as therapeutic software, coordinating care, integrating supply chain issues,” he said.

 

AI vs. spirometry for COPD

Researchers in the United States and Romania, led by Paul Bogdan, PhD, at the University of Southern California Viterbi School of Engineering, developed a model that predicted COPD with an accuracy of almost 99% (98.66%) and avoids many of the shortcomings of spirometry, Dr. Bogdan said.

USC Viterbi School of Engineering

The models developed by Dr. Bogdan and collaborators use a different principle than existing AI platforms, Dr. Bogdan said. They analyze the properties of the data. As he explained it, they exploit what he called the “geometry of these data” to make inferences and decisions on a patient’s risk for COPD.

“Deep learning is very good for images, for videos, but it doesn’t work that well for signals,” said Mihai Udrescu, PhD, one of the Romanian collaborators. “But if we process the data with the technique brought up by Paul [Bogdan] and his team at USC, deep learning also works well on physiological signals.”

Dr. Paul Bogdan

Said Dr. Bogdan, “Nobody thought about using physiological signals to predict COPD before this work. They used spirometry, but spirometry is cumbersome and several steps have to be performed in order to have an accurate spirometry.” His team’s AI models extract and analyze risk data based on 10 minutes of monitoring.

This technology also has the potential to improve accessibility of COPD screening, Dr. Udrescu said. “It can democratize the access to the health care because you don’t need to travel for 100 or 200 miles to see a specialist,” he said. “You just send an app to the mobile phone of a patient, the person puts on a smart watch and wears it for a couple of minutes and the data is either recorded locally or is transmitted and it is analyzed.” The computations can be done locally and in a matter of minutes, he said.

In Scotland, a 12-month feasibility study is underway to evaluate an AI model to identify COPD patients at greatest risk for adverse events. A press release from Lenus, the company developing the technology, said the study will use a COPD multidisciplinary team to consider real-time AI model outputs to enable proactive patient encounters and reduce emergency care visits.

Researchers in Paris built an AI model that showed a 68% accuracy in distinguishing people with asthma from people with COPD in administrative medical databases (BMC Pulmon Med. 2022 Sep 20. doi: 10.1186/s12890-022-02144-2). They found that asthma patients were younger than those with COPD (a mean of 49.9 vs. 72.1 years) and that COPD occurred mostly in men (68% vs. 33%). And an international team of researchers reported that an AI model that used chest CT scans determined that ever-smokers with COPD who met the imaging criteria for bronchiectasis were more prone to disease exacerbations (Radiology. 2022 Dec 13. doi: 10.1148/radiol.221109). 

 

AI in idiopathic pulmonary fibrosis

The AI model that Dr. Chattopadhyay and collaborators developed had an 88% accuracy in predicting IPF. The model, known as the zero-burden comorbidity risk score for IPF (ZCoR-IPF), identified IPF cases in adults age 45 and older 1-4 years sooner than in a variety of pulmonology practice settings.

The model accounted for about 700 different features of IPF, Dr. Chattopadhyay said, but it deviated from standard AI risk models in that it used a machine learning algorithm to extract disease features that aren’t well understood or even known. “We do not know what all the risk factors of IPF are,” he said. “People who don’t have all the risk factors still get IPF. So we have to step back from the raw EHR data from where the features are being generated automatically, and then you can apply standard ML tools.”

Researchers at Nagoya University in Japan also reported on an AI algorithm for predicting IPF that used 646,800 high-resolution CT images and medical records data from 1,068 patients. Their algorithm had an average diagnostic accuracy of 83.6% and, they reported, demonstrated good accuracy even in patients with signs of interstitial pneumonia or who had surgical lung biopsies (Respirology. 2022 Dec 13. doi: 10.1111/resp.14310).

 

Chat GPT: The next frontier in AI

Dr. Tseng last year led a group of researchers that fed questions from the United States Medical Licensing Exam to a ChatGPT model, which found it answered 60%-65% of questions correctly (PLOS Digit Health. 2023 Feb 9. doi: 10.1371/journal.pdig.0000198). As Dr. Tseng pointed out, that’s good enough to get a medical license.

It may be a matter of time before ChatGPT technology finds its way into the clinic, Dr. Tseng said. A quick ChatGPT query of how it could be used in medicine yielded 12 different answers, from patient triage to providing basic first aid instructions in an emergency.

Dr. Tseng, who’s pulmonology practice places an emphasis on virtual care delivery, went deeper than the ChatGPT answer. “If you’re a respiratory therapist and you’re trying to execute a complicated medical care plan written by a physician, there’s a natural disconnect between our language and their language,” he said. “What we have found is that GPT has significantly harmonized the care plan. And that’s amazing because you end up with this single-stream understanding of the care plan, where the language is halfway between a bedside clinician, like the respiratory therapist or nurse, and is also something that a physician can understand and take the bigger sort of direction of care from.”

 

Barriers to AI in clinic

Numerous barriers face widespread adoption of AI tools in the clinic, Dr. Tseng said, including physician and staff anxiety about learning new technology. “AI tools, for all purposes, are supposed to allay the cognitive burden and the tedium burden on clinicians, but end up actually costing more time,” he said.

Health care organizations will also need to retool for AI, a group of medical informatics and digital health experts, led by Laurie Lovett Novak, PhD, reported (JAMIA Open. 2023 May 3. doi: 10.1093/jamiaopen/ooad028). But it’s coming nonetheless, Dr. Novak, an associate professor of biomedical informatics at Vanderbilt University Medical Center in Nashville, Tenn., said in an interview.

“In the near future, managers in clinics and inpatient units will be overseeing care that involves numerous AI-based technologies, including predictive analytics, imaging tools, language models, and others,” she said. “Organizations need to support managers by implementing capabilities for algorithmo-vigilance.”

That would include dealing with what she called “algorithmic drift” – when the accuracy of an AI model wanes because of changes in the underlying data – and ensuring that models are unbiased and aren’t used in a way that contributes to inequities in health care. “These new organizational capabilities will demand new tools and new competencies,” she said. That would include policies and processes drawing guidance from medical societies for legal and regulatory direction for managers, staff training, and software documentation.

Dr. Tseng envisioned how AI would work in the clinic. “I personally think that, at some time in the near future, AI-driven care coordination, where the AI basically handles appointment scheduling, patient motivation, patient engagement and acts as their health navigator, will be superior to any human health navigator on the whole, only for the reason that AI is indefatigable,” Dr. Tseng said. “It doesn’t get tired, it doesn’t get burned out, and these health navigation care coordination roles are notoriously difficult.”

The physicians and researchers interviewed for this report had no relevant relationships to disclose.